Science.gov

Sample records for additional safety risks

  1. Additional safety risk to exceptionally approved drugs in Europe?

    PubMed Central

    Arnardottir, Arna H; Haaijer-Ruskamp, Flora M; Straus, Sabine M J; Eichler, Hans-Georg; de Graeff, Pieter A; Mol, Peter G M

    2011-01-01

    AIMS Regulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear ‘unmet medical need’. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability of serious safety issues. METHODS A retrospective cohort study was performed of new drugs approved in Europe between 1999 and 2009. The determinant was EC/CA vs. standard procedure approval. Outcome variables were frequency and timing of a first Direct Healthcare Professional Communication (DHPC). An association between approval procedure and the time from market approval to DHPC was assessed using Kaplan-Meyer survival analysis and Cox-regression to correct for covariates. RESULTS In total 289 new drugs were approved. Forty-six (16.4%) were approved under EC or CA, of which seven received a DHPC (15%). This was similar to the standard approval drugs (243), of which 33 received one or more DHPC (14%, P = 0.77). The probability of acquiring a DHPC for standard approval drugs vs. EC/CA drugs during 11-year follow-up is 22% (95% CI 14%, 29%) and 26% (95% CI 8%, 44%), respectively (log-rank P = 0.726). This difference remained not significant in the Cox-regression model: hazard ratio 0.94 (95% CI 0.40, 2.20). Only drug type was identified as a confounding covariate. CONCLUSION The EC/CA procedure is not associated with a higher probability of DHPCs despite limited clinical development data. These data do not support the view that early drug approval increases the risk of serious safety issues emerging after market approval. PMID:21501215

  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. 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)

  4. 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...

  5. 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

  6. Reducing the risk, managing safety.

    PubMed

    Aldridge, Peter

    2016-02-01

    Fire safety in healthcare premises has always been a challenge to those that discharge this duty. Statutory compliance should be a matter of course, but in an ever increasingly challenged NHS, even this is not a given. While the NHS is driven by managing very complex risk to deliver cutting edge healthcare, providers cannot be risk averse. Which risk, however, takes priority? Here Peter Aldridge, fire and corporate services manager at Leeds Teaching Hospitals NHS Trust, and Secretary to the National Association of Healthcare Fire Officers (NAHFO)--which will this month and next jointly stage fire safety seminars with IHEEM; see page 8--considers the key issues, with input from a fire officer at a leading mental health and community Trust. PMID:27017658

  7. 14 CFR 437.77 - Additional safety requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety... solid propellants. The FAA may also require the permittee to conduct additional analyses of the cause...

  8. Risk and Safety of Probiotics

    PubMed Central

    Doron, Shira; Snydman, David R.

    2015-01-01

    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. PMID:25922398

  9. 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 Section 437.77 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety requirements. The FAA may impose...

  10. 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 Section 437.77 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety requirements. The FAA may impose...

  11. 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 Section 437.77 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional safety requirements. The FAA may impose...

  12. 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.

  13. 47 CFR 36.605 - Calculation of safety net additive.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... exchange carriers shall not receive safety net additive for growth of Telecommunications Plant in Service... longer receive safety net additive after January 1, 2012 unless the carrier's realized total growth in Telecommunications Plant in Service was more than 14 percent during the qualifying period, defined as 2010 or...

  14. 47 CFR 36.605 - Calculation of safety net additive.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... exchange carriers shall not receive safety net additive for growth of Telecommunications Plant in Service... longer receive safety net additive after January 1, 2012 unless the carrier's realized total growth in Telecommunications Plant in Service was more than 14 percent during the qualifying period, defined as 2010 or...

  15. 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 Section 437.77 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.77 Additional...

  16. 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.

  17. 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. PMID:23831014

  18. 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.

  19. 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

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

    PubMed

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

    2016-04-01

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

  1. 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.

  2. Fire Risk Implications in Safety Analysis Reports

    SciTech Connect

    Blanchard, A.

    1999-03-31

    Fire can be a significant risk for facilities that store and handle radiological material. Such events must be evaluated as part of a comprehensive safety analysis. SRS has been developing methods to evaluate radiological fire risk in such facilities. These methods combined with the analysis techniques proposed by DOE-STD-3009-94 have provided a better understanding of how fire risks in nuclear facilities should be managed. To ensure that these new insights are properly disseminated the DOE Savannah River Office and the Defense Nuclear Facility Safety Board (DNFSB) requested Westinghouse Savannah River Company (WSRC) prepare this paper.

  3. 49 CFR 192.171 - Compressor stations: Additional safety equipment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... event of inadequate cooling or lubrication of the unit. (d) Each compressor station gas engine that... compressor station must have vent slots or holes in the baffles of each compartment to prevent gas from being... 49 Transportation 3 2010-10-01 2010-10-01 false Compressor stations: Additional safety...

  4. 49 CFR 192.171 - Compressor stations: Additional safety equipment.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... event of inadequate cooling or lubrication of the unit. (d) Each compressor station gas engine that... compressor station must have vent slots or holes in the baffles of each compartment to prevent gas from being... 49 Transportation 3 2011-10-01 2011-10-01 false Compressor stations: Additional safety...

  5. 47 CFR 36.605 - Calculation of safety net additive.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... from the difference between the uncapped expense adjustment for the study area in the qualifying year... receive safety net additive support as calculated in paragraph (b) of this section, if in any study area, the rural incumbent local exchange carrier realizes growth in end of period Telecommunications...

  6. Risk based limits for Operational Safety Requirements

    SciTech Connect

    Cappucci, A.J. Jr.

    1993-01-18

    OSR limits are designed to protect the assumptions made in the facility safety analysis in order to preserve the safety envelope during facility operation. Normally, limits are set based on ``worst case conditions`` without regard to the likelihood (frequency) of a credible event occurring. In special cases where the accident analyses are based on ``time at risk`` arguments, it may be desirable to control the time at which the facility is at risk. A methodology has been developed to use OSR limits to control the source terms and the times these source terms would be available, thus controlling the acceptable risk to a nuclear process facility. The methodology defines a new term ``gram-days``. This term represents the area under a source term (inventory) vs time curve which represents the risk to the facility. Using the concept of gram-days (normalized to one year) allows the use of an accounting scheme to control the risk under the inventory vs time curve. The methodology results in at least three OSR limits: (1) control of the maximum inventory or source term, (2) control of the maximum gram-days for the period based on a source term weighted average, and (3) control of the maximum gram-days at the individual source term levels. Basing OSR limits on risk based safety analysis is feasible, and a basis for development of risk based limits is defensible. However, monitoring inventories and the frequencies required to maintain facility operation within the safety envelope may be complex and time consuming.

  7. 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.

  8. 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.

  9. Perception of risk from automobile safety defects.

    PubMed

    Slovic, P; MacGregor, D; Kraus, N N

    1987-10-01

    Descriptions of safety engineering defects of the kind that compel automobile manufacturers to initiate a recall campaign were evaluated by individuals on a set of risk characteristic scales that included overall vehicle riskiness, manufacturer's ability to anticipate the defect, importance for vehicle operation, severity of consequences and likelihood of compliance with a recall notice. A factor analysis of the risk characteristics indicated that judgments could be summarized in terms of two composite scales, one representing the uncontrollability of the damage the safety defect might cause and the other representing the foreseeability of the defect by the manufacturer. Motor vehicle defects were found to be highly diverse in terms of the perceived qualities of their risks. Location of individual defects within the factor space was closely associated with perceived riskiness, perceived likelihood of purchasing another car from the same manufacturer, perceived likelihood of compliance with a recall notice, and actual compliance rates. PMID:3675807

  10. 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

  11. 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.

  12. 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.

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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.

  19. 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.

  20. Safety evaluation of substances consumed as technical ingredients (food additives).

    PubMed

    Poulsen, E

    1991-01-01

    The different types of acceptable daily intakes (ADIs) are described as used by the FAO/WHO Expert Committee on Food Additives (JECFA) and the EEC Scientific Committee for Food (SCF). The allocation is discussed of a full ADI or a temporary ADI, and examples are given for the establishment (or withdrawal) of these ADIs. The flavours cinnamyl anthranillate and the solvent 2-nitropropane (both withdrawn), the sweeteners cyclamate and saccharin and the antioxidant BHA (all three changed) but not abolished. For BHA and saccharin the ADI was retained by both committees in spite of some evidence of carcinogenicity to experimental animals. ADI--'not specified' is specially discussed and it is recommended that numerical ADIs are used whenever possible. With an ADI--'not specified' it should be stated which use (and intake) levels are toxicologically acceptable. Some compounds evaluated by the two committees are discussed, e.g. the colours: Allura red AC, erythrosine, canthaxanthin and the caramels; three anti-oxidants: BHA, BHT and the gallates; the sweeteners: polyols, aspartame, saccharin and cyclamates. Four recommendations are made: (1) a numerical basis be given for the levels allocated an ADI--'not specified' or 'acceptable'; (2) lowering of the conventional safety factor be considered when the effects found are trivial--higher safety factors be considered when the toxic effects are serious or even irreversible; (3) ADIs should, whenever possible, be based on a combination of human and animal data; (4) ADIs might be allocated to compounds indicating animal carcinogenicity, if the compound is non-genotoxic, the mechanism clearly secondary and/or species-specific.

  1. 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.

  2. 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. PMID:21534979

  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. 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. PMID:26408141

  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. Excitotoxic food additives--relevance of animal studies to human safety.

    PubMed

    Olney, J W

    1984-01-01

    Evidence is reviewed supporting the view that excitotoxic food additives pose a significant hazard to the developing nervous system of young children. The following points are stressed: (1) although blood-brain barriers protect most central neurons from excitotoxins, certain brain regions lack such protection (a characteristic common to all vertebrate species); (2) regardless of species, it requires only a transient increase in blood excitotoxin levels for neurons in unprotected brain regions to be "silently" destroyed; (3) humans may be at particularly high risk for this kind of brain damage, since ingestion of a given amount of excitotoxin causes much higher blood excitotoxin levels in humans than in other species; (4) in addition to the heightened risk on a species basis, risk may be further increased for certain consumer sub-populations due to youth, disease or genetic factors; (5) despite these reasons for maintaining a wide margin of safety in the use of excitotoxins in foods, no safety margin is currently being observed, i.e., a comparative evaluation of animal (extensive) and human (limited) data supports the conclusion that excitotoxins, as used in foods today, may produce blood elevations high enough to cause damage to the nervous system of young children, damage which is not detectable at the time of occurrence but which may give rise to subtle disturbances in neuroendocrine function in adolescence and/or adulthood.

  9. 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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Criteria for evaluating the safety of color additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.42 Criteria for evaluating the safety of...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Criteria for evaluating the safety of color additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.42 Criteria for evaluating the safety of...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Criteria for evaluating the safety of color additives. 70.42 Section 70.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Safety Evaluation § 70.42 Criteria for evaluating the safety of...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive Safety § 570.20 General principles for evaluating the safety of food additives. (a) In reaching...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive Safety § 570.20 General principles for evaluating the safety of food additives. (a) In reaching...

  17. 21 CFR 70.42 - Criteria for evaluating the safety of color additives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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...

  18. 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.

  19. Failure rate data for fusion safety and risk assessment

    SciTech Connect

    Cadwallader, L.C.

    1993-01-01

    The Fusion Safety Program (FSP) at the Idaho National Engineering Laboratory (INEL) conducts safety research in materials, chemical reactions, safety analysis, risk assessment, and in component research and development to support existing magnetic fusion experiments and also to promote safety in the design of future experiments. One of the areas of safety research is applying probabilistic risk assessment (PRA) methods to fusion experiments. To apply PRA, we need a fusion-relevant radiological dose code and a component failure rate data base. This paper describes the FSP effort to develop a failure rate data base for fusion-specific components.

  20. Failure rate data for fusion safety and risk assessment

    SciTech Connect

    Cadwallader, L.C.

    1993-04-01

    The Fusion Safety Program (FSP) at the Idaho National Engineering Laboratory (INEL) conducts safety research in materials, chemical reactions, safety analysis, risk assessment, and in component research and development to support existing magnetic fusion experiments and also to promote safety in the design of future experiments. One of the areas of safety research is applying probabilistic risk assessment (PRA) methods to fusion experiments. To apply PRA, we need a fusion-relevant radiological dose code and a component failure rate data base. This paper describes the FSP effort to develop a failure rate data base for fusion-specific components.

  1. Behavior-Based Safety and Occupational Risk Management

    ERIC Educational Resources Information Center

    Geller, E. Scott

    2005-01-01

    The behavior-based approach to managing occupational risk and preventing workplace injuries is reviewed. Unlike the typical top-down control approach to industrial safety, behavior-based safety (BBS) provides tools and procedures workers can use to take personal control of occupational risks. Strategies the author and his colleagues have been…

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ....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 under... Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT...

  3. 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.

  4. "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. PMID:25951078

  5. "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.

  6. 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...

  7. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the safety of a food additive whether he believes the experiments planned will yield data adequate for... 21 Food and Drugs 3 2011-04-01 2011-04-01 false General principles for evaluating the safety of food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  8. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the safety of a food additive whether he believes the experiments planned will yield data adequate for... 21 Food and Drugs 3 2010-04-01 2009-04-01 true General principles for evaluating the safety of food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  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. PMID:26775077

  10. 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.

  11. The safety and regulatory status of food, drug and cosmetics colour additives exempt from certification.

    PubMed

    Hallagan, J B; Allen, D C; Borzelleca, J F

    1995-06-01

    Colour additives exempt from certification (also known as 'natural colour additives') are commonly used in the United States to colour foods, drugs and cosmetics. The US Food and Drug Administration established regulations governing the use of these colour additives, and the labelling of the products that contain them. The safety of these colour additives has been demonstrated by safety testing programs that have yielded a significant amount of toxicology data, and also by a long and well documented history of safe use in the United States and elsewhere. In this report we review the data supporting the safety of the colour additives that are exempt from certification and approved for use in the USA, and conclude that the safety of these colour additives is well supported by the available data. Relevant aspects of the regulation of these colour additives are also described. PMID:7797179

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

    MedlinePlus

    ... Guideline for PATIENTS and their FAMILIES WOMEN WITH EPILEPSY: DRUG RISKS AND SAFETY DURING PREGNANCY This fact ... you understand which drugs are safest for treating epilepsy during pregnancy. It also gives information on how ...

  13. 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.

  14. A risk-informed approach to safety margins analysis

    SciTech Connect

    Curtis Smith; Diego Mandelli

    2013-07-01

    The Risk Informed Safety Margins Characterization (RISMC) Pathway is a systematic approach developed to characterize and quantify safety margins of nuclear power plant structures, systems and components. The model has been tested on the Advanced Test Reactor (ATR) at Idaho National Lab.

  15. TWRS safety and technical integration risk management plan

    SciTech Connect

    Fordham, R.A.

    1996-03-12

    The objectives of the Tank Waste Remediation System (TWRS) Safety and Technical Integration (STI) programmatic risk management program are to assess, analyze, and handle risks associated with TWRS STI responsibilities and to communicate information about the actions being taken and the results to enable decision making. The objective of this TWRS STI Risk Management Plan is to communicate a consistent approach to risk management that will be used by the organization.

  16. Broadening our expectations for viral safety risk mitigation.

    PubMed

    Kljavin, Ivar J

    2011-01-01

    CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) The production of biotechnology products using mammalian cell lines offers an inherent risk of viral contamination because of the scale of the process and the complexity of the materials employed. The testing of production cell lines, raw materials, and test execution at appropriate stages of production all combined with viral inactivation or removal strategies ensures that an infectious agent is absent from the purified final product. Perhaps because of these efforts, biotechnology products have not been linked to a negative clinical consequence. However, manufacturing viral contaminations still do occur and may have a great potential negative impact to our patients by disrupting the drug product supply chain. In this paper, additional end-to-end complementary viral safety program considerations are suggested beyond the traditional viral testing and inactivation/removal strategies. These additional points of consideration should be thought of as augmenting the above approaches to further provide a reasonable measure of mitigating the risk of viral contaminations within the biopharmaceutical manufacturing facility. The scope of this paper is on biologics produced in mammalian cells with an emphasis on viral contaminations involving Chinese hamster ovary cell production, although for the examples given as lessons learned with previous industry contaminations, vaccine production issues have been included as a general reference.

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

    EPA Science Inventory

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

  18. 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...

  19. 5 CFR 5201.105 - Additional rules for Mine Safety and Health Administration employees.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Health Administration employees. 5201.105 Section 5201.105 Administrative Personnel DEPARTMENT OF LABOR... for Mine Safety and Health Administration employees. The rules in this section apply to employees of the Mine Safety and Health Administration (MSHA) and are in addition to §§ 5201.101, 5201.102,...

  20. 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.

  1. 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.

  2. Quantitative risk assessment—a place in laser safety?

    NASA Astrophysics Data System (ADS)

    Gardner, R.; Smith, P. A.

    1995-02-01

    Since 1976 the United Kingdom Ministry of Defence (MOD) has used quantitative risk assessment (QRA) as a tool to manage the risks involved with airborne laser rangefinders and target designators. It has done this against the background of the Health and Safety at Work Act (1974) and the regulations made under this act. These apply equally to MOD and civilian employers. More recently there has been legislation requiring that all risks should be assessed. The MOD's use of QRA in laser safety is cited as an example of a useful tool, the use of which should not be precluded by further legislation.

  3. [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.

  4. 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.

  5. 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.

  6. Combining risk difference and risk ratio in noninferiority trials of safety.

    PubMed

    Broglio, Kristine R; Connor, Jason T; Berry, Scott M

    2013-01-01

    Prior to marketing, the long-term safety profile of a new therapy is often uncertain. One recommendation for premarket safety studies is to compare the new therapy to an appropriate control to determine whether the 95% confidence interval of the risk ratio is entirely less than a prespecified threshold (e.g., 1.8). The restriction to the risk ratio, however, has consequences that may not be intended. Risk difference may be a more appropriate measure of risk in this setting when event rates are very low. We propose using a suitable combination of risk ratio and risk difference in demonstrating noninferiority. PMID:23331235

  7. 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.

  8. 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.

  9. 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.

  10. 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. PMID:26614817

  11. 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

  12. 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.

  13. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false General principles for evaluating the safety of food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food...

  14. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false General principles for evaluating the safety of food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food...

  15. 5 CFR 8301.104 - Additional rules for employees of the Food Safety and Inspection Service.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Additional rules for employees of the Food Safety and Inspection Service. 8301.104 Section 8301.104 Administrative Personnel DEPARTMENT OF AGRICULTURE SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE DEPARTMENT OF AGRICULTURE § 8301.104 Additional rules for employees of...

  16. 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

  17. 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.

  18. Practice-specific risk perceptions and self-reported food safety practices.

    PubMed

    Levy, Alan S; Choinière, Conrad J; Fein, Sara B

    2008-06-01

    The relationship between risk perception and risk avoidance is typically analyzed using self-reported measures. However, in domains such as driving or food handling, the validity of responses about usual behavior is threatened because people think about the situations in which they are self-aware, such as when they encounter a hazard. Indeed, researchers have often noted a divergence between what people say about their behavior and how they actually behave. Thus, in order to draw conclusions about risk perceptions and risk avoidance from survey data, it is important to identify particular cognitive elements, such as those measured by questions about risk and safety knowledge, risk perceptions, or information search behavior, which may be effective antecedents of self-reported safety behavior. It is also important to identify and correct for potential sources of bias that may exist in the data. The authors analyze the Food and Drug Administration's 1998 Food Safety Survey to determine whether there are consistent cognitive antecedents for three types of safe food practices: preparation, eating, and cooling of foods. An assessment of measurement biases shows that endogeneity of food choices affects reports of food preparation. In addition, response bias affects reports of cooling practices as evidenced by its relation to knowledge and information search, a pattern of cognitive effects unique to cooling practices. After correcting for these biases, results show that practice-specific risk perceptions are the primary cognitive antecedents of safe food behavior, which has implications for the design of effective education messages about food safety.

  19. 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…

  20. 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…

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. [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.

  6. [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

  7. Safe patient care - safety culture and risk management in otorhinolaryngology.

    PubMed

    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 trainings into their

  8. Gun safety management with patients at risk for suicide.

    PubMed

    Simon, Robert I

    2007-10-01

    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 responsible for removing guns from the home. A call-back to the clinician from the designated person is required confirming that guns have been removed and secured according to plan. The principle of gun safety management applies to outpatients, inpatients, and emergency patients, although its implementation varies according to the clinical setting.

  9. 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.

  10. 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.

  11. 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. PMID:24974915

  12. Extracting additional risk managers information from a risk assessment of Listeria monocytogenes in deli meats.

    PubMed

    Pérez-Rodríguez, F; van Asselt, E D; Garcia-Gimeno, R M; Zurera, G; Zwietering, M H

    2007-05-01

    The risk assessment study of Listeria monocytogenes in ready-to-eat foods conducted by the U.S. Food and Drug Administration is an example of an extensive quantitative microbiological risk assessment that could be used by risk analysts and other scientists to obtain information and by managers and stakeholders to make decisions on food safety management. The present study was conducted to investigate how detailed sensitivity analysis can be used by assessors to extract more information on risk factors and how results can be communicated to managers and stakeholders in an understandable way. The extended sensitivity analysis revealed that the extremes at the right side of the dose distribution (at consumption, 9 to 11.5 log CFU per serving) were responsible for most of the cases of listeriosis simulated. For concentration at retail, values below the detection limit of 0.04 CFU/g and the often used limit for L. monocytogenes of 100 CFU/g (also at retail) were associated with a high number of annual cases of listeriosis (about 29 and 82%, respectively). This association can be explained by growth of L. monocytogenes at both average and extreme values of temperature and time, indicating that a wide distribution can lead to high risk levels. Another finding is the importance of the maximal population density (i.e., the maximum concentration of L. monocytogenes assumed at a certain temperature) for accurately estimating the risk of infection by opportunistic pathogens such as L. monocytogenes. According to the obtained results, mainly concentrations corresponding to the highest maximal population densities caused risk in the simulation. However, sensitivity analysis applied to the uncertainty parameters revealed that prevalence at retail was the most important source of uncertainty in the model.

  13. [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.

  14. 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.

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of Sciences-National Research Council. A petition will not be denied, however, by reason of the... of Sciences-National Research Council if, from available evidence, the Commissioner finds that the... data adequate for an evaluation of the safety of the additive....

  16. 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...

  17. 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...

  18. 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

  19. 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.

  20. Pesticide Exposure, Safety Issues, and Risk Assessment Indicators

    PubMed Central

    Damalas, Christos A.; Eleftherohorinos, Ilias G.

    2011-01-01

    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. PMID:21655127

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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).

  7. 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.

  8. 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. PMID:11332543

  9. Pharmaceutical company perspectives on current safety risk communications in Japan.

    PubMed

    Urushihara, Hisashi; Kobashi, Gen; Masuda, Hideaki; Taneichi, Setsuko; Yamamoto, Michiko; Nakayama, Takeo; Kawakami, Koji; Matsuda, Tsutomu; Ohta, Kaori; Sugimori, Hiroki

    2014-01-01

    In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, the Government of Japan established a responding inspection committee in 2008 to make recommendations for the restructuring of drug regulatory administration. The final report was issued in 2010. One agenda item of this restructuring was the improvement of drug-related safety risk communications. Our research group on drug safety risk communications, which is funded by the Government of Japan, surveyed pharmaceutical companies regarding their perspective on current risk communications. The survey was conducted using an anonymous questionnaire developed for this study which included the three operational domains of targets, contents, and measures of drug risk communication. Fifty-two of the 74 member companies of the Post-marketing Surveillance Subcommittee of the Japan Pharmaceutical Manufacturer's Association participated, and this response rate of more than 70% was considered sufficient to ensure the external validity of the survey results. Results showed that the most highly prioritized aspect of risk messaging was the strength of evidence, and that outcome evaluation of risk communication gained recognition. Further, while physicians and pharmacists were the most prioritized communication targets, pharmacovigilance departments devoted the most resources to regulators, at more than 30%. The Internet was recognized as a useful public source of risk information, whereas Drug Guides for Patients delivered on the web were considered under-recognized. Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted. PMID:24555168

  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. 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...

  12. 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

  13. 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…

  14. [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

  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. Safety risks for animals fed genetic modified (GM) plants.

    PubMed

    Bertoni, G; Marsan, P Ajmone

    2005-08-01

    GM plants are widely grown all over the world, but many constraints still tend to discourage their use in Europe. Potential risks suggested to be associated with the use of GM are unexpected gene effects, allergenic potential, antibiotic resistance, gene flow. GM feed safety is presently evaluated by adopting the concept of GM substantial equivalence, by comparison with non-GM isogenic crops. Comparison is based on a wide spectrum of chemical components and on livestock performance. From the available experimental data, currently utilized GM plants appear safe and show no effects on animals or animal products. Hence, although they potentially exist, safety risks caused by the use of GM plants appear to be so low as be negligible in comparison with their potential benefits, if appropriately designed. GM plants represent a valuable option for future breeding, to increase yield while reducing the use of pesticides, improve plant adaptation to unfavourable environments, and produce better quality crops, also from a nutritional point of view. Nonetheless, GM crops are novel foods and the assessment of their safety using a scientific sound approach seems essential to protect the environment, as well as the health of humans and livestock.

  17. Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment.

    PubMed

    Tobin, Thomas J; Tobin, Mary L

    2015-01-01

    Smoking cessation remains a positive therapeutic goal and should be encouraged for the millions of individuals who continue to smoke and struggle to quit. While psychiatric nurses should encourage patients to start or continue smoking cessation therapies, they must be aware of the additional safety concerns relating to the use of varenicline (Chantix). Research published subsequent to the last clinical update in this journal (Tobin, 2007 ) has prompted additional warnings from the Food and Drug Administration concerning varenicline for smoking cessation therapy. In particular, clinicians need to be aware of increased concerns about varenicline's association with neuropsychiatric side effects, seizures, and alcohol interactions. PMID:26514264

  18. 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.

  19. 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. PMID:27341034

  20. 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

  1. Gun safety management with patients at risk for suicide.

    PubMed

    Simon, Robert I

    2007-10-01

    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 responsible for removing guns from the home. A call-back to the clinician from the designated person is required confirming that guns have been removed and secured according to plan. The principle of gun safety management applies to outpatients, inpatients, and emergency patients, although its implementation varies according to the clinical setting. PMID:17967118

  2. 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.

  3. 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. PMID:22953160

  4. 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.

  5. 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.

  6. 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.

  7. The patient safety screener: validation of a brief suicide risk screener for emergency department settings.

    PubMed

    Boudreaux, Edwin D; Jaques, Michelle L; Brady, Kaitlyn M; Matson, Adam; Allen, Michael H

    2015-01-01

    This study evaluated the concurrent validity of a brief suicide risk screener for adults in the emergency department (ED). Two versions of the verbally administered Patient Safety Screener (2-item, 3-item) were compared to a reference standard, the Beck Scale for Suicide Ideation (BSSI). Analyses included measures of agreement (Kappa). Agreement between the Patient Safety Screener-2 and -3 and the BSSI (n = 951) was almost perfect for overall positive screening (K = 0.94-0.95) and past suicide attempts (K = 0.97-0.98). Agreement on ideation ranged from fair (K = 0.34) for the 2-item version to good (K = 0.61) for the 3-item version. The Patient Safety Screener's concurrent validity with the BSSI ranged from fair to almost perfect and warrants additional study. PMID:25826715

  8. 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.

  9. Safety and risk assessment of ceramide 3 in cosmetic products.

    PubMed

    Choi, Seul Min; Lee, Byung-Mu

    2015-10-01

    Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3. PMID:26206496

  10. Safety and risk assessment of ceramide 3 in cosmetic products.

    PubMed

    Choi, Seul Min; Lee, Byung-Mu

    2015-10-01

    Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3.

  11. 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

  12. 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. PMID:26557703

  13. 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.

  14. Pesticide safety among farmworkers: perceived risk and perceived control as factors reflecting environmental justice.

    PubMed Central

    Arcury, Thomas A; Quandt, Sara A; Russell, Gregory B

    2002-01-01

    Farmworkers in the United States constitute a population at risk for serious environmental and occupational illness and injury as well as health disparities typically associated with poverty. Pesticides are a major source of occupational injury and illness to which farmworkers are exposed. Efforts to provide safety training for farmworkers have not been fully evaluated. Based on the Health Belief Model, this analysis examines how safety information affects perceived pesticide safety risk and control among farmworkers and how perceived risk and control affect farmworker knowledge and safety behavior. Data are based on interviews conducted in 1999 with 293 farmworkers in eastern North Carolina as part of the Preventing Agricultural Chemical Exposure in North Carolina Farmworkers' Project. Perceived pesticide risk and perceived pesticide control scales were developed from interview items. Analysis of the items and scales showed that farmworkers had fairly high levels of perceived risk from pesticides and perceived control of pesticide safety. Receiving information about pesticide safety (e.g., warning signs) reduced perceived risk and increased perceived control. Pesticide exposure knowledge was strongly related to perceived risk. However, perceived risk had a limited relationship to safety knowledge and was not related to safety behavior. Perceived control was not related to pesticide exposure knowledge, but was strongly related to safety knowledge and safety behavior. A key tenet of environmental justice is that communities must have control over their environment. These results argue that for pesticide safety education to be effective, it must address issues of farmworker control in implementing workplace pesticide safety. PMID:11929733

  15. Modeling for regulatory purposes (risk and safety assessment).

    PubMed

    El-Masri, Hisham

    2013-01-01

    Chemicals provide many key building blocks that are converted into end-use products or used in industrial processes to make products that benefit society. Ensuring the safety of chemicals and their associated products is a key regulatory mission. Current processes and procedures for evaluating and assessing the impact of chemicals on human health, wildlife, and the environment were, in general, designed decades ago. These procedures depend on generation of relevant scientific knowledge in the laboratory and interpretation of this knowledge to refine our understanding of the related potential health risks. In practice, this often means that estimates of dose-response and time-course behaviors for apical toxic effects are needed as a function of relevant levels of exposure. In many situations, these experimentally determined functions are constructed using relatively high doses in experimental animals. In absence of experimental data, the application of computational modeling is necessary to extrapolate risk or safety guidance values for human exposures at low but environmentally relevant levels.

  16. [Sleepiness, safety on the road and management of risk].

    PubMed

    Garbarino, S; Traversa, F; Spigno, F

    2012-01-01

    Public health studies have shown that sleepiness at the wheel and other risks associated with sleep are responsible for 5% to 30% of road accidents, depending on the type of driver and/or road. In industrialized countries one-fifth of all traffic accidents can be ascribed to sleepiness behind the wheel. Sleep disorders and various common acute and chronic medical conditions together with lifestyles, extended work hours and prolonged wakefulness directly or indirectly affect the quality and quantity of one's sleep increasing the number of workers with sleep debt and staggered hours. These conditions may increase the risk of road accidents. Strategies to reduce this risk of both commercial and non-commercial drivers related to sleepiness include reliable diagnosis and treatment of sleep disorders, management of chronobiological conflicts, adequate catch-up sleep, and countermeasures against sleepiness at the wheel. Road transport safety requires the adoption of occupational health measures, including risk assessment, health education, technical-environmental prevention and health surveillance. PMID:23405652

  17. Bacterial-based additives for the production of artificial snow: what are the risks to human health?

    PubMed

    Lagriffoul, A; Boudenne, J L; Absi, R; Ballet, J J; Berjeaud, J M; Chevalier, S; Creppy, E E; Gilli, E; Gadonna, J P; Gadonna-Widehem, P; Morris, C E; Zini, S

    2010-03-01

    For around two decades, artificial snow has been used by numerous winter sports resorts to ensure good snow cover at low altitude areas or more generally, to lengthen the skiing season. Biological additives derived from certain bacteria are regularly used to make artificial snow. However, the use of these additives has raised doubts concerning the potential impact on human health and the environment. In this context, the French health authorities have requested the French Agency for Environmental and Occupational Health Safety (Afsset) to assess the health risks resulting from the use of such additives. The health risk assessment was based on a review of the scientific literature, supplemented by professional consultations and expertise. Biological or chemical hazards from additives derived from the ice nucleation active bacterium Pseudomonas syringae were characterised. Potential health hazards to humans were considered in terms of infectious, toxic and allergenic capacities with respect to human populations liable to be exposed and the means of possible exposure. Taking into account these data, a qualitative risk assessment was carried out, according to four exposure scenarios, involving the different populations exposed, and the conditions and routes of exposure. It was concluded that certain health risks can exist for specific categories of professional workers (mainly snowmakers during additive mixing and dilution tank cleaning steps, with risks estimated to be negligible to low if workers comply with safety precautions). P. syringae does not present any pathogenic capacity to humans and that the level of its endotoxins found in artificial snow do not represent a danger beyond that of exposure to P. syringae endotoxins naturally present in snow. However, the risk of possible allergy in some particularly sensitive individuals cannot be excluded. Another important conclusion of this study concerns use of poor microbiological water quality to make artificial snow.

  18. Bacterial-based additives for the production of artificial snow: what are the risks to human health?

    PubMed

    Lagriffoul, A; Boudenne, J L; Absi, R; Ballet, J J; Berjeaud, J M; Chevalier, S; Creppy, E E; Gilli, E; Gadonna, J P; Gadonna-Widehem, P; Morris, C E; Zini, S

    2010-03-01

    For around two decades, artificial snow has been used by numerous winter sports resorts to ensure good snow cover at low altitude areas or more generally, to lengthen the skiing season. Biological additives derived from certain bacteria are regularly used to make artificial snow. However, the use of these additives has raised doubts concerning the potential impact on human health and the environment. In this context, the French health authorities have requested the French Agency for Environmental and Occupational Health Safety (Afsset) to assess the health risks resulting from the use of such additives. The health risk assessment was based on a review of the scientific literature, supplemented by professional consultations and expertise. Biological or chemical hazards from additives derived from the ice nucleation active bacterium Pseudomonas syringae were characterised. Potential health hazards to humans were considered in terms of infectious, toxic and allergenic capacities with respect to human populations liable to be exposed and the means of possible exposure. Taking into account these data, a qualitative risk assessment was carried out, according to four exposure scenarios, involving the different populations exposed, and the conditions and routes of exposure. It was concluded that certain health risks can exist for specific categories of professional workers (mainly snowmakers during additive mixing and dilution tank cleaning steps, with risks estimated to be negligible to low if workers comply with safety precautions). P. syringae does not present any pathogenic capacity to humans and that the level of its endotoxins found in artificial snow do not represent a danger beyond that of exposure to P. syringae endotoxins naturally present in snow. However, the risk of possible allergy in some particularly sensitive individuals cannot be excluded. Another important conclusion of this study concerns use of poor microbiological water quality to make artificial snow

  19. 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.

  20. 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…

  1. 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...

  2. 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.…

  3. 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.

  4. 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.

  5. 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. PMID:25300041

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. Risk-Informed Safety Margin Characterization Methods Development Work

    SciTech Connect

    Smith, Curtis L; Ma, Zhegang; Tom Riley; 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.

  11. Evaluating life-safety risk of fieldwork at New Zealand's active volcanoes

    NASA Astrophysics Data System (ADS)

    Deligne, Natalia; Jolly, Gill; Taig, Tony; Webb, Terry

    2014-05-01

    Volcano observatories monitor active or potentially active volcanoes. Although the number and scope of remote monitoring instruments and methods continues to grow, in-person field data collection is still required for comprehensive monitoring. Fieldwork anywhere, and especially in mountainous areas, contains an element of risk. However, on volcanoes with signs of unrest, there is an additional risk of volcanic activity escalating while on site, with potentially lethal consequences. As an employer, a volcano observatory is morally and sometimes legally obligated to take reasonable measures to ensure staff safety and to minimise occupational risk. Here we present how GNS Science evaluates life-safety risk for volcanologists engaged in fieldwork on New Zealand volcanoes with signs of volcanic unrest. Our method includes several key elements: (1) an expert elicitation for how likely an eruption is within a given time frame, (2) quantification of, based on historical data when possible, given a small, moderate, or large eruption, the likelihood of exposure to near-vent processes, ballistics, or surge at various distances from the vent, and (3) estimate of fatality rate given exposure to these volcanic hazards. The final product quantifies hourly fatality risk at various distances from a volcanic vent; various thresholds of risk (for example, zones with more than 10-5 hourly fatality risk) trigger different levels of required approval to undertake work. Although an element of risk will always be present when conducting fieldwork on potentially active volcanoes, this is a first step towards providing objective guidance for go/no go decisions for volcanic monitoring.

  12. 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.

  13. 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.

  14. Risks worth Taking: Safety Agreements among Discordant Gay Couples

    PubMed Central

    Beougher, Sean C.; Chakravarty, Deepalika; Garcia, Carla C.; Darbes, Lynae A.; Neilands, Torsten B.; Hoff, Colleen C.

    2012-01-01

    As HIV research and prevention efforts increasingly target gay men in relationships, situational factors such as couple serostatus and agreements about sex become central to examinations of risk. Discordant gay couples are of particular interest because the risk of HIV infection is seemingly near-at-hand. Yet little is known about their sexual behaviors, agreements about sex, and safer sex efforts. The present study utilized longitudinal semi-structured, qualitative interviews to explore these issues among 12 discordant couples. Findings show that nearly every couple had agreements about reducing the likelihood of HIV transmission from one partner to the other. Negotiating these agreements involved establishing a level of acceptable risk, determining condom use, and employing other risk-reduction techniques, such as seropositioning and withdrawal. For half of the couples, these agreements did not involve using condoms; only two couples reported consistent condom use. Despite forgoing condoms, however, none reported seroconversion over the course of data collection. Additional issues are raised where long-term HIV prevention is concerned. Future prevention efforts with discordant couples should work with, rather than fight against, the couple’s decision to use condoms and endeavor to complement and accentuate their other safer sex efforts. PMID:22292838

  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. Supplemental studies for cardiovascular risk assessment in safety pharmacology: a critical overview.

    PubMed

    Picard, Sandra; Goineau, Sonia; Guillaume, Philippe; Henry, Joël; Hanouz, Jean-Luc; Rouet, René

    2011-12-01

    Safety Pharmacology studies for the cardiovascular risk assessment, as described in the ICH S7A and S7B guidelines, appear as being far from sufficient. The fact that almost all medicines withdrawn from the market because of life-threatening tachyarrhythmias (torsades-de-pointes) were shown as hERG blockers and QT interval delayers led the authorities to focus mainly on these markers. However, other surrogate biomarkers, e.g., TRIaD (triangulation, reverse-use-dependence, instability and dispersion of ventricular repolarization), have been identified to more accurately estimate the drug-related torsadogenic risk. In addition, more attention should be paid to other arrhythmias, not related to long QT and nevertheless severe and/or not self-extinguishing, e.g., atrial or ventricular fibrillation, resulting from altered electrical conduction or heterogeneous shortening of cardiac repolarization. Moreover, despite numerous clinical cases of drug-induced pulmonary hypertension, orthostatic hypotension, or heart valvular failure, few safety investigations are still conducted on drug interaction with cardiac and regional hemodynamics other than changes in aortic blood pressure evaluated in conscious large animals during the core battery mandatory studies. This critical review aims at discussing the usefulness, relevance, advantages, and limitations of some preclinical in vivo, in vitro, and in silico models, with high predictive values and currently used in supplemental safety studies.

  17. 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.

  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. 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.

  20. 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....

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

    PubMed

    Ezaki, Asami; Hori, Akiko

    2013-03-01

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

  2. Indicators of emerging hazards and risks to food safety.

    PubMed

    Kleter, Gijs A; Marvin, Hans J P

    2009-05-01

    There is a widely felt need to develop methods for the early identification of emerging hazards to food safety with the aim of preventing these hazards from becoming real risks and causing incidents. This paper reviews various activities and previous reports that describe methods to select indicators that can be used for the purpose of early identification of hazards. These indicators have been divided over three different environments, including (i) the environment surrounding food production, (ii) the food production chain from farm to fork, and (iii) consumers. Changes in these indicators are signals that may require follow-up action. Besides indicators that are linked to specific kinds of hazards, the indicators used for vulnerability assessment can help identifying weak spots in the food production system that are sensitive to a broader range of hazards. Based on the various indicators for emerging hazards that have thus been identified in literature, a set of generic indicators is provided that can be useful for the early identification of hazards.

  3. Evaluation of safety assessment methodologies in Rocky Flats Risk Assessment Guide (1985) and Building 707 Final Safety Analysis Report (1987)

    SciTech Connect

    Walsh, B.; Fisher, C.; Zigler, G.; Clark, R.A.

    1990-11-09

    FSARs. Rockwell International, as operating contractor at the Rocky Flats plant, conducted a safety analysis program during the 1980s. That effort resulted in Final Safety Analysis Reports (FSARs) for several buildings, one of them being the Building 707 Final Safety Analysis Report, June 87 (707FSAR) and a Plant Safety Analysis Report. Rocky Flats Risk Assessment Guide, March 1985 (RFRAG85) documents the methodologies that were used for those FSARs. Resources available for preparation of those Rocky Flats FSARs were very limited. After addressing the more pressing safety issues, some of which are described below, the present contractor (EG&G) intends to conduct a program of upgrading the FSARs. This report presents the results of a review of the methodologies described in RFRAG85 and 707FSAR and contains suggestions that might be incorporated into the methodology for the FSAR upgrade effort.

  4. Towards internationally acceptable standards for food additives and contaminants based on the use of risk analysis.

    PubMed

    Huggett, A; Petersen, B J; Walker, R; Fisher, C E; Notermans, S H; Rombouts, F M; Abbott, P; Debackere, M; Hathaway, S C; Hecker, E F; Knaap, A G; Kuznesof, P M; Meyland, I; Moy, G; Narbonne, J F; Paakkanen, J; Smith, M R; Tennant, D; Wagstaffe, P; Wargo, J; Würtzen, G

    1998-06-01

    Internationally acceptable norms need to incorporate sound science and consistent risk management principles in an open and transparent manner, as set out in the Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement). The process of risk analysis provides a procedure to reach these goals. The interaction between risk assessors and risk managers is considered vital to this procedure. This paper reports the outcome of a meeting of risk assessors and risk managers on specific aspects of risk analysis and its application to international standard setting for food additives and contaminants. Case studies on aflatoxins and aspartame were used to identify the key steps of the interaction process which ensure scientific justification for risk management decisions. A series of recommendations were proposed in order to enhance the scientific transparency in these critical phases of the standard setting procedure.

  5. 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. PMID:26889653

  6. 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.

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

    PubMed

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

    2016-01-01

    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. PMID:27287345

  8. 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.

  9. An intravenous medication safety system: preventing high-risk medication errors at the point of care.

    PubMed

    Hatcher, Irene; Sullivan, Mark; Hutchinson, James; Thurman, Susan; Gaffney, F Andrew

    2004-10-01

    Improving medication safety at the point of care--particularly for high-risk drugs--is a major concern of nursing administrators. The medication errors most likely to cause harm are administration errors related to infusion of high-risk medications. An intravenous medication safety system is designed to prevent high-risk infusion medication errors and to capture continuous quality improvement data for best practice improvement. Initial testing with 50 systems in 2 units at Vanderbilt University Medical Center revealed that, even in the presence of a fully mature computerized prescriber order-entry system, the new safety system averted 99 potential infusion errors in 8 months.

  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. Managing Risk in Safety Critical Operations - Lessons Learned from Space Operations

    NASA Technical Reports Server (NTRS)

    Gonzalez, Steven A.

    2002-01-01

    The Mission Control Center (MCC) at Johnson Space Center (JSC) has a rich legacy of supporting Human Space Flight operations throughout the Apollo, Shuttle and International Space Station eras. Through the evolution of ground operations and the Mission Control Center facility, NASA has gained a wealth of experience of what it takes to manage the risk in Safety Critical Operations, especially when human life is at risk. The focus of the presentation will be on the processes (training, operational rigor, team dynamics) that enable the JSC/MCC team to be so successful. The presentation will also share the evolution of the Mission Control Center architecture and how the evolution was introduced while managing the risk to the programs supported by the team. The details of the MCC architecture (e.g., the specific software, hardware or tools used in the facility) will not be shared at the conference since it would not give any additional insight as to how risk is managed in Space Operations.

  12. Are major behavioral and sociodemographic risk factors for mortality additive or multiplicative in their effects?

    PubMed

    Mehta, Neil; Preston, Samuel

    2016-04-01

    All individuals are subject to multiple risk factors for mortality. In this paper, we consider the nature of interactions between certain major sociodemographic and behavioral risk factors associated with all-cause mortality in the United States. We develop the formal logic pertaining to two forms of interaction between risk factors, additive and multiplicative relations. We then consider the general circumstances in which additive or multiplicative relations might be expected. We argue that expectations about interactions among socio-demographic variables, and their relation to behavioral variables, have been stated in terms of additivity. However, the statistical models typically used to estimate the relation between risk factors and mortality assume that risk factors act multiplicatively. We examine empirically the nature of interactions among five major risk factors associated with all-cause mortality: smoking, obesity, race, sex, and educational attainment. Data were drawn from the cross-sectional NHANES III (1988-1994) and NHANES 1999-2010 surveys, linked to death records through December 31, 2011. Our analytic sample comprised 35,604 respondents and 5369 deaths. We find that obesity is additive with each of the remaining four variables. We speculate that its additivity is a reflection of the fact that obese status is generally achieved later in life. For all pairings of socio-demographic variables, risks are multiplicative. For survival chances, it is much more dangerous to be poorly educated if you are black or if you are male. And it is much riskier to be a male if you are black. These traits, established at birth or during childhood, literally result in deadly combinations. We conclude that the identification of interactions among risk factors can cast valuable light on the nature of the process being studied. It also has public health implications by identifying especially vulnerable groups and by properly identifying the proportion of deaths

  13. A Qualitative Comparison of Susceptibility and Behavior in Recreational and Occupational Risk Environments: Implications for Promoting Health and Safety.

    PubMed

    Haas, Emily Joy; Mattson, Marifran

    2016-06-01

    Although internal factors that influence risk are frequently studied to understand human behavior, external factors, including social, cultural, and institutional factors, should be better utilized to inform ways to efficiently target, tailor, and promote safety messaging to at-risk populations. Semi-structured interviews obtained data from 37 motorcyclists and 18 mineworkers about their risk perceptions and behaviors within their respective dynamic environments. A comparative thematic analysis revealed information about external factors that influence risk perceptions and behaviors. Results support the importance of qualitative approaches for assessing and targeting individuals' risk perceptions and behaviors. In addition, segmenting at-risk subgroups within target populations and tailoring messages for these at-risk groups is critical for safety behavior modification. Practitioners should utilize strategic, culture-centric risk communication that takes into account external factors when determining when, who, and what to communicate via health promotion activities to more accurately disseminate valid, empathetic, and engaging communication with a higher level of fidelity. PMID:27186684

  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. Nuclear power plants in China's coastal zone: risk and safety

    NASA Astrophysics Data System (ADS)

    Lu, Qingshui; Gao, Zhiqiang; Ning, Jicai; Bi, Xiaoli; Gao, Wei

    2014-10-01

    Nuclear power plants are used as an option to meet the demands for electricity due to the low emission of CO2 and other contaminants. The accident at the Fukushima nuclear power plant in 2011 has forced the Chinese government to adjust its original plans for nuclear power. The construction of inland nuclear power plants was stopped, and construction is currently only permitted in coastal zones. However, one obstacle of those plants is that the elevation of those plants is notably low, ranging from 2 to 9 meters and a number of the nuclear power plants are located in or near geological fault zones. In addition, the population density is very high in the coastal zones of China. To reduce those risks of nuclear power plants, central government should close the nuclear power plants within the fault zones, evaluate the combined effects of storm surges, inland floods and tidal waves on nuclear power plants and build closed dams around nuclear power plants to prevent damage from storm surges and tidal waves. The areas without fault zones and with low elevation should be considered to be possible sites for future nuclear power plants if the elevation can be increased using soil or civil materials.

  16. 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. PMID:25603422

  17. 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.

  18. A Case Study of Measuring Process Risk for Early Insights into Software Safety

    NASA Technical Reports Server (NTRS)

    Layman, Lucas; Basili, Victor; Zelkowitz, Marvin V.; Fisher, Karen L.

    2011-01-01

    In this case study, we examine software safety risk in three flight hardware systems in NASA's Constellation spaceflight program. We applied our Technical and Process Risk Measurement (TPRM) methodology to the Constellation hazard analysis process to quantify the technical and process risks involving software safety in the early design phase of these projects. We analyzed 154 hazard reports and collected metrics to measure the prevalence of software in hazards and the specificity of descriptions of software causes of hazardous conditions. We found that 49-70% of 154 hazardous conditions could be caused by software or software was involved in the prevention of the hazardous condition. We also found that 12-17% of the 2013 hazard causes involved software, and that 23-29% of all causes had a software control. The application of the TPRM methodology identified process risks in the application of the hazard analysis process itself that may lead to software safety risk.

  19. 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

  20. The Concepts of Risk, Safety, and Security: Applications in Everyday Language.

    PubMed

    Boholm, Max; Möller, Niklas; Hansson, Sven Ove

    2016-02-01

    The concepts of risk, safety, and security have received substantial academic interest. Several assumptions exist about their nature and relation. Besides academic use, the words risk, safety, and security are frequent in ordinary language, for example, in media reporting. In this article, we analyze the concepts of risk, safety, and security, and their relation, based on empirical observation of their actual everyday use. The "behavioral profiles" of the nouns risk, safety, and security and the adjectives risky, safe, and secure are coded and compared regarding lexical and grammatical contexts. The main findings are: (1) the three nouns risk, safety, and security, and the two adjectives safe and secure, have widespread use in different senses, which will make any attempt to define them in a single unified manner extremely difficult; (2) the relationship between the central risk terms is complex and only partially confirms the distinctions commonly made between the terms in specialized terminology; (3) whereas most attempts to define risk in specialized terminology have taken the term to have a quantitative meaning, nonquantitative meanings dominate in everyday language, and numerical meanings are rare; and (4) the three adjectives safe, secure, and risky are frequently used in comparative form. This speaks against interpretations that would take them as absolute, all-or-nothing concepts.

  1. 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.

  2. 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.

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

    PubMed

    Lenz, Tobias L; Deutsch, Aaron J; Han, Buhm; Hu, Xinli; Okada, Yukinori; Eyre, Stephen; Knapp, Michael; Zhernakova, Alexandra; Huizinga, Tom W J; Abecasis, Gonçalo; 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

    2015-09-01

    Human leukocyte antigen (HLA) genes confer substantial 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 might result in additional non-additive risk effects. We tested the non-additive disease contributions of classical HLA alleles in patients and matched controls for five common autoimmune diseases: rheumatoid arthritis (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 of the five diseases, we observed highly significant, non-additive dominance effects (rheumatoid arthritis, P = 2.5 × 10(-12); 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 non-additive dominance effects were explained by interactions between specific classical HLA alleles (rheumatoid arthritis, P = 1.8 × 10(-3); T1D, P = 8.6 × 10(-27); celiac disease, P = 6.0 × 10(-100)). These interactions generally increased disease risk and explained moderate but significant fractions of phenotypic variance (rheumatoid arthritis, 1.4%; T1D, 4.0%; celiac disease, 4.1%) beyond a simple additive model. PMID:26258845

  4. Risk Management: the Economics and Mor ality of Safety Revisited

    NASA Astrophysics Data System (ADS)

    Adams, John

    The introduction to the proceedings of the Royal Academy of Engineering 2006 seminar on The Economics and Morality of Safety (RAEng 2006) concluded with a list of issues that were ‘worthy of further exploration’. I have reduced them to the following questions: Why do moral arguments about ‘rights’ persist unresolved?

  5. 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.

  6. 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

  7. A commentary on recent water safety initiatives in the context of water utility risk management.

    PubMed

    Hamilton, Paul D; Gale, Paul; Pollard, Simon J T

    2006-12-01

    Over the last decade, suppliers of drinking water have recognised the limitations of relying solely on end-product monitoring to ensure safe water quality and have sought to reinforce their approach by adopting preventative strategies where risks are proactively identified, assessed and managed. This is leading to the development of water safety plans; structured 'route maps' for managing risks to water supply, from catchment to consumer taps. This paper reviews the Hazard Analysis and Critical Control Point (HACCP) procedure on which many water safety plans are based and considers its appropriateness in the context of drinking water risk management. We examine water safety plans in a broad context, looking at a variety of monitoring, optimisation and risk management initiatives that can be taken to improve drinking water safety. These are cross-compared using a simple framework that facilitates an integrated approach to water safety. Finally, we look at how risk management practices are being integrated across water companies and how this is likely to affect the future development of water safety plans.

  8. Risk, Challenge and Safety: Implications for Play Quality and Playground Design

    ERIC Educational Resources Information Center

    Little, Helen; Eager, David

    2010-01-01

    In many countries playground design is driven more by safety than developmental benefits. As risk minimisation strategies become more stringent, many researchers and practitioners are questioning whether young children are able to take sufficient risks in play in order for their play experiences to be interesting and developmentally challenging.…

  9. 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,…

  10. Using in vitro/in silico data for consumer safety assessment of feed flavoring additives--A feasibility study using piperine.

    PubMed

    Thiel, A; Etheve, S; Fabian, E; Leeman, W R; Plautz, J R

    2015-10-01

    Consumer health risk assessment for feed additives is based on the estimated human exposure to the additive that may occur in livestock edible tissues compared to its hazard. We present an approach using alternative methods for consumer health risk assessment. The aim was to use the fewest possible number of animals to estimate its hazard and human exposure without jeopardizing the safety upon use. As an example we selected the feed flavoring substance piperine and applied in silico modeling for residue estimation, results from literature surveys, and Read-Across to assess metabolism in different species. Results were compared to experimental in vitro metabolism data in rat and chicken, and to quantitative analysis of residues' levels from the in vivo situation in livestock. In silico residue modeling showed to be a worst case: the modeled residual levels were considerably higher than the measured residual levels. The in vitro evaluation of livestock versus rodent metabolism revealed no major differences in metabolism between the species. We successfully performed a consumer health risk assessment without performing additional animal experiments. As shown, the use and combination of different alternative methods supports animal welfare consideration and provides future perspective to reducing the number of animals.

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. Web-based patient-reported outcomes in drug safety and risk management: challenges and opportunities?

    PubMed

    Banerjee, Anjan K; Ingate, Simon

    2012-06-01

    Patient-reported outcomes (PROs) from web-based sources are becoming increasingly important, providing opportunities for industry and regulators to understand the benefits and risks of medicines in a real-world context. Although some guidance exists for the use of adverse event (AE) reports from company-sponsored social network sites, this does not cover non-company-sponsored sites. Additionally, there are concerns about the validity of data from social media sources. Techniques for the collection, analysis and reporting of safety data from patients should be defined, and guidelines agreed, to cover PROs and patient-reported adverse drug-related events from more organized sources of patient outcomes. This review considers drivers for web-based PRO adoption in drug safety, the current regulatory framework and potential methodologies, and concludes that there is an urgent unmet need for guidelines on web-based PRO AEs. Stakeholders for the development of any such guidance should include industry, patients, regulators, academic groups and prescribers. PMID:22551007

  17. 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.

  18. 77 FR 71561 - Health and Safety Data Reporting; Addition of Certain Chemicals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-03

    ... shown to be a developmental toxicant in animals, resulting in fetal malformations and other effects, but.... Federal Register (41 FR 36902, September 1, 1976). 2. EPA. Integrated Risk Information System. Cadmium... Environmental Protection Agency; Receipt of Report and Request for Comments; Notice. Federal Register (76...

  19. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... additives stated in current publications of the National Academy of Sciences-National Research Council. A... those outlined in the publications of the National Academy of Sciences-National Research Council if... additive whether he believes the experiments planned will yield data adequate for an evaluation of...

  20. Safety assessment of butylated hydroxyanisole and butylated hydroxytoluene as antioxidant food additives.

    PubMed

    Williams, G M; Iatropoulos, M J; Whysner, J

    1999-01-01

    Butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) are widely used antioxidant food additives. They have been extensively studied for potential toxicities. This review details experimental studies of genotoxicity and carcinogenicity which bear on cancer hazard assessment of exposure to humans. We conclude that BHA and BHT pose no cancer hazard and, to the contrary, may be anticarcinogenic at current levels of food additive use.

  1. Perceived Risk and Other Predictors and Correlates of Teenagers' Safety Belt Use During the First Year of Licensure

    PubMed Central

    Ouimet, Marie Claude; Simons Morton, Bruce G.; Noelcke, Elizabeth A.; Williams, Allan F.; Leaf, William A.; Preusser, David F.; Hartos, Jessica L.

    2009-01-01

    Objectives Teenagers have the lowest rate of safety belt use and the highest crash rate compared to other age groups. Past studies on teenagers' belt use have mostly been cross-sectional. The first goals of this study were to examine, at licensure, teenagers' and parents' perceptions of risk of crash/injury for newly licensed teenagers when driving unbelted and teenagers' perceived and parents' intended consequences for safety belt rule violations. In addition, the comparability of these variables to other risky driving behaviors was explored. The second goal was to evaluate the importance of these variables in the prediction of teenagers' belt use during the first year of licensure, relative to other factors related to belt use, including demographics and substance use. Methods More than 2,000 parent-teenager dyads were interviewed by telephone, parents at permit and licensure and teenagers at permit, licensure, and 3, 6, and 12 months after licensure. Results Approximately a third of the teenagers reported at least once at 3, 6, or 12 months post-licensure not always using their safety belt in the past week. At licensure, participants' perceived risk of safety belt non-use was high and ranked among the behaviors most related to crash/injury for newly licensed teenagers, behind driving under the influence of alcohol or drugs. Parent-imposed consequences for safety belt rule violations were not as highly rated as parent-imposed consequences for driving under the influence of alcohol or drugs. Sequential logistic regression modeled the relationship between safety belt use and perceived risk and consequences of non-use, as well as other prospective predictors assessed at permit and licensure, and driving correlates measured after licensure. Teenagers' extreme perceived risk and parents' intended sure consequences for non-use were significant prospective predictors of regular use during the first year of licensure. Other significant predictors and correlates were race

  2. [Are the equipment safety standards sufficient to guarantee safety from risks?].

    PubMed

    Galassini, A

    1995-06-01

    The output of the work done by National and International Committee and Commission today gives an almost complete frame of Safety Standards for Medical Devices; EEC Harmonised Standards which have been translated in the National ones gave the Free Trade Act an effective push forward. This paper analyses the problem given by the "Safety Assumption" of certified products, which is based on a positive Project examination and/or a positive prototype test made by a Notified Body, as requested by the existing warranty that every unit produced after the applied control or test has the same behaviour as the verified one: on the other hand it is out of the reality to submit every unit produced after the tested one to the same control. For the necessary and requested assumption of safety of every unit produced after the verified one, it is mandatory to act on the complete productive process, in order to reach the certainty that every unit be absolutely identical to the approved one. It is therefore in the interest of the buyers to require in the Tender Specification not only the Safety Standard Certificate for the products to be quoted, but also the Quality Standard Certificate of the producer.

  3. 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.

  4. 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.

  5. Improving coeliac disease risk prediction by testing non-HLA variants additional to HLA variants

    PubMed Central

    Romanos, Jihane; Rosén, Anna; Kumar, Vinod; Trynka, Gosia; Franke, Lude; Szperl, Agata; Gutierrez-Achury, Javier; van Diemen, Cleo C; Kanninga, Roan; Jankipersadsing, Soesma A; Steck, Andrea; Eisenbarth, Georges; van Heel, David A; Cukrowska, Bozena; Bruno, Valentina; Mazzilli, Maria Cristina; Núñez, Concepcion; Bilbao, Jose Ramon; Mearin, M Luisa; Barisani, Donatella; Rewers, Marian; Norris, Jill M; Ivarsson, Anneli; Boezen, H Marieke; Liu, Edwin; Wijmenga, Cisca

    2014-01-01

    Background The majority of coeliac disease (CD) patients are not being properly diagnosed and therefore remain untreated, leading to a greater risk of developing CD-associated complications. The major genetic risk heterodimer, HLA-DQ2 and DQ8, is already used clinically to help exclude disease. However, approximately 40% of the population carry these alleles and the majority never develop CD. Objective We explored whether CD risk prediction can be improved by adding non-HLA-susceptible variants to common HLA testing. Design We developed an average weighted genetic risk score with 10, 26 and 57 single nucleotide polymorphisms (SNP) in 2675 cases and 2815 controls and assessed the improvement in risk prediction provided by the non-HLA SNP. Moreover, we assessed the transferability of the genetic risk model with 26 non-HLA variants to a nested case–control population (n=1709) and a prospective cohort (n=1245) and then tested how well this model predicted CD outcome for 985 independent individuals. Results Adding 57 non-HLA variants to HLA testing showed a statistically significant improvement compared to scores from models based on HLA only, HLA plus 10 SNP and HLA plus 26 SNP. With 57 non-HLA variants, the area under the receiver operator characteristic curve reached 0.854 compared to 0.823 for HLA only, and 11.1% of individuals were reclassified to a more accurate risk group. We show that the risk model with HLA plus 26 SNP is useful in independent populations. Conclusions Predicting risk with 57 additional non-HLA variants improved the identification of potential CD patients. This demonstrates a possible role for combined HLA and non-HLA genetic testing in diagnostic work for CD. PMID:23704318

  6. [Biological safety in the laboratory. Biological risk, standardization and practice].

    PubMed

    Vidal, D R; Paucod, J C; Thibault, F; Isoard, P

    1993-01-01

    Working with pathogens or genetically engineered micro-organisms is a potential hazard for scientists, health care workers, employees of pharmaceutical industry, and also for the environment. Carelessness, poor technique in the handling of infectious materials, needle sting or infectious aerosol exposure are the cause of laboratory acquired infection. Biosafety, corollary of biocontamination, is based on the combination of good microbiological techniques, facility design of the laboratory and safety equipment. So, four biosafety levels are appropriate for the operations performed and the hazard posed by the infectious agents. PMID:8250492

  7. Possible effects of protracted exposure on the additivity of risks from space radiations

    NASA Technical Reports Server (NTRS)

    Curtis, S. B.

    1996-01-01

    Conventional radiation risk assessments are presently based on the additivity assumption. This assumption states that risks from individual components of a complex radiation field involving many different types of radiation can be added to yield the total risk of the complex radiation field. If the assumption is not correct, the summations and integrations performed to obtain the presently quoted risk estimates are not appropriate. This problem is particularly important in the area of space radiation risk evaluation because of the many different types of high- and low-LET radiation present in the galactic cosmic ray environment. For both low- and high-LET radiations at low enough dose rates, the present convention is that the addivity assumption holds. Mathematically, the total risk, Rtot is assumed to be Rtot = summation (i) Ri where the summation runs over the different types of radiation present. If the total dose (or fluence) from each component is such that the interaction between biological lesions caused by separate single track traversals is negligible within a given cell, it is presently considered to be reasonable to accept the additivity assumption. However, when the exposure is protracted over many cell doubling times (as will be the case for extended missions to the moon or Mars), the possibility exists that radiation effects that depend on multiple cellular events over a long time period, such as is probably the case in radiation-induced carcinogenesis, may not be additive in the above sense and the exposure interval may have to be included in the evaluation procedure. It is shown, however, that "inverse" dose-rate effects are not expected from intermediate LET radiations arising from the galactic cosmic ray environment due to the "sensitive-window-in-the-cell-cycle" hypothesis.

  8. 76 FR 63929 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Drug Safety and Risk Management... public. Name of Committees: Drug Safety and Risk Management Advisory Committee and Dermatologic and... (Public Law 110-85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation...

  9. 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…

  10. 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.

  11. 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.

  12. 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.

  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. 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.

  15. [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.

  16. [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. PMID:27455605

  17. Risk assessment of combined photogenotoxic effects of sunlight and food additives.

    PubMed

    Salih, Fadhil M

    2006-06-01

    The presence of flavored colorants (peach and raspberry), flavors (caramel, citric acid and vanilla) and food preservatives (sodium nitrite, sodium nitrate, sodium benzoate, benzoic acid, potassium sorbate and sodium chloride) in Escherichia coli suspension during exposure to sunlight did not change the extent of cell survival. No effect on viability and mutation induction (kanamycin resistant) was also seen when cells were kept in contact with any of the additives for 80 min in the dark. However, when the relevant additive was present in cell suspension during sunlight exposure the number of induced mutations was increased to varying extents over that seen with sunlight alone. Raspberry and peach increased the number of mutations in a dose dependent manner, while vanilla produced mutations in an additive fashion. Nitrite, nitrate, benzoate, sorbate and benzoic acid increased mutation somewhat additively over that of sunlight. Sodium chloride and citric acid were not effective. The impact of this investigation reflects the significance of combination of sunlight and chemical food additives as potential risk, which requires special attention and necessitates further investigations to evaluate the risk.

  18. 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

  19. Risk-Oriented Safety Evaluation of the CAREM-25 Prototype Reactor

    SciTech Connect

    Baron, Jorge H.; McLeod, Jorge E. Nunez; Rivera, Selva S

    2001-05-15

    Construction of the CAREM-25 full-size prototype, a very low power nuclear power station [25 MW(electric)], is scheduled to begin in Argentina in 2001. The CAREM-25 is designed based on principles of inherent safety, passive safety functions, and ease of operation. This paper analyzes the safety philosophy from the point of view of risk by performing a level-III probabilistic safety assessment (PSA) of this prototype. The specific PSA steps are discussed, including a specially developed method to obtain representative initiating events, system analysis by fault trees, event development in event trees, plant and containment response analysis, containment event tree development, consequence calculations, and risk representation. The PSA results are presented and discussed in terms of their own values as well as in comparison to other PSA results performed for larger nuclear power plants (NPPs). The advantages of the CAREM-25 from the risk point of view are studied in terms of the effective reduction of both the probability of severe accident sequences and the potential consequences of such sequences (radiological and emergency preparedness impact). The risk point of view also provides a perspective to analyze the impact of several design modifications in order to further reduce the residual risk of the NPP. These design modifications, several of which have already been included in the prototype, are discussed and evaluated.

  20. 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.

  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. 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.

  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. Low edge safety factor operation and passive disruption avoidance in current carrying plasmas by the addition of stellarator rotational transform

    NASA Astrophysics Data System (ADS)

    Pandya, M. D.; ArchMiller, M. C.; Cianciosa, M. R.; Ennis, D. A.; Hanson, J. D.; Hartwell, G. J.; Hebert, J. D.; Herfindal, J. L.; Knowlton, S. F.; Ma, X.; Massidda, S.; Maurer, D. A.; Roberds, N. A.; Traverso, P. J.

    2015-11-01

    Low edge safety factor operation at a value less than two ( q (a )=1 /ι̷tot(a )<2 ) is routine on the Compact Toroidal Hybrid device with the addition of sufficient external rotational transform. Presently, the operational space of this current carrying stellarator extends down to q (a )=1.2 without significant n = 1 kink mode activity after the initial plasma current rise phase of the discharge. The disruption dynamics of these low edge safety factor plasmas depend upon the fraction of helical field rotational transform from external stellarator coils to that generated by the plasma current. We observe that with approximately 10% of the total rotational transform supplied by the stellarator coils, low edge q disruptions are passively suppressed and avoided even though q(a) < 2. When the plasma does disrupt, the instability precursors measured and implicated as the cause are internal tearing modes with poloidal, m, and toroidal, n, helical mode numbers of m /n =3 /2 and 4/3 observed on external magnetic sensors and m /n =1 /1 activity observed on core soft x-ray emissivity measurements. Even though the edge safety factor passes through and becomes much less than q(a) < 2, external n = 1 kink mode activity does not appear to play a significant role in the disruption phenomenology observed.

  5. The clinical safety of disabled patients: proposal for a methodology for analysis of health care risks and specific measures for improvement.

    PubMed

    Perea-Pérez, Bernardo; Labajo-González, Elena; Bratos-Murillo, Manuel; Santiago-Sáez, Andrés; Albarrán-Juan, Elena; Villa-Vigil, Alfonso

    2013-03-01

    The clinical risks associated with health care have been a known factor since ancient times, and their prevention has constituted one of the foundations of health care. However, concern for the risks involved in health care treatments has risen very significantly in recent years, becoming a modern current of concern for clinical health care risks which is referred to by the name of "patient safety" in the scientific literature. Unfortunately, there are no studies on patient safety in dental practice or case studies of adverse events in this practice. In addition to the lack of studies on adverse events in regular dental practice, there are even fewer references to treatment for disabled patients. In this article, we provide a "proposal for analysis" of the clinical risks associated with treating disabled patients, which will make it possible to evaluate the health care risks associated with the treatment of patients who have a specific disability, at one determined moment and in one specific environment.

  6. 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

  7. Vaccine safety: medical contraindications, myths, and risk communication.

    PubMed

    Smith, Michael

    2015-06-01

    On the basis of first principles, anaphylaxis to a vaccine or vaccine component is a contraindication to future receipt of that vaccine. • On the basis of strong evidence, live viral vaccines should not be administered to severely immunocompromised children. • On the basis of some evidence with consensus, children with egg allergies may receive inactivated influenza vaccine. • On the basis of strong evidence, neither measles-mumps-rubella vaccine nor thimerosal causes autism. • On the basis of some evidence with consensus, alternative vaccination schedules have no benefit and receipt of human papillomavirus vaccines does not result in promiscuity. • On the basis of first principles and consensus, vaccine risk communication requires a tailored approach to each individual family.

  8. Vaccine safety: medical contraindications, myths, and risk communication.

    PubMed

    Smith, Michael

    2015-06-01

    On the basis of first principles, anaphylaxis to a vaccine or vaccine component is a contraindication to future receipt of that vaccine. • On the basis of strong evidence, live viral vaccines should not be administered to severely immunocompromised children. • On the basis of some evidence with consensus, children with egg allergies may receive inactivated influenza vaccine. • On the basis of strong evidence, neither measles-mumps-rubella vaccine nor thimerosal causes autism. • On the basis of some evidence with consensus, alternative vaccination schedules have no benefit and receipt of human papillomavirus vaccines does not result in promiscuity. • On the basis of first principles and consensus, vaccine risk communication requires a tailored approach to each individual family. PMID:26034253

  9. 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

  10. Estimation of radiation risk in presence of classical additive and Berkson multiplicative errors in exposure doses.

    PubMed

    Masiuk, S V; Shklyar, S V; Kukush, A G; Carroll, R J; Kovgan, L N; Likhtarov, I A

    2016-07-01

    In this paper, the influence of measurement errors in exposure doses in a regression model with binary response is studied. Recently, it has been recognized that uncertainty in exposure dose is characterized by errors of two types: classical additive errors and Berkson multiplicative errors. The combination of classical additive and Berkson multiplicative errors has not been considered in the literature previously. In a simulation study based on data from radio-epidemiological research of thyroid cancer in Ukraine caused by the Chornobyl accident, it is shown that ignoring measurement errors in doses leads to overestimation of background prevalence and underestimation of excess relative risk. In the work, several methods to reduce these biases are proposed. They are new regression calibration, an additive version of efficient SIMEX, and novel corrected score methods.

  11. 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...

  12. 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.

  13. Knowledge Management and Safety Compliance in a High-Risk Distributed Organizational System

    PubMed Central

    Gressgård, Leif Jarle

    2014-01-01

    Background In a safety perspective, efficient knowledge management is important for learning purposes and thus to prevent errors from occurring repeatedly. The relationship between knowledge exchange among employees and safety behavior may be of particular importance in distributed organizational systems where similar high-risk activities take place at several locations. This study develops and tests hypotheses concerning the relationship between knowledge exchange systems usage, knowledge exchange in the organizational system, and safety compliance. Methods The operational context of the study is petroleum drilling and well operations involving distributed high-risk activities. The hypotheses are tested by use of survey data collected from a large petroleum operator company and eight of its main contractors. Results The results show that safety compliance is influenced by use of knowledge exchange systems and degree of knowledge exchange in the organizational system, both within and between units. System usage is the most important predictor, and safety compliance seems to be more strongly related to knowledge exchange within units than knowledge exchange between units. Conclusion Overall, the study shows that knowledge management is central for safety behavior. PMID:25180134

  14. 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.

  15. 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…

  16. 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…

  17. 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 ...

  18. 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…

  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 to…

  20. 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…

  1. 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.

  2. 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.

  3. Additive Genetic Risk from Five Serotonin System Polymorphisms Interacts with Interpersonal Stress to Predict Depression

    PubMed Central

    Vrshek-Schallhorn, Suzanne; Stroud, Catherine B.; Mineka, Susan; Zinbarg, Richard E.; Adam, Emma K.; Redei, Eva E.; Hammen, Constance; Craske, Michelle G.

    2016-01-01

    Behavioral genetic research supports polygenic models of depression in which many genetic variations each contribute a small amount of risk, and prevailing diathesis-stress models suggest gene-environment interactions (GxE). Multilocus profile scores of additive risk offer an approach that is consistent with polygenic models of depression risk. In a first demonstration of this approach in a GxE predicting depression, we created an additive multilocus profile score from five serotonin system polymorphisms (one each in the genes HTR1A, HTR2A, HTR2C, and two in TPH2). Analyses focused on two forms of interpersonal stress as environmental risk factors. Using five years of longitudinal diagnostic and life stress interviews from 387 emerging young adults in the Youth Emotion Project, survival analyses show that this multilocus profile score interacts with major interpersonal stressful life events to predict major depressive episode onsets (HR = 1.815, p = .007). Simultaneously, there was a significant protective effect of the profile score without a recent event (HR = 0.83, p = .030). The GxE effect with interpersonal chronic stress was not significant (HR = 1.15, p = .165). Finally, effect sizes for genetic factors examined ignoring stress suggested such an approach could lead to overlooking or misinterpreting genetic effects. Both the GxE effect and the protective simple main effect were replicated in a sample of early adolescent girls (N = 105). We discuss potential benefits of the multilocus genetic profile score approach and caveats for future research. PMID:26595467

  4. Risk communication: A handbook for communicating environmental, safety, and health risks. Second edition

    SciTech Connect

    Lundgren, R.; McMakin, A.

    1998-12-31

    As penalties for corporate and personal risk increase, communicating risk-related information can be a daunting challenge. Communication must be targeted, understandable, and effective without inadvertently provoking hostility and mistrust. This handbook presents strategies and guidance for conveying risk information effectively. In this second edition, readers get the latest updates on pertinent topics--including current laws, approaches, computer applications, stakeholder participation methods, and ways to evaluate effectiveness. All-new sections explain how to work with the media and represent risks pictorially. With the second edition readers will benefit even more by getting contemporary, practical advice on what to do and what to avoid for successful risk communication.

  5. Exploration of Tunnel Alignment using Geophysical Methods to Increase Safety for Planning and Minimizing Risk

    NASA Astrophysics Data System (ADS)

    Lehmann, Bodo; Orlowsky, Dirk; Misiek, Rüdiger

    2010-02-01

    Engineering geophysics provides valuable and continuous information for the planning and execution of tunnel construction projects. For geotechnical purposes special high-resolution geophysical methods have been developed during the last decades. The importance of applying geophysical methods in addition to usually used geological and geotechnical exploration techniques is increasing. The main goal is to achieve an accurate and continuous model of the subsurface in a relative short period of operation time. The routine application of engineering geophysical methods will increase in the coming years. Due to the high acceptance of engineering geophysics at construction sites, much wider application of geophysical investigations is expected. The combination of different methods—geophysics, geology, and geotechnics as well as the so-called joint interpretation techniques—will be of essential importance. Engineering geophysics will play an important role during the three phases: geological investigation, tunnel planning, and execution of tunnel construction. If hazards are well known in advance of a tunnel project the safety of workers will essentially be increased and geological risks will be minimized by means of successful and interdisciplinary cooperation.

  6. The potential carcinogenic risk of tanning beds: clinical guidelines and patient safety advice

    PubMed Central

    Mogensen, Mette; Jemec, Gregor BE

    2010-01-01

    Introduction: In 2009, the WHO listed ultraviolet (UV) radiation as a group 1 carcinogen. In spite of this, each year, millions of people tan indoor in Western countries. The aim of this review is to summarize evidence of tanning bed carcinogenesis and to present guidelines for use of tanning beds and patient safety advice. Methods: A narrative review of the literature was conducted based on both PubMed and Medline searches and on literature review of the retrieved papers. Results: Use of indoor tanning beds represents a significant and avoidable risk factor for the development of both melanoma and nonmelanoma skin cancers. Frequent tanners are more often adolescent females. Tanning beds have additional potential adverse effects such as burns, solar skin damage, infection, and possibly also addictive behavior. Discussion: The effort in preventing UV light-induced carcinogenesis should currently be aimed at developing new strategies for public health information. Tanning beds are one preventable source of UV radiation. In the majority of people solar UV radiation continues to be the major factor and therefore anti-tanning campaigns must always include sunbathers. PMID:21188119

  7. 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…

  8. 78 FR 64957 - Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-30

    ... Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Joint Meeting AGENCY: Food... public. Name of Committees: Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide advice and recommendations...

  9. There's No Place Like Home: The Public/Private Distinction in Children's Theorizing of Risk and Safety.

    ERIC Educational Resources Information Center

    Harden, Jeni

    2000-01-01

    Explores 9- to 15-year-old children's own constructions of risk and safety in their everyday lives in relation to the public/private dichotomy. Argues that children reflexively construct their landscapes of risk and safety around concepts of private, local, and public, leading from most to least safe. (JPB)

  10. 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…

  11. Violence and legalized brothel prostitution in Nevada: examining safety, risk, and prostitution policy.

    PubMed

    Brents, Barbara G; Hausbeck, Kathryn

    2005-03-01

    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 the issue of violence in the Nevada brothel industry. By drawing on interviews with prostitutes, managers, and policy makers, this article examines both prostitutes' perceptions of safety and risk and brothel managers' practices designed to mitigate violence. Discourses relate to three types of violence: interpersonal violence against prostitutes, violence against community order, and sexually transmitted diseases as violence. The authors conclude by arguing that the legalization of prostitution brings a level of public scrutiny, official regulation, and bureaucratization to brothels that decreases the risk of these 3 types of systematic violence.

  12. 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.

  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. 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

  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. PMID:26882074

  16. 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.

  17. 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.

  18. 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...

  19. Neuropsychological assessment of driving safety risk in older adults with and without neurologic disease.

    PubMed

    Anderson, Steven W; Aksan, Nazan; Dawson, Jeffrey D; Uc, Ergun Y; Johnson, Amy M; Rizzo, Matthew

    2012-01-01

    Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. A total of 345 legally licensed and active drivers over the age of 50, with no neurologic disease (N = 185), probable Alzheimer's disease (N = 40), Parkinson's disease (N = 91), or stroke (N = 29), completed vision testing, a battery of 10 neuropsychological tests, and an 18-mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems.

  20. Neuropsychological Assessment of Driving Safety Risk in Older Adults With and Without Neurologic Disease

    PubMed Central

    Anderson, Steven W.; Aksan, Nazan; Dawson, Jeffrey D.; Uc, Ergun Y.; Johnson, Amy M.; Rizzo, Matthew

    2013-01-01

    Decline in cognitive abilities can be an important contributor to the driving problems encountered by older adults, and neuropsychological assessment may provide a practical approach to evaluating this aspect of driving safety risk. The purpose of the present study was to evaluate several commonly used neuropsychological tests in the assessment of driving safety risk in older adults with and without neurological disease. A further goal of this study was to identify brief combinations of neuropsychological tests that sample performances in key functional domains and thus could be used to efficiently assess driving safety risk. 345 legally licensed and active drivers over the age of 50, with either no neurologic disease (N=185), probable Alzheimer's disease (N=40), Parkinson's disease (N=91), or stroke (N=29), completed vision testing, a battery of 10 neuropsychological tests, and an 18 mile drive on urban and rural roads in an instrumented vehicle. Performances on all neuropsychological tests were significantly correlated with driving safety errors. Confirmatory factor analysis was used to identify 3 key cognitive domains assessed by the tests (speed of processing, visuospatial abilities, and memory), and several brief batteries consisting of one test from each domain showed moderate corrected correlations with driving performance. These findings are consistent with the notion that driving places demands on multiple cognitive abilities that can be affected by aging and age-related neurological disease, and that neuropsychological assessment may provide a practical off-road window into the functional status of these cognitive systems. PMID:22943767

  1. 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.

  2. Food reformulations for improved health: A potential risk for microbial food safety?

    PubMed

    Sleator, Roy D; Hill, Colin

    2007-01-01

    While much information is available concerning the health promoting benefits associated with dietary reformulations (e.g. replacing sugar with aspartame and salt (NaCl) with KCl), to reduce the incidence of obesity and heart disease, potential food safety risks arising from such reformulations have received considerably less attention. Reformulation inevitably changes the intrinsic physico-chemical properties of the food, which may in turn support the growth of food-borne pathogens and ultimately their ability to cause disease. Thus, a better understanding of the microbiological food safety issues associated with product reformulation for increased health are required. PMID:17452083

  3. Food reformulations for improved health: A potential risk for microbial food safety?

    PubMed

    Sleator, Roy D; Hill, Colin

    2007-01-01

    While much information is available concerning the health promoting benefits associated with dietary reformulations (e.g. replacing sugar with aspartame and salt (NaCl) with KCl), to reduce the incidence of obesity and heart disease, potential food safety risks arising from such reformulations have received considerably less attention. Reformulation inevitably changes the intrinsic physico-chemical properties of the food, which may in turn support the growth of food-borne pathogens and ultimately their ability to cause disease. Thus, a better understanding of the microbiological food safety issues associated with product reformulation for increased health are required.

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

    PubMed

    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

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

    PubMed

    Hon, Carol K H; Liu, Yulin

    2016-09-22

    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.

  6. 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

  7. 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.

  8. Overall risk estimation for nonreactor nuclear facilities and implementation of safety goals

    SciTech Connect

    Kim, K.S.; Bradley, R.F.

    1993-06-01

    A typical safety analysis report (SAR) contains estimated frequencies.and consequences of various design basis accidents (DBA). However, the results are organized and presented in such a way that they are not conducive for summing up with mathematical rigor to express total or overall risk. This paper describes a mathematical formalism for deriving total risk indicators. The mathematical formalism is based on the complementary cumulative distribution function (CCDF) or exceedance probability of radioactivity release fraction and individual radiation dose. A simple protocol is presented for establishing exceedance probabilities from the results of DBA analyses typically available from an SAR. The exceedance probability of release fraction can be a useful indicator for gaining insights into the capability of confinement barriers, characteristics of source terms, and scope of the SAR. Fatality risks comparable to the DOE Safety Goals can be derived from the exceedance probability of individual doses. Example case analyses are presented to illustrate the use of the proposed protocol and mathematical formalism. The methodology is finally applied to proposed risk guidelines for individual accident events to show that these guidelines would be within the DOE Safety Goals.

  9. 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.

  10. Efficacy and Safety Assessment of the Addition of Bevacizumab to Adjuvant Therapy Agents in Cancer Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Ahmadizar, Fariba; Onland-Moret, N. Charlotte; de Boer, Anthonius; Liu, Geoffrey; Maitland-van der Zee, Anke H.

    2015-01-01

    Aim To evaluate the efficacy and safety of bevacizumab in the adjuvant cancer therapy setting within different subset of patients. Methods & Design/ Results PubMed, EMBASE, Cochrane and Clinical trials.gov databases were searched for English language studies of randomized controlled trials comparing bevacizumab and adjuvant therapy with adjuvant therapy alone published from January 1966 to 7th of May 2014. Progression free survival, overall survival, overall response rate, safety and quality of life were analyzed using random- or fixed-effects models according to the PRISMA guidelines. We obtained data from 44 randomized controlled trials (30,828 patients). Combining bevacizumab with different adjuvant therapies resulted in significant improvement of progression free survival (log hazard ratio, 0.87; 95% confidence interval (CI), 0.84–0.89), overall survival (log hazard ratio, 0.96; 95% CI, 0.94–0.98) and overall response rate (relative risk, 1.46; 95% CI: 1.33–1.59) compared to adjuvant therapy alone in all studied tumor types. In subgroup analyses, there were no interactions of bevacizumab with baseline characteristics on progression free survival and overall survival, while overall response rate was influenced by tumor type and bevacizumab dose (p-value: 0.02). Although bevacizumab use resulted in additional expected adverse drug reactions except anemia and fatigue, it was not associated with a significant decline in quality of life. There was a trend towards a higher risk of several side effects in patients treated by high-dose bevacizumab compared to the low-dose e.g. all grade proteinuria (9.24; 95% CI: 6.60–12.94 vs. 2.64; 95% CI: 1.29–5.40). Conclusions Combining bevacizumab with different adjuvant therapies provides a survival benefit across all major subsets of patients, including by tumor type, type of adjuvant therapy, and duration and dose of bevacizumab therapy. Though bevacizumab was associated with increased risks of some adverse drug

  11. Safety aspects of "sous vide" products and prevention of microbial risks.

    PubMed

    Martens, T

    1995-03-01

    The diversity and quantities of vacuum packed and vacuum cooked prepared meals and menu components are rapidly growing on the European market. Because of the minimal heat processing, high water activity, absence of preservatives, and the use of many different often exotic ingredients, these products have a high risk potential. For this reason, Anglo-Saxon governments and industries are very sceptical about the safety of "sous vide" products. Industrial practice, as well as parallel tests and recent studies on inoculated packs have shown that, in many cases, it is more a potential than a real risk. Quality is the primary concern for "sous vide" products, and safety must be guaranteed by the application of the Hazard Analysis Critical Control Point (HACCP) concept, along with an adequate combination of different inhibitory factors (temperature of heating and cooling, pH, incorporation of starter cultures, bacteriocins and some particular enzymes). PMID:7546442

  12. Risk assessment and water safety plan: case study in Beijing, China.

    PubMed

    Ye, Bixiong; Chen, Yuansheng; Li, Yonghua; Li, Hairong; Yang, Linsheng; Wang, Wuyi

    2015-06-01

    Two typical rural water utilities in Beijing, China were chosen to describe the principles and applications of water safety plans (WSP), to provide a methodological guide for the actual application and improve the quality of rural drinking water quality, and to establish an appropriate method for WSP applied in rural water supply. Hazards and hazardous events were identified and risk assessment was conducted for rural water supply systems. A total of 13 and 12 operational limits were defined for two utilities, respectively. The main risk factors that affect the water safety were identified in water sources, water processes, water disinfection systems and water utility management. The main control measures were strengthening the water source protection, monitoring the water treatment processes, establishing emergency mechanisms, improving chemical input and operating system management. WSP can be feasibly applied to the management of a rural water supply.

  13. 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.

  14. 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.

  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. The application of quantitative risk assessment to microbial food safety risks.

    PubMed

    Jaykus, L A

    1996-01-01

    Regulatory programs and guidelines for the control of foodborne microbial agents have existed in the U.S. for nearly 100 years. However, increased awareness of the scope and magnitude of foodborne disease, as well as the emergence of previously unrecognized human pathogens transmitted via the foodborne route, have prompted regulatory officials to consider new and improved strategies to reduce the health risks associated with pathogenic microorganisms in foods. Implementation of these proposed strategies will involve definitive costs for a finite level of risk reduction. While regulatory decisions regarding the management of foodborne disease risk have traditionally been done with the aid of the scientific community, a formal conceptual framework for the evaluation of health risks from pathogenic microorganisms in foods is warranted. Quantitative risk assessment (QRA), which is formally defined as the technical assessment of the nature and magnitude of a risk caused by a hazard, provides such a framework. Reproducing microorganisms in foods present a particular challenge to QRA because both their introduction and numbers may be affected by numerous factors within the food chain, with all of these factors representing significant stages in food production, handling, and consumption, in a farm-to-table type of approach. The process of QRA entails four designated phases: (1) hazard identification, (2) exposure assessment, (3) dose-response assessment, and (4) risk characterization. Specific analytical tools are available to accomplish the analyses required for each phase of the QRA. The purpose of this paper is to provide a description of the conceptual framework for quantitative microbial risk assessment within the standard description provided by the National Academy of Sciences (NAS) paradigm. Each of the sequential steps in QRA are discussed in detail, providing information on current applications, tools for conducting the analyses, and methodological and/or data

  18. 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.

  19. From aviation to medicine: applying concepts of aviation safety to risk management in ambulatory care

    PubMed Central

    Wilf-Miron, R; Lewenhoff, I; Benyamini, Z; Aviram, A

    2003-01-01

    

 The development of a medical risk management programme based on the aviation safety approach and its implementation in a large ambulatory healthcare organisation is described. The following key safety principles were applied: (1) errors inevitably occur and usually derive from faulty system design, not from negligence; (2) accident prevention should be an ongoing process based on open and full reporting; (3) major accidents are only the "tip of the iceberg" of processes that indicate possibilities for organisational learning. Reporting physicians were granted immunity, which encouraged open reporting of errors. A telephone "hotline" served the medical staff for direct reporting and receipt of emotional support and medical guidance. Any adverse event which had learning potential was debriefed, while focusing on the human cause of error within a systemic context. Specific recommendations were formulated to rectify processes conducive to error when failures were identified. During the first 5 years of implementation, the aviation safety concept and tools were successfully adapted to ambulatory care, fostering a culture of greater concern for patient safety through risk management while providing support to the medical staff. PMID:12571343

  20. An evaluation of EU legislation concerning risk assessment and preventive measures in occupational safety and health.

    PubMed

    Niskanen, Toivo; Naumanen, Paula; Hirvonen, Maria L

    2012-09-01

    The European Council Directive 89/391/EC of 12 June 1989 is concerned with the introduction of measures to encourage improvements in the occupational safety and health. For example, it deals with risk assessment and preventive measures. The Finnish legislation enacts the risk assessment and prevention measures in a similar way as the EU Directive 89/391/EC. The aim of this study was to examine: 1) the implementation of risk assessment process as a part of OSH management, and 2) the effectiveness of the OSH legislation concerned with risk assessment. The quantitative method involved an online questionnaire. The respondents were employers (N = 1478), workers (N = 1416) and occupational care (OHC) professionals' units (N = 469). Three quarters of the employer respondents and two thirds of the workers and OHC service providers felt that the EU legislative provisions have promoted the engagement of the management. According to the study, improvement is needed in ensuring the cooperation between employers and workers. The combined variables of Risk Assessment Process revealed positive impacts both on Cooperation and Management Measures and on the Concrete Preventive Measures among the employers and the workers. The combined variables of Use of Documents of Risk Assessments highlighted positive impacts on both the Exploiting of Results of Risk Assessments in Planning and Management and on the Exploiting of Results of Risk Assessment in Cooperation and Technology.

  1. 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

  2. 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.

  3. Proceedings of a consensus conference: Risk-Based Decision Making for Blood Safety.

    PubMed

    Leach Bennett, Judie; Blajchman, Morris A; Delage, Gilles; Fearon, Margaret; Devine, Dana

    2011-10-01

    Blood safety decision making has become increasingly complex, and a framework for risk-based decision making is, thus, needed. The purpose of this consensus conference was to bring together international experts in an effort to develop the foundations for such a framework. These proceedings are described with a view to making available to the transfusion medicine community the considerable amount of information and insight that was presented and that emerged through debate by the experts, panel members, and delegates.

  4. Proceedings of a consensus conference: Risk-Based Decision Making for Blood Safety.

    PubMed

    Leach Bennett, Judie; Blajchman, Morris A; Delage, Gilles; Fearon, Margaret; Devine, Dana

    2011-10-01

    Blood safety decision making has become increasingly complex, and a framework for risk-based decision making is, thus, needed. The purpose of this consensus conference was to bring together international experts in an effort to develop the foundations for such a framework. These proceedings are described with a view to making available to the transfusion medicine community the considerable amount of information and insight that was presented and that emerged through debate by the experts, panel members, and delegates. PMID:21763103

  5. Identifying food proteins with allergenic potential: evolution of approaches to safety assessment and research to provide additional tools.

    PubMed

    Ladics, Gregory S; Selgrade, MaryJane K

    2009-08-01

    A safety assessment process exists for genetically engineered crops that includes the evaluation of the expressed protein for allergenic potential. The objectives of this evaluation are twofold: (1) to protect allergic consumers from exposure to known allergenic or cross-reactive proteins, and (2) protect the general population from risks associated with the introduction of genes encoding proteins that are likely to become food allergens. The first systematic approach to address these concerns was formulated by Metcalfe et al. [Metcalfe, D.D., Astwood, J.D., Townsend, R., Sampson, H.A., Taylor, S.L., and Fuchs, R.L. 1996. Assessment of the allergenic potential of foods from genetically engineered crop plants. Crit. Rev. Food Sci. Nutr. 36(5), 165-186.] and subsequently Food and Agriculture Organization of the United Nations/World Health Organization (FAO/WHO) [FAO/WHO, 2001. Evaluation of allergenicity of genetically modified foods. Report of a Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology. January 22-25, 2001. Rome, Italy]. More recently, Codex [Codex Alimentarius Commission, 2003. Alinorm 03/34: Joint FAO/WHO Food Standard Programme, Codex Alimentarius Commission, Twenty-Fifth Session, Rome, Italy, 30 June-5 July, 2003. Appendix III, Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants, and Appendix IV, Annex on the assessment of possible allergenicity. pp. 47-60], noting that no single factor is recognized as an identifier for protein allergenicity, suggested a weight of evidence approach be conducted that takes into account a variety of factors and approaches for an overall assessment of allergenic potential. These various recommendations are based on what is known about allergens, including the history of exposure and safety of the gene(s) source; amino acid sequence identity to human allergens; stability to pepsin digestion in vitro; protein abundance in the crop and

  6. 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.

  7. Hazard and risk assessment of a nanoparticulate cerium oxide-based diesel fuel additive - a case study.

    PubMed

    Park, Barry; Donaldson, Kenneth; Duffin, Rodger; Tran, Lang; Kelly, Frank; Mudway, Ian; Morin, Jean-Paul; Guest, Robert; Jenkinson, Peter; Samaras, Zissis; Giannouli, Myrsini; Kouridis, Haris; Martin, Patricia

    2008-04-01

    Envirox is a scientifically and commercially proven diesel fuel combustion catalyst based on nanoparticulate cerium oxide and has been demonstrated to reduce fuel consumption, greenhouse gas emissions (CO(2)), and particulate emissions when added to diesel at levels of 5 mg/L. Studies have confirmed the adverse effects of particulates on respiratory and cardiac health, and while the use of Envirox contributes to a reduction in the particulate content in the air, it is necessary to demonstrate that the addition of Envirox does not alter the intrinsic toxicity of particles emitted in the exhaust. The purpose of this study was to evaluate the safety in use of Envirox by addressing the classical risk paradigm. Hazard assessment has been addressed by examining a range of in vitro cell and cell-free endpoints to assess the toxicity of cerium oxide nanoparticles as well as particulates emitted from engines using Envirox. Exposure assessment has taken data from modeling studies and from airborne monitoring sites in London and Newcastle adjacent to routes where vehicles using Envirox passed. Data have demonstrated that for the exposure levels measured, the estimated internal dose for a referential human in a chronic exposure situation is much lower than the no-observed-effect level (NOEL) in the in vitro toxicity studies. Exposure to nano-size cerium oxide as a result of the addition of Envirox to diesel fuel at the current levels of exposure in ambient air is therefore unlikely to lead to pulmonary oxidative stress and inflammation, which are the precursors for respiratory and cardiac health problems. PMID:18444008

  8. 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

  9. [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.

  10. Food safety in free-range and organic livestock systems: risk management and responsibility.

    PubMed

    Kijlstra, A; Meerburg, B G; Bos, A P

    2009-12-01

    Animal production systems that offer outdoor access to the animals have become increasingly popular in the Western world due to the growing general discontent of consumers with conventional bioindustrial farming practices. These open production systems offer improved animal welfare but may create new problems for animal health, resulting in increased food safety risks from bacterial, viral, or parasitic infections or environmental contaminants. Examples of these new problems include increased Toxoplasma gondii infections in pigs and high dioxin levels in eggs from free-range hens. In this review, the relation between positive and negative points of free-range and organic livestock production systems is discussed with reference to production in The Netherlands. We investigated how proponents of more animal welfare friendly systems deal with potential negative issues in public and whether any risk communication is used. Generally, we found that the existence of a dilemma is disputed or avoided in communication with the consumer. This avoidance could be detrimental for public trust in alternative animal production systems, should problems occur. To prevent future problems, it will be necessary to communicate about the relevant types and sources of the food safety risks to the consumers. The responsibility for protecting food safety should be properly divided among the various parties involved: producers, processors, governments, nongovernmental organizations, and consumers.

  11. Food safety in free-range and organic livestock systems: risk management and responsibility.

    PubMed

    Kijlstra, A; Meerburg, B G; Bos, A P

    2009-12-01

    Animal production systems that offer outdoor access to the animals have become increasingly popular in the Western world due to the growing general discontent of consumers with conventional bioindustrial farming practices. These open production systems offer improved animal welfare but may create new problems for animal health, resulting in increased food safety risks from bacterial, viral, or parasitic infections or environmental contaminants. Examples of these new problems include increased Toxoplasma gondii infections in pigs and high dioxin levels in eggs from free-range hens. In this review, the relation between positive and negative points of free-range and organic livestock production systems is discussed with reference to production in The Netherlands. We investigated how proponents of more animal welfare friendly systems deal with potential negative issues in public and whether any risk communication is used. Generally, we found that the existence of a dilemma is disputed or avoided in communication with the consumer. This avoidance could be detrimental for public trust in alternative animal production systems, should problems occur. To prevent future problems, it will be necessary to communicate about the relevant types and sources of the food safety risks to the consumers. The responsibility for protecting food safety should be properly divided among the various parties involved: producers, processors, governments, nongovernmental organizations, and consumers. PMID:20003752

  12. 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

  13. 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)

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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.

  19. 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

  20. Health, safety and environmental risk of a gas pipeline in an oil exploring area of Gachsaran.

    PubMed

    Kalatpoor, Omid; Goshtasp, Kambiz; Khavaji, Solieman

    2011-01-01

    The purpose of this study was assessing health, safety and environmental risk of a gas transfer pipeline in an oily area of Gachsaran. In this method, we used the Kent's pipeline risk assessment method except that to facilitate using the method more practically some changes were exerted into Kent's method. A pipeline with 16 kilometers length was selected considering surrounding nature of the pipeline. It was divided into two sections. Analogous to Kent's method, in this method, parameters included: interested party's injuries, corrosion, design factor, incorrect operation index and consequence scoring. The difference here was that for consequence scoring we used ALOHA 5.6 software instead of Kent's pattern. Results showed that health, safety and environmental risks of section 2 (the next 13 kilometers of outgoing pipeline from gas station after the first 3 kilometers) were greater. It seems the main cause of gaining a bigger risk number was related to more activities of interested parties around section 2. Because all figures gathered from indexes are almost close to gather except third parties activity.

  1. 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. PMID:26245526

  2. 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.

  3. Drug safety in pregnancy: utopia or achievable prospect? Risk information, risk research and advocacy in Teratology Information Services.

    PubMed

    Schaefer, Christof

    2011-03-01

    Even though from preclinical testing to drug risk labeling, the situation with drugs in pregnancy has improved substantially since the thalidomide scandal, there is still an increasing need to provide healthcare professionals and patients with updated individualized risk information for clinical decision making. For the majority of drugs, clinical experience is still insufficient with respect to their safety in pregnancy. There is often uncertainty in how to interpret the available scientific data. Based on 20 years of experience with Teratology Information Services (TIS) cooperating in the European Network of Teratology Information Services (ENTIS) methods of risk interpretation, follow-up of exposed pregnancies through the consultation process and their evaluation is discussed. Vitamin K antagonists, isotretinoin and angiotensin (AT) II-receptor-antagonists are presented as examples of misinterpretation of drug risks and subjects of research based on observational clinical data recorded in TIS. As many TIS are poorly funded, advocacy is necessary by establishing contacts with decision makers in health politics and administration, informing them of the high return in terms of health outcomes and cost savings provided by TIS as reference institutions in clinical teratology.

  4. Food additive carrageenan: Part I: A critical review of carrageenan in vitro studies, potential pitfalls, and implications for human health and safety.

    PubMed

    McKim, James M

    2014-03-01

    Carrageenan (CGN) has been used as a safe food additive for several decades. Confusion over nomenclature, basic CGN chemistry, type of CGN tested, interspecies biology, and misinterpretation of both in vivo and in vitro data has resulted in the dissemination of incorrect information regarding the human safety of CGN. The issue is exacerbated when mechanistic data obtained from in vitro experiments are directly translated to human hazard and used for risk assessment. This can lead to information that is taken out of experimental context and reported as a definitive effect in humans. In recent years, the use of cell-based models has increased and their ability to provide key information regarding chemical or drug safety is well established. In many instances, these new alternative approaches have started to replace the need to use animals altogether. In vitro systems can be extremely useful for understanding subcellular targets and mechanisms of adverse effects. However, care must be exercised when extrapolating the in vitro findings to in vivo effects. Often, issues such as chemical identity and purity, relevant dose, pharmacokinetic properties, solubility, protein binding, adsorption to plastics, and the use of cell models that are biologically and mechanistically relevant are overlooked or ignored. When this occurs, in vitro findings can provide misleading information that is not causally linked to in vivo events in animals or in humans. To date, there has not been a comprehensive review of the CGN in vitro literature, which has reported a wide range of biochemical effects related to this compound. An extensive effort has been made to evaluate as much of this literature as possible. This review focuses on the in vitro observation, the unique chemistry of CGN, and potential pitfalls of in vitro models used for hazard identification. The discussion of the in vitro studies discussed this review are supported by numerous in vivo studies. This provides a unique

  5. Goodness-of-fit tests for the additive risk model with (p > 2)-dimensional time-invariant covariates.

    PubMed

    Kim, J; Song, M S; Lee, S

    1998-01-01

    This paper presents methods for checking the goodness-of-fit of the additive risk model with p(> 2)-dimensional time-invariant covariates. The procedures are an extension of Kim and Lee (1996) who developed a test to assess the additive risk assumption for two-sample censored data. We apply the proposed tests to survival data from South Wales nikel refinery workers. Simulation studies are carried out to investigate the performance of the proposed tests for practical sample sizes. PMID:9880997

  6. 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.

  7. 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.

  8. Social signals of safety and risk confer utility and have asymmetric effects on observers' choices.

    PubMed

    Chung, Dongil; Christopoulos, George I; King-Casas, Brooks; Ball, Sheryl B; Chiu, Pearl H

    2015-06-01

    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

  9. 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

  10. 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. PMID:12646733

  11. 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.

  12. Water safety training as a potential means of reducing risk of young children's drowning.

    PubMed Central

    Asher, K. N.; Rivara, F. P.; Felix, D.; Vance, L.; Dunne, R.

    1995-01-01

    OBJECTIVES: To determine the effects of training in swimming and water safety on young preschool-children's ability to recover safely from a simulated episode of falling into a swimming pool. DESIGN: Randomized trial of 12 or eight weeks' duration water safety and swimming lessons for children 24 to 42 months old. OUTCOME MEASURES: Swimming ability, deck behavior, water recovery, and swimming to side after jumping into pool were measured before, during, and after the training program. RESULTS: 109 children completed the study (61 in the 12 week group, 48 in the eight week group). The average age was 34.2 months, 54% were male. Swimming ability, deck behavior, water recovery, and jump and swim skills improved over baseline levels in both groups. By the end of training, the 12 week group improved more than the eight week group only in swimming ability. Improvements in water recovery and jump and swim skills were associated positively with changes in swimming ability. CONCLUSIONS: Swimming ability and safety skills of young preschool children can be improved through training. Such programs may offer some protection for children at risk of drowning and there was no indication that this program increased the risk of drowning. However, pool fencing, other barriers around water, and parental supervision still remain the most important prevention strategies to reduce drowning in young children. PMID:9346036

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

    PubMed

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

    2002-09-01

    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.

  14. [Risk Analysis applied to food safety in Brazil: prospects and challenges].

    PubMed

    Figueiredo, Ana Virgínia de Almeida; Miranda, Maria Spínola

    2011-04-01

    The scope of this case study is to discuss the ideas of the Brazilian Codex Alimentarius Committee (CCAB) coordinated by National Institute of Metrology, Standardization and Industrial Quality (Inmetro), with respect to the Codex Alimentarius norm on Risk Analysis (RA) applied to Food Safety. The objectives of this investigation were to identify and analyze the opinion of CCAB members on RA and to register their proposals for the application of this norm in Brazil, highlighting the local limitations and potential detected. CCAB members were found to be in favor of the Codex Alimentarius initiative of instituting an RA norm to promote the health safety of foods that circulate on the international market. There was a consensus that the Brazilian government should incorporate RA as official policy to improve the country's system of food control and leverage Brazilian food exports. They acknowledge that Brazil has the technical-scientific capacity to apply this norm, though they stressed several political and institutional limitations. The members consider RA to be a valid initiative for tackling risks in food, due to its ability to improve food safety control measures adopted by the government.

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

    PubMed

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

    2002-09-01

    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. PMID:12141993

  16. 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. PMID:27289391

  17. 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.

  18. 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.

  19. 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,…

  20. 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.

  1. [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.

  2. The risk of stillbirth and infant death by each additional week of expectant management stratified by maternal age

    PubMed Central

    Page, Jessica M.; Snowden, Jonathan M.; Cheng, Yvonne W.; Doss, Amy; Rosenstein, Melissa G.; Caughey, Aaron B.

    2016-01-01

    OBJECTIVE The objective of the study was to examine fetal/infant mortality by gestational age at term stratified by maternal age. STUDY DESIGN A retrospective cohort study was conducted using 2005 US national birth certificate data. For each week of term gestation, the risk of mortality associated with delivery was compared with composite mortality risk of expectant management. The expectant management measure included stillbirth and infant death. This expectant management risk was calculated to estimate the composite mortality risk with remaining pregnant an additional week by combining the risk of stillbirth during the additional week of pregnancy and infant death risk following delivery at the next week. Maternal age was stratified by 35 years or more compared with women younger than 35 years as well as subgroup analyses of younger than 20, 20–34, 35–39, or 40 years old or older. RESULTS The fetal/infant mortality risk of expectant management is greater than the risk of infant death at 39 weeks’ gestation in women 35 years old or older (15.2 vs 10.9 of 10,000, P < .05). In women younger than 35 years old, the risk of expectant management also exceeded that of infant death at 39 weeks (21.3 vs 18.8 of 10,000, P < .05). For women younger than 35 years old, the overall expectant management risk is influenced by higher infant death risk and does not rise significantly until 41 weeks compared with women 35 years old or older in which it increased at 40 weeks. CONCLUSION Risk varies by maternal age, and delivery at 39 weeks minimizes fetal/infant mortality for both groups, although the magnitude of the risk reduction is greater in older women. PMID:23707677

  3. 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.

  4. [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.

  5. Safety evaluation and risk assessment of the herbicide Roundup and its active ingredient, glyphosate, for humans.

    PubMed

    Williams, G M; Kroes, R; Munro, I C

    2000-04-01

    Reviews on the safety of glyphosate and Roundup herbicide that have been conducted by several regulatory agencies and scientific institutions worldwide have concluded that there is no indication of any human health concern. Nevertheless, questions regarding their safety are periodically raised. This review was undertaken to produce a current and comprehensive safety evaluation and risk assessment for humans. It includes assessments of glyphosate, its major breakdown product [aminomethylphosphonic acid (AMPA)], its Roundup formulations, and the predominant surfactant [polyethoxylated tallow amine (POEA)] used in Roundup formulations worldwide. The studies evaluated in this review included those performed for regulatory purposes as well as published research reports. The oral absorption of glyphosate and AMPA is low, and both materials are eliminated essentially unmetabolized. Dermal penetration studies with Roundup showed very low absorption. Experimental evidence has shown that neither glyphosate nor AMPA bioaccumulates in any animal tissue. No significant toxicity occurred in acute, subchronic, and chronic studies. Direct ocular exposure to the concentrated Roundup formulation can result in transient irritation, while normal spray dilutions cause, at most, only minimal effects. The genotoxicity data for glyphosate and Roundup were assessed using a weight-of-evidence approach and standard evaluation criteria. There was no convincing evidence for direct DNA damage in vitro or in vivo, and it was concluded that Roundup and its components do not pose a risk for the production of heritable/somatic mutations in humans. Multiple lifetime feeding studies have failed to demonstrate any tumorigenic potential for glyphosate. Accordingly, it was concluded that glyphosate is noncarcinogenic. Glyphosate, AMPA, and POEA were not teratogenic or developmentally toxic. There were no effects on fertility or reproductive parameters in two multigeneration reproduction studies with

  6. Safety and efficacy of the addition of simvastatin to panitumumab in previously treated KRAS mutant metastatic colorectal cancer patients.

    PubMed

    Baas, Jara M; Krens, Lisanne L; Bos, Monique M; Portielje, Johanneke E A; Batman, Erdogan; van Wezel, Tom; Morreau, Hans; Guchelaar, Henk-Jan; Gelderblom, Hans

    2015-09-01

    Panitumumab has proven efficacy in patients with metastatic or locally advanced colorectal cancer patients, provided that they have no activating KRAS mutation in their tumour. Simvastatin blocks the mevalonate pathway and thereby interferes with the post-translational modification of KRAS. We hypothesize that the activity of the RAS-induced pathway in patients with a KRAS mutation might be inhibited by simvastatin. This would theoretically result in increased sensitivity to panitumumab, potentially comparable with tumours with wild-type KRAS. A Simon two-stage design single-arm, phase II study was designed to test the safety and efficacy of the addition of simvastatin to panitumumab in colorectal cancer patients with a KRAS mutation after failing fluoropyrimidine-based, oxaliplatin-based and irinotecan-based therapy. The primary endpoint of this study was the proportion of patients alive and free from progression 11 weeks after the first administration of panitumumab, aiming for at least 40%, which is comparable with, although slightly lower than, that in KRAS wild-type patients in this setting. If this 40% was reached, then the study would continue into the second step up to 46 patients. Explorative correlative analysis for mutations in the KRAS and related pathways was carried out. One of 14 patients was free from progression at the primary endpoint time. The median progression-free survival was 8.4 weeks and the median overall survival status was 19.6 weeks. We conclude that the concept of mutant KRAS phenotype expression modulation with simvastatin was not applicable in the clinic.

  7. Increased Risk of Additional Cancers Among Patients with Gastrointestinal Stromal Tumors: A Population-Based Study

    PubMed Central

    Murphy, James D.; Ma, Grace L.; Baumgartner, Joel M.; Madlensky, Lisa; Burgoyne, Adam M.; Tang, Chih-Min; Martinez, Maria Elena; Sicklick, Jason K.

    2015-01-01

    Purpose Most gastrointestinal stromal tumors (GIST) are considered non-hereditary or sporadic. However, single-institution studies suggest that GIST patients develop additional malignancies with increased frequencies. We hypothesized that we could gain greater insight into possible associations between GIST and other malignancies using a national cancer database inquiry. Methods Patients diagnosed with GIST (2001–2011) in the Surveillance, Epidemiology, and End Results database were included. Standardized prevalence ratios (SPRs) and standardized incidence ratios (SIRs) were used to quantify cancer risks incurred by GIST patients before and after GIST diagnoses, respectively, when compared with the general U.S. population. Results Of 6,112 GIST patients, 1,047 (17.1%) had additional cancers. There were significant increases in overall cancer rates: 44% (SPR=1.44) before diagnosis and 66% (SIR=1.66) after GIST diagnoses. Malignancies with significantly increased occurrence both before/after diagnoses included other sarcomas (SPR=5.24/SIR=4.02), neuroendocrine-carcinoid tumors (SPR=3.56/SIR=4.79), non-Hodgkin’s lymphoma (SPR=1.69/SIR=1.76), and colorectal adenocarcinoma (SPR=1.51/SIR=2.16). Esophageal adenocarcinoma (SPR=12.0), bladder adenocarcinoma (SPR=7.51), melanoma (SPR=1.46), and prostate adenocarcinoma (SPR=1.20) were significantly more common only before GIST. Ovarian carcinoma (SIR=8.72), small intestine adenocarcinoma (SIR=5.89), papillary thyroid cancer (SIR=5.16), renal cell carcinoma (SIR=4.46), hepatobiliary adenocarcinomas (SIR=3.10), gastric adenocarcinoma (SIR=2.70), pancreatic adenocarcinoma (SIR=2.03), uterine adenocarcinoma (SIR=1.96), non-small cell lung cancer (SIR=1.74), and transitional cell carcinoma of the bladder (SIR=1.65) were significantly more common only after GIST. Conclusion This is the first population-based study to characterize the associations and temporal relationships between GIST and other cancers, both by site and

  8. 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.

  9. Conclusions from a probabilistic safety analysis for FRJ-2 (DIDO) and realization of risk minimization measures

    SciTech Connect

    Wolters, J.; Nabbi, R.

    1997-12-01

    Feed and bleed cooling of the FRJ-2 research reactor can reduce the risk of core damage considerably as a probabilistic safety analysis has revealed. The question whether water circulation via the core would be maintained when the water in the tank has reached saturation point has been answered positively by an investigation with the thermohydraulic code CATHENA. A siphon with a water column and the special feature of self-acting restoration of the column after depressurization proved well during tests and will be installed as the relief equipment required to blow off the steam produced by the residual heat of the core during bleed cooling. 4 refs., 9 tabs.

  10. 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

  11. 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

  12. Steps to prevent SUDEP: the validity of risk factors in the SUDEP and seizure safety checklist: a case control study.

    PubMed

    Shankar, Rohit; Walker, Matthew; McLean, Brendan; Laugharne, Richard; Ferrand, Fucundo; Hanna, Jane; Newman, Craig

    2016-09-01

    Our objectives were to compare people with epilepsy (PWE) who died of sudden unexpected death in epilepsy (SUDEP) with live controls using the risk factor items of the SUDEP and Seizure Safety Checklist. All 48 SUDEPs of 93 epilepsy deaths which occurred in Cornwall UK 2004-2012 were compared to 220 live controls using the SUDEP and Seizure Safety Checklist, an evidenced based tool used to communicate person centered risk of SUDEP to PWE. The odds ratio for having a specific factor in those who died was compared to controls and ranked according to P value using a sequential Bonferroni correction for multiple comparisons. Of the 17 modifiable and non-modifiable risk factors analyzed 9 were statistically significant of which 7 are potentially modifiable. Well known modifiable factors such as nocturnal monitoring, compliance and sleeping position featured prominently in the risk association. This is the first case control study exploring the risk factors for SUDEP since 2009. The findings are compared to the current considered risk factors as identified in a major recent review. The study further validates certain SUDEP risk factors. It highlights that the majority of risk factors strongly associated with SUDEP are potentially modifiable. There is an emerging profile to rank the risk factors. It furthers the evidence to use structured risk assessment and communication tools such as the SUDEP and Seizure Safety Checklist in daily clinical practice. It highlights key areas for a person centered discussion to empower PWE to mitigate risk. PMID:27334909

  13. 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

  14. 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. PMID:23487557

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

    PubMed Central

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

    2013-01-01

    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. PMID:23487557

  16. Risk-Informing Safety Reviews for Non-Reactor Nuclear Facilities

    SciTech Connect

    Mubayi, V.; Azarm, A.; Yue, M.; Mukaddam, W.; Good, G.; Gonzalez, F.; Bari, R.A.

    2011-03-13

    This paper describes a methodology used to model potential accidents in fuel cycle facilities that employ chemical processes to separate and purify nuclear materials. The methodology is illustrated with an example that uses event and fault trees to estimate the frequency of a specific energetic reaction that can occur in nuclear material processing facilities. The methodology used probabilistic risk assessment (PRA)-related tools as well as information about the chemical reaction characteristics, information on plant design and operational features, and generic data about component failure rates and human error rates. The accident frequency estimates for the specific reaction help to risk-inform the safety review process and assess compliance with regulatory requirements.

  17. 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

  18. 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.

  19. 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. PMID:26724505

  20. 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.

  1. 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.

  2. [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. PMID:27173908

  3. [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.

  4. 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

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

    PubMed

    Sánchez, Cecilia A; Baker, Michelle L

    2016-02-01

    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 rescue

  6. 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.

  7. The effects of risk perception and flight experience on airline pilots' locus of control with regard to safety operation behaviors.

    PubMed

    You, Xuqun; Ji, Ming; Han, Haiyan

    2013-08-01

    The primary objective of this paper was to integrate two research traditions, social cognition approach and individual state approach, and to understand the relationships between locus of control (LOC), risk perception, flight time, and safety operation behavior (SOB) among Chinese airline pilots. The study sample consisted of 193 commercial airline pilots from China Southern Airlines Ltd. The results showed that internal locus of control directly affected pilot safety operation behavior. Risk perception seemed to mediate the relationship between locus of control and safety operation behaviors, and total flight time moderated internal locus of control. Thus, locus of control primarily influences safety operation behavior indirectly by affecting risk perception. The total effect of internal locus of control on safety behaviors is larger than that of external locus of control. Furthermore, the safety benefit of flight experience is more pronounced among pilots with high internal loci of control in the early and middle flight building stages. Practical implications for aviation safety and directions for future research are also discussed.

  8. 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.

  9. 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

  10. 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. PMID:24426015

  11. 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.

  12. 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.

  13. Managing children's risk of injury in the home: does parental teaching about home safety reduce young children's hazard interactions?

    PubMed

    Morrongiello, Barbara A; McArthur, Brae Anne; Bell, Melissa

    2014-10-01

    Past research confirms that parents extend much effort to teach their young children about safety, but little is known about this process. The present study examined mothers' use of teaching as a strategy to manage young children's risk of home injury and how this impacts children's hazard interactions. Mothers of three-year-olds completed an in-home room-by-room interview in which they identified injury hazards that concern them, reported on use of teaching to manage risk of injury from these hazards, rated children's understanding of these safety issues and compliance with behavioral guidelines regarding these safety issues, and reported on children's recent interactions with these hazards. They also completed questionnaire measures of how difficult the child is to manage and the child's typical level of risk taking. Results revealed that children's understanding of safety impacted both their compliance and hazard interactions, moderating the impact of risk taking on compliance and also the impact of children's difficult-to-manage score on hazard interactions. These findings demonstrate that teaching strategies need to effectively enhance children's understanding of the safety issue in order to reduce children's risk of hazard interactions.

  14. [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

  15. [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

  16. How to interpret a small increase in AUC with an additional risk prediction marker: decision analysis comes through.

    PubMed

    Baker, Stuart G; Schuit, Ewoud; Steyerberg, Ewout W; Pencina, Michael J; Vickers, Andrew; Vickers, Andew; Moons, Karel G M; Mol, Ben W J; Lindeman, Karen S

    2014-09-28

    An important question in the evaluation of an additional risk prediction marker is how to interpret a small increase in the area under the receiver operating characteristic curve (AUC). Many researchers believe that a change in AUC is a poor metric because it increases only slightly with the addition of a marker with a large odds ratio. Because it is not possible on purely statistical grounds to choose between the odds ratio and AUC, we invoke decision analysis, which incorporates costs and benefits. For example, a timely estimate of the risk of later non-elective operative delivery can help a woman in labor decide if she wants an early elective cesarean section to avoid greater complications from possible later non-elective operative delivery. A basic risk prediction model for later non-elective operative delivery involves only antepartum markers. Because adding intrapartum markers to this risk prediction model increases AUC by 0.02, we questioned whether this small improvement is worthwhile. A key decision-analytic quantity is the risk threshold, here the risk of later non-elective operative delivery at which a patient would be indifferent between an early elective cesarean section and usual care. For a range of risk thresholds, we found that an increase in the net benefit of risk prediction requires collecting intrapartum marker data on 68 to 124 women for every correct prediction of later non-elective operative delivery. Because data collection is non-invasive, this test tradeoff of 68 to 124 is clinically acceptable, indicating the value of adding intrapartum markers to the risk prediction model.

  17. How to interpret a small increase in AUC with an additional risk prediction marker: Decision analysis comes through

    PubMed Central

    Baker, Stuart G.; Schuit, Ewoud; Steyerberg, Ewout W.; Pencina, Michael J.; Vickers, Andew; Moons, Karel G. M.; Mol, Ben W.J.; Lindeman, Karen S.

    2014-01-01

    An important question in the evaluation of an additional risk prediction marker is how to interpret a small increase in the area under the receiver operating characteristic curve (AUC). Many researchers believe that a change in AUC is a poor metric because it increases only slightly with the addition of a marker with a large odds ratio. Because it is not possible on purely statistical grounds to choose between the odds ratio and AUC, we invoke decision analysis, which incorporates costs and benefits. For example a timely estimate of the risk of later non-elective operative delivery can help a woman in labor decide if she wants an early elective cesarean section to avoid greater complications from possible later non-elective operative delivery. A basic risk prediction model for later non-elective operative delivery involves only antepartum markers. Because adding intrapartum markers to this risk prediction model increases AUC by 0.02, we questioned whether this small improvement is worthwhile. A key decision-analytic quantity is the risk threshold, here the risk of later non-elective operative delivery at which a patient would be indifferent between an early elective cesarean section and usual care. For a range of risk thresholds, we found that an increase in the net benefit of risk prediction requires collecting intrapartum marker data on 68 to 124 women for every correct prediction of later non-elective operative delivery. Because data collection is non-invasive, this test tradeoff of 68 to 124 is clinically acceptable, indicating the value of adding intrapartum markers to the risk prediction model. PMID:24825728

  18. 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

  19. 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), ...

  20. Historical Data Enhances Safety Supervision System Performance in T1DM Insulin Therapy Risk Management★

    PubMed Central

    Hughes-Karvetski, Colleen; Patek, Stephen D.; Breton, Marc D.; Kovatchev, Boris P.

    2012-01-01

    Safety measures to prevent or mitigate hypoglycemia are an important component of open loop, closed loop, and advisory mode insulin therapy control settings in type 1 diabetes. In recent work, we introduce a method for the automatic, gradual attenuation of the insulin pump delivery rate when a risk of hypoglycemia is detected, a method that we refer to as brakes. In the methods presented here, we demonstrate the use of historical glucose measurement data to inform and enhance the ability of the brakes to prevent hypoglycemia in real-time. The updated brakes are based on a patient-specific, time-varying model that reflects the typical trajectory of glycemic fluctuations throughout the day. Historical heightened risk of hypoglycemia throughout the day prompts an increase in the aggressiveness of insulin attenuation as compared to the original brakes that are based on real-time data alone. Through the use of available real-time data supplemented with historical glucose information to assess hypoglycemic risk, we are able to better anticipate and prevent hypoglycemia. PMID:22342221

  1. From Barnyard to Food Table: the Omnipresence of Hepatitis E virus and Risk for Zoonotic Infection and Food Safety

    PubMed Central

    Meng, Xiang-Jin

    2011-01-01

    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. PMID:21316404

  2. [Food additives and genetically modified food--a risk for allergic patients?].

    PubMed

    Wüthrich, B

    1999-04-01

    Adverse reactions to food and food additives must be classified according to pathogenic criteria. It is necessary to strictly differentiate between an allergy, triggered by a substance-specific immunological mechanism, and an intolerance, in which no specific immune reaction can be established. In contrast to views expressed in the media, by laymen and patients, adverse reactions to additives are less frequent than is believed. Due to frequently "alternative" methods of examination, an allergy to food additives is often wrongly blamed as the cause of a wide variety of symptoms and illness. Diagnosing an allergy or intolerance to additives normally involves carrying out double-blind, placebo-controlled oral provocation tests with food additives. Allergic reactions to food additives occur particularly against additives which are organic in origin. In principle, it is possible that during the manufacture of genetically modified plants and food, proteins are transferred which potentially create allergies. However, legislation exists both in the USA (Federal Drug Administration, FDA) and in Switzerland (Ordinance on the approval process for GM food, GM food additives and GM accessory agents for processing) which require a careful analysis before a genetically modified product is launched, particularly where foreign genes are introduced. Products containing genetically modified organisms (GMO) as additives must be declared. In addition, the source of the foreign protein must be identified. The "Round-up ready" (RR) soya flour introduced in Switzerland is no different from natural soya flour in terms of its allergenic potential. Genetically modified food can be a blessing for allergic individuals if gene technology were to succeed in removing the allergen (e.g. such possibilities exist for rice). The same caution shown towards genetically modified food might also be advisable for foreign food in our diet. Luckily, the immune system of the digestive tract in healthy people

  3. [Food additives and genetically modified food--a risk for allergic patients?].

    PubMed

    Wüthrich, B

    1999-04-01

    Adverse reactions to food and food additives must be classified according to pathogenic criteria. It is necessary to strictly differentiate between an allergy, triggered by a substance-specific immunological mechanism, and an intolerance, in which no specific immune reaction can be established. In contrast to views expressed in the media, by laymen and patients, adverse reactions to additives are less frequent than is believed. Due to frequently "alternative" methods of examination, an allergy to food additives is often wrongly blamed as the cause of a wide variety of symptoms and illness. Diagnosing an allergy or intolerance to additives normally involves carrying out double-blind, placebo-controlled oral provocation tests with food additives. Allergic reactions to food additives occur particularly against additives which are organic in origin. In principle, it is possible that during the manufacture of genetically modified plants and food, proteins are transferred which potentially create allergies. However, legislation exists both in the USA (Federal Drug Administration, FDA) and in Switzerland (Ordinance on the approval process for GM food, GM food additives and GM accessory agents for processing) which require a careful analysis before a genetically modified product is launched, particularly where foreign genes are introduced. Products containing genetically modified organisms (GMO) as additives must be declared. In addition, the source of the foreign protein must be identified. The "Round-up ready" (RR) soya flour introduced in Switzerland is no different from natural soya flour in terms of its allergenic potential. Genetically modified food can be a blessing for allergic individuals if gene technology were to succeed in removing the allergen (e.g. such possibilities exist for rice). The same caution shown towards genetically modified food might also be advisable for foreign food in our diet. Luckily, the immune system of the digestive tract in healthy people

  4. 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

  5. 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

  6. [OCCUPATIONAL HEALTH RISK ASSESSMENT AND MANAGEMENT IN WORKERS IN IMPROVEMENT OF NATIONAL POLICY IN OCCUPATIONAL HYGIENE AND SAFETY].

    PubMed

    Shur, P Z; Zaĭtseva, N V; Alekseev, V B; Shliapnikov, D M

    2015-01-01

    In accordance with the international documents in the field of occupational safety and hygiene, the assessment and minimization of occupational risks is a key instrument for the health maintenance of workers. One of the main ways to achieve it is the minimization of occupational risks. Correspondingly, the instrument for the implementation of this method is the methodology of analysis of occupational risks. In Russian Federation there were the preconditions for the formation of the system for the assessment and management of occupational risks. As the target of the national (state) policy in the field of occupational safety in accordance with ILO Conventions it can be offered the prevention of accidents and injuries to health arising from work or related with it, minimizing the causes of hazards inherent in the working environment, as far as it is reasonably and practically feasible. Global trend ofusing the methodology of the assessment and management of occupational risks to life and health of citizens requires the improvement of national policies in the field of occupational hygiene and safety. Achieving an acceptable level of occupational risk in the formation of national policy in the field of occupational hygiene and safety can be considered as one of the main tasks. PMID:26155652

  7. 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

  8. 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.

  9. 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. PMID:25347684

  10. How to evaluate the risks of work equipment and installations for health and safety? Research and activities of the German Committee for Plant Safety and consequences for regulation.

    PubMed

    Pieper, R

    2012-01-01

    Work equipment and installations with a high risk for health and safety of employees should be paid a special attention. The German Product Safety Act, which is aimed to manufacturers or distributors in order to protect consumers, maintains a conclusive catalogue of these so-called "installations in need of monitoring" fixing the work equipment and installations for which such special inspections can be demanded. This catalogue has remained unchanged for decades and has been transformed nearly unmodified into the Plant Safety Ordinance. Currently, there is a discussion about this catalogue in Germany. A major point of concern is the definition and the significance of "especially" dangerous work equipment and installations. Two recent research projects are dealing with the problem how to define "especially".

  11. Combination and Selection of Traffic Safety Expert Judgments for the Prevention of Driving Risks

    PubMed Central

    Cabello, Enrique; Conde, Cristina; de Diego, Isaac Martín; Moguerza, Javier M.; Redchuk, Andrés

    2012-01-01

    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. PMID:23202184

  12. Methods of Articulating and Managing Earthquake Risk Used by the CA Seismic Safety Commission

    NASA Astrophysics Data System (ADS)

    Turner, F.

    2005-12-01

    The California Seismic Safety Commission is a public policy advisory agency of state government. It uses several approaches to measuring progress, assigning priorities, and identifying earthquake risk management issues since its formation 30 years ago. Most issues are measured anecdotally and priorities are set by judgment. However, a few programs have measurement and monitoring systems in place such as the state's unreinforced masonry building retrofit program which issues biannual progress reports with mitigation rates for each local government. Other approaches include tracking large earthquake mitigation projects, and identifying gaps in efforts. These are summarized in the state's Multi-Hazard Mitigation Plan, Chapter 4 and its appendices as well as the California Earthquake Loss Reduction Plan which will be desribed briefly in this paper.

  13. 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.

  14. The effect of rights-based fisheries management on risk taking and fishing safety.

    PubMed

    Pfeiffer, Lisa; Gratz, Trevor

    2016-03-01

    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.

  15. 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

  16. The effect of rights-based fisheries management on risk taking and fishing safety.

    PubMed

    Pfeiffer, Lisa; Gratz, Trevor

    2016-03-01

    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

  17. 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. PMID:24214493

  18. 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

  19. Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy.

    PubMed

    Ní Ainle, Fionnuala; Wong, Audris; Appleby, Niamh; Byrne, Brigitte; Regan, Carmen; Hassan, Tayyaba; Milner, Marie; Sullivan, Ann O; White, Barry; O'Donnell, James

    2008-10-01

    Low molecular weight heparin (LMWH) is widely regarded as the anticoagulant treatment of choice for the prevention and treatment of venous thromboembolism during pregnancy. However, previous studies have demonstrated that the pharmacokinetic profiles of LMWH vary significantly with increasing gestation. Consequently, it remains unclear whether LMWH regimens recommended for use in nonpregnant individuals can be safely extrapolated to pregnant women. The aims of this study were to assess the safety and the efficacy of tinzaparin sodium (Innohep) administered only once daily during pregnancy. A systematic retrospective review identified a cohort of 37 high-risk pregnancies which had been managed using tinzaparin 175 IU/kg once daily. In 26 cases, the index pregnancy had been complicated by development of an acute venous thromboembolism (17 deep vein thrombosis and nine pulmonary embolism). For each individual, case notes were examined and data extracted using a predetermined questionnaire. No episodes of recurrent venous thromboembolism were identified amongst this cohort of pregnancies managed using once daily LMWH administration. However, two unusual thrombotic complications were observed, including a parietal infarct in one patient, and a postpartum cerebral venous thrombosis in another. Once daily tinzaparin was well tolerated, with no cases of heparin-induced thrombocytopaenia, symptomatic osteoporosis, or foetal malformations. Tinzaparin dose modification based upon peak anti-Xa levels occurred in 45% of the cases examined. The present study is the largest study to have examined the clinical efficacy of once daily LMWH for use in pregnant women at high risk of venous thromboembolism. Our data support the safety and efficacy of antenatal tinzaparin at a dose of 175 IU/kg. In order to determine whether this once daily regimen provides equivalent (or indeed greater) thromboprophylaxis to twice daily LMWH regimens during pregnancy will require highly powered direct

  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. 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.

  2. 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.

  3. 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. PMID:16910351

  4. 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. PMID:19364084

  5. Changes in diet, cardiovascular risk factors and modelled cardiovascular risk following diagnosis of diabetes: 1-year results from the ADDITION-Cambridge trial cohort

    PubMed Central

    Savory, L A; Griffin, S J; Williams, K M; Prevost, A T; Kinmonth, A-L; Wareham, N J; Simmons, R K

    2014-01-01

    Aims To describe change in self-reported diet and plasma vitamin C, and to examine associations between change in diet and cardiovascular disease risk factors and modelled 10-year cardiovascular disease risk in the year following diagnosis of Type 2 diabetes. Methods Eight hundred and sixty-seven individuals with screen-detected diabetes underwent assessment of self-reported diet, plasma vitamin C, cardiovascular disease risk factors and modelled cardiovascular disease risk at baseline and 1 year (n = 736) in the ADDITION-Cambridge trial. Multivariable linear regression was used to quantify the association between change in diet and cardiovascular disease risk at 1 year, adjusting for change in physical activity and cardio-protective medication. Results Participants reported significant reductions in energy, fat and sodium intake, and increases in fruit, vegetable and fibre intake over 1 year. The reduction in energy was equivalent to an average-sized chocolate bar; the increase in fruit was equal to one plum per day. There was a small increase in plasma vitamin C levels. Increases in fruit intake and plasma vitamin C were associated with small reductions in anthropometric and metabolic risk factors. Increased vegetable intake was associated with an increase in BMI and waist circumference. Reductions in fat, energy and sodium intake were associated with reduction in HbA1c, waist circumference and total cholesterol/modelled cardiovascular disease risk, respectively. Conclusions Improvements in dietary behaviour in this screen-detected population were associated with small reductions in cardiovascular disease risk, independently of change in cardio-protective medication and physical activity. Dietary change may have a role to play in the reduction of cardiovascular disease risk following diagnosis of diabetes. PMID:24102972

  6. 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. PMID:25086439

  7. Framework for microbial food-safety risk assessments amenable to Bayesian modeling.

    PubMed

    Williams, Michael S; Ebel, Eric D; Vose, David

    2011-04-01

    Regulatory agencies often perform microbial risk assessments to evaluate the change in the number of human illnesses as the result of a new policy that reduces the level of contamination in the food supply. These agencies generally have regulatory authority over the production and retail sectors of the farm-to-table continuum. Any predicted change in contamination that results from new policy that regulates production practices occurs many steps prior to consumption of the product. This study proposes a framework for conducting microbial food-safety risk assessments; this framework can be used to quantitatively assess the annual effects of national regulatory policies. Advantages of the framework are that estimates of human illnesses are consistent with national disease surveillance data (which are usually summarized on an annual basis) and some of the modeling steps that occur between production and consumption can be collapsed or eliminated. The framework leads to probabilistic models that include uncertainty and variability in critical input parameters; these models can be solved using a number of different Bayesian methods. The Bayesian synthesis method performs well for this application and generates posterior distributions of parameters that are relevant to assessing the effect of implementing a new policy. An example, based on Campylobacter and chicken, estimates the annual number of illnesses avoided by a hypothetical policy; this output could be used to assess the economic benefits of a new policy. Empirical validation of the policy effect is also examined by estimating the annual change in the numbers of illnesses observed via disease surveillance systems.

  8. Occupational exposures and risk of hepatitis B virus infection among public safety workers.

    PubMed

    Averhoff, Francisco M; Moyer, Linda A; Woodruff, Bradley A; Deladisma, Adeline M; Nunnery, Joni; Alter, Miriam J; Margolis, Harold S

    2002-06-01

    We conducted a questionnaire and seroprevalence survey to determine the frequency and type of occupational exposures (OEs) and the risk of hepatitis B virus (HBV) infection experienced by public safety workers (PSWs). Of the 2910 PSWs who completed the survey, 6.8% reported at least one OE in the previous 6 months, including needlestick (1.0%), being cut with a contaminated object (2.8%), mucous membrance exposure to blood (0.9%), and being bitten by a human (3.5%). The rate of OE varied by occupation with 2.7% of firefighters, 3.2% of sheriff officers, 6.6% of corrections officers, and 7.4% of police officers reporting > or = 1 OE (P < 0.001). The HBV infection prevalence was 8.6%, and after adjustment for age and race, it was comparable to the overall US prevalence and did not vary by occupation. By multivariate analysis, HBV infection was not associated with any OEs, but it was associated with older age, being nonwhite, and a previous history of a sexually transmitted disease. This study demonstrated that although OEs are not uncommon among PSWs, HBV infection was more likely to be associated with nonoccupational risk factors. Administration of hepatitis B vaccine to PSWs early in their careers will prevent HBV infection associated with occupational and non-OEs. PMID:12085488

  9. 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.

  10. 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.

  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. The impact of the OECD on the development of national/international risk/safety assessment frameworks.

    PubMed

    Gaugitsch, Helmut

    2006-01-01

    The role of OECD in the development of national and international risk/safety assessment frameworks is presented and discussed. The most relevant OECD bodies in this context have contributed a lot to the development of international biosafety frameworks, inter alia by organizing international conferences in the areas of food/feed and environmental safety of GMOs, focusing on practical and current scientific issues. The OECD Consensus Documents as well as the OECD Product Database have provided a good basis for risk/safety assessment frameworks and their implementation. The relevance for the OECD work in the international area is discussed, in particular, with respect to the work undertaken under the Cartagena Protocol on Biosafety, the Codex Alimentarius Commission and its work in biotechnology, as well as under the International Plant Protection Convention. An outlook and suggestions for future directions of OECD work in this area are presented.

  13. 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. PMID:25424034

  14. 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

  15. 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.

  16. Safety assessment of biotechnology products for potential risk of food allergy: implications of new research.

    PubMed

    Selgrade, MaryJane K; Bowman, Christal C; Ladics, Gregory S; Privalle, Laura; Laessig, Susan A

    2009-07-01

    Food allergy is a potential risk associated with use of transgenic proteins in crops. Currently, safety assessment involves consideration of the source of the introduced protein, in silico amino acid sequence homology comparisons to known allergens, physicochemical properties, protein abundance in the crop, and, when appropriate, specific immunoglobulin E binding studies. Recently conducted research presented at an International Life Sciences Institute/Health and Environmental Sciences Institute-hosted workshop adds to the scientific foundation for safety assessment of transgenic proteins in five areas: structure/activity, serum screening, animal models, quantitative proteomics, and basic mechanisms. A web-based tool is now available that integrates a database of allergenic proteins with a variety of computational tools which could be used to improve our ability to predict allergenicity based on structural analysis. A comprehensive strategy and model protocols have been developed for conducting meaningful serum screening, an extremely challenging process. Several animal models using oral sensitization with adjuvant and one dermal sensitization model have been developed and appear to distinguish allergenic from non-allergenic food extracts. Data presented using a mouse model suggest that pepsin resistance is indicative of allergenicity. Certain questions remain to be addressed before considering animal model validation. Gel-free mass spectrometry is a viable alternative to more labor-intensive approaches to quantitative proteomics. Proteomic data presented on four nontransgenic varieties of soy suggested that if known allergen expression in genetically modified crops falls within the range of natural variability among commercial varieties, there appears to be no need to test further. Finally, basic research continues to elucidate the etiology of food allergy. PMID:19363142

  17. Safety assessment of biotechnology products for potential risk of food allergy: implications of new research.

    PubMed

    Selgrade, MaryJane K; Bowman, Christal C; Ladics, Gregory S; Privalle, Laura; Laessig, Susan A

    2009-07-01

    Food allergy is a potential risk associated with use of transgenic proteins in crops. Currently, safety assessment involves consideration of the source of the introduced protein, in silico amino acid sequence homology comparisons to known allergens, physicochemical properties, protein abundance in the crop, and, when appropriate, specific immunoglobulin E binding studies. Recently conducted research presented at an International Life Sciences Institute/Health and Environmental Sciences Institute-hosted workshop adds to the scientific foundation for safety assessment of transgenic proteins in five areas: structure/activity, serum screening, animal models, quantitative proteomics, and basic mechanisms. A web-based tool is now available that integrates a database of allergenic proteins with a variety of computational tools which could be used to improve our ability to predict allergenicity based on structural analysis. A comprehensive strategy and model protocols have been developed for conducting meaningful serum screening, an extremely challenging process. Several animal models using oral sensitization with adjuvant and one dermal sensitization model have been developed and appear to distinguish allergenic from non-allergenic food extracts. Data presented using a mouse model suggest that pepsin resistance is indicative of allergenicity. Certain questions remain to be addressed before considering animal model validation. Gel-free mass spectrometry is a viable alternative to more labor-intensive approaches to quantitative proteomics. Proteomic data presented on four nontransgenic varieties of soy suggested that if known allergen expression in genetically modified crops falls within the range of natural variability among commercial varieties, there appears to be no need to test further. Finally, basic research continues to elucidate the etiology of food allergy.

  18. 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. PMID:26542377

  19. 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

  20. 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.

  1. 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.

  2. Probiotics as Additives on Therapy in Allergic Airway Diseases: A Systematic Review of Benefits and Risks

    PubMed Central

    Das, Rashmi Ranjan; Naik, Sushree Samiksha; Singh, Meenu

    2013-01-01

    Background. We conducted a systematic review to find out the role of probiotics in treatment of allergic airway diseases.  Methods. A comprehensive search of the major electronic databases was done till March 2013. Trials comparing the effect of probiotics versus placebo were included. A predefined set of outcome measures were assessed. Continuous data were expressed as standardized mean difference with 95% CI. Dichotomous data were expressed as odds ratio with 95% CI. P value < 0.05 was considered as significant. Results. A total of 12 studies were included. Probiotic intake was associated with a significantly improved quality of life score in patients with allergic rhinitis (SMD −1.9 (95% CI −3.62, −0.19); P = 0.03), though there was a high degree of heterogeneity. No improvement in quality of life score was noted in asthmatics. Probiotic intake also improved the following parameters: longer time free from episodes of asthma and rhinitis and decrease in the number of episodes of rhinitis per year. Adverse events were not significant. Conclusion. As the current evidence was generated from few trials with high degree of heterogeneity, routine use of probiotics as an additive on therapy in subjects with allergic airway diseases cannot be recommended. PMID:23956972

  3. 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.

  4. 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. PMID:23793111

  5. Patient safety and minimizing risk with insulin administration - role of insulin degludec.

    PubMed

    Aye, Myint M; Atkin, Stephen L

    2014-01-01

    Diabetes is a lifelong condition requiring ongoing medical care and patient self-management. Exogenous insulin therapy is essential in type 1 diabetes and becomes a necessity in patients with longstanding type 2 diabetes who fail to achieve optimal control with lifestyle modification, oral agents, and glucagon-like peptide 1-based therapy. One of the risks that hinders insulin use is hypoglycemia. Optimal insulin therapy should therefore minimize the risk of hypoglycemia while improving glycemic control. Insulin degludec (IDeg) is a novel basal insulin that, following subcutaneous injection, assembles into a depot of soluble multihexamer chains. These subsequently release IDeg monomers that are absorbed at a slow and steady rate into the circulation, with the terminal half-life of IDeg being ~25 hours. Thus, it requires only once-daily dosing unlike other basal insulin preparations that often require twice-daily dosing. Despite its long half-life, once-daily IDeg does not cause accumulation of insulin in the circulation after reaching steady state. IDeg once a day will produce a steady-state profile with a lower peak:trough ratio than other basal insulins. In clinical trials, this profile translates into a lower frequency of nocturnal hypoglycemia compared with insulin glargine, as well as an ability to allow some flexibility in dose timing without compromising efficacy and safety. Indeed, a study that tested the extremes of dosing intervals of 8 and 40 hours showed no detriment in either glycemic control or hypoglycemic frequency versus insulin glargine given at the same time each day. While extreme flexibility in dose timing is not recommended, these findings are reassuring. This may be particularly beneficial to elderly patients, patients with learning difficulties, or others who have to rely on health-care professionals for their daily insulin injections. Further studies are required to confirm whether this might benefit adherence to treatment, reduce long

  6. Patient safety and minimizing risk with insulin administration – role of insulin degludec

    PubMed Central

    Aye, Myint M; Atkin, Stephen L

    2014-01-01

    Diabetes is a lifelong condition requiring ongoing medical care and patient self-management. Exogenous insulin therapy is essential in type 1 diabetes and becomes a necessity in patients with longstanding type 2 diabetes who fail to achieve optimal control with lifestyle modification, oral agents, and glucagon-like peptide 1-based therapy. One of the risks that hinders insulin use is hypoglycemia. Optimal insulin therapy should therefore minimize the risk of hypoglycemia while improving glycemic control. Insulin degludec (IDeg) is a novel basal insulin that, following subcutaneous injection, assembles into a depot of soluble multihexamer chains. These subsequently release IDeg monomers that are absorbed at a slow and steady rate into the circulation, with the terminal half-life of IDeg being ~25 hours. Thus, it requires only once-daily dosing unlike other basal insulin preparations that often require twice-daily dosing. Despite its long half-life, once-daily IDeg does not cause accumulation of insulin in the circulation after reaching steady state. IDeg once a day will produce a steady-state profile with a lower peak:trough ratio than other basal insulins. In clinical trials, this profile translates into a lower frequency of nocturnal hypoglycemia compared with insulin glargine, as well as an ability to allow some flexibility in dose timing without compromising efficacy and safety. Indeed, a study that tested the extremes of dosing intervals of 8 and 40 hours showed no detriment in either glycemic control or hypoglycemic frequency versus insulin glargine given at the same time each day. While extreme flexibility in dose timing is not recommended, these findings are reassuring. This may be particularly beneficial to elderly patients, patients with learning difficulties, or others who have to rely on health-care professionals for their daily insulin injections. Further studies are required to confirm whether this might benefit adherence to treatment, reduce long

  7. Research strategies for safety evaluation of nanomaterials, part IV: risk assessment of nanoparticles.

    PubMed

    Tsuji, Joyce S; Maynard, Andrew D; Howard, Paul C; James, John T; Lam, Chiu-Wing; Warheit, David B; Santamaria, Annette B

    2006-01-01

    Nanoparticles are small-scale substances (<100 nm) with unique properties and, thus, complex exposure and health risk implications. This symposium review summarizes recent findings in exposure and toxicity of nanoparticles and their application for assessing human health risks. Characterization of airborne particles indicates that exposures will depend on particle behavior (e.g., disperse or aggregate) and that accurate, portable, and cost-effective measurement techniques are essential for understanding exposure. Under many conditions, dermal penetration of nanoparticles may be limited for consumer products such as sunscreens, although additional studies are needed on potential photooxidation products, experimental methods, and the effect of skin condition on penetration. Carbon nanotubes apparently have greater pulmonary toxicity (inflammation, granuloma) in mice than fine-scale carbon graphite, and their metal content may affect toxicity. Studies on TiO2 and quartz illustrate the complex relationship between toxicity and particle characteristics, including surface coatings, which make generalizations (e.g., smaller particles are always more toxic) incorrect for some substances. These recent toxicity and exposure data, combined with therapeutic and other related literature, are beginning to shape risk assessments that will be used to regulate the use of nanomaterials in consumer products. PMID:16177233

  8. Posttraumatic stress disorder, alone or additively with early life adversity, is associated with obesity and cardiometabolic risk

    PubMed Central

    Farr, Olivia M.; Ko, Byung-Joon; Joung, Kyoung Eun; Zaichenko, Lesya; Usher, Nicole; Tsoukas, Michael; Thakkar, Bindiya; Davis, Cynthia R.; Crowell, Judith A.; Mantzoros, Christos S.

    2015-01-01

    Background and Aims There is some evidence that posttraumatic stress disorder (PTSD) and early life adversity may influence metabolic outcomes such as obesity, diabetes, and cardiovascular disease. However, whether and how these interact is not clear. Methods We analyzed data from a cross-sectional and a longitudinal study to determine how PTSD severity influences obesity, insulin sensitivity, and key measures and biomarkers of cardiovascular risk. We then looked at how PTSD and early life adversity may interact to impact these same outcomes. Results PTSD severity is associated with increasing risk of obesity, diabetes, and cardiovascular disease, with higher symptoms correlating with higher values of BMI, leptin, fibrinogen, and blood pressure, and lower values of insulin sensitivity. PTSD and early life adversity have an additive effect on these metabolic outcomes. The longitudinal study confirmed findings from the cross sectional study and showed that fat mass, leptin, CRP, ICAM, and TNFRII were significantly increased with higher PTSD severity during a 2.5 year follow-up period. Conclusions Individuals with early life adversity and PTSD are at high risk and should be monitored carefully for obesity, insulin resistance, and cardiometabolic risk. PMID:25770759

  9. Working the night shift: a necessary time for training or a risk to health and safety?

    PubMed

    Morrison, I; Flower, D; Hurley, J; McFadyen, R J

    2013-01-01

    The European Working Time Directive (EWTD) limits excessive night shifts and restricts the working week to no more than 48 hours. The underlying rationale is to minimise the health risks to all workers. Here we debate the impact of night rotas for doctors-in-training on patient safety and medical education; when the EWTD was agreed these topics may not have been considered, either systematically or objectively. The impacts of diurnal rhythms on human functions affect all night workers, but the nature of rostered medical and surgical work has little precedent in other industries or even in the contracts of other healthcare staff. For example, rostered night duties need to be distinguished from permanent night shift work. On-call medical night work from training doctors is generally required for short periods and usually involves fewer patients. It is an important time in training, where clinical responsibility and decision-making can be matured in a supervised setting. To comply with the EWTD most hospitals have adopted rota patterns that aim to cover the clinical needs, while ensuring no doctor works for more than 48 hours in an average working week. To monitor this process longterm studies are necessary to evaluate effects on a doctor's health and on patient care generally. The EWTD has also led to a loss of continuity of patient care; does this really matter? PMID:24087803

  10. Clinical efficacy and safety of arbekacin for high-risk infections in patients with hematological malignancies.

    PubMed

    Miura, Katsuhiro; Nakagawa, Masaru; Takahashi, Hiromichi; Uchino, Yoshihito; Kodaira, Hitomi; Iriyama, Noriyoshi; Sakagami, Masashi; Ohtake, Shimon; Kobayashi, Sumiko; Hojo, Atsuko; Kurita, Daisuke; Kobayashi, Yujin; Kusuda, Machiko; Hirabayashi, Yukio; Hatta, Yoshihiro; Takei, Masami

    2016-03-01

    We performed a clinical trial to investigate the efficacy and safety of arbekacin (ABK), a unique aminoglycoside with activity against methicillin-resistant Staphylococcus aureus (MRSA), in patients with hematological malignancies complicated by high-risk infections. ABK was administered intravenously at a dose of approximately 5 mg/kg with various broad-spectrum β-lactams, followed by therapeutic drug monitoring (TDM). A total of 54 febrile or infectious episodes were registered, and TDM was performed in 44 (81%) cases. The absolute neutrophil count was below 500/μl in 49 (91%) cases, and cytotoxic chemotherapy was being administered in 47 (87%) cases. Before initiation of ABK, 52 (96%) patients had received fluoroquinolones (n = 37) and/or broad-spectrum β-lactams (n = 34). There were 10 cases of documented infections including one of MRSA pneumonia, and 44 cases of febrile neutropenia. The efficacy at the end of treatment was 80% for all patients, and efficacy was significantly higher in patients attaining maximum concentrations ≥ 16 µg/ml or receiving TDM-guided dose-adjustment of ABK (n = 19, 95 vs. 71%, P = 0.039). Renal toxicity was observed in six cases (11%) but was generally acceptable. This study demonstrated that TDM-guided ABK administration may be applicable under limited conditions for patients with hematological malignancies.

  11. 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.

  12. Rate of Corneal Collagen Crosslinking Redo in Private Practice: Risk Factors and Safety

    PubMed Central

    Antoun, Joelle; Slim, Elise; el Hachem, Rami; Chelala, Elias; Jabbour, Elyse; Cherfan, Georges; Jarade, Elias F.

    2015-01-01

    Objective. To report the rate of progression of keratectasia after primary crosslinking (CXL) and evaluate the safety and efficiency of CXL redo. Materials and Methods. We conducted a retrospective analysis of the patients who underwent CXL between 2010 and 2013 at the Beirut Eye Specialist Hospital, Lebanon. Progression of keratectasia was based on the presence of an increase in maximum keratometry of 1.00 D, a change in the map difference between two consecutive topographies of 1.00 D, a deterioration of visual acuity, or any change in the refraction. Primary and redo CXL were done using the same protocol. Results. Among the 221 eyes of 130 patients who underwent CXL, 7 eyes (3.17%) of five patients met the criteria of progression. All patients reported a history of allergic conjunctivitis and eye rubbing and progressed within 9 to 48 months. No complications were noted and all patients were stable 1 year after CXL redo. Conclusion. Allergic conjunctivitis and eye rubbing were the only risk factors associated with keratoconus progression after CXL. A close followup is thus mandatory, even years after the procedure. CXL redo seems to be a safe and efficient technique to halt the progression after a primary CXL. PMID:25874118

  13. Evidence for the safety of gum tragacanth (Asiatic Astragalus spp.) and modern criteria for the evaluation of food additives.

    PubMed

    Anderson, D M

    1989-01-01

    Gum tragacanth (GT), affirmed as GRAS within the USA since 1961, was evaluated as 'ADI not specified' by JECFA in 1985. Within the EEC, GT has been permitted temporarily as a food additive (E413), without an ADI, since 1974; a decision regarding its permanent status must be reached before the end of 1988. This review collates the dietary, toxicological, immunological and chemical data available and presents the pre-requisite data concerning the 'Need' and low levels of utilization of GT.

  14. 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…

  15. Addition of dipeptidyl peptidase-4 inhibitors to sulphonylureas and risk of hypoglycaemia: systematic review and meta-analysis

    PubMed Central

    Moore, Nicholas; Arnaud, Mickael; Robinson, Philip; Raschi, Emanuel; De Ponti, Fabrizio; Bégaud, Bernard; Pariente, Antoine

    2016-01-01

    Objective To quantify the risk of hypoglycaemia associated with the concomitant use of dipeptidyl peptidase-4 (DPP-4) inhibitors and sulphonylureas compared with placebo and sulphonylureas. Design Systematic review and meta-analysis. Data sources Medline, ISI Web of Science, SCOPUS, Cochrane Central Register of Controlled Trials, and clinicaltrial.gov were searched without any language restriction. Study selection Placebo controlled randomised trials comprising at least 50 participants with type 2 diabetes treated with DPP-4 inhibitors and sulphonylureas. Review methods Risk of bias in each trial was assessed using the Cochrane Collaboration tool. The risk ratio of hypoglycaemia with 95% confidence intervals was computed for each study and then pooled using fixed effect models (Mantel Haenszel method) or random effect models, when appropriate. Subgroup analyses were also performed (eg, dose of DPP-4 inhibitors). The number needed to harm (NNH) was estimated according to treatment duration. Results 10 studies were included, representing a total of 6546 participants (4020 received DPP-4 inhibitors plus sulphonylureas, 2526 placebo plus sulphonylureas). The risk ratio of hypoglycaemia was 1.52 (95% confidence interval 1.29 to 1.80). The NNH was 17 (95% confidence interval 11 to 30) for a treatment duration of six months or less, 15 (9 to 26) for 6.1 to 12 months, and 8 (5 to 15) for more than one year. In subgroup analysis, no difference was found between full and low doses of DPP-4 inhibitors: the risk ratio related to full dose DPP-4 inhibitors was 1.66 (1.34 to 2.06), whereas the increased risk ratio related to low dose DPP-4 inhibitors did not reach statistical significance (1.33, 0.92 to 1.94). Conclusions Addition of DPP-4 inhibitors to sulphonylurea to treat people with type 2 diabetes is associated with a 50% increased risk of hypoglycaemia and to one excess case of hypoglycaemia for every 17 patients in the first six months of treatment. This

  16. 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.

  17. 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.

  18. 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.

  19. U.S. Food and Drug Administration perspective of the inclusion of effects of low-level exposures in safety and risk assessment.

    PubMed

    Gaylor, D W; Bolger, P M; Schwetz, B A

    1998-02-01

    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

  20. 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

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. Biostatistical considerations in pharmacovigilance and pharmacoepidemiology: linking quantitative risk assessment in pre-market licensure application safety data, post-market alert reports and formal epidemiological studies.

    PubMed

    O'Neill, R T

    This paper deals with a conceptual discussion of a variety of statistical concepts, methods and strategies that are relevant to the quantitative assessment of risk derived from safety data collected during the pre- and post-marketing phase of a new drug's life cycle. A call is made for the use of more standard approaches to the analysis of safety data that are statistically and epidemiologically rigorous and for attempts to link the strategies for pre-market safety assessment with strategies for post-market safety evaluation. This link may be facilitated by recognizing the limitations and complementary roles played by pre- and post-market safety data collection schemes and by linking the quantitative analyses utilized for either exploratory or confirmatory purposes of risk assessment in each phase of safety data collection. Examples are provided of studies specifically designed to evaluate risk in a post approval setting and several available guidelines intended to improve the quality of these studies are discussed.

  7. 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.

  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. 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.

  10. 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.

  11. 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

    2015-06-01

    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.

  12. 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. PMID:21698604

  13. 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.

  14. 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.

  15. A Novel Method for Assessing Drug Degradation Product Safety Using Physiologically-Based Pharmacokinetic Models and Stochastic Risk Assessment.

    PubMed

    Nguyen, Hoa Q; Stamatis, Stephen D; Kirsch, Lee E

    2015-09-01

    Patient safety risk due to toxic degradation products is a potentially critical quality issue for a small group of useful drug substances. Although the pharmacokinetics of toxic drug degradation products may impact product safety, these data are frequently unavailable. The objective of this study is to incorporate the prediction capability of physiologically based pharmacokinetic (PBPK) models into a rational drug degradation product risk assessment procedure using a series of model drug degradants (substituted anilines). The PBPK models were parameterized using a combination of experimental and literature data and computational methods. The impact of model parameter uncertainty was incorporated into stochastic risk assessment procedure for estimating human safe exposure levels based on the novel use of a statistical metric called "PROB" for comparing probability that a human toxicity-target tissue exposure exceeds the rat exposure level at a critical no-observed-adverse-effect level. When compared with traditional risk assessment calculations, this novel PBPK approach appeared to provide a rational basis for drug instability risk assessment by focusing on target tissue exposure and leveraging physiological, biochemical, biophysical knowledge of compounds and species. PMID:25900395

  16. A Novel Method for Assessing Drug Degradation Product Safety Using Physiologically-Based Pharmacokinetic Models and Stochastic Risk Assessment.

    PubMed

    Nguyen, Hoa Q; Stamatis, Stephen D; Kirsch, Lee E

    2015-09-01

    Patient safety risk due to toxic degradation products is a potentially critical quality issue for a small group of useful drug substances. Although the pharmacokinetics of toxic drug degradation products may impact product safety, these data are frequently unavailable. The objective of this study is to incorporate the prediction capability of physiologically based pharmacokinetic (PBPK) models into a rational drug degradation product risk assessment procedure using a series of model drug degradants (substituted anilines). The PBPK models were parameterized using a combination of experimental and literature data and computational methods. The impact of model parameter uncertainty was incorporated into stochastic risk assessment procedure for estimating human safe exposure levels based on the novel use of a statistical metric called "PROB" for comparing probability that a human toxicity-target tissue exposure exceeds the rat exposure level at a critical no-observed-adverse-effect level. When compared with traditional risk assessment calculations, this novel PBPK approach appeared to provide a rational basis for drug instability risk assessment by focusing on target tissue exposure and leveraging physiological, biochemical, biophysical knowledge of compounds and species.

  17. 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

  18. 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…

  19. Increased bioclogging and corrosion risk by sulfate addition during iodine recovery at a natural gas production plant.

    PubMed

    Lim, Choon-Ping; Zhao, Dan; Takase, Yuta; Miyanaga, Kazuhiko; Watanabe, Tomoko; Tomoe, Yasuyoshi; Tanji, Yasunori

    2011-02-01

    Iodine recovery at a natural gas production plant in Japan involved the addition of sulfuric acid for pH adjustment, resulting in an additional about 200 mg/L of sulfate in the waste brine after iodine recovery. Bioclogging occurred at the waste brine injection well, causing a decrease in well injectivity. To examine the factors that contribute to bioclogging, an on-site experiment was conducted by amending 10 L of brine with different conditions and then incubating the brine for 5 months under open air. The control case was exposed to open air but did not receive additional chemicals. When sulfate addition was coupled with low iodine, there was a drastic increase in the total amount of accumulated biomass (and subsequently the risk of bioclogging) that was nearly six times higher than the control. The bioclogging-associated corrosion rate of carbon steel was 84.5 μm/year, which is four times higher than that observed under other conditions. Analysis of the microbial communities by denaturing gradient gel electrophoresis revealed that the additional sulfate established a sulfur cycle and induced the growth of phototrophic bacteria, including cyanobacteria and purple bacteria. In the presence of sulfate and low iodine levels, cyanobacteria and purple bacteria bloomed, and the accumulation of abundant biomass may have created a more conducive environment for anaerobic sulfate-reducing bacteria. It is believed that the higher corrosion rate was caused by a differential aeration cell that was established by the heterogeneous distribution of the biomass that covered the surface of the test coupons. PMID:20922384

  20. Improving contractor safety performance in a high risk multi-project environment

    SciTech Connect

    Ashiedu, R.I.; Okoene, A.C.

    1996-11-01

    Up to 80% of the Exploration and Production activities of Oil and Gas operations are being executed by contractors. The industry`s safety performance is therefore what the contractors make of it, implying that any meaningful performance improvement must derive directly from improvements in the contractor`s safety performance. A detailed review has been conducted on the operator contractor safety management interface, leading to the establishment of a controlled series of improvement initiatives. These initiatives which must be driven by the operator should commence with an enlightenment that to improve safety would improve overall business. Contractor involvement, development programme for contractor safety management system and rigorous auditing to check compliance with systems and procedures, being the main focus. The result of implementing these improvement initiatives demonstrate their effectiveness. Injury levels will be kept low with a sustained reduction trend.

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. Meta-analysis identifies 29 additional ulcerative colitis risk loci, increasing the number of confirmed associations to 47

    PubMed Central

    Anderson, Carl A.; Boucher, Gabrielle; Lees, Charlie W.; Franke, Andre; D’Amato, Mauro; Taylor, Kent D.; Lee, James C.; Goyette, Philippe; Imielinski, Marcin; Latiano, Anna; Lagacé, Caroline; Scott, Regan; Amininejad, Leila; Bumpstead, Suzannah; Baidoo, Leonard; Baldassano, Robert N.; Barclay, Murray; Bayless, Theodore M.; Brand, Stephan; Büning, Carsten; Colombel, Jean-Frédéric; Denson, Lee A.; De Vos, Martine; Dubinsky, Marla; Edwards, Cathryn; Ellinghaus, David; Fehrmann, Rudolf S.N.; Floyd, James A.B.; Florin, Tim; Franchimont, Denis; Franke, Lude; Georges, Michel; Glas, Jürgen; Glazer, Nicole L.; Guthery, Stephen L.; Haritunians, Talin; Hayward, Nicholas K.; Hugot, Jean-Pierre; Jobin, Gilles; Laukens, Debby; Lawrance, Ian; Lémann, Marc; Levine, Arie; Libioulle, Cecile; Louis, Edouard; McGovern, Dermot P.; Milla, Monica; Montgomery, Grant W.; Morley, Katherine I.; Mowat, Craig; Ng, Aylwin; Newman, William; Ophoff, Roel A; Papi, Laura; Palmieri, Orazio; Peyrin-Biroulet, Laurent; Panés, Julián; Phillips, Anne; Prescott, Natalie J.; Proctor, Deborah D.; Roberts, Rebecca; Russell, Richard; Rutgeerts, Paul; Sanderson, Jeremy; Sans, Miquel; Schumm, Philip; Seibold, Frank; Sharma, Yashoda; Simms, Lisa; Seielstad, Mark; Steinhart, A. Hillary; Targan, Stephan R.; van den Berg, Leonard H.; Vatn, Morten; Verspaget, Hein; Walters, Thomas; Wijmenga, Cisca; Wilson, David C.; Westra, Harm-Jan; Xavier, Ramnik J.; Zhao, Zhen Z.; Ponsioen, Cyriel Y.; Andersen, Vibeke; Torkvist, Leif; Gazouli, Maria; Anagnou, Nicholas P.; Karlsen, Tom H.; Kupcinskas, Limas; Sventoraityte, Jurgita; Mansfield, John C.; Kugathasan, Subra; Silverberg, Mark S.; Halfvarson, Jonas; Rotter, Jerome I.; Mathew, Christopher G.; Griffiths, Anne M.; Gearry, Richard; Ahmad, Tariq; Brant, Steven R.; Chamaillard, Mathias; Satsangi, Jack; Cho, Judy H.; Schreiber, Stefan; Daly, Mark J.; Barrett, Jeffrey C.; Parkes, Miles; Annese, Vito; Hakonarson, Hakon; Radford-Smith, Graham; Duerr, Richard H.; Vermeire, Séverine; Weersma, Rinse K.; Rioux, John D.

    2011-01-01

    Genome-wide association studies (GWAS) and candidate gene studies in ulcerative colitis (UC) have identified 18 susceptibility loci. We conducted a meta-analysis of 6 UC GWAS, comprising 6,687 cases and 19,718 controls, and followed-up the top association signals in 9,628 cases and 12,917 controls. We identified 29 additional risk loci (P<5×10-8), increasing the number of UC associated loci to 47. After annotating associated regions using GRAIL, eQTL data and correlations with non-synonymous SNPs, we identified many candidate genes providing potentially important insights into disease pathogenesis, including IL1R2, IL8RA/B, IL7R, IL12B, DAP, PRDM1, JAK2, IRF5, GNA12 and LSP1. The total number of confirmed inflammatory bowel disease (IBD) risk loci is now 99, including a minimum of 28 shared association signals between Crohn’s disease (CD) and UC. PMID:21297633

  7. The Safety, Tolerability and Risks Associated with the Use of Newer Generation Antidepressant Drugs: A Critical Review of the Literature.

    PubMed

    Carvalho, André F; Sharma, Manu S; Brunoni, André R; Vieta, Eduard; Fava, Giovanni A

    2016-01-01

    Newer generation antidepressant drugs (ADs) are widely used as the first line of treatment for major depressive disorders and are considered to be safer than tricyclic agents. In this critical review, we evaluated the literature on adverse events, tolerability and safety of selective serotonin reuptake inhibitors, serotonin noradrenaline reuptake inhibitors, bupropion, mirtazapine, trazodone, agomelatine, vilazodone, levomilnacipran and vortioxetine. Several side effects are transient and may disappear after a few weeks following treatment initiation, but potentially serious adverse events may persist or ensue later. They encompass gastrointestinal symptoms (nausea, diarrhea, gastric bleeding, dyspepsia), hepatotoxicity, weight gain and metabolic abnormalities, cardiovascular disturbances (heart rate, QT interval prolongation, hypertension, orthostatic hypotension), genitourinary symptoms (urinary retention, incontinence), sexual dysfunction, hyponatremia, osteoporosis and risk of fractures, bleeding, central nervous system disturbances (lowering of seizure threshold, extrapyramidal side effects, cognitive disturbances), sweating, sleep disturbances, affective disturbances (apathy, switches, paradoxical effects), ophthalmic manifestations (glaucoma, cataract) and hyperprolactinemia. At times, such adverse events may persist after drug discontinuation, yielding iatrogenic comorbidity. Other areas of concern involve suicidality, safety in overdose, discontinuation syndromes, risks during pregnancy and breast feeding, as well as risk of malignancies. Thus, the rational selection of ADs should consider the potential benefits and risks, likelihood of responsiveness to the treatment option and vulnerability to adverse events. The findings of this review should alert the physician to carefully review the appropriateness of AD prescription on an individual basis and to consider alternative treatments if available. PMID:27508501

  8. 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. PMID:26224125

  9. Retail food safety risks for populations of different races, ethnicities, and income levels.

    PubMed

    Signs, Renata J; Darcey, Valerie L; Carney, Trish A; Evans, Alison A; Quinlan, Jennifer J

    2011-10-01

    Research has found that populations with low socioeconomic status (SES) and minority populations have greater access to small corner markets and less access to supermarkets than high-SES and Caucasian populations. This represents a significant difference in the farm-to-fork continuum that these populations experience. This research examined whether differential retail access to foods results in different food safety risks at the retail level for consumers with different demographics. U.S. Census Bureau census tracts with high African American, Asian, Hispanic, Caucasian, low-SES, and high-SES populations were identified in Philadelphia, PA. Approximately 60 retail food establishments were sampled in each census tract category from June 2008 to June 2010. Food samples collected at stores included milk, eggs, lunchmeat, sandwiches, and ready-to-eat (RTE) fresh fruit, greens, and herbs, when available. With the exception of milk and eggs, only food that had been handled and/or prepared at the retail level was sampled. Food samples were tested for temperature, aerobic plate count, coliforms, fecal coliforms, Escherichia coli, Staphylococcus aureus, and Listeria monocytogenes. The results indicated that internal egg temperatures were higher in samples from low-SES census tracts than in eggs from Caucasian census tracts, and eggs were more often found unrefrigerated in markets in low-SES and Asian census tracts. Milk samples from markets in Hispanic and low-SES census tracts had higher aerobic plate counts than high-SES census tract samples. Sandwiches from markets in high-SES census tracts had higher coliform counts than sandwiches from markets in all other census tract categories. Markets in Asian census tracts had a higher incidence of fecal coliform contamination on sandwiches than markets in Caucasian census tracts. Fecal coliforms were present in a percentage of RTE greens from markets in all census tracts except African American, with the highest percentages of

  10. 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...

  11. Rebuilding a safety culture

    NASA Technical Reports Server (NTRS)

    Rodney, George A.

    1991-01-01

    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.

  12. Food safety and risk assessment: naturally occurring potential toxicants and anti-nutritive compounds in plant foods.

    PubMed

    Sanders, Thomas A B

    2003-01-01

    The centralisation and globalisation of the world food supply presents opportunities for massive epidemics of food borne illness. Food processing generally decreases exposure to naturally occurring toxicants. A significant number of deaths are caused in both developed and developing countries from the consumption of naturally occurring toxicants and this exceeds the numbers attributable to artificial food contaminants and pollutants. The risk posed by naturally occurring toxicants is greater in developing countries where food choice and facilities for food processing are limited. The main risk in developed countries is from food important from areas where food safety controls are inadequate. Toxins derived from marine algae present a specific threat to health especially as seafood is being traded from areas where poisoning by algal toxins is known to occur. A systematic approach to food safety using HACCP methodology and identity preservation of the food are crucial in the prevention of food related illness. There is also a need for international agreed standards for tolerable levels of naturally occurring toxicants in foodstuffs but these should derived not be set unreasonably low as this would threaten food security in developing countries. The occurrence of a number of fatalities in developing countries among people consuming herbal teas and dietary supplements underscores the need to assess the safety of these products before they are placed on the market. PMID:15806954

  13. The refinement of uncertainty/safety factors in risk assessment by the incorporation of data on toxicokinetic variability in humans.

    PubMed

    Dorne, J L C M; Renwick, A G

    2005-07-01

    The derivation of safe levels of exposure in humans for compounds that are assumed to cause threshold toxicity has relied on the application of a 100-fold uncertainty factor to a measure for the threshold, such as the no observed adverse effect level (NOAEL) or the benchmark dose (BMD). This 100-fold safety factor consists of the product of two 10-fold factors allowing for human variability and interspecies differences. The International Programme on Chemical Safety has suggested the subdivision of these 10-fold factors to allow for variability in toxicokinetics and toxicodynamics. This subdivision allows the replacement of the default uncertainty factors with a chemical-specific adjustment factor (CSAF) when suitable data are available. This short review describes potential options to refine safety factors used in risk assessment, with particular emphasis on pathway-related uncertainty factors associated with variability in kinetics. These pathway-related factors were derived from a database that quantified interspecies differences and human variability in phase I metabolism, phase II metabolism, and renal excretion. This approach allows metabolism and pharmacokinetic data in healthy adults and subgroups of the population to be incorporated in the risk-assessment process and constitutes an intermediate approach between simple default factors and chemical-specific adjustment factors. PMID:15800035

  14. The refinement of uncertainty/safety factors in risk assessment by the incorporation of data on toxicokinetic variability in humans.

    PubMed

    Dorne, J L C M; Renwick, A G

    2005-07-01

    The derivation of safe levels of exposure in humans for compounds that are assumed to cause threshold toxicity has relied on the application of a 100-fold uncertainty factor to a measure for the threshold, such as the no observed adverse effect level (NOAEL) or the benchmark dose (BMD). This 100-fold safety factor consists of the product of two 10-fold factors allowing for human variability and interspecies differences. The International Programme on Chemical Safety has suggested the subdivision of these 10-fold factors to allow for variability in toxicokinetics and toxicodynamics. This subdivision allows the replacement of the default uncertainty factors with a chemical-specific adjustment factor (CSAF) when suitable data are available. This short review describes potential options to refine safety factors used in risk assessment, with particular emphasis on pathway-related uncertainty factors associated with variability in kinetics. These pathway-related factors were derived from a database that quantified interspecies differences and human variability in phase I metabolism, phase II metabolism, and renal excretion. This approach allows metabolism and pharmacokinetic data in healthy adults and subgroups of the population to be incorporated in the risk-assessment process and constitutes an intermediate approach between simple default factors and chemical-specific adjustment factors.

  15. Food safety and risk assessment: naturally occurring potential toxicants and anti-nutritive compounds in plant foods.

    PubMed

    Sanders, Thomas A B

    2003-01-01

    The centralisation and globalisation of the world food supply presents opportunities for massive epidemics of food borne illness. Food processing generally decreases exposure to naturally occurring toxicants. A significant number of deaths are caused in both developed and developing countries from the consumption of naturally occurring toxicants and this exceeds the numbers attributable to artificial food contaminants and pollutants. The risk posed by naturally occurring toxicants is greater in developing countries where food choice and facilities for food processing are limited. The main risk in developed countries is from food important from areas where food safety controls are inadequate. Toxins derived from marine algae present a specific threat to health especially as seafood is being traded from areas where poisoning by algal toxins is known to occur. A systematic approach to food safety using HACCP methodology and identity preservation of the food are crucial in the prevention of food related illness. There is also a need for international agreed standards for tolerable levels of naturally occurring toxicants in foodstuffs but these should derived not be set unreasonably low as this would threaten food security in developing countries. The occurrence of a number of fatalities in developing countries among people consuming herbal teas and dietary supplements underscores the need to assess the safety of these products before they are placed on the market.

  16. 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.

  17. Shift work in nursing: is it really a risk factor for nurses' health and patients' safety?

    PubMed

    Admi, Hanna; Tzischinsky, Orna; Epstein, Rachel; Herer, Paula; Lavie, Peretz

    2008-01-01

    There is evidence in the scientific literature of the adverse physiological and psychological effects of shift work, including disruption to biological rhythm, sleep disorders, health problems, diminished performance at work, job dissatisfaction, and social isolation. In this study, the results of health problems and sleep disorders between female and male nurses, between daytime and shift nurses, and between sleep-adjusted and non-sleep-adjusted shift nurses were compared. Also the relationship between adjustment to shift work and organizational outcomes (errors and incidents and absenteeism from work) was analyzed. Gender, age, and weight were more significant factors than shift work in determining the well-being of nurses. Shift work by itself was not found to be a risk factor for nurses' health and organizational outcomes in this study. Moreover, nurses who were identified as being "non-adaptive" to shift work were found to work as effectively and safely as their adaptive colleagues in terms of absenteeism from work and involvement in professional errors and accidents. This research adds two additional findings to the field of shift work studies. The first finding is that female shift workers complain significantly more about sleep disorders than male shift workers. Second, although high rates of nurses whose sleep was not adapted to shift work were found, this did not have a more adverse impact on their health, absenteeism rates, or performance (reported errors and incidents), compared to their "adaptive" and "daytime" colleagues. PMID:18777974

  18. 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

  19. 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. PMID:27177395

  20. 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.

  1. Quality of life, Risk Assessment, and Safety Research in Liver Transplantation: New Frontiers in Health Services and Outcomes Research

    PubMed Central

    Butt, Zeeshan; Parikh, Neehar D.; Skaro, Anton; Ladner, Daniela; Cella, David

    2013-01-01

    Purpose of review In this review, we briefly summarize three fruitful, emerging areas in liver transplantation research: quality of life; risk assessment; and patient safety. Our goal is to highlight recent findings in these areas, with a call for increased integration of social scientists and transplant clinicians to address how best to shape policy and improve outcomes. Recent findings After liver transplantation, recipients generally experience clinically significant, sustained improvement in their physical, social and emotional well-being. However, a sizeable minority of patients do experience excess morbidity that may benefit from ongoing surveillance and/or intervention. There is growing body of research that describes risks associated with liver transplantation, which can be useful aids to better inform decision making by patients, clinicians, payers, and policy makers. In contrast, there has been a relative lack of empirical data on transplant patient safety vulnerabilities, placing the field of surgery in stark contrast to other high risk industries, where such assessments inform continuous process improvement. Summary Health services and outcomes research has grown in importance in the liver transplantation literature, but several important questions remain unanswered that merit programmatic, interdisciplinary research. PMID:22476225

  2. Antibodies to Leptospira among blood donors in higher-risk areas of Australia: possible implications for transfusion safety

    PubMed Central

    Faddy, Helen; Seed, Clive; Lau, Colleen; Racloz, Vanessa; Flower, Robert; Smythe, Lee; Burns, Mary-Anne; Dohnt, Michael; Craig, Scott; Harley, Robert; Weinstein, Philip

    2015-01-01

    Background Leptospirosis is one of the most common bacterial zoonoses worldwide, and clinical manifestations range from asymptomatic infection to acute febrile illness, multi-organ failure and death. Asymptomatic, acute bacteraemia in a blood donor provides a potential for transfusion-transmission, although only a single such case from India has been recorded. Human leptospirosis is uncommon in developed countries; however, the state of Queensland in Australia has one of the highest rates among developed countries, especially after increased rainfall. This study examined the prevalence of antibodies to Leptospira spp. in blood donors residing in higher-risk areas of Australia, to evaluate the appropriateness of current blood safety guidelines. Materials and methods Plasma samples collected from blood donors residing in higher-risk areas of Australia during 2009 and 2011 were included in the study. All samples were tested for the presence of antibodies to 22 leptospiral serovars using the microscopic agglutination test. Result No sample had antibody titres suggestive of a current or recent infection, however, seven samples (1.44%, 95% CI: 0.38–2.50%) had titres suggestive of a past infection. Discussion This study provides data that may support the appropriateness of current relevant donor selection policies in Australia. Given that the risk profile for leptospirosis is expanding and that the infection is likely to become more prevalent with climate change, this disease may become more of a concern for transfusion safety in the future. PMID:24960651

  3. 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

  4. Information tools for environmental risk assessment of low level presence - an introduction to the reviews of the environmental safety of proteins used in genetically engineered plants.

    PubMed

    Roberts, Andrew

    2011-01-01

    Since the first regulatory approval of a genetically engineered (GE) plant was issued in 1992, hundreds of additional GE plants, thousands of regulatory decisions and millions of tons of GE grain and seed have been produced. In an increasingly global economy, the grain and seeds move relatively freely across national jurisdictions, but the regulatory decisions and associated data and analyses do not. Combined with the realities of agricultural production, this has led to a legal and regulatory challenge due to the low level presence (LLP) of GE grain or seeds that do not have regulatory approvals in the country of destination. In order to assist regulators in conducting environmental risk assessments related to LLP, reviews of environmental safety data, including associated regulatory analyses and decisions, for proteins commonly introduced in GE plants have been produced.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. Methods of Assessing the Risks Associated with Lack of Water Supplies, Water Safety Plan for National Conditions

    NASA Astrophysics Data System (ADS)

    Rybka, Sławomir

    2012-06-01

    Article shows the desire to obtain risk-control options, and bringing it to a tolerable level. Subjects were ways of managing and dealing with risk. Methods of dealing with aspects of the protection of industrial buildings and high-risk critical infrastructure vulnerability analysis methodology to the loss of integrity. Also a set method to deal with aspects of the protection of industrial buildings and high-risk critical infrastructure that is the analysis of susceptibility to loss of integrity. The article also presents the basic principles of water safety plan based on national and foreign research publications. In the next part of article WSP methodology was concluded, outlining the actions which use significantly reduces the risk of threats that could lead to supply of contaminated tap water or total interruption of its supply. In further considerations the most important steps in creating WSP were presented. In the final section the principle of modular computer system operation that is used for network management for urban water supply in Rzeszow was presented.

  10. Predicting contamination by the fuel additive cerium oxide engineered nanoparticles within the United Kingdom and the associated risks.

    PubMed

    Johnson, Andrew C; Park, Barry

    2012-11-01

    As a fuel additive, cerium oxide nanoparticles may become widely dispersed throughout the environment. Commercial information from the United Kingdom (UK) on the use of cerium oxide nanoparticles was used to perform a modeling and risk assessment exercise. Discharge from exhausts took into account the likely removal by filters fitted to these vehicles. For predicting current soil exposure, scenarios were examined, ranging from dispersion occurring across the entire UK landmass to only within the urban area to only 20 m on either side of road networks. For soils, the highest predicted contamination level was 0.016 mg/kg within 20 m of a road following seven years of continuous deposition. This value would represent 0.027% of reported natural background cerium. If usage were to double for five more years, levels would not be expected to exceed 0.04 mg/kg. River water contamination considered direct aerial deposition and indirect contamination via runoff in the water and entrained soil sediment, with the highest level of 0.02 ng/L predicted. The highest predicted water concentration of 300 ng/L was associated with water draining from a road surface, assuming a restricted deposition spread. These predictions are well below most toxicological levels of concern.

  11. [Efficiency and safety of generic Atorvastatine in patients at high cardiovascular risk].

    PubMed

    Chorbinskayva, S A; Stepanova, I I; Baryshnikova, G A; Pokutniy, N F; Zverkov, I V; Blohina, O E

    2016-01-01

    Statines are first choice medications for hypercholesterolemia and combined hyperlipidemia of varying severity in wide population of patients. Atorvastatine is one of the most effective statines. In Russia, Atorvastatine is represented by nearly twenty drugs most of which are generics. The article covers data on efficiency, safety and good tolerance of Liptonorm--a generic Atorvastatine. PMID:27164745

  12. A closer look at associations between hospital leadership walkrounds and patient safety climate and risk reduction: a cross-sectional study.

    PubMed

    Schwendimann, René; Milne, Judy; Frush, Karen; Ausserhofer, Dietmar; Frankel, Allan; Sexton, J Bryan

    2013-01-01

    Leadership walkrounds (WRs) are widely used in health care organizations to improve patient safety. This retrospective, cross-sectional study evaluated the association between WRs and caregiver assessments of patient safety climate and patient safety risk reduction across 49 hospitals in a nonprofit health care system. Linear regression analyses using units' participation in WRs were conducted. Survey results from 706 hospital units revealed that units with ≥ 60% of caregivers reporting exposure to at least 1 WR had a significantly higher safety climate, greater patient safety risk reduction, and a higher proportion of feedback on actions taken as a result of WRs compared with those units with <60% of caregivers reporting exposure to WRs. WR participation at the unit level reflects a frequency effect as a function of units with none/low, medium, and high leadership WR exposure.

  13. Safety in the Chemical Laboratory: Risk Management: A Growing Concern in University Chemistry Laboratories.

    ERIC Educational Resources Information Center

    Orr, Edward W.; Ghee, William K.

    1985-01-01

    This article (1) defines risk management and discusses alternatives to treating exposures facing those operating chemical laboratories; (2) indicates how two Virginia universities did or did not apply the risk management concept to their laboratory settings; and (3) identifies potential sources of information on this subject. (JN)

  14. Public health safety and transplant with increased-risk organs: striking the balance.

    PubMed

    Batra, Ramesh; Katariya, Nitin; Hewitt, Winston; Mathur, Amit; Reddy, Sudhakar; Moss, Adyr; Segev, Dorry; Singer, Andrew

    2015-04-01

    There is significant variability amongst transplant centers, Organ Procurement Organizations (OPO), members of public, and patients about organs from Public Health Service increased risk donors. This has therefore required regulatory bodies like Centers for Disease Control and Prevention to formulate policies for transplant centers and OPOs to minimize risk of infectious transmission to recipients of solid-organ transplants from such donors.

  15. 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.

  16. 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

  17. 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

  18. 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.

  19. [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.

  20. [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. PMID:22624477