Science.gov

Sample records for additional safety risks

  1. Risk assessment for safety

    NASA Astrophysics Data System (ADS)

    Hadlock, Charles R.; Glaser, Peter E.

    The application of probabilistic risk-assessment techniques to space missions is discussed, with a focus on the International Space Station. The types of hazards likely to be caused by random events; design, operational, and management errors; and intentional intervention are examined along with their secondary effects; and the top-level safety requirements defined by NASA are considered. It is suggested that such qualitative stipulations be supplemented with more quantitative measures such as used in the nuclear-power industry; the major features of such quantitative methods are reviewed.

  2. [Safety of food additives in Japan].

    PubMed

    Ito, Sumio

    2011-01-01

    Recently, many accidents relating to food happened in Japan. The consumer's distrust for food, food companies, and the administration is increasing. The consumer especially has an extreme refusal feeling for chemicals such as food additives and agricultural chemicals, and begins to request agricultural chemical-free vegetables and food additive-free food. Food companies also state no agricultural chemicals and no food additives to correspond with consumers' request and aim at differentiating. The food additive is that the Ministry of Health, Labour and Welfare specifies the one that person's health might not be ruined by providing for Food Sanitation Law Article 10 in our country. The standard for food additives and standard for use of food additives are provided according to regulations of Food Sanitation Law Article 11. Therefore, it is thought that the food additive used is safe now. Then, it reports on the procedure and the safety examination, etc. in our country for designation for food additive this time.

  3. Safety optimization through risk management

    NASA Astrophysics Data System (ADS)

    Wright, K.; Peltonen, P.

    The paper discusses the overall process of system safety optimization in the space program environment and addresses in particular methods that enhance the efficiency of this activity. Effective system safety optimization is achieved by concentrating the available engineering and safety assurance resouces on the main risk contributors. The qualitative risk contributor identification by means of the hazard analyses and the FMECA constitute the basis for the system safety process. The risk contributors are ranked firstly on a qualitative basis according to the consequence severities. This ranking is then refined by mishap propagation/recovery time considerations and by probabilistic means (PRA). Finally, in order to broaden and extend the use of risk contributor ranking as a managerial tool in project resource assignment, quality, manufacturing and operations related critical characteristics, i.e. risk influencing factors, are identified for managerial visibility.

  4. [Risk management and patient safety].

    PubMed

    Lessing, C

    2009-06-01

    Risk management and patient safety are of indisputable importance for the quality of health care. At the same time they confront all professional groups in the health system with high demands. The Action Alliance for Patient Safety inc. wants to demonstrate ways in which measures for avoiding errors and improving safety can reach the healthcare practice. Interdisciplinary cooperation and the availability of mutually developed materials are the maxims of the work of the society.

  5. Science and Safety: 'Acceptable' Risk

    ERIC Educational Resources Information Center

    Science News, 1976

    1976-01-01

    Stresses ways to answer questions related to widespread publicity - are nuclear reactors safe, will dangerous research in genetic manipulation be banned? - with emphasis on true meaning of safety as related to risks. (EB)

  6. 47 CFR 36.605 - Calculation of safety net additive.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 2 2010-10-01 2010-10-01 false Calculation of safety net additive. 36.605... § 36.605 Calculation of safety net additive. (a) “Safety net additive support.” A rural incumbent local exchange carrier shall receive safety net additive support if it satisfies the conditions set forth...

  7. Safety risk management for ESA space systems

    NASA Astrophysics Data System (ADS)

    Wright, K. M.

    1991-08-01

    ESA's safety program as defined in ESA PSS-01-40, system safety requirements for ESA space systems, comprise the systematic identification and evaluation of space system hazardous characteristics and their associated risks, together with a process of safety optimization through hazard and risk reduction, and implementation verification. This safety optimization and verification process is termed safety risk management. The fundamental principles of safety risk management are discussed.

  8. 14 CFR 437.77 - Additional safety requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Additional safety requirements. 437.77..., DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety requirements. The FAA may impose additional safety requirements on an applicant or permittee proposing...

  9. 14 CFR 437.77 - Additional safety requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Additional safety requirements. 437.77..., DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety requirements. The FAA may impose additional safety requirements on an applicant or permittee proposing...

  10. 14 CFR 437.77 - Additional safety requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Additional safety requirements. 437.77..., DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety requirements. The FAA may impose additional safety requirements on an applicant or permittee proposing...

  11. 14 CFR 437.77 - Additional safety requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Additional safety requirements. 437.77..., DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety requirements. The FAA may impose additional safety requirements on an applicant or permittee proposing...

  12. 14 CFR 437.77 - Additional safety requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Additional safety requirements. 437.77..., DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety requirements. The FAA may impose additional safety requirements on an applicant or permittee proposing...

  13. Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

    NASA Technical Reports Server (NTRS)

    Hill, Janice; Victor, Daniel

    2008-01-01

    When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

  14. Risk control and food safety

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The 11th International Symposium on Toxic Microorganisms of the Joint Panel on Toxic Microorganisms, US-Japan Cooperative Program on Development and Utilization of Natural Resources (UJNR), was held March 4-9, 2012 in Tokyo, Japan. Having the theme "Risk Control and Food Safety," it was the most re...

  15. Risk and safety of probiotics.

    PubMed

    Doron, Shira; Snydman, David R

    2015-05-15

    Probiotics have been used safely for years. Safety outcomes are inconsistently reported in published clinical trials. In 2011, a report released by the Agency for Healthcare Research and Quality concluded that, although the existing probiotic clinical trials reveal no evidence of increased risk, "the current literature is not well equipped to answer questions on the safety of probiotics in intervention studies with confidence." Critics point out that the preponderance of evidence, including the long history of safe probiotic use as well as data from clinical trials, and animal and in vitro studies all support the assumption that probiotics are generally safe for most populations. Theoretical risks have been described in case reports, clinical trial results and experimental models, include systemic infections, deleterious metabolic activities, excessive immune stimulation in susceptible individuals, gene transfer and gastrointestinal side effects. More research is needed to properly describe the incidence and severity of adverse events related to probiotics.

  16. Risk-based Spacecraft Fire Safety Experiments

    NASA Technical Reports Server (NTRS)

    Apostolakis, G.; Catton, I.; Issacci, F.; Paulos, T.; Jones, S.; Paxton, K.; Paul, M.

    1992-01-01

    Viewgraphs on risk-based spacecraft fire safety experiments are presented. Spacecraft fire risk can never be reduced to a zero probability. Probabilistic risk assessment is a tool to reduce risk to an acceptable level.

  17. 49 CFR 192.171 - Compressor stations: Additional safety equipment.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 3 2013-10-01 2013-10-01 false Compressor stations: Additional safety equipment...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Design...

  18. 49 CFR 192.171 - Compressor stations: Additional safety equipment.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Compressor stations: Additional safety equipment...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Design...

  19. 49 CFR 192.171 - Compressor stations: Additional safety equipment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 3 2010-10-01 2010-10-01 false Compressor stations: Additional safety equipment...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Design...

  20. Environment, Safety, and Health Risk Assessment Program (ESHRAP)

    SciTech Connect

    Eide, Steven Arvid; Thomas Wierman

    2003-12-01

    The Environment, Safety and Health Risk Assessment Program (ESHRAP) models human safety and health risk resulting from waste management and environmental restoration activities. Human safety and health risks include those associated with storing, handling, processing, transporting, and disposing of radionuclides and chemicals. Exposures to these materials, resulting from both accidents and normal, incident-free operation, are modeled. In addition, standard industrial risks (falls, explosions, transportation accidents, etc.) are evaluated. Finally, human safety and health impacts from cleanup of accidental releases of radionuclides and chemicals to the environment are estimated. Unlike environmental impact statements and safety analysis reports, ESHRAP risk predictions are meant to be best estimate, rather than bounding or conservatively high. Typically, ESHRAP studies involve risk predictions covering the entire waste management or environmental restoration program, including such activities as initial storage, handling, processing, interim storage, transportation, and final disposal. ESHRAP can be used to support complex environmental decision-making processes and to track risk reduction as activities progress.

  1. Software Safety Risk in Legacy Safety-Critical Computer Systems

    NASA Technical Reports Server (NTRS)

    Hill, Janice; Baggs, Rhoda

    2007-01-01

    Safety-critical computer systems must be engineered to meet system and software safety requirements. For legacy safety-critical computer systems, software safety requirements may not have been formally specified during development. When process-oriented software safety requirements are levied on a legacy system after the fact, where software development artifacts don't exist or are incomplete, the question becomes 'how can this be done?' The risks associated with only meeting certain software safety requirements in a legacy safety-critical computer system must be addressed should such systems be selected as candidates for reuse. This paper proposes a method for ascertaining formally, a software safety risk assessment, that provides measurements for software safety for legacy systems which may or may not have a suite of software engineering documentation that is now normally required. It relies upon the NASA Software Safety Standard, risk assessment methods based upon the Taxonomy-Based Questionnaire, and the application of reverse engineering CASE tools to produce original design documents for legacy systems.

  2. Socioeconomic Considerations in Dam Safety Risk Analysis.

    DTIC Science & Technology

    1987-06-01

    The analytical review and summary critique of literature related to risk analysis was conducted for the purpose of highlighting those ideas, concepts...alternative solutions. The critique of the philosophical and analytical bases of risk analysis as further directed toward the specific problem of dam...safety risk analysis . Dam safety is unique in that it represents an extreme situation characteristic of low probability/high consequence event

  3. Public risk perception of food additives and food scares. The case in Suzhou, China.

    PubMed

    Wu, Linhai; Zhong, Yingqi; Shan, Lijie; Qin, Wei

    2013-11-01

    This study examined the factors affecting public risk perception of food additive safety and possible resulting food scares using a survey conducted in Suzhou, Jiangsu Province, China. The model was proposed based on literature relating to the role of risk perception and information perception of public purchase intention under food scares. Structural equation modeling (SEM) was used for data analysis. The results showed that attitude towards behavior, subjective norm and information perception exerted moderate to high effect on food scares, and the effects were also mediated by risk perceptions of additive safety. Significant covariance was observed between attitudes toward behavior, subjective norm and information perception. Establishing an effective mechanism of food safety risk communication, releasing information of government supervision on food safety in a timely manner, curbing misleading media reports on public food safety risk, and enhancing public knowledge of the food additives are key to the development and implementation of food safety risk management policies by the Chinese government.

  4. 9. BUILDING 65 ADDITION. LASER SAFETY TEAM. FLOOR PLAN, ELEVATIONS, ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    9. BUILDING 65 ADDITION. LASER SAFETY TEAM. FLOOR PLAN, ELEVATIONS, ETC. March 21, 1973 - Frankford Arsenal, Building No. 65, South of Tacony Street between Bridge Street & tracks of former Pennsylvania Railroad, Philadelphia, Philadelphia County, PA

  5. 47 CFR 54.1304 - Calculation of safety net additive.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... additive unless the carrier's realized total growth in Telecommunications Plant in Service (TPIS) was more... (CONTINUED) UNIVERSAL SERVICE High Cost Loop Support for Rate-of-Return Carriers § 54.1304 Calculation of..., a rate-of-return incumbent local exchange carrier shall receive safety net additive support...

  6. Flight Safety Aircraft Risk: A Growing Problem

    NASA Astrophysics Data System (ADS)

    Haber, J. M.

    2012-01-01

    In recent years there has been a growing awareness of the need to have appropriate criteria for protection of aircraft from debris resulting from the flight termination of a malfunctioning space booster. There have been several sequences of events that have interacted to bring us to the current risk management problem. With the advent of the US initiative to have common flight safety analysis processes and criteria, it was recognized that the traditional aircraft protection approach was inadequate. It did not consider the added public concern for catastrophic events. While the probability may have been small for downing a large commercial passenger plane, the public outrage if it happened would not be adequately measured by the individual risk to passengers nor the collective (societal risk) presented by a single airplane. Over a period of a number of years the US has developed and evolved a criterion to address catastrophic risk protection. Beginning in the same time period, it was recognized the assertion that all debris with masses greater than one gram were lethal to aircraft was unduly conservative. Over this same period initiatives have been developed to refine aircraft vulnerability models. There were, however, two significant unconservative assumptions that were made in the early years. It was presumed that significant risk to aircraft could only occur in the launch area. In addition, aircraft risk assessments, when they were made were based on debris lists designed to protect people on the ground (typically debris with an impact kinetic energy greater than 11 ft-lb). Good debris lists for aircraft protection do not yet exist. However, it has become increasingly clear that even with partial breakup lists large regions were required from which aircraft flight would be restricted using the normal exclusion approaches. We provide a review of these events and an indication of the way forward.

  7. Risk-Based Explosive Safety Analysis

    DTIC Science & Technology

    2016-11-30

    safety siting of energetic liquids and propellants can be greatly aided by the use of risk-based methodologies. The low probability of exposed...of energetic liquids and propellants can be greatly aided by the use of risk-based methodologies. The low probability of exposed personnel and the

  8. Occupational safety risk management in Australian mining.

    PubMed

    Joy, J

    2004-08-01

    In the past 15 years, there has been a major safety improvement in the Australian mining industry. Part of this change can be attributed to the development and application of risk assessment methods. These systematic, team-based techniques identify, assess and control unacceptable risks to people, assets, the environment and production. The outcomes have improved mine management systems. This paper discusses the risk assessment approach applied to equipment design and mining operations, as well as the specific risk assessment methodology. The paper also discusses the reactive side of risk management, incident and accident investigation. Systematic analytical methods have also been adopted by regulatory authorities and mining companies to investigate major losses.

  9. Risks associated with endotoxins in feed additives produced by fermentation.

    PubMed

    Wallace, R John; Gropp, Jürgen; Dierick, Noël; Costa, Lucio G; Martelli, Giovanna; Brantom, Paul G; Bampidis, Vasileios; Renshaw, Derek W; Leng, Lubomir

    2016-01-15

    Increasingly, feed additives for livestock, such as amino acids and vitamins, are being produced by Gram-negative bacteria, particularly Escherichia coli. The potential therefore exists for animals, consumers and workers to be exposed to possibly harmful amounts of endotoxin from these products. The aim of this review was to assess the extent of the risk from endotoxins in feed additives and to calculate how such risk can be assessed from the properties of the additive. Livestock are frequently exposed to a relatively high content of endotoxin in the diet: no additional hazard to livestock would be anticipated if the endotoxin concentration of the feed additive falls in the same range as feedstuffs. Consumer exposure will be unaffected by the consumption of food derived from animals receiving endotoxin-containing feed, because the small concentrations of endotoxin absorbed do not accumulate in edible tissues. In contrast, workers processing a dusty additive may be exposed to hazardous amounts of endotoxin even if the endotoxin concentration of the product is low. A calculation method is proposed to compare the potential risk to the worker, based on the dusting potential, the endotoxin concentration and technical guidance of the European Food Safety Authority, with national exposure limits.

  10. HANFORD SAFETY ANALYSIS & RISK ASSESSMENT HANDBOOK (SARAH)

    SciTech Connect

    EVANS, C B

    2004-12-21

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

  11. Laser safety: Risks, hazards, and control measures

    PubMed Central

    Smalley, Penny J.

    2011-01-01

    Now that laser technology has emerged from hospital operating rooms, and has become available to office practices, clinics, and private enterprises, the burden of responsibility for safety has shifted from hospital staff to the individual user, often without benefit of appropriate or adequate resources. What remains, regardless of the practice site, application, or system in use, is the constant goal of establishing and maintaining a laser safe environment for the patient, the staff, and the user, at all times. This should be the goal of all who are involved with the sale, purchase, application, and management of all medical laser systems–under all circumstances. Laser safety is EVERYONE'S concern! A laser is as safe or as hazardous as the user–and that user's knowledge and skill, defines how well laser safety is managed. Of all hazards, complacency is the most dangerous, and it is imperative to develop a risk management perspective on laser safety. Proper safety management requires a fourfold approach including: knowledge of standards, identification of hazards and risks, implementation of appropriate control measures, and consistent program audit to demonstrate quality assurance. PMID:24155518

  12. Food safety risks and consumer health.

    PubMed

    Chassy, Bruce M

    2010-11-30

    The major food safety risks are not eating a healthy diet, and failure to avoid foodborne illness. Over one billion people in the world suffer from food insecurity and malnutrition. Nutritionally enhanced transgenic crops such as Golden Rice are one potential strategy for reducing malnutrition in the world. Transgenic crops are subjected to a rigorous pre-market safety assessment. The safety of novel proteins and other products is established, and through compositional analysis and animal studies, the safety of any observed changes is evaluated. These studies provide evidence that the new product is as safe as, or safer than, comparable varieties. It must be asked, however, if this rigorous analysis is necessary, because unregulated crops produced by other breeding methods also undergo genetic changes and contain unintended effects. Golden Rice poses infinitesimally small, if any, risk to consumers whilst it has the potential to spare millions of lives each year. However, because it is a transgenic crop, it cannot be deployed without years of expensive pre-market safety review. Paradoxically, if Golden Rice had been produced by less precise conventional methods of breeding, it would already be in the hands of poor farmers. It is concluded that the hyper-precautionary regulatory process applied to transgenic crops works to the extreme disadvantage of the hungry and the poor.

  13. Risk informed resource allocation policy: safety can save costs.

    PubMed

    Pasman, H J

    2000-01-07

    During economic doldrums, decision making on investments for safety is even more difficult than it already is when funds are abundant. This paper attempts to offer some guidance. After stating the present challenge to prevention of losses in the process industries, the systematic approach of quantified risk assessment is briefly reviewed and improvements in the methodology are mentioned. In addition, attention is given to the use of a risk matrix to survey a plant and to derive a plan of action. Subsequently, the reduction of risk is reviewed. Measures for prevention, protection, and mitigation are discussed. The organization of safety has become at least as important as technical safety of equipment and standards. It is reflected in the introduction of a safety management system. Furthermore, the design process in a pro-active approach is described and the concept of inherent safety is briefly addressed. The concept of Layer of Protection Analysis is explained and also the reason why it is relevant to provide a cost-benefit analysis. Finally, after comments regarding the cost of accidents, the basics of costing and profitability are summarized and a way is suggested to apply this approach to risk-reducing measures. An example is provided on how a selection can be made from a number of alternatives.

  14. Risk Informed Margins Management as part of Risk Informed Safety Margin Characterization

    SciTech Connect

    Curtis Smith

    2014-06-01

    The ability to better characterize and quantify safety margin is important to improved decision making about Light Water Reactor (LWR) design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margin management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. In addition, as research and development in the LWR Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. To support decision making related to economics, readability, and safety, the Risk Informed Safety Margin Characterization (RISMC) Pathway provides methods and tools that enable mitigation options known as risk informed margins management (RIMM) strategies.

  15. RISK-INFORMED SAFETY MARGIN CHARACTERIZATION

    SciTech Connect

    Nam Dinh; Ronaldo Szilard

    2009-07-01

    The concept of safety margins has served as a fundamental principle in the design and operation of commercial nuclear power plants (NPPs). Defined as the minimum distance between a system’s “loading” and its “capacity”, plant design and operation is predicated on ensuring an adequate safety margin for safety-significant parameters (e.g., fuel cladding temperature, containment pressure, etc.) is provided over the spectrum of anticipated plant operating, transient and accident conditions. To meet the anticipated challenges associated with extending the operational lifetimes of the current fleet of operating NPPs, the United States Department of Energy (USDOE), the Idaho National Laboratory (INL) and the Electric Power Research Institute (EPRI) have developed a collaboration to conduct coordinated research to identify and address the technological challenges and opportunities that likely would affect the safe and economic operation of the existing NPP fleet over the postulated long-term time horizons. In this paper we describe a framework for developing and implementing a Risk-Informed Safety Margin Characterization (RISMC) approach to evaluate and manage changes in plant safety margins over long time horizons.

  16. Evaluation of residue drum storage safety risks

    SciTech Connect

    Conner, W.V.

    1994-06-17

    A study was conducted to determine if any potential safety problems exist in the residue drum backlog at the Rocky Flats Plant. Plutonium residues stored in 55-gallon drums were packaged for short-term storage until the residues could be processed for plutonium recovery. These residues have now been determined by the Department of Energy to be waste materials, and the residues will remain in storage until plans for disposal of the material can be developed. The packaging configurations which were safe for short-term storage may not be safe for long-term storage. Interviews with Rocky Flats personnel involved with packaging the residues reveal that more than one packaging configuration was used for some of the residues. A tabulation of packaging configurations was developed based on the information obtained from the interviews. A number of potential safety problems were identified during this study, including hydrogen generation from some residues and residue packaging materials, contamination containment loss, metal residue packaging container corrosion, and pyrophoric plutonium compound formation. Risk factors were developed for evaluating the risk potential of the various residue categories, and the residues in storage at Rocky Flats were ranked by risk potential. Preliminary drum head space gas sampling studies have demonstrated the potential for formation of flammable hydrogen-oxygen mixtures in some residue drums.

  17. 46 CFR 308.104 - Additional war risk insurance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 8 2010-10-01 2010-10-01 false Additional war risk insurance. 308.104 Section 308.104 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Hull and Disbursements Insurance § 308.104 Additional war risk insurance. Owners or charterers...

  18. 46 CFR 308.104 - Additional war risk insurance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 8 2014-10-01 2014-10-01 false Additional war risk insurance. 308.104 Section 308.104 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Hull and Disbursements Insurance § 308.104 Additional war risk insurance. Owners or charterers...

  19. 46 CFR 308.104 - Additional war risk insurance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 8 2011-10-01 2011-10-01 false Additional war risk insurance. 308.104 Section 308.104 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Hull and Disbursements Insurance § 308.104 Additional war risk insurance. Owners or charterers...

  20. 46 CFR 308.104 - Additional war risk insurance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 8 2012-10-01 2012-10-01 false Additional war risk insurance. 308.104 Section 308.104 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Hull and Disbursements Insurance § 308.104 Additional war risk insurance. Owners or charterers...

  1. 46 CFR 308.104 - Additional war risk insurance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 8 2013-10-01 2013-10-01 false Additional war risk insurance. 308.104 Section 308.104 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Hull and Disbursements Insurance § 308.104 Additional war risk insurance. Owners or charterers...

  2. Software Safety Risk in Legacy Safety-Critical Computer Systems

    NASA Technical Reports Server (NTRS)

    Hill, Janice L.; Baggs, Rhoda

    2007-01-01

    Safety Standards contain technical and process-oriented safety requirements. Technical requirements are those such as "must work" and "must not work" functions in the system. Process-Oriented requirements are software engineering and safety management process requirements. Address the system perspective and some cover just software in the system > NASA-STD-8719.13B Software Safety Standard is the current standard of interest. NASA programs/projects will have their own set of safety requirements derived from the standard. Safety Cases: a) Documented demonstration that a system complies with the specified safety requirements. b) Evidence is gathered on the integrity of the system and put forward as an argued case. [Gardener (ed.)] c) Problems occur when trying to meet safety standards, and thus make retrospective safety cases, in legacy safety-critical computer systems.

  3. Using the Job Demands-Resources model to investigate risk perception, safety climate and job satisfaction in safety critical organizations.

    PubMed

    Nielsen, Morten Birkeland; Mearns, Kathryn; Matthiesen, Stig Berge; Eid, Jarle

    2011-10-01

    Using the Job Demands-Resources model (JD-R) as a theoretical framework, this study investigated the relationship between risk perception as a job demand and psychological safety climate as a job resource with regard to job satisfaction in safety critical organizations. In line with the JD-R model, it was hypothesized that high levels of risk perception is related to low job satisfaction and that a positive perception of safety climate is related to high job satisfaction. In addition, it was hypothesized that safety climate moderates the relationship between risk perception and job satisfaction. Using a sample of Norwegian offshore workers (N = 986), all three hypotheses were supported. In summary, workers who perceived high levels of risk reported lower levels of job satisfaction, whereas this effect diminished when workers perceived their safety climate as positive. Follow-up analyses revealed that this interaction was dependent on the type of risks in question. The results of this study supports the JD-R model, and provides further evidence for relationships between safety-related concepts and work-related outcomes indicating that organizations should not only develop and implement sound safety procedures to reduce the effects of risks and hazards on workers, but can also enhance other areas of organizational life through a focus on safety.

  4. Benchmarking Global Food Safety Performances: The Era of Risk Intelligence.

    PubMed

    Valleé, Jean-Charles Le; Charlebois, Sylvain

    2015-10-01

    Food safety data segmentation and limitations hamper the world's ability to select, build up, monitor, and evaluate food safety performance. Currently, there is no metric that captures the entire food safety system, and performance data are not collected strategically on a global scale. Therefore, food safety benchmarking is essential not only to help monitor ongoing performance but also to inform continued food safety system design, adoption, and implementation toward more efficient and effective food safety preparedness, responsiveness, and accountability. This comparative study identifies and evaluates common elements among global food safety systems. It provides an overall world ranking of food safety performance for 17 Organisation for Economic Co-Operation and Development (OECD) countries, illustrated by 10 indicators organized across three food safety risk governance domains: risk assessment (chemical risks, microbial risks, and national reporting on food consumption), risk management (national food safety capacities, food recalls, food traceability, and radionuclides standards), and risk communication (allergenic risks, labeling, and public trust). Results show all countries have very high food safety standards, but Canada and Ireland, followed by France, earned excellent grades relative to their peers. However, any subsequent global ranking study should consider the development of survey instruments to gather adequate and comparable national evidence on food safety.

  5. Physicians' and nurses' perceptions of patient safety risks in the emergency department.

    PubMed

    Källberg, Ann-Sofie; Ehrenberg, Anna; Florin, Jan; Östergren, Jan; Göransson, Katarina E

    2017-02-28

    The emergency department has been described as a high-risk area for errors. It is also known that working conditions such as a high workload and shortage off staff in the healthcare field are common factors that negatively affect patient safety. A limited amount of research has been conducted with regard to patient safety in Swedish emergency departments. Additionally, there is a lack of knowledge about clinicians' perceptions of patient safety risks. Therefore, the purpose of this study was to describe emergency department clinicians' experiences with regard to patient safety risks.

  6. Risk Classification and Risk-based Safety and Mission Assurance

    NASA Technical Reports Server (NTRS)

    Leitner, Jesse A.

    2014-01-01

    Recent activities to revamp and emphasize the need to streamline processes and activities for Class D missions across the agency have led to various interpretations of Class D, including the lumping of a variety of low-cost projects into Class D. Sometimes terms such as Class D minus are used. In this presentation, mission risk classifications will be traced to official requirements and definitions as a measure to ensure that projects and programs align with the guidance and requirements that are commensurate for their defined risk posture. As part of this, the full suite of risk classifications, formal and informal will be defined, followed by an introduction to the new GPR 8705.4 that is currently under review.GPR 8705.4 lays out guidance for the mission success activities performed at the Classes A-D for NPR 7120.5 projects as well as for projects not under NPR 7120.5. Furthermore, the trends in stepping from Class A into higher risk posture classifications will be discussed. The talk will conclude with a discussion about risk-based safety and mission assuranceat GSFC.

  7. Additional information for impact response of the restart safety rods

    SciTech Connect

    Yau, W.W.F.

    1991-10-14

    WSRC-RP-91-677 studied the structural response of the safety rods under the conditions of brake failure and accidental release. It was concluded that the maximum impact loading to the safety rod is 6020 pounds based on conservative considerations that energy dissipation attributable to fluid resistance and reactor superstructure flexibility. The staffers of the Defense Nuclear Facility Safety Board reviewed the results and inquired about the extent of conservatism. By request of the RESTART team, I reassessed the impact force due to these conservative assumptions. This memorandum reports these assessments.

  8. Integrating Safety Assessment Methods using the Risk Informed Safety Margins Characterization (RISMC) Approach

    SciTech Connect

    Curtis Smith; Diego Mandelli

    2013-03-01

    Safety is central to the design, licensing, operation, and economics of nuclear power plants (NPPs). As the current light water reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of systems, structures, and components (SSC) degradations or failures that initiate safety significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very high degree of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated primarily based on engineering judgment backed by a set of conservative engineering calculations. The ability to better characterize and quantify safety margin is important to improved decision making about LWR design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margin management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. In addition, as research and development (R&D) in the LWR Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. To support decision making related to economics, readability, and safety, the RISMC Pathway provides methods and tools that enable mitigation options known as margins management strategies. The purpose of the RISMC Pathway R&D is to support plant decisions for risk

  9. [Risk assessment and chemical safety under REACH].

    PubMed

    Foth, Heidi

    2008-12-01

    Under the new European chemical legislation REACH (EG 1907/2006), dangerous properties of chemical substances will be evaluated and data gaps will be closed. This information is needed for other regulations, such as safety at the working place or for the safe handling of products. Existing knowledge on chemical compounds must be broadened because previous regulations have focused on high production volume compounds. The evaluation procedures needed too much time, and for the majority of non-evaluated substances a new strategy is needed. REACH places the duty for registration of substances with the producers and importers. Data gaps for risk evaluation will be closed. Competent authorities will be relieved from the primary risk evaluation of most substances. Alternative strategies of evaluation using previous information and non-animal testing approaches will be supported to avoid animal testing where appropriate. The new European chemical agency ECHA will use the provided information in order to identify very dangerous chemical substances which should be controlled by authorization of its use and the circumstances thereof.

  10. 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.

  11. Radiation safety attached to radioactive sources management - additional aspects

    SciTech Connect

    Kositsyn, V.F.

    1993-12-31

    Radiation sources are used in many scientific areas. Safety management requirements are determined for them with guarantee of the international and national dose limits unexceeding. As a rule, such dose limits are being developed concerning the type, energy, and flux of main radiation. Lack of knowledge of these attendant radiations can put personnel in danger. The study of the attendant neutron and gamma-radiations for plutonium 128 alpha sources was made.

  12. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive... proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will yield data adequate...

  13. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive... proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will yield data adequate...

  14. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive... proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will yield data adequate...

  15. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive... and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will...

  16. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive... and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will...

  17. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive... and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will...

  18. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive... and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will...

  19. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive... and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will...

  20. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive... proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a food additive whether he believes the experiments planned will yield data adequate...

  1. Risk perception and safety in Norwegian offshore workers

    SciTech Connect

    Rundmo, T.

    1996-12-31

    The relationships between perception of risk, behavior and involvement in accidents are receiving increased attention in the offshore oil industry. How employees perceive the risk they are exposed to during the conduct of their work may contribute to an understanding of risk management and thereby to the safety of their working conditions. A self-completion questionnaire survey was carried out among employees on a representative sample of offshore oil installations in the Norwegian part of the North Sea in 1990. In 1994 a follow-up study was carried out. A total of 915 respondents replied to our questionnaire in 1990 and 1138 in 1994. The studies were financed by the Norwegian Petroleum Directorate. There were significantly fewer of the personnel who felt at risk in 1994 compared to 1990 and a greater percentage of the personnel were satisfied with the safety and contingency measures and experienced job stress to a greater extent in 1990 than they did in 1994. Emotional reactions caused by potentially-hazardous risk sources were dependent on the respondents perceived controllability of the risk sources. The study also showed that there were significant positive correlations between organizational factors, safety status, perceived risk, and accidents. However, safety cannot be improved by changing risk perception. It is the factors that cause variations in risk perception as well as behavior and safety which should be the focus of safety promotion.

  2. 5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF....104 Additional rules for employees of the Food Safety and Inspection Service. Any employee of the Food Safety and Inspection Service not otherwise required to obtain approval for outside employment...

  3. 5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF....104 Additional rules for employees of the Food Safety and Inspection Service. Any employee of the Food Safety and Inspection Service not otherwise required to obtain approval for outside employment...

  4. 5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF....104 Additional rules for employees of the Food Safety and Inspection Service. Any employee of the Food Safety and Inspection Service not otherwise required to obtain approval for outside employment...

  5. 5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF....104 Additional rules for employees of the Food Safety and Inspection Service. Any employee of the Food Safety and Inspection Service not otherwise required to obtain approval for outside employment...

  6. 5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF....104 Additional rules for employees of the Food Safety and Inspection Service. Any employee of the Food Safety and Inspection Service not otherwise required to obtain approval for outside employment...

  7. 77 FR 76419 - Health and Safety Data Reporting; Addition of Certain Chemicals; Withdrawal of Final Rule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-28

    ...-2011-0363; FRL-9375-3] RIN 2070-AJ89 Health and Safety Data Reporting; Addition of Certain Chemicals.... SUMMARY: EPA is withdrawing the final Toxic Substances Control Act (TSCA) section 8(d) Health and Safety Data Reporting Rule that it issued on December 3, 2012. The health and safety data reporting rule...

  8. Chemical Mixture Risk Assessment Additivity-Based Approaches

    EPA Science Inventory

    Powerpoint presentation includes additivity-based chemical mixture risk assessment methods. Basic concepts, theory and example calculations are included. Several slides discuss the use of "common adverse outcomes" in analyzing phthalate mixtures.

  9. Critical factors and paths influencing construction workers' safety risk tolerances.

    PubMed

    Wang, Jiayuan; Zou, Patrick X W; Li, Penny P

    2016-08-01

    While workers' safety risk tolerances have been regarded as a main reason for their unsafe behaviors, little is known about why different people have different risk tolerances even when confronting the same situation. The aim of this research is to identify the critical factors and paths that influence workers' safety risk tolerance and to explore how they contribute to accident causal model from a system thinking perceptive. A number of methods were carried out to analyze the data collected through interviews and questionnaire surveys. In the first and second steps of the research, factor identification, factor ranking and factor analysis were carried out, and the results show that workers' safety risk tolerance can be influenced by four groups of factors, namely: (1) personal subjective perception; (2) work knowledge and experiences; (3) work characteristics; and (4) safety management. In the third step of the research, hypothetical influencing path model was developed and tested by using structural equation modeling (SEM). It is found that the effects of external factors (safety management and work characteristics) on risk tolerance are larger than that of internal factors (personal subjective perception and work knowledge & experiences). Specifically, safety management contributes the most to workers' safety risk tolerance through its direct effect and indirect effect; while personal subjective perception comes the second and can act as an intermedia for work characteristics. This research provides an in-depth insight of workers' unsafe behaviors by depicting the contributing factors as shown in the accident causal model developed in this research.

  10. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a color additive whether he believes the experiments planned will yield data adequate for...

  11. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a color additive whether he believes the experiments planned will yield data adequate for...

  12. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a color additive whether he believes the experiments planned will yield data adequate for...

  13. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a color additive whether he believes the experiments planned will yield data adequate for...

  14. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a color additive whether he believes the experiments planned will yield data adequate for...

  15. [Weighing use and safety of therapeutic agents and feed additives (author's transl)].

    PubMed

    van der Wal, P

    1982-02-01

    (1) The pros and cons of using feed additives and therapeutic agents may be successfully weighed in the light of carefully considered consumer requirements. (2) The socio-economic interests of the producer and the welfare of the animal will also determine the response of the production apparatus to consumer requirements. (3) Consumption of the current amounts of products of animal origin and maintenance of price and quality will only be feasible in the event of rational large-scale production in which constituents used in nutrition, prophylaxis and therapeutics are highly important factors. (4) Using these ingredients should be preceded by accurate evaluation of their use and safety. Testing facilities, conduct of studies and reporting should be such as to make the results nationally and internationally acceptable to all those concerned. (5) In deciding whether feed constituents are acceptable in view of the established use and safety, compliance will have to be sought with those standards which are accepted in other fields of society. Measures which result in raising the price of food without actually helping to reduce the risks to the safety of man, animals and environment, are likely to be rejected by any well-informed consumer who is aware of the facts. (6) For accurate weighing of use and safety at a national level, possibilities are hardly adequate in Europe. Decisions reached within the framework of the European Community, also tuned to U.S.A.- conditions are rightly encouraged. A centrally managed professionally staffed and equipped test system in the European Community would appear to be indispensable.

  16. Therapeutic risk management of the suicidal patient: safety planning.

    PubMed

    Matarazzo, Bridget B; Homaifar, Beeta Y; Wortzel, Hal S

    2014-05-01

    This column is the fourth in a series describing a model for therapeutic risk management of the suicidal patient. Previous columns presented an overview of the therapeutic risk management model, provided recommendations for how to augment risk assessment using structured assessments, and discussed the importance of risk stratification in terms of both severity and temporality. This final column in the series discusses the safety planning intervention as a critical component of therapeutic risk management of suicide risk. We first present concerns related to the relatively common practice of using no-suicide contracts to manage risk. We then present the safety planning intervention as an alternative approach and provide recommendations for how to use this innovative strategy to therapeutically mitigate risk in the suicidal patient.

  17. "The Dose Makes the Poison": Informing Consumers About the Scientific Risk Assessment of Food Additives.

    PubMed

    Bearth, Angela; Cousin, Marie-Eve; Siegrist, Michael

    2016-01-01

    Intensive risk assessment is required before the approval of food additives. During this process, based on the toxicological principle of "the dose makes the poison,ˮ maximum usage doses are assessed. However, most consumers are not aware of these efforts to ensure the safety of food additives and are therefore sceptical, even though food additives bring certain benefits to consumers. This study investigated the effect of a short video, which explains the scientific risk assessment and regulation of food additives, on consumers' perceptions and acceptance of food additives. The primary goal of this study was to inform consumers and enable them to construct their own risk-benefit assessment and make informed decisions about food additives. The secondary goal was to investigate whether people have different perceptions of food additives of artificial (i.e., aspartame) or natural origin (i.e., steviolglycoside). To attain these research goals, an online experiment was conducted on 185 Swiss consumers. Participants were randomly assigned to either the experimental group, which was shown a video about the scientific risk assessment of food additives, or the control group, which was shown a video about a topic irrelevant to the study. After watching the video, the respondents knew significantly more, expressed more positive thoughts and feelings, had less risk perception, and more acceptance than prior to watching the video. Thus, it appears that informing consumers about complex food safety topics, such as the scientific risk assessment of food additives, is possible, and using a carefully developed information video is a successful strategy for informing consumers.

  18. Inherent Risk or Risky Decision? Coach's Failure to Use Safety Device an Assumed Risk

    ERIC Educational Resources Information Center

    Dodds, Mark A.; Bochicchio, Kristi Schoepfer

    2013-01-01

    The court examined whether a coach's failure to implement a safety device during pitching practice enhanced the risk to the athlete or resulted in a suboptimal playing condition, in the context of the assumption of risk doctrine.

  19. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

    EPA Pesticide Factsheets

    President William Jefferson Clinton's Executive Order that each Federal agency assess safety risks to children; and ensure that policies, programs, activities, and standards address disproportionate risks. Also established the Task Force.

  20. Ensuring the quality of occupational safety risk assessment.

    PubMed

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

    2013-03-01

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

  1. Organizing patient safety research to identify risks and hazards

    PubMed Central

    Battles, J; Lilford, R

    2003-01-01

    Patient safety has become an international priority with major research programmes being carried out in the USA, UK, and elsewhere. The challenge is how to organize research efforts that will produce the greatest yield in making health care safer for patients. Patient safety research initiatives can be considered in three different stages: (1) identification of the risks and hazards; (2) design, implementation, and evaluation of patient safety practices; and (3) maintaining vigilance to ensure that a safe environment continues and patient safety cultures remain in place. Clearly, different research methods and approaches are needed at each of the different stages of the continuum. A number of research approaches can be used at stage 1 to identify risks and hazards including the use of medical records and administrative record review, event reporting, direct observation, process mapping, focus groups, probabilistic risk assessment, and safety culture assessment. No single method can be universally applied to identify risks and hazards in patient safety. Rather, multiple approaches using combinations of these methods should be used to increase identification of risks and hazards of health care associated injury or harm to patients. PMID:14645888

  2. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... AND HUMAN SERVICES (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for...) Upon written request describing the proposed use of an additive and the proposed experiments to... additive whether he believes the experiments planned will yield data adequate for an evaluation of...

  3. Seniors' perceptions of vehicle safety risks and needs.

    PubMed

    Shaw, Lynn; Polgar, Jan Miller; Vrkljan, Brenda; Jacobson, Jill

    2010-01-01

    The investigation of vehicle safety needs for older drivers and passengers is integral for their safe transportation. A program of research on safe transportation for seniors was launched through AUTO21, a Canadian Network of Centres of Excellence. This national research network focuses on a wide range of automotive issues, from materials and design to safety and societal issues. An inductive qualitative inquiry of seniors' driving experiences, safety feature use, and strategies to prevent injury and manage risks was a first step in this program. We conducted interviews and focus groups with 58 seniors without disabilities and 9 seniors with disabilities. We identified a lack of congruity between the vehicle and safety feature design and seniors' needs. Seniors described strategies to manage their safety and that of others. Specific aspects of vehicle design, safety features, and action strategies that support safer use and operation of a vehicle by seniors are outlined.

  4. 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...

  5. Occupational health and safety: Designing and building with MACBETH a value risk-matrix for evaluating health and safety risks

    NASA Astrophysics Data System (ADS)

    Lopes, D. F.; Oliveira, M. D.; Costa, C. A. Bana e.

    2015-05-01

    Risk matrices (RMs) are commonly used to evaluate health and safety risks. Nonetheless, they violate some theoretical principles that compromise their feasibility and use. This study describes how multiple criteria decision analysis methods have been used to improve the design and the deployment of RMs to evaluate health and safety risks at the Occupational Health and Safety Unit (OHSU) of the Regional Health Administration of Lisbon and Tagus Valley. ‘Value risk-matrices’ (VRMs) are built with the MACBETH approach in four modelling steps: a) structuring risk impacts, involving the construction of descriptors of impact that link risk events with health impacts and are informed by scientific evidence; b) generating a value measurement scale of risk impacts, by applying the MACBETH-Choquet procedure; c) building a system for eliciting subjective probabilities that makes use of a numerical probability scale that was constructed with MACBETH qualitative judgments on likelihood; d) and defining a classification colouring scheme for the VRM. A VRM built with OHSU members was implemented in a decision support system which will be used by OHSU members to evaluate health and safety risks and to identify risk mitigation actions.

  6. [Endorsement of risk management and patient safety by certification of conformity in health care quality assessment].

    PubMed

    Waßmuth, Ralf

    2015-01-01

    Certification of conformity in health care should provide assurance of compliance with quality standards. This also includes risk management and patient safety. Based on a comprehensive definition of quality, beneficial effects on the management of risks and the enhancement of patient safety can be expected from certification of conformity. While these effects have strong face validity, they are currently not sufficiently supported by evidence from health care research. Whether this relates to a lack of evidence or a lack of investigation remains open. Advancing safety culture and "climate", as well as learning from adverse events rely in part on quality management and are at least in part reflected in the certification of healthcare quality. However, again, evidence of the effectiveness of such measures is limited. Moreover, additional factors related to personality, attitude and proactive action of healthcare professionals are crucial factors in advancing risk management and patient safety which are currently not adequately reflected in certification of conformity programs.

  7. Total Risk Approach in Applying PRA to Criticality Safety

    SciTech Connect

    Huang, S T

    2005-03-24

    As nuclear industry continues marching from an expert-base support to more procedure-base support, it is important to revisit the total risk concept to criticality safety. A key objective of criticality safety is to minimize total criticality accident risk. The purpose of this paper is to assess key constituents of total risk concept pertaining to criticality safety from an operations support perspective and to suggest a risk-informed means of utilizing criticality safety resources for minimizing total risk. A PRA methodology was used to assist this assessment. The criticality accident history was assessed to provide a framework for our evaluation. In supporting operations, the work of criticality safety engineers ranges from knowing the scope and configurations of a proposed operation, performing criticality hazards assessment to derive effective controls, assisting in training operators, response to floor questions, surveillance to ensure implementation of criticality controls, and response to criticality mishaps. In a compliance environment, the resource of criticality safety engineers is increasingly being directed towards tedious documentation effort to meet some regulatory requirements to the effect of weakening the floor support for criticality safety. By applying a fault tree model to identify the major contributors of criticality accidents, a total risk picture is obtained to address relative merits of various actions. Overall, human failure is the key culprit in causing criticality accidents. Factors such as failure to follow procedures, lacks of training, lack of expert support at the floor level etc. are main contributors. Other causes may include lack of effective criticality controls such as inadequate criticality safety evaluation. Not all of the causes are equally important in contributing to criticality mishaps. Applying the limited resources to strengthen the weak links would reduce risk more than continuing emphasis on the strong links of

  8. Risk management modeling and its application in maritime safety

    NASA Astrophysics Data System (ADS)

    Qin, Ting-Rong; Chen, Wei-Jiong; Zeng, Xiang-Kun

    2008-12-01

    Quantified risk assessment (QRA) needs mathematicization of risk theory. However, attention has been paid almost exclusively to applications of assessment methods, which has led to neglect of research into fundamental theories, such as the relationships among risk, safety, danger, and so on. In order to solve this problem, as a first step, fundamental theoretical relationships about risk and risk management were analyzed for this paper in the light of mathematics, and then illustrated with some charts. Second, man-machine-environment-management (MMEM) theory was introduced into risk theory to analyze some properties of risk. On the basis of this, a three-dimensional model of risk management was established that includes: a goal dimension; a management dimension; an operation dimension. This goal management operation (GMO) model was explained and then emphasis was laid on the discussion of the risk flowchart (operation dimension), which lays the groundwork for further study of risk management and qualitative and quantitative assessment. Next, the relationship between Formal Safety Assessment (FSA) and Risk Management was researched. This revealed that the FSA method, which the international maritime organization (IMO) is actively spreading, comes from Risk Management theory. Finally, conclusion were made about how to apply this risk management method to concrete fields efficiently and conveniently, as well as areas where further research is required.

  9. Insomnia risks and costs: health, safety, and quality of life.

    PubMed

    Rosekind, Mark R; Gregory, Kevin B

    2010-08-01

    The effect of insomnia on next-day functioning, health, safety, and quality of life results in a substantial societal burden and economic cost. The annual direct cost of insomnia has been estimated in the billions of US dollars and is attributed to the association of insomnia with the increased risk of certain psychiatric and medical comorbidities that result in increased healthcare service utilization. It is well known that psychiatric conditions, anxiety and depression in particular, are comorbid with insomnia. However, emerging data have shown links with several common and costly medical conditions such as heart disease and diabetes. Furthermore, studies show that patients who have insomnia have more emergency department and physician visits, laboratory tests, and prescription drug use than those who do not have insomnia, increasing direct and indirect consumption of healthcare resources. Insomnia also has been shown to negatively affect daytime functioning, including workplace productivity, as well as workplace and public safety. These daytime effects of insomnia are translated into indirect costs that are reportedly higher than the direct costs of this disorder. These observations have significant implications for managed care organizations and healthcare providers. Improvements in diagnosing and treating insomnia can significantly reduce the healthcare cost of insomnia and its comorbid disorders, while providing additional economic benefits from improved daytime functioning and from increased productivity.

  10. Operational Risk Management and Military Aviation Safety

    DTIC Science & Technology

    1999-09-01

    accidents has caused the leadership to seek to reduce its mishap rate. The Army’s Class A aviation mishap rate declined after it implemented risk management (RM...principles in 1987. This reduction caught the attention of Air Force leadership who have since stated that the application of operational risk ... management (ORM) is how the Air Force will reduce, even eliminate, mishaps. With current budget constraints, ORM is considered to be the most cost

  11. Risk assessment prioritization in the Office of Pipeline Safety

    SciTech Connect

    Wolf, G.J.

    1994-12-31

    The Office of Pipeline Safety (OPS) of the Research and Special Programs Administration (RSPA), US Department of Transportation, is developing and implementing a process of Risk Assessment Prioritization (RAP). The objective of RAP is to use pipeline safety resources to yield the greatest improvement to pipeline safety and protection of the environment without unduly burdening industry, government, or the public. The RAP process involves extensive participation by stakeholders outside of OPS who have interests in pipeline safety and environmental protection. The process will be used to calculate a numeric value as the basis for prioritization of pipeline safety activity, whether by rulemaking or other alternatives, such as compliance emphasis, education, research, information dissemination, and interactive external relations. The RAP process will identify pipeline safety issues and their multiple solutions. A panel of experts will rate each solution for its effect on the probability and consequence of accident occurrence, and the cost to implement the solution. Using the ratings, OPS will calculate a risk reduction value for each solution. Resources will be assigned to implementing the solutions having the highest risk reduction values. OPS management will establish an action plan aimed at implementing solutions having the highest risk reduction value, while continuing action on those solutions mandated by law.

  12. Compressed natural gas bus safety: a quantitative risk assessment.

    PubMed

    Chamberlain, Samuel; Modarres, Mohammad

    2005-04-01

    This study assesses the fire safety risks associated with compressed natural gas (CNG) vehicle systems, comprising primarily a typical school bus and supporting fuel infrastructure. The study determines the sensitivity of the results to variations in component failure rates and consequences of fire events. The components and subsystems that contribute most to fire safety risk are determined. Finally, the results are compared to fire risks of the present generation of diesel-fueled school buses. Direct computation of the safety risks associated with diesel-powered vehicles is possible because these are mature technologies for which historical performance data are available. Because of limited experience, fatal accident data for CNG bus fleets are minimal. Therefore, this study uses the probabilistic risk assessment (PRA) approach to model and predict fire safety risk of CNG buses. Generic failure data, engineering judgments, and assumptions are used in this study. This study predicts the mean fire fatality risk for typical CNG buses as approximately 0.23 fatalities per 100-million miles for all people involved, including bus passengers. The study estimates mean values of 0.16 fatalities per 100-million miles for bus passengers only. Based on historical data, diesel school bus mean fire fatality risk is 0.091 and 0.0007 per 100-million miles for all people and bus passengers, respectively. One can therefore conclude that CNG buses are more prone to fire fatality risk by 2.5 times that of diesel buses, with the bus passengers being more at risk by over two orders of magnitude. The study estimates a mean fire risk frequency of 2.2 x 10(-5) fatalities/bus per year. The 5% and 95% uncertainty bounds are 9.1 x 10(-6) and 4.0 x 10(-5), respectively. The risk result was found to be affected most by failure rates of pressure relief valves, CNG cylinders, and fuel piping.

  13. Safety Assessment for Explosive Risk (SAFER) peer review report.

    SciTech Connect

    Heimdahl, Olaf E. R.; LaHoud, Paul; Chapman, Leon Darrel

    2004-08-01

    At the direction of the Department of Defense Explosives Safety Board (DDESB), a Peer Review Team was established to review the status of development of the risk-based explosives safety siting process and criteria as currently implemented in the software 'Safety Assessment for Explosive Risk (SAFER)' Version 2.1. The objective of the Peer Review Team was to provide an independent evaluation of the components of the SAFER model, the ongoing development of the model and the risk assessment process and criteria. This peer review report addressed procedures; protocols; physical and statistical science algorithms; related documents; and software quality assurance, validation and verification. Overall, the risk-based method in SAFER represents a major improvement in the Department of Defense (DoD) approach to explosives safety management. The DDESB and Risk Based Explosives Safety Criteria Team (RBESCT) have made major strides in developing a methodology, which over time may become a worldwide model. The current status of all key areas of the SAFER code has been logically developed and is defensible. Continued improvement and refinement can be expected as implementation proceeds. A consistent approach to addressing and refining uncertainty in each of the primary areas (probability of event, consequences of event and exposure) will be a very beneficial future activity.

  14. 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.

  15. 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.

  16. Accessory child safety harnesses: do the risks outweigh the benefits?

    PubMed

    Brown, Julie; Wainohu, Derek; Aquilina, Peter; Suratno, Basuki; Kelly, Paul; Bilston, Lynne E

    2010-01-01

    Accessory child safety harnesses are available in some countries as alternative restraints for young children or as an accessory restraint used with booster seats. Their use, in Australia at least, is becoming more common. There have been concerns that the risk of misuse of these restraints outweighs any potential benefit this system might have over a retractable lap-shoulder belt system used with a booster seat. However to date there is no evidence to confirm or deny this. This study used laboratory simulated frontal crash tests to examine the performance of accessory child safety harness systems compared to the lap-shoulder belt when used alone and when used with two common designs of Australian booster seat. The performance of the child safety harness system when misused was also investigated. The results demonstrate that the correctly used child safety harness system performed no better than the lap-shoulder system, and in fact allows for a greater risk of submarining. Furthermore, one common form of child safety harness misuse, where the harness is over-tightened causing the lap belt to be positioned high over the abdomen, allowed extremely undesirable dummy motion. This involved gross submarining and direct contact between the harness system and the dummy's neck. These findings suggest that the risks associated with accessory child safety harness systems most likely outweigh any potential benefits, in frontal impacts at least.

  17. Health, safety and environmental risk management in laboratory fields

    PubMed Central

    Yarahmadi, Rasoul; Moridi, Parvin; Roumiani, YarAllah

    2016-01-01

    Background: Research project risks are uncertain contingent events or situations that, if transpire, will have positive or negative effects on objectives of a project. The Management of Health and Safety at Work (MHSW) Regulations 1999 require all employers and the self-employed persons to assess the risks from their work on anyone who may be affected by their activities. Risk assessment is the first step in risk-management procedure, and due to its importance, it has been deemed to be a vital process while having a unique place in the researchbased management systems. Methods: In this research, a two-pronged study was carried out. Firstly, health and safety issues were studied and analyzed by means of ISO 14121. Secondly, environmental issues were examined with the aid of Failure Mode and Effect Analysis. Both processes were utilized to determine the risk level independently for each research laboratory and corrective measure priorities in each field (laboratory). Results: Data analysis showed that the total main and inherent risks in laboratory sites reduced by 38% to 86%. Upon comparing the average risk levels before and after implementing the control and protective actions utilizing risk management approaches which were separate from health, safety and environmental aspects, a highly effective significance (p<0.001) was obtained for inherent risk reduction. Analysis of health, safety and environmental control priorities with the purpose of comparing the ratio of the number of engineering measures to the amount of management ones showed a relatively significant increase. Conclusion: The large number of engineering measures was attributed to the employment of a variety of timeworn machinery (old technologies) along with using devices without basic protection components. PMID:27284544

  18. Developing Probabilistic Safety Performance Margins for Unknown and Underappreciated Risks

    NASA Technical Reports Server (NTRS)

    Benjamin, Allan; Dezfuli, Homayoon; Everett, Chris

    2015-01-01

    Probabilistic safety requirements currently formulated or proposed for space systems, nuclear reactor systems, nuclear weapon systems, and other types of systems that have a low-probability potential for high-consequence accidents depend on showing that the probability of such accidents is below a specified safety threshold or goal. Verification of compliance depends heavily upon synthetic modeling techniques such as PRA. To determine whether or not a system meets its probabilistic requirements, it is necessary to consider whether there are significant risks that are not fully considered in the PRA either because they are not known at the time or because their importance is not fully understood. The ultimate objective is to establish a reasonable margin to account for the difference between known risks and actual risks in attempting to validate compliance with a probabilistic safety threshold or goal. In this paper, we examine data accumulated over the past 60 years from the space program, from nuclear reactor experience, from aircraft systems, and from human reliability experience to formulate guidelines for estimating probabilistic margins to account for risks that are initially unknown or underappreciated. The formulation includes a review of the safety literature to identify the principal causes of such risks.

  19. A Software Safety Risk Taxonomy for Use in Retrospective Safety Cases

    NASA Technical Reports Server (NTRS)

    Hill, Janice L.

    2007-01-01

    Safety standards contain technical and process-oriented safely requirements. The best time to include these requirements is early in the development lifecycle of the system. When software safety requirements are levied on a legacy system after the fact, a retrospective safety case will need to be constructed for the software in the system. This can be a difficult task because there may be few to no art facts available to show compliance to the software safely requirements. The risks associated with not meeting safely requirements in a legacy safely-critical computer system must be addressed to give confidence for reuse. This paper introduces a proposal for a software safely risk taxonomy for legacy safely-critical computer systems, by specializing the Software Engineering Institute's 'Software Development Risk Taxonomy' with safely elements and attributes.

  20. Health and safety risks in production agriculture.

    PubMed Central

    Von Essen, S G; McCurdy, S A

    1998-01-01

    Production agriculture is associated with a variety of occupational illnesses and injuries. Agricultural workers are at higher risk of death or disabling injury than most other workers. Traumatic injury commonly occurs from working with machinery or animals. Respiratory illness and health problems from exposures to farm chemicals are major concerns, and dermatoses, hearing loss, certain cancers, and zoonotic infections are important problems. Innovative means of encouraging safe work practices are being developed. Efforts are being made to reach all groups of farmworkers, including migrant and seasonal workers, farm youth, and older farmers. PMID:9795581

  1. Health and safety risks in production agriculture.

    PubMed

    Von Essen, S G; McCurdy, S A

    1998-10-01

    Production agriculture is associated with a variety of occupational illnesses and injuries. Agricultural workers are at higher risk of death or disabling injury than most other workers. Traumatic injury commonly occurs from working with machinery or animals. Respiratory illness and health problems from exposures to farm chemicals are major concerns, and dermatoses, hearing loss, certain cancers, and zoonotic infections are important problems. Innovative means of encouraging safe work practices are being developed. Efforts are being made to reach all groups of farmworkers, including migrant and seasonal workers, farm youth, and older farmers.

  2. Analysis of occupational accidents: prevention through the use of additional technical safety measures for machinery

    PubMed Central

    Dźwiarek, Marek; Latała, Agata

    2016-01-01

    This article presents an analysis of results of 1035 serious and 341 minor accidents recorded by Poland's National Labour Inspectorate (PIP) in 2005–2011, in view of their prevention by means of additional safety measures applied by machinery users. Since the analysis aimed at formulating principles for the application of technical safety measures, the analysed accidents should bear additional attributes: the type of machine operation, technical safety measures and the type of events causing injuries. The analysis proved that the executed tasks and injury-causing events were closely connected and there was a relation between casualty events and technical safety measures. In the case of tasks consisting of manual feeding and collecting materials, the injuries usually occur because of the rotating motion of tools or crushing due to a closing motion. Numerous accidents also happened in the course of supporting actions, like removing pollutants, correcting material position, cleaning, etc. PMID:26652689

  3. Gun Safety Management with Patients at Risk for Suicide

    ERIC Educational Resources Information Center

    Simon, Robert I.

    2007-01-01

    Guns in the home are associated with a five-fold increase in suicide. All patients at risk for suicide must be asked if guns are available at home or easily accessible elsewhere, or if they have intent to buy or purchase a gun. Gun safety management requires a collaborative team approach including the clinician, patient, and designated person…

  4. Risk Management: Earning Recognition with an Automated Safety Program

    ERIC Educational Resources Information Center

    Lansberry, Linden; Strasburger, Tom

    2012-01-01

    Risk management is a huge task that requires diligent oversight to avoid penalties, fines, or lawsuits. Add in the burden of limited resources that schools face today, and the challenge of meeting the required training, reporting, compliance, and other administrative issues associated with a safety program is almost insurmountable. Despite an…

  5. Risk-based versus deterministic explosives safety criteria

    SciTech Connect

    Wright, R.E.

    1996-12-01

    The Department of Defense Explosives Safety Board (DDESB) is actively considering ways to apply risk-based approaches in its decision- making processes. As such, an understanding of the impact of converting to risk-based criteria is required. The objectives of this project are to examine the benefits and drawbacks of risk-based criteria and to define the impact of converting from deterministic to risk-based criteria. Conclusions will be couched in terms that allow meaningful comparisons of deterministic and risk-based approaches. To this end, direct comparisons of the consequences and impacts of both deterministic and risk-based criteria at selected military installations are made. Deterministic criteria used in this report are those in DoD 6055.9-STD, `DoD Ammunition and Explosives Safety Standard.` Risk-based criteria selected for comparison are those used by the government of Switzerland, `Technical Requirements for the Storage of Ammunition (TLM 75).` The risk-based criteria used in Switzerland were selected because they have been successfully applied for over twenty-five years.

  6. Risk analysis of sulfites used as food additives in China.

    PubMed

    Zhang, Jian Bo; Zhang, Hong; Wang, Hua Li; Zhang, Ji Yue; Luo, Peng Jie; Zhu, Lei; Wang, Zhu Tian

    2014-02-01

    This study was to analyze the risk of sulfites in food consumed by the Chinese people and assess the health protection capability of maximum-permitted level (MPL) of sulfites in GB 2760-2011. Sulfites as food additives are overused or abused in many food categories. When the MPL in GB 2760-2011 was used as sulfites content in food, the intake of sulfites in most surveyed populations was lower than the acceptable daily intake (ADI). Excess intake of sulfites was found in all the surveyed groups when a high percentile of sulfites in food was in taken. Moreover, children aged 1-6 years are at a high risk to intake excess sulfites. The primary cause for the excess intake of sulfites in Chinese people is the overuse and abuse of sulfites by the food industry. The current MPL of sulfites in GB 2760-2011 protects the health of most populations.

  7. An Autopsy Checklist: A Monitor of Safety and Risk Management.

    PubMed

    Shkrum, Michael James; Kent, Jessica

    2016-09-01

    Any autopsy has safety and risk management issues, which can arise in the preautopsy, autopsy, and postautopsy phases. The London Health Sciences Department of Pathology and Laboratory Medicine Autopsy Checklist was developed to address these issues. The current study assessed 1 measure of autopsy safety: the effectiveness of the checklist in documenting pathologists' communication of the actual or potential risk of blood-borne infections to support staff. Autopsy checklists for cases done in 2012 and 2013 were reviewed. The frequency of communication, as recorded in checklists, by pathologists to staff of previously diagnosed blood-borne infections (hepatitis B/C and human immunodeficiency virus) or the risk of infection based on lifestyle (eg, intravenous drug abuse) was tabulated. These data were compared with medical histories of the deceased and circumstances of their deaths described in the final autopsy reports. Information about blood-borne infections was recorded less frequently in the checklists compared with the final reports. Of 4 known human immunodeficiency virus cases, there was no checklist documentation in 3. All 11 hand injuries were documented. None of these cases had known infectious risks. The Autopsy Checklist is a standardized means of documenting safety and risk issues arising during the autopsy process, but its effectiveness relies on accurate completion.

  8. Risk assessment and its application to flight safety analysis

    SciTech Connect

    Keese, D.L.; Barton, W.R.

    1989-12-01

    Potentially hazardous test activities have historically been a part of Sandia National Labs mission to design, develop, and test new weapons systems. These test activities include high speed air drops for parachute development, sled tests for component and system level studies, multiple stage rocket experiments, and artillery firings of various projectiles. Due to the nature of Sandia's test programs, the risk associated with these activities can never be totally eliminated. However, a consistent set of policies should be available to provide guidance into the level of risk that is acceptable in these areas. This report presents a general set of guidelines for addressing safety issues related to rocket flight operations at Sandia National Laboratories. Even though the majority of this report deals primarily with rocket flight safety, these same principles could be applied to other hazardous test activities. The basic concepts of risk analysis have a wide range of applications into many of Sandia's current operations. 14 refs., 1 tab.

  9. Safety basis for the 241-AN-107 mixer pump installation and caustic addition

    SciTech Connect

    Van Vleet, R.J.

    1994-10-05

    This safety Basis was prepared to determine whether or not the proposed activities of installing a 76 HP jet mixer pump and the addition of approximately 50,000 gallons of 19 M (50:50 wt %) aqueous caustic are within the safety envelope as described by Tank Farms (chapter six of WHC-SD-WM-ISB-001, Rev. 0). The safety basis covers the components, structures and systems for the caustic addition and mixer pump installation. These include: installation of the mixer pump and monitoring equipment; operation of the mixer pump, process monitoring equipment and caustic addition; the pump stand, caustic addition skid, the electrical skid, the video camera system and the two densitometers. Also covered is the removal and decontamination of the mixer pump and process monitoring system. Authority for this safety basis is WHC-IP-0842 (Waste Tank Administration). Section 15.9, Rev. 2 (Unreviewed Safety Questions) of WHC-IP-0842 requires that an evaluation be performed for all physical modifications.

  10. Multiobjective Risk Partitioning: An Application to Dam Safety Risk Analysis

    DTIC Science & Technology

    1988-04-01

    expectation distorts, and a’most eliminates, the distinctive features of many viable alternative policy options that could lead to the reduction of the risk...height of the dam) from 20 to 30 million dollirs would contribute to a negligible reduction of 0.1 units of conventional (unconditional) expected social...results could be easily influenced by either a change in the return period of the PMH or by the choice of the distribution. Therefore, it is

  11. [Safe patient care: safety culture and risk management in otorhinolaryngology].

    PubMed

    St Pierre, M

    2013-04-01

    Safety culture is positioned at the heart of an organisation's vulnerability to error because of its role in framing organizational awareness to risk and in providing and sustaining effective strategies of risk management. Safety related attitudes of leadership and management play a crucial role in the development of a mature safety culture ("top-down process"). A type marker for organizational culture and thus a predictor for an organizations maturity in respect to safety is information flow and in particular an organization's general way of coping with information that suggests anomaly. As all values and beliefs, relationships, learning, and other aspects of organizational safety culture are about sharing and processing information, safety culture has been termed "informed culture". An informed culture is free of blame and open for information provided by incidents. "Incident reporting systems" are the backbone of a reporting culture, where good information flow is likely to support and encourage other kinds of cooperative behavior, such as problem solving, innovation, and inter-departmental bridging. Another facet of an informed culture is the free flow of information during perioperative patient care. The World Health Organisation's "safe surgery checklist" is the most prevalent example of a standardized information exchange aimed at preventing patient harm due to information deficit. In routine tasks mandatory standard operating procedures have gained widespread acceptance in guaranteeing the highest possible process quality.Technical and non-technical skills of healthcare professionals are the decisive human resource for an efficient and safe delivery of patient care and the avoidance of errors. The systematic enhancement of staff qualification by providing training opportunities can be a major investment in patient safety. In recent years several otorhinolaryngology departments have started to incorporate simulation based team trainings into their curriculum.

  12. Developing safety performance functions incorporating reliability-based risk measures.

    PubMed

    Ibrahim, Shewkar El-Bassiouni; Sayed, Tarek

    2011-11-01

    Current geometric design guides provide deterministic standards where the safety margin of the design output is generally unknown and there is little knowledge of the safety implications of deviating from these standards. Several studies have advocated probabilistic geometric design where reliability analysis can be used to account for the uncertainty in the design parameters and to provide a risk measure of the implication of deviation from design standards. However, there is currently no link between measures of design reliability and the quantification of safety using collision frequency. The analysis presented in this paper attempts to bridge this gap by incorporating a reliability-based quantitative risk measure such as the probability of non-compliance (P(nc)) in safety performance functions (SPFs). Establishing this link will allow admitting reliability-based design into traditional benefit-cost analysis and should lead to a wider application of the reliability technique in road design. The present application is concerned with the design of horizontal curves, where the limit state function is defined in terms of the available (supply) and stopping (demand) sight distances. A comprehensive collision and geometric design database of two-lane rural highways is used to investigate the effect of the probability of non-compliance on safety. The reliability analysis was carried out using the First Order Reliability Method (FORM). Two Negative Binomial (NB) SPFs were developed to compare models with and without the reliability-based risk measures. It was found that models incorporating the P(nc) provided a better fit to the data set than the traditional (without risk) NB SPFs for total, injury and fatality (I+F) and property damage only (PDO) collisions.

  13. RECENT ADDITIONS OF CRITICALITY SAFETY RELATED INTEGRAL BENCHMARK DATA TO THE ICSBEP AND IRPHEP HANDBOOKS

    SciTech Connect

    J. Blair Briggs; Lori Scott; Yolanda Rugama; Enrico Sartori

    2009-09-01

    High-quality integral benchmark experiments have always been a priority for criticality safety. However, interest in integral benchmark data is increasing as efforts to quantify and reduce calculational uncertainties accelerate to meet the demands of future criticality safety needs to support next generation reactor and advanced fuel cycle concepts. The importance of drawing upon existing benchmark data is becoming more apparent because of dwindling availability of critical facilities worldwide and the high cost of performing new experiments. Integral benchmark data from the International Handbook of Evaluated Criticality Safety Benchmark Experiments and the International Handbook of Reactor Physics Benchmark Experiments are widely used. Benchmark data have been added to these two handbooks since the last Nuclear Criticality Safety Division Topical Meeting in Knoxville, Tennessee (September 2005). This paper highlights these additions.

  14. Hybrid Safety Analysis Using Functional and Risk Decompositions

    SciTech Connect

    COOPER,J. ARLIN; JOHNSON,ALICE J.; WERNER,PAUL W.

    2000-07-15

    Safety analysis of complex systems depends on decomposing the systems into manageable subsystems, from which analysis can be rolled back up to the system level. The authors have found that there is no single best way to decompose; in fact hybrid combinations of decompositions are generally necessary to achieve optimum results. They are currently using two backbone coordinated decompositions--functional and risk, supplemented by other types, such as organizational. An objective is to derive metrics that can be used to efficiently and accurately aggregate information through analysis, to contribute toward assessing system safety, and to contribute information necessary for defensible decisions.

  15. Driving behaviours, traffic risk and road safety: comparative study between Malaysia and Singapore.

    PubMed

    Khan, Saif ur Rehman; Khalifah, Zainab Binti; Munir, Yasin; Islam, Talat; Nazir, Tahira; Khan, Hashim

    2015-01-01

    The present study aims to investigate differences in road safety attitude, driver behaviour and traffic risk perception between Malaysia and Singapore. A questionnaire-based survey was conducted among a sample of Singaporean (n = 187) and Malaysian (n = 313) road users. The data was analysed using confirmatory factor analysis and structural equation modelling applied to measure comparative fit indices of Malaysian and Singaporean respondents. The results show that the perceived traffic risk of Malaysian respondents is higher than Singaporean counterparts. Moreover, the structural equation modelling has confirmed perceived traffic risk performing the role of full mediation between perceived driving skills and perceived road safety for both the countries, while perceived traffic skills was found to perform the role of partial mediation between aggression and anxiety, on one hand, and road safety, on the other hand, in Malaysia and Singapore. In addition, in both countries, a weak correlation between perceived driving skills, aggression and anxiety with perceived road safety was found, while a strong correlation exists with traffic risk perception. The findings of this study have been discussed in terms of theoretical, practical and conceptual implications for both scholars and policy-makers to better understand the young drivers' attitude and behaviour relationship towards road safety measures with a view to future research.

  16. Workplace road safety risk management: An investigation into Australian practices.

    PubMed

    Warmerdam, Amanda; Newnam, Sharon; Sheppard, Dianne; Griffin, Mark; Stevenson, Mark

    2017-01-01

    In Australia, more than 30% of the traffic volume can be attributed to work-related vehicles. Although work-related driver safety has been given increasing attention in the scientific literature, it is uncertain how well this knowledge has been translated into practice in industry. It is also unclear how current practice in industry can inform scientific knowledge. The aim of the research was to use a benchmarking tool developed by the National Road Safety Partnership Program to assess industry maturity in relation to risk management practices. A total of 83 managers from a range of small, medium and large organisations were recruited through the Victorian Work Authority. Semi-structured interviews aimed at eliciting information on current organisational practices, as well as policy and procedures around work-related driving were conducted and the data mapped onto the benchmarking tool. Overall, the results demonstrated varying levels of maturity of risk management practices across organisations, highlighting the need to build accountability within organisations, improve communication practices, improve journey management, reduce vehicle-related risk, improve driver competency through an effective workplace road safety management program and review organisational incident and infringement management. The findings of the study have important implications for industry and highlight the need to review current risk management practices.

  17. Space Reactor Launch Safety--An Acceptably Low Risk

    SciTech Connect

    Weitzberg, Abraham; Wright, Steven

    2008-01-21

    Results from previous space reactor and radioisotope power source risk assessments were combined to provide a scoping assessment of the possible risks from the launch of a reactor power system for use on the surface of the moon or Mars. It is assumed that future reactor power system launches would be subject to the same rigorous safety analysis and launch approval process as past nuclear payload launches. Using the same methodology that has gained approval of past launches, it was determined that the mission risk would be 0.029 person-rem worldwide which translates to 1.5*10{sup -5} latent health effects. It is seen that the only significant sources of radiological risks from a non-operating reactor are possible inadvertent criticality accidents and the consequences of such events have been shown to be extremely low. Passive means such as spectral shift poisons or high reactor core length/diameter ratios have been shown to be able to reduce or eliminate the possibility of the more credible criticality accidents, such as flooding or sand burial. This paper advances the premise that, for design purposes, future space reactor surface-power designs should primarily address the credible accidents and not the hypothetical accidents. For launch accidents and other safety assessments, a probabilistic risk assessment approach will have to be used to assess the safety impact of all types of accidents, including the hypothetical accidents. With this approach, the design of the system will not be burdened with design features that are based on hypothetical criticality accidents having negligible risk. Moreover, there is little chance of convincingly demonstrating that these design features can substantially reduce or eliminated the risk associated with hypothetical criticality accidents.

  18. Quantitative assessment of building fire risk to life safety.

    PubMed

    Guanquan, Chu; Jinhua, Sun

    2008-06-01

    This article presents a quantitative risk assessment framework for evaluating fire risk to life safety. Fire risk is divided into two parts: probability and corresponding consequence of every fire scenario. The time-dependent event tree technique is used to analyze probable fire scenarios based on the effect of fire protection systems on fire spread and smoke movement. To obtain the variation of occurrence probability with time, Markov chain is combined with a time-dependent event tree for stochastic analysis on the occurrence probability of fire scenarios. To obtain consequences of every fire scenario, some uncertainties are considered in the risk analysis process. When calculating the onset time to untenable conditions, a range of fires are designed based on different fire growth rates, after which uncertainty of onset time to untenable conditions can be characterized by probability distribution. When calculating occupant evacuation time, occupant premovement time is considered as a probability distribution. Consequences of a fire scenario can be evaluated according to probability distribution of evacuation time and onset time of untenable conditions. Then, fire risk to life safety can be evaluated based on occurrence probability and consequences of every fire scenario. To express the risk assessment method in detail, a commercial building is presented as a case study. A discussion compares the assessment result of the case study with fire statistics.

  19. Perceived safety and controllability of events: Markers of risk for marijuana use in young adults?

    PubMed

    Sartor, Carolyn E; Ecker, Anthony H; Kraus, Shane W; Leeman, Robert F; Dukes, Kristin N; Foster, Dawn W

    2017-03-01

    Drawing on constructs from the trauma literature, the current study evaluated perceptions of safety and controllability of events as potential markers of risk for marijuana use. In addition, we characterized these perceptions in relation to individual level substance abuse risk factors (marijuana expectancies, impulsivity, depression, and anxiety), gender, and race. Data were collected via web survey from college students at two northeastern universities (n=228, 82.0% female). Controllability of events (CE) was rated significantly higher by Blacks than Whites. Safety/vulnerability (SV) and CE were associated with impulsivity, depression, and anxiety. CE was also associated with marijuana expectancies. Logistic regression analyses revealed a modest but significant association between SV and lifetime use even after adjusting for race, gender, age, and individual level substance abuse risk factors (odds ratio=1.10, 95% confidence intervals:1.02-1.18). No association between SV and past 3month frequency of use or between CE and either marijuana outcome was found. Findings support a link between perceptions of safety and ever using marijuana. They further demonstrate overlap of both perceived safety and controllability of events with substance use related risk factors, and suggest that they differ by race. Additional studies that assess substance use more broadly and query trauma history, using larger, more diverse samples, are needed to more fully grasp the relevance of these constructs to substance use, including their potential as targets for substance abuse prevention efforts.

  20. The Safety of Thoracentesis in Patients with Uncorrected Bleeding Risk

    PubMed Central

    Argento, A. Christine; Murphy, Terrence E.; Araujo, Katy L. B.; Pisani, Margaret A.

    2013-01-01

    Background: Thoracentesis is commonly performed to evaluate pleural effusions. Many medications (warfarin, heparin, clopidogrel) or physiological factors (elevated International Normalized Ratio [INR], thrombocytopenia, uremia) increase the risk for bleeding. Frequently these medications are withheld or transfusions are performed to normalize physiological parameters before a procedure. The safety of performing thoracentesis without correction of these bleeding risks has not been prospectively evaluated. Methods: This prospective observational cohort study enrolled 312 patients who underwent thoracentesis. All patients were evaluated for the presence of risk factors for bleeding. Hematocrit levels were obtained pre- and postprocedure, and the occurrence of postprocedural hemothorax was evaluated. Measurements and Main Results: Thoracenteses were performed in 312 patients, 42% of whom had a risk for bleeding. Elevated INR, secondary to liver disease or warfarin, and renal disease were the two most common etiologies for bleeding risk, although many patients had multiple potential bleeding risks. There was no significant difference in pre- and postprocedural hematocrit levels in patients with a bleeding risk when compared with patients with no bleeding risk. No patient developed a hemothorax as a result of the thoracentesis. Conclusions: This single-center, observational study suggests that thoracentesis may be safely performed without prior correction of coagulopathy, thrombocytopenia, or medication-induced bleeding risk. This may reduce the morbidity associated with transfusions or withholding of medications. PMID:23952852

  1. [Safety of food additives from a German and European point of view].

    PubMed

    Gürtler, R

    2010-06-01

    There are about 300 food additives permitted in the EU for which a re-evaluation program was initiated recently. Occasionally, it is speculated that the use of single food additives might be of safety concern. First results of the re-evaluation could give an impression on how such concerns were taken into account by responsible authorities, such as the European Food Safety Authority (EFSA). For some of the food additives, the lowest dose resulting in adverse effects was lower in recent studies compared to previous studies. Thus, the acceptable daily intake (ADI) derived applying the common uncertainty factor was lower than the ADI derived using data from previous studies. Therefore, it has to be considered whether the conditions of use need to be modified for these food additives.

  2. 47 CFR 5.311 - Additional requirements related to safety of the public.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... safety of the public. In addition to the notification requirements of § 5.309, for experiments that may... bands and geographic area as the planned experiment and, as appropriate, their end users; (b) Rapid identification, and elimination, of any harm the experiment may cause; and (c) Identifying an alternate means...

  3. 47 CFR 5.311 - Additional requirements related to safety of the public.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... safety of the public. In addition to the notification requirements of § 5.309, for experiments that may... bands and geographic area as the planned experiment and, as appropriate, their end users; (b) Rapid identification, and elimination, of any harm the experiment may cause; and (c) Identifying an alternate means...

  4. Pesticide exposure, safety issues, and risk assessment indicators.

    PubMed

    Damalas, Christos A; Eleftherohorinos, Ilias G

    2011-05-01

    approved pesticides and the approval of the new compounds in the near future. Thus, new tools or techniques with greater reliability than those already existing are needed to predict the potential hazards of pesticides and thus contribute to reduction of the adverse effects on human health and the environment. On the other hand, the implementation of alternative cropping systems that are less dependent on pesticides, the development of new pesticides with novel modes of action and improved safety profiles, and the improvement of the already used pesticide formulations towards safer formulations (e.g., microcapsule suspensions) could reduce the adverse effects of farming and particularly the toxic effects of pesticides. In addition, the use of appropriate and well-maintained spraying equipment along with taking all precautions that are required in all stages of pesticide handling could minimize human exposure to pesticides and their potential adverse effects on the environment.

  5. Fine-tuning Food Safety Objectives and risk assessment.

    PubMed

    Havelaar, Arie H; Nauta, Maarten J; Jansen, Jaap T

    2004-05-15

    Food Safety Objectives (FSOs) have been proposed as a practical tool to translate public health targets for food safety into tolerable levels of pathogens in a food product. The FSO concept is subject to intensive debate, and has not been developed in detail. We evaluate the proposed definition of FSOs and their implementation from the perspective of Quantitative Microbiological Risk Assessment (QMRA). The relationship between QMRA and FSOs is illustrated by a model for the public health risk of Shiga-producing Escherichia coli in steak tartare. We conclude that the proposed definition of FSOs needs to be modified to properly account for variability in and uncertainty about the contamination of food with pathogenic microorganisms and emphasize that both prevalence and concentration of pathogens must be considered. For this purpose, we propose the P-D equivalence curve, a simple graphical tool to separate "tolerable" from "non-tolerable" combinations of prevalence and concentration (dose).

  6. Safety risk analysis of an innovative environmental technology.

    PubMed

    Parnell, G S; Frimpon, M; Barnes, J; Kloeber, J M; Deckro, R E; Jackson, J A

    2001-02-01

    The authors describe a decision and risk analysis performed for the cleanup of a large Department of Energy mixed-waste subsurface disposal area governed by the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). In a previous study, the authors worked with the site decision makers, state regulators, and U.S. Environmental Protection Agency regional regulators to develop a CERCLA-based multiobjective decision analysis value model and used the model to perform a screening analysis of 28 remedial alternatives. The analysis results identified an innovative technology, in situ vitrification, with high effectiveness versus cost. Since this technology had not been used on this scale before, the major uncertainties were contaminant migration and pressure buildup. Pressure buildup was a safety concern due to the potential risks to worker safety. With the help of environmental technology experts remedial alternative changes were identified to mitigate the concerns about contaminant migration and pressure buildup. The analysis results showed that the probability of an event with a risk to worker safety had been significantly reduced. Based on these results, site decision makers have refocused their test program to examine in situ vitrification and have continued the use of the CERCLA-based decision analysis methodology to analyze remedial alternatives.

  7. Toward a Safety Risk-Based Classification of Unmanned Aircraft

    NASA Technical Reports Server (NTRS)

    Torres-Pomalas, Wilfredo

    2016-01-01

    There is a trend of growing interest and demand for greater access of unmanned aircraft (UA) to the National Airspace System (NAS) as the ongoing development of UA technology has created the potential for significant economic benefits. However, the lack of a comprehensive and efficient UA regulatory framework has constrained the number and kinds of UA operations that can be performed. This report presents initial results of a study aimed at defining a safety-risk-based UA classification as a plausible basis for a regulatory framework for UA operating in the NAS. Much of the study up to this point has been at a conceptual high level. The report includes a survey of contextual topics, analysis of safety risk considerations, and initial recommendations for a risk-based approach to safe UA operations in the NAS. The next phase of the study will develop and leverage deeper clarity and insight into practical engineering and regulatory considerations for ensuring that UA operations have an acceptable level of safety.

  8. Phosphazene Based Additives for Improvement of Safety and Battery Lifetimes in Lithium-Ion Batteries

    SciTech Connect

    Mason K Harrup; Kevin L Gering; Harry W Rollins; Sergiy V Sazhin; Michael T Benson; David K Jamison; Christopher J Michelbacher

    2011-10-01

    There need to be significant improvements made in lithium-ion battery technology, principally in the areas of safety and useful lifetimes to truly enable widespread adoption of large format batteries for the electrification of the light transportation fleet. In order to effect the transition to lithium ion technology in a timely fashion, one promising next step is through improvements to the electrolyte in the form of novel additives that simultaneously improve safety and useful lifetimes without impairing performance characteristics over wide temperature and cycle duty ranges. Recent efforts in our laboratory have been focused on the development of such additives with all the requisite properties enumerated above. We present the results of the study of novel phosphazene based electrolytes additives.

  9. 77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice..., 2012, Drug Safety and Risk Management Advisory Committee meeting due to unanticipated weather conditions caused by Hurricane Sandy. Name of Committee: Drug Safety and Risk Management Advisory...

  10. 77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-24

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... (REMS) with Elements to Assure Safe Use (ETASU) before CDER's Drug Safety and Risk Management...

  11. Understanding children's injury-risk behavior: wearing safety gear can lead to increased risk taking.

    PubMed

    Morrongiello, Barbara A; Walpole, Beverly; Lasenby, Jennifer

    2007-05-01

    The present study examined whether school-age children show risk compensation and engage in greater risk taking when wearing safety gear compared to when not doing so when running an obstacle course containing hazards that could lead to physical injury. Because sensation seeking has been shown to influence risk taking, this child attribute was also assessed and related to risk compensation. Children 7-12 years of age were videotaped navigating the obstacle course twice, once wearing safety gear and once without safety gear, with reverse directions used to minimize possible practice effects. The time it took the child to run through the course and the number of reckless behaviors (e.g., falls, trips, bumping into things) that the child made while running the course were compared for the gear and no-gear conditions. Results indicated that children went more quickly and behaved more recklessly when wearing safety gear than when not wearing gear, providing evidence of risk compensation. Moreover, those high in sensation seeking showed greater risk compensation compared with other children. Implications for childhood injury prevention are discussed.

  12. For Our Own Safety: Examining the Safety of High-Risk Interventions for Children and Young People

    ERIC Educational Resources Information Center

    Nunno, Michael A., Ed.; Day, David M., Ed.; Bullard, Lloyd B., Ed.

    2008-01-01

    "For Our Own Safety" is devoted entirely to the subject of, and risks associated with, restraint and seclusion of children. This book is a collection of the diverse viewpoints presented at the international symposium, "Examining the Safety of High-Risk Interventions for Children and Young People" (Ithaca, New York, June 1-4, 2005). It presents…

  13. Additional risk of end-of-the-pipe geoengineering technologies

    NASA Astrophysics Data System (ADS)

    Bohle, Martin

    2014-05-01

    qualitatively from the known successes. They do not tackle the initial cause, namely the carbon-dioxide inputs that are too high. This is their additional specific risk. 'The acceptability of geoengineering will be determined as much by social, legal and political issues as by scientific and technical factors', conclude Adam Corner and Nick Pidgeon (2010) when reviewing social and ethical implications of geoengineering the climate. It is to debate in that context that most geoengineering technologies are 'end of the pipe technologies', what involves an additional specific risk. Should these technologies be part of the toolbox to tackle anthropogenic climate change? Adam Corner and Nick Pidgeon 2010, Geoengineering the climate: The social and ethical implications, Environment Vol. 52.

  14. Risk Perception of Food Safety by School Food-handlers

    PubMed Central

    Monego, Estelamaris Tronco; Campos, Maria Raquel Hidalgo

    2014-01-01

    An exploratory descriptive study was conducted with a qualitative approach that used focus groups. The objective of this study was to identify the risk perception of food safety by school food-handlers. The results indicated that the food production process has certain inadequacies, including the weak risk perception by the food-handlers regarding the student's health. The students, the pedagogical team, and the principal contribute to this behaviour, which can affect the quality of the final product—the served meal. The social devaluation of the food-handlers is also discussed. It is necessary to improve the food-handlers’ training sessions, with the purpose of modifying risk perception and to allow the school community to be involved in healthy and safe feeding practices. PMID:24847589

  15. [Occupational risks among public safety and security forces].

    PubMed

    Candura, S M; Verni, P; Minelli, C M; Rosso, G L; Cappelli, M I; Strambi, S; Martellosio, V

    2006-01-01

    The present paper tries to identify the occupational risk factors (physical, chemical, biological, psychological), variable depending on jobs and tasks, to which the heterogeneous public safety/security workers are exposed. The fight against criminality and public order maintenance imply (sometimes fatal) traumatic risks, and expose to psychophysical and sensorial tiring, unfavourable macro- and microclimatic conditions, the risk of baropathy (air navigation, underwater activities), noise (generated by firearms and several other sources), vibrations and shakings (automatic weapons, transport vehicles), the risk of electric injury, ionizing (X and gamma rays) and non-inonizing (ultraviolet rays, microwaves and radiofrequencies, electromagnetic fields) radiations. Chemical hazards include carbon monoxide and other combustion products (fires, urban traffic), substances released in chemical accidents, tear gases, lead (firing grounds, metal works, environmental pollution), solvents, lubrificants and cutting oils (mechanic repair and maintenance), laboratory materials and reagents, irritant and/or sensitizing agents contained in gloves. The main biological risks are tetanus, blood-borne diseases (viral hepatitis, AIDS), aerogenous diseases (e.g., tuberculosis, Legionnaire's disease, epidemic cerebrospinal meningitis), dog- or horse-transmitted zoonosis. Finally, emotional, psychosomatic and behavioural stress-related disorders (e.g., burn-out syndrome, post-traumatic stress disorder) are typically frequent. The presence of numerous and diversified hazards among public safety/security forces imposes the adoption of occupational medicine measures, including risk assessment, health education, technical and environmental prevention, personal protective devices, sanitary surveillance and biological monitoring, clinical interventions (diagnosis, therapy and rehabilitation of occupational accidents and illnesses), prompt medico-legal evaluation of occupational

  16. Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland.

    PubMed

    Baron, Patrick; Frattaroli, Shannon

    2016-01-01

    The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain.

  17. Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland

    PubMed Central

    Baron, Patrick; Frattaroli, Shannon

    2016-01-01

    The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain. PMID:27341034

  18. Advanced korean industrial safety and health policy with risk assessment.

    PubMed

    Kwon, Hyuckmyun; Cho, Jae Hyun; Moon, Il; Choi, Jaewook; Park, Dooyong; Lee, Youngsoon

    2010-09-01

    This article describes a systematic roadmap master plan for advanced industrial safety and health policy in Korea, with an emphasis on. Since Korean industries had first emergence of industrial safety and health policy in 1953, enormous efforts have been made on upgrading the relevant laws in order to reflect real situation of industrial work environment in accordance with rapid changes of Korean and global business over three decades. Nevertheless, current policy has major defects; too much techniques-based articles, diverged contents in less organization, combined enforcement and punishments and finally enforcing regulations full of commands and control. These deficiencies have make it difficult to accommodate changes of social, industrial and employment environment in customized fashion. The approach to the solution must be generic at the level of paradigm-shift rather than local modifications and enhancement. The basic idea is to establish a new system integrated with a risk assessment scheme, which encourages employers to apply to their work environment under comprehensive responsibility. The risk assessment scheme is designed to enable to inspect employers' compliances afterwards. A project comprises four yearly phases based on applying zones; initially designating and operating a specified risk zone, gradually expanding the special zones during a period of 3 years (2010-2012) and the final zone expanded to entire nation. In each phase, the intermediate version of the system is updated through a process of precise and unbiased validation in terms of its operability, feasibility and sustainability with building relevant infrastructures as needed.

  19. 46 CFR 308.204 - Additional war risk protection and indemnity insurance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 8 2010-10-01 2010-10-01 false Additional war risk protection and indemnity insurance... OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.204 Additional war risk protection and indemnity insurance. Owners or charterers may obtain, on an excess basis, additional war...

  20. 46 CFR 308.204 - Additional war risk protection and indemnity insurance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 8 2012-10-01 2012-10-01 false Additional war risk protection and indemnity insurance... OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.204 Additional war risk protection and indemnity insurance. Owners or charterers may obtain, on an excess basis, additional war...

  1. 46 CFR 308.204 - Additional war risk protection and indemnity insurance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 8 2014-10-01 2014-10-01 false Additional war risk protection and indemnity insurance... OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.204 Additional war risk protection and indemnity insurance. Owners or charterers may obtain, on an excess basis, additional war...

  2. 46 CFR 308.204 - Additional war risk protection and indemnity insurance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 8 2011-10-01 2011-10-01 false Additional war risk protection and indemnity insurance... OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.204 Additional war risk protection and indemnity insurance. Owners or charterers may obtain, on an excess basis, additional war...

  3. 46 CFR 308.204 - Additional war risk protection and indemnity insurance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 8 2013-10-01 2013-10-01 false Additional war risk protection and indemnity insurance... OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.204 Additional war risk protection and indemnity insurance. Owners or charterers may obtain, on an excess basis, additional war...

  4. High Energy Density Additives for Hybrid Fuel Rockets to Improve Performance and Enhance Safety

    NASA Technical Reports Server (NTRS)

    Jaffe, Richard L.

    2014-01-01

    We propose a conceptual study of prototype strained hydrocarbon molecules as high energy density additives for hybrid rocket fuels to boost the performance of these rockets without compromising safety and reliability. Use of these additives could extend the range of applications for which hybrid rockets become an attractive alternative to conventional solid or liquid fuel rockets. The objectives of the study were to confirm and quantify the high enthalpy of these strained molecules and to assess improvement in rocket performance that would be expected if these additives were blended with conventional fuels. We confirmed the chemical properties (including enthalpy) of these additives. However, the predicted improvement in rocket performance was too small to make this a useful strategy for boosting hybrid rocket performance.

  5. Effects of a Workplace Intervention Targeting Psychosocial Risk Factors on Safety and Health Outcomes.

    PubMed

    Hammer, Leslie B; Truxillo, Donald M; Bodner, Todd; Rineer, Jennifer; Pytlovany, Amy C; Richman, Amy

    2015-01-01

    The goal of this study was to test the effectiveness of a workplace intervention targeting work-life stress and safety-related psychosocial risk factors on health and safety outcomes. Data were collected over time using a randomized control trial design with 264 construction workers employed in an urban municipal department. The intervention involved family- and safety-supportive supervisor behavior training (computer-based), followed by two weeks of behavior tracking and a four-hour, facilitated team effectiveness session including supervisors and employees. A significant positive intervention effect was found for an objective measure of blood pressure at the 12-month follow-up. However, no significant intervention results were found for self-reported general health, safety participation, or safety compliance. These findings suggest that an intervention focused on supervisor support training and a team effectiveness process for planning and problem solving should be further refined and utilized in order to improve employee health with additional research on the beneficial effects on worker safety.

  6. Effects of a Workplace Intervention Targeting Psychosocial Risk Factors on Safety and Health Outcomes

    PubMed Central

    Hammer, Leslie B.; Truxillo, Donald M.; Bodner, Todd; Rineer, Jennifer; Pytlovany, Amy C.; Richman, Amy

    2015-01-01

    The goal of this study was to test the effectiveness of a workplace intervention targeting work-life stress and safety-related psychosocial risk factors on health and safety outcomes. Data were collected over time using a randomized control trial design with 264 construction workers employed in an urban municipal department. The intervention involved family- and safety-supportive supervisor behavior training (computer-based), followed by two weeks of behavior tracking and a four-hour, facilitated team effectiveness session including supervisors and employees. A significant positive intervention effect was found for an objective measure of blood pressure at the 12-month follow-up. However, no significant intervention results were found for self-reported general health, safety participation, or safety compliance. These findings suggest that an intervention focused on supervisor support training and a team effectiveness process for planning and problem solving should be further refined and utilized in order to improve employee health with additional research on the beneficial effects on worker safety. PMID:26557703

  7. 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.

  8. Lithium-Ion Electrolytes Containing Flame Retardant Additives for Increased Safety Characteristics

    NASA Technical Reports Server (NTRS)

    Smart, Marshall C. (Inventor); Smith, Kiah A. (Inventor); Bugga, Ratnakumar V. (Inventor); Prakash, Surya G. (Inventor); Krause, Frederick Charles (Inventor)

    2014-01-01

    The invention discloses various embodiments of Li-ion electrolytes containing flame retardant additives that have delivered good performance over a wide temperature range, good cycle life characteristics, and improved safety characteristics, namely, reduced flammability. In one embodiment of the invention there is provided an electrolyte for use in a lithium-ion electrochemical cell, the electrolyte comprising a mixture of an ethylene carbonate (EC), an ethyl methyl carbonate (EMC), a fluorinated co-solvent, a flame retardant additive, and a lithium salt. In another embodiment of the invention there is provided an electrolyte for use in a lithium-ion electrochemical cell, the electrolyte comprising a mixture of an ethylene carbonate (EC), an ethyl methyl carbonate (EMC), a flame retardant additive, a solid electrolyte interface (SEI) film forming agent, and a lithium salt.

  9. A risk-based decision support framework for selection of appropriate safety measure system for underground coal mines.

    PubMed

    Samantra, Chitrasen; Datta, Saurav; Mahapatra, Siba Sankar

    2017-03-01

    In the context of underground coal mining industry, the increased economic issues regarding implementation of additional safety measure systems, along with growing public awareness to ensure high level of workers safety, have put great pressure on the managers towards finding the best solution to ensure safe as well as economically viable alternative selection. Risk-based decision support system plays an important role in finding such solutions amongst candidate alternatives with respect to multiple decision criteria. Therefore, in this paper, a unified risk-based decision-making methodology has been proposed for selecting an appropriate safety measure system in relation to an underground coal mining industry with respect to multiple risk criteria such as financial risk, operating risk, and maintenance risk. The proposed methodology uses interval-valued fuzzy set theory for modelling vagueness and subjectivity in the estimates of fuzzy risk ratings for making appropriate decision. The methodology is based on the aggregative fuzzy risk analysis and multi-criteria decision making. The selection decisions are made within the context of understanding the total integrated risk that is likely to incur while adapting the particular safety system alternative. Effectiveness of the proposed methodology has been validated through a real-time case study. The result in the context of final priority ranking is seemed fairly consistent.

  10. Of Acceptable Risk: Science and the Determination of Safety.

    ERIC Educational Resources Information Center

    Lowrance, William W.

    This book looks at the problems of determination of safety and the underlying concept of safety itself. It is believed that if certain pervasive themes are properly appreciated, the whole field of safety will be better understood. The first chapter of the book sketches the general nature of safety decisions, defining safety as a measure of the…

  11. 75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug...

  12. Risk Compensation in Children: Why Do Children Show It in Reaction to Wearing Safety Gear?

    ERIC Educational Resources Information Center

    Morrongiello, Barbara A.; Lasenby, Jennifer; Walpole, Beverly

    2007-01-01

    School-age children's self-reported risk compensation (greater risk-taking when wearing safety gear compared to when not doing so) was investigated using 6 common play situations. Children responded to hypothetical scenarios by rating intended risk-taking when wearing safety gear and not doing so, and by providing explanations for their behavior.…

  13. Safety concerns and risk management of multiple sclerosis therapies.

    PubMed

    Soelberg Sorensen, P

    2016-11-27

    Currently, more than ten drugs have been approved for treatment of relapsing-remitting multiple sclerosis (MS). Newer treatments may be more effective, but have less favorable safety record. Interferon-β preparations and glatiramer acetate treatment require frequent subcutaneous or intramuscular injections and are only moderately effective, but have very rarely life-threatening adverse effects, whereas teriflunomide and dimethyl fumarate are administered orally and have equal or better efficacy, but have more potentially severe adverse effects. The highly effective therapies fingolimod, natalizumab, daclizumab, and alemtuzumab have more serious adverse effects, some of which may be life-threatening. The choice between drugs should be based on a benefit-risk evaluation and tailored to the individual patient's requirements in a dialogue between the patient and treating neurologist. Patients with average disease activity can choose between dimethyl fumarate and teriflunomide or the "old injectable." Patients with very active MS may choose a more effective drug as the initial treatment. In case of side effects on one drug, switch to another drug can be tried. Suboptimal effect of the first drug indicates escalation to a highly efficacious drug. A favorable benefit-risk balance can be maintained by appropriate patient selection and appropriate risk management on therapy. New treatments will within the coming 1-2 years change our current treatment algorithm for relapsing-remitting MS.

  14. Characterization and safety evaluation of a Deinococcus member as feed additive for hens.

    PubMed

    Wu, Szu-Yin; Li, I-Chen; Lin, Yi-Chin; Chen, Chin-Chu

    2016-04-01

    As previous studies mainly focus on understanding the mechanisms of radioresistance in Deinococcus bacteria, the present study aimed at characterizing and verifying the safety use of the GKB-Aid 1995 strain, a member of the radiation-resistant bacterial genus Deinococcus, as an ingredient in feed supplements. Using Vitek 2 system and 16S rRNA gene sequencing, GKB-Aid 1995 most resembles Deinococcus grandis. The Ames test, in vitro chromosomal test, in vivo micronucleus test and acute toxicity test were performed subsequently for its safety evaluation. As there is a possibility that the pigment of GKB-Aid 1995 can pass from feed to eggs intended for human consumption, an acute toxicity test was also carried out in pigmented egg yolk. The results confirmed that GKB-Aid 1995 was non-genotoxic in three genotoxicity experiments, and the LD50 of GKB-Aid 1995 and the pigmented egg yolk in ICR mice was greater than 10 and 12 g kg(-1) body weight, respectively. Overall, these data indicate that GKB-Aid 1995 is a non-toxic substance with no genotoxicity and is therefore safe to be used as a feed supplement or feed additive. This study suggests there is potential in developing GKB-Aid 1995 as an animal feed additive intended to enhance yolk coloration to meet the demand of consumers.

  15. Exploring Canadians' and Europeans' Health Care Professionals' Perception of Biological Risks, Patient Safety, and Professional's Safety Practices.

    PubMed

    Bernard, Laurence; Bernard, Agnès; Biron, Alain; Lavoie-Tremblay, Mélanie

    2017-04-03

    Patient safety has become a worldwide concern in relation to infectious diseases (Ebola/severe acute respiratory syndrome/flu). During the pandemic, different sanitary responses were documented between Europe and North America in terms of vaccination and compliance with infection prevention and control measures. The purpose of this study was to explore the health care professional's perceptions of biological risks, patient safety, and their practices in European and Canadian health care facilities. A qualitative-descriptive design was used to explore the perceptions of biological risks and patient safety practices among health care professionals in 3 different facilities. Interviews (n = 39) were conducted with health care professionals in Canada and Europe. The thematic analysis pinpointed 3 main themes: risk and infectious disease, patient safety, and occupational health and safety. These themes fit within safety cultures described by participants: individual culture, blame culture, and collaborative culture. The preventive terminology used in the European health care facility focuses on hospital hygiene from the perspective of environmental risk (individual culture). In Canadian health care facilities, the focus was on risk management for infection prevention either from a punitive perspective (blame culture) or from a collaborative perspective (collaborative culture). This intercultural dialogue described the contextual realities on different continents regarding the perceptions of health care professionals about risks and infections.

  16. Food safety in the domestic environment: the effect of consumer risk information on human disease risks.

    PubMed

    Nauta, Maarten J; Fischer, Arnout R H; van Asselt, Esther D; de Jong, Aarieke E I; Frewer, Lynn J; de Jonge, Rob

    2008-02-01

    The improvement of food safety in the domestic environment requires a transdisciplinary approach, involving interaction between both the social and natural sciences. This approach is applied in a study on risks associated with Campylobacter on broiler meat. First, some web-based information interventions were designed and tested on participant motivation and intentions to cook more safely. Based on these self-reported measures, the intervention supported by the emotion "disgust" was selected as the most promising information intervention. Its effect on microbial cross-contamination was tested by recruiting a set of participants who prepared a salad with chicken breast fillet carrying a known amount of tracer bacteria. The amount of tracer that could be recovered from the salad revealed the transfer and survival of Campylobacter and was used as a measure of hygiene. This was introduced into an existing risk model on Campylobacter in the Netherlands to assess the effect of the information intervention both at the level of exposure and the level of human disease risk. We showed that the information intervention supported by the emotion "disgust" alone had no measurable effect on the health risk. However, when a behavioral cue was embedded within the instruction for the salad preparation, the risk decreased sharply. It is shown that a transdisciplinary approach, involving research on risk perception, microbiology, and risk assessment, is successful in evaluating the efficacy of an information intervention in terms of human health risks. The approach offers a novel tool for science-based risk management in the area of food safety.

  17. 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.

  18. Setting priorities for reducing risk and advancing patient safety.

    PubMed

    Gaffey, Ann D

    2016-04-01

    We set priorities every day in both our personal and professional lives. Some decisions are easy, while others require much more thought, participation, and resources. The difficult or less appealing priorities may not be popular, may receive push-back, and may be resource intensive. Whether personal or professional, the urgency that accompanies true priorities becomes a driving force. It is that urgency to ensure our patients' safety that brings many of us to work each day. This is not easy work. It requires us to be knowledgeable about the enterprise we are working in and to have the professional skills and competence to facilitate setting the priorities that allow our organizations to minimize risk and maximize value.

  19. Natural Disasters and Safety Risks at Nuclear Power Stations

    NASA Astrophysics Data System (ADS)

    Tutnova, T.

    2012-04-01

    In the aftermath of Fukushima natural-technological disaster the global opinion on nuclear energy divided even deeper. While Germany, Italy and the USA are currently reevaluating their previous plans on nuclear growth, many states are committed to expand nuclear energy output. In China and France, where the industry is widely supported by policymakers, there is little talk about abandoning further development of nuclear energy. Moreover, China displays the most remarkable pace of nuclear development in the world: it is responsible for 40% of worldwide reactors under construction, and aims at least to quadruple its nuclear capacity by 2020. In these states the consequences of Fukushima natural-technological accident will probably result in safety checks and advancement of new reactor technologies. Thus, China is buying newer reactor design from the USA which relies on "passive safety systems". It means that emergency power generators, crucial for reactor cooling in case of an accident, won't depend on electricity, so that tsunami won't disable them like it happened in the case of Fukushima. Nuclear energy managed to draw lessons from previous nuclear accidents where technological and human factors played crucial role. But the Fukushima lesson shows that the natural hazards, nevertheless, were undervalued. Though the ongoing technological advancements make it possible to increase the safety of nuclear power plants with consideration of natural risks, it is not just a question of technology improvement. A necessary action that must be taken is the reevaluation of the character and sources of the potential hazards which natural disasters can bring to nuclear industry. One of the examples is a devastating impact of more than one natural disaster happening at the same time. This subject, in fact, was not taken into account before, while it must be a significant point in planning sites for new nuclear power plants. Another important lesson unveiled is that world nuclear

  20. Risks and issues in fire safety on the Space Station

    NASA Technical Reports Server (NTRS)

    Friedman, Robert

    1993-01-01

    A fire in the inhabited portion of a spacecraft is a greatly feared hazard, but fire protection in space operations is complicated by two factors. First, the spacecraft cabin is an enclosed volume, which limits the resources for fire fighting and the options for crew escape. Second, an orbiting spacecraft experiences a balance of forces, creating a near-zero-gravity (microgravity) environment that profoundly affects the characteristics of fire initiation, spread, and suppression. The current Shuttle Orbiter is protected by a fire-detection and suppression system whose requirements are derived of necessity from accepted terrestrial and aircraft standards. While experience has shown that Shuttle fire safety is adequate, designers recognize that improved systems to respond specifically to microgravity fire characteristics are highly desirable. Innovative technology is particularly advisable for the Space Station, a forthcoming space community with a complex configuration and long-duration orbital missions, in which the effectiveness of current fire-protection systems is unpredictable. The development of risk assessments to evaluate the probabilities and consequences of fire incidents in spacecraft are briefly reviewed. It further discusses the important unresolved issues and needs for improved fire safety in the Space Station, including those of material selection, spacecraft atmospheres, fire detection, fire suppression, and post-fire restoration.

  1. Risks and issues in fire safety on the Space Station

    NASA Astrophysics Data System (ADS)

    Friedman, Robert

    1993-12-01

    A fire in the inhabited portion of a spacecraft is a greatly feared hazard, but fire protection in space operations is complicated by two factors. First, the spacecraft cabin is an enclosed volume, which limits the resources for fire fighting and the options for crew escape. Second, an orbiting spacecraft experiences a balance of forces, creating a near-zero-gravity (microgravity) environment that profoundly affects the characteristics of fire initiation, spread, and suppression. The current Shuttle Orbiter is protected by a fire-detection and suppression system whose requirements are derived of necessity from accepted terrestrial and aircraft standards. While experience has shown that Shuttle fire safety is adequate, designers recognize that improved systems to respond specifically to microgravity fire characteristics are highly desirable. Innovative technology is particularly advisable for the Space Station, a forthcoming space community with a complex configuration and long-duration orbital missions, in which the effectiveness of current fire-protection systems is unpredictable. The development of risk assessments to evaluate the probabilities and consequences of fire incidents in spacecraft are briefly reviewed. It further discusses the important unresolved issues and needs for improved fire safety in the Space Station, including those of material selection, spacecraft atmospheres, fire detection, fire suppression, and post-fire restoration.

  2. Additives

    NASA Technical Reports Server (NTRS)

    Smalheer, C. V.

    1973-01-01

    The chemistry of lubricant additives is discussed to show what the additives are chemically and what functions they perform in the lubrication of various kinds of equipment. Current theories regarding the mode of action of lubricant additives are presented. The additive groups discussed include the following: (1) detergents and dispersants, (2) corrosion inhibitors, (3) antioxidants, (4) viscosity index improvers, (5) pour point depressants, and (6) antifouling agents.

  3. Risk-Informed Safety Margin Characterization Methods Development Work

    SciTech Connect

    Smith, Curtis L; Ma, Zhegang; Riley, Tom; Mandelli, Diego; Nielsen, Joseph W; Alfonsi, Andrea; Rabiti, Cristian

    2014-09-01

    This report summarizes the research activity developed during the Fiscal year 2014 within the Risk Informed Safety Margin and Characterization (RISMC) pathway within the Light Water Reactor Sustainability (LWRS) campaign. This research activity is complementary to the one presented in the INL/EXT-??? report which shows advances Probabilistic Risk Assessment Analysis using RAVEN and RELAP-7 in conjunction to novel flooding simulation tools. Here we present several analyses that prove the values of the RISMC approach in order to assess risk associated to nuclear power plants (NPPs). We focus on simulation based PRA which, in contrast to classical PRA, heavily employs system simulator codes. Firstly we compare, these two types of analyses, classical and RISMC, for a Boiling water reactor (BWR) station black out (SBO) initiating event. Secondly we present an extended BWR SBO analysis using RAVEN and RELAP-5 which address the comments and suggestions received about he original analysis presented in INL/EXT-???. This time we focus more on the stochastic analysis such probability of core damage and on the determination of the most risk-relevant factors. We also show some preliminary results regarding the comparison between RELAP5-3D and the new code RELAP-7 for a simplified Pressurized Water Reactors system. Lastly we present some conceptual ideas regarding the possibility to extended the RISMC capabilities from an off-line tool (i.e., as PRA analysis tool) to an online-tool. In this new configuration, RISMC capabilities can be used to assist and inform reactor operator during real accident scenarios.

  4. Safety impact--the risk/benefits of functional foods.

    PubMed

    Pascal, Gérard

    2009-12-01

    It is amazing to see how much the approach of the food risk analysis evolved in the recent years. For half a century and the birth of the risk assessment methodology in the food domain, only no appreciable health risk was considered acceptable by the manager. This is the vocabulary used in the case of a voluntary, deliberated human action, as the use of food additives (definition of ADI). In the case of risks not resulting from such an action, as that of the presence of contaminants, the risk assessor allocates provisional tolerable daily, weekly or monthly intake that are the basis for regulation. This vocabulary is in agreement with the objective which consists in approaching closer possible of the zero risk which is the wish of a majority of the consumers. Some years ago, the risk managers insisted to obtain from the assessors as often as possible a quantitative risk evaluation. More recently even, the managers would like to decide on the basis of a balance of risk and benefit acceptable for management purposes. Finally, they hope that general principles and tools will be available for conducting a quantitative risk-benefit analysis for foods and food ingredients. What is possible in the case of functional foods (FF)? Based on the definition of FF proposed in the programme FUFOSE, one has to distinguish between different situations in order to assess the risk: that of a micro-, that of a macro-component or that of a whole food. These situations have been clearly described in the document resulting from FOSIE. The standardized methodology relevant to assess micro-components is not well adapted to the assessment of whole food. Concepts of substantial equivalence and of history of safe use could be useful tools in this case. However, quantitative risk assessment remains a very difficult exercise. If a process for the assessment of health benefit of FF has been proposed as an outcome of the PASSCLAIM action, the quantification of this benefit needs adequate tools

  5. Cost-effectiveness analysis of risk-reduction measures to reach water safety targets.

    PubMed

    Lindhe, Andreas; Rosén, Lars; Norberg, Tommy; Bergstedt, Olof; Pettersson, Thomas J R

    2011-01-01

    Identifying the most suitable risk-reduction measures in drinking water systems requires a thorough analysis of possible alternatives. In addition to the effects on the risk level, also the economic aspects of the risk-reduction alternatives are commonly considered important. Drinking water supplies are complex systems and to avoid sub-optimisation of risk-reduction measures, the entire system from source to tap needs to be considered. There is a lack of methods for quantification of water supply risk reduction in an economic context for entire drinking water systems. The aim of this paper is to present a novel approach for risk assessment in combination with economic analysis to evaluate risk-reduction measures based on a source-to-tap approach. The approach combines a probabilistic and dynamic fault tree method with cost-effectiveness analysis (CEA). The developed approach comprises the following main parts: (1) quantification of risk reduction of alternatives using a probabilistic fault tree model of the entire system; (2) combination of the modelling results with CEA; and (3) evaluation of the alternatives with respect to the risk reduction, the probability of not reaching water safety targets and the cost-effectiveness. The fault tree method and CEA enable comparison of risk-reduction measures in the same quantitative unit and consider costs and uncertainties. The approach provides a structured and thorough analysis of risk-reduction measures that facilitates transparency and long-term planning of drinking water systems in order to avoid sub-optimisation of available resources for risk reduction.

  6. Multivariate qualitative analysis of banned additives in food safety using surface enhanced Raman scattering spectroscopy

    NASA Astrophysics Data System (ADS)

    He, Shixuan; Xie, Wanyi; Zhang, Wei; Zhang, Liqun; Wang, Yunxia; Liu, Xiaoling; Liu, Yulong; Du, Chunlei

    2015-02-01

    A novel strategy which combines iteratively cubic spline fitting baseline correction method with discriminant partial least squares qualitative analysis is employed to analyze the surface enhanced Raman scattering (SERS) spectroscopy of banned food additives, such as Sudan I dye and Rhodamine B in food, Malachite green residues in aquaculture fish. Multivariate qualitative analysis methods, using the combination of spectra preprocessing iteratively cubic spline fitting (ICSF) baseline correction with principal component analysis (PCA) and discriminant partial least squares (DPLS) classification respectively, are applied to investigate the effectiveness of SERS spectroscopy for predicting the class assignments of unknown banned food additives. PCA cannot be used to predict the class assignments of unknown samples. However, the DPLS classification can discriminate the class assignment of unknown banned additives using the information of differences in relative intensities. The results demonstrate that SERS spectroscopy combined with ICSF baseline correction method and exploratory analysis methodology DPLS classification can be potentially used for distinguishing the banned food additives in field of food safety.

  7. Multivariate qualitative analysis of banned additives in food safety using surface enhanced Raman scattering spectroscopy.

    PubMed

    He, Shixuan; Xie, Wanyi; Zhang, Wei; Zhang, Liqun; Wang, Yunxia; Liu, Xiaoling; Liu, Yulong; Du, Chunlei

    2015-02-25

    A novel strategy which combines iteratively cubic spline fitting baseline correction method with discriminant partial least squares qualitative analysis is employed to analyze the surface enhanced Raman scattering (SERS) spectroscopy of banned food additives, such as Sudan I dye and Rhodamine B in food, Malachite green residues in aquaculture fish. Multivariate qualitative analysis methods, using the combination of spectra preprocessing iteratively cubic spline fitting (ICSF) baseline correction with principal component analysis (PCA) and discriminant partial least squares (DPLS) classification respectively, are applied to investigate the effectiveness of SERS spectroscopy for predicting the class assignments of unknown banned food additives. PCA cannot be used to predict the class assignments of unknown samples. However, the DPLS classification can discriminate the class assignment of unknown banned additives using the information of differences in relative intensities. The results demonstrate that SERS spectroscopy combined with ICSF baseline correction method and exploratory analysis methodology DPLS classification can be potentially used for distinguishing the banned food additives in field of food safety.

  8. DEVELOPMENT OF RISK-BASED AND TECHNOLOGY-INDEPENDENT SAFETY CRITERIA FOR GENERATION IV SYSTEMS

    SciTech Connect

    William E. Kastenberg; Edward Blandford; Lance Kim

    2009-03-31

    This project has developed quantitative safety goals for Generation IV (Gen IV) nuclear energy systems. These safety goals are risk based and technology independent. The foundations for a new approach to risk analysis has been developed, along with a new operational definition of risk. This project has furthered the current state-of-the-art by developing quantitative safety goals for both Gen IV reactors and for the overall Gen IV nuclear fuel cycle. The risk analysis approach developed will quantify performance measures, characterize uncertainty, and address a more comprehensive view of safety as it relates to the overall system. Appropriate safety criteria are necessary to manage risk in a prudent and cost-effective manner. This study is also important for government agencies responsible for managing, reviewing, and for approving advanced reactor systems because they are charged with assuring the health and safety of the public.

  9. Risk and safety concerns in anesthesiology practice: The present perspective

    PubMed Central

    Bajwa, Sukhminder Jit Singh; Kaur, Jasbir

    2012-01-01

    Newer developments and advancements in anesthesiology, surgical, and medical fields have widened the functional scope of anesthesiologist thus increasing his professional responsibilities and obligations. While at workplace, anesthesiologist is exposed to a wide array of potential hazards that can be detrimental to his overall health. Numerous risks and safety concerns have been mentioned in the literature, but the magnitude of challenges in anesthesiology practice are far greater than those cited and anticipated. Many times these challenging situations are unavoidable and the attending anesthesiologist has to deal with them on an individual basis. These hazards not only affect the general health but can be extremely threatening in various other ways that can increase the potential risks of morbidity and mortality. This article is an attempt to bring a general awareness among anesthesia fraternity about the various health hazards associated with anesthesia practice. Also, a genuine attempt has been made to enumerate the various preventive methods and precautions that should be adopted to make practice of anesthesiology safe and smooth. PMID:25885495

  10. Estimated Daily Intake and Safety of FD&C Food Colour Additives in the US Population.

    PubMed

    Bastaki, Maria; Farrell, Thomas; Bhusari, Sachin; Bi, Xiaoyu; Scrafford, Carolyn

    2017-03-23

    A refined exposure assessment was undertaken to calculate the Estimated Daily Intake (EDI) of the seven FD&C straight colour additives and five FD&C colour lakes ("synthetic" food colours) approved in the United States (US). The EDIs were calculated for the US population as a whole and specific age groups, including children 2-5 y, children 6-12 y, adolescents 13-18 y, and adults 19+ y. Actual use data were collected from an industry survey of companies who are users of these colour additives in a variety of products, with additional input from food colour manufacturers. Food consumption data were obtained from the National Health and Nutrition Examination Survey (NHANES). The assessment was further refined by adjusting the intake to more realistic scenarios based on the fraction of products containing colour within specific food categories using data provided by the Mintel International Group LTD. The results of the analysis indicate that a) the use levels reported by industry are consistent with the concentrations measured analytically by the US Food and Drug Administration; b) exposure to food colour additives in the US by average and high intake consumers is well below the Acceptable Daily Intake (ADI) of each colour additive as published by the Joint WHO/FAO Committee on Food Additives (JECFA) and allows wide margins of safety; and c) for children to reach the intake assumed in the Southampton study, they would have to consume at least 30 times more foods and beverages daily than the high consumers (95%) and the foods would have to contain four different colours at maximum use levels, a clearly unrealistic scenario. It is concluded that food colour use as currently practiced in the US is safe and does not result in excessive exposure to the population, even at conservative ranges of food consumption and levels of use.

  11. Toxicological safety assessment of genetically modified Bacillus thuringiensis with additional N-acyl homoserine lactonase gene.

    PubMed

    Peng, Donghai; Zhou, Chenfei; Chen, Shouwen; Ruan, Lifang; Yu, Ziniu; Sun, Ming

    2008-01-01

    The aim of the present study is to evaluate the toxicology safety to mammals of a genetically modified (GM) Bacillus thuringiensis with an additional N-acyl homoserine lactones gene (aiiA), which possesses insecticidal activity together with restraint of bacterial pathogenicity and is intended for use as a multifunctional biopesticide. Safety assessments included an acute oral toxicity test and 28-d animal feeding study in Wistar rats, primary eye and dermal irritation in Zealand White rabbits, and delayed contact hypersensitivity in guinea pigs. Tests were conducted using spray-dried powder preparation. This GM product showed toxicity neither in oral acute toxicity test nor in 28-d animal feeding test at a dose of 5,000 mg/kg body weight. During the animal feeding test, there were no significant differences in growth, food and water consumption, hematology, blood biochemical indices, organ weights, and histopathology finding between rats in controls and tested groups. Tested animals in primary eye and dermal irritation and delayed contact hypersensitivity test were also devoid of any toxicity compared to controls. All the above results demonstrated that the GM based multifunctional B. thuringiensis has low toxicity and low eye and dermal irritation and would not cause hypersensitivity to laboratory mammals and therefore could be regarded as safe for use as a pesticide.

  12. Risking 'Safety': Breast Cancer, Prognosis, and the Strategic Enterprise of Life.

    PubMed

    Ehlers, Nadine

    2016-03-01

    Living in modern biopolitical risk culture might be seen as synonymous with living in prognosis time, in the sense that risk of illness is endlessly forecast (prognosticated) in the broad social arena. 'Safety,' in this context, is framed as the anticipatory guarding against risk or disease in order to 'make live.' Thinking of risk and safety in these ways is limited, however, in that the prognosis cannot account for the individual's life or death drama. This paper asks: how are we to understand the constellation of risk, prognosis, and safety in relation to 'the subject in breast cancer prognosis'?

  13. Use of anatomical and kinetic models in the evaluation of human food additive safety.

    PubMed

    Roth, William L

    2005-09-22

    Toxicological testing in animals is relied upon as a surrogate for clinical testing of most food additives. Both animal and human clinical test results are generally available for direct additives when high levels of exposure are expected. Limited animal studies or in vitro test results may be the only sources of toxicological data available when low levels of exposure (microg/person/day) are expected and where no effects of the additive on the food itself are desired. Safety assessment of such materials for humans requires mathematical extrapolation from any effects observed in test animals to arrive at acceptable daily intakes (ADIs) for humans. Models of anatomy may be used to estimate tissue and organ weights where that information is missing and necessary for evaluation of a data set. The effect of growth on target tissue exposure during critical phases of organ development can be more accurately assessed when models of growth and known physiological changes are combined with pharmacokinetic results for test species. Kinetic models, when combined with limited chemical property, kinetic, and distribution data, can often be used to predict steady-state plasma and tissue levels of a test material over the range of doses employed in chronic studies to aid in interpretation of effects that are often nonlinear with respect to delivered dose. A better understanding of the reasons for nonlinearity of effects in animals improves our confidence in extrapolation to humans.

  14. Risk assessment for the combinational effects of food color additives: neural progenitor cells and hippocampal neurogenesis.

    PubMed

    Park, Mikyung; Park, Hee Ra; Kim, So Jung; Kim, Min-Sun; Kong, Kyoung Hye; Kim, Hyun Soo; Gong, Ein Ji; Kim, Mi Eun; Kim, Hyung Sik; Lee, Byung Mu; Lee, Jaewon

    2009-01-01

    In 2006, the Korea Food and Drug Administration reported that combinations of dietary colors such as allura red AC (R40), tartrazine (Y4), sunset yellow FCF (Y5), amaranth (R2), and brilliant blue FCF (B1) are widely used in food manufacturing. Although individual tar food colors are controlled based on acceptable daily intake (ADI), there is no apparent information available for how combinations of these additives affect food safety. In the current study, the potencies of single and combination use of R40, Y4, Y5, R2, and B1 were examined on neural progenitor cell (NPC) toxicity, a biomarker for developmental stage, and neurogenesis, indicative of adult central nervous system (CNS) functions. R40 and R2 reduced NPC proliferation and viability in mouse multipotent NPC, in the developing CNS model. Among several combinations tested in mouse model, combination of Y4 and B1 at 1000-fold higher than average daily intake in Korea significantly decreased numbers of newly generated cells in adult mouse hippocampus, indicating potent adverse actions on hippocampal neurogenesis. However, other combinations including R40 and R2 did not affect adult hippocampal neurogenesis in the dentate gyrus. Evidence indicates that single and combination use of most tar food colors may be safe with respect to risk using developmental NPC and adult hippocampal neurogenesis. However, the response to excessively high dose combination of Y4 and B1 is suggestive of synergistic effects to suppress proliferation of NPC in adult hippocampus. Data indicated that combinations of tar colors may adversely affect both developmental and adult hippocampal neurogenesis; thus, further extensive studies are required to assess the safety of these additive combinations.

  15. 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.

  16. Overview of Risk Mitigation for Safety-Critical Computer-Based Systems

    NASA Technical Reports Server (NTRS)

    Torres-Pomales, Wilfredo

    2015-01-01

    This report presents a high-level overview of a general strategy to mitigate the risks from threats to safety-critical computer-based systems. In this context, a safety threat is a process or phenomenon that can cause operational safety hazards in the form of computational system failures. This report is intended to provide insight into the safety-risk mitigation problem and the characteristics of potential solutions. The limitations of the general risk mitigation strategy are discussed and some options to overcome these limitations are provided. This work is part of an ongoing effort to enable well-founded assurance of safety-related properties of complex safety-critical computer-based aircraft systems by developing an effective capability to model and reason about the safety implications of system requirements and design.

  17. A risk-based approach to cost-benefit analysis of software safety activities

    SciTech Connect

    Fortier, S.C. ); Michael, J.B. )

    1993-01-01

    Assumptions about the economics of making a system safe are usually not explicitly stated in industrial and software models of safety-critical systems. These assumptions span a wide spectrum of economic tradeoffs with respect to resources expended to make a system safe. The missing component in these models that is necessary for capturing the effect of economic tradeoffs is risk. A qualitative risk-based software safety model is proposed that combines features of industrial and software systems safety models. The risk-based model provides decision makers with a basis for performing cost-benefit analyses of software safety-related activities.

  18. A risk-based approach to cost-benefit analysis of software safety activities

    SciTech Connect

    Fortier, S.C.; Michael, J.B.

    1993-05-01

    Assumptions about the economics of making a system safe are usually not explicitly stated in industrial and software models of safety-critical systems. These assumptions span a wide spectrum of economic tradeoffs with respect to resources expended to make a system safe. The missing component in these models that is necessary for capturing the effect of economic tradeoffs is risk. A qualitative risk-based software safety model is proposed that combines features of industrial and software systems safety models. The risk-based model provides decision makers with a basis for performing cost-benefit analyses of software safety-related activities.

  19. 77 FR 34051 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-08

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm....

  20. Brown bear habituation to people - Safety, risks, and benefits

    USGS Publications Warehouse

    Herrero, Stephen; Smith, Tom; DeBruyn, Terry D.; Gunther, Kerry; Matt, Colleen A.

    2005-01-01

    Recently, brown bear (Ursus arctos) viewing has increased in coastal Alaska and British Columbia, as well as in interior areas such as Yellowstone National Park. Viewing is most often being done under conditions that offer acceptable safety to both people and bears. We analyze and comment on the underlying processes that lead brown bears to tolerate people at close range. Although habituation is an important process influencing the distance at which bears tolerate people, other variables also modify levels of bear-to-human tolerance. Because bears may react internally with energetic costs before showing an overt reaction to humans, we propose a new term, the Overt Reaction Distance, to emphasize that what we observe is the external reaction of a bear. In this paper we conceptually analyze bear viewing in terms of benefits and risks to people and bears. We conclude that managers and policy-makers must develop site-specific plans that identify the extent to which bear-to-human habituation and tolerance will be permitted. The proposed management needs scientific underpinning. It is our belief that bear viewing, where appropriate, may promote conservation of bear populations, habitats, and ecosystems as it instills respect and concern in those who participate.

  1. [Ibuprofen versus steroids: risk and benefit, efficacy and safety].

    PubMed

    Giovannini, M; Mandelli, M; Gualdi, C; Palazzo, S

    2013-01-01

    In the last few years we have observed an upward trend in the employment of ibuprofen as anti-inflammatory and antipyretic therapy. Therefore the pediatrician has often a precious option in the anti-inflammatory and antipyretic treatment in children instead of using steroids and paracetamol. In clinical practice ibuprofen can be used in the treatment of headache, toothache, otalgy, dysmenorrhea, neuralgia, arthralgia, myalgia, abdominal pain and fever: it is the first choice for these common diseases. However, the use of steroids is a routine, even if non-corticosteroid anti-inflammatory molecules could be useful. Certainly steroids are powerful anti-inflammatory, indicated for the treatment of chronic inflammatory disorders and in acute respiratory and allergic diseases. Beside, thanks to their chemical and pharmacological profile, they also provide patients with an antipyretic effect. However, the use of steroids must be reserved to cases in which other classical antipyretics such as non-steroidal anti-inflammatory drugs are not effective. The possible side effects and risks associated with stepping down steroids must be considered. Although "steroids-phobia" should be discouraged, steroids are to be reserved only as the first indication. In all other cases the pediatrician can use ibuprofen, whose efficacy and safety are widely demonstrated by now.

  2. Risk perception, risk management and safety assessment: what can governments do to increase public confidence in their vaccine system?

    PubMed

    MacDonald, Noni E; Smith, Jennifer; Appleton, Mary

    2012-09-01

    For decades vaccine program managers and governments have devoted many resources to addressing public vaccine concerns, vaccine risk perception, risk management and safety assessment. Despite ever growing evidence that vaccines are safe and effective, public concerns continue. Education and evidence based scientific messages have not ended concerns. How can governments and programs more effectively address the public's vaccine concerns and increase confidence in the vaccine safety system? Vaccination hesitation has been attributed to concerns about vaccine safety, perceptions of high vaccine risks and low disease risk and consequences. Even when the public believes vaccines are important for protection many still have concerns about vaccine safety. This overview explores how heuristics affect public perception of vaccines and vaccine safety, how the public finds and uses vaccine information, and then proposes strategies for changes in the approach to vaccine safety communications. Facts and evidence confirming the safety of vaccines are not enough. Vaccine beliefs and behaviours must be shaped. This will require a shift in the what, when, how and why of vaccine risk and benefit communication content and practice. A change to a behavioural change strategy such as the WHO COMBI program that has been applied to disease eradication efforts is suggested.

  3. Bridging the Divide between Safety and Risk Management for your Project or Program

    NASA Technical Reports Server (NTRS)

    Lutomski, Mike

    2005-01-01

    This presentation will bridge the divide between these separate but overlapping disciplines and help explain how to use Risk Management as an effective management decision support tool that includes safety. Risk Management is an over arching communication tool used by management to prioritize and effectively mitigate potential problems before they concur. Risk Management encompasses every kind of potential problem that can occur on a program or project. Some of these are safety issues such as hazards that have a specific likelihood and consequence that need to be controlled and included to show an integrated picture of accepted) mitigated, and residual risk. Integrating safety and other assurance disciplines is paramount to accurately representing a program s or projects risk posture. Risk is made up of several components such as technical) cost, schedule, or supportability. Safety should also be a consideration for every risk. The safety component can also have an impact on the technical, cost, and schedule aspect of a given risk. The current formats used for communication of safety and risk issues are not consistent or integrated. The presentation will explore the history of these disciplines, current work to integrate them, and suggestions for integration for the future.

  4. Assessing risk: the role of probabilistic risk assessment (PRA) in patient safety improvement.

    PubMed

    Wreathall, J; Nemeth, C

    2004-06-01

    Morbidity and mortality due to "medical errors" compel better understanding of health care as a system. Probabilistic risk assessment (PRA) has been used to assess the designs of high hazard, low risk systems such as commercial nuclear power plants and chemical manufacturing plants and is now being studied for its potential in the improvement of patient safety. PRA examines events that contribute to adverse outcomes through the use of event tree analysis and determines the likelihood of event occurrence through fault tree analysis. It complements tools already in use in patient safety such as failure modes and effects analyses (FMEAs) and root cause analyses (RCAs). PRA improves on RCA by taking account of the more complex causal interrelationships that are typical in health care. It also enables the analyst to examine potential solution effectiveness by direct graphical representations. However, PRA simplifies real world complexity by forcing binary conditions on events, and it lacks adequate probability data (although recent developments help to overcome these limitations). Its reliance on expert assessment calls for deep domain knowledge which has to come from research performed at the "sharp end" of acute care.

  5. 5 CFR 5201.105 - Additional rules for Mine Safety and Health Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... company or other person engaged in mining activities subject to the Federal Mine Safety and Health Act of 1977 (Mine Safety and Health Act), 30 U.S.C. 801 et seq. A company or other person shall be deemed to... another company or other person engaged in such mining activities. A company or other person shall not...

  6. “Shake, Rattle and Roll”: risk assessment and management for food safety during two Christchurch earthquakes

    PubMed Central

    2012-01-01

    Problem Two earthquakes recently struck the Christchurch region. The 2010 earthquake in Canterbury was strong yet sustained less damage than the 2011 earthquake in Christchurch, which although not as strong, was more damaging and resulted in 185 deaths. Both required activation of a food safety response. Context The food safety response for both earthquakes was focused on reducing the risk of gastroenteritis by limiting the use of contaminated water and food, both in households and food businesses. Additional food safety risks were identified in the 2011 Christchurch earthquake due to the use of large-scale catering for rescue workers, volunteers and residents unable to return home. Action Using a risk assessment framework, the food safety response involved providing water and food safety advice, issuing a boil water notice for the region and initiating water testing on reticulation systems. Food businesses were contacted to ensure the necessary measures were being taken. Additional action during the 2011 Christchurch earthquake response included making contact with food businesses using checklists and principles developed in the first response and having regular contact with those providing catering for large numbers. Outcome In the 2010 earthquake in Canterbury, several cases of gastroenteritis were reported, although most resulted from person-to-person contact rather than contamination of food. There was a small increase in gastroenteritis cases following the 2011 Christchurch earthquake. Discussion The food safety response for both earthquakes was successful in meeting the goal of ensuring that foodborne illness did not put additional pressure on hospitals or affect search and rescue efforts. PMID:23908913

  7. Risk perception and safety in the UK offshore oil and gas industry

    SciTech Connect

    Flin, R.H.; Mearns, K.; Gordon, R.P.E.; Fleming, M.T.

    1996-12-31

    This paper presents a selection of the final results from a study of risk perception and safety attitudes in workers on UKCS offshore oil and gas platforms, which was sponsored by the HSE Offshore Safety Division, Amerada Hess, British Gas, BP, Conoco, Elf Enterprise and Total Oil Marine. The study was designed in conjunction with Dr Rundmo of Trondheim University who was carrying out a matched survey with Norwegian offshore workers for the Norwegian Petroleum Directorate`. A representative sample of 622 UKCS workers on six production platforms were surveyed about their job characteristics, perceived risks, safety attitudes, safety satisfaction, accidents and injuries and the Safety Case. The results indicate that the relative feelings of safety in relation to major hazards (e.g. explosion, blow-out) are aligned with QRA calculations. In general, the workforce feel safe but are aware of the hazards in their environment. Further analyses and statistical modelling indicates that organizational factors (e.g. management commitment to safety, safety attitudes) have the greatest direct effect on workers perception of risk and their satisfaction with safety measures. The British and Norwegian data sets are now being merged and preliminary findings will be mentioned. To explore the emerging issues further, a new study on human factors in UK offshore safety has just been launched with the support of OSD, OCA and six operating and contractor companies. A brief outline will be presented.

  8. A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design.

    PubMed

    Xu, Stanley; Hambidge, Simon J; McClure, David L; Daley, Matthew F; Glanz, Jason M

    2013-08-30

    In the examination of the association between vaccines and rare adverse events after vaccination in postlicensure observational studies, it is challenging to define appropriate risk windows because prelicensure RCTs provide little insight on the timing of specific adverse events. Past vaccine safety studies have often used prespecified risk windows based on prior publications, biological understanding of the vaccine, and expert opinion. Recently, a data-driven approach was developed to identify appropriate risk windows for vaccine safety studies that use the self-controlled case series design. This approach employs both the maximum incidence rate ratio and the linear relation between the estimated incidence rate ratio and the inverse of average person time at risk, given a specified risk window. In this paper, we present a scan statistic that can identify appropriate risk windows in vaccine safety studies using the self-controlled case series design while taking into account the dependence of time intervals within an individual and while adjusting for time-varying covariates such as age and seasonality. This approach uses the maximum likelihood ratio test based on fixed-effects models, which has been used for analyzing data from self-controlled case series design in addition to conditional Poisson models.

  9. Critical review of the safety assessment of nano-structured silica additives in food.

    PubMed

    Winkler, Hans Christian; Suter, Mark; Naegeli, Hanspeter

    2016-06-10

    The development of nano-materials is viewed as one of the most important technological advances of the 21st century and new applications of nano-sized particles in the production, processing, packaging or storage of food are expected to emerge soon. This trend of growing commercialization of engineered nano-particles as part of modern diet will substantially increase oral exposure. Contrary to the proven benefits of nano-materials, however, possible adverse health effects have generally received less attention. This problem is very well illustrated by nano-structured synthetic amorphous silica (SAS), which is a common food additive since several decades although the relevant risk assessment has never been satisfactorily completed. A no observed adverse effect level of 2500 mg SAS particles/kg body weight per day was derived from the only available long-term administration study in rodents. However, extrapolation to a safe daily intake for humans is problematic due to limitations of this chronic animal study and knowledge gaps as to possible local intestinal effects of SAS particles, primarily on the gut-associated lymphoid system. This uncertainty is aggravated by digestion experiments indicating that dietary SAS particles preserve their nano-sized structure when reaching the intestinal lumen. An important aspect is whether food-borne particles like SAS alter the function of dendritic cells that, embedded in the intestinal mucosa, act as first-line sentinels of foreign materials. We conclude that nano-particles do not represent a completely new threat and that most potential risks can be assessed following procedures established for conventional chemical hazards. However, specific properties of food-borne nano-particles should be further examined and, for that purpose, in vitro tests with decision-making cells of the immune system are needed to complement existing in vivo studies.

  10. A joint discussion model for assessing safety, health, and environmental risks

    SciTech Connect

    Abbott, R.E.

    1995-12-01

    Industries competing in the global marketplace constantly evaluate potential opportunities for joint ventures and partnerships all over the world. In the petroleum industry, these prospects to explore for and produce oil and gas range geographically from densely populated areas, to offshore, to the remote reaches of a tropical rainforest. There are numerous risks associated with these prospects which must be assessed so that the best investments are selected. The risk categories include: commercial, technical geological, political and safety, health and environmental (SHE). SHE risks are sometimes the most difficult to assess within businesses because they do not allow an easy evaluation of economic impact or other quantification. Additionally, these issues are often not familiar to business development personnel and consequently are not evaluated on an equal basis with other risk criteria. This paper presents a joint discussion model that facilitates the communication between SHE personnel and other members of the multi-disciplinary teams responsible for evaluating and selecting the most attractive prospects. This tool uses a simple approach in contrast to the many quantitative decision-making software products currently available. It provides a set of questions related to relevant SHE issues, establishes a way to approximate the level of uncertainty in the answers, and sums the results so that a comparison among prospects is possible. In the end, a more rigorous, consistent SHE assessment of all prospects is made, and the rationale for each decision is archived so that improvement in the process over time is made easier.

  11. Development of safety concept of electric wheelchair driving support system based on assessment of risk.

    PubMed

    Kurozumi, Ryota; Yamamoto, Toru; Fujisawa, Shoichiro

    2015-01-01

    In this research, we pay attention to the electric wheelchair driving support. We look at the functional safety of the electric wheelchair. Based on intrinsically-safe electric wheelchair, we add driving support system to increase functional safety. The driving support system processes the environmental information sensor data including the 3D laser Range scanner and biological monitoring sensor data including electrooculogram, and assists avoidance of dangerous objects. We have developed safety concept that based on assessment of risk.

  12. Impacts of soil and water pollution on food safety and health risks in China.

    PubMed

    Lu, Yonglong; Song, Shuai; Wang, Ruoshi; Liu, Zhaoyang; Meng, Jing; Sweetman, Andrew J; Jenkins, Alan; Ferrier, Robert C; Li, Hong; Luo, Wei; Wang, Tieyu

    2015-04-01

    Environmental pollution and food safety are two of the most important issues of our time. Soil and water pollution, in particular, have historically impacted on food safety which represents an important threat to human health. Nowhere has that situation been more complex and challenging than in China, where a combination of pollution and an increasing food safety risk have affected a large part of the population. Water scarcity, pesticide over-application, and chemical pollutants are considered to be the most important factors impacting on food safety in China. Inadequate quantity and quality of surface water resources in China have led to the long-term use of waste-water irrigation to fulfill the water requirements for agricultural production. In some regions this has caused serious agricultural land and food pollution, especially for heavy metals. It is important, therefore, that issues threatening food safety such as combined pesticide residues and heavy metal pollution are addressed to reduce risks to human health. The increasing negative effects on food safety from water and soil pollution have put more people at risk of carcinogenic diseases, potentially contributing to 'cancer villages' which appear to correlate strongly with the main food producing areas. Currently in China, food safety policies are not integrated with soil and water pollution management policies. Here, a comprehensive map of both soil and water pollution threats to food safety in China is presented and integrated policies addressing soil and water pollution for achieving food safety are suggested to provide a holistic approach.

  13. Achieving safety/risk goals for less ATR backup power upgrades

    SciTech Connect

    Atkinson, S.A.

    1995-10-01

    The Advanced Test Reactor probabilistic risk assessment for internal fire and flood events defined a relatively high risk for a total loss of electric power possibly leading to core damage. Backup power sources were disabled due to fire and flooding in the diesel generator area with propagation of the flooding to a common switchgear room. The ATR risk assessment was employed to define options for relocation of backup power system components to achieve needed risk reduction while minimizing costs. The risk evaluations were performed using sensitivity studies and importance measures. The risk-based evaluations of relocation options for backup power systems saved over $3 million from what might have been otherwise considered {open_quotes}necessary{close_quotes} for safety/risk improvement. The ATR experience shows that the advantages of a good risk assessment are to define risk significance, risk specifics, and risk solutions which enable risk goals to be achieved at the lowest cost.

  14. Determinants of Food Safety Risks: A Multi-disciplinary Approach

    ERIC Educational Resources Information Center

    Knight, Andrew; Warland, Rex

    2005-01-01

    This research employs a multi-disciplinary approach by developing a model that draws upon psychometric, cultural, and reflexive modernization perspectives of risk perception. Using data from a 1999 national telephone survey, we tested our model on three food risks ? pesticides, Salmonella, and fat. Results showed that perceptions of risks do vary…

  15. Food additive carrageenan: Part II: A critical review of carrageenan in vivo safety studies.

    PubMed

    Weiner, Myra L

    2014-03-01

    Carrageenan (CGN) is a seaweed-derived high molecular weight (Mw) hydrocolloid, primarily used as a stabilizer and thickener in food. The safety of CGN regarding its use in food is reviewed. Based on experimental studies in animals, ingested CGN is excreted quantitatively in the feces. Studies have shown that CGN is not significantly degraded by low gastric pH or microflora in the gastrointestinal (GI) tract. Due to its Mw, structure and its stability when bound to protein, CGN is not significantly absorbed or metabolized. CGN also does not significantly affect the absorption of nutrients. Subchronic and chronic feeding studies in rodents indicate that CGN at doses up to 5% in the diet does not induce any toxicological effects other than soft stools or diarrhea, which are a common effect for non-digestible high molecular weight compounds. Review of several studies from numerous species indicates that food grade CGN does not produce intestinal ulceration at doses up to 5% in the diet. Effects of CGN on the immune system following parenteral administration are well known, but not relevant to food additive uses. The majority of the studies evaluating the immunotoxicity potential were conducted with CGN administered in drinking water or by oral gavage where CGN exists in a random, open structured molecular conformation, particularly the lambda form; hence, it has more exposure to the intestinal mucosa than when bound to protein in food. Based on the many animal subchronic and chronic toxicity studies, CGN has not been found to affect the immune system, as judged by lack of effects on organ histopathology, clinical chemistry, hematology, normal health, and the lack of target organ toxicities. In these studies, animals consumed CGN at orders of magnitude above levels of CGN in the human diet: ≥1000 mg/kg/d in animals compared to 18-40 mg/kg/d estimated in the human diet. Dietary CGN has been shown to lack carcinogenic, tumor promoter, genotoxic, developmental, and

  16. RiskSOAP: Introducing and applying a methodology of risk self-awareness in road tunnel safety.

    PubMed

    Chatzimichailidou, Maria Mikela; Dokas, Ioannis M

    2016-05-01

    Complex socio-technical systems, such as road tunnels, can be designed and developed with more or less elements that can either positively or negatively affect the capability of their agents to recognise imminent threats or vulnerabilities that possibly lead to accidents. This capability is called risk Situation Awareness (SA) provision. Having as a motive the introduction of better tools for designing and developing systems that are self-aware of their vulnerabilities and react to prevent accidents and losses, this paper introduces the Risk Situation Awareness Provision (RiskSOAP) methodology to the field of road tunnel safety, as a means to measure this capability in this kind of systems. The main objective is to test the soundness and the applicability of RiskSOAP to infrastructure, which is advanced in terms of technology, human integration, and minimum number of safety requirements imposed by international bodies. RiskSOAP is applied to a specific road tunnel in Greece and the accompanying indicator is calculated twice, once for the tunnel design as defined by updated European safety standards and once for the 'as-is' tunnel composition, which complies with the necessary safety requirements, but calls for enhancing safety according to what EU and PIARC further suggest. The derived values indicate the extent to which each tunnel version is capable of comprehending its threats and vulnerabilities based on its elements. The former tunnel version seems to be more enhanced both in terms of it risk awareness capability and safety as well. Another interesting finding is that despite the advanced tunnel safety specifications, there is still room for enriching the safe design and maintenance of the road tunnel.

  17. 75 FR 7606 - Safety and Efficacy Review for Additional Ingredients in Over-the-Counter Drug Products for Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-22

    ... applications (TEAs). We are currently evaluating the safety and effectiveness of these ingredients. DATES... found eligible for possible addition to an OTC drug monograph via the TEA process described in 21 CFR... inclusion in an OTC drug monograph under the TEA process on the basis of foreign marketing...

  18. Treatment of Passive Component Reliability in Risk-Informed Safety Margin Characterization FY 2010 Report

    SciTech Connect

    Robert W Youngblood

    2010-09-01

    The Risk-Informed Safety Margin Characterization (RISMC) pathway is a set of activities defined under the U.S. Department of Energy (DOE) Light Water Reactor Sustainability Program. The overarching objective of RISMC is to support plant life-extension decision-making by providing a state-of-knowledge characterization of safety margins in key systems, structures, and components (SSCs). A technical challenge at the core of this effort is to establish the conceptual and technical feasibility of analyzing safety margin in a risk-informed way, which, unlike conventionally defined deterministic margin analysis, is founded on probabilistic characterizations of SSC performance.

  19. 77 FR 71561 - Health and Safety Data Reporting; Addition of Certain Chemicals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-03

    ...) of the Toxic Substances Control Act (TSCA) to recommend chemicals and chemical mixtures to EPA for..., any chemical substance or mixture'' to submit lists of health and safety studies conducted or initiated by or for such person with respect to such substance or mixture at any time, known to such...

  20. Application of a risk management system to improve drinking water safety.

    PubMed

    Jayaratne, Asoka

    2008-12-01

    The use of a comprehensive risk management framework is considered a very effective means of managing water quality risks. There are many risk-based systems available to water utilities such as ISO 9001 and Hazard Analysis and Critical Control Point (HACCP). In 2004, the World Health Organization's (WHO) Guidelines for Drinking Water Quality recommended the use of preventive risk management approaches to manage water quality risks. This paper describes the framework adopted by Yarra Valley Water for the development of its Drinking Water Quality Risk Management Plan incorporating HACCP and ISO 9001 systems and demonstrates benefits of Water Safety Plans such as HACCP.

  1. Comparison of a Traditional Probabilistic Risk Assessment Approach with Advanced Safety Analysis

    SciTech Connect

    Smith, Curtis L; Mandelli, Diego; Zhegang Ma

    2014-11-01

    As part of the Light Water Sustainability Program (LWRS) [1], the purpose of the Risk Informed Safety Margin Characterization (RISMC) [2] Pathway research and development (R&D) is to support plant decisions for risk-informed margin management with the aim to improve economics, reliability, and sustain safety of current NPPs. In this paper, we describe the RISMC analysis process illustrating how mechanistic and probabilistic approaches are combined in order to estimate a safety margin. We use the scenario of a “station blackout” (SBO) wherein offsite power and onsite power is lost, thereby causing a challenge to plant safety systems. We describe the RISMC approach, illustrate the station blackout modeling, and contrast this with traditional risk analysis modeling for this type of accident scenario. We also describe our approach we are using to represent advanced flooding analysis.

  2. Condoms and Contexts: Profiles of Sexual Risk and Safety Among Young Heterosexually Active Men

    PubMed Central

    Masters, N. Tatiana; Casey, Erin; Beadnell, Blair; Morrison, Diane M.; Hoppe, Marilyn J.; Wells, Elizabeth A.

    2014-01-01

    Heterosexual men’s sexual safety behavior is important to controlling the U.S. epidemic of sexually transmitted infections (STIs), including HIV. While sexual safety is often treated as a single behavior, such as condom use, it can also be conceptualized as resulting from multiple factors. Doing so can help us achieve more nuanced understandings of sexual risk and safety within partner-related contexts. We used Latent Class Analysis with data collected online from 18-25 year old heterosexually active U.S. men (n = 432) to empirically derive a typology of the patterns of sexual safety strategies they employ. Indicators were sexual risk reduction strategies used in the past year with the most recent female sex partner: Condom use, discussing sexual histories, STI testing, agreeing to be monogamous, and discussing birth control. We identified four subgroups: Risk Takers (12%), Condom Reliers (25%), Multistrategists (28%), and Relationship Reliers (35%). Partner-related context factors – number of past-year sex partners, relationship commitment, and sexual concurrency – predicted subgroup membership. Findings support tailoring STI prevention to men’s sexual risk-safety subgroups. Interventions should certainly continue to encourage condom use, but should also include information on how partner-related context factors and alternate sexual safety strategies can help men reduce risk for themselves and their partners. PMID:25256019

  3. The spread model of food safety risk under the supply-demand disturbance.

    PubMed

    Wang, Jining; Chen, Tingqiang

    2016-01-01

    In this paper, based on the imbalance of the supply-demand relationship of food, we design a spreading model of food safety risk, which is about from food producers to consumers in the food supply chain. We use theoretical analysis and numerical simulation to describe the supply-demand relationship and government supervision behaviors' influence on the risk spread of food safety and the behaviors of the food producers and the food retailers. We also analyze the influence of the awareness of consumer rights protection and the level of legal protection of consumer rights on the risk spread of food safety. This model contributes to the explicit investigation of the influence relationship among supply-demand factors, the regulation behavioral choice of government, the behavioral choice of food supply chain members and food safety risk spread. And this paper provides a new viewpoint for considering food safety risk spread in the food supply chain, which has a great reference for food safety management.

  4. Condoms and Contexts: Profiles of Sexual Risk and Safety Among Young Heterosexually Active Men.

    PubMed

    Masters, N Tatiana; Casey, Erin; Beadnell, Blair; Morrison, Diane M; Hoppe, Marilyn J; Wells, Elizabeth A

    2015-01-01

    Heterosexual men's sexual safety behavior is important to controlling the U.S. epidemic of sexually transmitted infections (STIs), including human immunodeficiency virus (HIV). While sexual safety is often treated as a single behavior, such as condom use, it can also be conceptualized as resulting from multiple factors. Doing so can help us achieve more nuanced understandings of sexual risk and safety within partner-related contexts. We used latent class analysis with data collected online from 18- to 25-year-old heterosexually active U.S. men (n = 432) to empirically derive a typology of the patterns of sexual safety strategies they employed. Indicators were sexual risk-reduction strategies used in the past year with the most recent female sex partner: condom use, discussing sexual histories, STI testing, agreeing to be monogamous, and discussing birth control. We identified four subgroups: Risk Takers (12%), Condom Reliers (25%), Multistrategists (28%), and Relationship Reliers (35%). Partner-related context factors--number of past-year sex partners, relationship commitment, and sexual concurrency--predicted subgroup membership. Findings support tailoring STI prevention to men's sexual risk-safety subgroups. Interventions should certainly continue to encourage condom use but should also include information on how partner-related context factors and alternate sexual safety strategies can help men reduce risk for themselves and their partners.

  5. Risk-Taking, Safety and Older People. Selected Bibliographies on Ageing 3.

    ERIC Educational Resources Information Center

    Jackson, Wendy, Comp.

    This annotated bibliography, which was developed as part of a series of selected bibliographies on aging for Great Britain's Centre for Policy on Ageing, contains a total of 368 entries organized under the following subject headings: risk (identification, nature, responsibilities, risk taking, security); environmental safety (hazards, design,…

  6. Listening to Excluded Young People's Experiences of e-Safety and Risk

    ERIC Educational Resources Information Center

    Cranmer, Sue

    2013-01-01

    This article reports on excluded young people's experiences with and management of e-safety and risk. It has importance in exploring these concerns given that excluded young people's voices are very often absent in education and technology research and yet they are potentially more at risk when using Information and Communication Technologies than…

  7. Aviation Safety Risk Modeling: Lessons Learned From Multiple Knowledge Elicitation Sessions

    NASA Technical Reports Server (NTRS)

    Luxhoj, J. T.; Ancel, E.; Green, L. L.; Shih, A. T.; Jones, S. M.; Reveley, M. S.

    2014-01-01

    Aviation safety risk modeling has elements of both art and science. In a complex domain, such as the National Airspace System (NAS), it is essential that knowledge elicitation (KE) sessions with domain experts be performed to facilitate the making of plausible inferences about the possible impacts of future technologies and procedures. This study discusses lessons learned throughout the multiple KE sessions held with domain experts to construct probabilistic safety risk models for a Loss of Control Accident Framework (LOCAF), FLightdeck Automation Problems (FLAP), and Runway Incursion (RI) mishap scenarios. The intent of these safety risk models is to support a portfolio analysis of NASA's Aviation Safety Program (AvSP). These models use the flexible, probabilistic approach of Bayesian Belief Networks (BBNs) and influence diagrams to model the complex interactions of aviation system risk factors. Each KE session had a different set of experts with diverse expertise, such as pilot, air traffic controller, certification, and/or human factors knowledge that was elicited to construct a composite, systems-level risk model. There were numerous "lessons learned" from these KE sessions that deal with behavioral aggregation, conditional probability modeling, object-oriented construction, interpretation of the safety risk results, and model verification/validation that are presented in this paper.

  8. Risks, designs, and research for fire safety in spacecraft

    NASA Technical Reports Server (NTRS)

    Friedman, Robert; Sacksteder, Kurt R.; Urban, David

    1991-01-01

    Current fire protection for spacecraft relies mainly on fire prevention through the use of nonflammable materials and strict storage controls of other materials. The Shuttle also has smoke detectors and fire extinguishers, using technology similar to aircraft practices. While experience has shown that the current fire protection is adequate, future improvements in fire safety technology to meet the challenges of long duration space missions, such as the Space Station Freedom, are essential. All spacecraft fire protection systems, however, must deal with the unusual combustion characteristics and operational problems in the low gravity environment. The features of low gravity combustion that affect spacecraft fire safety, and the issues in fire protection for Freedom that must be addressed eventually to provide effective and conservative fire protection systems are discussed.

  9. The roads ahead: collision risks, trends, and safety of drivers.

    PubMed

    Straus, Sandy Helene; Gu, Xiaojun

    2009-06-01

    The propensity of fatal traffic collisions transcends driver age and reinforces the need to evaluate, among other factors, the impact of roadway lighting and other features of driver vision, perception, and performance. Collisions may result from a driver's inability to notice delineation, recognize warnings, and other possible road safety controls during various lighting conditions. Hence we compare the relative accident involvement ratio (RAIR) of collisions of millions of drivers from two U.S. States over an 11-year period, 1991-2001. We associate collision trends through RAIR with bathtub curves that are commonly identified with product failure and reliability engineering. Hence we observe the need for improved and automated driver's license testing techniques and applications, especially as these relate to the visual and cognitive abilities of drivers of all ages. Our findings may ultimately improve motorist safety, save lives, and benefit numerous other states, countries, and agencies, including, but not limited to, aviation, commercial vehicles, maritime, and rail sectors, among others.

  10. Efficacy and safety of addition of bevacizumab to FOLFIRI or irinotecan/bolus 5-FU/LV (IFL) in patients with metastatic colorectal cancer

    PubMed Central

    Chen, Ke; Gong, Yinya; Zhang, Qi; Shen, Yanping; Zhou, Taoqi

    2016-01-01

    Abstract Recent studies have paid much attention on the safety of bevacizumab as adjuvant chemotherapy for metastatic colorectal cancer. The aim of this meta-analysis was to study the efficacy and safety of bevacizumab in combination with irinotecan, bolus followed by infusional 5-fluorouracil, and leucovorin (FOLFIRI) and, irinotecan, bolus fluorouracil, leucovorin (IFL) for patients with metastatic colorectal cancer (mCRC). An electronic search of related trials was conducted from PubMed, EMBASE, Cochrane Library databases. Risk ratio (RRs) and its 95% confidence intervals (95% CIs) were calculated by using either DerSimonian–Laird method or Mantel–Haenszel method according to the heterogeneity of included articles. The risk of mortality, therapeutic efficacy, and adverse effect were meta-analyzed. In total, 6 RCTs including 2165 participants (1109 in the treatment group, 1056 in the control group) were included in this meta-analysis. Compared with FOLFIRI-panitumumab/cetuximab, the bevacizumab addition significantly reduced the complete response (CR) rate (RR [95%CI] = 0.31[0.11, 0.89], P = 0.03) and the risk of grade 3/4 adverse event (RR [95%CI] = 0.89[0.80, 0.98], P = 0.01). Compared with FOLFIRI and IFL alone, the addition of bevacizumb significantly increased the partial response (PR) and objective response (OR) rates. Compared with IFL alone, the addition of bevacizumb significantly reduced the mortality risk of PFS (RR [95%CI] = 0.53[0.42, 0.66], P < 0.00001) and OS (RR[95%CI] = 0.70[0.60, 0.82], P < 0.00001), but increased the risk of adverse events (RR[95%CI] = 1.14[1.06, 1.21], P = 0.0002). Combination chemotherapy of bevacizumab plus FOLFIRI or IFL had a relative high efficacy and acceptable safety for treatment of mCRC. PMID:27861344

  11. Development of Risk Assessment Matrix for NASA Engineering and Safety Center

    NASA Technical Reports Server (NTRS)

    Malone, Roy W., Jr.; Moses, Kelly

    2004-01-01

    This paper describes a study, which had as its principal goal the development of a sufficiently detailed 5 x 5 Risk Matrix Scorecard. The purpose of this scorecard is to outline the criteria by which technical issues can be qualitatively and initially prioritized. The tool using this score card has been proposed to be one of the information resources the NASA Engineering and Safety Center (NESC) takes into consideration when making decisions with respect to incoming information on safety concerns across the entire NASA agency. The contents of this paper discuss in detail each element of the risk matrix scorecard, definitions for those elements and the rationale behind the development of those definitions. This scorecard development was performed in parallel with the tailoring of the existing Futron Corporation Integrated Risk Management Application (IRMA) software tool. IRMA was tailored to fit NESC needs for evaluating incoming safety concerns and was renamed NESC Assessment Risk Management Application (NAFMA) which is still in developmental phase.

  12. Danger zone: Men, masculinity and occupational health and safety in high risk occupations

    PubMed Central

    Stergiou-Kita, Mary; Mansfield, Elizabeth; Bezo, Randy; Colantonio, Angela; Garritano, Enzo; Lafrance, Marc; Lewko, John; Mantis, Steve; Moody, Joel; Power, Nicole; Theberge, Nancy; Westwood, Eleanor; Travers, Krista

    2016-01-01

    The workplace is a key setting where gender issues and organizational structures may influence occupational health and safety practices. The enactment of dominant norms of masculinity in high risk occupations can be particularly problematic, as it exposes men to significant risks for injuries and fatalities. To encourage multi-disciplinary collaborations and advance knowledge in the intersecting areas of gender studies, men’s health, work and workplace health and safety, a national network of thirteen researchers and health and safety stakeholders completed a critical literature review examining the intersection between masculinities and men’s workplace health and safety in order to: (i) account for research previously undertaken in this area; (ii) identify themes that may inform our understanding of masculinity and workplace health and safety and; (iii) identify research and practice gaps in relation to men’s workplace health and safety. In this paper we present key themes from this review. Recommendations are made regarding: (i) how to define gender; (ii) how to attend to and identify how masculinities may influence workers’ identities, perceptions of occupational risks and how institutionalized practices can reinforce norms of masculinity; (iii) the importance of considering how masculinities may intersect with other variables (e.g. historical context, age, class, race, geographical location) and; (iv) the added significance of present-day labour market forces on men’s occupational health and safety. PMID:27239098

  13. Safety profile of Tysabri: international risk management plan.

    PubMed

    Iaffaldano, P; D'Onghia, M; Trojano, Maria

    2009-10-01

    Therapeutic monoclonal antibodies are potent new tools for a molecular targeted approach to modify the course of multiple sclerosis (MS). Natalizumab is a monoclonal antibody targeted against alpha-4 integrin that has proved to be very effective in the treatment of MS. It is well tolerated, although severe side effects have been reported that have conditioned its use as a second-line drug for the treatment of MS. The clinical benefit of natalizumab should be weighed carefully against the potential risk of serious adverse events. Therefore, risk management plans have already been developed in order to prevent or minimise risks relating to natalizumab. Data so far obtained from these observational programs confirm the already demonstrated risk-benefit profile of natalizumab in clinical trials.

  14. Women with Epilepsy: Drug Risks and Safety During Pregnancy

    MedlinePlus

    ... pregnancy is related to three major birth defects: neural tube defects, facial clefts, and hypospadias. This last defect ... in the first trimester lowers the risk of neural tube defects and facial clefts. The evidence is weak ...

  15. Risk and Safety in Post-Soviet Russia

    DTIC Science & Technology

    2008-09-01

    annual equivalent doses to the population in 1995 (mrem/year). Type of Radiation Seversk Samus settlement Orlovka village External 7.78 0.01 0.01...the surrounding countryside. Risk of Death Seversk Samus Orlovka 4x10-" 8x lOŘ 2X10Ř 90 12.0: RADIATION RISK RESULTING FROM NUCLEAR TESTS AT

  16. Understanding safety and production risks in rail engineering planning and protection.

    PubMed

    Wilson, John R; Ryan, Brendan; Schock, Alex; Ferreira, Pedro; Smith, Stuart; Pitsopoulos, Julia

    2009-07-01

    Much of the published human factors work on risk is to do with safety and within this is concerned with prediction and analysis of human error and with human reliability assessment. Less has been published on human factors contributions to understanding and managing project, business, engineering and other forms of risk and still less jointly assessing risk to do with broad issues of 'safety' and broad issues of 'production' or 'performance'. This paper contains a general commentary on human factors and assessment of risk of various kinds, in the context of the aims of ergonomics and concerns about being too risk averse. The paper then describes a specific project, in rail engineering, where the notion of a human factors case has been employed to analyse engineering functions and related human factors issues. A human factors issues register for potential system disturbances has been developed, prior to a human factors risk assessment, which jointly covers safety and production (engineering delivery) concerns. The paper concludes with a commentary on the potential relevance of a resilience engineering perspective to understanding rail engineering systems risk. Design, planning and management of complex systems will increasingly have to address the issue of making trade-offs between safety and production, and ergonomics should be central to this. The paper addresses the relevant issues and does so in an under-published domain - rail systems engineering work.

  17. Children at risk: predictors of car safety seat misuse in Ontario.

    PubMed

    Snowdon, Anne W; Hussein, Abdulkadir A; Ahmed, S Ejaz

    2008-07-01

    When used correctly, child safety seats can reduce the risk of death and serious injury by 54% in toddlers and 71% in infants [National Highway Traffic Safety Administration (NHTSA), 2001. Traffic Safety Facts 2001. Children (DOT HS 809 471), U.S. Department of Transportation, Washington, DC]. The purpose of this study was to identify factors that predict correct use of car safety seats. The study was conducted in a large urban area in Southwestern Ontario and a small urban and rural area in Northern Ontario. Participants were 1263 caregivers who completed a self-report survey on their knowledge and use of car safety seats for their children (N=2199). Logistic regression analysis revealed that female caregivers, caregivers with higher levels of education, and caregivers who reported that finding information about the correct use of child safety seats was "difficult" were more likely to report correctly using car safety seats. The results also showed that children aged 7 months to 8 years old had substantially lower odds of being in the correct car safety seat compared to children aged 6 months or younger, or children aged 9 years or older. The high risk nature of misuse of child seats for infants and younger children may be an important cue to action for health professionals to develop comprehensive prevention strategies.

  18. Proposal of a risk-factor-based analytical approach for integrating occupational health and safety into project risk evaluation.

    PubMed

    Badri, Adel; Nadeau, Sylvie; Gbodossou, André

    2012-09-01

    Excluding occupational health and safety (OHS) from project management is no longer acceptable. Numerous industrial accidents have exposed the ineffectiveness of conventional risk evaluation methods as well as negligence of risk factors having major impact on the health and safety of workers and nearby residents. Lack of reliable and complete evaluations from the beginning of a project generates bad decisions that could end up threatening the very existence of an organization. This article supports a systematic approach to the evaluation of OHS risks and proposes a new procedure based on the number of risk factors identified and their relative significance. A new concept called risk factor concentration along with weighting of risk factor categories as contributors to undesirable events are used in the analytical hierarchy process multi-criteria comparison model with Expert Choice(©) software. A case study is used to illustrate the various steps of the risk evaluation approach and the quick and simple integration of OHS at an early stage of a project. The approach allows continual reassessment of criteria over the course of the project or when new data are acquired. It was thus possible to differentiate the OHS risks from the risk of drop in quality in the case of the factory expansion project.

  19. Additional Studies of the Criticality Safety of Failed Used Nuclear Fuel

    SciTech Connect

    Marshall, William BJ J; Wagner, John C

    2013-01-01

    Commercial used nuclear fuel (UNF) in the United States is expected to remain in storage for periods potentially greater than 40 years. Extended storage (ES) time and irradiation to high-burnup values (>45 GWd/t) may increase the potential for fuel failure during normal and accident conditions involving storage and transportation. Fuel failure, depending on the severity, could result in changes to the geometric configuration of the fuel, which has safety and regulatory implications. The likelihood and extent of fuel reconfiguration and its impact on the safety of the UNF is not well understood. The objective of this work is to assess and quantify the impact of fuel reconfiguration due to fuel failure on criticality safety of UNF in storage and transportation casks. Criticality analyses are conducted considering representative UNF designs covering a range of enrichments and burnups in multiple cask systems. Prior work developed a set of failed fuel configuration categories and specific configurations were evaluated to understand trends and quantify the consequences of worst-case potential reconfiguration progressions. These results will be summarized here and indicate that the potential impacts on subcriticality can be rather significant for certain configurations (e.g., >20% keff). It can be concluded that the consequences of credible fuel failure configurations from ES or transportation following ES are manageable (e.g., <5% keff). The current work expands on these efforts and examines some modified scenarios and modified approaches to investigate the effectiveness of some techniques for reducing the calculated increase in keff. The areas included here are more realistic modeling of some assembly types and the effect of reconfiguration of some assemblies in the storage and transportation canister.

  20. Risk analysis of Safety Service Patrol (SSP) systems in Virginia.

    PubMed

    Dickey, Brett D; Santos, Joost R

    2011-12-01

    The transportation infrastructure is a vital backbone of any regional economy as it supports workforce mobility, tourism, and a host of socioeconomic activities. In this article, we specifically examine the incident management function of the transportation infrastructure. In many metropolitan regions, incident management is handled primarily by safety service patrols (SSPs), which monitor and resolve roadway incidents. In Virginia, SSP allocation across highway networks is based typically on average vehicle speeds and incident volumes. This article implements a probabilistic network model that partitions "business as usual" traffic flow with extreme-event scenarios. Results of simulated network scenarios reveal that flexible SSP configurations can improve incident resolution times relative to predetermined SSP assignments.

  1. Do Health Professionals Need Additional Competencies for Stratified Cancer Prevention Based on Genetic Risk Profiling?

    PubMed Central

    Chowdhury, Susmita; Henneman, Lidewij; Dent, Tom; Hall, Alison; Burton, Alice; Pharoah, Paul; Pashayan, Nora; Burton, Hilary

    2015-01-01

    There is growing evidence that inclusion of genetic information about known common susceptibility variants may enable population risk-stratification and personalized prevention for common diseases including cancer. This would require the inclusion of genetic testing as an integral part of individual risk assessment of an asymptomatic individual. Front line health professionals would be expected to interact with and assist asymptomatic individuals through the risk stratification process. In that case, additional knowledge and skills may be needed. Current guidelines and frameworks for genetic competencies of non-specialist health professionals place an emphasis on rare inherited genetic diseases. For common diseases, health professionals do use risk assessment tools but such tools currently do not assess genetic susceptibility of individuals. In this article, we compare the skills and knowledge needed by non-genetic health professionals, if risk-stratified prevention is implemented, with existing competence recommendations from the UK, USA and Europe, in order to assess the gaps in current competences. We found that health professionals would benefit from understanding the contribution of common genetic variations in disease risk, the rationale for a risk-stratified prevention pathway, and the implications of using genomic information in risk-assessment and risk management of asymptomatic individuals for common disease prevention. PMID:26068647

  2. Do Health Professionals Need Additional Competencies for Stratified Cancer Prevention Based on Genetic Risk Profiling?

    PubMed

    Chowdhury, Susmita; Henneman, Lidewij; Dent, Tom; Hall, Alison; Burton, Alice; Pharoah, Paul; Pashayan, Nora; Burton, Hilary

    2015-06-09

    There is growing evidence that inclusion of genetic information about known common susceptibility variants may enable population risk-stratification and personalized prevention for common diseases including cancer. This would require the inclusion of genetic testing as an integral part of individual risk assessment of an asymptomatic individual. Front line health professionals would be expected to interact with and assist asymptomatic individuals through the risk stratification process. In that case, additional knowledge and skills may be needed. Current guidelines and frameworks for genetic competencies of non-specialist health professionals place an emphasis on rare inherited genetic diseases. For common diseases, health professionals do use risk assessment tools but such tools currently do not assess genetic susceptibility of individuals. In this article, we compare the skills and knowledge needed by non-genetic health professionals, if risk-stratified prevention is implemented, with existing competence recommendations from the UK, USA and Europe, in order to assess the gaps in current competences. We found that health professionals would benefit from understanding the contribution of common genetic variations in disease risk, the rationale for a risk-stratified prevention pathway, and the implications of using genomic information in risk-assessment and risk management of asymptomatic individuals for common disease prevention.

  3. Lawn Care Pesticides. Risks Remain Uncertain While Prohibited Safety Claims Continue

    DTIC Science & Technology

    1990-03-23

    United States General Accounting Office Report to the Chairman, SubcommitteeGAO on Toxic Substances, Environmental AD -A280 721 Oversight, Research...vides to the public about the safety of its products, federal enforcement actions taken against lawn care pesticide safety advertising claims, and...in reassessing the risks of these pesticides. FIFRA also authorizes EPA to take enforcement action against advertising claims made by pesticide

  4. Assessing patient safety risk before the injury occurs: an introduction to sociotechnical probabilistic risk modelling in health care

    PubMed Central

    Marx, D; Slonim, A

    2003-01-01

    Since 1 July 2001 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has required each accredited hospital to conduct at least one proactive risk assessment annually. Failure modes and effects analysis (FMEA) was recommended as one tool for conducting this task. This paper examines the limitations of FMEA and introduces a second tool used by the aviation and nuclear industries to examine low frequency, high impact events in complex systems. The adapted tool, known as sociotechnical probabilistic risk assessment (ST-PRA), provides an alternative for proactively identifying, prioritizing, and mitigating patient safety risk. The uniqueness of ST-PRA is its ability to model combinations of equipment failures, human error, at risk behavioral norms, and recovery opportunities through the use of fault trees. While ST-PRA is a complex, high end risk modelling tool, it provides an opportunity to visualize system risk in a manner that is not possible through FMEA. PMID:14645893

  5. Assessing patient safety risk before the injury occurs: an introduction to sociotechnical probabilistic risk modelling in health care.

    PubMed

    Marx, D A; Slonim, A D

    2003-12-01

    Since 1 July 2001 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has required each accredited hospital to conduct at least one proactive risk assessment annually. Failure modes and effects analysis (FMEA) was recommended as one tool for conducting this task. This paper examines the limitations of FMEA and introduces a second tool used by the aviation and nuclear industries to examine low frequency, high impact events in complex systems. The adapted tool, known as sociotechnical probabilistic risk assessment (ST-PRA), provides an alternative for proactively identifying, prioritizing, and mitigating patient safety risk. The uniqueness of ST-PRA is its ability to model combinations of equipment failures, human error, at risk behavioral norms, and recovery opportunities through the use of fault trees. While ST-PRA is a complex, high end risk modelling tool, it provides an opportunity to visualize system risk in a manner that is not possible through FMEA.

  6. Use of System Safety Risk Assessments for the Space Shuttle Reusable Solid Rocket Motor (RSRM)

    NASA Technical Reports Server (NTRS)

    Greenhalgh, Phillip O.; McCool, Alex (Technical Monitor)

    2001-01-01

    This paper discusses the System Safety approach used to assess risk for the Space Shuttle Reusable Solid Rocket Motor (RSRM). Previous to the first RSRM flight in the fall of 1988, all systems were analyzed extensively to assure that hazards were identified, assessed and that the baseline risk was understood and appropriately communicated. Since the original RSRM baseline was established, Thiokol and NASA have implemented a number of initiatives that have further improved the RSRM. The robust design, completion of rigorous testing and flight success of the RSRM has resulted in a wise reluctance to make changes. One of the primary assessments required to accompany the documentation of each proposed change and aid in the decision making process is a risk assessment. Documentation supporting proposed changes, including the risk assessments from System Safety, are reviewed and assessed by Thiokol and NASA technical management. After thorough consideration, approved changes are implemented adding improvements to and reducing risk of the Space Shuttle RSRM.

  7. Safety Planning Intervention: A Brief Intervention to Mitigate Suicide Risk

    ERIC Educational Resources Information Center

    Stanley, Barbara; Brown, Gregory K.

    2012-01-01

    The usual care for suicidal patients who are seen in the emergency department (ED) and other emergency settings is to assess level of risk and refer to the appropriate level of care. Brief psychosocial interventions such as those administered to promote lower alcohol intake or to reduce domestic violence in the ED are not typically employed for…

  8. Segregated Schools in Segregated Societies: Issues of Safety and Risk

    ERIC Educational Resources Information Center

    Leonard, Madeleine

    2006-01-01

    In segregated societies such as Northern Ireland, schools may become sites of risk rather than sites of learning. This is particularly likely to be the case in interface areas, which are demarcated by peace-lines and other symbolic boundaries. Drawing on maps and focus group discussions with teenagers from interface areas in North Belfast, the…

  9. Evaluation of Herbal Medicines: Value Addition to Traditional Medicines Through Metabolism, Pharmacokinetic and Safety Studies.

    PubMed

    Thelingwani, Roslyn; Masimirembwa, Collen

    2014-01-01

    The safety and efficacy of herbal medicines remain major issues of concern especially in the developing world where the use is high. The World Health Organisation estimates up to 80% of the population in Africa relies on herbal medicines for treatment of many diseases. Minimum safety evaluations need to be done for both the herbal and conventional drugs, in particular when there is a high likelihood of co-administration. This is particularly important in Africa where there is increased access to antiretrovirals in the treatment of HIV/AIDS, which are being used in a population background characterized by rampant use of herbal medicines. Many techniques used in the discovery and evaluation of conventional drugs can be adapted to herbal medicines. Such evaluations will add value to herbal medicines as doctors and patients will be better informed on which drugs and herbal medicines to take or not take together. This can also lead to the adoption of guidelines by regulatory agents such as the European Medicines Agency (EMA), Food and Drug Administration (FDA) and governmental agencies controlling the use of medicines. Of current interest is the evaluation of drug-herb interactions (DHI) involving the absorption, distribution, metabolism and excretion (ADME) of medicines where there is a promising possibility to adopt the current FDA and EMA guidelines on the evaluation of herbal medicines for drug-drug interactions (DDI). In this review we demonstrate progress made so far in DHI and point to possible future developments that will contribute to the safe use of herbal medicines.

  10. A risk characterization of safety research areas for Integral Fast Reactor program planning

    SciTech Connect

    Mueller, C.J.; Cahalan, J.E.; Hill, D.J.; Kramer, J.M.; Marchaterre, J.F.; Pedersen, D.R.; Sevy, R.H.; Tilbrook, R.W.; Wei, T.Y.; Wright, A.E.

    1988-01-01

    This paper characterizes the areas of Integral Fast Reactor (IFR) safety research in terms of their importance in addressing the risk of core disruption sequences for innovative designs. Such sequences have traditionally been determined to constitute the primary risk to public health and safety. All core disruption sequences are folded into four fault categories: classic unprotected (unscrammed) events; loss of decay heat; local fault propagation; and failure of critical reactor structures. Event trees are used to describe these sequences and the areas in the IFR Safety and related Base Technology research programs are discussed with respect to their relevance in addressing the key issues in preventing or delimiting core disruptive sequences. Thus a measure of potential for risk reduction is obtained for guidance in establishing research priorites.

  11. Crash risk and aberrant driving behaviors among bus drivers: the role of personality and attitudes towards traffic safety.

    PubMed

    Mallia, Luca; Lazuras, Lambros; Violani, Cristiano; Lucidi, Fabio

    2015-06-01

    Several studies have shown that personality traits and attitudes toward traffic safety predict aberrant driving behaviors and crash involvement. However, this process has not been adequately investigated in professional drivers, such as bus drivers. The present study used a personality-attitudes model to assess whether personality traits predicted aberrant self-reported driving behaviors (driving violations, lapses, and errors) both directly and indirectly, through the effects of attitudes towards traffic safety in a large sample of bus drivers. Additionally, the relationship between aberrant self-reported driving behaviors and crash risk was also assessed. Three hundred and one bus drivers (mean age=39.1, SD=10.7 years) completed a structured and anonymous questionnaire measuring personality traits, attitudes toward traffic safety, self-reported aberrant driving behaviors (i.e., errors, lapses, and traffic violations), and accident risk in the last 12 months. Structural equation modeling analysis revealed that personality traits were associated to aberrant driving behaviors both directly and indirectly. In particular altruism, excitement seeking, and normlessness directly predicted bus drivers' attitudes toward traffic safety which, in turn, were negatively associated with the three types of self-reported aberrant driving behaviors. Personality traits relevant to emotionality directly predicted bus drivers' aberrant driving behaviors, without any mediation of attitudes. Finally, only self-reported violations were related to bus drivers' accident risk. The present findings suggest that the hypothesized personality-attitudes model accounts for aberrant driving behaviors in bus drivers, and provide the empirical basis for evidence-based road safety interventions in the context of public transport.

  12. [New international initiatives to create systems of effective risk prediction and food safety].

    PubMed

    Efimochkinal, N R; Bagryantseva, E C; Dupouy, E C; Khotimchenko, S A; Permyakov, E V; Sheveleva, S A; Arnautov, O V

    2016-01-01

    Ensuring food safety is one of the most important problems that is directly related to health protection of the population. The problem is particularly relevant on aglobalscale because ofincreasingnumberoffood-borne diseases andimportance of the health consequence early detection. In accordance with the position of the Codex Alimentarius Commission, food safety concept also includes quality. In this case, creation of the national, supranational and international early warning systems related to the food safety, designed with the purpose to prevent or minimize risks on different stages of the food value chain in various countries, regions and climate zones specific to national nutrition and lifestyle in different groups of population, gains particular importance. The article describes the principles and working examples of international, supranational and national food safety early warning systems. Great importance is given to the hazards of microbial origin - emergent pathogens. Example of the rapid reaction to the appearance of cases, related to the melanin presence in infant formula, are presented. Analysis of the current food safety and quality control system in Russian Federation shows that main improvements are mostly related to the development of the efficient monitoring, diagnostics and rapid alert procedures forfood safety on interregional and international levels that will allow to estimate real contamination of food with the most dangerous pathogens, chemical and biological contaminants, and the development of the electronic database and scientifically proved algorithms for food safety and quality management for targeted prevention activities against existing and emerging microbiological and other etiology risks, and public health protection.

  13. Confounders in interpreting pathology for safety and risk assessment

    SciTech Connect

    Wolf, Douglas C. . E-mail: wolf.doug@epa.gov; Mann, Peter C.

    2005-02-01

    The contribution of pathology to toxicity assessment is invaluable but often not clearly understood. Pathology endpoints are the central response around which human health risk assessment is frequently determined; therefore, it is important that the general toxicology community understand current concepts and nomenclature of toxicologic pathology. Toxicologic pathology encompasses the study of changes in tissue morphology that help define the risk of exposure to xenobiotics. Toxicologic pathology is a discipline that has changed and adapted over time including methods of analysis and nomenclature of lesions. As risk assessments are updated for chemicals in commerce, frequently the older literature must be reviewed and reevaluated. When interpreting pathology data from animal studies, it is important to consider the biological significance of a lesion as well as its relationship to the ultimate adverse health effect. Assessing the potential for a chemical to cause harm to humans must include the examination of the entire pathology database in context of the study design, the mode of action of the chemical of concern, and using the most current interpretation of a lesion to determine the significance for human health effects of a particular tissue response.

  14. Confounders in interpreting pathology for safety and risk assessment.

    PubMed

    Wolf, Douglas C; Mann, Peter C

    2005-02-01

    The contribution of pathology to toxicity assessment is invaluable but often not clearly understood. Pathology endpoints are the central response around which human health risk assessment is frequently determined; therefore, it is important that the general toxicology community understand current concepts and nomenclature of toxicologic pathology. Toxicologic pathology encompasses the study of changes in tissue morphology that help define the risk of exposure to xenobiotics. Toxicologic pathology is a discipline that has changed and adapted over time including methods of analysis and nomenclature of lesions. As risk assessments are updated for chemicals in commerce, frequently the older literature must be reviewed and reevaluated. When interpreting pathology data from animal studies, it is important to consider the biological significance of a lesion as well as its relationship to the ultimate adverse health effect. Assessing the potential for a chemical to cause harm to humans must include the examination of the entire pathology database in context of the study design, the mode of action of the chemical of concern, and using the most current interpretation of a lesion to determine the significance for human health effects of a particular tissue response.

  15. Improvement in safety and cycle life of lithium-ion batteries by employing quercetin as an electrolyte additive

    NASA Astrophysics Data System (ADS)

    Lee, Meng-Lun; Li, Yu-Han; Yeh, Jien-Wei; Shih, Han C.

    2012-09-01

    Quercetin, an organic antioxidant, has been employed as an additive in lithium-ion cells to enhance the electrochemical performance to enhance the cycle life and the overcharging characteristics of LiPF6/EC + EMC + DMC (1 M) when used as an electrolyte. A LiCoO2/graphite full cell with 0.05% quercetin showed a significant improvement in safety associated with overcharging tolerance and thermal stability, without causing damage in C-rate capability, and even a small improvement in cycle life performance. The quercetin-containing lithium battery showed an improvement in its electrochemical properties with 92% capacity retention after 350 cycles from 2.8 to 4.3 V, at a rate of 1 C; compared to 85% capacity retention for a cell without quercetin operated under the same conditions. The electrochemical impedance spectroscopy (EIS) results for the LiCoO2 cathode show that the addition of 0.05% quercetin provides a significant suppression in the impedance of the cell after 60 cycles. The improvement might result from the formation of a passivation microstructure (from quercetin oxidation) on the electrode's surface. The quercetin-containing batteries provided long term cycling and a high safety performance, making them a viable power source for applications involving electric devices with significant safety requirements.

  16. Widespread non-additive and interaction effects within HLA loci modulate the risk of autoimmune diseases

    PubMed Central

    Lenz, Tobias L.; Deutsch, Aaron J.; Han, Buhm; Hu, Xinli; Okada, Yukinori; Eyre, Stephen; Knapp, Michael; Zhernakova, Alexandra; Huizinga, Tom W.J.; Abecasis, Goncalo; Becker, Jessica; Boeckxstaens, Guy E.; Chen, Wei-Min; Franke, Andre; Gladman, Dafna D.; Gockel, Ines; Gutierrez-Achury, Javier; Martin, Javier; Nair, Rajan P.; Nöthen, Markus M.; Onengut-Gumuscu, Suna; Rahman, Proton; Rantapää-Dahlqvist, Solbritt; Stuart, Philip E.; Tsoi, Lam C.; Van Heel, David A.; Worthington, Jane; Wouters, Mira M.; Klareskog, Lars; Elder, James T.; Gregersen, Peter K.; Schumacher, Johannes; Rich, Stephen S.; Wijmenga, Cisca; Sunyaev, Shamil R.; de Bakker, Paul I.W.; Raychaudhuri, Soumya

    2015-01-01

    Human leukocyte antigen (HLA) genes confer strong risk for autoimmune diseases on a log-additive scale. Here we speculated that differences in autoantigen binding repertoires between a heterozygote’s two expressed HLA variants may result in additional non-additive risk effects. We tested non-additive disease contributions of classical HLA alleles in patients and matched controls for five common autoimmune diseases: rheumatoid arthritis (RA, Ncases=5,337), type 1 diabetes (T1D, Ncases=5,567), psoriasis vulgaris (Ncases=3,089), idiopathic achalasia (Ncases=727), and celiac disease (Ncases=11,115). In four out of five diseases, we observed highly significant non-additive dominance effects (RA: P=2.5×1012; T1D: P=2.4×10−10; psoriasis: P=5.9×10−6; celiac disease: P=1.2×10−87). In three of these diseases, the dominance effects were explained by interactions between specific classical HLA alleles (RA: P=1.8×10−3; T1D: P=8.6×1027; celiac disease: P=6.0×10−100). These interactions generally increased disease risk and explained moderate but significant fractions of phenotypic variance (RA: 1.4%, T1D: 4.0%, and celiac disease: 4.1%, beyond a simple additive model). PMID:26258845

  17. Gender Effects in Young Road Users on Road Safety Attitudes, Behaviors and Risk Perception

    PubMed Central

    Cordellieri, Pierluigi; Baralla, Francesca; Ferlazzo, Fabio; Sgalla, Roberto; Piccardi, Laura; Giannini, Anna Maria

    2016-01-01

    In the present study, we investigated gender-related effects on road safety attitudes in 2681 young drivers (1458 males, 54.4%; aged 18–22) who filled out several scales assessing attitudes toward road safety issues, driving behavior in specific hypothetical situations, accident risk perception, and concerns about such a risk. We focused only on young drivers to better understand the role of gender in road safety attitudes in a period of life in which risky behaviors are widespread for males and females. Indeed, there is still no agreement as to the nature of these gender differences. According to some authors, the effects of gender on being involved in a crash due to driving skills are either non-existent or largely explained by differences in alcohol consumption. In our study, we found gender differences in road safety attitudes (i.e., “negative attitude toward traffic rules and risky driving”; “negative attitude toward drugs and alcohol” and “tolerance toward speeding”) and in driver behavior (i.e., “errors in inattentive driving” and “driving violations”). This result is consistent in all drivers coming from nine different European countries. Our analyses yielded an important finding concerning risk perception. The results indicate that the level of risk perception during driving is the same for males and females. However, these two groups differ in the level of concern about this risk, with males being less concerned about the risk of a road accident. This suggests that the main difference between these two groups is not strictly related to judgment of the perceived risk probability but rather to the level of concern experienced about the consequences of the risk. This difference between risk perception and worry could explain differences in the frequency of car accidents in the two groups. The present findings may provide new insights for the development of gender-based prevention programs. PMID:27729877

  18. Integrated risk reduction framework to improve railway hazardous materials transportation safety.

    PubMed

    Liu, Xiang; Saat, M Rapik; Barkan, Christopher P L

    2013-09-15

    Rail transportation plays a critical role to safely and efficiently transport hazardous materials. A number of strategies have been implemented or are being developed to reduce the risk of hazardous materials release from train accidents. Each of these risk reduction strategies has its safety benefit and corresponding implementation cost. However, the cost effectiveness of the integration of different risk reduction strategies is not well understood. Meanwhile, there has been growing interest in the U.S. rail industry and government to best allocate resources for improving hazardous materials transportation safety. This paper presents an optimization model that considers the combination of two types of risk reduction strategies, broken rail prevention and tank car safety design enhancement. A Pareto-optimality technique is used to maximize risk reduction at a given level of investment. The framework presented in this paper can be adapted to address a broader set of risk reduction strategies and is intended to assist decision makers for local, regional and system-wide risk management of rail hazardous materials transportation.

  19. Safety Planning for Military (SAFE MIL): rationale, design, and safety considerations of a randomized controlled trial to reduce suicide risk among psychiatric inpatients.

    PubMed

    Ghahramanlou-Holloway, Marjan; Brown, Gregory K; Currier, Glenn W; Brenner, Lisa; Knox, Kerry L; Grammer, Geoffrey; Carreno-Ponce, Jaime T; Stanley, Barbara

    2014-09-01

    Mental health related hospitalizations and suicide are both significant public health problems within the United States Department of Defense (DoD). To date, few evidence-based suicide prevention programs have been developed for delivery to military personnel and family members admitted for psychiatric inpatient care due to suicidal self-directed violence. This paper describes the rationale and detailed methodology for a study called Safety Planning for Military (SAFE MIL) which involves a randomized controlled trial (RCT) at the largest military treatment facility in the United States. The purpose of this study is to test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning Intervention (Stanley and Brown, 2012). Primary outcomes, measured by blinded assessors at one and six months following psychiatric discharge, include suicide ideation, suicide-related coping, and attitudes toward help seeking. Additionally, given the study's focus on a highly vulnerable patient population, a description of safety considerations for human subjects' participation is provided. Based on this research team's experience, the implementation of an infrastructure in support of RCT research within DoD settings and the processing of regulatory approvals for a clinical trial with high risk suicidal patients are expected to take up to 18-24 months. Recommendations for expediting the advancement of clinical trials research within the DoD are provided in order to maximize cost efficacy and minimize the research to practice gap.

  20. Behavioral risk factors associated with listeriosis in the home: a review of consumer food safety studies.

    PubMed

    Evans, Ellen W; Redmond, Elizabeth C

    2014-03-01

    Listeria monocytogenes causes human listeriosis, which is associated with the highest hospitalization and mortality rates of all foodborne illnesses. In recent years, the incidence of listeriosis has doubled in Europe, almost exclusively among older adults (≥ 60 years of age). Food safety factors associated with increased risk of listeriosis include lack of adherence to "use by" dates and ineffective refrigerated storage of foods. Consequently, older adult consumers' implementation of safe food practices should be evaluated. This article is a review of consumer food safety cognitive and behavioral data relating to risk factors associated with listeriosis in the home as reported in 165 consumer food safety studies. Overall, only 41% of studies included assessment of consumer cognitive or behavioral data associated with listeriosis; of these studies 59% included data on safe refrigeration, 54% included data on storage time for opened ready-to-eat foods, and 49% included data on adherence to use-by dates. In most (83%) of the studies, survey-based data collection methods (questionnaires/interviews) were used; thus, the majority of findings were based on self-report (74%) and knowledge (44%). Observation (31%) and focus groups (12%) were less commonly used, resulting in a lack of actual behaviors and attitudinal data relating to listeriosis risk factors. Only 7% of studies included food safety data for older adults. Although older adults may fail to implement recommended practices, this review reveals a need for in-depth research to determine food safety attitudes and actual behaviors of older adults in conjunction with knowledge and selfreport of practices linked to increased risks of listeriosis. Such data combined with review findings would inform targeted food safety education to reduce risks associated with listeriosis in the home.

  1. High-risk food consumption and food safety practices in a Canadian community.

    PubMed

    Nesbitt, Andrea; Majowicz, Shannon; Finley, Rita; Marshall, Barbara; Pollari, Frank; Sargeant, Jan; Ribble, Carl; Wilson, Jeff; Sittler, Nancy

    2009-12-01

    Understanding consumers' high-risk food consumption patterns and food handling in the home is critical in reducing foodborne illness. This study was conducted to determine the prevalence of unsafe food practices of individuals in a Canadian-based population, specifically, high-risk food consumption and home food safety practices. During November 2005 to March 2006, a sample of 2,332 randomly selected residents of the Waterloo Region (Ontario, Canada) participated in a telephone survey of food consumption and food safety. Questions covered consumption of high-risk foods, hand washing practices, safe food handling knowledge, source of food safety education, meat thawing and cooking practices, cross-contamination after raw food preparation, and refrigeration temperatures. Certain high-risk food behaviors were common among respondents and were associated with demographic characteristics. In general, unsafe practices increased with increasing total annual household income level. Males were more likely to report engaging in risky practices than were females. Specific high-risk behaviors of public health concern were reported by elderly individuals (e.g., consuming undercooked eggs), children (e.g., consuming chicken nuggets), and rural residents (e.g., drinking unpasteurized milk). Respondents appeared to know proper food safety practices, but did not put them into practice. Thus, educational programs emphasizing specific practices to improve food safety should be directed to targeted audiences, and they should stress the importance of consumer behavior in the safety of foods prepared at home. Further investigation of consumer perceptions is needed to design such programs to effectively increase the implementation of safe food practices by consumers.

  2. Applying Risk Society Theory to findings of a scoping review on caregiver safety.

    PubMed

    Macdonald, Marilyn; Lang, Ariella

    2014-03-01

    Chronic Illness represents a growing concern in the western world and individuals living with chronic illness are primarily managed at home by family caregivers. A scoping review of the home-care literature (2004-2009; updated with review articles from 2010 to January 2013) on the topic of the caregiver revealed that this group experiences the following safety-related concerns: caregivers are conscripted to the role, experience economic hardship, risk being abused as well as abusing, and may well become patients themselves. Methodology and methods used in the scoping review are presented as well as a brief overview of the findings. The concepts of risk and safety are defined. Risk Society Theory is introduced and used as a lens to view the findings, and to contribute to an understanding of the construction of risk in contemporary health-care.

  3. Risk-Based Fire Safety Experiment Definition for Manned Spacecraft

    NASA Technical Reports Server (NTRS)

    Apostolakis, G. E.; Ho, V. S.; Marcus, E.; Perry, A. T.; Thompson, S. L.

    1989-01-01

    Risk methodology is used to define experiments to be conducted in space which will help to construct and test the models required for accident sequence identification. The development of accident scenarios is based on the realization that whether damage occurs depends on the time competition of two processes: the ignition and creation of an adverse environment, and the detection and suppression activities. If the fire grows and causes damage faster than it is detected and suppressed, then an accident occurred. The proposed integrated experiments will provide information on individual models that apply to each of the above processes, as well as previously unidentified interactions and processes, if any. Initially, models that are used in terrestrial fire risk assessments are considered. These include heat and smoke release models, detection and suppression models, as well as damage models. In cases where the absence of gravity substantially invalidates a model, alternate models will be developed. Models that depend on buoyancy effects, such as the multizone compartment fire models, are included in these cases. The experiments will be performed in a variety of geometries simulating habitable areas, racks, and other spaces. These simulations will necessitate theoretical studies of scaling effects. Sensitivity studies will also be carried out including the effects of varying oxygen concentrations, pressures, fuel orientation and geometry, and air flow rates. The experimental apparatus described herein includes three major modules: the combustion, the fluids, and the command and power modules.

  4. The Addition of Vascular Calcification Scores to Traditional Risk Factors Improves Cardiovascular Risk Assessment in Patients with Chronic Kidney Disease

    PubMed Central

    Diouf, Momar; Temmar, Mohamed; Renard, Cédric; Choukroun, Gabriel; Massy, Ziad A.

    2015-01-01

    Background Although a variety of non-invasive methods for measuring cardiovascular (CV) risk (such as carotid intima media thickness, pulse wave velocity (PWV), coronary artery and aortic calcification scores (measured either by CT scan or X-ray) and the ankle brachial index (ABI)) have been evaluated separately in chronic kidney disease (CKD) cohorts, few studies have evaluated these methods simultaneously. Here, we looked at whether the addition of non-invasive methods to traditional risk factors (TRFs) improves prediction of the CV risk in patients at different CKD stages. Methods We performed a prospective, observational study of the relationship between the outputs of non-invasive measurement methods on one hand and mortality and CV outcomes in 143 patients at different CKD stages on the other. During the follow-up period, 44 patients died and 30 CV events were recorded. We used Cox models to calculate the relative risk for outcomes. To assess the putative clinical value of each method, we also determined the categorical net reclassification improvement (NRI) and the integrated discrimination improvement. Results Vascular calcification, PWV and ABI predicted all-cause mortality and CV events in univariate analyses. However, after adjustment for TRFs, only aortic and coronary artery calcification scores were found to be significant, independent variables. Moreover, the addition of coronary artery calcification scores to TRFs improved the specificity of prediction by 20%. Conclusion The addition of vascular calcification scores (especially the coronary artery calcification score) to TRFs appears to improve CV risk assessment in a CKD population. PMID:26181592

  5. Evaluating criticality safety of TRU waste with NDA measurements and risk analyses

    SciTech Connect

    Hochel, R.C.; Hofstetter, K.J.; Sigg, R.A.; Winn, W.G.; Chay, S.C.

    1994-09-01

    The criticality safety of {sup 239}Pu in 55-gal. drums stored in TRU waste containers (concrete culverts) was evaluated using NDA neutron and gamma measurements and risk analyses. The neutron measurements yielded a {sup 239}Pu mass and k{sub eff} for a culvert, which contains up to 14 drums. The gamma measurements helped reveal and correct for any interfering neutron sources in the waste. Conservation probabilistic risk analyses were developed for both drums and culverts.

  6. Bayesian Safety Risk Modeling of Human-Flightdeck Automation Interaction

    NASA Technical Reports Server (NTRS)

    Ancel, Ersin; Shih, Ann T.

    2015-01-01

    Usage of automatic systems in airliners has increased fuel efficiency, added extra capabilities, enhanced safety and reliability, as well as provide improved passenger comfort since its introduction in the late 80's. However, original automation benefits, including reduced flight crew workload, human errors or training requirements, were not achieved as originally expected. Instead, automation introduced new failure modes, redistributed, and sometimes increased workload, brought in new cognitive and attention demands, and increased training requirements. Modern airliners have numerous flight modes, providing more flexibility (and inherently more complexity) to the flight crew. However, the price to pay for the increased flexibility is the need for increased mode awareness, as well as the need to supervise, understand, and predict automated system behavior. Also, over-reliance on automation is linked to manual flight skill degradation and complacency in commercial pilots. As a result, recent accidents involving human errors are often caused by the interactions between humans and the automated systems (e.g., the breakdown in man-machine coordination), deteriorated manual flying skills, and/or loss of situational awareness due to heavy dependence on automated systems. This paper describes the development of the increased complexity and reliance on automation baseline model, named FLAP for FLightdeck Automation Problems. The model development process starts with a comprehensive literature review followed by the construction of a framework comprised of high-level causal factors leading to an automation-related flight anomaly. The framework was then converted into a Bayesian Belief Network (BBN) using the Hugin Software v7.8. The effects of automation on flight crew are incorporated into the model, including flight skill degradation, increased cognitive demand and training requirements along with their interactions. Besides flight crew deficiencies, automation system

  7. Development safety update reports and proposals for effective and efficient risk communication.

    PubMed

    Urushihara, Hisashi; Kawakami, Koji

    2010-05-01

    The periodic safety reporting to regulatory authorities is globally harmonized for postmarketing medicinal products by the International Conference on Harmonisation (ICH) guidelines, and is being extended for investigational drugs. To facilitate effective safety risk communication regarding investigational drugs, and to reduce duplicate periodic reporting to the US and EU by sponsors during development programmes, standardized Development Safety Update Reports (DSURs) are to be implemented in the near future. In this current opinion article, after extensively reviewing the relevant report from the CIOMS VII Working Group and the ICH draft guideline regarding DSURs, we discuss an effective and efficient approach to its application. To ensure effective risk communication, we recommend that DSURs be made available to all the ethics committees and participating investigators around the world for the purpose of continuing review during ongoing clinical trials. Furthermore, in order to maintain the consistency and integrity of safety information throughout the life-cycle of a drug, we believe it would be substantially more prudent and efficient to start a single, integrated, life-cycle periodic safety report covering both development and postmarketing, as proposed by the CIOMS VII Working Group, rather than maintain separate DSURs and Periodic Safety Update Reports, which can overlap considerably in content. To this end, we believe that the international regulatory community should undertake the new initiative for integrated periodic reporting immediately.

  8. Safety evaluation of disposable baby diapers using principles of quantitative risk assessment.

    PubMed

    Rai, Prashant; Lee, Byung-Mu; Liu, Tsung-Yun; Yuhui, Qin; Krause, Edburga; Marsman, Daniel S; Felter, Susan

    2009-01-01

    Baby diapers are complex products consisting of multiple layers of materials, most of which are not in direct contact with the skin. The safety profile of a diaper is determined by the biological properties of individual components and the extent to which the baby is exposed to each component during use. Rigorous evaluation of the toxicological profile and realistic exposure conditions of each material is important to ensure the overall safety of the diaper under normal and foreseeable use conditions. Quantitative risk assessment (QRA) principles may be applied to the safety assessment of diapers and similar products. Exposure to component materials is determined by (1) considering the conditions of product use, (2) the degree to which individual layers of the product are in contact with the skin during use, and (3) the extent to which some components may be extracted by urine and delivered to skin. This assessment of potential exposure is then combined with data from standard safety assessments of components to determine the margin of safety (MOS). This study examined the application of QRA to the safety evaluation of baby diapers, including risk assessments for some diaper ingredient chemicals for which establishment of acceptable and safe exposure levels were demonstrated.

  9. 76 FR 37131 - Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and... and Risk Management Advisory Committee. General Function of the Committees: To provide advice...

  10. Use of a systematic risk analysis method to improve safety in the production of paediatric parenteral nutrition solutions

    PubMed Central

    Bonnabry, P; Cingria, L; Sadeghipour, F; Ing, H; Fonzo-Christe, C; Pfister, R

    2005-01-01

    resulted in a significant risk reduction as shown by risk analysis. Residual failure opportunities were also quantified, allowing additional actions to be taken to reduce the risk of labelling mistakes. This study illustrates the usefulness of prospective risk analysis methods in healthcare processes. More systematic use of risk analysis is needed to guide continuous safety improvement of high risk activities. PMID:15805453

  11. Hazard and risk assessment for indirect potable reuse schemes: An approach for use in developing Water Safety Plans.

    PubMed

    Dominguez-Chicas, Angelina; Scrimshaw, Mark D

    2010-12-01

    This paper describes research undertaken to develop an approach for facilitating an initial hazard assessment and risk characterisation for a proposed indirect potable reuse scheme, as part of the water safety plan recommended by the World Health Organization. The process involved a description and evaluation of the catchment, which was the sewerage system supplying the sewage treatment works that would provide the effluent to supply the pilot scale indirect potable reuse water treatment plant. Hazards, sources and barriers throughout the proposed system were identified and evaluated. An initial assessment of the possible hazards, highlighted chemical hazards as predominating, and assessment of risks, using a heat map as output, categorised most hazards as medium or high risk. However, this outcome has been influenced by a precautionary approach which assigned a high likelihood to the occurrence of hazards where no data was available on their occurrence in the system. As more data becomes available, and the waster safety plan develops, it is anticipated that the risk heat map will become more specific. Additionally, high quality targets, to drinking water standards, have been set, although water from the potable reuse plant will be discharged to receiving waters where it will undergo natural attenuation prior to further treatment to potable standards before distribution. The assessment has demonstrated the usefulness of the approach where data is initially limited, in generating a heat map allowing for prioritisation of hazards to a practical level.

  12. Ultraviolet radiation and the athlete: risk, sun safety, and barriers to implementation of protective strategies.

    PubMed

    Jinna, Sphoorthi; Adams, Brian B

    2013-07-01

    Ultraviolet (UV) radiation plays a pivotal role in the development of both melanoma and non-melanoma skin cancers. Numerous factors potentially place athletes at high risk for developing these cancers. Various prevention strategies ameliorate this risk, including avoiding sun exposure during peak UV exposure hours, applying sunscreen with a sun protection factor of 30 or above before participating in outdoor sports, wearing hats and sunglasses, and reducing exposure with long pants and long-sleeve shirts. The literature, however, cites several barriers to these prevention approaches, including sports' competition rules, the lack of availability of sunscreen, and the lack of information about sun safety behaviors. Sun safety education programs prove effective in getting athletes to participate in prevention strategies. This article reviews the effect of UV radiation on athletes' skin and provides sports medicine clinicians with suggestions to improve the sun safety behaviors of their athletes.

  13. The Attitude of Civil Engineering Students towards Health and Safety Risk Management: A Case Study

    ERIC Educational Resources Information Center

    Petersen, A. K.; Reynolds, J. H.; Ng, L. W. T.

    2008-01-01

    The highest rate of accidents and injuries in British industries has been reported by the construction industry during the past decade. Since then stakeholders have recognised that a possible solution would be to inculcate a good attitude towards health and safety risk management in undergraduate civil engineering students and construction…

  14. How Children and Their Families Construct and Negotiate Risk, Safety and Danger

    ERIC Educational Resources Information Center

    Backett-Milburn, Kathryn; Harden, Jeni

    2004-01-01

    This article presents an analysis of the family context and everyday negotiations around risk, safety and danger between children and parents in four families drawn from a larger qualitative study. The challenges of analysing accounts from several family members are highlighted. Case study families are described; and fragments of their interwoven…

  15. FRAMEWORK FOR EVALUATION OF PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELS FOR USE IN SAFETY OR RISK ASSESSMENT

    EPA Science Inventory

    ABSTRACT

    Proposed applications of increasingly sophisticated biologically-based computational models, such as physiologically-based pharmacokinetic (PBPK) models, raise the issue of how to evaluate whether the models are adequate for proposed uses including safety or risk ...

  16. Violence and Legalized Brothel Prostitution in Nevada: Examining Safety, Risk, and Prostitution Policy

    ERIC Educational Resources Information Center

    Brents, Barbara G.; Hausbeck, Kathryn

    2005-01-01

    This article examines violence in legalized brothels in Nevada. Debates over prostitution policies in the United States have long focused on questions of safety and risk. These discourses inevitably invoke the coupling of violence and prostitution, though systematic examinations of the relationship between the two are sparse. This article explores…

  17. Extended Editorial: Research and Education in Reliability, Maintenance, Quality Control, Risk and Safety.

    ERIC Educational Resources Information Center

    Ramalhoto, M. F.

    1999-01-01

    Introduces a special theme journal issue on research and education in quality control, maintenance, reliability, risk analysis, and safety. Discusses each of these theme concepts and their applications to naval architecture, marine engineering, and industrial engineering. Considers the effects of the rapid transfer of research results through…

  18. Measures and Risk Indicators for Early Insight into Software Safety. Development of Fault-Tolerant Systems

    DTIC Science & Technology

    2008-10-01

    or contribute Measures and Risk Indicators for Early Insight Into Software Safety Kathleen Dangle and Linda Esker Fraunhofer Center – Maryland...Integration-based processes. E-mail: kdangle@fc-md.umd.edu Linda Esker is an FC- MD senior engineer, pro- viding expertise to gov- ernment programs in program

  19. Evaluation of the "Respect Not Risk" Firearm Safety Lesson for 3rd-Graders

    ERIC Educational Resources Information Center

    Liller, Karen D.; Perrin, Karen; Nearns, Jodi; Pesce, Karen; Crane, Nancy B.; Gonzalez, Robin R.

    2003-01-01

    The purpose of this study was to evaluate the MORE HEALTH "Respect Not Risk" Firearm Safety Lesson for 3rd-graders in Pinellas County, Florida. Six schools representative of various socioeconomic levels were selected as the test sites. Qualitative and quantitative data were collected. A total of 433 matched pretests/posttests were used…

  20. Commercial Vessel Safety. Risk Assessment Study. Volume I. Survey of Data for Marine Risk Assessment.

    DTIC Science & Technology

    1979-09-01

    involving barge transport of hazardous chemicals. Twenty three data systems in the following categories were reviewed: marine safety activities, marine ... pollution , marine traffic, vessel repair costs, vessel accidents, personnel injuries, vessel population, and vessel violation injuries. Discussions of

  1. Safety margins estimation method considering uncertainties within the risk-informed decision-making framework

    SciTech Connect

    Martorell, S.; Nebot, Y.; Vilanueva, J. F.; Carlos, S.; Serradell, V.

    2006-07-01

    The adoption by regulators of the risk-informed decision-making philosophy has opened the debate on the role of the deterministic and probabilistic approaches to support regulatory matters of concern to NPP safety (e.g. safety margins, core damage frequency, etc.). However, the typical separation of the application fields does not imply that both methods cannot benefit from each other. On the contrary, there is a growing interest nowadays aimed at developing methods for using probabilistic safety analysis results into requirements and assumptions in deterministic analysis and vice versa. Thus, it appears an interesting challenge for the technical community aimed at combining best estimate thermal-hydraulic codes with probabilistic techniques to produce an effective and feasible technology, which should provide more realistic, complete and logical measure of reactor safety. This paper proposes a new unified framework to estimate safety margins using a best estimate thermal-hydraulic code with help of data and models from a level 1 LPSA (low power and shutdown probabilistic safety assessment - PSA) and considering simultaneously the uncertainty associated to both probabilistic and thermal-hydraulic codes. It is also presented an application example that demonstrates the performance and significance of the method and the relevance of the results achieved to the safety of nuclear power plants. (authors)

  2. Risk-Informed Safety Assurance and Probabilistic Assessment of Mission-Critical Software-Intensive Systems

    NASA Technical Reports Server (NTRS)

    Guarro, Sergio B.

    2010-01-01

    This report validates and documents the detailed features and practical application of the framework for software intensive digital systems risk assessment and risk-informed safety assurance presented in the NASA PRA Procedures Guide for Managers and Practitioner. This framework, called herein the "Context-based Software Risk Model" (CSRM), enables the assessment of the contribution of software and software-intensive digital systems to overall system risk, in a manner which is entirely compatible and integrated with the format of a "standard" Probabilistic Risk Assessment (PRA), as currently documented and applied for NASA missions and applications. The CSRM also provides a risk-informed path and criteria for conducting organized and systematic digital system and software testing so that, within this risk-informed paradigm, the achievement of a quantitatively defined level of safety and mission success assurance may be targeted and demonstrated. The framework is based on the concept of context-dependent software risk scenarios and on the modeling of such scenarios via the use of traditional PRA techniques - i.e., event trees and fault trees - in combination with more advanced modeling devices such as the Dynamic Flowgraph Methodology (DFM) or other dynamic logic-modeling representations. The scenarios can be synthesized and quantified in a conditional logic and probabilistic formulation. The application of the CSRM method documented in this report refers to the MiniAERCam system designed and developed by the NASA Johnson Space Center.

  3. PAT-1 safety analysis report addendum author responses to request for additional information.

    SciTech Connect

    Weiner, Ruth F.; Schmale, David T.; Kalan, Robert J.; Akin, Lili A.; Miller, David Russell; Knorovsky, Gerald Albert; Yoshimura, Richard Hiroyuki; Lopez, Carlos; Harding, David Cameron; Jones, Perry L.; Morrow, Charles W.

    2010-09-01

    The Plutonium Air Transportable Package, Model PAT-1, is certified under Title 10, Code of Federal Regulations Part 71 by the U.S. Nuclear Regulatory Commission (NRC) per Certificate of Compliance (CoC) USA/0361B(U)F-96 (currently Revision 9). The National Nuclear Security Administration (NNSA) submitted SAND Report SAND2009-5822 to NRC that documented the incorporation of plutonium (Pu) metal as a new payload for the PAT-1 package. NRC responded with a Request for Additional Information (RAI), identifying information needed in connection with its review of the application. The purpose of this SAND report is to provide the authors responses to each RAI. SAND Report SAND2010-6106 containing the proposed changes to the Addendum is provided separately.

  4. Additive pressor effects of caffeine and stress in male medical students at risk for hypertension.

    PubMed

    Shepard, J D; al'Absi, M; Whitsett, T L; Passey, R B; Lovallo, W R

    2000-05-01

    The effects of caffeine on blood pressure (BP) and cortisol secretion were examined during elevated work stress in medical students at high versus low risk for hypertension. Among 31 male medical students who were regular consumers of caffeine, 20 were considered at low risk for hypertension (negative parental history and all screening BP < 125/78 mm Hg) and 11 at high risk based on epidemiologic criteria (positive parental history and average screening BPs between 125/78 and 139/89 mm Hg). Cortisol levels and ambulatory BP were measured with and without caffeine during two lectures (low work stress) and two exams (high work stress) in a randomized, double-blind, crossover trial. Caffeine consumption and exam stress increased cortisol secretion in both groups (P < .05). BP increased with caffeine or exam stress in both groups, low versus high risk, respectively (Caffeine: + 5/4 vs + 3/3 mm Hg; Stress: + 4/1 vs + 7/3 mm Hg; P < .05). The combination of stress and caffeine caused additive increases in BP (Low Risk + 9/5 mm Hg, High Risk + 10/6 mm Hg) such that 46% of high-risk participants had average systolic BP > or = 140 mm Hg. This combined effect of stress and caffeine on BP suggests that it may be beneficial for individuals at high risk for hypertension to refrain from the use of caffeinated beverages, particularly at times when work demands and attendant stressors are high. For the same reasons, recent intake of caffeine should be controlled in patients undergoing BP measurement for the diagnosis of hypertension.

  5. Risk and safety requirements for diagnostic and therapeutic procedures in allergology: World Allergy Organization Statement.

    PubMed

    Kowalski, Marek L; Ansotegui, Ignacio; Aberer, Werner; Al-Ahmad, Mona; Akdis, Mubeccel; Ballmer-Weber, Barbara K; Beyer, Kirsten; Blanca, Miguel; Brown, Simon; Bunnag, Chaweewan; Hulett, Arnaldo Capriles; Castells, Mariana; Chng, Hiok Hee; De Blay, Frederic; Ebisawa, Motohiro; Fineman, Stanley; Golden, David B K; Haahtela, Tari; Kaliner, Michael; Katelaris, Connie; Lee, Bee Wah; Makowska, Joanna; Muller, Ulrich; Mullol, Joaquim; Oppenheimer, John; Park, Hae-Sim; Parkerson, James; Passalacqua, Giovanni; Pawankar, Ruby; Renz, Harald; Rueff, Franziska; Sanchez-Borges, Mario; Sastre, Joaquin; Scadding, Glenis; Sicherer, Scott; Tantilipikorn, Pongsakorn; Tracy, James; van Kempen, Vera; Bohle, Barbara; Canonica, G Walter; Caraballo, Luis; Gomez, Maximiliano; Ito, Komei; Jensen-Jarolim, Erika; Larche, Mark; Melioli, Giovanni; Poulsen, Lars K; Valenta, Rudolf; Zuberbier, Torsten

    2016-01-01

    One of the major concerns in the practice of allergy is related to the safety of procedures for the diagnosis and treatment of allergic disease. Management (diagnosis and treatment) of hypersensitivity disorders involves often intentional exposure to potentially allergenic substances (during skin testing), deliberate induction in the office of allergic symptoms to offending compounds (provocation tests) or intentional application of potentially dangerous substances (allergy vaccine) to sensitized patients. These situations may be associated with a significant risk of unwanted, excessive or even dangerous reactions, which in many instances cannot be completely avoided. However, adverse reactions can be minimized or even avoided if a physician is fully aware of potential risk and is prepared to appropriately handle the situation. Information on the risk of diagnostic and therapeutic procedures in allergic diseases has been accumulated in the medical literature for decades; however, except for allergen specific immunotherapy, it has never been presented in a systematic fashion. Up to now no single document addressed the risk of the most commonly used medical procedures in the allergy office nor attempted to present general requirements necessary to assure the safety of these procedures. Following review of available literature a group of allergy experts within the World Allergy Organization (WAO), representing various continents and areas of allergy expertise, presents this report on risk associated with diagnostic and therapeutic procedures in allergology and proposes a consensus on safety requirements for performing procedures in allergy offices. Optimal safety measures including appropriate location, type and required time of supervision, availability of safety equipment, access to specialized emergency services, etc. for various procedures have been recommended. This document should be useful for allergists with already established practices and experience as well

  6. Relationship among Food-Safety Knowledge, Beliefs, and Risk-Reduction Behavior in University Students in Japan

    ERIC Educational Resources Information Center

    Takeda, Sayaka; Akamatsu, Rie; Horiguchi, Itsuko; Marui, Eiji

    2011-01-01

    Objective: To identify whether university students who have both food-safety knowledge and beliefs perform risk-reduction behaviors. Design: Cross-sectional research using a questionnaire that included food-safety knowledge, perceptions, risk-reduction behavior, stages for the selection of safer food based on the Transtheoretical Model, and…

  7. An Investigation into Risks Awareness and E-Safety Needs of Children on the Internet: A Study of Devon, UK

    ERIC Educational Resources Information Center

    Annansingh, Fenio; Veli, Thomas

    2016-01-01

    Purpose: This paper aims to investigate children interaction in cyberspace and their use of Web 2.0 technologies. It sought their perception of internet risks as well as their knowledge and experience with electronic safety (e-safety) measures. It also considered parents', teachers' and other stakeholders' perception of internet risks, e-safety…

  8. A Safety Checkpoint to Eliminate Cancer Risk of the Immune Evasive Cells Derived from Human Embryonic Stem Cells.

    PubMed

    He, Jingjin; Rong, Zhili; Fu, Xuemei; Xu, Yang

    2017-01-16

    Human embryonic stem cells (hESCs) hold great promise in the regenerative therapy of many currently untreatable human diseases. One of the key bottlenecks is the immune rejection of hESC-derived allografts by the recipient. To overcome this challenge, we have established new approaches to induce immune protection of hESC-derived allografts through the coexpression of immune suppressive molecules CTLA4-Ig and PD-L1. However, this in turn raises a safety concern of cancer risk because these hESC-derived cells can evade immune surveillance. To address this safety concern, we developed a safety checkpoint so that the immune evasive hESC-derived cells in the graft can be effectively eliminated if any cellular transformation is detected. In this context, we knock-in the suicidal gene herpes simplex virus thymidine kinase (HSVTK) into the constitutive HPRT locus of CP hESCs (knock-in hESCs expressing CTLA4-Ig and PD-L1), denoted CPTK hESCs. Employing humanized mice (Hu-mice) reconstituted with human immune system, we demonstrated that the CPTK hESC-derived cells are protected from immune rejection. In addition, CPTK hESC-derived cells can be efficiently eliminated in vitro and in vivo with FDA approved TK-targeting drug ganciclovir. Therefore, this new safety checkpoint improves the feasibility to use the immune evasive hESC-derived cells for regenerative medicine. Stem Cells 2017.

  9. Adiponectin Provides Additional Information to Conventional Cardiovascular Risk Factors for Assessing the Risk of Atherosclerosis in Both Genders

    PubMed Central

    Yoon, Jin-Ha; Kim, Sung-Kyung; Choi, Ho-June; Choi, Soo-In; Cha, So-Youn; Koh, Sang-Baek

    2013-01-01

    Background This study evaluated the relation between adiponectin and atherosclerosis in both genders, and investigated whether adiponectin provides useful additional information for assessing the risk of atherosclerosis. Methods We measured serum adiponectin levels and other cardiovascular risk factors in 1033 subjects (454 men, 579 women) from the Korean Genomic Rural Cohort study. Carotid intima–media-thickness (CIMT) was used as measure of atherosclerosis. Odds ratios (ORs) with 95% confidence intervals (95% CI) were calculated using multiple logistic regression, and receiver operating characteristic curves (ROC), the category-free net reclassification improvement (NRI) and integrated discrimination improvement (IDI) were calculated. Results After adjustment for conventional cardiovascular risk factors, such as age, waist circumference, smoking history, low-density and high-density lipoprotein cholesterol, triglycerides, systolic blood pressure and insulin resistance, the ORs (95%CI) of the third tertile adiponectin group were 0.42 (0.25–0.72) in men and 0.47 (0.29–0.75) in women. The area under the curve (AUC) on the ROC analysis increased significantly by 0.025 in men and 0.022 in women when adiponectin was added to the logistic model of conventional cardiovascular risk factors (AUC in men: 0.655 to 0.680, p = 0.038; AUC in women: 0.654 to 0.676, p = 0.041). The NRI was 0.32 (95%CI: 0.13–0.50, p<0.001), and the IDI was 0.03 (95%CI: 0.01–0.04, p<0.001) for men. For women, the category-free NRI was 0.18 (95%CI: 0.02–0.34, p = 0.031) and the IDI was 0.003 (95%CI: −0.002–0.008, p = 0.189). Conclusion Adiponectin and atherosclerosis were significantly related in both genders, and these relationships were independent of conventional cardiovascular risk factors. Furthermore, adiponectin provided additional information to conventional cardiovascular risk factors regarding the risk of atherosclerosis. PMID:24116054

  10. Assessing the additive risks of PSII herbicide exposure to the Great Barrier Reef.

    PubMed

    Lewis, Stephen E; Schaffelke, Britta; Shaw, Melanie; Bainbridge, Zoë T; Rohde, Ken W; Kennedy, Karen; Davis, Aaron M; Masters, Bronwyn L; Devlin, Michelle J; Mueller, Jochen F; Brodie, Jon E

    2012-01-01

    Herbicide residues have been measured in the Great Barrier Reef lagoon at concentrations which have the potential to harm marine plant communities. Monitoring on the Great Barrier Reef lagoon following wet season discharge show that 80% of the time when herbicides are detected, more than one are present. These herbicides have been shown to act in an additive manner with regards to photosystem-II inhibition. In this study, the area of the Great Barrier Reef considered to be at risk from herbicides is compared when exposures are considered for each herbicide individually and also for herbicide mixtures. Two normalisation indices for herbicide mixtures were calculated based on current guidelines and PSII inhibition thresholds. The results show that the area of risk for most regions is greatly increased under the proposed additive PSII inhibition threshold and that the resilience of this important ecosystem could be reduced by exposure to these herbicides.

  11. Probabilistic Causal Analysis for System Safety Risk Assessments in Commercial Air Transport

    NASA Technical Reports Server (NTRS)

    Luxhoj, James T.

    2003-01-01

    Aviation is one of the critical modes of our national transportation system. As such, it is essential that new technologies be continually developed to ensure that a safe mode of transportation becomes even safer in the future. The NASA Aviation Safety Program (AvSP) is managing the development of new technologies and interventions aimed at reducing the fatal aviation accident rate by a factor of 5 by year 2007 and by a factor of 10 by year 2022. A portfolio assessment is currently being conducted to determine the projected impact that the new technologies and/or interventions may have on reducing aviation safety system risk. This paper reports on advanced risk analytics that combine the use of a human error taxonomy, probabilistic Bayesian Belief Networks, and case-based scenarios to assess a relative risk intensity metric. A sample case is used for illustrative purposes.

  12. Additional Treatments for High-Risk Obstetric Antiphospholipid Syndrome: a Comprehensive Review.

    PubMed

    Ruffatti, Amelia; Hoxha, Ariela; Favaro, Maria; Tonello, Marta; Colpo, Anna; Cucchini, Umberto; Banzato, Alessandra; Pengo, Vittorio

    2016-06-25

    Most investigators currently advocate prophylactic-dose heparin plus low-dose aspirin as the preferred treatment of otherwise healthy women with obstetric antiphospholipid syndrome, whilst women with a history of vascular thrombosis alone or associated with pregnancy morbidity are usually treated with therapeutic heparin doses in association with low-dose aspirin in an attempt to prevent both thrombosis and pregnancy morbidity. However, the protocols outlined above fail in about 20 % of pregnant women with antiphospholipid syndrome. Identifying risk factors associated with pregnancy failure when conventional therapies are utilized is an important step in establishing guidelines to manage these high-risk patients. Some clinical and laboratory risk factors have been found to be related to maternal-foetal complications in pregnant women on conventional therapy. However, the most efficacious treatments to administer to high-risk antiphospholipid syndrome women in addition to conventional therapy in order to avoid pregnancy complications are as yet unestablished. This is a comprehensive review on this topic and an invitation to participate in a multicentre study in order to identify the best additional treatments to be used in this subset of antiphospholipid syndrome patients.

  13. RISK-INFORMED BALANCING OF SAFETY, NONPROLIFERATION, AND ECONOMICS FOR THE SFR

    SciTech Connect

    Apostolakis, George; Driscoll, Michael; Golay, Michael; Kadak, Andrew; Todreas, Neil; Aldmir, Tunc; Denning, Richard; Lineberry, Michael

    2011-10-20

    A substantial barrier to the implementation of Sodium-cooled Fast Reactor (SFR) technology in the short term is the perception that they would not be economically competitive with advanced light water reactors. With increased acceptance of risk-informed regulation, the opportunity exists to reduce the costs of a nuclear power plant at the design stage without applying excessive conservatism that is not needed in treating low risk events. In the report, NUREG-1860, the U.S. Nuclear Regulatory Commission describes developmental activities associated with a risk-informed, scenario-based technology neutral framework (TNF) for regulation. It provides quantitative yardsticks against which the adequacy of safety risks can be judged. We extend these concepts to treatment of proliferation risks. The objective of our project is to develop a risk-informed design process for minimizing the cost of electricity generation within constraints of adequate safety and proliferation risks. This report describes the design and use of this design optimization process within the context of reducing the capital cost and levelized cost of electricity production for a small (possibly modular) SFR. Our project provides not only an evaluation of the feasibility of a risk-informed design process but also a practical test of the applicability of the TNF to an actual advanced, non-LWR design. The report provides results of five safety related and one proliferation related case studies of innovative design alternatives. Applied to previously proposed SFR nuclear energy system concepts We find that the TNF provides a feasible initial basis for licensing new reactors. However, it is incomplete. We recommend improvements in terms of requiring acceptance standards for total safety risks, and we propose a framework for regulation of proliferation risks. We also demonstrate methods for evaluation of proliferation risks. We also suggest revisions to scenario-specific safety risk acceptance standards

  14. [The real-world effectiveness of personal protective equipment and additional risks for workers' health].

    PubMed

    Denisov, É I; Morozova, T V; Adeninskaia, E E; Kur'erov, N N

    2013-01-01

    The effectiveness of personal protective equipment (PPE) of hearing, respiratory organs and hands is considered. It is shown that real effect of PPE is twice lower than declared by supplier; this presumes some derating system. The aspects of discomfort and additional risks are analyzed. The hygienic and physiologic evaluation of PPE is required along with elaboration of an official document (OSH standard or sanitary regulation) on selection, personal fit, organization of use and individual training of workers and their motivation.

  15. Review of Research Trends and Methods in Nano Environmental, Health, and Safety Risk Analysis.

    PubMed

    Erbis, Serkan; Ok, Zeynep; Isaacs, Jacqueline A; Benneyan, James C; Kamarthi, Sagar

    2016-08-01

    Despite the many touted benefits of nanomaterials, concerns remain about their possible environmental, health, and safety (EHS) risks in terms of their toxicity, long-term accumulation effects, or dose-response relationships. The published studies on EHS risks of nanomaterials have increased significantly over the past decade and half, with most focused on nanotoxicology. Researchers are still learning about health consequences of nanomaterials and how to make environmentally responsible decisions regarding their production. This article characterizes the scientific literature on nano-EHS risk analysis to map the state-of-the-art developments in this field and chart guidance for the future directions. First, an analysis of keyword co-occurrence networks is investigated for nano-EHS literature published in the past decade to identify the intellectual turning points and research trends in nanorisk analysis studies. The exposure groups targeted in emerging nano-EHS studies are also assessed. System engineering methods for risk, safety, uncertainty, and system reliability analysis are reviewed, followed by detailed descriptions where applications of these methods are utilized to analyze nanomaterial EHS risks. Finally, the trends, methods, future directions, and opportunities of system engineering methods in nano-EHS research are discussed. The analysis of nano-EHS literature presented in this article provides important insights on risk assessment and risk management tools associated with nanotechnology, nanomanufacturing, and nano-enabled products.

  16. Human health and safety risks management in underground coal mines using fuzzy TOPSIS.

    PubMed

    Mahdevari, Satar; Shahriar, Kourosh; Esfahanipour, Akbar

    2014-08-01

    The scrutiny of health and safety of personnel working in underground coal mines is heightened because of fatalities and disasters that occur every year worldwide. A methodology based on fuzzy TOPSIS was proposed to assess the risks associated with human health in order to manage control measures and support decision-making, which could provide the right balance between different concerns, such as safety and costs. For this purpose, information collected from three hazardous coal mines namely Hashouni, Hojedk and Babnizu located at the Kerman coal deposit, Iran, were used to manage the risks affecting the health and safety of their miners. Altogether 86 hazards were identified and classified under eight categories: geomechanical, geochemical, electrical, mechanical, chemical, environmental, personal, and social, cultural and managerial risks. Overcoming the uncertainty of qualitative data, the ranking process is accomplished by fuzzy TOPSIS. After running the model, twelve groups with different risks were obtained. Located in the first group, the most important risks with the highest negative effects are: materials falling, catastrophic failure, instability of coalface and immediate roof, firedamp explosion, gas emission, misfire, stopping of ventilation system, wagon separation at inclines, asphyxiation, inadequate training and poor site management system. According to the results, the proposed methodology can be a reliable technique for management of the minatory hazards and coping with uncertainties affecting the health and safety of miners when performance ratings are imprecise. The proposed model can be primarily designed to identify potential hazards and help in taking appropriate measures to minimize or remove the risks before accidents can occur.

  17. MTHFR homozygous mutation and additional risk factors for cerebral infarction in a large Italian family.

    PubMed

    Del Balzo, Francesca; Spalice, Alberto; Perla, Massimo; Properzi, Enrico; Iannetti, Paola

    2009-01-01

    Several cases with cerebral infarctions associated with the C677T mutation in the methylenetetrahydrofolate reductase gene (MTHFR) have been reported. Given the large number of asymptomatic individuals with the MTHFR mutation, additional risk factors for cerebral infarction should be considered. This study describes a large family with the MTHFR mutation and a combination of heterozygous factor V Leiden mutations and different additional exogenous and endogenous thrombogenic risk factors. Psychomotor retardation and a left fronto-insular infarct associated with the MTHFR mutation together with diminished factor VII and low level of protein C was documented in the first patient. In the second patient, generalized epilepsy and a malacic area in the right nucleus lenticularis was associated with the MTHFR mutation and a low level of protein C. In the third patient, right hemiparesis and a left fronto-temporal porencephalic cyst were documented, together with the MTHFR mutation and hyperhomocysteinemia. An extensive search of additional circumstantial and genetic thrombogenic risk factors should be useful for prophylaxis and prognosis of infants with cerebral infarctions associated with the MTHFR mutation and of their related family members.

  18. Mobile phone radiation health risk controversy: the reliability and sufficiency of science behind the safety standards

    PubMed Central

    2010-01-01

    There is ongoing discussion whether the mobile phone radiation causes any health effects. The International Commission on Non-Ionizing Radiation Protection, the International Committee on Electromagnetic Safety and the World Health Organization are assuring that there is no proven health risk and that the present safety limits protect all mobile phone users. However, based on the available scientific evidence, the situation is not as clear. The majority of the evidence comes from in vitro laboratory studies and is of very limited use for determining health risk. Animal toxicology studies are inadequate because it is not possible to "overdose" microwave radiation, as it is done with chemical agents, due to simultaneous induction of heating side-effects. There is a lack of human volunteer studies that would, in unbiased way, demonstrate whether human body responds at all to mobile phone radiation. Finally, the epidemiological evidence is insufficient due to, among others, selection and misclassification bias and the low sensitivity of this approach in detection of health risk within the population. This indicates that the presently available scientific evidence is insufficient to prove reliability of the current safety standards. Therefore, we recommend to use precaution when dealing with mobile phones and, whenever possible and feasible, to limit body exposure to this radiation. Continuation of the research on mobile phone radiation effects is needed in order to improve the basis and the reliability of the safety standards. PMID:20205835

  19. 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.

  20. Safe patient care – safety culture and risk management in otorhinolaryngology

    PubMed Central

    St. Pierre, Michael

    2013-01-01

    Safety culture is positioned at the heart of an organization’s vulnerability to error because of its role in framing organizational awareness to risk and in providing and sustaining effective strategies of risk management. Safety related attitudes of leadership and management play a crucial role in the development of a mature safety culture (“top-down process”). A type marker for organizational culture and thus a predictor for an organization’s maturity in respect to safety is information flow and in particular an organization’s general way of coping with information that suggests anomaly. As all values and beliefs, relationships, learning, and other aspects of organizational safety culture are about sharing and processing information, safety culture has been termed “informed culture”. An informed culture is free of blame and open for information provided by incidents. “Incident reporting systems” are the backbone of a reporting culture, where good information flow is likely to support and encourage other kinds of cooperative behavior, such as problem solving, innovation, and inter-departmental bridging. Another facet of an informed culture is the free flow of information during perioperative patient care. The World Health Organization’s safe surgery checklist” is the most prevalent example of a standardized information exchange aimed at preventing patient harm due to information deficit. In routine tasks mandatory standard operating procedures have gained widespread acceptance in guaranteeing the highest possible process quality. Technical and non-technical skills of healthcare professionals are the decisive human resource for an efficient and safe delivery of patient care and the avoidance of errors. The systematic enhancement of staff qualification by providing training opportunities can be a major investment in patient safety. In recent years several otorhinolaryngology departments have started to incorporate stimulation based team

  1. 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.

  2. Roy's safety-first portfolio principle in financial risk management of disastrous events.

    PubMed

    Chiu, Mei Choi; Wong, Hoi Ying; Li, Duan

    2012-11-01

    Roy pioneers the concept and practice of risk management of disastrous events via his safety-first principle for portfolio selection. More specifically, his safety-first principle advocates an optimal portfolio strategy generated from minimizing the disaster probability, while subject to the budget constraint and the mean constraint that the expected final wealth is not less than a preselected disaster level. This article studies the dynamic safety-first principle in continuous time and its application in asset and liability management. We reveal that the distortion resulting from dropping the mean constraint, as a common practice to approximate the original Roy's setting, either leads to a trivial case or changes the problem nature completely to a target-reaching problem, which produces a highly leveraged trading strategy. Recognizing the ill-posed nature of the corresponding Lagrangian method when retaining the mean constraint, we invoke a wisdom observed from a limited funding-level regulation of pension funds and modify the original safety-first formulation accordingly by imposing an upper bound on the funding level. This model revision enables us to solve completely the safety-first asset-liability problem by a martingale approach and to derive an optimal policy that follows faithfully the spirit of the safety-first principle and demonstrates a prominent nature of fighting for the best and preventing disaster from happening.

  3. Exploring Typical and Atypical Safety Climate Perceptions of Practitioners in the Repair, Maintenance, Minor Alteration and Addition (RMAA) Sector in Hong Kong

    PubMed Central

    Hon, Carol K.H.; Liu, Yulin

    2016-01-01

    The safety of repair, maintenance, minor alteration and addition (RMAA) work is an under-explored area. This study explored the typical and atypical safety climate perceptions of practitioners in the RMAA sector in Hong Kong, based on a self-administered questionnaire survey of 662 local practitioners in the industry. Profile analysis, via multidimensional scaling of the respondents’ scores of three safety climate scales, identified one typical perception: high in management commitment to occupational health and safety (OHS) and employee involvement, low in applicability for safety rules and regulations, and low in responsibility for OHS. The respondents were clustered into typical and atypical perception groups according to their safety climate scores’ match to the typical perception. A comparison of demographics between the two groups with logistic regression found that work level and direct employer significantly affect their classification. A multivariate analysis of variance of safety performance measures between the two groups indicated that the typical group had a significantly higher level of safety compliance than the atypical group, with no significant difference in safety participation or injury. The significance of this study lies in revealing the typical safety climate perception profile pattern of RMAA works and offering a new perspective of safety climate research. PMID:27669269

  4. Assessment of occupational safety risks in Floridian solid waste systems using Bayesian analysis.

    PubMed

    Bastani, Mehrad; Celik, Nurcin

    2015-10-01

    Safety risks embedded within solid waste management systems continue to be a significant issue and are prevalent at every step in the solid waste management process. To recognise and address these occupational hazards, it is necessary to discover the potential safety concerns that cause them, as well as their direct and/or indirect impacts on the different types of solid waste workers. In this research, our goal is to statistically assess occupational safety risks to solid waste workers in the state of Florida. Here, we first review the related standard industrial codes to major solid waste management methods including recycling, incineration, landfilling, and composting. Then, a quantitative assessment of major risks is conducted based on the data collected using a Bayesian data analysis and predictive methods. The risks estimated in this study for the period of 2005-2012 are then compared with historical statistics (1993-1997) from previous assessment studies. The results have shown that the injury rates among refuse collectors in both musculoskeletal and dermal injuries have decreased from 88 and 15 to 16 and three injuries per 1000 workers, respectively. However, a contrasting trend is observed for the injury rates among recycling workers, for whom musculoskeletal and dermal injuries have increased from 13 and four injuries to 14 and six injuries per 1000 workers, respectively. Lastly, a linear regression model has been proposed to identify major elements of the high number of musculoskeletal and dermal injuries.

  5. Safety.

    ERIC Educational Resources Information Center

    Education in Science, 1996

    1996-01-01

    Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)

  6. Cardiovascular safety risk assessment for new candidate drugs from functional and pathological data: Conference report.

    PubMed

    Klein, Stephanie K; Redfern, Will S

    2015-01-01

    This is a report on a 2-day joint meeting between the British Society of Toxicological Pathology (BSTP) and the Safety Pharmacology Society (SPS) held in the UK in November 2013. Drug induced adverse effects on the cardiovascular system are associated with the attrition of more marketed and candidate drugs than any other safety issue. The objectives of this meeting were to foster inter-disciplinary approaches to address cardiovascular risk assessment, improve understanding of the respective disciplines, and increase awareness of new technologies. These aims were achieved. This well attended meeting covered both 'purely functional' cardiovascular adverse effects of drugs (e.g., electrophysiological and haemodynamic changes) as well as adverse effects encompassing both functional and pathological changes. Most of the presentations focused on nonclinical safety data, with information on translation to human where known. To reflect the content of the presentations we have cited key references and review articles.

  7. Road safety risk evaluation and target setting using data envelopment analysis and its extensions.

    PubMed

    Shen, Yongjun; Hermans, Elke; Brijs, Tom; Wets, Geert; Vanhoof, Koen

    2012-09-01

    Currently, comparison between countries in terms of their road safety performance is widely conducted in order to better understand one's own safety situation and to learn from those best-performing countries by indicating practical targets and formulating action programmes. In this respect, crash data such as the number of road fatalities and casualties are mostly investigated. However, the absolute numbers are not directly comparable between countries. Therefore, the concept of risk, which is defined as the ratio of road safety outcomes and some measure of exposure (e.g., the population size, the number of registered vehicles, or distance travelled), is often used in the context of benchmarking. Nevertheless, these risk indicators are not consistent in most cases. In other words, countries may have different evaluation results or ranking positions using different exposure information. In this study, data envelopment analysis (DEA) as a performance measurement technique is investigated to provide an overall perspective on a country's road safety situation, and further assess whether the road safety outcomes registered in a country correspond to the numbers that can be expected based on the level of exposure. In doing so, three model extensions are considered, which are the DEA based road safety model (DEA-RS), the cross-efficiency method, and the categorical DEA model. Using the measures of exposure to risk as the model's input and the number of road fatalities as output, an overall road safety efficiency score is computed for the 27 European Union (EU) countries based on the DEA-RS model, and the ranking of countries in accordance with their cross-efficiency scores is evaluated. Furthermore, after applying clustering analysis to group countries with inherent similarity in their practices, the categorical DEA-RS model is adopted to identify best-performing and underperforming countries in each cluster, as well as the reference sets or benchmarks for those

  8. Influence of parenteral administration routes and additional factors on vaccine safety and immunogenicity: a review of recent literature.

    PubMed

    Herzog, Christian

    2014-03-01

    Vaccines have to be administered via an appropriate route, i.e. a route, which is optimal regarding safety, immunogenicity and practicability. In addition, there are factors, such as body site, needle length, injection technique, depth of injection, type of antigen, vaccine formulation, adjuvants, age, sex, race/ethnicity, body mass, and pre-existing immunity, which can have an impact on the reactogenicity and tolerability and/or on the immunogenicity of a given vaccine. For parenteral vaccine administration there are currently three routes licensed: intramuscular, subcutaneous and intradermal, either by using conventional hypodermic needles or by using alternative or needle-free injection devices. The factors potentially impacting on the 'performance' of a given route of administration, as reported in recent literature, are outlined and discussed in view of their importance. These factors need to be accounted and controlled for when designing vaccine studies and should be reported in a transparent and standardised way in publications.

  9. Goodness-of-fit methods for additive-risk models in tumorigenicity experiments.

    PubMed

    Ghosh, Debashis

    2003-09-01

    In tumorigenicity experiments, a complication is that the time to event is generally not observed, so that the time to tumor is subject to interval censoring. One of the goals in these studies is to properly model the effect of dose on risk. Thus, it is important to have goodness of fit procedures available for assessing the model fit. While several estimation procedures have been developed for current-status data, relatively little work has been done on model-checking techniques. In this article, we propose numerical and graphical methods for the analysis of current-status data using the additive-risk model, primarily focusing on the situation where the monitoring times are dependent. The finite-sample properties of the proposed methodology are examined through numerical studies. The methods are then illustrated with data from a tumorigenicity experiment.

  10. Risk assessment of additives through soft drinks and nectars consumption on Portuguese population: a 2010 survey.

    PubMed

    Diogo, Janina S G; Silva, Liliana S O; Pena, Angelina; Lino, Celeste M

    2013-12-01

    This study investigated whether the Portuguese population is at risk of exceeding ADI levels for acesulfame-K, saccharin, aspartame, caffeine, benzoic and sorbic acid through an assessment of dietary intake of additives and specific consumption of four types of beverages, traditional soft drinks and soft drinks based on mineral waters, energetic drinks, and nectars. The highest mean levels of additives were found for caffeine in energetic drinks, 293.5mg/L, for saccharin in traditional soft drinks, 18.4 mg/L, for acesulfame-K and aspartame in nectars, with 88.2 and 97.8 mg/L, respectively, for benzoic acid in traditional soft drinks, 125.7 mg/L, and for sorbic acid in soft drinks based on mineral water, 166.5 mg/L. Traditional soft drinks presented the highest acceptable daily intake percentages (ADIs%) for acesulfame-K, aspartame, benzoic and sorbic acid and similar value for saccharin (0.5%) when compared with soft drinks based on mineral water, 0.7%, 0.08%, 7.3%, and 1.92% versus 0.2%, 0.053%, 0.6%, and 0.28%, respectively. However for saccharin the highest percentage of ADI was obtained for nectars, 0.9%, in comparison with both types of soft drinks, 0.5%. Therefore, it is concluded that the Portuguese population is not at risk of exceeding the established ADIs for the studied additives.

  11. An object-oriented approach to risk and reliability analysis : methodology and aviation safety applications.

    SciTech Connect

    Dandini, Vincent John; Duran, Felicia Angelica; Wyss, Gregory Dane

    2003-09-01

    This article describes how features of event tree analysis and Monte Carlo-based discrete event simulation can be combined with concepts from object-oriented analysis to develop a new risk assessment methodology, with some of the best features of each. The resultant object-based event scenario tree (OBEST) methodology enables an analyst to rapidly construct realistic models for scenarios for which an a priori discovery of event ordering is either cumbersome or impossible. Each scenario produced by OBEST is automatically associated with a likelihood estimate because probabilistic branching is integral to the object model definition. The OBEST methodology is then applied to an aviation safety problem that considers mechanisms by which an aircraft might become involved in a runway incursion incident. The resulting OBEST model demonstrates how a close link between human reliability analysis and probabilistic risk assessment methods can provide important insights into aviation safety phenomenology.

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

    SciTech Connect

    REEP, I.E.

    1999-05-12

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

  13. Projected Impact of Compositional Verification on Current and Future Aviation Safety Risk

    NASA Technical Reports Server (NTRS)

    Reveley, Mary S.; Withrow, Colleen A.; Leone, Karen M.; Jones, Sharon M.

    2014-01-01

    The projected impact of compositional verification research conducted by the National Aeronautic and Space Administration System-Wide Safety and Assurance Technologies on aviation safety risk was assessed. Software and compositional verification was described. Traditional verification techniques have two major problems: testing at the prototype stage where error discovery can be quite costly and the inability to test for all potential interactions leaving some errors undetected until used by the end user. Increasingly complex and nondeterministic aviation systems are becoming too large for these tools to check and verify. Compositional verification is a "divide and conquer" solution to addressing increasingly larger and more complex systems. A review of compositional verification research being conducted by academia, industry, and Government agencies is provided. Forty-four aviation safety risks in the Biennial NextGen Safety Issues Survey were identified that could be impacted by compositional verification and grouped into five categories: automation design; system complexity; software, flight control, or equipment failure or malfunction; new technology or operations; and verification and validation. One capability, 1 research action, 5 operational improvements, and 13 enablers within the Federal Aviation Administration Joint Planning and Development Office Integrated Work Plan that could be addressed by compositional verification were identified.

  14. Increased risk of delayed cerebral ischemia in subarachnoid hemorrhage patients with additional intracerebral hematoma.

    PubMed

    Platz, Johannes; Güresir, Erdem; Wagner, Marlies; Seifert, Volker; Konczalla, Juergen

    2017-02-01

    OBJECTIVE Delayed cerebral ischemia (DCI) has a major impact on the outcome of patients suffering from aneurysmal subarachnoid hemorrhage (SAH). The aim of this study was to assess the influence of an additional intracerebral hematoma (ICH) on the occurrence of DCI. METHODS The authors conducted a single-center retrospective analysis of cases of SAH involving patients treated between 2006 and 2011. Patients who died or were transferred to another institution within 10 days after SAH without the occurrence of DCI were excluded from the analysis. RESULTS Additional ICH was present in 123 (24.4%) of 504 included patients (66.7% female). ICH was classified as frontal in 72 patients, temporal in 24, and perisylvian in 27. DCI occurred in 183 patients (36.3%). A total of 59 (32.2%) of these 183 patients presented with additional ICH, compared with 64 (19.9%) of the 321 without DCI (p = 0.002). In addition, DCI was detected significantly more frequently in patients with higher World Federation of Neurosurgical Societies (WFNS) grades. The authors compared the original and modified Fisher Scales with respect to the occurrence of DCI. The modified Fisher Scale (mFS) was superior to the original Fisher Scale (oFS) in predicting DCI. Furthermore, they suggest a new classification based on the mFS, which demonstrates the impact of additional ICH on the occurrence of DCI. After the different scales were corrected for age, sex, WFNS score, and aneurysm site, the oFS no longer was predictive for the occurrence of DCI, while the new scale demonstrated a superior capacity for prediction as compared with the mFS. CONCLUSIONS Additional ICH was associated with an increased risk of DCI in this study. Furthermore, adding the presence or absence of ICH to the mFS improved the identification of patients at the highest risk for the development of DCI. Thus, a simple adjustment of the mFS might help to identify patients at high risk for DCI.

  15. Probabilistic risk analysis toward cost-effective 3S (safety, safeguards, security) implementation

    NASA Astrophysics Data System (ADS)

    Suzuki, Mitsutoshi; Mochiji, Toshiro

    2014-09-01

    Probabilistic Risk Analysis (PRA) has been introduced for several decades in safety and nuclear advanced countries have already used this methodology in their own regulatory systems. However, PRA has not been developed in safeguards and security so far because of inherent difficulties in intentional and malicious acts. In this paper, probabilistic proliferation and risk analysis based on random process is applied to hypothetical reprocessing process and physical protection system in nuclear reactor with the Markov model that was originally developed by the Proliferation Resistance and Physical Protection Working Group (PRPPWG) in Generation IV International Framework (GIF). Through the challenge to quantify the security risk with a frequency in this model, integrated risk notion among 3S to pursue the cost-effective installation of those countermeasures is discussed in a heroic manner.

  16. Probabilistic risk analysis toward cost-effective 3S (safety, safeguards, security) implementation

    SciTech Connect

    Suzuki, Mitsutoshi; Mochiji, Toshiro

    2014-09-30

    Probabilistic Risk Analysis (PRA) has been introduced for several decades in safety and nuclear advanced countries have already used this methodology in their own regulatory systems. However, PRA has not been developed in safeguards and security so far because of inherent difficulties in intentional and malicious acts. In this paper, probabilistic proliferation and risk analysis based on random process is applied to hypothetical reprocessing process and physical protection system in nuclear reactor with the Markov model that was originally developed by the Proliferation Resistance and Physical Protection Working Group (PRPPWG) in Generation IV International Framework (GIF). Through the challenge to quantify the security risk with a frequency in this model, integrated risk notion among 3S to pursue the cost-effective installation of those countermeasures is discussed in a heroic manner.

  17. Safety Risk Knowledge Elicitation in Support of Aeronautical R and D Portfolio Management: A Case Study

    NASA Technical Reports Server (NTRS)

    Shih, Ann T.; Ancel, Ersin; Jones, Sharon Monica; Reveley, Mary S.; Luxhoj, James T.

    2012-01-01

    Aviation is a problem domain characterized by a high level of system complexity and uncertainty. Safety risk analysis in such a domain is especially challenging given the multitude of operations and diverse stakeholders. The Federal Aviation Administration (FAA) projects that by 2025 air traffic will increase by more than 50 percent with 1.1 billion passengers a year and more than 85,000 flights every 24 hours contributing to further delays and congestion in the sky (Circelli, 2011). This increased system complexity necessitates the application of structured safety risk analysis methods to understand and eliminate where possible, reduce, and/or mitigate risk factors. The use of expert judgments for probabilistic safety analysis in such a complex domain is necessary especially when evaluating the projected impact of future technologies, capabilities, and procedures for which current operational data may be scarce. Management of an R&D product portfolio in such a dynamic domain needs a systematic process to elicit these expert judgments, process modeling results, perform sensitivity analyses, and efficiently communicate the modeling results to decision makers. In this paper a case study focusing on the application of an R&D portfolio of aeronautical products intended to mitigate aircraft Loss of Control (LOC) accidents is presented. In particular, the knowledge elicitation process with three subject matter experts who contributed to the safety risk model is emphasized. The application and refinement of a verbal-numerical scale for conditional probability elicitation in a Bayesian Belief Network (BBN) is discussed. The preliminary findings from this initial step of a three-part elicitation are important to project management practitioners as they illustrate the vital contribution of systematic knowledge elicitation in complex domains.

  18. The use of individual and societal risk criteria within the Dutch flood safety policy--nationwide estimates of societal risk and policy applications.

    PubMed

    Jonkman, Sebastiaan N; Jongejan, Ruben; Maaskant, Bob

    2011-02-01

    The Dutch government is in the process of revising its flood safety policy. The current safety standards for flood defenses in the Netherlands are largely based on the outcomes of cost-benefit analyses. Loss of life has not been considered separately in the choice for current standards. This article presents the results of a research project that evaluated the potential roles of two risk metrics, individual and societal risk, to support decision making about new flood safety standards. These risk metrics are already used in the Dutch major hazards policy for the evaluation of risks to the public. Individual risk concerns the annual probability of death of a person. Societal risk concerns the probability of an event with many fatalities. Technical aspects of the use of individual and societal risk metrics in flood risk assessments as well as policy implications are discussed. Preliminary estimates of nationwide levels of societal risk are presented. Societal risk levels appear relatively high in the southwestern part of the country where densely populated dike rings are threatened by a combination of river and coastal floods. It was found that cumulation, the simultaneous flooding of multiple dike rings during a single flood event, has significant impact on the national level of societal risk. Options for the application of the individual and societal risk in the new flood safety policy are presented and discussed.

  19. Preparing for safety issues following drug approval: pre-approval risk management considerations

    PubMed Central

    Sharrar, Robert G.

    2013-01-01

    Risk management plans and risk minimization plans as well as postapproval commitment studies are based on risks identified pre-approval that need to be further characterized or minimized in the postmarketing environment. Although the implementation of these activities are conducted in the postapproval arena, the design of the plans and studies as well as the development of effective postapproval tools and mitigation strategies should be carried out pre-approval. The pre-approval period also provides the opportunity to fully understand the treatment population that is included in the clinical trial program and to determine how the target population for the drug after approval may differ from the clinical trial patient population. When regulators or sponsors have expressed concerns about safety issues identified during clinical development, the result may be a postapproval commitment in the form of a registry or an observational safety study or, in the US, a Risk Evaluation and Mitigation Strategy (REMS) as a condition of approval. Specific examples are given for risk mitigation activities that can be conducted pre-approval. PMID:25114783

  20. Stepwise quantitative risk assessment as a tool for characterization of microbiological food safety.

    PubMed

    van Gerwen, S J; te Giffel, M C; van't Riet, K; Beumer, R R; Zwietering, M H

    2000-06-01

    This paper describes a system for the microbiological quantitative risk assessment for food products and their production processes. The system applies a stepwise risk assessment, allowing the main problems to be addressed before focusing on less important problems. First, risks are assessed broadly, using order of magnitude estimates. Characteristic numbers are used to quantitatively characterize microbial behaviour during the production process. These numbers help to highlight the major risk-determining phenomena, and to find negligible aspects. Second, the risk-determining phenomena are studied in more detail. Both general and/or specific models can be used for this and varying situations can be simulated to quantitatively describe the risk-determining phenomena. Third, even more detailed studies can be performed where necessary, for instance by using stochastic variables. The system for quantitative risk assessment has been implemented as a decision supporting expert system called SIEFE: Stepwise and Interactive Evaluation of Food safety by an Expert System. SIEFE performs bacterial risk assessments in a structured manner, using various information sources. Because all steps are transparent, every step can easily be scrutinized. In the current study the effectiveness of SIEFE is shown for a cheese spread. With this product, quantitative data concerning the major risk-determining factors were not completely available to carry out a full detailed assessment. However, this did not necessarily hamper adequate risk estimation. Using ranges of values instead helped identifying the quantitatively most important parameters and the magnitude of their impact. This example shows that SIEFE provides quantitative insights into production processes and their risk-determining factors to both risk assessors and decision makers, and highlights critical gaps in knowledge.

  1. [Risk communication efforts regarding drug safety in the US and EU, and Japan].

    PubMed

    Yamamoto, Michiko

    2012-01-01

    In pharmacovigilance, it has been recognized that it is essential to share the information regarding the risk of drugs among stakeholders and to have risk communication (RC) which enables consumers to make their own judgments regarding the risk. In particular, RC between the governmental agencies and consumers is given a high priority. Hence, its provisions and initiatives should be considered thoroughly. I present a brief overview of current proactive approaches for RC to protect the patient's rights, to increase openness and transparency and to share information in the US and EU. Following the Food and Drug Administration Amendment Act (FDAAA), Institute of Medicine of the National Academies (IOM) recommended that FDA makes efforts for RC. The RC Advisory Committee was established and consumers are involved as its members. FDA published "Guidance Drug Safety Information" in 2007 and "Strategic Plan for RC" in 2009. Thus, its framework has been developed. European Medicines Agency (EMA) issued "Work programme 2010" and "EMA Communication on safety related issues", which indicated its policies and measures. EMA is promoting development of the framework for Patient Involvement (e.g., members of scientific committees). Regarding the direct patient reporting of adverse drug reactions, FDA began that in 2003 and EMA recommends to encourage it for EU Member States, and it has already started in some countries. RC has important roles to take safety measures for drugs and to protect patient's rights, therefore such an approach for it be implemented is expected in Japan.

  2. The Cold War legacy of regulatory risk analysis: The Atomic Energy Commission and radiation safety

    NASA Astrophysics Data System (ADS)

    Boland, Joseph B.

    From its inception in 1946 the Atomic Energy Commission pioneered the use of risk analysis as a mode of regulatory rationality and political rhetoric, yet historical treatments of risk analysis nearly always overlook the important role it played in the administration of atomic energy during the early Cold War. How this absence from history has been achieved and why it characterizes most historical accounts are the subjects of Chapter II. From there, this study goes on to develop the thesis that the advent of the atomic bomb was a world-shattering event that forced the Truman administration to choose between two novel alternatives: (1) movement towards global governance based initially on cooperative control of atomic energy or (2) unsparing pursuit of nuclear superiority. I refer to these as nuclear internationalism and nuclear nationalism, respectively. Each defined a social risk hierarchy. With the triumph of nuclear nationalism, nuclear annihilation was designated the greatest risk and a strong nuclear defense the primary means of prevention. The AEC's mission in the 1950s consisted of the rapid development of a nuclear arsenal, continual improvements in weapons technologies, and the promotion of nuclear power. The agency developed a risk-based regulatory framework through its dominant position within the National Committee on Radiation Protection. It embraced a technocratic model of risk analysis whose articulation and application it controlled, largely in secret. It used this to undergird a public rhetoric of reassurance and risk minimization. In practice, safety officials adjusted exposure levels within often wide parameters and with considerable fluidity in order to prevent safety concerns from interfering with operations. Secrecy, the political climate of the time, and a lack of accountability enabled the agency to meld technical assessments with social value judgments in a manner reflective of nuclear nationalism's risk hierarchy. In the late fifties

  3. Relative Importance and Additive Effects of Maternal and Infant Risk Factors on Childhood Asthma

    PubMed Central

    Rosas-Salazar, Christian; James, Kristina; Escobar, Gabriel; Gebretsadik, Tebeb; Li, Sherian Xu; Carroll, Kecia N.; Walsh, Eileen; Mitchel, Edward; Das, Suman; Kumar, Rajesh; Yu, Chang; Dupont, William D.; Hartert, Tina V.

    2016-01-01

    Background Environmental exposures that occur in utero and during early life may contribute to the development of childhood asthma through alteration of the human microbiome. The objectives of this study were to estimate the cumulative effect and relative importance of environmental exposures on the risk of childhood asthma. Methods We conducted a population-based birth cohort study of mother-child dyads who were born between 1995 and 2003 and were continuously enrolled in the PRIMA (Prevention of RSV: Impact on Morbidity and Asthma) cohort. The individual and cumulative impact of maternal urinary tract infections (UTI) during pregnancy, maternal colonization with group B streptococcus (GBS), mode of delivery, infant antibiotic use, and older siblings at home, on the risk of childhood asthma were estimated using logistic regression. Dose-response effect on childhood asthma risk was assessed for continuous risk factors: number of maternal UTIs during pregnancy, courses of infant antibiotics, and number of older siblings at home. We further assessed and compared the relative importance of these exposures on the asthma risk. In a subgroup of children for whom maternal antibiotic use during pregnancy information was available, the effect of maternal antibiotic use on the risk of childhood asthma was estimated. Results Among 136,098 singleton birth infants, 13.29% developed asthma. In both univariate and adjusted analyses, maternal UTI during pregnancy (odds ratio [OR] 1.2, 95% confidence interval [CI] 1.18, 1.25; adjusted OR [AOR] 1.04, 95%CI 1.02, 1.07 for every additional UTI) and infant antibiotic use (OR 1.21, 95%CI 1.20, 1.22; AOR 1.16, 95%CI 1.15, 1.17 for every additional course) were associated with an increased risk of childhood asthma, while having older siblings at home (OR 0.92, 95%CI 0.91, 0.93; AOR 0.85, 95%CI 0.84, 0.87 for each additional sibling) was associated with a decreased risk of childhood asthma, in a dose-dependent manner. Compared with vaginal

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

    PubMed

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

    2014-01-01

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

  5. Real-Time Safety Risk Assessment Based on a Real-Time Location System for Hydropower Construction Sites

    PubMed Central

    Fan, Qixiang; Qiang, Maoshan

    2014-01-01

    The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns. PMID:25114958

  6. THE COMBINED CARCINOGENIC RISK FOR EXPOSURE TO MIXTURES OF DRINKING WATER DISINFECTION BY-PRODUCTS MAY BE LESS THAN ADDITIVE

    EPA Science Inventory

    The Combined Carcinogenic Risk for Exposure to Mixtures of Drinking Water Disinfection By-Products May be Less Than Additive

    Risk assessment methods for chemical mixtures in drinking water are not well defined. Current default risk assessments for chemical mixtures assume...

  7. Health, safety, and environmental risks from energy production: A year-long reality check

    SciTech Connect

    Oldenburg, C.M.

    2011-04-01

    Large-scale carbon dioxide capture and storage (CCS) offers the benefit of reducing CO{sub 2} emissions and thereby mitigating climate change risk, but it will also bring its own health, safety, and environmental risks. Curtis M. Oldenburg, Editor-in-Chief, considers these risks in the context of the broader picture of energy production. Over the last year, there have been major acute health, safety, and environmental (HSE) consequences related to accidents involving energy production from every major primary energy source. These are, in chronological order: (i) the Upper Big Branch (coal) Mine disaster, (ii) the Gulf of Mexico Macondo (oil) well blowout, (iii) the San Bruno (natural gas) pipeline leak and explosion, and (iv) the Fukushima (nuclear) reactor radioactivity releases. Briefly, the Upper Big Branch Mine disaster occurred in West Virginia on April 5, 2010, when natural methane in the mine ignited, causing the deaths of 29 miners, the worst coal mine disaster in the USA since 1970. Fifteen days later, the Macondo oil well in the Gulf of Mexico suffered a blowout, with a gas explosion and fire on the floating drilling platform that killed 11 people. The oil and gas continued to flow out of the well at the seafloor until July 15, 2010, spilling a total of approximately 5 million barrels of oil into the sea. On September 9, 2010, a 30-inch (76-cm) buried, steel, natural gas pipeline in San Bruno, California, leaked gas and exploded in a residential neighborhood, killing 8 people in their homes and burning a total of 38 homes. Flames were up to 1000 ft (300 m) high, and the initial explosion itself reportedly measured 1.1 on the Richter scale. Finally, on March 11, 2011, a magnitude 9.0 earthquake off the coast of Japan's main island, Honshu, caused a tsunami that crippled the backup power and associated cooling systems for six reactor cores and their spent fuel storage tanks at the Fukushima nuclear power plant. At time of writing, workers trying to bring

  8. Risk-Informed Safety Margin Characterization (RISMC): Integrated Treatment of Aleatory and Epistemic Uncertainty in Safety Analysis

    SciTech Connect

    R. W. Youngblood

    2010-10-01

    The concept of “margin” has a long history in nuclear licensing and in the codification of good engineering practices. However, some traditional applications of “margin” have been carried out for surrogate scenarios (such as design basis scenarios), without regard to the actual frequencies of those scenarios, and have been carried out with in a systematically conservative fashion. This means that the effectiveness of the application of the margin concept is determined in part by the original choice of surrogates, and is limited in any case by the degree of conservatism imposed on the evaluation. In the RISMC project, which is part of the Department of Energy’s “Light Water Reactor Sustainability Program” (LWRSP), we are developing a risk-informed characterization of safety margin. Beginning with the traditional discussion of “margin” in terms of a “load” (a physical challenge to system or component function) and a “capacity” (the capability of that system or component to accommodate the challenge), we are developing the capability to characterize probabilistic load and capacity spectra, reflecting both aleatory and epistemic uncertainty in system response. For example, the probabilistic load spectrum will reflect the frequency of challenges of a particular severity. Such a characterization is required if decision-making is to be informed optimally. However, in order to enable the quantification of probabilistic load spectra, existing analysis capability needs to be extended. Accordingly, the INL is working on a next-generation safety analysis capability whose design will allow for much more efficient parameter uncertainty analysis, and will enable a much better integration of reliability-related and phenomenology-related aspects of margin.

  9. The Evaluation of Triphenyl Phosphate as a Flame Retardant Additive to Improve the Safety of Lithium-Ion Battery Electrolytes

    NASA Technical Reports Server (NTRS)

    Smart, M. C.; Krause, F. C.; Hwang, C.; West, W. C.; Soler, J.; Prakash, G. K. S.; Ratnakumar, B. V.

    2011-01-01

    With the intent of improving the safety characteristics of lithium ion cells, electrolytes containing flame retardant additives have been investigated. A number of triphenyl phosphate-containing electrolytes were evaluated in both coin cells and experimental three electrode lithium-ion cells (containing reference electrodes). A number of chemistries were investigated, including MCMB carbon/LiNi(0.8)Co(0.2)O2 (NCO), graphite/LiNi(0.8)Co(0.15)Al(0.05)O2 (NCA), Li/Li(Li(0.17)Ni(0.25)Mn(0.58))O2, Li/LiNiMnCoO2 (NMC) and graphite/LiNiMnCoO2 (NMC), to study the effect that different electrolyte compositions have upon performance. A wide range of TPP-containing electrolytes were demonstrated to have good compatibility with the C/NCO, C/NCA, and Li/NMC systems, however, poor performance was initially observed with the high voltage C/NMC system. This necessitated the development of improved electrolytes with stabilizing additives, leading to formulations containing lithium bis(oxalato)borate (LiBOB) that displayed substantially improved performance.

  10. Hazardous organic compounds in biogas plant end products--soil burden and risk to food safety.

    PubMed

    Suominen, K; Verta, M; Marttinen, S

    2014-09-01

    The end products (digestate, solid fraction of the digestate, liquid fraction of the digestate) of ten biogas production lines in Finland were analyzed for ten hazardous organic compounds or compound groups: polychlorinated dibenzo-p-dioxins and furans (PCDD/Fs), polychlorinated biphenyls (PCB(7)), polyaromatic hydrocarbons (PAH(16)), bis-(2-ethylhexyl) phthalate (DEHP), perfluorinated alkyl compounds (PFCs), linear alkylbenzene sulfonates (LASs), nonylphenols and nonylphenol ethoxylates (NP+NPEOs), polybrominated diphenyl ethers (PBDEs), hexabromocyclododecane (HBCD) and tetrabromobisphenol A (TBBPA). Biogas plant feedstocks were divided into six groups: municipal sewage sludge, municipal biowaste, fat, food industry by-products, animal manure and others (consisting of milling by-products (husk) and raw former foodstuffs of animal origin from the retail trade). There was no clear connection between the origin of the feedstocks of a plant and the concentrations of hazardous organic compounds in the digestate. For PCDD/Fs and for DEHP, the median soil burden of the compound after a single addition of digestate was similar to the annual atmospheric deposition of the compound or compound group in Finland or other Nordic countries. For PFCs, the median soil burden was somewhat lower than the atmospheric deposition in Finland or Sweden. For NP+NPEOs, the soil burden was somewhat higher than the atmospheric deposition in Denmark. The median soil burden of PBDEs was 400 to 1000 times higher than the PBDE air deposition in Finland or in Sweden. With PBDEs, PFCs and HBCD, the impact of the use of end products should be a focus of further research. Highly persistent compounds, such as PBDE- and PFC-compounds may accumulate in agricultural soil after repeated use of organic fertilizers containing these compounds. For other compounds included in this study, agricultural use of biogas plant end products is unlikely to cause risk to food safety in Finland.

  11. Application of classification algorithms for analysis of road safety risk factor dependencies.

    PubMed

    Kwon, Oh Hoon; Rhee, Wonjong; Yoon, Yoonjin

    2015-02-01

    Transportation continues to be an integral part of modern life, and the importance of road traffic safety cannot be overstated. Consequently, recent road traffic safety studies have focused on analysis of risk factors that impact fatality and injury level (severity) of traffic accidents. While some of the risk factors, such as drug use and drinking, are widely known to affect severity, an accurate modeling of their influences is still an open research topic. Furthermore, there are innumerable risk factors that are waiting to be discovered or analyzed. A promising approach is to investigate historical traffic accident data that have been collected in the past decades. This study inspects traffic accident reports that have been accumulated by the California Highway Patrol (CHP) since 1973 for which each accident report contains around 100 data fields. Among them, we investigate 25 fields between 2004 and 2010 that are most relevant to car accidents. Using two classification methods, the Naive Bayes classifier and the decision tree classifier, the relative importance of the data fields, i.e., risk factors, is revealed with respect to the resulting severity level. Performances of the classifiers are compared to each other and a binary logistic regression model is used as the basis for the comparisons. Some of the high-ranking risk factors are found to be strongly dependent on each other, and their incremental gains on estimating or modeling severity level are evaluated quantitatively. The analysis shows that only a handful of the risk factors in the data dominate the severity level and that dependency among the top risk factors is an imperative trait to consider for an accurate analysis.

  12. Evaluation of the Safety Detective Program: A Classroom-Based Intervention to Increase Kindergarten Children's Understanding of Home Safety Hazards and Injury-Risk Behaviors to Avoid.

    PubMed

    Morrongiello, Barbara A; Bell, Melissa; Park, Katey; Pogrebtsova, Katya

    2016-01-01

    Home injuries are a leading cause of mortality and morbidity for young children. Most programs that aim to improve their knowledge of home safety have been narrowly focused on one injury type and/or required specialized personnel for delivery. The purpose of the current study was to evaluate the effectiveness of a new Safety Detective Program that was designed to teach young children (4-6 years) about several types of home safety hazards and unsafe behaviors, with the program delivered in a classroom setting by non-experts based on manualized training. The current study used a randomized group, pre-post design to evaluate the effectiveness of the program to increase children's knowledge and understanding of home safety hazards and injury-risk behaviors to avoid. Children participated in six structured sessions, covering burns, falls, drowning, and poisoning. Each session involved play-based activities (storybook, song, and game or craft) to teach main messages about hazards and injury-risk behaviors, a take home activity, and a parent information sheet about the injury type covered that day. An individually administered photo-sort task with follow-up interview was used to measure intervention and control group participants' knowledge and understanding of injury-risk behaviors before and after program delivery. Children in the intervention, but not the control, group exhibited significant gains in their knowledge and understanding of home safety hazards and injury-risk behaviors to avoid, establishing the effectiveness of the program. This evaluation indicates that the Safety Detective Program can be delivered in classrooms without requiring specialized personnel or extensive training and with positive changes obtained. The program holds much promise as a means of improving kindergarten children's understanding of a broad range of home hazards and injury-risk behaviors that are relevant to their safety.

  13. Appraisal of Risk Perception in Occupational Health and Safety Research in Developing Countries.

    PubMed

    Hilhorst

    1996-10-01

    This paper addresses scientists in the field of occupational health and safety, with a special emphasis on research in developing countries. The article is based on findings of and a method used in a recent study of occupational health and safety in mines in Africa and Latin America. Dialog between technical experts and social scientists is needed to synthesize the values of society and the facts of nature into policy decisions that are both politically legitimate and consistent with the current state of technical knowledge. The author asks how researchers in the field of occupational health can take two axioms of the social sciences into account: 1) the concept of human agency, and 2) the notion that risk perception is socially constructed: rather than being determined by "real" risks, it is shaped by the adversarial context of, among other factors, the nature of labor relations, values in society, and personal histories. With regard to first axiom, it is shown why actors' risk perceptions and their context need indeed to be taken seriously. With regard to the second, a methodologic outline is given to complement technical research on occupational hygiene with risk-perception appraisal. The method is actor-oriented, building on the perceptions, views, and opinions of the different groups of relevant actors. Systematic integration of this method into technological studies could enrich them, contributing substantially to their applicability.

  14. Risk assessment of nitrate and oxytetracycline addition on coastal ecosystem functions.

    PubMed

    Feng-Jiao, Liu; Shun-Xing, Li; Feng-Ying, Zheng; Xu-Guang, Huang; Yue-Gang, Zuo; Teng-Xiu, Tu; Xue-Qing, Wu

    2014-01-01

    Diatoms dominate phytoplankton communities in the well-mixed coastal and upwelling regions. Coastal diatoms are often exposed to both aquaculture pollution and eutrophication. But how these exposures influence on coastal ecosystem functions are unknown. To examine these influences, a coastal centric diatom, Conticribra weissflogii was maintained at different concentrations of nitrate (N) and/or oxytetracycline (OTC). Algal density, cell growth cycle, protein, chlorophyll a, superoxide dismutase (SOD) activity, and malonaldehyde (MDA) were determined for the assessment of algal biomass, lifetime, nutritional value, photosynthesis and respiration, antioxidant capacity, and lipid peroxidation, respectively. When N addition was combined with OTC pollution, the cell growth cycles were shortened by 56-73%; algal density, SOD activities, the concentrations of chlorophyll a, protein, and MDA varied between 73 and 121%, 19 and 397%, 52 and 693%, 19 and 875%, and 66 and 2733% of the values observed in N addition experiments, respectively. According to P-value analysis, the influence of OTC on algal density and SOD activity was not significant, but the effect on cell growth cycle, protein, chlorophyll a, and MDA were significant (P<0.05). The influence of N addition with simultaneous OTC pollution on the above six end points was significant. Algal biomass, lifetime, nutrition, antioxidant capacity, lipid peroxidation, photosynthesis, and respiration were all affected by the addition of OTC and N. Coastal ecosystem functions were severely affected by N and OTC additions, and the influence was increased in the order: Nrisk assessment of aquaculture pollution on coastal ecosystem functions.

  15. Common genetic variants, acting additively, are a major source of risk for autism

    PubMed Central

    2012-01-01

    Background Autism spectrum disorders (ASD) are early onset neurodevelopmental syndromes typified by impairments in reciprocal social interaction and communication, accompanied by restricted and repetitive behaviors. While rare and especially de novo genetic variation are known to affect liability, whether common genetic polymorphism plays a substantial role is an open question and the relative contribution of genes and environment is contentious. It is probable that the relative contributions of rare and common variation, as well as environment, differs between ASD families having only a single affected individual (simplex) versus multiplex families who have two or more affected individuals. Methods By using quantitative genetics techniques and the contrast of ASD subjects to controls, we estimate what portion of liability can be explained by additive genetic effects, known as narrow-sense heritability. We evaluate relatives of ASD subjects using the same methods to evaluate the assumptions of the additive model and partition families by simplex/multiplex status to determine how heritability changes with status. Results By analyzing common variation throughout the genome, we show that common genetic polymorphism exerts substantial additive genetic effects on ASD liability and that simplex/multiplex family status has an impact on the identified composition of that risk. As a fraction of the total variation in liability, the estimated narrow-sense heritability exceeds 60% for ASD individuals from multiplex families and is approximately 40% for simplex families. By analyzing parents, unaffected siblings and alleles not transmitted from parents to their affected children, we conclude that the data for simplex ASD families follow the expectation for additive models closely. The data from multiplex families deviate somewhat from an additive model, possibly due to parental assortative mating. Conclusions Our results, when viewed in the context of results from genome

  16. Social signals of safety and risk confer utility and have asymmetric effects on observers’ choices

    PubMed Central

    Chung, Dongil; Ball, Sheryl B; Chiu, Pearl H

    2015-01-01

    Individuals’ risk attitudes are known to guide choices about uncertain options. However, in the presence of others’ decisions, these choices can be swayed and manifest as riskier or safer behavior than one would express alone. To test the mechanisms underlying effective social ‘nudges’ in human decision-making, we used functional neuroimaging and a task in which participants made choices about gambles alone and after observing others’ selections. Against three alternative explanations, we found that observing others’ choices of gambles increased the subjective value (utility) of those gambles for the observer. This ‘other-conferred utility’ was encoded in ventromedial prefrontal cortex, and these neural signals predicted conformity. We further identified a parametric interaction with individual risk preferences in anterior cingulate cortex and insula. These data provide a neuromechanistic account of how information from others is integrated with individual preferences that may explain preference-congruent susceptibility to social signals of safety and risk. PMID:25984890

  17. Interim qualitative risk assessment for an LNG refueling station and review of relevant safety issues

    SciTech Connect

    Siu, N.; Herring, S.; Cadwallader, L.; Reece, W.; Byers, J.

    1997-07-01

    This report is a qualitative assessment of the public and worker risk involved with the operation of a liquefied natural (LNG) vehicle refueling facility. This study includes facility maintenance and operations, tanker truck delivers and end-use vehicle fueling; it does not treat the risks of LNG vehicles on roadways. Accident initiating events are identified by using a Master Logic Diagram, a Failure Modes and Effects analysis and historical operating experiences. The event trees were drawn to depict possible sequences of mitigating events following the initiating events. The phenomenology of LNG and other vehicle fuels is discussed to characterize the hazard posed by LNG usage. Based on the risk modeling and analysis, recommendations are given to improve the safety of LNG refueling stations in the areas of procedures and training, station design, and the dissemination of best practice information throughout the LNG community.

  18. Qualitative Risk Assessment for an LNG Refueling Station and Review of Relevant Safety Issues

    SciTech Connect

    Siu, N.; Herring, J.S.; Cadwallader, L.; Reece, W.; Byers, J.

    1998-02-01

    This report is a qualitative assessment of the public and worker risk involved with the operation of a liquefied natural gas (LNG) vehicle refueling facility. This study includes facility maintenance and operations, tank truck deliveries, and end-use vehicle fueling; it does not treat the risks of LNG vehicles on roadways. Accident initiating events are identified by using a Master Logic Diagram, a Failure Modes and Effects Analysis, and historical operating experiences. The event trees were drawn to depict possible sequences of mitigating events following the initiating events. The phenomenology of LNG and other vehicle fuels is discussed to characterize the hazard posed by LNG usage. Based on the risk modeling and analysis, recommendations are given to improve the safety of LNG refueling stations in the areas of procedures and training, station design, and the dissemination of ``best practice`` information throughout the LNG community.

  19. EPA Proposes Revisions to its Risk Management Program to Improve Chemical Process Safety and Further Protect Communities and First Responders

    EPA Pesticide Factsheets

    WASHINGTON - The U.S. Environmental Protection Agency (EPA) is proposing to revise its Risk Management Program (RMP) regulations to improve chemical process safety, assist local emergency authorities in planning for and responding to accidents, and

  20. Factors Influencing Young Children's Risk of Unintentional Injury: Parenting Style and Strategies for Teaching about Home Safety

    ERIC Educational Resources Information Center

    Morrongiello, Barbara A.; Corbett, Michael; Lasenby, Jennifer; Johnston, Natalie; McCourt, Meghan

    2006-01-01

    This study examined mothers' teaching about home-safety issues to 24-30 month and 36-42 month old children, explored the relationship of teaching strategies to parenting styles, and assessed how these factors are related to children's risk of unintentional injury. A structured interview assessed home-safety issues relevant to falls, burns, cuts,…

  1. Risk-based process safety assessment and control measures design for offshore process facilities.

    PubMed

    Khan, Faisal I; Sadiq, Rehan; Husain, Tahir

    2002-09-02

    Process operation is the most hazardous activity next to the transportation and drilling operation on an offshore oil and gas (OOG) platform. Past experiences of onshore and offshore oil and gas activities have revealed that a small mis-happening in the process operation might escalate to a catastrophe. This is of especial concern in the OOG platform due to the limited space and compact geometry of the process area, less ventilation, and difficult escape routes. On an OOG platform, each extra control measure, which is implemented, not only occupies space on the platform and increases congestion but also adds extra load to the platform. Eventualities in the OOG platform process operation can be avoided through incorporating the appropriate control measures at the early design stage. In this paper, the authors describe a methodology for risk-based process safety decision making for OOG activities. The methodology is applied to various offshore process units, that is, the compressor, separators, flash drum and driers of an OOG platform. Based on the risk potential, appropriate safety measures are designed for each unit. This paper also illustrates that implementation of the designed safety measures reduces the high Fatal accident rate (FAR) values to an acceptable level.

  2. Utah farm owner/operators' safety practices and risk awareness regarding confined space work in agriculture.

    PubMed

    Pate, M L; Merryweather, A S

    2012-10-01

    The purpose of this study was to describe current safety practices and risk awareness associated with confined spaces in agriculture among Utah farm owner/operators. There were 399 farm owner/operators in the sample. The final response rate was 82.2%. The typical farm owner/operator in this study was male, between the ages of 50 and 59, with some education beyond high school. Grain and dairy production comprised 48.7% of the operations responding to the survey. A majority (50.2%) of respondents reported having entered a confined space without an observer waiting from the outside. All but 9.5% of the respondents indicated that they had no written emergency response plan in the event of a confined space emergency involving an entrant. Only 49.1% of farm owner/operators perceived entering a grain bin while unloading as a high risk for fatal injury. More research is needed to determine the farmers' knowledge of the variety of hazards associated with confined space work. Few farm owner/operators reported using accessible safety equipment. A limited number of respondents indicated having access to gas monitors, lifeline and harness systems, or ventilation blowers with flexible ducting. This may be associated with the costs of the equipment, or lack of awareness of the need for specific safety equipment.

  3. Safety knowledge and risk behaviour of injured and uninjured young skiers and snowboarders

    PubMed Central

    Macnab, Andrew J; Cadman, Robert E; Greenlaw, Julia V

    1998-01-01

    BACKGROUND: Earlier studies of ski injury indicated that youths were at increased risk of injury, that males were most likely to injure the head or face, and that females were most likely to injure the knee. OBJECTIVE: To obtain information about safety knowledge and risk behaviour that might contribute to injury among young skiers and snow-boarders. DESIGN: Survey of knowledge and behaviour in injured and noninjured cohorts. SETTING: Blackcomb Mountain, Whistler, British Columbia. PARTICIPANTS: A total of 863 noninjured and 118 injured skiers and snowboarders aged five to 17 years using Blackcomb during 1993/94. INTERVENTION: Skier Knowledge Inventory Questionnaire. RESULTS: The injured cohort had less knowledge of the Skiers Responsibility Code. In both groups, almost half had had no lessons, 31% had had bindings adjusted by nonprofessionals and chair lift safety bars were used one ride in four by children age 13 to 17 years. The injuried cohort wore helmets slightly less often. Both groups regularly skied through the trees (60% to 70%), and one-thirds had skied on closed runs. Excessive speed was identified as the major cause of injury. Skiers did not recognize jumping as contributing to injury. CONCLUSIONS: Lack of knowledge of safety rules was more prevalent among the injured cohort. Skiing without due care – including skiing through tress, skiing on closed runs, skiing with excessive speed and jumping, particularly by snowboarders – were identified as potential causes of injury. PMID:20401273

  4. Water- and wastewater-related disease and infection risks: what is an appropriate value for the maximum tolerable additional burden of disease?

    PubMed

    Mara, Duncan

    2011-06-01

    The maximum additional burden of water- and wastewater-related disease of 10-6 disability-adjusted life year (DALY) loss per person per year (pppy), used in the WHO Drinking-water Quality Guidelines and the WHO Guidelines for Wastewater Use in Agriculture, is based on US EPA'S acceptance of a 70-year lifetime waterborne cancer risk of 10(-5) per person, equivalent to an annual risk of 1.4x10(-7) per person which is four orders of magnitude lower than the actual all-cancer incidence in the USA in 2009 of 1.8x10(-3) pppy. A maximum additional burden of 10(-4) DALY loss pppy would reduce this risk to a more cost-effective, but still low, risk of 1.4x10(-5) pppy. It would increase the DALY loss pppy in low- and middle-income countries due to diarrhoeal diseases from the current level of 0.0119 pppy to 0.0120 pppy, and that due to ascariasis from 0.0026 pppy to 0.0027 pppy, but neither increase is of public-health significance. It is therefore recommended that the maximum additional burden of disease from these activities be increased to a DALY loss of 10(-4) pppy as this provides an adequate margin of public-health safety in relation to waterborne-cancer deaths, diarrhoeal disease and ascariasis in all countries.

  5. Reciprocal Effects of Positive Future Expectations, Threats to Safety, and Risk Behavior Across Adolescence.

    PubMed

    Prince, Dana M; Epstein, Marina; Nurius, Paula S; Gorman-Smith, Deborah; Henry, David B

    2016-09-12

    We examined the reciprocal relationships among positive future expectations, expected threats to future safety, depression, and individual substance use and delinquency using 4 waves of data (N = 248-338) from African American and Latino adolescent male participants in the Chicago Youth Development Study. Individual positive future expectations and expected threats to safety were assessed at each wave and modeled as latent constructs. Individual substance use and delinquency were assessed at each wave and represented as ordinal variables ranging from low to high. Categorical autoregressive cross-lagged structural models were used to examine the hypothesized reciprocal relationships between both aspects of future expectations construct and risk behavior across adolescence. Analyses show that future expectations has important effects on youth substance use and involvement in delinquency, both of which in turn decrease positive expectations and increase expectation of threats to future safety across adolescence. Similarly, low positive expectations for the future continued to predict increased substance use and involvement in delinquency. The expected threats to safety construct was significantly correlated with delinquency within time. These effects are observed across adolescence after controlling for youth depression and race. Findings support the reciprocal effects hypothesis of a negative reinforcing cycle in the relationships between future expectations and both substance use and involvement in delinquent behavior across adolescence. The enduring nature of these relationships underscores the importance of future expectation as a potential change mechanism for intervention and prevention efforts to promote healthy development; vulnerable racial and ethnic minority male adolescents may especially benefit from such intervention.

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

    SciTech Connect

    Garvin, L.J.

    1997-05-20

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

  7. Knowledge and perceived implementation of food safety risk analysis framework in Latin America and the Caribbean region.

    PubMed

    Cherry, C; Mohr, A Hofelich; Lindsay, T; Diez-Gonzalez, F; Hueston, W; Sampedro, F

    2014-12-01

    Risk analysis is increasingly promoted as a tool to support science-based decisions regarding food safety. An online survey comprising 45 questions was used to gather information on the implementation of food safety risk analysis within the Latin American and Caribbean regions. Professionals working in food safety in academia, government, and private sectors in Latin American and Caribbean countries were contacted by email and surveyed to assess their individual knowledge of risk analysis and perceptions of its implementation in the region. From a total of 279 participants, 97% reported a familiarity with risk analysis concepts; however, fewer than 25% were able to correctly identify its key principles. The reported implementation of risk analysis among the different professional sectors was relatively low (46%). Participants from industries in countries with a long history of trade with the United States and the European Union, such as Mexico, Brazil, and Chile, reported perceptions of a higher degree of risk analysis implementation (56, 50, and 20%, respectively) than those from the rest of the countries, suggesting that commerce may be a driver for achieving higher food safety standards. Disagreement among respondents on the extent of the use of risk analysis in national food safety regulations was common, illustrating a systematic lack of understanding of the current regulatory status of the country. The results of this survey can be used to target further risk analysis training on selected sectors and countries.

  8. Managing occupational risk in creative practice: a new perspective for occupational health and safety.

    PubMed

    Oughton, Nicholas

    2013-01-01

    There has been little recognition of the fact that creative production operates in a somewhat different environment and timeframe to that associated with traditional industries. This has resulted in the application of an orthodox, generic or ``one size fits all'' framework of Occupational Health and Safety (OHS) systems across all industries. With the rapid growth of ``creative industry,'' certain challenges arise from the application of this "generic" strategy, mainly because the systems currently employed may not be entirely suitable for creative practice. Some OHS practitioners suggest that the current OHS paradigm is failing. This paper questions the appropriateness of applying a twentieth century OHS model in the present industrial context, and considers what framework will best provide for the well-being of creative workers and their enterprise in the twenty-first century. The paper questions the notion of "Risk" and the paradox associated with "Risk Management," particularly in the context of the creative process. Clearly, risk taking contributes to creative enterprise and effective risk management should accommodate both risk minimization and risk exploitation.

  9. Impact of risk attitudes and perception on game theoretic driving interactions and safety.

    PubMed

    Arbis, David; Dixit, Vinayak V; Rashidi, Taha Hossein

    2016-09-01

    This study employs game theory to investigate behavioural norms of interaction between drivers at a signalised intersection. The choice framework incorporates drivers' risk perception as well as their risk attitudes. A laboratory experiment is conducted to study the impact of risk attitudes and perception in crossing behaviour at a signalised intersection. The laboratory experiment uses methods from experimental economics to induce incentives and study revealed behaviour. Conflicting drivers are considered to have symmetric disincentives for crashing, to represent a no-fault car insurance environment. The study is novel as it uses experimental data collection methods to investigate perceived risk. Further, it directly integrates perceived risk of crashing with other active drivers into the modelling structure. A theoretical model of intersection crossing behaviour is also developed in this paper. This study shows that right-of-way entitlements assigned without authoritative penalties to at-fault drivers may still improve perceptions of safety. Further, risk aversion amongst drivers attributes to manoeuvring strategies at or below Nash mixed strategy equilibrium. These findings offer a theoretical explanation for interactive manoeuvres that lead to crashes, as opposed to purely statistical methods which provide correlation but not necessarily explanation.

  10. Safety leadership and systems thinking: application and evaluation of a risk management framework in the mining industry.

    PubMed

    Donovan, Sarah-Louise; Salmon, Paul M; Lenné, Michael G; Horberry, Tim

    2017-03-18

    Safety leadership is an important factor in supporting safety in high-risk industries. This article contends that applying systems-thinking methods to examine safety leadership can support improved learning from incidents. A case study analysis was undertaken of a large-scale mining landslide incident in which no injuries or fatalities were incurred. A multi-method approach was adopted, in which the Critical Decision Method, Rasmussen's Risk Management Framework, and Accimap method were applied to examine the safety leadership decisions and actions which enabled the safe outcome. The approach enabled Rasmussen's predictions regarding safety and performance to be examined in the safety leadership context, with findings demonstrating the distribution of safety leadership across leader and system levels, and the presence of vertical integration as key to supporting the successful safety outcome. In doing so, the findings also demonstrate the usefulness of applying systems-thinking methods to examine and learn from incidents in terms of what 'went right'. The implications, including future research directions, are discussed. Practitioner Summary This paper presents a case study analysis, in which systems-thinking methods are applied to the examination of safety leadership decisions and actions during a large-scale mining landslide incident. The findings establish safety leadership as a systems phenomenon, and furthermore, demonstrate the usefulness of applying systems-thinking methods to learn from incidents in terms of what 'went right'. Implications, including future research directions, are discussed.

  11. [Safety and risk factor analysis on Polygoni Multiflori Radix base on ancient traditional Chinese medicine literatures].

    PubMed

    Song, Hai-bo; Du, Xiao-xi; Guo, Xiao-xin; Ren, Jing-tian; Yang, Le; Pang, Yu

    2015-03-01

    Traditional Chinese medicine Polygoni Multiflori Radix is dried roots of Polygonaceae Polygortum multiflorum Thunb. Its clinical application records were first discovered in literatures of the Tang dynasty. The origins, efficacy, toxicity, processing and taboos of Polygoni Multiflori Radix have been discussed in many ancient herb literatures. In recent years, with the increase in the public awareness in health, Polygoni Multiflori Radix admits preparations have been more widely applied in the treatment and prevention of diseases. However, there have been more and more reports about Polygoni Multiflori Radix induced liver injury, the safety of Polygoni Multiflori Radix has increasingly attracted attention of the society. In this paper, the authors summarized and analyzed the toxicity and medication risk factors of Polygoni Multiflori Radix recorded in ancient herb literatures, and proposed that more attention shall be given to the effect of the planting and processing methods on the components and toxicity of Polygoni Multiflori Radix in safety studies, which provides clues for the further studies.

  12. Self-enhancement, crash-risk optimism and the impact of safety advertisements on young drivers.

    PubMed

    Harré, Niki; Foster, Susan; O'neill, Maree

    2005-05-01

    In Study 1, young drivers (aged between 16 and 29 years, N = 314) rated their driving attributes relative to their peers. They also rated their likelihood of being involved in a crash relative to their peers (crash-risk optimism), their crash history, stereotype of the young driver, and concern over another health issue. A self-enhancement bias was found for all items in which self/other comparisons were made. These items formed two major factors, perceived relative driving ability and perceived relative driving caution. These factors and perceived luck relative to peers in avoiding crashes significantly predicted crash-risk optimism. In Study 2, an experimental group of young drivers (N = 173) watched safety advertisements that showed drinking and dangerous driving resulting in a crash, and a control group (N = 193) watched advertisements showing people choosing not to drive after drinking. Each group then completed the self/other comparisons used in Study 1. The same factors were found, but only driving caution significantly predicted crash-risk optimism. The experimental group showed more self-enhancement on driving ability than the control group. In both studies, men showed substantially more self-enhancement than women about their driving ability. Implications for safety interventions are discussed.

  13. Synergistic effect of rice husk addition on hydrothermal treatment of sewage sludge: fate and environmental risk of heavy metals.

    PubMed

    Shi, Wansheng; Liu, Chunguang; Shu, Youju; Feng, Chuanping; Lei, Zhongfang; Zhang, Zhenya

    2013-12-01

    Hydrothermal treatment (HTT) at 200°C was applied to immobilize heavy metals (HMs) and the effect of rice husk (RH) addition was investigated based on total HMs concentration, fractionation and leaching tests. The results indicated that a synergistic effect of RH addition and HTT could be achieved on reducing the risk of HMs from medium and low risk to no risk. Metals were redistributed and transformed from weakly bounded state to stable state during the HTT process under RH addition. Notably at a RH/sludge ratio of 1/1.75 (d.w.), all the HMs showed no eco-toxicity and no leaching toxicity, with the concentrations of leachable Cr, Ni, Cu and Cd decreased by 17%, 89%, 95% and 93%, respectively. This synergistic effect of RH addition and HTT on the risk reduction of HMs implies that HTT process with RH addition could be a promising and safe disposal technology for sewage sludge treatment in practice.

  14. An integrated framework for safety, quality and risk management: an information and incident management system based on a universal patient safety classification

    PubMed Central

    Runciman, W B; Williamson, J A H; Deakin, A; Benveniste, K A; Bannon, K; Hibbert, P D

    2006-01-01

    More needs to be done to improve safety and quality and to manage risks in health care. Existing processes are fragmented and there is no single comprehensive source of information about what goes wrong. An integrated framework for the management of safety, quality and risk is needed, with an information and incident management system based on a universal patient safety classification. The World Alliance for Patient Safety provides a platform for the development of a coherent approach; 43 desirable attributes for such an approach are discussed. An example of an incident management and information system serving a patient safety classification is presented, with a brief account of how and where it is currently used. Any such system is valueless unless it improves safety and quality. Quadruple‐loop learning (personal, local, national and international) is proposed with examples of how an exemplar system has been successfully used at the various levels. There is currently an opportunity to “get it right” by international cooperation via the World Health Organization to develop an integrated framework incorporating systems that can accommodate information from all sources, manage and monitor things that go wrong, and allow the worldwide sharing of information and the dissemination of tools for the implementation of strategies which have been shown to work. PMID:17142615

  15. Additive genetic variation in schizophrenia risk is shared by populations of African and European descent.

    PubMed

    de Candia, Teresa R; Lee, S Hong; Yang, Jian; Browning, Brian L; Gejman, Pablo V; Levinson, Douglas F; Mowry, Bryan J; Hewitt, John K; Goddard, Michael E; O'Donovan, Michael C; Purcell, Shaun M; Posthuma, Danielle; Visscher, Peter M; Wray, Naomi R; Keller, Matthew C

    2013-09-05

    To investigate the extent to which the proportion of schizophrenia's additive genetic variation tagged by SNPs is shared by populations of European and African descent, we analyzed the largest combined African descent (AD [n = 2,142]) and European descent (ED [n = 4,990]) schizophrenia case-control genome-wide association study (GWAS) data set available, the Molecular Genetics of Schizophrenia (MGS) data set. We show how a method that uses genomic similarities at measured SNPs to estimate the additive genetic correlation (SNP correlation [SNP-rg]) between traits can be extended to estimate SNP-rg for the same trait between ethnicities. We estimated SNP-rg for schizophrenia between the MGS ED and MGS AD samples to be 0.66 (SE = 0.23), which is significantly different from 0 (p(SNP-rg = 0) = 0.0003), but not 1 (p(SNP-rg = 1) = 0.26). We re-estimated SNP-rg between an independent ED data set (n = 6,665) and the MGS AD sample to be 0.61 (SE = 0.21, p(SNP-rg = 0) = 0.0003, p(SNP-rg = 1) = 0.16). These results suggest that many schizophrenia risk alleles are shared across ethnic groups and predate African-European divergence.

  16. Consumer product safety: Risk assessment of exposure to asbestos emissions from hand-held hair dryers

    NASA Astrophysics Data System (ADS)

    Hallenbeck, William H.

    1981-01-01

    The United States Consumer Product Safety Commission (CPSC) is concerned that consumer exposure to asbestos from consumer products may present an unreasonable risk of injury. Recently, CPSC has obtained agreement by industry to cease production and distribution of hair dryers containing asbestos heat insulation. CPSC intends to broaden its investigation by selecting consumer products containing asbestos for “priority attention.” The Commission does not intend to make quantitative estimates of cancer risks posed by exposure to asbestos fibers in making regulatory decisions. This position may lead to a serious waste of resources for the Commission, industry, and society. The Commission should focus its initial attention on those products for which the release of asbestos is significant enough to cause an unreasonable health risk. To make a risk assessment for a particular use of asbestos, CPSC must acquire or request data on asbestos emissions and define “unreasonable risk to health.” In an attempt to give some meaning to the phrase “risk assessment,” the primary goal of this paper is to present a detailed risk assessment of exposure to asbestos from hand-held hair dryers. Several scenarios of use are presented using various assumptions regarding time of operation, mixing of fibers in a small room, rate of fiber emission, and time of exposure. The worst case analysis of the health risk of exposure to hair dryer emissions is based on several conservative assumptions and shows that the increased number of deaths per year due to respiratory cancer is 4 for the entire United States population. A more representative case analysis shows the increased number of deaths to be on the order of 0.15 per year.

  17. Direct Human Contact with Siloxanes (Silicones) – Safety or Risk Part 1. Characteristics of Siloxanes (Silicones)

    PubMed Central

    Mojsiewicz-Pieńkowska, Krystyna; Jamrógiewicz, Marzena; Szymkowska, Katarzyna; Krenczkowska, Dominika

    2016-01-01

    Siloxanes are commonly known as silicones. They belong to the organosilicon compounds and are exclusively obtained by synthesis. Their chemical structure determines a range of physicochemical properties which were recognized as unique. Due to the susceptibility to chemical modifications, ability to create short, long or complex polymer particles, siloxanes found an application in many areas of human life. Siloxanes differ in particle size, molecular weight, shape and chemical groups. As a result, this determines the different physico-chemical properties, that directly affect the safety or the risk of their use. The areas that can be a source of danger to human health will be commented in this paper. PMID:27303296

  18. What is safety culture and risk-taking like at a large steel manufacturing company?

    PubMed

    Nordlöf, Hasse

    2012-01-01

    Focus group interviews were conducted at a large steel manufacturing company with 1000 employees, in order to answer the research question: what is the safety culture and risk-taking like at the company, according to employees? Ten focus groups were used for data collection consisting of 6-8 employees each. The participants were operators from production. The interviews lasted 75 min and were digitally recorded and thereafter verbatim transcribed. Descriptive data was also collected from all participants by allowing them to fill out a short questionnaire. The results of this study will be presented at the conference as a poster presentation.

  19. Management of personal safety risk for lever operation in mechanical railway signal boxes.

    PubMed

    Muffett, Bob; Wilson, John R; Clarke, Theresa; Coplestone, Anthony; Lowe, Emma; Robinson, John; Smith, Stuart

    2014-03-01

    Despite increased implementation of computer control systems in managing and regulating rail networks, mechanical signal boxes using lever operation will be in place for years to come. A rolling risk assessment programme identified a number of levers in mechanical signal boxes within the UK rail network which potentially presented unacceptable personal safety risk to signallers. These levers operate both points and signals and the risk is primarily the weights which have to be moved when pulling and pushing the levers. Operating difficulties are often compounded by the design and condition of lever frames, the linkages to the points/signals, maintenance regimes, the workspace and the postures and strategies adopted by signallers. Lever weights were measured as from 15 kg to 180 kg at over 160 boxes, using a specially designed and constructed device. Taken together with examination of injury and sickness absence data, interviews and field observations, and biomechanical computer modelling, the measurement programme confirmed the potential risks. A risk management programme has been implemented, comprising lever weight measurement, training of operations staff, a structured maintenance regime and renewal or redesign for boxes/levers where, after maintenance, a criterion weight level is still exceeded. For a feasible management programme, the first alert (or 1st action) value for further assessment is 55 kg, a second action level requiring specified maintenance is 80-99 kg, and a third action level requiring the lever to be signed out of use is 100 kg.

  20. Risk-Informed Safety Margin Characterization Case Study: Selection of Electrical Equipment to Be Subjected to Environmental Qualification

    SciTech Connect

    D. P. Blanchard; R. W. Youngblood

    2014-06-01

    The Risk-Informed Safety Margin Characterization (RISMC) pathway of the DOE’s Light Water Reactor Sustainability (LWRS) program focuses on advancing the state of the art in safety analysis and risk assessment to support decision-making on nuclear power plant operation well beyond the originally designed lifetime of the plants (i.e., beyond 60 years). Among the issues being addressed in RISMC is the significance of SSC aging and how confident we are about our understanding of its impact on the margin between the loads SSCs are expected to see during normal operation and accident conditions, and the SSC capacities (their ability to resist those loads) as the SSCs age. In this paper, a summary is provided of a case study that examines SSC aging from an environmental qualification (EQ) perspective. The case study illustrates how the state of knowledge regarding SSC margin can be characterized given the overall integrated plant design, and was developed to demonstrate a method for deciding on which cables to focus, which cables are not so important from an environmental qualification margin standpoint, and what plant design features or operating characteristics determine the role that environmental qualification plays in establishing a safety case on which decisions regarding margin can be made. The selection of cables for which demonstration of margin with respect to aging and environmental challenges uses a technique known as Prevention Analysis. Prevention Analysis is a Boolean method for optimal selection of SSCs (that is, those combinations of SSCs both necessary and sufficient to meet a predetermined selection criterion) in a manner that allows demonstration that plant-level safety can be demonstrated by the collection of selected SSCs alone. Choosing the set of SSCs that is necessary and sufficient to satisfy the safety objectives, and demonstrating that the safety objectives can be met effectively, determines where resources are best allocated to assure SSC

  1. The addition of whole soy flour to cafeteria diet reduces metabolic risk markers in wistar rats

    PubMed Central

    2013-01-01

    Background Soybean is termed a functional food because it contains bioactive compounds. However, its effects are not well known under unbalanced diet conditions. This work is aimed at evaluating the effect of adding whole soy flour to a cafeteria diet on intestinal histomorphometry, metabolic risk and toxicity markers in rats. Methods In this study, 30 male adult Wistar rats were used, distributed among three groups (n = 10): AIN-93 M diet, cafeteria diet (CAF) and cafeteria diet with soy flour (CAFS), for 56 days. The following parameters were measured: food intake; weight gain; serum concentrations of triglycerides, total cholesterol, HDL-c, glycated hemoglobin (HbA1c), aspartate (AST) and alanine (ALT) aminotransferases and Thiobarbituric Acid Reactive Substances (TBARS); humidity and lipid fecal content; weight and fat of the liver. The villous height, the crypt depth and the thickness of the duodenal and ileal circular and longitudinal muscle layers of the animals were also measured. Results There was a significant reduction in the food intake in the CAF group. The CAFS showed lower serum concentrations of triglycerides and serum TBARS and a lower percentage of hepatic fat, with a corresponding increase in thickness of the intestinal muscle layers. In the CAF group, an increase in the HbA1c, ALT, lipid excretion, liver TBARS and crypt depth, was observed associated with lower HDL-c and villous height. The addition of soy did not promote any change in these parameters. Conclusions The inclusion of whole soy flour in a high-fat diet may be helpful in reducing some markers of metabolic risk; however, more studies are required to clarify its effects on unbalanced diets. PMID:24119309

  2. Upholding science in health, safety and environmental risk assessments and regulations.

    PubMed

    Aschner, Michael; Autrup, Herman N; Berry, Sir Colin L; Boobis, Alan R; Cohen, Samuel M; Creppy, Edmond E; Dekant, Wolfgang; Doull, John; Galli, Corrado L; Goodman, Jay I; Gori, Gio B; Greim, Helmut A; Joudrier, Philippe; Kaminski, Norbert E; Klaassen, Curtis D; Klaunig, James E; Lotti, Marcello; Marquardt, Hans W J; Pelkonen, Olavi; Sipes, I Glenn; Wallace, Kendall B; Yamazaki, Hiroshi

    2016-09-14

    A public appeal has been advanced by a large group of scientists, concerned that science has been misused in attempting to quantify and regulate unmeasurable hazards and risks.(1) The appeal recalls that science is unable to evaluate hazards that cannot be measured, and that science in such cases should not be invoked to justify risk assessments in health, safety and environmental regulations. The appeal also notes that most national and international statutes delineating the discretion of regulators are ambiguous about what rules of evidence ought to apply. Those statutes should be revised to ensure that the evidence for regulatory action is grounded on the standards of the scientific method, whenever feasible. When independent scientific evidence is not possible, policies and regulations should be informed by publicly debated trade-offs between socially desirable uses and social perceptions of affordable precaution. This article explores the premises, implications and actions supporting the appeal and its objectives.

  3. Risk analysis-based food safety policy: scientific factors versus socio-cultural factors.

    PubMed

    De Rosa, Mauro; van Knapen, Frans; Brom, Frans W A

    2008-09-15

    The purpose of this article is to illustrate the importance of socio-cultural factors in risk management and the need to incorporate these factors in a standard, internationally recognized (WTO) framework. This was achieved by analysing the relevance of these factors in three cases. It can be concluded that the pre-eminent role of science in food-related regulatory decisions is debatable. At a risk management level, other factors, such as cultural, social, or economic issues, are often more important than scientific advice in determining policy. There is a need for transparency at an international level as trade barriers are gradually being removed and these other factors are becoming more apparent. Therefore it is important that all the factors implicated in the food safety policy-making process are recognized in a standard framework.

  4. Fire and scald burn risks in urban communities: who is at risk and what do they believe about home safety?

    PubMed

    Parker, E M; Gielen, A C; McDonald, E M; Shields, W C; Trump, A R; Koon, K M; Jones, V

    2013-08-01

    While largely preventable, fire and hot water-related injuries are common in the United States. Measures recommended to reduce these injuries are smoke alarms (SAs) and lowered hot water temperatures. This study aims to: (i) describe the prevalence of working SAs and safe water temperatures among low-income, urban communities and (ii) explore the relationship between these behaviors and individuals' knowledge and beliefs about them. In this cross-sectional study, the Health Belief Model was used as a guide for understanding the safety behaviors. A total of 603 households had their SAs and hot tap water temperatures tested and were surveyed about their knowledge and beliefs related to these safety behaviors. We found that 40% of households had working SAs on every level and 57% had safe hot water temperatures. Perceived severity and self-efficacy were significantly associated with SA coverage, whereas perceived susceptibility and beliefs about benefits were significantly associated with safe hot water temperatures. This study demonstrates the need to increase the number of homes with working SAs and safe hot water temperatures. Messages focused on a safe home environment could communicate the ease and harm reduction features of SAs and benefits and risk reduction features of safe hot water temperatures.

  5. Evaluating the Cost, Safety, and Proliferation Risks of Small Floating Nuclear Reactors.

    PubMed

    Ford, Michael J; Abdulla, Ahmed; Morgan, M Granger

    2017-01-17

    It is hard to see how our energy system can be decarbonized if the world abandons nuclear power, but equally hard to introduce the technology in nonnuclear energy states. This is especially true in countries with limited technical, institutional, and regulatory capabilities, where safety and proliferation concerns are acute. Given the need to achieve serious emissions mitigation by mid-century, and the multidecadal effort required to develop robust nuclear governance institutions, we must look to other models that might facilitate nuclear plant deployment while mitigating the technology's risks. One such deployment paradigm is the build-own-operate-return model. Because returning small land-based reactors containing spent fuel is infeasible, we evaluate the cost, safety, and proliferation risks of a system in which small modular reactors are manufactured in a factory, and then deployed to a customer nation on a floating platform. This floating small modular reactor would be owned and operated by a single entity and returned unopened to the developed state for refueling. We developed a decision model that allows for a comparison of floating and land-based alternatives considering key International Atomic Energy Agency plant-siting criteria. Abandoning onsite refueling is beneficial, and floating reactors built in a central facility can potentially reduce the risk of cost overruns and the consequences of accidents. However, if the floating platform must be built to military-grade specifications, then the cost would be much higher than a land-based system. The analysis tool presented is flexible, and can assist planners in determining the scope of risks and uncertainty associated with different deployment options.

  6. Screening for Chemical Contributions to Breast Cancer Risk: A Case Study for Chemical Safety Evaluation

    PubMed Central

    Ackerman, Janet M.; Dairkee, Shanaz H.; Fenton, Suzanne E.; Johnson, Dale; Navarro, Kathleen M.; Osborne, Gwendolyn; Rudel, Ruthann A.; Solomon, Gina M.; Zeise, Lauren; Janssen, Sarah

    2015-01-01

    Background Current approaches to chemical screening, prioritization, and assessment are being reenvisioned, driven by innovations in chemical safety testing, new chemical regulations, and demand for information on human and environmental impacts of chemicals. To conceptualize these changes through the lens of a prevalent disease, the Breast Cancer and Chemicals Policy project convened an interdisciplinary expert panel to investigate methods for identifying chemicals that may increase breast cancer risk. Methods Based on a review of current evidence, the panel identified key biological processes whose perturbation may alter breast cancer risk. We identified corresponding assays to develop the Hazard Identification Approach for Breast Carcinogens (HIA-BC), a method for detecting chemicals that may raise breast cancer risk. Finally, we conducted a literature-based pilot test of the HIA-BC. Results The HIA-BC identifies assays capable of detecting alterations to biological processes relevant to breast cancer, including cellular and molecular events, tissue changes, and factors that alter susceptibility. In the pilot test of the HIA-BC, chemicals associated with breast cancer all demonstrated genotoxic or endocrine activity, but not necessarily both. Significant data gaps persist. Conclusions This approach could inform the development of toxicity testing that targets mechanisms relevant to breast cancer, providing a basis for identifying safer chemicals. The study identified important end points not currently evaluated by federal testing programs, including altered mammary gland development, Her2 activation, progesterone receptor activity, prolactin effects, and aspects of estrogen receptor β activity. This approach could be extended to identify the biological processes and screening methods relevant for other common diseases. Citation Schwarzman MR, Ackerman JM, Dairkee SH, Fenton SE, Johnson D, Navarro KM, Osborne G, Rudel RA, Solomon GM, Zeise L, Janssen S. 2015

  7. Health economics and outcomes methods in risk-based decision-making for blood safety.

    PubMed

    Custer, Brian; Janssen, Mart P

    2015-08-01

    Analytical methods appropriate for health economic assessments of transfusion safety interventions have not previously been described in ways that facilitate their use. Within the context of risk-based decision-making (RBDM), health economics can be important for optimizing decisions among competing interventions. The objective of this review is to address key considerations and limitations of current methods as they apply to blood safety. Because a voluntary blood supply is an example of a public good, analyses should be conducted from the societal perspective when possible. Two primary study designs are recommended for most blood safety intervention assessments: budget impact analysis (BIA), which measures the cost to implement an intervention both to the blood operator but also in a broader context, and cost-utility analysis (CUA), which measures the ratio between costs and health gain achieved, in terms of reduced morbidity and mortality, by use of an intervention. These analyses often have important limitations because data that reflect specific aspects, for example, blood recipient population characteristics or complication rates, are not available. Sensitivity analyses play an important role. The impact of various uncertain factors can be studied conjointly in probabilistic sensitivity analyses. The use of BIA and CUA together provides a comprehensive assessment of the costs and benefits from implementing (or not) specific interventions. RBDM is multifaceted and impacts a broad spectrum of stakeholders. Gathering and analyzing health economic evidence as part of the RBDM process enhances the quality, completeness, and transparency of decision-making.

  8. Veterans Affairs Health Care: Addition to GAO’s High Risk List and Actions Needed for Removal

    DTIC Science & Technology

    2015-04-29

    VETERANS AFFAIRS HEALTH CARE Addition to GAO’s High Risk List and Actions Needed for Removal Statement of Debra A...Draper Director, Health Care Testimony Before the Committee on Veterans’ Affairs, U.S. Senate For Release on Delivery Expected at 2:30 p.m. ET...to 00-00-2015 4. TITLE AND SUBTITLE Veterans Affairs Health Care: Addition to GAO’s High Risk List and Actions Needed for Removal 5a. CONTRACT

  9. The apolipoprotein epsilon4 allele confers additional risk in children with familial hypercholesterolemia.

    PubMed

    Wiegman, Albert; Sijbrands, Eric J G; Rodenburg, Jessica; Defesche, Joep C; de Jongh, Saskia; Bakker, Henk D; Kastelein, John J P

    2003-06-01

    Children with familial hypercholesterolemia (FH) exhibit substantial variance of LDL cholesterol. In previous studies, family members of children with FH were included, which may have influenced results. To avoid such bias, we studied phenotype in 450 unrelated children with FH and in 154 affected sib-pairs. In known families with classical FH, diagnosis was based on plasma LDL cholesterol above the age- and gender-specific 95th percentile. Girls had 0.47 +/- 0.15 mmol/L higher LDL cholesterol, compared with boys (p = 0.002). Also in girls, HDL cholesterol increased by 0.07 +/- 0.03 mmol/L per 5 y (pfor trend = 0.005); this age effect was not observed in boys. The distribution of apolipoprotein (apo) E genotypes was not significantly different between probands, their paired affected siblings, or a Dutch control population. Carriers with or without one epsilon4 allele had similar LDL and HDL cholesterol levels. Within the affected sib-pairs, the epsilon4 allele explained 72.4% of the variance of HDL cholesterol levels (-0.15 mmol/L, 95% confidence interval -0.24 to -0.05, p = 0.003). The effect of apoE4 on HDL cholesterol differed with an analysis based on probands or on affected sib-pairs. The affected sib-pair model used adjustment for shared environment, type of LDL receptor gene mutation, and a proportion of additional genetic factors and may, therefore, be more accurate in estimating effects of risk factors on complex traits. We conclude that the epsilon4 allele was associated with lower HDL cholesterol levels in an affected sib-pair analysis, which strongly suggests that apoE4 influences HDL cholesterol levels in FH children. Moreover, the strong association suggests that apoE4 carries an additional disadvantage for FH children.

  10. The use of meta-analytical tools in risk assessment for food safety.

    PubMed

    Gonzales-Barron, Ursula; Butler, Francis

    2011-06-01

    This communication deals with the use of meta-analysis as a valuable tool for the synthesis of food safety research, and in quantitative risk assessment modelling. A common methodology for the conduction of meta-analysis (i.e., systematic review and data extraction, parameterisation of effect size, estimation of overall effect size, assessment of heterogeneity, and presentation of results) is explained by reviewing two meta-analyses derived from separate sets of primary studies of Salmonella in pork. Integrating different primary studies, the first meta-analysis elucidated for the first time a relationship between the proportion of Salmonella-carrier slaughter pigs entering the slaughter lines and the resulting proportion of contaminated carcasses at the point of evisceration; finding that the individual studies on their own could not reveal. On the other hand, the second application showed that meta-analysis can be used to estimate the overall effect of a critical process stage (chilling) on the incidence of the pathogen under study. The derivation of a relationship between variables and a probabilistic distribution is illustrations of the valuable quantitative information synthesised by the meta-analytical tools, which can be incorporated in risk assessment modelling. Strengths and weaknesses of meta-analysis within the context of food safety are also discussed.

  11. Freight-train derailment rates for railroad safety and risk analysis.

    PubMed

    Liu, Xiang; Rapik Saat, M; Barkan, Christopher P L

    2017-01-01

    Derailments are the most common type of train accident in the United States. They cause damage to infrastructure, rolling stock and lading, disrupt service, and have the potential to cause casualties, and harm the environment. Train safety and risk analysis relies on accurate assessment of derailment likelihood. Derailment rate - the number of derailments normalized by traffic exposure - is a useful statistic to estimate the likelihood of a derailment. Despite its importance, derailment rate analysis using multiple factors has not been previously developed. In this paper, we present an analysis of derailment rates on Class I railroad mainlines based on data from the U.S. Federal Railroad Administration and the major freight railroads. The point estimator and confidence interval of train and car derailment rates are developed by FRA track class, method of operation and annual traffic density. The analysis shows that signaled track with higher FRA track class and higher traffic density is associated with a lower derailment rate. The new accident rates have important implications for safety and risk management decisions, such as the routing of hazardous materials.

  12. Use of a risk assessment method to improve the safety of negative pressure wound therapy.

    PubMed

    Lelong, Anne-Sophie; Martelli, Nicolas; Bonan, Brigitte; Prognon, Patrice; Pineau, Judith

    2014-06-01

    To conduct a risk analysis of the negative pressure wound therapy (NPWT) care process and to improve the safety of NPWT, a working group of nurses, hospital pharmacists, physicians and hospital managers performed a risk analysis for the process of NPWT care. The failure modes, effects and criticality analysis (FMECA) method was used for this analysis. Failure modes and their consequences were defined and classified as a function of their criticality to identify priority actions for improvement. By contrast to classical FMECA, the criticality index (CI) of each consequence was calculated by multiplying occurrence, severity and detection scores. We identified 13 failure modes, leading to 20 different consequences. The CI of consequences was initially 712, falling to 357 after corrective measures were implemented. The major improvements proposed included the establishment of 6-monthly training cycles for nurses, physicians and surgeons and the introduction of computerised prescription for NPWT. The FMECA method also made it possible to prioritise actions as a function of the criticality ranking of consequences and was easily understood and used by the working group. This study is, to our knowledge, the first to use the FMECA method to improve the safety of NPWT.

  13. Bladder explosion during transurethral resection of prostate: Bladder diverticula as an additional risk factor

    PubMed Central

    Vincent, D. Paul

    2017-01-01

    Vesical explosion during transurethral resection of the prostate (TURP) is a very rare occurrence. Very few cases have been reported in the literature. The literature was reviewed pertaining to the etiology of bladder explosion during transurethral resection. The underlying mechanism for intravesical explosion is the generation and trapping of explosive gasses under the dome of the bladder which eventually detonates when it comes into contact with the cautery electrode during TURP. Various techniques have been suggested to prevent this dreaded complication. A 75-year-old male with chronic retention of urine underwent TURP. There was Grade 2 trilobar enlargement of the prostate. There were multiple diverticula with one large diverticulum in the dome of the bladder. During hemostasis, there was a loud pop sound and the bladder exploded. Lower midline laparotomy was performed and the intraperitoneal bladder rupture was repaired. He had an uneventful postoperative recovery, and he is asymptomatic at 6 months of follow-up. Even though all the precautions were taken to avoid this complication, bladder rupture was encountered. The presence of multiple diverticula is being suggested as an additional risk factor for this complication as the bladder is thinned out and also possibly due to trapping of air bubble within the diverticulum. In such cases where there are multiple bladder diverticula, the employment of a suprapubic trocar for continuous drainage of the air bubble, could well be a practical consideration. PMID:28216933

  14. Disease Risk Perception and Safety Practices: A Survey of Australian Flying Fox Rehabilitators

    PubMed Central

    Sánchez, Cecilia A.; Baker, Michelle L.

    2016-01-01

    Interactions with flying foxes pose disease transmission risks to volunteer rehabilitators (carers) who treat injured, ill, and orphaned bats. In particular, Australian bat lyssavirus (ABLV) can be transmitted directly from flying foxes to humans in Australia. Personal protective equipment (PPE) and rabies vaccination can be used to protect against lyssavirus infection. During May and June 2014, active Australian flying fox carers participated in an online survey (SOAR: Survey Of Australian flying fox Rehabilitators) designed to gather demographic data, assess perceptions of disease risk, and explore safety practices. Responses to open-ended questions were analysed thematically. A logistic regression was performed to assess whether rehabilitators’ gender, use of PPE, threat perception, and years of experience predicted variation in their odds of being bitten or scratched. Eligible responses were received from 122 rehabilitators located predominantly on the eastern coast of Australia. Eighty-four percent of respondents were female. Years of experience ranged from <1 to 30 years (median 5 years). Respondents were highly educated. All rehabilitators were vaccinated against rabies and 94% received a rabies titre check at least every two years. Sixty-three percent of carers did not perceive viruses in flying foxes as a potential threat to their health, yet 74% of carers reported using PPE when handling flying foxes. Eighty-three percent of rehabilitators had received a flying fox bite or scratch at some point during their career. Carers provide an important community service by rescuing and rehabilitating flying foxes. While rehabilitators in this study have many excellent safety practices, including a 100% vaccination rate against rabies, there is room for improvement in PPE use. We recommend 1) the establishment of an Australia-wide set of guidelines for safety when caring for bats and 2) that the responsible government agencies in Australia support carers who

  15. Safety-critical event risk associated with cell phone tasks as measured in naturalistic driving studies: A systematic review and meta-analysis.

    PubMed

    Simmons, Sarah M; Hicks, Anne; Caird, Jeff K

    2016-02-01

    A systematic review and meta-analysis of naturalistic driving studies involving estimates of safety-critical event risk associated with handheld device use while driving is described. Fifty-seven studies identified from targeted databases, journals and websites were reviewed in depth, and six were ultimately included. These six studies, published between 2006 and 2014, encompass seven sets of naturalistic driver data and describe original research that utilized naturalistic methods to assess the effects of distracting behaviors. Four studies involved non-commercial drivers of light vehicles and two studies involved commercial drivers of trucks and buses. Odds ratios quantifying safety-critical event (SCE) risk associated with talking, dialing, locating or answering, and texting or browsing were extracted. Stratified meta-analysis of pooled odds ratios was used to estimate SCE risk by distraction type; meta-regression was used to test for sources of heterogeneity. The results indicate that tasks that require drivers to take their eyes off the road, such as dialing, locating a phone and texting, increase SCE risk to a greater extent than tasks that do not require eyes off the road such as talking. Although talking on a handheld device did not increase SCE risk, further research is required to determine whether it indirectly influences SCE risk (e.g., by encouraging other cell phone activities). In addition, a number of study biases and quality issues of naturalistic driving studies are discussed.

  16. Safety of anti-immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infection

    PubMed Central

    Cruz, A A; Lima, F; Sarinho, E; Ayre, G; Martin, C; Fox, H; Cooper, P J

    2007-01-01

    Background Although the role of immunoglobulin E (IgE) in immunity against helminth parasites is unclear, there is concern that therapeutic antibodies that neutralize IgE (anti-IgE) may be unsafe in subjects at risk of helminth infection. Objective We conducted an exploratory study to investigate the safety of omalizumab (anti-IgE) in subjects with allergic asthma and/or perennial allergic rhinitis at high risk of intestinal helminth infection. The primary safety outcome was risk of infections with intestinal helminths during anti-IgE therapy. Methods A randomized, double-blind, placebo-controlled trial was conducted in 137 subjects (12–30 years) at high risk of geohelminth infection. All subjects received pre-study anthelmintic treatment, followed by 52 weeks' treatment with omalizumab or placebo. Results Of the omalizumab subjects 50% (34/68) experienced at least one intestinal geohelminth infection compared with 41% (28/69) of placebo subjects [odds ratio (OR) 1.47, 95% confidence interval (CI) 0.74–2.95, one-sided P = 0.14; OR (adjusted for study visit, baseline infection status, gender and age) 2.2 (0.94–5.15); one-sided P = 0.035], providing some evidence for a potential increased incidence of geohelminth infection in subjects receiving omalizumab. Omalizumab therapy was well tolerated, and did not appear to be associated with increased morbidity attributable to intestinal helminths as assessed by clinical and laboratory adverse events, maximal helminth infection intensities and additional anthelmintic requirements. Time to first infection (OR 1.30, 95% CI 0.79–2.15, one-sided P = 0.15) was similar between treatment groups. Infection severity and response to anthelmintics appeared to be unaffected by omalizumab therapy. Conclusions In this exploratory study of allergic subjects at high risk of helminth infections, omalizumab therapy appeared to be safe and well tolerated, but may be associated with a modest increase in the incidence of geohelminth

  17. [Food additives and healthiness].

    PubMed

    Heinonen, Marina

    2014-01-01

    Additives are used for improving food structure or preventing its spoilage, for example. Many substances used as additives are also naturally present in food. The safety of additives is evaluated according to commonly agreed principles. If high concentrations of an additive cause adverse health effects for humans, a limit of acceptable daily intake (ADI) is set for it. An additive is a risk only when ADI is exceeded. The healthiness of food is measured on the basis of nutrient density and scientifically proven effects.

  18. Light Water Reactor Sustainability Program Risk Informed Safety Margin Characterization (RISMC) Advanced Test Reactor Demonstration Case Study

    SciTech Connect

    Curtis Smith; David Schwieder; Cherie Phelan; Anh Bui; Paul Bayless

    2012-08-01

    Safety is central to the design, licensing, operation, and economics of Nuclear Power Plants (NPPs). Consequently, the ability to better characterize and quantify safety margin holds the key to improved decision making about LWR design, operation, and plant life extension. A systematic approach to characterization of safety margins and the subsequent margins management options represents a vital input to the licensee and regulatory analysis and decision making that will be involved. The purpose of the RISMC Pathway R&D is to support plant decisions for risk-informed margins management with the aim to improve economics, reliability, and sustain safety of current NPPs. Goals of the RISMC Pathway are twofold: (1) Develop and demonstrate a risk-assessment method coupled to safety margin quantification that can be used by NPP decision makers as part of their margin recovery strategies. (2) Create an advanced “RISMC toolkit” that enables more accurate representation of NPP safety margin. This report describes the RISMC methodology demonstration where the Advanced Test Reactor (ATR) was used as a test-bed for purposes of determining safety margins. As part of the demonstration, we describe how both the thermal-hydraulics and probabilistic safety calculations are integrated and used to quantify margin management strategies.

  19. Spatio-temporal assessment of food safety risks in Canadian food distribution systems using GIS.

    PubMed

    Hashemi Beni, Leila; Villeneuve, Sébastien; LeBlanc, Denyse I; Côté, Kevin; Fazil, Aamir; Otten, Ainsley; McKellar, Robin; Delaquis, Pascal

    2012-09-01

    While the value of geographic information systems (GIS) is widely applied in public health there have been comparatively few examples of applications that extend to the assessment of risks in food distribution systems. GIS can provide decision makers with strong computing platforms for spatial data management, integration, analysis, querying and visualization. The present report addresses some spatio-analyses in a complex food distribution system and defines influence areas as travel time zones generated through road network analysis on a national scale rather than on a community scale. In addition, a dynamic risk index is defined to translate a contamination event into a public health risk as time progresses. More specifically, in this research, GIS is used to map the Canadian produce distribution system, analyze accessibility to contaminated product by consumers, and estimate the level of risk associated with a contamination event over time, as illustrated in a scenario.

  20. Percutaneous renal biopsy of native kidneys: efficiency, safety and risk factors associated with major complications

    PubMed Central

    Torres Muñoz, Abel; Valdez-Ortiz, Rafael; González-Parra, Carlos; Espinoza-Dávila, Elvy; Morales-Buenrostro, Luis E.; Correa-Rotter, Ricardo

    2011-01-01

    Introduction The use of an automated biopsy device and real-time ultrasound (current technology) for percutaneous renal biopsies (PRBs) has improved the likelihood of obtaining adequate tissue for diagnosis and has reduced the complications associated with renal biopsies. Our objective was to evaluate the efficacy and safety of the current PRB procedure and identify possible risk factors for the development of major complications. Material and methods We collected all native kidney PRBs performed with current technology in our institute from January 1998 to April 2008. Studied variables were collected from the patient's chart at the time of the biopsy. Results We analyzed 623 (96.4%) of 646 renal biopsies performed with the current automated procedure guided by real-time ultrasound. Although the effectiveness was 97.6%, there were 110 complications. Fourteen (2.24%) of these complications were major: 9 cases of renal hematoma, 2 cases with macroscopic hematuria (which needed blood transfusion), 1 case of intestinal perforation (which required exploratory laparotomy), 1 nephrectomy and 1 case of a dissecting hematoma. The logistic regression analysis demonstrated the following risk factors for developing major complications: diastolic blood pressure ≥ 90 mmHg, RR 7.6 (95% CI 1.35-43); platelet count ≤ 120×103/µl; RR 7.0 (95% CI 1.9-26.2); and blood urea nitrogen (BUN) ≥ 60 mg/dl, RR 9.27 (95% CI 2.8-30.7). Conclusions The observed efficacy and safety of the current technique in the present study were similar to observations in previous studies. Diastolic blood pressure ≥ 90 mmHg, platelets ≤ 120×103/µl and BUN ≥ 60 mg/dl were independent risk factors for the development of major complications following PRB. PMID:22291827

  1. Genetically modified foods: safety, risks and public concerns-a review.

    PubMed

    Bawa, A S; Anilakumar, K R

    2013-12-01

    Genetic modification is a special set of gene technology that alters the genetic machinery of such living organisms as animals, plants or microorganisms. Combining genes from different organisms is known as recombinant DNA technology and the resulting organism is said to be 'Genetically modified (GM)', 'Genetically engineered' or 'Transgenic'. The principal transgenic crops grown commercially in field are herbicide and insecticide resistant soybeans, corn, cotton and canola. Other crops grown commercially and/or field-tested are sweet potato resistant to a virus that could destroy most of the African harvest, rice with increased iron and vitamins that may alleviate chronic malnutrition in Asian countries and a variety of plants that are able to survive weather extremes. There are bananas that produce human vaccines against infectious diseases such as hepatitis B, fish that mature more quickly, fruit and nut trees that yield years earlier and plants that produce new plastics with unique properties. Technologies for genetically modifying foods offer dramatic promise for meeting some areas of greatest challenge for the 21st century. Like all new technologies, they also pose some risks, both known and unknown. Controversies and public concern surrounding GM foods and crops commonly focus on human and environmental safety, labelling and consumer choice, intellectual property rights, ethics, food security, poverty reduction and environmental conservation. With this new technology on gene manipulation what are the risks of "tampering with Mother Nature"?, what effects will this have on the environment?, what are the health concerns that consumers should be aware of? and is recombinant technology really beneficial? This review will also address some major concerns about the safety, environmental and ecological risks and health hazards involved with GM foods and recombinant technology.

  2. Legitimating a nuclear critic: John Gofman, radiation safety, and cancer risks.

    PubMed

    Semendeferi, Ioanna

    2008-01-01

    Whether low-level ionizing radiation has an effect on humans has been a polarizing issue for the last fifty years. The epicenter of this controversy has been the validity of the linear non-threshold dose-response model, according to which any amount of radiation, however small, causes damage to human genes and health. In the late 1960s and early 1970s, the nuclear scientist and medical researcher John Gofman (1918-2007) played a pivotal role in the debate. Historical accounts have treated Gofman as a radical antinuclear scientist whose unscientific arguments put enormous political pressure on the nuclear power industry and regulatory agencies. Gofman's bitter struggle with the Atomic Energy Commission, which funded his research at Lawrence Livermore National Laboratory, partly accounts for this view. However, my analysis of Gofman's involvement in the low-level radiation debate shows how he also helped shift the focus in radiation safety from the risks of genetic damage or leukemia to somatic or cancer risks. His arguments led to the introduction of the linear non-threshold radiation model as a means of numerically estimating cancer risks. This was a watershed event in radiation-safety science and politics. Gofman's case sheds light on the process by which a scientist could secure legitimation even when his technical arguments threatened the government's interests. I conclude that it also points to an open issue in the history of antinuclear scientists, or of other politically active scientists or technology critics: treating them as critics should not preclude historians from treating them as scientists.

  3. [Safety Walkround as a risk assessment tool: the first Italian experience].

    PubMed

    Levati, A; Amato, S; Adrario, E; De Flaviis, C; Delia, C; Milesi, S; Petrini, F; Bevilacqua, L

    2009-01-01

    In 2007 the Study Group "Clinical Risk Management" of the Italian Society of Anaesthesia and Intensive Care Unit (SIAARTI) performed a multicentric study in Intensive Care Unit (ICU) to assess the feasibility and efficacy of the Safety WalkRound (SWR) as a tool for the risk assessment. As the environment and organization of ICU are more complex than anaesthesia ones, mainly due to the severity of patients, high number of involved healthcare givers and different kinds of procedures, the Study Group decided that a check list is not fit for ICU and , after a careful review of the literature, chose to test the Safety WalkRound. in four Italian General ICUs. The SWR was born in 2003 when Frankel plans a structured interview of 15 questions (about 50% open) to collect operators' opinion about rate and type of errors, near misses, communication, problems regarding the report of adverse events and suggestions to increase patient safety. Consequently SWR is a tool of risk assessment alternative to the Incident Reporting which is marked by a diffuse underreporting of operators. Although the SWR is a new tool not validated in Italian language neither published in Italy on PubMed journals , the Study Group has decided that it might be fit for the organization of Italian Healthcare System. A back translation of the validated model of Joint Commission was provided and the translated version has been lightly changed to be employed in hospitals with and without Incident Reporting . The questions have been changed or introduced on the basis of the organization vulnerabilities detected with observational techniques or Focus Group. The interview performed in Italy contains 16 questions classified into five groups: a) error, b) error prevention, c) communication, teamwork and leadership, d) error discussion and e) relationship with patients and their families. The answers collected have been analyzed to detect the vulnerabilities in the organizations and specify the improvements to

  4. The Evaluation of Triphenyl Phosphate as a Flame Retardant Additive to Improve the Safety of Lithium-Ion Battery Electrolytes

    NASA Technical Reports Server (NTRS)

    Smart, M. C.; Krause, F. C.; Hwang, C.; Westa, W. C.; Soler, J.; Prakash, G. K. S.; Ratnakumar, B. V.

    2011-01-01

    NASA is actively pursuing the development of advanced electrochemical energy storage and conversion devices for future lunar and Mars missions. The Exploration Technology Development Program, Energy Storage Project is sponsoring the development of advanced Li-ion batteries and PEM fuel cell and regenerative fuel cell systems for the Altair Lunar Lander, Extravehicular Activities (EVA), and rovers and as the primary energy storage system for Lunar Surface Systems. At JPL, in collaboration with NASA-GRC, NASA-JSC and industry, we are actively developing advanced Li-ion batteries with improved specific energy, energy density and safety. One effort is focused upon developing Li-ion battery electrolyte with enhanced safety characteristics (i.e., low flammability). A number of commercial applications also require Li-ion batteries with enhanced safety, especially for automotive applications.

  5. Apheresis and intravenous immunoglobulins used in addition to conventional therapy to treat high-risk pregnant antiphospholipid antibody syndrome patients. A prospective study.

    PubMed

    Ruffatti, Amelia; Favaro, Maria; Hoxha, Ariela; Zambon, Alessandra; Marson, Piero; Del Ross, Teresa; Calligaro, Antonia; Tonello, Marta; Nardelli, Giovanni B

    2016-06-01

    Pregnant women with triple antibody positive antiphospholipid syndrome (APS) who have had thrombosis or a history of early, severe pregnancy complications are generally considered at high risk of pregnancy loss. The objectives of this study were to investigate the efficacy and safety of a relatively new treatment protocol used in addition to conventional therapy in high-risk pregnant patients affected with primary APS. The study's two inclusion criteria were: (1) the presence of triple antiphospholipid positivity, (2) previous thrombosis and/or a history of one or more early, severe pregnancy complications. Eighteen pregnancies occurring between 2002 and 2015 in 14 APS patients, (mean age 34.8±3.6 SD) were monitored. All 14 (100%) patients had triple antiphospholipid positivity. In addition, six of them (42.8%) had a history of thrombosis, four (28.6%) had one or more previous early and severe pregnancy complications, and four (30.8%) met both clinical study criteria. The study protocol included weekly plasmapheresis or immunoadsorption and fortnightly 1g/kg intravenous immunoglobulins. Seventeen of the pregnancies (94.4%) produced live neonates, all born between the 26th and 37th weeks of gestation (mean 33.1±3.5 SD). One female (5.5%), born prematurely at 24 weeks, died of sepsis a week after birth. There were two cases (11.1%) of severe pregnancy complications. No treatment side effects were registered. Given the high live birth rate and the safety associated to it, the study protocol described here could be taken into consideration by medical teams treating high-risk APS pregnant patients.

  6. Halogenated flame retardants: do the fire safety benefits justify the risks?

    PubMed

    Shaw, Susan D; Blum, Arlene; Weber, Roland; Kannan, Kurunthachalam; Rich, David; Lucas, Donald; Koshland, Catherine P; Dobraca, Dina; Hanson, Sarah; Birnbaum, Linda S

    2010-01-01

    Since the 1970s, an increasing number of regulations have expanded the use of brominated and chlorinated flame retardants. Many of these chemicals are now recognized as global contaminants and are associated with adverse health effects in animals and humans, including endocrine and thyroid disruption, immunotoxicity, reproductive toxicity, cancer, and adverse effects on fetal and child development and neurologic function. Some flame retardants such as polybrominated diphenyl ethers (PBDEs) have been banned or voluntarily phased out by manufacturers because of their environmental persistence and toxicity, only to be replaced by other organohalogens of unknown toxicity. Despite restrictions on further production in some countries, consumer products previously treated with banned retardants are still in use and continue to release toxic chemicals into the environment, and the worldwide use of organohalogen retardants continues to increase. This paper examines major uses and known toxic effects of commonly-used organohalogen flame retardants, replacements for those that have been phased out, their combustion by-products, and their effectiveness at reducing fire hazard. Policy and other solutions to maintain fire safety while reducing toxicity are suggested. The major conclusions are: (1) Flammability regulations can cause greater adverse environmental and health impacts than fire safety benefits. (2) The current options for end-of-life disposal of products treated with organohalogens retardants are problematic. (3) Life-cycle analyses evaluating benefits and risks should consider the health and environmental effects of the chemicals, as well as their fire safety impacts. (4) Most fire deaths and most fire injuries result from inhaling carbon monoxide, irritant gases, and soot. The incorporation of organohalogens can increase the yield of these toxic by-products during combustion. (5) Fire-safe cigarettes, fire-safe candles, child-resistant lighters, sprinklers, and

  7. The role of the radiation safety specialist as witness: risk communication with attorneys, judges, and jurors.

    PubMed

    Johnson, R H

    2001-12-01

    As nuclear workers and members of the public continue to fear radiation in this litigious society, specialists in radiation safety will often be called upon as experts to explain the significance of radiation exposures or as fact witnesses to explain radiation safety practices. Radiation risk communication with attorneys, judges, and jurors presents special challenges to the communication skills of health physicists. Your role as the radiation specialist is to present testimony, either in the form of a deposition or as a trial witness, in a way that a judge or jury can understand. As a specialist in radiation safety, you will also need to educate the attorney that you work with so that he or she can ask the right questions and defend challenges in the case. The way that you communicate to attorneys, judges, and jurors could have a great impact on the case's outcome. As a radiation specialist, your testimony is not only to present the scientific basis for radiation health risks, but also to persuade the judge or jurors in the direction of the desired outcome of the case. Insights from the Myers-Briggs Type Indicator show that judges and jurors are most likely persuaded by "Sensing" language that is specific, detailed, measurable, and verifiable with their five senses. Thus, the conceptual, abstract, and theoretical "Intuitive" language often favored by radiation experts may not be understood or appreciated by a judge or jurors. They may also prefer the more personal, empathetic, and caring "Feeling" language rather than the impersonal, logical, and analytical "Thinking" language favored by health physicists. People's feelings about radiation risks are a big factor in radiation cases and providing testimony to address feeling-based conclusions requires a very different communication approach than normally used by health physicists. An understanding of language preferences can be crucial for effective communication with attorneys, judges, and jurors. These insights

  8. A Risk Assessment Model for Reduced Aircraft Separation: A Quantitative Method to Evaluate the Safety of Free Flight

    NASA Technical Reports Server (NTRS)

    Cassell, Rick; Smith, Alex; Connors, Mary; Wojciech, Jack; Rosekind, Mark R. (Technical Monitor)

    1996-01-01

    As new technologies and procedures are introduced into the National Airspace System, whether they are intended to improve efficiency, capacity, or safety level, the quantification of potential changes in safety levels is of vital concern. Applications of technology can improve safety levels and allow the reduction of separation standards. An excellent example is the Precision Runway Monitor (PRM). By taking advantage of the surveillance and display advances of PRM, airports can run instrument parallel approaches to runways separated by 3400 feet with the same level of safety as parallel approaches to runways separated by 4300 feet using the standard technology. Despite a wealth of information from flight operations and testing programs, there is no readily quantifiable relationship between numerical safety levels and the separation standards that apply to aircraft on final approach. This paper presents a modeling approach to quantify the risk associated with reducing separation on final approach. Reducing aircraft separation, both laterally and longitudinally, has been the goal of several aviation R&D programs over the past several years. Many of these programs have focused on technological solutions to improve navigation accuracy, surveillance accuracy, aircraft situational awareness, controller situational awareness, and other technical and operational factors that are vital to maintaining flight safety. The risk assessment model relates different types of potential aircraft accidents and incidents and their contribution to overall accident risk. The framework links accident risks to a hierarchy of failsafe mechanisms characterized by procedures and interventions. The model will be used to assess the overall level of safety associated with reducing separation standards and the introduction of new technology and procedures, as envisaged under the Free Flight concept. The model framework can be applied to various aircraft scenarios, including parallel and in

  9. Update on Cardiovascular Safety of Tyrosine Kinase Inhibitors: With a Special Focus on QT Interval, Left Ventricular Dysfunction and Overall Risk/Benefit.

    PubMed

    Shah, Rashmi R; Morganroth, Joel

    2015-08-01

    We previously reviewed the cardiovascular safety of 16 tyrosine kinase inhibitors (TKIs), approved for use in oncology as of 30 September 2012. Since then, the indications for some of them have been widened and an additional nine TKIs have also been approved as of 30 April 2015. Eight of these nine are indicated for use in oncology and one (nintedanib) for idiopathic pulmonary fibrosis. This report is an update on the cardiovascular safety of those 16 TKIs, including the post-marketing data concerning their pro-arrhythmic effects, and reviews the cardiovascular safety of the nine new TKIs approved since (afatinib, cabozantinib, ceritinib, dabrafenib, ibrutinib, lenvatinib, nintedanib, ponatinib, and trametinib). As before, we focus on specific aspects of cardiovascular safety, namely their potential to induce QT interval prolongation, left ventricular (LV) dysfunction and hypertension but now also summarise the risks of arterial thromboembolic events (ATEs) associated with these agents. Of the newer TKIs, cabozantinib and ceritinib have been shown to induce a mild to moderate degree of QTc interval prolongation while cardiac dysfunction has been reported with the use of afatinib, dabrafenib, lenvatinib, ponatinib and trametinib. The label for axitinib was revised to include a new association with cardiac dysfunction. Hypertension is associated with cabozantinib, lenvatinib, nintedanib, ponatinib and trametinib. Ponatinib, within 10 months of its approval in December 2012, required voluntary (temporary) suspension of its marketing until significant safety revisions (restricted indication, additional warnings and precautions about the risk of arterial occlusion and thromboembolic events and amended dose) were made to its label. Compared with the previous 16 TKIs, more of the recently introduced TKIs are associated with the risk of LV dysfunction, and fewer with QT prolongation. Available data on morbidity and mortality associated with TKIs, together with post

  10. From barnyard to food table: the omnipresence of hepatitis E virus and risk for zoonotic infection and food safety.

    PubMed

    Meng, Xiang-Jin

    2011-10-01

    Hepatitis E virus (HEV) is an important but extremely understudied pathogen. The mechanisms of HEV replication and pathogenesis are poorly understood, and a vaccine against HEV is not yet available. HEV is classified in the family Hepeviridae consisting of at least four recognized major genotypes. Genotypes 1 and 2 HEV are restricted to humans and associated with epidemics in developing countries, whereas genotypes 3 and 4 HEV are zoonotic and responsible for sporadic cases worldwide. The identification and characterization of a number of animal strains of HEV from pigs, chickens, rabbits, rats, mongoose, deer, and possibly cattle and sheep have significantly broadened the host range and diversity of HEV. The demonstrated ability of cross-species infection by some animal strains of HEV raises public health concerns for zoonotic HEV infection. Pigs are a recognized reservoir for HEV, and pig handlers are at increased risk of zoonotic HEV infection. Sporadic cases of hepatitis E have been definitively linked to the consumption of raw or undercooked animal meats such as pig livers, sausages, and deer meats. In addition, since large amounts of viruses excreted in feces, animal manure land application and runoffs can contaminate irrigation and drinking water with concomitant contamination of produce or shellfish. HEV RNA of swine origin has been detected in swine manure, sewage water and oysters, and consumption of contaminated shellfish has also been implicated in sporadic cases of hepatitis E. Therefore, the animal strains of HEV pose not only a zoonotic risk but also food and environmental safety concerns.

  11. Surrogate safety measure for evaluating rear-end collision risk related to kinematic waves near freeway recurrent bottlenecks.

    PubMed

    Li, Zhibin; Ahn, Seongchae; Chung, Koohong; Ragland, David R; Wang, Wei; Yu, Jeong Whon

    2014-03-01

    This study presents a surrogate safety measure for evaluating the rear-end collision risk related to kinematic waves near freeway recurrent bottlenecks using aggregated traffic data from ordinary loop detectors. The attributes of kinematic waves that accompany rear-end collisions and the traffic conditions at detector stations spanning the collision locations were examined to develop the rear-end collision risk index (RCRI). Together with RCRI, standard deviations in occupancy were used to develop a logistic regression model for estimating rear-end collision likelihood near freeway recurrent bottlenecks in real-time. The parameters in the logistic regression models were calibrated using collision data gathered from the 6-mile study site between 2006 and 2007. Findings indicated that an additional unit increase in RCRI results in increasing the odds of rear-end collision by 21.1%, a unit increase in standard deviation of upstream occupancy increases the odds by 19.5%, and a unit increase in standard deviation of downstream occupancy increases the odds by 18.7%. The likelihood of rear-end collisions is highest when the traffic approaching from upstream is near capacity state while downstream traffic is highly congested. The paper also reports on the findings from comparing the predicted number of rear-end collisions at the study site using the proposed model with the observed traffic collision data from 2008. The proposed model's true positive rates were higher than those of existing real-time crash prediction models.

  12. The Hermes safety strategy

    NASA Astrophysics Data System (ADS)

    Rosso, R.

    1992-08-01

    The principal safety objectives and safety assurance strategies of the Hermes space vehicle program are discussed. The highlights of the Hermes safety assurance strategy are reviewed with particular reference to risk identification, risk evaluation, risk reduction, and risk acceptance. The application of the safety assurance strategy to Phase I definition studies and safety objectives of the Hermes X 2000 mission are then discussed.

  13. A national standard for psychosocial safety climate (PSC): PSC 41 as the benchmark for low risk of job strain and depressive symptoms.

    PubMed

    Bailey, Tessa S; Dollard, Maureen F; Richards, Penny A M

    2015-01-01

    Despite decades of research from around the world now permeating occupational health and safety (OHS) legislation and guidelines, there remains a lack of tools to guide practice. Our main goal was to establish benchmark levels of psychosocial safety climate (PSC) that would signify risk of job strain (jobs with high demands and low control) and depression in organizations. First, to justify our focus on PSC, using interview data from Australian employees matched at 2 time points 12 months apart (n = 1081), we verified PSC as a significant leading predictor of job strain and in turn depression. Next, using 2 additional data sets (n = 2097 and n = 1043) we determined benchmarks of organizational PSC (range 12-60) for low-risk (PSC at 41 or above) and high-risk (PSC at 37 or below) of employee job strain and depressive symptoms. Finally, using the newly created benchmarks we estimated the population attributable risk (PAR) and found that improving PSC in organizations to above 37 could reduce 14% of job strain and 16% of depressive symptoms in the working population. The results provide national standards that organizations and regulatory agencies can utilize to promote safer working environments and lower the risk of harm to employee mental health.

  14. The effect of rights-based fisheries management on risk taking and fishing safety

    PubMed Central

    Pfeiffer, Lisa; Gratz, Trevor

    2016-01-01

    Commercial fishing is a dangerous occupation despite decades of regulatory initiatives aimed at making it safer. We posit that rights-based fisheries management (the individual allocation of fishing quota to vessels or fishing entities, also called catch shares) can improve safety by solving many of the problems associated with the competitive race to fish experienced in fisheries around the world. The competitive nature of such fisheries results in risky behavior such as fishing in poor weather, overloading vessels with fishing gear, and neglecting maintenance. Although not necessarily intended to address safety issues, catch shares eliminate many of the economic incentives to fish as rapidly as possible. We develop a dataset and methods to empirically evaluate the effects of the adoption of catch shares management on a particularly risky type of behavior: the propensity to fish in stormy weather. After catch shares was implemented in an economically important US West Coast fishery, a fisherman’s probability of taking a fishing trip in high wind conditions decreased by 82% compared with only 31% in the former race to fish fishery. Overall, catch shares caused the average annual rate of fishing on high wind days to decrease by 79%. These results are evidence that institutional changes can significantly reduce individual, voluntary risk exposure and result in safer fisheries. PMID:26884188

  15. The effect of rights-based fisheries management on risk taking and fishing safety.

    PubMed

    Pfeiffer, Lisa; Gratz, Trevor

    2016-03-08

    Commercial fishing is a dangerous occupation despite decades of regulatory initiatives aimed at making it safer. We posit that rights-based fisheries management (the individual allocation of fishing quota to vessels or fishing entities, also called catch shares) can improve safety by solving many of the problems associated with the competitive race to fish experienced in fisheries around the world. The competitive nature of such fisheries results in risky behavior such as fishing in poor weather, overloading vessels with fishing gear, and neglecting maintenance. Although not necessarily intended to address safety issues, catch shares eliminate many of the economic incentives to fish as rapidly as possible. We develop a dataset and methods to empirically evaluate the effects of the adoption of catch shares management on a particularly risky type of behavior: the propensity to fish in stormy weather. After catch shares was implemented in an economically important US West Coast fishery, a fisherman's probability of taking a fishing trip in high wind conditions decreased by 82% compared with only 31% in the former race to fish fishery. Overall, catch shares caused the average annual rate of fishing on high wind days to decrease by 79%. These results are evidence that institutional changes can significantly reduce individual, voluntary risk exposure and result in safer fisheries.

  16. The risk/safety assessment of transgenic crops: the transportability of data.

    PubMed

    Kearns, Peter; Dagallier, Bertrand; Suwabe, Kazuyuki

    2014-12-01

    This paper presents the activities and publications of Organisation for Economic Co-operation and Developments (OECD's) Working Group on Harmonisation of Regulatory Oversight in Biotechnology and the Task Force for the Safety of Novel Foods and Feeds. The main outputs of the work are the Series of "consensus documents" of the respective groups. These documents compile information which is intended to be used by those involved in the business of risk/safety assessment. These documents are one means of ensuring the transportability of data amongst authorities. An increasing trend in both the Working Group and Task Force is to consider crop species which are relevant to tropical regions and therefore to countries that are not necessarily members of the OECD. For example, the Working Group has recently published a consensus document on bananas and plantains while the Task Force has published a document on cassava. This trend towards crops of greater interest in the tropics is likely to continue into the future.

  17. The Human Bathtub: Safety and Risk Predictions Including the Dynamic Probability of Operator Errors

    SciTech Connect

    Duffey, Romney B.; Saull, John W.

    2006-07-01

    Reactor safety and risk are dominated by the potential and major contribution for human error in the design, operation, control, management, regulation and maintenance of the plant, and hence to all accidents. Given the possibility of accidents and errors, now we need to determine the outcome (error) probability, or the chance of failure. Conventionally, reliability engineering is associated with the failure rate of components, or systems, or mechanisms, not of human beings in and interacting with a technological system. The probability of failure requires a prior knowledge of the total number of outcomes, which for any predictive purposes we do not know or have. Analysis of failure rates due to human error and the rate of learning allow a new determination of the dynamic human error rate in technological systems, consistent with and derived from the available world data. The basis for the analysis is the 'learning hypothesis' that humans learn from experience, and consequently the accumulated experience defines the failure rate. A new 'best' equation has been derived for the human error, outcome or failure rate, which allows for calculation and prediction of the probability of human error. We also provide comparisons to the empirical Weibull parameter fitting used in and by conventional reliability engineering and probabilistic safety analysis methods. These new analyses show that arbitrary Weibull fitting parameters and typical empirical hazard function techniques cannot be used to predict the dynamics of human errors and outcomes in the presence of learning. Comparisons of these new insights show agreement with human error data from the world's commercial airlines, the two shuttle failures, and from nuclear plant operator actions and transient control behavior observed in transients in both plants and simulators. The results demonstrate that the human error probability (HEP) is dynamic, and that it may be predicted using the learning hypothesis and the minimum

  18. Combination and selection of traffic safety expert judgments for the prevention of driving risks.

    PubMed

    Cabello, Enrique; Conde, Cristina; de Diego, Isaac Martín; Moguerza, Javier M; Redchuk, Andrés

    2012-11-02

    In this paper, we describe a new framework to combine experts’ judgments for the prevention of driving risks in a cabin truck. In addition, the methodology shows how to choose among the experts the one whose predictions fit best the environmental conditions. The methodology is applied over data sets obtained from a high immersive cabin truck simulator in natural driving conditions. A nonparametric model, based in Nearest Neighbors combined with Restricted Least Squared methods is developed. Three experts were asked to evaluate the driving risk using a Visual Analog Scale (VAS), in order to measure the driving risk in a truck simulator where the vehicle dynamics factors were stored. Numerical results show that the methodology is suitable for embedding in real time systems.

  19. [Risk hidden in the small print? : Some food additives may trigger pseudoallergic reactions].

    PubMed

    Zuberbier, Torsten; Hengstenberg, Claudine

    2016-06-01

    Some food additives may trigger pseudoallergenic reactions. However, the prevalence of such an overreaction is - despite the increasing number of food additives - rather low in the general population. The most common triggers of pseudoallergic reactions to food are naturally occurring ingredients. However, symptoms in patients with chronic urticaria should improve significantly on a pseudoallergen-free diet. In addition, some studies indicate that certain food additives may also have an impact on the symptoms of patients with neurodermatitis and asthma.

  20. Applicability and feasibility of systematic review for performing evidence-based risk assessment in food and feed safety.

    PubMed

    Aiassa, E; Higgins, J P T; Frampton, G K; Greiner, M; Afonso, A; Amzal, B; Deeks, J; Dorne, J-L; Glanville, J; Lövei, G L; Nienstedt, K; O'connor, A M; Pullin, A S; Rajić, A; Verloo, D

    2015-01-01

    Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their "key elements" [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment.

  1. The role of parental risk judgements, transport safety attitudes, transport priorities and accident experiences on pupils' walking to school.

    PubMed

    Mehdizadeh, Milad; Nordfjaern, Trond; Mamdoohi, Amir Reza; Shariat Mohaymany, Afshin

    2017-03-02

    Walking to school could improve pupils' health condition and might also reduce the use of motorized transport modes, which leads to both traffic congestion and air pollution. The current study aims to examine the role of parental risk judgements (i.e. risk perception and worry), transport safety attitudes, transport priorities and accident experiences on pupils' walking and mode choices on school trips in Iran, a country with poor road safety records. A total of 1078 questionnaires were randomly distributed among pupils at nine public and private schools in January 2014 in Rasht, Iran. Results from valid observations (n=711) showed that parents with high probability assessments of accidents and strong worry regarding pupils' accident risk while walking were less likely to let their children walk to school. Parents with high safety knowledge were also more likely to allow their pupils to walk to school. Parents who prioritized convenience and accessibility in transport had a stronger tendency to choose motorized modes over walking modes. Also, parents who prioritized safety and security in transport were less likely to allow pupils to walk to school. Elasticities results showed that a one percent increase in priorities of convenience and accessibility, priorities of safety and security, car ownership and walking time from home to school reduced walking among pupils by a probability of 0.62, 0.20, 0.86 and 0.57%, respectively. A one percent increase in parental safety knowledge increased the walking probability by around 0.25%. A 1 unit increase in parental probability assessment and worry towards pupils' walking, decreased the probability of choosing walking mode by 0.11 and 0.05, respectively. Policy-makers who aim to promote walking to schools should improve safety and security of the walking facilities and increase parental safety knowledge.

  2. Using naturalistic driving data to explore the association between traffic safety-related events and crash risk at driver level.

    PubMed

    Wu, Kun-Feng; Aguero-Valverde, Jonathan; Jovanis, Paul P

    2014-11-01

    There has been considerable research conducted over the last 40 years using traffic safety-related events to support road safety analyses. Dating back to traffic conflict studies from the 1960s these observational studies of driver behavior have been criticized due to: poor quality data; lack of available and useful exposure measures linked to the observations; the incomparability of self-reported safety-related events; and, the difficulty in assessing culpability for safety-related events. This study seeks to explore the relationships between driver characteristics and traffic safety-related events, and between traffic safety-related events and crash involvement while mitigating some of those limitations. The Virginia Tech Transportation Institute 100-Car Naturalistic Driving Study dataset, in which the participants' vehicles were instrumented with various cameras and sensors during the study period, was used for this study. The study data set includes 90 drivers observed for 12-13 months driving. This study focuses on single vehicle run-off-road safety-related events only, including 14 crashes and 182 safety-related events (30 near crashes, and 152 crash-relevant incidents). Among the findings are: (1) drivers under age 25 are significantly more likely to be involved in safety-related events and crashes; and (2) significantly positive correlations exist between crashes, near crashes, and crash-relevant incidents. Although there is still much to learn about the factors affecting the positive correlation between safety-related events and crashes, a Bayesian multivariate Poisson log-normal model is shown to be useful to quantify the associations between safety-related events and crash risk while controlling for driver characteristics.

  3. Risk and safety in context: medical pluralism and agency in childbirth in an eastern Moroccan oasis.

    PubMed

    Capelli, Irene

    2011-12-01

    This article aims to improve the understandings of safety and risk in childbirth in Morocco from a critical medical anthropological perspective. It is based upon nine weeks' of fieldwork undertaken in the town of Ifli,(1) an oasis in Eastern Morocco, on the border with Algeria. Ethnographic material stemmed mainly from participant observation and semi-structured interviews conducted between April and July 2009. This research sheds light on the interplay between the socio-cultural context and the broader political economy of health in shaping the knowledge and practices of childbirth. The core issues emerging from the fieldwork are the local concepts of risk in the birthing process through mothers' and birth attendants' experiences within medical pluralistic frames of reference. This article shall argue that ethnographic insights can play a crucial role not only in understanding socio-cultural dimensions of childbirth, but also in implementing novel approaches to reproductive health care in this area, such as the exchange of experiences between trained and local, non-trained midwives.(2).

  4. Paleoflood Data, Extreme Floods and Frequency: Data and Models for Dam Safety Risk Scenarios

    NASA Astrophysics Data System (ADS)

    England, J. F.; Godaire, J.; Klinger, R.

    2007-12-01

    Extreme floods and probability estimates are crucial components in dam safety risk analysis and scenarios for water-resources decision making. The field-based collection of paleoflood data provides needed information on the magnitude and probability of extreme floods at locations of interest in a watershed or region. The stratigraphic record present along streams in the form of terrace and floodplain deposits represent direct indicators of the magnitude of large floods on a river, and may provide 10 to 100 times longer records than conventional stream gaging records of large floods. Paleoflood data is combined with gage and historical streamflow estimates to gain insights to flood frequency scaling, model extrapolations and uncertainty, and provide input scenarios to risk analysis event trees. We illustrate current data collection and flood frequency modeling approaches via case studies in the western United States, including the American River in California and the Arkansas River in Colorado. These studies demonstrate the integration of applied field geology, hydraulics, and surface-water hydrology. Results from these studies illustrate the gains in information content on extreme floods, provide data- based means to separate flood generation processes, guide flood frequency model extrapolations, and reduce uncertainties. These data and scenarios strongly influence water resources management decisions.

  5. Additive composite ABCG2, SLC2A9 and SLC22A12 scores of high-risk alleles with alcohol use modulate gout risk.

    PubMed

    Tu, Hung-Pin; Chung, Chia-Min; Min-Shan Ko, Albert; Lee, Su-Shin; Lai, Han-Ming; Lee, Chien-Hung; Huang, Chung-Ming; Liu, Chiu-Shong; Ko, Ying-Chin

    2016-09-01

    The aim of the present study was to evaluate the contribution of urate transporter genes and alcohol use to the risk of gout/tophi. Eight variants of ABCG2, SLC2A9, SLC22A12, SLC22A11 and SLC17A3 were genotyped in male individuals in a case-control study with 157 gout (33% tophi), 106 asymptomatic hyperuricaemia and 295 control subjects from Taiwan. The multilocus profiles of the genetic risk scores for urate gene variants were used to evaluate the risk of asymptomatic hyperuricaemia, gout and tophi. ABCG2 Q141K (T), SLC2A9 rs1014290 (A) and SLC22A12 rs475688 (C) under an additive model and alcohol use independently predicted the risk of gout (respective odds ratio for each factor=2.48, 2.03, 1.95 and 2.48). The additive composite Q141K, rs1014290 and rs475688 scores of high-risk alleles were associated with gout risk (P<0.0001). We observed the supramultiplicative interaction effect of genetic urate scores and alcohol use on gout and tophi risk (P for interaction=0.0452, 0.0033). The synergistic effect of genetic urate score 5-6 and alcohol use indicates that these combined factors correlate with gout and tophi occurrence.

  6. Risk Level Based Management System: a control banding model for occupational health and safety risk management in a highly regulated environment

    SciTech Connect

    Zalk, D; Kamerzell, R; Paik, S; Kapp, J; Harrington, D; Swuste, P

    2009-05-27

    The Risk Level Based Management System (RLBMS) is an occupational risk management (ORM) model that focuses occupational safety, hygeiene, and health (OSHH) resources on the highest risk procedures at work. This article demonstrates the model's simplicity through an implementation within a heavily regulated research institution. The model utilizes control banding strategies with a stratification of four risk levels (RLs) for many commonly performed maintenance and support activities, characterizing risk consistently for comparable tasks. RLBMS creates an auditable tracking of activities, maximizes OSHH professional field time, and standardizes documentation and control commensurate to a given task's RL. Validation of RLs and their exposure control effectiveness is collected in a traditional quantitative collection regime for regulatory auditing. However, qualitative risk assessment methods are also used within this validation process. Participatory approaches are used throughout the RLBMS process. Workers are involved in all phases of building, maintaining, and improving this model. This work participation also improves the implementation of established controls.

  7. Accelerometry-based gait analysis, an additional objective approach to screen subjects at risk for falling.

    PubMed

    Senden, R; Savelberg, H H C M; Grimm, B; Heyligers, I C; Meijer, K

    2012-06-01

    This study investigated whether the Tinetti scale, as a subjective measure for fall risk, is associated with objectively measured gait characteristics. It is studied whether gait parameters are different for groups that are stratified for fall risk using the Tinetti scale. Moreover, the discriminative power of gait parameters to classify elderly according to the Tinetti scale is investigated. Gait of 50 elderly with a Tinneti>24 and 50 elderly with a Tinetti≤24 was analyzed using acceleration-based gait analysis. Validated algorithms were used to derive spatio-temporal gait parameters, harmonic ratio, inter-stride amplitude variability and root mean square (RMS) from the accelerometer data. Clear differences in gait were found between the groups. All gait parameters correlated with the Tinetti scale (r-range: 0.20-0.73). Only walking speed, step length and RMS showed moderate to strong correlations and high discriminative power to classify elderly according to the Tinetti scale. It is concluded that subtle gait changes that have previously been related to fall risk are not captured by the subjective assessment. It is therefore worthwhile to include objective gait assessment in fall risk screening.

  8. USING DOSE ADDITION TO ESTIMATE CUMULATIVE RISKS FROM EXPOSURES TO MULTIPLE CHEMICALS

    EPA Science Inventory

    The Food Quality Protection Act (FQPA) of 1996 requires the EPA to consider the cumulative risk from exposure to multiple chemicals that have a common mechanism of toxicity. Three methods, hazard index (HI), point-of-departure index (PODI), and toxicity equivalence factor (TEF), ...

  9. Polymorphism FXII 46C>T and cardiovascular risk: additional data from Spanish and Tunisian patients

    PubMed Central

    Athanasiadis, Georgios; Esteban, Esther; Vidal, Magdanela Gayà; Torres, Robert Carreras; Bahri, Raoudha; Moral, Pedro

    2009-01-01

    Background Previous studies showed an association between Coagulation Factor XII 46C>T polymorphism and variation in FXII plasma levels, as 46C>T seems to affect the translation efficiency. Case-control studies in Spanish samples indicated that genotype T/T is an independent risk factor for venous thrombosis, ischemic stroke and acute coronary artery disease. In this study, we tried to reaffirm the importance of 46C>T in two samples from Spain and Tunisia. Findings A Transmission Disequilibrium Test (TDT) based on 101 family trios from Barcelona with one offspring affected by ischemic heart disease and a classical case-control study based on 76 patients with IHD and 118 healthy individuals from North and Centre-South Tunisia were conducted. Subjects were genotyped for 46C>T and data were analyzed accordingly, revealing no association in any of the two samples (TDT: P = 0.16, relative risk 1.17; case-control study: P = 0.59, odds ratio 1.36). Conclusion The results suggest that 46C>T is not a risk factor for ischemic heart disease in any of the two analyzed samples and therefore the polymorphism seems not to be a universal risk factor for cardiovascular diseases. PMID:19646235

  10. Analysis of the attitudes and needs/demands of dental practitioners in the field of patient safety and risk management.

    PubMed

    Yamalik, Nermin; Van Dijk, Ward

    2013-12-01

    Patient safety is a relatively new discipline aimed at improving the quality of care, minimising treatment errors and improving the safety of patients. Although health professions always have a specific concern for patient safety, few practitioners have a clear understanding of the broad context and not all health-care providers practice it. This might well be because of limited availability of information and materials as well as a lack of national or international laws and regulations. Thus, through member National Dental Associations (NDAs) of FDI (World Dental Federation), the present study aimed at analysing the attitudes of dental practitioners to the issues of patient safety and risk management, and the availability of materials and laws and regulations. Determination of their specific needs and demands in these fields was also attempted. For this purpose, an online questionnaire was developed for the member NDAs to respond. Questions mainly focused on the awareness regarding patient safety, availability of materials and regulations and the particular topics for which dentists needed further knowledge and information. A total of 40 responses were received. While some countries lack any documents, patient safety documents and materials were available in some countries but they were mostly limited to infection control and radiation protection and did not address other important aspects of patient safety. The NDAs clearly demanded more information. A significant number of countries also lacked national laws and/or regulations regarding patient safety. Although dentistry always has a genuine concern for patient safety, the findings of the survey suggest that yet more efforts are needed to improve the knowledge, understanding and awareness of dental practitioners regarding its broad context and the relatively 'new' patient safety culture. NDAs, dental educators, national, regional and international dental organisations and health authorities all can play

  11. A Safety Risk Assessment Methodology for Decision Support Systems with an Application to the Expedite Departure Path Tool

    NASA Technical Reports Server (NTRS)

    Snyder, Phillip T.; Landis, Michael R. (Technical Monitor)

    2001-01-01

    In support of the NASA Advanced Air Transportation Technologies Project, the Volpe National Transportation Systems Center has developed a methodology to perform safety risk assessments for air traffic control/air traffic management decision Support systems and concepts. Changes in controller, pilot, and/or airline dispatcher tasks that are affected by the decision support system are related to associated hazards. These hazards are then assessed either qualitatively or quantitatively in terms of likelihood of occurring and the impact if they do occur. Those items that show a potential safety hazard level increase can then have research plans developed to address those safety risks areas. An application of this methodology will he demonstrated using the AATT decision support tool Expedite Departure Path.

  12. Safety of virus-resistant transgenic plants two decades after their introduction: lessons from realistic field risk assessment studies.

    PubMed

    Fuchs, Marc; Gonsalves, Dennis

    2007-01-01

    Potential safety issues have been raised with the development and release of virus-resistant transgenic plants. This review focuses on safety assessment with a special emphasis on crops that have been commercialized or extensively tested in the field such as squash, papaya, plum, grape, and sugar beet. We discuss topics commonly perceived to be of concern to the environment and to human health--heteroencapsidation, recombination, synergism, gene flow, impact on nontarget organisms, and food safety in terms of allergenicity. The wealth of field observations and experimental data is critically evaluated to draw inferences on the most relevant issues. We also express inside views on the safety and benefits of virus-resistant transgenic plants, and recommend realistic risk assessment approaches to assist their timely deregulation and release.

  13. Risk reduction of falls and fractures, reduction of back pain and safety in elderly high risk patients receiving combined therapy with alfacalcidol and alendronate: a prospective study.

    PubMed

    Schacht, Erich; Ringe, Johann D

    2011-01-01

    Efficacy and safety of a new combination package containing 4 or 12 self-explanatory one-week blisters, each with one tablet of 70 mg alendronate (CAS 260055-05-8) and 7 capsules of 1 microg alfacalcidol (CAS 41294-56-8) (Tevabone) on muscle power, muscle function, balance and back pain was investigated in an open, multi-centered, uncontrolled, prospective study on a cohort of elderly patients with a high risk of falls and fractures. 818 practicing physicians all over Germany recruited 2579 patients for a 3-month observational trial being treated with the above combination package. 92.4% were women [89.7% of the women had postmenopausal osteoporosis (PMO)]. Their average age was 74.1 years and the mean body mass index 26.4 kg/m2. 55.4% had a history of falls. Prevalent vertebral and non-vertebral fractures were documented in 62.9% and 61.4% of the patients, respectively, and a creatinine clearance below 65 ml/min was documented in 65.5%. Main outcome parameters were the Chair Rising Test (CRT), Timed Up and Go Test (TUG), back pain and safety at onset and after 3 months. In addition an evaluation of the package design was done at the end of the study. The percentage of patients able to perform the CRT within 10 sec increased from 26.3% to 42.9% after 3 months (increase 63%, p < 0.0001), while successful performance within 10 sec of TUG increased by 54% (p < 0.0001) from 30.6% at onset to 47.1% after 3 months. The average overall improvement of CRT was 2.3 sec (p < 0.0001) and of TUG amounted to 2.4 sec (p < 0.0001). It was shown in another recently published study that a mean increase of 2.6 sec in the performance of TUG results in a 24% increased risk for non-vertebral fractures. Mean back pain measured by a 0-10 visual analogue scale decreased significantly by 41% from 5.9 to 3.5 (p < 0.0001). Throughout the study, 178 adverse events (AE) were reported in 85 of the 2579 patients (incidence: 3.3 %). Only 3 patients experienced serious AE, 2 without causal

  14. Risk Factors for Additional Surgery after Iatrogenic Perforations due to Endoscopic Submucosal Dissection

    PubMed Central

    Kim, Gi Jun; Ji, Jeong Seon; Kim, Byung Wook; Choi, Hwang

    2017-01-01

    Objectives. Endoscopic resection (ER) is commonly performed to treat gastric epithelial neoplasms and subepithelial tumors. The aim of this study was to predict the risk factors for surgery after ER-induced perforation. Methods. We retrospectively reviewed the data on patients who received gastric endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) between January 2010 and March 2015. Patients who were confirmed to have perforation were classified into surgery and nonsurgery groups. We aimed to determine the risk factors for surgery in patients who developed iatrogenic gastric perforations. Results. A total of 1183 patients underwent ER. Perforation occurred in 69 (5.8%) patients, and 9 patients (0.8%) required surgery to manage the perforation. In univariate analysis, anterior location of the lesion, a subepithelial lesion, two or more postprocedure pain killers within 24 hrs, and increased heart rate within 24 hrs after the procedure were the factors related to surgery. In logistic regression analysis, the location of the lesion at the anterior wall and using two or more postprocedure pain killers within 24 hrs were risk factors for surgery. Conclusion. Most cases of perforations after ER can be managed conservatively. When a patient requires two or more postprocedure pain killers within 24 hrs and the lesion is located on the anterior wall, early surgery should be considered instead of conservative management. PMID:28316622

  15. Safety regulations, firm size, and the risk of accidents in E&P operations on the Gulf of Mexico outer continental shelf

    SciTech Connect

    Iledare, O.O.; Pulsipher, A.G.; Baumann, R.H.; Dismukes, D.E.

    1996-12-31

    The current expanded role of smaller independent oil producers in the OCS has led to concern about the possibility of increased risk of accidents in E&P operations on the Gulf of Mexico OCS. In addition, questions have been posed concerning the effects of the Minerals Management Service`s (MMS) safety regulations and inspection program, firm size, and industry practices on the risk of accidents in E&P operations on the Gulf of Mexico OCS. The specific purposes of the study reported in this paper were to ascertain (1) whether any empirical justification exists for the widespread concern that an increase in independents relative share of E&P operations in the Gulf OCS region will be detrimental to safety, and (2) whether MMS policies and safety programs have reduced the frequency or severity of accidents on the OCS. Our statistical and descriptive analyses of data on accidents from MMS provide no statistical evidence to support the apprehension that an expanded role for independents in E&P activity constitutes any major threat to safety on the OCS. Further, the results of our econometrics analysis confirm the expectation that the more effective MMS inspectors are at detecting incidents of noncompliance the lower the rate of accidents on the OCS is, ceteris paribus. In addition the results indicate that the variability in platform exposure years--cumulative age of operating platform--in comparison to other factors explains a significant portion of the variation in accidents per operating platform. That is, the platform aging process provides more opportunity for accidents than any other contributing factors. Our econometrics analysis also suggests that, if the other factors contributing to offshore accidents are held constant, the responsiveness of accident rate to drilling activity is inelastic while the response of accident rate to production activity levels is elastic.

  16. Approaches in the risk assessment of genetically modified foods by the Hellenic Food Safety Authority.

    PubMed

    Varzakas, Theodoros H; Chryssochoidis, G; Argyropoulos, D

    2007-04-01

    Risk analysis has become important to assess conditions and take decisions on control procedures. In this context it is considered a prerequisite in the evaluation of GM food. Many consumers worldwide worry that food derived from genetically modified organisms (GMOs) may be unhealthy and hence regulations on GMO authorisations and labelling have become more stringent. Nowadays there is a higher demand for non-GM products and these products could be differentiated from GM products using the identity preservation system (IP) that could apply throughout the grain processing system. IP is the creation of a transparent communication system that encompasses HACCP, traceability and related systems in the supply chain. This process guarantees that certain characteristics of the lots of food (non-GM origin) are maintained "from farm to fork". This article examines the steps taken by the Hellenic Food Safety Authority to examine the presence of GMOs in foods. The whole integrated European legislation framework currently in place still needs to be implemented in Greece. Penalties should be enforced to those who import, process GMOs without special licence and do not label those products. Similar penalties should be enforced to those companies that issue false certificates beyond the liabilities taken by the food enterprises for farmers' compensation. We argue that Greece has no serious reasons to choose the use of GMOs due to the fact that the structural and pedologic characteristics of the Greek agriculture favour the biological and integrated cultivation more. Greece is not in favour of the politics behind coexistence of conventional and GM plants and objects to the use of GMOs in the food and the environment because the processor has a big burden in terms of money, time and will suffer a great deal in order to prove that their products are GMO free or that any contamination is adventitious or technically unavoidable. Moreover, Greece owns a large variety of genetic

  17. Food Safety and Quality. Uniform, Risk-Based Inspection System Needed to Ensure Safe Food Supply,

    DTIC Science & Technology

    1992-06-01

    Concerned about the effectiveness of the federal food safety inspection system, the Chairman, Subcommittee on Oversight and Investigations, House...federal resources for inspection, and (3) agencies are effectively coordinating their food safety and quality inspection efforts.

  18. Combined Effects of High Pressure Processing and Addition of Soy Sauce and Olive Oil on Safety and Quality Characteristics of Chicken Breast Meat

    PubMed Central

    Kruk, Zbigniew A.; Kim, Hyun Joo; Kim, Yun Ji; Rutley, David L.; Jung, Samooel; Lee, Soo Kee; Jo, Cheorun

    2014-01-01

    This study was conducted to evaluate the combined effect of high pressure (HP) with the addition of soy sauce and/or olive oil on the quality and safety of chicken breast meats. Samples were cut into 100 g pieces and 10% (w/w) of soy sauce (SS), 10% (w/w) of olive oil (OO), and a mixture of both 5% of soy sauce and 5% olive oil (w/w) (SO) were pressurized into meat with high pressure at 300 or 600 MPa. Cooking loss was lower in OO samples than SS samples. With increased pressure to 600 MPa, the oleic acid content of OO samples increased. The total unsaturated fatty acids were the highest in SO and OO 600 MPa samples. Lipid oxidation was retarded by addition of olive oil combined with HP. The addition of olive oil and soy sauce followed by HP decreased the amount of volatile basic nitrogen during storage and reduced the population of pathogens. Sensory evaluation indicated that the addition of olive oil enhanced the overall acceptance and willingness to buy. In conclusion, the combination of HP with the addition of soy sauce and/or olive oil is an effective technology that can improve chemical, health, sensory qualities and safety of chicken breast. PMID:25049950

  19. The Development of Dynamic Human Reliability Analysis Simulations for Inclusion in Risk Informed Safety Margin Characterization Frameworks

    SciTech Connect

    Jeffrey C. Joe; Diego Mandelli; Ronald L. Boring; Curtis L. Smith; Rachel B. Shirley

    2015-07-01

    The United States Department of Energy is sponsoring the Light Water Reactor Sustainability program, which has the overall objective of supporting the near-term and the extended operation of commercial nuclear power plants. One key research and development (R&D) area in this program is the Risk-Informed Safety Margin Characterization pathway, which combines probabilistic risk simulation with thermohydraulic simulation codes to define and manage safety margins. The R&D efforts to date, however, have not included robust simulations of human operators, and how the reliability of human performance or lack thereof (i.e., human errors) can affect risk-margins and plant performance. This paper describes current and planned research efforts to address the absence of robust human reliability simulations and thereby increase the fidelity of simulated accident scenarios.

  20. 77 FR 35466 - Pilot Project Grants in Support of Railroad Safety Risk Reduction Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ... railroad accidents caused by Electronic Device Distraction (EDD), by improving safety culture and making... of electronic devices socially unacceptable and improving safety culture using peer-to-peer coaching... devices socially unacceptable, thereby improving the safety culture and eliminating or reducing...

  1. The efficacy and safety of maraviroc addition to a stable antiretroviral regimen in subjects with suppressed plasma HIV-RNA is not influenced by age.

    PubMed

    Blanco, José-Ramón; Arroyo-Manzano, David; Rojas-Liévano, John F; Crespo, Manuel; Bravo, Isa; Pasquau, Juan; Garcia Del Toro, Miguel; Herrero, Cristina; Rivero, Antonio; Moreno, Santiago; Llibre, Josep Maria

    2015-09-01

    There are few data about the immunovirological efficacy, safety/tolerability, and durability of maraviroc (MVC) addition to aging patients on suppressive antiretroviral therapy (cART) and undetectable viral load (<50 copies/ml). The aging population is underrepresented in most HIV clinical trials. This study included 80 patients aged ≥50 years and 161 aged <50 years and showed that after 48 weeks of treatment, there was no between-group differences in the median increase of CD4(+) T cells or the virological suppression rate. Safety and tolerability were also comparable. In multivariable analysis, the effect of age was not modified and was independent of the response to MVC. An immunological recovery of ≥100 CD4(+) T cells was significantly less common in those with a longer HIV history (≥15 years) (OR 0.43; p=0.016) or having <200/mm(3) CD4(+) T cells at MVC initiation (OR 0.27; p=0.004). Meanwhile, achieving a CD4/CD8 ratio ≥0.5 at week 48 was less likely in those with CD4(+) T cell counts <200 at MVC initiation (OR 0.09; p<0.0001) or with a previous AIDS event (OR 0.43; p=0.028). In summary, the immunovirological efficacy, safety/tolerability, and durability of MVC addition in patients virologically suppressed were independent of the patient's age at treatment onset.

  2. Towards a Fuzzy Bayesian Network Based Approach for Safety Risk Analysis of Tunnel-Induced Pipeline Damage.

    PubMed

    Zhang, Limao; Wu, Xianguo; Qin, Yawei; Skibniewski, Miroslaw J; Liu, Wenli

    2016-02-01

    Tunneling excavation is bound to produce significant disturbances to surrounding environments, and the tunnel-induced damage to adjacent underground buried pipelines is of considerable importance for geotechnical practice. A fuzzy Bayesian networks (FBNs) based approach for safety risk analysis is developed in this article with detailed step-by-step procedures, consisting of risk mechanism analysis, the FBN model establishment, fuzzification, FBN-based inference, defuzzification, and decision making. In accordance with the failure mechanism analysis, a tunnel-induced pipeline damage model is proposed to reveal the cause-effect relationships between the pipeline damage and its influential variables. In terms of the fuzzification process, an expert confidence indicator is proposed to reveal the reliability of the data when determining the fuzzy probability of occurrence of basic events, with both the judgment ability level and the subjectivity reliability level taken into account. By means of the fuzzy Bayesian inference, the approach proposed in this article is capable of calculating the probability distribution of potential safety risks and identifying the most likely potential causes of accidents under both prior knowledge and given evidence circumstances. A case concerning the safety analysis of underground buried pipelines adjacent to the construction of the Wuhan Yangtze River Tunnel is presented. The results demonstrate the feasibility of the proposed FBN approach and its application potential. The proposed approach can be used as a decision tool to provide support for safety assurance and management in tunnel construction, and thus increase the likelihood of a successful project in a complex project environment.

  3. Benefits and concerns associated with biotechnology-derived foods: can additional research reduce children health risks?

    PubMed

    Cantani, A

    2009-01-01

    The development of techniques devised for the genetic manipulation of foods poses new risks for children with food allergy (FA). The introduction of foreign allergenic proteins from different foods into previously tolerated foods may trigger allergic reactions, often complicating with anaphylactic shock in a subset of allergic babies. Children with FA, even if subjected to preventative diets, always challenge the risk of developing allergic manifestations after unintentional intake of a non tolerated food in restaurant settings, with relatives or schoolmates, etc, where product labelling is necessarily lacking. The introduction of potentially allergenic proteins into foods generally considered safe for allergic children can be done deliberately, by either substantially altering the food ingredients, or by genetic manipulation which change the composition or transfer allergens, or unintentionally by qualitycontrol failures, due to contaminations in the production process, or to genetic mismanipulation. There is a controversy between multinationals often favored by governments and consumer association resistance, thus an equidistant analysis poses some unprecedented impediments. The importance of FA and the potential of transgenic plants to bring food allergens into the food supply should not be disregarded. The expression in soybeans of a Brazil nut protein resulted in a food allergen ex-pressed in widely used infant formulas, so paving the way to an often reported multinational debacle. Genetic engineering poses innovative ethical and social concerns, as well as serious challenges to the environment, human health, animal welfare, and the future of agriculture. In this paper will be emphasized practical concepts more crucial for pediatricians.

  4. Benefits and concerns associated with biotechnology-derived foods: can additional research reduce children health risks?

    PubMed

    Cantani, A

    2006-01-01

    The development of techniques devised for the genetic manipulation of foods poses new risks for children with food allergy (FA). The introduction of foreign allergenic proteins from different foods into previously tolerated foods may trigger allergic reactions, often complicating with anaphylactic shock in a subset of allergic babies. Children with FA, even if subjected to preventative diets, always challenge the risk of developing allergic manifestations after unintentional intake of a non tolerated food in restaurant settings, with relatives or schoolmates, etc, where product labelling is necessarily lacking. The introduction of potentially allergenic proteins into foods generally considered safe for allergic children can be done deliberately, by either substantially altering the food ingredients, or by genetic manipulation which change the composition or transfer allergens, or unintentionally by quality-control failures, due to contaminations in the production process, or to genetic mismanipulation. There is a controversy between multinationals often favored by governments and consumer association resistance, thus an equidistant analysis poses some unprecedented impediments. The importance of FA and the potential of transgenic plants to bring food allergens into the food supply should not be disregarded. The expression in soybeans of a Brazil nut protein resulted in a food allergen expressed in widely used infant formulas, so paving the way to an often reported multinational debacle. Genetic engineering poses innovative ethical and social concerns, as well as serious challenges to the environment, human health, animal welfare, and the future of agriculture. In this paper will be emphasized practical concepts more crucial for pediatricians.

  5. Fungal colonization - an additional risk factor for diseased dogs and cats?

    PubMed

    Biegańska, Małgorzata; Dardzińska, Weronika; Dworecka-Kaszak, Bożena

    2014-01-01

    The aim of the presented mini-review is to review the literature data referring to opportunistic mycoses in pet dogs and cats suffering from other concurrent diseases, comparable to human medical disorders with high risk of secondary mycoses. This review also presents the preliminary results of a project aimed at understanding the fungal colonization and occurrence of secondary mycoses in pets suffering from metabolic disorders, neoplasms and viral infections. The incidence of opportunistic mycoses is higher in such individuals, mostly because of their impaired immunity. The main risk factors are primary and secondary types of immunodeficiency connected with anti-cancer treatment or neoplastic disease itself. Moreover, literature data and the results of our investigations show that Candida yeasts are prevalent among diabetic animals and indicate that these fungi are the main etiological agents of secondary infections of the oral cavity, GI and urogenital tracts. Other important conditions possibly favoring the development of mycoses are concurrent infections of cats with FeLV and FIV viruses. Thus, in all cases of the mentioned underlying diseases, animals should be carefully monitored by repeated mycological examination, together with inspection of other parameters. Also, the prophylaxis of opportunistic mycoses should be carefully considered alike other factors influencing the prognosis and the outcome of primary diseases.

  6. From the field: Brown bear habituation to people - Safety, risks, and benefits

    USGS Publications Warehouse

    Herrero, S.; Smith, T.; DeBruyn, T.D.; Gunther, K.; Matt, C.A.

    2005-01-01

    Recently, brown bear (Ursus arctos) viewing has increased in coastal Alaska and British Columbia, as well as in interior areas such as Yellowstone National Park. Viewing is most often being done under conditions that offer acceptable safety to both people and bears. We analyze and comment on the underlying processes that lead brown bears to tolerate people at close range. Although habituation is an important process influencing the distance at which bears tolerate people, other variables also modify levels of bear-to-human tolerance. Because bears may react internally with energetic costs before showing an overt reaction to humans, we propose a new term, the Overt Reaction Distance, to emphasize that what we observe is the external reaction of a bear. In this paper we conceptually analyze bear viewing in terms of benefits and risks to people and bears. We conclude that managers and policy-makers must develop site-specific plans that identify the extent to which bear-to-human habituation and tolerance will be permitted. The proposed management needs scientific underpinning. It is our belief that bear viewing, where appropriate, may promote conservation of bear populations, habitats, and ecosystems as it instills respect and concern in those who participate.

  7. Data Safety Monitoring Boards and Other Study Methodologies that Address Subject Safety in "High-Risk" Therapeutic Trials in Youths

    ERIC Educational Resources Information Center

    Carandang, Carlo; Santor, Darcy; Gardner, David M.; Carrey, Normand; Kutcher, Stan

    2007-01-01

    The underlying proposition for any experimental/therapeutic trial is the uncertainty that the risks of treatment will be outweighed by its benefits. For some therapeutic interventions (e.g., exercise programs, vitamin supplementation), the potential for treatment-emergent adverse events may prima facie be low or negligible, whereas for others…

  8. Effect of tiger nut fibre addition on the quality and safety of a dry-cured pork sausage ("Chorizo") during the dry-curing process.

    PubMed

    Sánchez-Zapata, E; Zunino, V; Pérez-Alvarez, J A; Fernández-López, J

    2013-11-01

    There is a growing interest in the revalorization of co-products from the food industry. Co-products from tiger nuts (Cyperus esculentus) milk production are a suitable fibre source. "Chorizo" is the most popular dry-cured meat product in Spain. The aim of this work was to study the effect of the tiger nut fibre addition (0, 5, and 7.5%) on the quality (composition, physicochemical, and sensorial properties) and safety (oxidation and microbial quality) of a Spanish dry-cured sausage, during the 28days of its dry-curing process. Tiger nut fibre (TNF) addition decreased fat and increased moisture content. The addition of TNF significantly increased (p<0.05) the total dietary fibre content of "Chorizo". Lightness (L*), yellowness (b*) and redness index (a*/b*) were significantly (p<0.05) affected by the fibre content. The addition of 5% and 7.5% TNF to chorizo provided rich fibre and a healthier product. Although there were slight changes in the physicochemical properties, its quality (traditional characteristics) and its safety remained.

  9. Regulatory use of computational toxicology tools and databases at the United States Food and Drug Administration's Office of Food Additive Safety.

    PubMed

    Arvidson, Kirk B; Chanderbhan, Ronald; Muldoon-Jacobs, Kristi; Mayer, Julie; Ogungbesan, Adejoke

    2010-07-01

    Over 10 years ago, the Office of Food Additive Safety (OFAS) in the FDA's Center for Food Safety and Applied Nutrition implemented the formal use of structure-activity relationship analysis and quantitative structure-activity relationship (QSAR) analysis in the premarket review of food-contact substances. More recently, OFAS has implemented the use of multiple QSAR software packages and has begun investigating the use of metabolism data and metabolism predictive models in our QSAR evaluations of food-contact substances. In this article, we provide an overview of the programs used in OFAS as well as a perspective on how to apply multiple QSAR tools in the review process of a new food-contact substance.

  10. Ecological risk analysis as a key factor in environmental safety system development in the Arctic region of the Russian Federation

    NASA Astrophysics Data System (ADS)

    Bolsunovskaya, Y. A.; Bolsunovskaya, L. M.

    2015-02-01

    Due to specific natural and climatic conditions combined with human intervention, the Arctic is regarded as a highly sensitive region to any environmental pressures. Arctic projects require continuous environmental monitoring. This poses for the government of the Russian Federation (RF) a tremendous task concerning the formation and implementation of sustainable nature management policy within the international framework. The current article examines the basic constraints to the effective ecological safety system implementation in the Arctic region of the RF. The ecological risks and their effects which influence the sustainable development of the region were analyzed. The model of complex environmental safety system was proposed.

  11. The effectiveness of power-generating complexes constructed on the basis of nuclear power plants combined with additional sources of energy determined taking risk factors into account

    NASA Astrophysics Data System (ADS)

    Aminov, R. Z.; Khrustalev, V. A.; Portyankin, A. V.

    2015-02-01

    The effectiveness of combining nuclear power plants equipped with water-cooled water-moderated power-generating reactors (VVER) with other sources of energy within unified power-generating complexes is analyzed. The use of such power-generating complexes makes it possible to achieve the necessary load pickup capability and flexibility in performing the mandatory selective primary and emergency control of load, as well as participation in passing the night minimums of electric load curves while retaining high values of the capacity utilization factor of the entire power-generating complex at higher levels of the steam-turbine part efficiency. Versions involving combined use of nuclear power plants with hydrogen toppings and gas turbine units for generating electricity are considered. In view of the fact that hydrogen is an unsafe energy carrier, the use of which introduces additional elements of risk, a procedure for evaluating these risks under different conditions of implementing the fuel-and-hydrogen cycle at nuclear power plants is proposed. Risk accounting technique with the use of statistical data is considered, including the characteristics of hydrogen and gas pipelines, and the process pipelines equipment tightness loss occurrence rate. The expected intensities of fires and explosions at nuclear power plants fitted with hydrogen toppings and gas turbine units are calculated. In estimating the damage inflicted by events (fires and explosions) occurred in nuclear power plant turbine buildings, the US statistical data were used. Conservative scenarios of fires and explosions of hydrogen-air mixtures in nuclear power plant turbine buildings are presented. Results from calculations of the introduced annual risk to the attained net annual profit ratio in commensurable versions are given. This ratio can be used in selecting projects characterized by the most technically attainable and socially acceptable safety.

  12. Evaluation of Daptomycin Exposure and Efficacy and Safety Endpoints To Support Risk-versus-Benefit Considerations.

    PubMed

    Bhavnani, Sujata M; Ambrose, Paul G; Hammel, Jeffrey P; Rubino, Christopher M; Drusano, George L

    2015-12-28

    The choice of an antimicrobial agent must balance optimization of efficacy endpoints with the minimization of safety events. The risk versus benefit of daptomycin for patients with Staphylococcus aureus bacteremia with or without infective endocarditis receiving daptomycin at 6, 8, and 10 mg/kg of body weight/day was assessed. The relationships between the area under the concentration-time curve over 24 h (AUC)/MIC ratio and both clinical response and time to decreased susceptibility were evaluated using data from patients with such infections who received daptomycin at 6 mg/kg/day. Using these relationships, plus the previously identified relationship between the minimum concentration and an elevation in the creatine phosphokinase (CPK) concentration (CPK elevation) (S. M. Bhavnani, C. M. Rubino, P. G. Ambrose, and G. L. Drusano, Clin Infect Dis 50:1568-1574, 2010) and Monte Carlo simulation, the probability of each outcome by MIC for daptomycin at 6, 8, and 10 mg/kg/day was calculated. The function for exposure-response relationships for clinical response (P = 0.06) and time to decreased susceptibility (P = 0.01) resembled U and inverted U shapes, respectively. Multivariable analyses demonstrated AUC/MIC ratio, creatinine clearance, albumin concentration, and disease category to be predictors of clinical response. The results of simulations failed to demonstrate large improvements in the probabilities of clinical success among cohorts of simulated patients defined by the above-described predictive factors or the probability of decreased susceptibility at 30 days when the daptomycin dose was increased from 6 to 10 mg/kg/day. The probability of CPK elevation increased from 0.073 to 0.156 over this dose range. These data can be used to inform risk-versus-benefit decisions for daptomycin dose selection in patients with S. aureus bacteremia with or without infective endocarditis. The risk of CPK elevation, which is reversible, should be weighed in the context of the

  13. Application of hazard analysis and critical control point methodology and risk-based grading to consumer food safety surveys.

    PubMed

    Røssvoll, Elin Halbach; Ueland, Øydis; Hagtvedt, Therese; Jacobsen, Eivind; Lavik, Randi; Langsrud, Solveig

    2012-09-01

    Traditionally, consumer food safety survey responses have been classified as either "right" or "wrong" and food handling practices that are associated with high risk of infection have been treated in the same way as practices with lower risks. In this study, a risk-based method for consumer food safety surveys has been developed, and HACCP (hazard analysis and critical control point) methodology was used for selecting relevant questions. We conducted a nationally representative Web-based survey (n = 2,008), and to fit the self-reported answers we adjusted a risk-based grading system originally developed for observational studies. The results of the survey were analyzed both with the traditional "right" and "wrong" classification and with the risk-based grading system. The results using the two methods were very different. Only 5 of the 10 most frequent food handling violations were among the 10 practices associated with the highest risk. These 10 practices dealt with different aspects of heat treatment (lacking or insufficient), whereas the majority of the most frequent violations involved storing food at room temperature for too long. Use of the risk-based grading system for survey responses gave a more realistic picture of risks associated with domestic food handling practices. The method highlighted important violations and minor errors, which are performed by most people and are not associated with significant risk. Surveys built on a HACCP-based approach with risk-based grading will contribute to a better understanding of domestic food handling practices and will be of great value for targeted information and educational activities.

  14. U.S. Food and Drug Administration perspective of the inclusion of effects of low-level exposures in safety and risk assessment.

    PubMed Central

    Gaylor, D W; Bolger, P M; Schwetz, B A

    1998-01-01

    A brief overview is provided of some of the general safety and risk assessment procedures used by the different centers of the U.S. Food and Drug Administration (U.S. FDA) to evaluate low-level exposures. The U.S. FDA protects public health by regulating a wide variety of consumer products including foods, human and animal drugs, biologics, and medical devices under the federal Food, Drug, and Cosmetic Act. The diverse legal and regulatory standards in the act allow for the consideration of benefits for some products (e.g., drugs) but preclude them from others (e.g., food additives). When not precluded by statutory mandates (e.g., Delaney prohibition), the U.S. FDA considers both physiologic adaptive responses and beneficial effects. For the basic safety assessment paradigm as presently used, for example in the premarket approval of food additives, the emphasis is on the identification of adverse effects and no observed adverse effect level(s) (NOAEL). Generally, the NOAEL is divided by safety factors to establish an acceptable exposure level. This safety assessment paradigm does not preclude the consideration of effects whether they are biologically adaptive or beneficial at lower dose levels. The flexibility to consider issues such as mechanisms of action and adaptive and beneficial responses depends on the product under consideration. For carcinogenic contaminants and radiation from medical devices, the U.S. FDA considers the potential cancer risk at low exposure levels. This generally involves downward extrapolation from the observed dose-response range. The consideration of adverse effects of other toxicologic end points (e.g., reproductive, immunologic, neurologic, developmental) associated with low exposure levels is also becoming more of a reality (e.g., endocrine disrupters). The evaluation of the biologic effects of low-level exposures to toxic substances must include whether the effect is adverse or a normal physiologic adaptive response and also

  15. Risk factors and mortality associated with undertriage at a level I safety-net trauma center: a retrospective study

    PubMed Central

    Barsi, Chris; Harris, Peter; Menaik, Rich; Reis, Nicholas C; Munnangi, Swapna; Elfond, Mikhail

    2016-01-01

    Purpose The primary objective of this study was to determine the risk factors associated with undertriage and the risk factors for mortality among the undertriaged patients at a level I safety-net trauma center. Methods A retrospective analysis was performed of all trauma patients who presented to a level I safety-net trauma center with an injury severity score >15 over a 2-year period (2013–2014). Univariate and multivariate regression analyses were used to determine the risk factors predictive of undertriage in major trauma patients (injury severity score >15) and of mortality in undertriaged patients. Results During the 2-year study period, 334 of 2,485 admitted trauma patients presented with major trauma and were included in our study. From the univariate analysis, variables that were found to be independently associated with mortality in undertriaged patients included intubation, Glasgow Coma Scale score, revised trauma score, and dementia. Independent risk factors that were found to be significantly associated with undertriage in severely injured trauma patients included Glasgow Coma Scale score, motor vehicle crash, falls, revised trauma score, systolic blood pressure, heart rate, intubation, and dementia. When a multivariate analysis was performed to evaluate the statistically significant risk factors, dementia was found to be significantly associated with undertriage in severely injured trauma patients. Conclusion Severely injured trauma patients with dementia are at significant risk for undertriage. Early identification of these risk factors while triaging at a level I safety-net trauma center could translate into improved patient outcomes following severe trauma. PMID:27877069

  16. Apollo experience report: Safety activities

    NASA Technical Reports Server (NTRS)

    Rice, C. N.

    1975-01-01

    A description is given of the flight safety experiences gained during the Apollo Program and safety, from the viewpoint of program management, engineering, mission planning, and ground test operations was discussed. Emphasis is placed on the methods used to identify the risks involved in flight and in certain ground test operations. In addition, there are discussions on the management and engineering activities used to eliminate or reduce these risks.

  17. Concentration addition-based approach for aquatic risk assessment of realistic pesticide mixtures in Portuguese river basins.

    PubMed

    Silva, Emília; Cerejeira, Maria José

    2015-05-01

    A two-tiered outline for the predictive environmental risk assessment of chemical mixtures with effect assessments based on concentration addition (CA) approaches as first tier and consideration of independent action (IA) as the second tier was applied based on realistic pesticide mixtures measured in surface waters from 2002 to 2008 within three important Portuguese river basins ('Mondego', 'Sado' and 'Tejo'). The CA-based risk quotients, based on acute data and an assessment factor of 100, exceeded 1 in more than 39 % of the 281 samples, indicating a potential risk for the aquatic environment, namely to algae. Seven herbicide compounds and three insecticides were the most toxic compounds in the pesticide mixtures and provided at least 50 % of the mixture's toxicity in almost 100 % of the samples with risk quotients based on the sum of toxic units (RQSTU) above 1. In eight samples, the maximum cumulative ratio (MCR) and the Junghan's ratio values indicated that a chemical-by-chemical approach underestimated the toxicity of the pesticide mixtures, and CA predicted higher mixture toxicity than that of IA. From a risk management perspective, the results pointed out that, by deriving appropriate programmes of measures to a limited number of pesticides with the highest contribution to the total mixture toxicity, relevant benefits also on mixture impact could be produced.

  18. ePORT, NASA's Computer Database Program for System Safety Risk Management Oversight (Electronic Project Online Risk Tool)

    NASA Technical Reports Server (NTRS)

    Johnson, Paul W.

    2008-01-01

    ePORT (electronic Project Online Risk Tool) provides a systematic approach to using an electronic database program to manage a program/project risk management processes. This presentation will briefly cover the standard risk management procedures, then thoroughly cover NASA's Risk Management tool called ePORT. This electronic Project Online Risk Tool (ePORT) is a web-based risk management program that provides a common framework to capture and manage risks, independent of a programs/projects size and budget. It is used to thoroughly cover the risk management paradigm providing standardized evaluation criterion for common management reporting, ePORT improves Product Line, Center and Corporate Management insight, simplifies program/project manager reporting, and maintains an archive of data for historical reference.

  19. Compliance of expatriates with perceived and real health and safety risks in overseas oil and gas operations

    SciTech Connect

    Allen, J.S.

    1996-12-31

    A survey of health and safety concerns amongst an expatriate community in Balikpapan, East Kalimantan, Indonesia, revealed discrepancies between recommended and actual practices, and perceived versus real risks. Eighty-three responses were obtained from an expatriate community of approximately 200 households. Most responders do not follow the advice given prior to transfer regarding malaria prophylaxis. Most responders drive their own vehicles, despite the fact that most had no preparation regarding local traffic laws. A significant number lack adequate seat belts. Most felt insufficiently informed prior to transfer. Forty-three percent would consider using a psychological counseling service. Ranked of greatest importance for health and safety were access to medical care, food/water quality, and traffic safety. These responses suggest ways that companies can better prepare families for transfer to this area.

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

    SciTech Connect

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

    2004-12-01

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

  1. Lawn Care Pesticide Risks Remain Uncertain While Prohibited Safety Claims Continue

    DTIC Science & Technology

    1990-03-28

    against prohibited lawn care pesticide safety advertising claims. Nearly 4 years ago we reported to this Subcommittee on EPA’s lack of progress in...being taken against safety advertising claims made by the pesticides industry. 2 In that report, wi concluded that there is considerable uncertainty...Avail and jor Dld Special advertising safety claims. We recommended that EPA take steps to strengthen and improve its program for controlling such claims

  2. Insulin resistance: an additional risk factor in the pathogenesis of cardiovascular disease in type 2 diabetes.

    PubMed

    Patel, Tushar P; Rawal, Komal; Bagchi, Ashim K; Akolkar, Gauri; Bernardes, Nathalia; Dias, Danielle da Silva; Gupta, Sarita; Singal, Pawan K

    2016-01-01

    Sedentary life style and high calorie dietary habits are prominent leading cause of metabolic syndrome in modern world. Obesity plays a central role in occurrence of various diseases like hyperinsulinemia, hyperglycemia and hyperlipidemia, which lead to insulin resistance and metabolic derangements like cardiovascular diseases (CVDs) mediated by oxidative stress. The mortality rate due to CVDs is on the rise in developing countries. Insulin resistance (IR) leads to micro or macro angiopathy, peripheral arterial dysfunction, hampered blood flow, hypertension, as well as the cardiomyocyte and the endothelial cell dysfunctions, thus increasing risk factors for coronary artery blockage, stroke and heart failure suggesting that there is a strong association between IR and CVDs. The plausible linkages between these two pathophysiological conditions are altered levels of insulin signaling proteins such as IR-β, IRS-1, PI3K, Akt, Glut4 and PGC-1α that hamper insulin-mediated glucose uptake as well as other functions of insulin in the cardiomyocytes and the endothelial cells of the heart. Reduced AMPK, PFK-2 and elevated levels of NADP(H)-dependent oxidases produced by activated M1 macrophages of the adipose tissue and elevated levels of circulating angiotensin are also cause of CVD in diabetes mellitus condition. Insulin sensitizers, angiotensin blockers, superoxide scavengers are used as therapeutics in the amelioration of CVD. It evidently becomes important to unravel the mechanisms of the association between IR and CVDs in order to formulate novel efficient drugs to treat patients suffering from insulin resistance-mediated cardiovascular diseases. The possible associations between insulin resistance and cardiovascular diseases are reviewed here.

  3. Experimental Simulation of the Radionuclide Behaviour in the Process of Creating Additional Safety Barriers in Solid Radioactive Waste Repositories Containing Irradiated Graphite

    NASA Astrophysics Data System (ADS)

    Pavliuk, A. O.; Kotlyarevskiy, S. G.; Bespala, E. V.; Zakarova, E. V.; Rodygina, N. I.; Ermolaev, V. M.; Proshin, I. M.; Volkova, A.

    2016-08-01

    Results of the experimental modeling of radionuclide behavior when creating additional safety barriers in solid radioactive waste repositories are presented. The experiments were run on the repository mockup containing solid radioactive waste fragments including irradiated graphite. The repository mockup layout is given; the processes with radionuclides that occur during the barrier creation with a clayey solution and during the following barrier operation are investigated. The results obtained confirm high anti-migration and anti-filtration properties of clay used for the barrier creation even under the long-term excessive water saturation of rocks confining the repository.

  4. Linking quantitative exposure assessment and risk management using the food safety objective concept: an example with Listeria monocytogenes in different cross-contamination scenarios.

    PubMed

    Pérez-Rodríguez, F; Todd, E C D; Valero, A; Carrasco, E; García, R M; Zurera, G

    2006-10-01

    A practical approach was used to achieve specified food safety objectives (FSOs) by incorporating risk assessment methodology. A series of cross-contamination scenarios at the retail level were evaluated in a spreadsheet and ranked according to their level of risk, and the degree to which they exceeded an FSO for Listeria monocytogenes (100 CFU/g) was determined. Percentiles and analyses of variance were used to identify which scenarios would be most likely not to achieve the FSO. It was also possible to incorporate into the model the effect of additional risk management interventions (e.g., hand washing method) by using "what if" scenarios analysis. The highest risk corresponded to the use of the same gloves to handle contaminated meat and then sliced ham compared with the safer method of using different gloves to handle each product. Nevertheless, in all scenarios bacterial concentrations could be higher than 10(8) CFU/g. A significant lack of knowledge regarding the transfer rates of L. monocytogenes was revealed, which provided the model with an important uncertainty component. The "what if" scenarios analysis based on the scenario representing handling food with bare hands followed by hand washing (scenario 2) revealed that the hand washing procedure had less impact than expected. This study illustrates the use of scenarios to model the most effective food processes and thus provide risk managers with appropriate information on which to base their decisions.

  5. Risk and safety management in infertility and assisted reproductive technology (ART): from the doctor's office to the ART procedure.

    PubMed

    de Ziegler, Dominique; Gambone, Joseph C; Meldrum, David R; Chapron, Charles

    2013-12-01

    Risk and safety management (RSM) is receiving increasing attention in medicine, with the goals of reducing medical error and increasing quality of care. The principles and tools of RSM can and should be applied to assisted reproductive technology (ART), a field that has already made significant progress in reducing the undesirable and sometimes dangerous consequences of treatment. ART is a prime area of medicine to contribute and help to lead the application of RSM and patient safety because it has been ahead of many other fields of medicine in standardizing treatment, certifying and auditing practitioners, and reporting standardized outcomes, and because treatments are applied to otherwise healthy individuals where exposure to risk may be less acceptable.

  6. Light Water Reactor Sustainability Program Technical Basis Guide Describing How to Perform Safety Margin Configuration Risk Management

    SciTech Connect

    Curtis Smith; James Knudsen; Bentley Harwood

    2013-08-01

    The INL has carried out a demonstration of the RISMC approach for the purpose of configuration risk management. We have shown how improved accuracy and realism can be achieved by simulating changes in risk – as a function of different configurations – in order to determine safety margins as the plant is modified. We described the various technical issues that play a role in these configuration-based calculations with the intent that future applications can take advantage of the analysis benefits while avoiding some of the technical pitfalls that are found for these types of calculations. Specific recommendations have been provided on a variety of topics aimed at improving the safety margin analysis and strengthening the technical basis behind the analysis process.

  7. The global counterfeit drug trade: patient safety and public health risks.

    PubMed

    Mackey, Tim K; Liang, Bryan A

    2011-11-01

    Counterfeit drugs are a global problem with significant and well-documented consequences for global health and patient safety, including drug resistance and patient deaths. This multibillion-dollar industry does not respect geopolitical borders, and threatens public health in both rich and resource-poor nations alike. The epidemiology of counterfeits is also wide in breadth and scope, including thousands of counterfeit incidents per year, encompassing all types of therapeutic classes, and employing a complex global supply chain network enabling this illegal activity. In addition, information technologies available through the Internet and sales via online pharmacies have allowed the criminal element to thrive in an unregulated environment of anonymity, deception, and lack of adequate enforcement. Though recent global enforcement efforts have led to arrests of online counterfeit sellers, such actions have not stemmed supplies from illegal online sellers or kept up with their creativity in illegally selling their products. To address this issue, we propose a global policy framework utilizing public-private partnership models with centralized surveillance reporting that would enable cooperation and coordination to combat this global health crisis.

  8. The safety and risk factors of major hepatobiliary pancreatic surgery in patients older than 80 years

    PubMed Central

    Kim, Jong Hun; Lee, Huisong; Hong, Geun; Lee, Hyeon Kook

    2016-01-01

    Purpose Recently, the number of elderly patients has increased due to a longer life expectancy. Among these elderly patients, more octogenarians will be diagnosed with major hepatobiliary pancreatic (HBP) diseases. Therefore, we need to evaluate the safety and risk factors of major HBP surgery in patients older than 80 years. Methods From January 2000 to April 2015, patients who underwent major HBP surgery were identified. The patients were divided into 2 groups according to their age at the time of surgery: Group O (≥80 years) and group Y (<80 years). The patient characteristics and intra- and postoperative outcomes were retrospectively investigated in the 2 groups. Results The median age was 84 years (range, 80–95 years) in group O and 61 years (range, 27–79 years) in group Y. group O had worse American Society of Anesthesiologists (ASA) physical status (ASA ≥ III: 23% vs. 7%, P = 0.002) and was associated with a higher rate of hypertension and heart problems as comorbidities. There were significant differences in albumin and BUN, favoring group Y. The length of intensive care unit stay was longer in group O, whereas the overall complication and mortality rates did not show statistical difference. But, there was a significant difference in systemic complication of both Clavien-Dindo classification grade ≥II and ≥III as complications were divided into surgical site complication and systemic complication. Conclusion Major HBP surgery can be performed safely in patients older than 80 years if postoperative management is appropriately provided. PMID:27904850

  9. Efficacy and Safety of Atrasentan in Patients With Cardiovascular Risk and Early Atherosclerosis

    PubMed Central

    Raichlin, Eugenia; Prasad, Abhiram; Mathew, Verghese; Kent, Bailey; Holmes, David R.; Pumper, Geralyn M.; Nelson, Rebecca E.; Lerman, Lilach O.; Lerman, Amir

    2009-01-01

    Endothelin plays an important role in the pathogenesis of atherosclerosis. The aim of the study was to evaluate the safety and hemodynamic and metabolic responses to 6 months treatment with atrasentan, the selective endothelin-A receptor antagonist. Seventy-two patients with multiple cardiovascular risk factors and nonobstructive coronary artery disease on coronary angiogram were randomly assigned in a double-blind manner to atrasentan or placebo. Mean aortic blood pressure decreased from 92±10 to 80±10 mm Hg (P<0.001) in the atrasentan group and did not change in the placebo group (93±10 and 92±11 mm Hg; P=0.84). The difference between the groups was significant (P<0.001). No effect on heart rate was observed. In a subgroup of patients not treated with angiotensin-converting enzyme inhibitor, creatinine level decreased in the atrasentan versus the placebo group (P=0.011). Fasting glucose (P=0.026), glycosylated hemoglobin level (P=0.041), triglyceride l (P=0.013), lipoprotein-A (P=0.046), and uric acid levels (P=0.048) decreased significantly in the atrasentan group compared with the placebo group. No progression of angiographic coronary disease was observed. The most common adverse effects with atrasentan were nasal stuffiness, headache, and edema. In conclusion, 6 months of treatment with atrasentan results in a reduction of blood pressure and improvement in glucose and lipid metabolism. These findings suggest the beneficial role of atrasentan in the treatment of hypertension and metabolic syndrome. PMID:18695150

  10. Implementing Toxicity Testing in the 21st Century (TT21C): Making safety decisions using toxicity pathways, and progress in a prototype risk assessment.

    PubMed

    Adeleye, Yeyejide; Andersen, Melvin; Clewell, Rebecca; Davies, Michael; Dent, Matthew; Edwards, Sue; Fowler, Paul; Malcomber, Sophie; Nicol, Beate; Scott, Andrew; Scott, Sharon; Sun, Bin; Westmoreland, Carl; White, Andrew; Zhang, Qiang; Carmichael, Paul L

    2015-06-05

    chemical in a case study mode. This contribution represents a 'work-in-progress' and is meant to both highlight concepts that are well-developed and identify aspects of the overall process which require additional development. To guide our understanding of what a pathways-based risk assessment could look like in practice, we chose to work on a case study chemical (quercetin) with a defined human exposure and to bring a multidisciplinary team of chemists, biologists, modellers and risk assessors to work together towards a safety assessment. Our goal was to see if the in vitro dose response for quercetin could be sufficiently understood to construct a TT21C risk assessment without recourse to rodent carcinogenicity study data. The data presented include high throughput pathway biomarkers (p-H2AX, p-ATM, p-ATR, p-Chk2, p53, p-p53, MDM2 and Wip1) and markers of cell-cycle, apoptosis and micronuclei formation, plus gene transcription in HT1080 cells. Eighteen point dose response curves were generated using flow cytometry and imaging to determine the concentrations that resulted in significant perturbation. NOELs and BMDs were compared to the output from biokinetic modelling and the potential for in vitro to in vivo extrapolation explored. A first tier risk assessment was performed comparing the total quercetin concentration in the in vitro systems with the predicted total quercetin concentration in plasma and tissues. The shortcomings of this approach and recommendations for improvement are described. This paper therefore describes the current progress in an ongoing research effort aimed at providing a pathways-based, proof-of-concept in vitro-only safety assessment for a consumer use product.

  11. Safety and risk in a context of cultureAn anthropological perspective on the relativity of health and care.

    PubMed

    Sachs, L

    1990-01-01

    The question of safety and risk in people's ideas about health and care is approached here from an anthropological perspective. One strength of such an interpretive approach which seems especially important in this context, is that, although the researcher provides an account of the beliefs and actions of other people, the exercise is undertaken with an awareness that the interpretation is itself a product of particular historical and cultural determinants.Cultures, including those of industrial-capitalistic societies like Sweden, form systems of meanings which provide explanations of how the world works, of what is thought of as real and what is designated as natural and inevitable as well as what is morally right. These meanings link people to one another and form the basis for social action. It is thus within this framework that the notion of risk and safety get their content and meaning.In this line of thought a description is provided of what happens when people meet in joint health care encounters where their interests do not coincide, their understanding of what is going' on is not the same, or their expectations of what the other should or should not do differ. How considerations of safety and risk in our health care may be interpreted by people with other health theories and views or other understandings about such things as what life is, what is a person, what is good health, a good life or a normal body, and what death means, are also discussed. An attempt is made to profile the need to define variations in the notions of risk and safety in health care over cultural boundaries with examples from cross-cultural studies.

  12. Efficacy and safety of fluticasone furoate/vilanterol or tiotropium in subjects with COPD at cardiovascular risk

    PubMed Central

    Covelli, Henry; Pek, Bonavuth; Schenkenberger, Isabelle; Scott-Wilson, Catherine; Emmett, Amanda; Crim, Courtney

    2016-01-01

    Background Fluticasone furoate/vilanterol (FF/VI) is a novel, once-daily, inhaled corticosteroid/long-acting β2-agonist combination approved for the treatment of COPD and asthma. We compared the safety and efficacy of FF/VI and tiotropium (TIO) in subjects with moderate-to-severe COPD with greater risk for comorbid cardiovascular disease (CVD). Methods This randomized, blinded, double-dummy, parallel-group study compared a once-daily morning dose of FF/VI 100/25 mcg delivered via ELLIPTA™ with TIO 18 mcg via HandiHaler® for 12 weeks in subjects with diagnosed COPD, forced expiratory volume in 1 second (FEV1) 30%–70% predicted, and CVD or CVD risk. The primary endpoint was change from baseline in 24-hour weighted mean FEV1 on Day 84. Other efficacy endpoints included time to onset of bronchodilation, trough FEV1, other spirometry measures, rescue medication use, symptoms, quality of life (St George’s Respiratory Questionnaire-COPD [SGRQ-C]), and health status (COPD Assessment Tests [CAT]) measures. Safety endpoints included cardiovascular monitoring, cortisol excretion, COPD exacerbations, and adverse events, including prespecified drug effects. Results Both FF/VI and TIO improved the 24-hour weighted mean FEV1 from baseline after 12 weeks with no significant difference between treatments. Other endpoints favored FF/VI for time to onset of bronchodilation, rescue medication use, dyspnea, SGRQ-C and CAT scores, or favored TIO for change from baseline in forced vital capacity and inspiratory capacity. Pneumonia occurred more frequently in the FF/VI group, and two TIO-treated subjects died following cardiovascular events. Other safety measures were similar between groups, and cardiovascular monitoring did not reveal increased CVD risk. Conclusion Both FF/VI and TIO were efficacious in improving lung function in subjects with COPD and comorbid CVD or CVD risk factors, with minor differences in efficacy and safety profiles. PMID:26730183

  13. A simplified method for quantitative assessment of the relative health and safety risk of environmental management activities

    SciTech Connect

    Eide, S.A.; Smith, T.H.; Peatross, R.G.; Stepan, I.E.

    1996-09-01

    This report presents a simplified method to assess the health and safety risk of Environmental Management activities of the US Department of Energy (DOE). The method applies to all types of Environmental Management activities including waste management, environmental restoration, and decontamination and decommissioning. The method is particularly useful for planning or tradeoff studies involving multiple conceptual options because it combines rapid evaluation with a quantitative approach. The method is also potentially applicable to risk assessments of activities other than DOE Environmental Management activities if rapid quantitative results are desired.

  14. Food Safety Instruction Improves Knowledge and Behavior Risk and Protection Factors for Foodborne Illnesses in Pregnant Populations.

    PubMed

    Kendall, Patricia; Scharff, Robert; Baker, Susan; LeJeune, Jeffrey; Sofos, John; Medeiros, Lydia

    2017-02-21

    Objective This study compared knowledge and food-handling behavior after pathogen-specific (experimental treatment) versus basic food safety instruction (active control) presented during nutrition education classes for low-income English- and Spanish-language pregnant women. Methods Subjects (n = 550) were randomly assigned to treatment groups in two different locations in the United States. Food safety instruction was part of an 8-lesson curriculum. Food safety knowledge and behavior were measured pre/post intervention. Descriptive data were analyzed by Chi-Square or ANOVA; changes after intervention were analyzed by regression analysis. Results Knowledge improved after intervention in the pathogen-specific treatment group compared to active control, especially among Spanish-language women. Behavior change after intervention for the pathogen-specific treatment group improved for thermometer usage, refrigeration and consumption of foods at high risk for safety; however, all other improvements in behavior were accounted for by intervention regardless of treatment group. As expected, higher pre-instruction behavioral competency limited potential gain in behavior post-instruction due to a ceiling effect. This effect was more dominant among English-language women. Improvements were also linked to formal education completed, a partner at home, and other children in the home. Conclusions for Practice This study demonstrated that pathogen-specific food safety instruction leads to enhance knowledge and food handling behaviors that may improve the public health of pregnant women and their unborn children, especially among Spanish-language women. More importantly, food safety instruction, even at the most basic level, benefited pregnant women's food safety knowledge and food-handling behavior after intervention.

  15. Hospital safety climate, psychosocial risk factors and needlestick injuries in Japan.

    PubMed

    Smith, Derek R; Muto, Takashi; Sairenchi, Toshimi; Ishikawa, Yumiko; Sayama, Shizue; Yoshida, Atsushi; Townley-Jones, Maureen

    2010-01-01

    To investigate the interactions between safety climate, psychosocial issues and Needlestick and Sharps Injuries (NSI), a cross-sectional study was undertaken among nurses at a university teaching hospital in Japan (89% response rate). NSI were correlated with various aspects of hospital safety climate including supporting one another at work, the protection of staff against blood-borne diseases being a high management priority, managers doing their part to protect staff from blood-borne disease, having unsafe work practices corrected by supervisors, having the opportunity to use safety equipment to protect against blood-borne disease exposures, having an uncluttered work area, and having minimal conflict within their department. In conclusion, this study has demonstrated the importance of hospital safety climate in Japanese health care practice, particularly its relationship with NSI. Although the provision of safer devices remains critical in preventing injuries, ensuring a positive safety climate will also be essential in meeting these important challenges for nurses' occupational health.

  16. Health and Safety in Practical Science in Schools: A UK Perspective 2, Using Model Risk Assessments

    ERIC Educational Resources Information Center

    Borrows, Peter

    2008-01-01

    The previous article in this series explained the difference between hazard and risk. If the risk is too high, steps must be taken to reduce it to a sufficiently low level by adopting suitable protective control measures. If a practical activity in a science lesson has some risk associated with it then one way of reducing the risk might be to…

  17. Rebuilding a safety culture

    NASA Astrophysics Data System (ADS)

    Rodney, George A.

    1991-11-01

    The development of a culture of safety and NASA since the Challenger accident is reviewed. The technical elements of the strengthened NASA safety program are described, including problem reporting, risk/assessment/risk management, operational safety, and safety assurance are addressed. Future directions in the development of safety are considered.

  18. Risk assessment of nitrate and petroleum-derived hydrocarbon addition on Contricriba weissflogii biomass, lifetime, and nutritional value.

    PubMed

    Shun-Xing, Li; Feng-Jiao, Liu; Feng-Ying, Zheng; Xu-Guang, Huang; Yue-Gang, Zuo

    2014-03-15

    Coastal diatoms are often exposed to both petroleum-derived hydrocarbon pollution and eutrophication. How these exposures influence on algal biomass, lifetime, and nutritional value are unknown. To examine a more accurate risk assessment of the pollutants on the role of diatoms in coastal ecosystem functions, Conticribra weissflogii was maintained at different concentrations of nitrate (N) and/or water-soluble fractions of No.0 diesel oil (WSF). Algal density, cell growth cycle, protein, chlorophyll a, superoxide dismutase (SOD) activity, and malonaldehyde (MDA) were determined for the assessment of algal biomass, lifetime, nutritional value, photosynthesis and respiration, antioxidant capacity, and lipid peroxidation, respectively.When N addition was combined with WSF pollution, the cell growth cycles were shortened by 27-44%; SOD activities were decreased by 1-64%; algal density, the concentrations of chlorophyll a, protein, and MDA were varied between 38 and 310%, 62 and 712%, 4 and 124%, and 19 and 233% of the values observed in N addition experiments, respectively. Coastal ecosystem functions were severely weakened by N and WSF additions, and the influence was increased in the order: Nrisk assessment of petroleum-derived hydrocarbon on coastal ecosystem functions.

  19. Additive Synergism between Asbestos and Smoking in Lung Cancer Risk: A Systematic Review and Meta-Analysis

    PubMed Central

    Ngamwong, Yuwadee; Tangamornsuksan, Wimonchat; Lohitnavy, Ornrat; Chaiyakunapruk, Nathorn; Scholfield, C. Norman; Reisfeld, Brad; Lohitnavy, Manupat

    2015-01-01

    Smoking and asbestos exposure are important risks for lung cancer. Several epidemiological studies have linked asbestos exposure and smoking to lung cancer. To reconcile and unify these results, we conducted a systematic review and meta-analysis to provide a quantitative estimate of the increased risk of lung cancer associated with asbestos exposure and cigarette smoking and to classify their interaction. Five electronic databases were searched from inception to May, 2015 for observational studies on lung cancer. All case-control (N = 10) and cohort (N = 7) studies were included in the analysis. We calculated pooled odds ratios (ORs), relative risks (RRs) and 95% confidence intervals (CIs) using a random-effects model for the association of asbestos exposure and smoking with lung cancer. Lung cancer patients who were not exposed to asbestos and non-smoking (A-S-) were compared with; (i) asbestos-exposed and non-smoking (A+S-), (ii) non-exposure to asbestos and smoking (A-S+), and (iii) asbestos-exposed and smoking (A+S+). Our meta-analysis showed a significant difference in risk of developing lung cancer among asbestos exposed and/or smoking workers compared to controls (A-S-), odds ratios for the disease (95% CI) were (i) 1.70 (A+S-, 1.31–2.21), (ii) 5.65; (A-S+, 3.38–9.42), (iii) 8.70 (A+S+, 5.8–13.10). The additive interaction index of synergy was 1.44 (95% CI = 1.26–1.77) and the multiplicative index = 0.91 (95% CI = 0.63–1.30). Corresponding values for cohort studies were 1.11 (95% CI = 1.00–1.28) and 0.51 (95% CI = 0.31–0.85). Our results point to an additive synergism for lung cancer with co-exposure of asbestos and cigarette smoking. Assessments of industrial health risks should take smoking and other airborne health risks when setting occupational asbestos exposure limits. PMID:26274395

  20. Additive Synergism between Asbestos and Smoking in Lung Cancer Risk: A Systematic Review and Meta-Analysis.

    PubMed

    Ngamwong, Yuwadee; Tangamornsuksan, Wimonchat; Lohitnavy, Ornrat; Chaiyakunapruk, Nathorn; Scholfield, C Norman; Reisfeld, Brad; Lohitnavy, Manupat

    2015-01-01

    Smoking and asbestos exposure are important risks for lung cancer. Several epidemiological studies have linked asbestos exposure and smoking to lung cancer. To reconcile and unify these results, we conducted a systematic review and meta-analysis to provide a quantitative estimate of the increased risk of lung cancer associated with asbestos exposure and cigarette smoking and to classify their interaction. Five electronic databases were searched from inception to May, 2015 for observational studies on lung cancer. All case-control (N = 10) and cohort (N = 7) studies were included in the analysis. We calculated pooled odds ratios (ORs), relative risks (RRs) and 95% confidence intervals (CIs) using a random-effects model for the association of asbestos exposure and smoking with lung cancer. Lung cancer patients who were not exposed to asbestos and non-smoking (A-S-) were compared with; (i) asbestos-exposed and non-smoking (A+S-), (ii) non-exposure to asbestos and smoking (A-S+), and (iii) asbestos-exposed and smoking (A+S+). Our meta-analysis showed a significant difference in risk of developing lung cancer among asbestos exposed and/or smoking workers compared to controls (A-S-), odds ratios for the disease (95% CI) were (i) 1.70 (A+S-, 1.31-2.21), (ii) 5.65; (A-S+, 3.38-9.42), (iii) 8.70 (A+S+, 5.8-13.10). The additive interaction index of synergy was 1.44 (95% CI = 1.26-1.77) and the multiplicative index = 0.91 (95% CI = 0.63-1.30). Corresponding values for cohort studies were 1.11 (95% CI = 1.00-1.28) and 0.51 (95% CI = 0.31-0.85). Our results point to an additive synergism for lung cancer with co-exposure of asbestos and cigarette smoking. Assessments of industrial health risks should take smoking and other airborne health risks when setting occupational asbestos exposure limits.

  1. Major histocompatibility complex harbors widespread genotypic variability of non-additive risk of rheumatoid arthritis including epistasis

    PubMed Central

    Wei, Wen-Hua; Bowes, John; Plant, Darren; Viatte, Sebastien; Yarwood, Annie; Massey, Jonathan; Worthington, Jane; Eyre, Stephen

    2016-01-01

    Genotypic variability based genome-wide association studies (vGWASs) can identify potentially interacting loci without prior knowledge of the interacting factors. We report a two-stage approach to make vGWAS applicable to diseases: firstly using a mixed model approach to partition dichotomous phenotypes into additive risk and non-additive environmental residuals on the liability scale and secondly using the Levene’s (Brown-Forsythe) test to assess equality of the residual variances across genotype groups per marker. We found widespread significant (P < 2.5e-05) vGWAS signals within the major histocompatibility complex (MHC) across all three study cohorts of rheumatoid arthritis. We further identified 10 epistatic interactions between the vGWAS signals independent of the MHC additive effects, each with a weak effect but jointly explained 1.9% of phenotypic variance. PTPN22 was also identified in the discovery cohort but replicated in only one independent cohort. Combining the three cohorts boosted power of vGWAS and additionally identified TYK2 and ANKRD55. Both PTPN22 and TYK2 had evidence of interactions reported elsewhere. We conclude that vGWAS can help discover interacting loci for complex diseases but require large samples to find additional signals. PMID:27109064

  2. The possibilities of applying a risk-oriented approach to the NPP reliability and safety enhancement problem

    NASA Astrophysics Data System (ADS)

    Komarov, Yu. A.

    2014-10-01

    An analysis and some generalizations of approaches to risk assessments are presented. Interconnection between different interpretations of the "risk" notion is shown, and the possibility of applying the fuzzy set theory to risk assessments is demonstrated. A generalized formulation of the risk assessment notion is proposed in applying risk-oriented approaches to the problem of enhancing reliability and safety in nuclear power engineering. The solution of problems using the developed risk-oriented approaches aimed at achieving more reliable and safe operation of NPPs is described. The results of studies aimed at determining the need (advisability) to modernize/replace NPP elements and systems are presented together with the results obtained from elaborating the methodical principles of introducing the repair concept based on the equipment technical state. The possibility of reducing the scope of tests and altering the NPP systems maintenance strategy is substantiated using the risk-oriented approach. A probabilistic model for estimating the validity of boric acid concentration measurements is developed.

  3. Non-valvular atrial fibrillation patients with none or one additional risk factor of the CHA2DS2-VASc score. A comprehensive net clinical benefit analysis for warfarin, aspirin, or no therapy.

    PubMed

    Lip, Gregory Y H; Skjøth, Flemming; Nielsen, Peter B; Larsen, Torben Bjerregaard

    2015-10-01

    Oral anticoagulation (OAC) to prevent stroke has to be balanced against the potential harm of serious bleeding, especially intracranial haemorrhage (ICH). We determined the net clinical benefit (NCB) balancing effectiveness and safety of no antithrombotic therapy, aspirin and warfarin in AF patients with none or one stroke risk factor. Using Danish registries, we determined NCB using various definitions intrinsic to our cohort (Danish weights at 1 and 5 year follow-up), with risk weights which were derived from the hazard ratio (HR) of death following an event, relative to HR of death after ischaemic stroke. When aspirin was compared to no treatment, NCB was neutral or negative for both risk strata. For warfarin vs no treatment, NCB using Danish weights was neutral where no risk factors were present and using five years follow-up. For one stroke risk factor, NCB was positive for warfarin vs no treatment, for one year and five year follow-up. For warfarin vs aspirin use in patients with no risk factors, NCB was positive with one year follow-up, but neutral with five year follow-up. With one risk factor, NCB was generally positive for warfarin vs aspirin. In conclusion, we show a positive overall advantage (i.e. positive NCB) of effective stroke prevention with OAC, compared to no therapy or aspirin with one additional stroke risk factor, using Danish weights. 'Low risk' AF patients with no additional stroke risk factors (i.e.CHA2DS2-VASc 0 in males, 1 in females) do not derive any advantage (neutral or negative NCB) with aspirin, nor with warfarin therapy in the long run.

  4. Application of high-density data for hazard prediction, safety assesment, and risk characterization

    EPA Science Inventory

    There are long lists of chemicals that require some level of evaluation for safety determination. These include the European Union’s Registration, Evaluation, Authorization and Restriction of Chemical substances (REACH) program, Environment Canada’s existing substances evaluatio...

  5. Early Engagement of Safety and Mission Assurance Expertise Using Systems Engineering Tools: A Risk-Based Approach to Early Identification of Safety and Assurance Requirements

    NASA Technical Reports Server (NTRS)

    Darpel, Scott; Beckman, Sean

    2016-01-01

    Decades of systems engineering practice have demonstrated that the earlier the identification of requirements occurs, the lower the chance that costly redesigns will needed later in the project life cycle. A better understanding of all requirements can also improve the likelihood of a design's success. Significant effort has been put into developing tools and practices that facilitate requirements determination, including those that are part of the model-based systems engineering (MBSE) paradigm. These efforts have yielded improvements in requirements definition, but have thus far focused on a design's performance needs. The identification of safety & mission assurance (S&MA) related requirements, in comparison, can occur after preliminary designs are already established, yielding forced redesigns. Engaging S&MA expertise at an earlier stage, facilitated by the use of MBSE tools, and focused on actual project risk, can yield the same type of design life cycle improvements that have been realized in technical and performance requirements.

  6. Risk management for drinking water safety in low and middle income countries - cultural influences on water safety plan (WSP) implementation in urban water utilities.

    PubMed

    Omar, Yahya Y; Parker, Alison; Smith, Jennifer A; Pollard, Simon J T

    2017-01-15

    We investigated cultural influences on the implementation of water safety plans (WSPs) using case studies from WSP pilots in India, Uganda and Jamaica. A comprehensive thematic analysis of semi-structured interviews (n=150 utility customers, n=32 WSP 'implementers' and n=9 WSP 'promoters'), field observations and related documents revealed 12 cultural themes, offered as 'enabling', 'limiting', or 'neutral', that influence WSP implementation in urban water utilities to varying extents. Aspects such as a 'deliver first, safety later' mind set; supply system knowledge management and storage practices; and non-compliance are deemed influential. Emergent themes of cultural influence (ET1 to ET12) are discussed by reference to the risk management, development studies and institutional culture literatures; by reference to their positive, negative or neutral influence on WSP implementation. The results have implications for the utility endorsement of WSPs, for the impact of organisational cultures on WSP implementation; for the scale-up of pilot studies; and they support repeated calls from practitioner communities for cultural attentiveness during WSP design. Findings on organisational cultures mirror those from utilities in higher income nations implementing WSPs - leadership, advocacy among promoters and customers (not just implementers) and purposeful knowledge management are critical to WSP success.

  7. Addition of Ezetimibe to statins for patients at high cardiovascular risk: Systematic review of patient-important outcomes.

    PubMed

    Fei, Yutong; Guyatt, Gordon Henry; Alexander, Paul Elias; El Dib, Regina; Siemieniuk, Reed A C; Vandvik, Per Olav; Nunnally, Mark E; Gomaa, Huda; Morgan, Rebecca L; Agarwal, Arnav; Zhang, Ying; Bhatnagar, Neera; Spencer, Frederick A

    2017-01-16

    Ezetimibe is widely used in combination with statins to reduce low-density lipoprotein. We sought to examine the impact of ezetimibe when added to statins on patient-important outcomes. Medline, EMBASE, CINAHL, and CENTRAL were searched through July, 2016. Randomized controlled trials (RCTs) of ezetimibe combined with statins versus statins alone that followed patients for at least 6 months and reported on at least one of all-cause mortality, cardiovascular deaths, non-fatal myocardial infarctions (MI), and non-fatal strokes were included. Pairs of reviewers extracted study data and assessed risk of bias independently and in duplicate. Quality of evidence was assessed using the GRADE approach. We conducted a narrative review with complementary subgroup and sensitivity analyses. IMPROVE-IT study enrolled 93% of all patients enrolled in the 8 included trials. Our analysis of the IMPROVE-IT study results showed that in patients at high risk of cardiovascular events, ezetimibe added to statins was associated with i) a likely reduction in non-fatal MI (17 fewer/1000 treated over 6 years, moderate certainty in evidence); ii) a possible reduction in non-fatal stroke (6 fewer/1000 treated over 6 years, low certainty); iii) no impact on myopathy (moderate certainty); iv) potentially no impact on all-cause mortality and cardiovascular death (both moderate certainty); and v) possibly no impact on cancer (low certainty). Addition of ezetimibe to moderate-dose statins is likely to result in 17 fewer MIs and possibly 6 fewer strokes/1000 treated over 6 years but is unlikely to reduce all-cause mortality or cardiovascular death. Patients who place a high value on a small absolute reduction in MI and are not adverse to use of an additional medication over a long duration may opt for ezetimibe in addition to statin therapy. Our analysis revealed no increased specific harms associated with addition of ezetimibe to statins.

  8. Genetic predisposition to coronary heart disease and stroke using an additive genetic risk score: a population-based study in Greece

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Objective: To determine the extent to which the risk for incident coronary heart disease (CHD) increases in relation to a genetic risk score (GRS) that additively integrates the influence of high-risk alleles in nine documented single nucleotide polymorphisms (SNPs) for CHD, and to examine whether t...

  9. Reshaping the carcinogenic risk assessment of medicines: international harmonisation for drug safety, industry/regulator efficiency or both?

    PubMed

    Abraham, John; Reed, Tim

    2003-07-01

    The most significant institutional entity involved in the harmonisation of drug testing standards worldwide is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which comprises the three pharmaceutical industry associations and regulatory agencies of the EU, US and Japan. It is often claimed that such harmonisation will both accelerate the development and approval of new drugs and preserve safety standards, if not strengthen safety regimes. Drawing on extensive documentary research and interviews, this paper systematically examines whether the efforts by the ICH to improve industrial and regulatory efficiency by harmonising drug testing requirements is likely to raise, maintain or compromise safety standards in carcinogenic risk assessment of pharmaceuticals. The evidence suggests that, in the field of carcinogenicity testing, the ICH management of international harmonisation of medicines regulation is not achieving simultaneous improvements in safety standards and acceleration of drug development. Rather, the latter is being achieved at the expense of the former. Indeed, the ICH may be converting permissive regulatory practices of the past into new scientific standards for the future. These findings are significant as many expert scientific advisers to drug regulatory agencies seem to have accepted uncritically the conclusions reached by the ICH, which may affect a potential patient population of half a billion and tens of thousands of clinical trials.

  10. Molecular basis of inherited antithrombin deficiency in Portuguese families: identification of genetic alterations and screening for additional thrombotic risk factors.

    PubMed

    David, Dezsö; Ribeiro, Sofia; Ferrão, Lénia; Gago, Teresa; Crespo, Francisco

    2004-06-01

    Antithrombin (AT), the most important coagulation serine proteases inhibitor, plays an important role in maintaining the hemostatic balance. Inherited AT deficiency, mainly characterized by predisposition to recurrent venous thromboembolism, is transmitted in an autosomal dominant manner. In this study, we analyzed the underlying genetic alterations in 12 unrelated Portuguese thrombophilic families with AT deficiency. At the same time, the modulating effect of the FV Leiden mutation, PT 20210A, PAI-1 4G, and MTHFR 677T allelic variants, on the thrombotic risk of AT deficient patients was also evaluated. Three novel frameshift alterations, a 4-bp deletion in exon 4 and two 1-bp insertions in exon 6, were identified in six unrelated type I AT deficient families. A novel missense mutation in exon 3a, which changes the highly conserved F147 residue, and a novel splice site mutation in the invariant acceptor AG dinucleotide of intron 2 were also identified in unrelated type I AT deficient families. In addition to these, two previously reported missense mutations changing the AT reactive site bond (R393-S394) and leading to type II-RS deficiency, and a previously reported cryptic splice site mutation (IVS4-14G-->A), were also identified. In these families, increased thrombotic risk associated with co-inheritance of the FV Leiden mutation and of the PAI-1 4G variant was also observed. In conclusion, we present the first data regarding the underlying genetic alterations in Portuguese thrombophilic families with AT deficiency, and confirm that the FV Leiden mutation and probably the PAI-1 4G variant represent additional thrombotic risk factors in these families.

  11. Addition of a fracture risk assessment to a coordinator's role improved treatment rates within 6 months of screening in a fragility fracture screening program.

    PubMed

    Beaton, D E; Vidmar, M; Pitzul, K B; Sujic, R; Rotondi, N K; Bogoch, E R; Sale, J E M; Jain, R; Weldon, J

    2017-03-01

    We evaluated the impact of a more intensive version of an existing post-fracture coordinator-based fracture prevention program and found that the addition of a full-risk assessment improved treatment rates. These findings provide additional support for more intensive programs aimed at reducing the risk of re-fractures.

  12. Medical-device risk management and public safety: using cost-benefit as a measurement of effectiveness

    NASA Astrophysics Data System (ADS)

    Hughes, Allen A.

    1994-12-01

    Public safety can be enhanced through the development of a comprehensive medical device risk management. This can be accomplished through case studies using a framework that incorporates cost-benefit analysis in the evaluation of risk management attributes. This paper presents a framework for evaluating the risk management system for regulatory Class III medical devices. The framework consists of the following sixteen attributes of a comprehensive medical device risk management system: fault/failure analysis, premarket testing/clinical trials, post-approval studies, manufacturer sponsored hospital studies, product labeling, establishment inspections, problem reporting program, mandatory hospital reporting, medical literature surveillance, device/patient registries, device performance monitoring, returned product analysis, autopsy program, emergency treatment funds/interim compensation, product liability, and alternative compensation mechanisms. Review of performance histories for several medical devices can reveal the value of information for many attributes, and also the inter-dependencies of the attributes in generating risk information flow. Such an information flow network is presented as a starting point for enhancing medical device risk management by focusing on attributes with high net benefit values and potential to spur information dissemination.

  13. [Experience of justification of hygienic standards of food safety with the use of criteria for the risk population health].

    PubMed

    Zaytseva, N V; Tutelyan, V A; Shur, P Z; Khotimchenko, S A; Sheveleva, S A

    2014-01-01

    In the article there is presented the experience of justification of hygienic standards of food safety with the use of criteria for the risk for population health. Health risk assessment under the impact of tetracyclines with food showed that the content of residual amounts of these antibiotics at the level of 10 mg/kg (permissible residual tetracycline accepted in Customs Union Member Countries (CUMC) will not increase the risk to public health, including the most sensitive groups of the population. The assessment ofthe health risk associated with the receipt of ractopamine with food, showed that eating foods containing ractopamine at ADI level (0-1 mg/kg body weight), and even at the limit of quantification levels in meat products, is inadmissible because of unacceptable risk of functional disorders and diseases of the cardiovascular system. The results of the substantiation of the permissible levels of nitrates content in crop production showed that at the level of exposure according to hygienic standards established in the CUMC as at the recommended and actual consumption levels of products ofplant origin, the health risk as carcinogenic and non-carcinogenic, does not exceed acceptable levels. The results of the assessment of the risk associated with the permissible levels of L. monocytogenes in certain food groups showed that an exposure level of hygienic standards established in the CUMC, standards of Codex Alimentarius Commission and EU documents (before release to the market by the manufacturer) the health risk does not exceed the maximum permissible level of the appearance of serious diseases. Adoption of standards of Codex Alimentarius Commission and the EU (for handling products in the market) is not acceptable because it can lead to an unacceptable risk of listeriosis for the population of the Russian Federation as a whole, and for the most sensitive groups.

  14. A Risk Analysis Methodology to Address Human and Organizational Factors in Offshore Drilling Safety: With an Emphasis on Negative Pressure Test

    NASA Astrophysics Data System (ADS)

    Tabibzadeh, Maryam

    According to the final Presidential National Commission report on the BP Deepwater Horizon (DWH) blowout, there is need to "integrate more sophisticated risk assessment and risk management practices" in the oil industry. Reviewing the literature of the offshore drilling industry indicates that most of the developed risk analysis methodologies do not fully and more importantly, systematically address the contribution of Human and Organizational Factors (HOFs) in accident causation. This is while results of a comprehensive study, from 1988 to 2005, of more than 600 well-documented major failures in offshore structures show that approximately 80% of those failures were due to HOFs. In addition, lack of safety culture, as an issue related to HOFs, have been identified as a common contributing cause of many accidents in this industry. This dissertation introduces an integrated risk analysis methodology to systematically assess the critical role of human and organizational factors in offshore drilling safety. The proposed methodology in this research focuses on a specific procedure called Negative Pressure Test (NPT), as the primary method to ascertain well integrity during offshore drilling, and analyzes the contributing causes of misinterpreting such a critical test. In addition, the case study of the BP Deepwater Horizon accident and their conducted NPT is discussed. The risk analysis methodology in this dissertation consists of three different approaches and their integration constitutes the big picture of my whole methodology. The first approach is the comparative analysis of a "standard" NPT, which is proposed by the author, with the test conducted by the DWH crew. This analysis contributes to identifying the involved discrepancies between the two test procedures. The second approach is a conceptual risk assessment framework to analyze the causal factors of the identified mismatches in the previous step, as the main contributors of negative pressure test

  15. Re-examining safety in numbers: interactions between risk dilution and collective detection depend upon predator targeting behaviour

    PubMed Central

    Bednekoff, P. A.; Lima, S. L.

    1998-01-01

    Many studies document that individuals visually scan for predators less frequently when in the safety of larger groups. This widely replicated effect has generally been explained in terms of distinct predator detection and risk-dilution effects. We show that a strict distinction between detection and dilution disappears when information about attacks is imperfectly shared (as it is in reality). Furthermore, dilution and detection effects change depending on when during an attack the predator targets a particular prey individual for pursuit. Realistic detection and dilution effects probably interact with each other and also with the targeting behaviour of predators. Instead of considering detection and dilution effects on vigilance, it may be more profitable to consider each prey's probability of being targeted during an attack and its probability of escaping if attacked. This perspective emphasizes that a full understanding of safety in numbers requires an understanding of predator targeting strategies.

  16. Evaluating the safety risk of roadside features for rural two-lane roads using reliability analysis.

    PubMed

    Jalayer, Mohammad; Zhou, Huaguo

    2016-08-01

    The severity of roadway departure crashes mainly depends on the roadside features, including the sideslope, fixed-object density, offset from fixed objects, and shoulder width. Common engineering countermeasures to improve roadside safety include: cross section improvements, hazard removal or modification, and delineation. It is not always feasible to maintain an object-free and smooth roadside clear zone as recommended in design guidelines. Currently, clear zone width and sideslope are used to determine roadside hazard ratings (RHRs) to quantify the roadside safety of rural two-lane roadways on a seven-point pictorial scale. Since these two variables are continuous and can be treated as random, probabilistic analysis can be applied as an alternative method to address existing uncertainties. Specifically, using reliability analysis, it is possible to quantify roadside safety levels by treating the clear zone width and sideslope as two continuous, rather than discrete, variables. The objective of this manuscript is to present a new approach for defining the reliability index for measuring roadside safety on rural two-lane roads. To evaluate the proposed approach, we gathered five years (2009-2013) of Illinois run-off-road (ROR) crash data and identified the roadside features (i.e., clear zone widths and sideslopes) of 4500 300ft roadway segments. Based on the obtained results, we confirm that reliability indices can serve as indicators to gauge safety levels, such that the greater the reliability index value, the lower the ROR crash rate.

  17. Development of an Updated Societal-Risk Goal for Nuclear Power Safety

    SciTech Connect

    Vicki Bier; Michael Corradini; Robert Youngblood; Caleb Roh; Shuji Liu

    2014-07-01

    This report briefly summarizes work done in FY 2013 on the subject LDRD. The working hypothesis is that societal disruption should be addressed in a safety goal. This is motivated by the point that the Fukushima disaster resulted in very little public dose, but enormous societal disruption; a goal that addressed societal disruption would fill a perceived gap in the US NRC safety goal structure. This year's work entailed analyzing the consequences of postulated accidents at various reactor sites in the US, specifically with a view to quantifying the number of people relocated and the duration of their relocation, to see whether this makes sense as a measure of societal disruption.

  18. Meat and bone meal and mineral feed additives may increase the risk of oral prion disease transmission

    USGS Publications Warehouse

    Johnson, Christopher J.; McKenzie, Debbie; Pedersen, Joel A.; Aiken, Judd M.

    2011-01-01

    Ingestion of prion-contaminated materials is postulated to be a primary route of prion disease transmission. Binding of prions to soil (micro)particles dramatically enhances peroral disease transmission relative to unbound prions, and it was hypothesized that micrometer-sized particles present in other consumed materials may affect prion disease transmission via the oral route of exposure. Small, insoluble particles are present in many substances, including soil, human foods, pharmaceuticals, and animal feeds. It is known that meat and bone meal (MBM), a feed additive believed responsible for the spread of bovine spongiform encephalopathy (BSE), contains particles smaller than 20 μm and that the pathogenic prion protein binds to MBM. The potentiation of disease transmission via the oral route by exposure to MBM or three micrometer-sized mineral feed additives was determined. Data showed that when the disease agent was bound to any of the tested materials, the penetrance of disease was increased compared to unbound prions. Our data suggest that in feed or other prion-contaminated substances consumed by animals or, potentially, humans, the addition of MBM or the presence of microparticles could heighten risks of prion disease acquisition.

  19. Meat and bone meal and mineral feed additives may increase the risk of oral prion disease transmission

    USGS Publications Warehouse

    Johnson, C.J.; McKenzie, D.; Pedersen, J.A.; Aiken, Judd M.

    2011-01-01

    Ingestion of prion-contaminated materials is postulated to be a primary route of prion disease transmission. Binding of prions to soil (micro)particles dramatically enhances peroral disease transmission relative to unbound prions, and it was hypothesized that micrometer-sized particles present in other consumed materials may affect prion disease transmission via the oral route of exposure. Small, insoluble particles are present in many substances, including soil, human foods, pharmaceuticals, and animal feeds. It is known that meat and bone meal (MBM), a feed additive believed responsible for the spread of bovine spongiform encephalopathy (BSE), contains particles smaller than 20 ??m and that the pathogenic prion protein binds to MBM. The potentiation of disease transmission via the oral route by exposure to MBM or three micrometer-sized mineral feed additives was determined. Data showed that when the disease agent was bound to any of the tested materials, the penetrance of disease was increased compared to unbound prions. Our data suggest that in feed or other prion-contaminated substances consumed by animals or, potentially, humans, the addition of MBM or the presence of microparticles could heighten risks of prion disease acquisition. Copyright ?? 2011 Taylor & Francis Group, LLC.

  20. MEAT AND BONE MEAL AND MINERAL FEED ADDITIVES MAY INCREASE THE RISK OF ORAL PRION DISEASE TRANSMISSION

    PubMed Central

    Johnson, Christopher J.; McKenzie, Debbie; Pedersen, Joel A.; Aiken, Judd M.

    2011-01-01

    Ingestion of prion-contaminated materials is postulated to be a primary route of prion disease transmission. Binding of prions to soil (micro)particles dramatically enhances peroral disease transmission relative to unbound prions, and it was hypothesized that micrometer–sized particles present in other consumed materials may affect prion disease transmission via the oral route of exposure. Small, insoluble particles are present in many substances, including soil, human foods, pharmaceuticals, and animal feeds. It is known that meat and bone meal (MBM), a feed additive believed responsible for the spread of bovine spongiform encephalopathy (BSE), contains particles smaller than 20 μm and that the pathogenic prion protein binds to MBM. The potentiation of disease transmission via the oral route by exposure to MBM or three micrometer-sized mineral feed additives was determined. Data showed that when the disease agent was bound to any of the tested materials, the penetrance of disease was increased compared to unbound prions. Our data suggest that in feed or other prion–contaminated substances consumed by animals or, potentially, humans, the addition of MBM or the presence of microparticles could heighten risks of prion disease acquisition. PMID:21218345

  1. Risk evaluation of land subsidence and its application to metro safety operation in Shanghai

    NASA Astrophysics Data System (ADS)

    Liu, J.; Wang, H.; Yan, X.

    2015-11-01

    Based on sufficiently investigating characteristics and risk connotation of land subsidence, a risk evaluation index system for land subsidence disaster is established, which is combined with the sensitivity feature of the hazard bearing body to land subsidence. An appropriate evaluation method system is established by using an improved fuzzy analytic hierarchy process method. So risk evaluation is developed for providing theoretical basis and technical support for the regional management of land subsidence prevention and control. On this basis, as a case of Shanghai metro, firstly, the paper studies the identifying risk sources of the metro. According to metro linear characteristics, external indexes of representing subsidence risk are obtained. Studying the subsidence risk of the metro, relevant achievement has provided the technical basis for daily main monitoring, early warning and work arrangement.

  2. Perceived Fall Risk and Functional Decline: Gender Differences in Patient's Willingness to Discuss Fall Risk, Fall History, or to Have a Home Safety Evaluation

    PubMed Central

    Greenberg, Marna Rayl; Moore, Elizabeth C.; Nguyen, Michael C.; Stello, Brian; Goldberg, Arnold; Barraco, Robert D.; Porter, Bernadette G.; Kurt, Anita; Dusza, Stephen W.; Kane, Bryan G.

    2016-01-01

    The CDC reports that among older adults, falls are the leading cause of injury-related death and rates of fall-related fractures among older women are twice those of men. We set out to 1) determine patient perceptions (analyzed by gender) about their perceived fall risk compared to their actual risk for functional decline and death and 2) to report their comfort level in discussing their fall history or a home safety plan with their provider. Elders who presented to the Emergency Department (ED†) were surveyed. The survey included demographics, the Falls Efficacy Scale (FES) and the Vulnerable Elders Survey (VES); both validated surveys measuring fall concern and functional decline. Females had higher FES scores (mean 12.3, SD 5.9) than males (mean 9.7, SD 5.9 p = .007) in the 146 surveys analyzed. Females were more likely to report an increased fear of falling, and almost three times more likely to have a VES score of 3 or greater than males (OR = 2.86, 95% CI: 1.17-7.00, p = .02). A strong correlation was observed between FES and VES scores (r = 0.80, p < .001). No difference in correlation was observed between males and females, p = .26. Participants (77 percent) reported they would be comfortable discussing their fall risk with a provider; there was no difference between genders (p = .57). In this study, irrespective of gender, there appears to be a high association between subjects’ perceived fall risk and risk for functional decline and death. The majority of patients are likely willing to discuss their fall risk with their provider. These findings may suggest a meaningful opportunity for fall risk mitigation in this setting. PMID:27354852

  3. On the use of hierarchical probabilistic models for characterizing and managing uncertainty in risk/safety assessment.

    PubMed

    Kodell, Ralph L; Chen, James J

    2007-04-01

    A general probabilistically-based approach is proposed for both cancer and noncancer risk/safety assessments. The familiar framework of the original ADI/RfD formulation is used, substituting in the numerator a benchmark dose derived from a hierarchical pharmacokinetic/pharmacodynamic model and in the denominator a unitary uncertainty factor derived from a hierarchical animal/average human/sensitive human model. The empirical probability distributions of the numerator and denominator can be combined to produce an empirical human-equivalent distribution for an animal-derived benchmark dose in external-exposure units.

  4. FIRE SAFETY IN NUCLEAR POWER PLANTS: A RISK-INFORMED AND PERFORMANCE-BASED APPROACH

    SciTech Connect

    AZARM,M.A.; TRAVIS,R.J.

    1999-11-14

    The consideration of risk in regulatory decision-making has long been a part of NRC's policy and practice. Initially, these considerations were qualitative and were based on risk insights. The early regulations relied on good practices, past insights, and accepted standards. As a result, most NRC regulations were prescriptive and were applied uniformly to all areas within the regulatory scope. Risk technology is changing regulations by prioritizing the areas within regulatory scope based on risk, thereby focusing on the risk-important areas. Performance technology, on the other hand, is changing the regulations by allowing requirements to be adjusted based on the specific performance expected and manifested, rather than a prior prescriptive requirement. Consistent with the objectives of risk-informed and performance-based regulatory requirements, BNL evaluated the feasibility of applying risk- and performance-technologies to modifying NRC's current regulations on fire protection for nuclear power plants. This feasibility study entailed several case studies (trial applications). This paper describes the results of two of them. Besides the case studies, the paper discusses an overall evaluation of methodologies for fire-risk analysis to support the risk-informed regulation. It identifies some current shortcomings and proposes some near-term solutions.

  5. Risk assessment of medical devices: Evaluation of microbiological and toxicological safety

    NASA Astrophysics Data System (ADS)

    Dorpema, J. W.

    1995-02-01

    Safety assessment of medical devices includes sterilization and biological evaluation or biocompatibility testing. Sterilization by ETO gas is critised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program.

  6. Developing Science-based Approaches to Reduce Produce Safety Risks at the End-user Levels

    Technology Transfer Automated Retrieval System (TEKTRAN)

    An increasing number of food-borne illness outbreaks associated with the consumption of contaminated fresh and fresh-cut produce significantly impacted public health and consumer confidence. The urgent need to improve produce safety demands actions from growers, processors and consumers. The main ob...

  7. Food safety and organic meats.

    PubMed

    Van Loo, Ellen J; Alali, Walid; Ricke, Steven C

    2012-01-01

    The organic meat industry in the United States has grown substantially in the past decade in response to consumer demand for nonconventionally produced products. Consumers are often not aware that the United States Department of Agriculture (USDA) organic standards are based only on the methods used for production and processing of the product and not on the product's safety. Food safety hazards associated with organic meats remain unclear because of the limited research conducted to determine the safety of organic meat from farm-to-fork. The objective of this review is to provide an overview of the published results on the microbiological safety of organic meats. In addition, antimicrobial resistance of microbes in organic food animal production is addressed. Determining the food safety risks associated with organic meat production requires systematic longitudinal studies that quantify the risks of microbial and nonmicrobial hazards from farm-to-fork.

  8. Fault Management in an Objectives-Based/Risk-Informed View of Safety and Mission Success

    NASA Technical Reports Server (NTRS)

    Groen, Frank

    2012-01-01

    Theme of this talk: (1) Net-benefit of activities and decisions derives from objectives (and their priority) -- similarly: need for integration, value of technology/capability. (2) Risk is a lack of confidence that objectives will be met. (2a) Risk-informed decision making requires objectives. (3) Consideration of objectives is central to recent guidance.

  9. The challenge of defining risk-based metrics to improve food safety: inputs from the BASELINE project.

    PubMed

    Manfreda, Gerardo; De Cesare, Alessandra

    2014-08-01

    In 2002, the Regulation (EC) 178 of the European Parliament and of the Council states that, in order to achieve the general objective of a high level of protection of human health and life, food law shall be based on risk analysis. However, the Commission Regulation No 2073/2005 on microbiological criteria for foodstuffs requires that food business operators ensure that foodstuffs comply with the relevant microbiological criteria. Such criteria define the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of micro-organisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch. The same Regulation describes a food safety criterion as a mean to define the acceptability of a product or a batch of foodstuff applicable to products placed on the market; moreover, it states a process hygiene criterion as a mean indicating the acceptable functioning of the production process. Both food safety criteria and process hygiene criteria are not based on risk analysis. On the contrary, the metrics formulated by the Codex Alimentarius Commission in 2004, named Food Safety Objective (FSO) and Performance Objective (PO), are risk-based and fit the indications of Regulation 178/2002. The main aims of this review are to illustrate the key differences between microbiological criteria and the risk-based metrics defined by the Codex Alimentarius Commission and to explore the opportunity and also the possibility to implement future European Regulations including PO and FSO as supporting parameters to microbiological criteria. This review clarifies also the implications of defining an appropriate level of human protection, how to establish FSO and PO and how to implement them in practice linked to each other through quantitative risk assessment models. The contents of this review should clarify the context for application of the results collected during the EU funded project named BASELINE (www

  10. Effect of Community Engagement Interventions on Patient Safety and Risk Reduction Efforts in Primary Health Facilities: Evidence from Ghana

    PubMed Central

    Alhassan, Robert Kaba; Nketiah-Amponsah, Edward; Spieker, Nicole; Arhinful, Daniel Kojo; Ogink, Alice; van Ostenberg, Paul; Rinke de Wit, Tobias F.

    2015-01-01

    Background Patient safety and quality care remain major challenges to Ghana’s healthcare system. Like many health systems in Africa, this is largely because demand for healthcare is outstripping available human and material resource capacity of healthcare facilities and new investment is insufficient. In the light of these demand and supply constraints, systematic community engagement (SCE) in healthcare quality assessment can be a feasible and cost effective option to augment existing quality improvement interventions. SCE entails structured use of existing community groups to assess healthcare quality in health facilities. Identified quality gaps are discussed with healthcare providers, improvements identified and rewards provided if the quality gaps are closed. Purpose This paper evaluates whether or not SCE, through the assessment of health service quality, improves patient safety and risk reduction efforts by staff in healthcare facilities. Methods A randomized control trail was conducted in 64 primary healthcare facilities in the Greater Accra and Western regions of Ghana. Patient risk assessments were conducted in 32 randomly assigned intervention and control facilities. Multivariate multiple regression test was used to determine effect of the SCE interventions on staff efforts towards reducing patient risk. Spearman correlation test was used to ascertain associations between types of community groups engaged and risk assessment scores of healthcare facilities. Findings Clinic staff efforts towards increasing patient safety and reducing risk improved significantly in intervention facilities especially in the areas of leadership/accountability (Coef. = 10.4, p<0.05) and staff competencies (Coef. = 7.1, p<0.05). Improvement in service utilization and health resources could not be attributed to the interventions because these were outside the control of the study and might have been influenced by institutional or national level developments between the

  11. Risks of drowning and safety concerns at the beaches of Karachi--perspective from lifeguards.

    PubMed

    Shaikh, Masood Ali

    2014-05-01

    Going to beaches is a popular pastime for many people in Karachi. Lifeguards have been deployed on many beaches for the safety and protection of beachgoers. This cross-sectional survey was conducted to study the opinions and experiences of lifeguards posted at eight beaches of Karachi. Ignorance among beachgoers about how dangerous it could be at seaside, was reported by 19 (61.3%) out of 31 lifeguards interviewed. Lifeguards had to put up with verbal and physical abuse while discharging their duties, with verbal abuse being the universal experience. Improved record keeping of drowning and near-drowning data would help make better evidence-informed beach-safety decisions in Karachi for reducing the morbidity and mortality burden owing to drowning.

  12. Aviation System Safety and Pilot Risk Perception: Implications for Enhancing Decision-Making Skills

    NASA Technical Reports Server (NTRS)

    Green, Mavis F.

    2001-01-01

    This research explores risk perception in a defined population of flight instructors and the implications of these views for flight training. Flight instructors and students engaged in collegiate aviation flight training were interviewed for this qualitative study. Thirty-three percent of the instructors interviewed reported that flying is not a risky activity. This is important because research identifies risk perception as one factor influencing instructional choices. These choices can then impact the subsequent decision-making processes of flight students. Facilitating pilot decision-making through the use of an appropriate type of learning that incorporates the modeling of consensually validated cognitive procedures and risk management processes is discussed.

  13. [Evaluation of the risk of delayed adverse effects of chronic combined exposure to radiation and chemical factors with the purpose to ensure safety in orbital and exploration space missions].

    PubMed

    Shafirkin, A V; Mukhamedieva, L N; Tatarkin, S V; Barantseva, M Iu

    2012-01-01

    The work had the aim to anatomize the existing issues with providing safety in extended orbital and exploration missions for ensuing estimation of actual values of the total radiation risk for the crew, and risks of other delayed effects of simultaneous exposure to ionizing radiation and chemical pollutants in cabin air, and a number of other stressful factors inevitable in space flight. The flow of chronic experiments for separate and combined studies with reproduction of air makeup and radiation doses in actual orbital and predicted exploration missions is outlined. To set safety limits, new approaches should be applied to the description of gradual norm degradation to pathologies in addition to several generalized quantitative indices of adaptation and straining of the regulatory systems, as well as of effectiveness of the compensatory body reserve against separate and combined exposure.

  14. A qualitative investigation of Hispanic construction worker perspectives on factors impacting worksite safety and risk

    PubMed Central

    2011-01-01

    Background Hispanic workers have higher rates of injury and death on construction worksites than workers of other ethnicities. Language barriers and cultural differences have been hypothesized as reasons behind the disparate rates. Methods We conducted two series of focus groups with union and non-union Hispanic construction workers to ask them about their perceptions of the causes for the unequal rates. Spanish transcripts were translated and coded in QSR NVivo software for common themes. Results Workers reported a difficult work environment characterized by supervisor pressure, competition for jobs and intimidation with regard to raising safety concerns. Language barriers or cultural factors were not strongly represented as causative factors behind the rates. Conclusion The results of this study have informed the development of an intervention trial that seeks to prevent falls and silica dust exposure by training contractors employing Hispanic construction workers in the elements of safety leadership, including building respect for their Hispanic workers and facilitating their participation in a safety program. PMID:21962128

  15. Evaluating safety risk of locating above ground utility structures in the highway right-of-way.

    PubMed

    El Esawey, Mohamed; Sayed, Tarek

    2012-11-01

    Roadside safety has been a concern for highway engineers and designers for many decades. A significant part of this concern is related to collisions with utility poles. Current practices and standards for placing utility poles are based on a combination of qualitative guidelines/heuristics and relatively outdated findings. Accordingly, there is a need to study the safety level associated with placing utility poles at different lateral offsets from the edge of the travel-way. In this paper a Safety Performance Function (SPF) is developed to relate roadway and roadside variables to utility pole collision frequency. It was found that increasing the poles offset has a more significant effect on reducing the frequency of utility pole collisions compared to increasing poles spacing. Based on the developed utility pole-SPF, design charts were provided to facilitate calculations and decision-making process. The developed utility pole-SPF was compared to a widely-used utility pole collisions model and the differences in the type of data and the development methodology were highlighted.

  16. Will the Occupational Safety and Health Administration's Proposed Standards for Occupational Exposure to Respirable Crystalline Silica Reduce Workplace Risk?

    PubMed

    Dudley, Susan E; Morriss, Andrew P

    2015-07-01

    The Occupational Safety and Health Administration (OSHA) is developing regulations to amend existing standards for occupational exposure to respirable crystalline silica by establishing a new permissible exposure limit as well as a series of ancillary provisions for controlling exposure. This article briefly reviews OSHA's proposed regulatory approach and the statutory authority on which it is based. It then evaluates OSHA's preliminary determination of significant risk and its analysis of the risk reduction achievable by its proposed controls. It recognizes that OSHA faces multiple challenges in devising a regulatory approach that reduces exposures and health risks and meets its statutory goal. However, the greatest challenge to reducing risks associated with silica exposure is not the lack of incentives (for either employers or employees) but rather lack of information, particularly information on the relative toxicity of different forms of silica. The article finds that OSHA's proposed rule would contribute little in the way of new information, particularly since it is largely based on information that is at least a decade old--a significant deficiency, given the rapidly changing conditions observed over the last 45 years. The article concludes with recommendations for alternative approaches that would be more likely to generate information needed to improve worker health outcomes.

  17. Final safety analysis report for the Galileo mission: Volume 3 (Book 1), Nuclear risk analysis document: Revision 1

    SciTech Connect

    Not Available

    1989-01-13

    It is the purpose of the NRAD to provide an analysis of the range of potential consequences of accidents which have been identified that are associated with the launching and deployment of the Galileo mission spacecraft. The specific consequences analyzed are those associated with the possible release of radioactive material (fuel) of the Radioisotope Thermoelectric Generators (RTGs). They are in terms of radiation doses to people and areas of deposition of radioactive material. These consequence analyses can be used in several ways. One way is to identify the potential range of consequences which might have to be dealt with if there were to be an accident with a release of fuel, so as to assure that, given such an accident, the health and safety of the public will be reasonably protected. Another use of the information, in conjunction with accident and release probabilities, is to estimate the risks associated with the mission. That is, most space launches occur without incident. Given an accident, the most probable result relative to the RTGs is complete containment of the radioactive material. Only a small fraction of accidents might result in a release of fuel and subsequent radiological consequences. The combination of probability with consequence is risk, which can be compared to other human and societal risks to assure that no undue risks are implied by undertaking the mission. 4 refs., 11 figs., 31 tabs.

  18. Final safety analysis report for the Galileo mission: Volume 3 (Book 2), Nuclear risk analysis document: Appendices: Revision 1

    SciTech Connect

    Not Available

    1989-01-25

    It is the purpose of the NRAD to provide an analysis of the range of potential consequences of accidents which have been identified that are associated with the launching and deployment of the Galileo mission spacecraft. The specific consequences analyzed are those associated with the possible release of radioactive material (fuel) of the Radioisotope Thermoelectric Generators (RTGs). They are in terms of radiation doses to people and areas of deposition of radioactive material. These consequence analyses can be used in several ways. One way is to identify the potential range of consequences which might have to be dealt with if there were to be an accident with a release of fuel, so as to assure that, given such an accident, the health and safety of the public will be reasonably protected. Another use of the information, in conjunction with accident and release probabilities, is to estimate the risks associated with the mission. That is, most space launches occur without incident. Given an accident, the most probable result relative to the RTGs is complete containment of the radioactive material. Only a small fraction of accidents might result in a release of fuel and subsequent radiological consequences. The combination of probability with consequence is risk, which can be compared to other human and societal risks to assure that no undue risks are implied by undertaking the mission. Book 2 contains eight appendices.

  19. Solidifying Safety

    NASA Technical Reports Server (NTRS)

    Covault, Craig

    2003-01-01

    Contents include the following: 1. Solidifying Safety: NASA s new safety organization spools up, as the 1SS program grapples with long-term risk. 2. Earth to Orbit O'Keefe telling skeptical lawmakers Orbital Space Plan (OSP) will cover exploration vision. China's rapid pace.

  20. Interaction of Occupational and Personal Risk Factors in Workforce Health and Safety

    PubMed Central

    Pandalai, Sudha; Wulsin, Victoria; Chun, HeeKyoung

    2012-01-01

    Most diseases, injuries, and other health conditions experienced by working people are multifactorial, especially as the workforce ages. Evidence supporting the role of work and personal risk factors in the health of working people is frequently underused in developing interventions. Achieving a longer, healthy working life requires a comprehensive preventive approach. To help develop such an approach, we evaluated the influence of both occupational and personal risk factors on workforce health. We present 32 examples illustrating 4 combinatorial models of occupational hazards and personal risk factors (genetics, age, gender, chronic disease, obesity, smoking, alcohol use, prescription drug use). Models that address occupational and personal risk factors and their interactions can improve our understanding of health hazards and guide research and interventions. PMID:22021293

  1. A second common mutation in the methylenetetrahydrofolate reductase gene: an additional risk factor for neural-tube defects?

    PubMed Central

    van der Put, N M; Gabreëls, F; Stevens, E M; Smeitink, J A; Trijbels, F J; Eskes, T K; van den Heuvel, L P; Blom, H J

    1998-01-01

    Recently, we showed that homozygosity for the common 677(C-->T) mutation in the methylenetetrahydrofolate reductase (MTHFR) gene, causing thermolability of the enzyme, is a risk factor for neural-tube defects (NTDs). We now report on another mutation in the same gene, the 1298(A-->C) mutation, which changes a glutamate into an alanine residue. This mutation destroys an MboII recognition site and has an allele frequency of .33. This 1298(A-->C) mutation results in decreased MTHFR activity (one-way analysis of variance [ANOVA] P < .0001), which is more pronounced in the homozygous than heterozygous state. Neither the homozygous nor the heterozygous state is associated with higher plasma homocysteine (Hcy) or a lower plasma folate concentration-phenomena that are evident with homozygosity for the 677(C-->T) mutation. However, there appears to be an interaction between these two common mutations. When compared with heterozygosity for either the 677(C-->T) or 1298(A-->C) mutations, the combined heterozygosity for the 1298(A-->C) and 677(C-->T) mutations was associated with reduced MTHFR specific activity (ANOVA P < .0001), higher Hcy, and decreased plasma folate levels (ANOVA P <.03). Thus, combined heterozygosity for both MTHFR mutations results in similar features as observed in homozygotes for the 677(C-->T) mutation. This combined heterozygosity was observed in 28% (n =86) of the NTD patients compared with 20% (n =403) among controls, resulting in an odds ratio of 2.04 (95% confidence interval: .9-4.7). These data suggest that the combined heterozygosity for the two MTHFR common mutations accounts for a proportion of folate-related NTDs, which is not explained by homozygosity for the 677(C-->T) mutation, and can be an additional genetic risk factor for NTDs. PMID:9545395

  2. Insight into "Calculated Risk": An Application to the Prioritization of Emerging Infectious Diseases for Blood Transfusion Safety.

    PubMed

    Neslo, R E J; Oei, W; Janssen, M P

    2017-02-23

    Increasing identification of transmissions of emerging infectious diseases (EIDs) by blood transfusion raised the question which of these EIDs poses the highest risk to blood safety. For a number of the EIDs that are perceived to be a threat to blood safety, evidence on actual disease or transmission characteristics is lacking, which might render measures against such EIDs disputable. On the other hand, the fact that we call them "emerging" implies almost by definition that we are uncertain about at least some of their characteristics. So what is the relative importance of various disease and transmission characteristics, and how are these influenced by the degree of uncertainty associated with their actual values? We identified the likelihood of transmission by blood transfusion, the presence of an asymptomatic phase of infection, prevalence of infection, and the disease impact as the main characteristics of the perceived risk of disease transmission by blood transfusion. A group of experts in the field of infectious diseases and blood transfusion ranked sets of (hypothetical) diseases with varying degrees of uncertainty associated with their disease characteristics, and used probabilistic inversion to obtain probability distributions for the weight of each of these risk characteristics. These distribution weights can be used to rank both existing and newly emerging infectious diseases with (partially) known characteristics. Analyses show that in case there is a lack of data concerning disease characteristics, it is the uncertainty concerning the asymptomatic phase and the disease impact that are the most important drivers of the perceived risk. On the other hand, if disease characteristics are well established, it is the prevalence of infection and the transmissibility of the disease by blood transfusion that will drive the perceived risk. The risk prioritization model derived provides an easy to obtain and rational expert assessment of the relative importance of

  3. An outline of a risk assessment-based system of meat safety assurance and its future prospects.

    PubMed

    Berends, B R; van Knapen, F

    1999-10-01

    Discussed are the outlines of a risk assessment-based system of meat safety assurance to replace the current meat inspection. An example of a system that uses the Hazard Analysis of Critical Control Points (HACCP)-principles in the entire production chain from stable to table is also given. Continuous evaluation of risks is the main driving force of the new system. Only then the system has the means to remain flexible and provide for the data necessary to convince trade partners that the products they buy are safe. A monitoring system that keeps track of the important health hazards in the entire chain from stable to table is therefore necessary. This includes monitoring of cases of disease in the human population caused by the hazardous agents of concern. Coordination of the monitoring and control and processing of the information is done by an independent body. Furthermore, the system demands a production from stable to table that is based on the ideas of Integrated Quality Control (IQC), HACCP, and certification of production processes and quality control procedures. Clear legislation provides for criteria about acceptable or unacceptable health risks for the consumer and determines at what moments which risks should be controlled by the producers. Simultaneously, the legislation has to be flexible enough to be able to adapt quickly to any changes in risks, or in the way risks should be controlled. In the new system current meat inspection can easily be carried out by employees of the slaughter houses and is no longer a direct responsibility of the authorities. The authorities only demand certain safety levels and verify whether producers stick to these. Producers remain fully responsible for the safety and quality of their products, and fully liable in case of any damage to the consumers' health. However, it is to be expected that some EU Member-States miss the organizational and agricultural basis for a successful application of the new system. Consequences

  4. Risk assessment of pesticides and other stressors in bees: Principles, data gaps and perspectives from the European Food Safety Authority.

    PubMed

    Rortais, Agnès; Arnold, Gérard; Dorne, Jean-Lou; More, Simon J; Sperandio, Giorgio; Streissl, Franz; Szentes, Csaba; Verdonck, Frank

    2017-06-01

    Current approaches to risk assessment in bees do not take into account co-exposures from multiple stressors. The European Food Safety Authority (EFSA) is deploying resources and efforts to move towards a holistic risk assessment approach of multiple stressors in bees. This paper describes the general principles of pesticide risk assessment in bees, including recent developments at EFSA dealing with risk assessment of single and multiple pesticide residues and biological hazards. The EFSA Guidance Document on the risk assessment of plant protection products in bees highlights the need for the inclusion of an uncertainty analysis, other routes of exposures and multiple stressors such as chemical mixtures and biological agents. The EFSA risk assessment on the survival, spread and establishment of the small hive beetle, Aethina tumida, an invasive alien species, is provided with potential insights for other bee pests such as the Asian hornet, Vespa velutina. Furthermore, data gaps are identified at each step of the risk assessment, and recommendations are made for future research that could be supported under the framework of Horizon 2020. Finally, the recent work conducted at EFSA is presented, under the overarching MUST-B project ("EU efforts towards the development of a holistic approach for the risk assessment on MUltiple STressors in Bees") comprising a toolbox for harmonised data collection under field conditions and a mechanistic model to assess effects from pesticides and other stressors such as biological agents and beekeeping management practices, at the colony level and in a spatially complex landscape. Future perspectives at EFSA include the development of a data model to collate high quality data to calibrate and validate the model to be used as a regulatory tool. Finally, the evidence collected within the framework of MUST-B will support EFSA's activities on the development of a holistic approach to the risk assessment of multiple stressors in bees. In

  5. Risk assessment strategies as a tool in the application of the Appropriate Level of Protection (ALOP) and Food Safety Objective (FSO) by risk managers.

    PubMed

    Gkogka, E; Reij, M W; Gorris, L G M; Zwietering, M H

    2013-10-01

    In the course of the last decade, the Appropriate Level of Protection (ALOP), the Food Safety Objective (FSO) and their associated metrics have been proposed by the World Trade Organization and Codex Alimentarius as a means for competent authorities to ultimately translate governmental public health policy regarding food safety into risk-based targets for the food industry. The industry needs to meet these targets through the effective choice of control measures that are part of its operational food safety management system. The aim of this study was to put the practical application of ALOP and FSO to the test in the case of Salmonella in chicken meat in the Netherlands. Two different risk assessment approaches were applied to derive potential ALOP and FSO values, a 'top-down' approach based on epidemiological data and a 'bottom-up' approach based on food supply chain data. To this end, two stochastic models specific to the Dutch situation were built. Comparisons between 23 countries in Europe were also made using the top-down model. The mean estimated current Level Of Protection values were similar for the two approaches applied, with the bottom-up model yielding 87 cases per 100,000 inhabitants per year (95% CI: 0.03, 904) and the top-down model 71 (95% CI: 9.9, 155). The estimated FSO values on the other hand were considerably different with the mean 'top down' FSO being -4.6 log CFU/g (95% CI: -5.4, -4.1) and the mean 'bottom-up' FSO -6.0 log CFU/g (95% CI: -8.1, -2.9) reflecting major differences in the output distributions of this parameter obtained with the two approaches. Significant differences were observed between current LOP values for different EU countries, although it was not clear whether this was due to actual differences in the factors influencing the risk of salmonellosis or due to the quality of the available data.

  6. Improvement of microbiological safety and sensorial quality of pork jerky by electron beam irradiation and by addition of onion peel extract and barbecue flavor

    NASA Astrophysics Data System (ADS)

    Kim, Hyun-Joo; Jung, Samooel; Yong, Hae In; Bae, Young Sik; Kang, Suk Nam; Kim, Il Suk; Jo, Cheorun

    2014-05-01

    The combined effects of electron-beam (EB) irradiation and addition of onion peel (OP) extract and barbecue flavor (BF) on inactivation of foodborne pathogens and the quality of pork jerky was investigated. Prepared pork jerky samples were irradiated (0, 1, 2, and 4 kGy) and stored for 2 month at 25 °C. The D10 values of Listeria monocytogenes, Escherichia coli, and Salmonella typhimurium observed in the OP treated samples were 0.19, 0.18, and 0.19 kGy, whereas those in control were 0.25, 0.23, and 0.20 kGy, respectively. Irradiated samples with OP extract and BF had substantially lower total aerobic bacterial counts than the control had. Samples with added OP extract and BF had lower peroxide values than the control had. Sensory evaluation indicated that overall acceptability of treated samples was not changed up to 2 kGy. Therefore, EB irradiation, combined with OP extract and BF, has improved the microbiological safety with no negative effects on the quality of pork jerky.

  7. Identification of unique food handling practices that could represent food safety risks for minority consumers.

    PubMed

    Henley, Shauna C; Stein, Susan E; Quinlan, Jennifer J

    2012-11-01

    Foodborne illness caused by Salmonella and Campylobacter is a concern for consumers, and there is evidence that minority racial-ethnic populations experience greater rates of illness because of these pathogens. The limited body of research concerning food safety knowledge and practices among minority consumers has focused more on general food safety knowledge than on culturally specific food handling practices. The purpose of the research reported here was to explore food handling behaviors of minority racial-ethnic consumers through in-depth discussions in focus group settings. In this way, we hoped to identify potential unique, previously unidentified food handling practices among these consumers. Nine focus groups were held in Philadelphia, PA. Three focus groups were conducted with African American consumers, three with Hispanic consumers, and three with Asian consumers. In all, 56 consumers participated. Data were recorded, transcribed, and analyzed for unique and potentially unsafe food handling behaviors. Potentially unsafe food handling practices identified among all three groups included extended time to transport food from retail to home and washing of raw poultry. Culturally unique behaviors within groups included (i) using hot water (Asian, Hispanic) or acidic solutions (African American, Hispanic) to clean raw poultry, (ii) purchasing live poultry (Asian, Hispanic), (iii) cooking poultry overnight (African American), and (iv) preparing bite-size pieces of meat prior to cooking (Asian, Hispanic). To have focus groups include a limited number of participants and nonrandom sampling means that these themes and trends cannot be extrapolated to represent food mishandling among these populations in general. Results presented here allow modification of an existing food safety survey to identify the prevalence of these food handling practices among consumers of different demographics.

  8. Pathogen Inactivation Technologies: The Advent of Pathogen-Reduced Blood Components to Reduce Blood Safety Risk.

    PubMed

    Devine, Dana V; Schubert, Peter

    2016-06-01

    Pathogen inactivation technologies represent a shift in blood safety from a reactive approach to a proactive protective strategy. Commercially available technologies demonstrate effective killing of most viruses, bacteria, and parasites and are capable of inactivating passenger leukocytes in blood products. The use of pathogen inactivation causes a decrease in the parameters of products that can be readily measured in laboratory assays but that do not seem to cause any alteration in hemostatic effect of plasma or platelet transfusions. Effort needs to be made to further develop these technologies so that the negative quality impact is ameliorated without reducing the pathogen inactivation effectiveness.

  9. Nuclear safety policy working group recommendations on nuclear propulsion safety for the space exploration initiative

    NASA Technical Reports Server (NTRS)

    Marshall, Albert C.; Lee, James H.; Mcculloch, William H.; Sawyer, J. Charles, Jr.; Bari, Robert A.; Cullingford, Hatice S.; Hardy, Alva C.; Niederauer, George F.; Remp, Kerry; Rice, John W.

    1993-01-01

    An interagency Nuclear Safety Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative (SEI) nuclear propulsion program. These recommendations, which are contained in this report, should facilitate the implementation of mission planning and conceptual design studies. The NSPWG has recommended a top-level policy to provide the guiding principles for the development and implementation of the SEI nuclear propulsion safety program. In addition, the NSPWG has reviewed safety issues for nuclear propulsion and recommended top-level safety requirements and guidelines to address these issues. These recommendations should be useful for the development of the program's top-level requirements for safety functions (referred to as Safety Functional Requirements). The safety requirements and guidelines address the following topics: reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, safeguards, risk/reliability, operational safety, ground testing, and other considerations.

  10. Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration.

    PubMed

    Ball, Robert; Horne, Dale; Izurieta, Hector; Sutherland, Andrea; Walderhaug, Mark; Hsu, Henry

    2011-05-01

    The public health community faces increasing demands for improving vaccine safety while simultaneously increasing the number of vaccines available to prevent infectious diseases. The passage of the US Food and Drug Administration (FDA) Amendment Act of 2007 formalized the concept of life-cycle management of the risks and benefits of vaccines, from early clinical development through many years of use in large numbers of people. Harnessing scientific and technologic advances is necessary to improve vaccine-safety evaluation. The Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research is working to improve the FDA's ability to monitor vaccine safety by improving statistical, epidemiologic, and risk-assessment methods, gaining access to new sources of data, and exploring the use of genomics data. In this article we describe the current approaches, new resources, and future directions that the FDA is taking to improve the evaluation of vaccine safety.

  11. Hemolysate-mediated platelet aggregation: an additional risk mechanism contributing to thrombosis of continuous flow ventricular assist devices.

    PubMed

    Tran, Phat L; Pietropaolo, Maria-Grazia; Valerio, Lorenzo; Brengle, William; Wong, Raymond K; Kazui, Toshinobu; Khalpey, Zain I; Redaelli, Alberto; Sheriff, Jawaad; Bluestein, Danny; Slepian, Marvin J

    2016-07-01

    Despite the clinical success and growth in the utilization of continuous flow ventricular assist devices (cfVADs) for the treatment of advanced heart failure, hemolysis and thrombosis remain major limitations. Inadequate and/or ineffective anticoagulation regimens, combined with high pump speed and non-physiological flow patterns, can result in hemolysis which often is accompanied by pump thrombosis. An unexpected increase in cfVADs thrombosis was reported by multiple major VAD implanting centers in 2014, highlighting the association of hemolysis and a rise in lactate dehydrogenase (LDH) presaging thrombotic events. It is well established that thrombotic complications arise from the abnormal shear stresses generated by cfVADs. What remains unknown is the link between cfVAD-associated hemolysis and pump thrombosis. Can hemolysis of red blood cells (RBCs) contribute to platelet aggregation, thereby, facilitating prothrombotic complications in cfVADs? Herein, we examine the effect of RBC-hemolysate and selected major constituents, i.e., lactate dehydrogenase (LDH) and plasma free hemoglobin (pHb) on platelet aggregation, utilizing electrical resistance aggregometry. Our hypothesis is that elements of RBCs, released as a result of shear-mediated hemolysis, will contribute to platelet aggregation. We show that RBC hemolysate and pHb, but not LDH, are direct contributors to platelet aggregation, posing an additional risk mechanism for cfVAD thrombosis.

  12. Cumulative effects of bamboo sawdust addition on pyrolysis of sewage sludge: Biochar properties and environmental risk from metals.

    PubMed

    Jin, Junwei; Wang, Minyan; Cao, Yucheng; Wu, Shengchun; Liang, Peng; Li, Yanan; Zhang, Jianyun; Zhang, Jin; Wong, Ming Hung; Shan, Shengdao; Christie, Peter

    2017-03-01

    A novel type of biochar was produced by mixing bamboo sawdust with sewage sludge (1:1, w/w) via a co-pyrolysis process at 400-600°C. Changes in physico-chemical properties and the intrinsic speciation of metals were investigated before and after pyrolysis. Co-pyrolysis resulted in a lower biochar yield but a higher C content in the end product compared with use of sludge alone as the raw material. FT-IR analysis indicates that phosphine derivatives containing PH bonds were formed in the co-pyrolyzed biochars. In addition, co-pyrolysis of sludge with bamboo sawdust transformed the potentially toxic metals in the sludge into more stable fractions, leading to a considerable decrease in their direct toxicity and bioavailability in the co-pyrolyzed biochar. In conclusion, the co-pyrolysis technology provides a feasible method for the safe disposal of metal-contaminated sewage sludge in an attempt to minimize the environmental risk from potentially toxic metals after land application.

  13. [The critical incident reporting system as an instrument of risk management for better patient safety].

    PubMed

    Panzica, M; Krettek, C; Cartes, M

    2011-09-01

    The probability that an inpatient will be harmed by a medical procedure is at least 3% of all patients. As a consequence, hospital risk management has become a central management task in the health care sector. The critical incident reporting system (CIRS) as a voluntary instrument for reporting (near) incidents plays a key role in the implementation of a risk management system. The goal of the CIRS is to register system errors without assigning guilt or meting out punishment and at the same time increasing the number of voluntary reports.

  14. Critical appraisal of the safety and efficacy of insulin detemir in glycemic control and cardiovascular risk management in diabetics

    PubMed Central

    Le Floch, Jean-Pierre

    2010-01-01

    Insulin detemir is an analog of human insulin designed to provide a long duration of basal insulin action. This is achieved by protracted absorption from the injection depot, which results in part from increased self-association of insulin detemir molecules and in part from reversible albumin binding. Subsequent albumin binding in the circulation is thought to buffer changes in the effects at target tissues that could otherwise arise from variability in absorption rate. In consequence, insulin detemir has shown a less variable pharmacodynamic profile than alternative basal insulins; this manifests as more consistent temporal glucose reduction profiles in repeat-clamp studies. In clinical trials, insulin detemir has been characterized by consistent risk reductions in hypoglycemia, as well as reduced weight gain in comparison with other basal insulins. Given some recent associations that have been made in prospective and epidemiologic studies between glucose variability and/or hypoglycemia and increased cardiovascular risk, and the long-known association between excess weight and cardiovascular risk, it is possible that the clinical profile of insulin detemir may carry prognostic value with regard to cardiovascular safety, although this is yet to be substantiated. There have also been some concerns raised recently over the use of insulin analogs and cancer risk, but available clinical data and the receptor interaction profile of insulin detemir suggest no excess in risk in comparison with human insulin therapy. Optimal approaches for the clinical use of insulin detemir have been emerging through an increasing clinical study base, and the analog is becoming established as a potentially valuable therapy option. PMID:21437089

  15. Safety and risk assessment of the genetically modified Lactococci on rats intestinal bacterial flora.

    PubMed

    Lee, Kai-Chien; Liu, Chin-Feng; Lin, Tzu-Hsing; Pan, Tzu-Ming

    2010-08-15

    The interaction between Lactococcus lactis NZ9000/pNZPNK and intestinal microflora was evaluated as a method to assess safety of genetically modified microorganisms (GMMs). L. lactis NZ9000/pNZPNK is one kind of GMM and able to produce the intracellular subtilisin NAT (nattokinase) under induction with nisin. The host strain L. lactis NZ9000 was a generally recognized as safe (GRAS) microorganism. Six groups of Wistar rats were orally administered with L. lactis NZ9000/pNZPNK and L. lactis NZ9000 for 6 weeks. Fecal and cecal contents were collected to determine the number of L. lactis NZ9000, L. lactis NZ9000/pNZPNK, Lactobacillus, coliform bacteria, beneficial bacteria Bifidobacterium and harmful bacteria Clostridium perfringens. The liver, spleen, kidney and blood were evaluated for the bacterial translocation. After 6 weeks consumption with GM and non-GM Lactococcus, no adverse effects were observed on the rat's body weight, hematological or serum biochemical parameters, or intestinal microflora. The bacterial translocation test showed that L. lactis NZ9000/pNZPNK did not translocate to any organ or blood. Bifidobacterium was significantly increased in feces after administration of both Lactococcus strains (L. lactis NZ9000 and L. lactis NZ9000/pNZPNK), while C. perfringens remained undetectable during the experiment. These results suggested that L. lactis NZ9000/pNZPNK could be safe in animal experiments and monitoring of the interaction between test strains and intestinal microflora might be applied as a method for other GMM safety assessments.

  16. Risk of Cardiovascular Hospitalizations from Exposure to Coarse Particulate Matter (PM10) Below the European Union Safety Threshold.

    PubMed

    Vaduganathan, Muthiah; De Palma, Giuseppe; Manerba, Alessandra; Goldoni, Matteo; Triggiani, Marco; Apostoli, Pietro; Dei Cas, Livio; Nodari, Savina

    2016-04-15

    The association between exposure to air pollution and acute cardiovascular (CV) events is well documented; however, limited data are available evaluating the public health safety of various "doses" of particular matter (PM) below currently accepted safety thresholds. We explored the cross-sectional association between PM with aerodynamic diameter <10 μm (PM10) and daily CV hospitalizations in Brescia, Italy, using Poisson regression models adjusted for age, gender, and meteorologic indices. Average daily exposure to PM10 obtained from arithmetic means of air pollution data were captured by 4 selected monitoring stations. PM10 data were expressed as daily means (lag 0-day) or 3-day moving averages (lag 3-day) and categorized according to the European Union daily limit value of 50 μg/m(3). From September 2004 to September 2007, data from 6,000 acute CV admissions to a tertiary referral center were collected. An increase of 1 μg/m(3) PM10 at lag 0-day was independently associated with higher rates of acute hospitalizations for composite CV-related events (relative risk [RR] 1.004, 95% confidence interval [CI] 1.002 to 1.006), acute heart failure (RR 1.004, 95% CI 1.001 to 1.008), acute coronary syndromes (RR 1.002, 95% CI 0.999 to 1.005), malignant ventricular arrhythmias (RR 1.004, 95% CI 0.999 to 1.010), and atrial fibrillation (RR 1.008, 95% CI 1.003 to 1.012). Similar results were obtained using PM10 lag 3-day data. The excess PM10 CV hospitalization risk (by lag 0-day and lag 3-day) did not vary significantly above and below the 50 μg/m(3) safety threshold or by age and gender. In conclusion, increased levels of PM10, even below the current limits set by the European Union, were associated with excess risk for admissions for acute CV events.

  17. Assessment of food safety risks associated with preslaughter activities during the traditional slaughter of goats in Gauteng, South Africa.

    PubMed

    Qekwana, Nenene Daniel; Oguttu, James Wabwire

    2014-06-01

    The South African Department of Agriculture, Forestry and Fisheries estimated in 2012 that there were 2.033 million goats in the country. Of these animals, less than 0.5% are slaughtered at registered abattoirs. Although informal and traditional slaughter of goats for home consumption is permitted under the South African Meat Safety Act 40 of 2000, the responsibility for ensuring that products are safe is left to the traditional or ritual slaughter practitioners. The objective of the present study was to assess whether preslaughter activities associated with traditional or ritual slaughter promote or reduce food-associated risks and to recommend mitigation strategies for potential food safety hazards. Structured interviews were conducted with 105 selected respondents (in and around Tshwane, South Africa) who had been involved in traditional goat slaughter. Approximately 70% of goats slaughtered were obtained from sources that could be traced to ascertain the origin of the goats. None of the respondents were aware of the need for a health declaration for slaughter stock. Some slaughter practitioners (21%) perform prepurchase inspection of stock to ascertain their health status. However, this percentage is very small, and the approach is based on indigenous knowledge systems. The majority of respondents (67.6%) travelled 1 to 11 km to obtain a goat for traditional slaughter. Although approximately 70% of slaughter goats were transported by vehicles, the vehicles used did not meet the legal standard. More than two-thirds of goats were tied to a tree while waiting to be slaughtered, and the rest were held in a kraal. The holding period ranged from 1 to 72 h, but more than 70% of the animals were slaughtered within 36 h. This study revealed that traditional and ritual slaughter involves some preslaughter activities with potential to mitigate the risk of slaughtering animals that are not fit for human consumption. Such activities include prepurchase inspection, obtaining

  18. Light-Weight Radioisotope Heater Unit Final Safety Analysis Report (LWRHU FSAR): Volume 3, Nuclear Risk Analysis Document

    SciTech Connect

    Not Available

    1988-11-30

    The Light-Weight Radioisotope Heater Unit (LWRHU) Final Safety Analysis Report (FSAR), Volume 2, Accident Model Document (AMD) describes potential accident scenarios during the Galileo mission and evaluates the response of the LWRHUs to the associated accident environments. Any resulting source terms, consisting of PuO2 (with Pu-238 the dominant radionuclide), are then described in terms of curies released, particle size distribution, release location, and probabilities. This volume (LWRHU-FSAR, Volume 3, Nuclear Risk Analysis Document (NRAD)) contains the radiological analyses which estimate the consequences of the accident scenarios described in the AMD. It also contains the quantification of mission risks resulting from the LWRHUs based on consideration of all accident scenarios and their probabilities. Estimates of source terms and their characteristics derived in the AMD are used as inputs to the analyses in the NRAD. The Failure Abort Sequence Trees (FASTs) presented in the AMD define events for which source terms occur and quantify them. Based on this information, three types of source term cases (most probable, maximum, and expectation) for each mission phase were developed for use in evaluating the radiological consequences and mission risks. 4 refs., 5 figs., 8 tabs.

  19. Commercial vehicles and road safety in Pakistan: exploring high-risk attributes among drivers and vehicles.

    PubMed

    Mir, Mohammed Umer; Razzak, Junaid Abdul; Ahmad, Khabir

    2013-01-01

    Road traffic injuries are on the rise in developing countries with a disproportionately high number of crashes involving commercial vehicles. Baseline information on risk factors is necessary to develop targeted prevention programmes. A survey of commercial drivers was conducted at the largest bus and truck station in Rawalpindi, Pakistan. Structured interviews elicited information from 857 drivers on their socio-demographics, high-risk driving behaviours, fatigue, use of drugs while driving, vehicle maintenance and health conditions, as well as crash involvement. A binary logistic regression analysis was used to investigate the factors associated with crash involvement in the last five years. Overall, 92 (11.2%) drivers reported having had a road crash in the last 5 years. Factors independently associated with the occurrence of crashes were alcohol use (OR 2.2, 95% CI 1.1-4.4), poor vehicle maintenance (OR 3.4, 95% CI 1.7-7.01) and lack of seat belt use (OR 2.7, 95% CI 1.3-5.6). The high prevalence of high-risk attributes in the study population indicates a great need for targeted risk prevention.

  20. Safety and efficacy of azacitidine in elderly patients with intermediate to high-risk myelodysplastic syndromes

    PubMed Central

    Navada, Shyamala C.; Silverman, Lewis R.

    2016-01-01

    Myelodysplastic syndromes (MDS) represent a clonal hematopoietic stem cell disorder characterized by morphologic features of dyspoiesis, a hyperproliferative bone marrow, and one or more peripheral blood cytopenias. In patients classified according to the Revised International Prognostic Scoring System (R-IPSS) with intermediate or higher-risk disease, there is an increased risk of death due to progressive bone marrow failure or transformation to acute myeloid leukemia (AML). Azacitidine was the first DNA hypomethylating agent approved by the United States (US) Food and Drug Administration (FDA) for the treatment of MDS and the only therapy that has demonstrated a significant survival benefit over conventional care regimens (CCRs) in patients with intermediate or higher-risk disease. Prolonged survival is independent of achieving a complete remission. Azacitidine has been used in older patients with both clinical and hematological improvement as well as an acceptable side effect profile. The most common adverse effect is myelosuppression. These findings support the use of azacitidine as an effective treatment in older patients with higher-risk MDS. PMID:28042456