WorldWideScience

Sample records for premarket safety assessment

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

    Science.gov (United States)

    Chuang-Stein, Christy; Xia, H Amy

    2013-01-01

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

  2. Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation.

    Science.gov (United States)

    Saito, Masami; Iwasaki, Kiyotaka

    2017-03-01

    Our aim was to conduct a scoping review of the regulations for hemodialyzers in the safety evaluation in Japan and the United States, and to evaluate the criteria for premarketing clinical trials and postmarketing safety reports to inform the development of a sophisticated premarketing evaluation in Japan. Regulations for approval of hemodialyzers were identified from the databases of the Ministry of Health, Labor and Welfare in Japan and the Federal Drug Agency (FDA) in the United States (US). The criteria for premarket clinical trials and postmarketing safety reports were evaluated for both countries. Standards in Japan required evaluation of blood compatibility and reporting of acute adverse effects by a premarketing clinical trial in 6 of 86 applications with semipermeable membrane materials deemed to be different to those of previously approved devices from 1983 to 31 August 2015. By comparison, the clinical trial was required in one of 545 approvals in the US from 1976 to 29 January 2016, but blood compatibility was not the point. All postmarketing adverse effects identified in Japan were included in the set of 'warnings'. The more stringent requirements for evaluation of blood compatibility and acute adverse effects in Japan seemed to be related to differences in the history of quality management systems for medical devices between the two countries. This study revealed that there were differences between Japan and the US in requiring the premarketing clinical trials for the hemodialyzers. Our findings could be useful for constructing sophisticated premarketing safety evaluation.

  3. Premarket safety and efficacy studies for ADHD medications in children.

    Directory of Open Access Journals (Sweden)

    Florence T Bourgeois

    Full Text Available Attention-deficit hyperactivity disorder (ADHD is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing.We identified all ADHD medications approved by the Food and Drug Administration (FDA and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug's clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials.A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419. Eleven drugs (55% were approved after <100 participants were studied and 14 (70% after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9, with 5 (38% drugs approved after participants were studied <4 weeks and 10 (77% after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed.Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved.

  4. A pre-marketing ALT signal predicts post-marketing liver safety.

    Science.gov (United States)

    Moylan, Cynthia A; Suzuki, Ayako; Papay, Julie I; Yuen, Nancy A; Ames, Michael; Hunt, Christine M

    2012-08-01

    Drug induced liver injury during drug development is evidenced by a higher incidence of serum alanine aminotransferase (ALT) elevations in treated versus placebo populations and termed an "ALT signal". We sought to quantify whether an ALT signal in pre-marketing clinical trials predicted post-marketing hepatotoxicity. Incidence of ALT elevations (ALT ≥ 3 times upper limits normal [× ULN]) for drug and placebo of new chemical entities and approved drugs associated with hepatotoxicity was calculated using the Food and Drug Administration (FDA) website. Post-marketing liver safety events were identified using the FDA Adverse Event Reporting System (AERS). The association of FDA AERS signal score (EB05 ≥ 2) and excess risk of pre-marketing ALT elevation (difference in incidence of ALT ≥ 3× ULN in treated versus placebo) was examined. An ALT signal of ≥ 1.2% was significantly associated with a post-marketing liver safety signal (p ≤ 0.013) and a 71.4% positive predictive value. An absent ALT signal was associated with a high likelihood of post-marketing liver safety; negative predictive value of 89.7%. Daily drug dose information improved the prediction of post-marketing liver safety. A cut-off of 1.2% increase in ALT ≥ 3× ULN in treated versus placebo groups provides an easily calculated method for predicting post-marketing liver safety.

  5. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    Science.gov (United States)

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

  6. Causality Assessment in Premarketing Drug Clinical Trials: Regulatory Evolution in the USA and Ongoing Concerns.

    Science.gov (United States)

    Goldman, Stephen A

    2016-10-01

    Since 1993, how to assess the causality of serious adverse events in premarketing drug clinical trials has undergone sustained regulatory evolution in the USA. In that year, an investigational drug study for chronic hepatitis B virus infection was emergently stopped after a patient suddenly exhibited hepatic failure and lactic acidosis, which later developed, along with pancreatitis and peripheral neuropathy, in several others after drug discontinuation. Five patients eventually died, including three despite emergency liver transplantation. The drug's multisystem toxicity was not predicted by preclinical animal studies, with grave injury to human mitochondria subsequently implicated. A concerned US Food and Drug Administration (FDA) created a task force whose findings would have a lasting impact on the agency's thinking. In 1994, the FDA proposed to amend its investigational new drug reporting requirements largely based on task force recommendations for ways to enhance the likelihood that sponsors and investigators would consider investigational agents as a possible cause of serious adverse events mimicking the underlying disease or concomitant drug toxicity. Then, in its 1997 final rule for expedited safety reporting requirements for drugs and biologics, the FDA advised sponsors that such reporting of serious, unexpected clinical trial cases would be expected when "there is a reasonable suspected causal relationship between the investigational product and the adverse event (i.e., the causal relationship cannot be ruled out)." This last clause was codified into the suspected adverse drug reaction definition in the FDA's 2003 safety reporting requirements for drugs and biologics proposed rule. The negatively received suspected adverse drug reaction and proposed causality standard were not adopted in the FDA's 2010 finalized investigational new drug safety reporting regulations, the agency stating that "'reasonable possibility' means there is evidence to suggest a

  7. Premarket Approvals (PMA)

    Data.gov (United States)

    U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

  8. Premarket Approvals (PMA)

    Data.gov (United States)

    U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

  9. The inadequacies of pre-market chemical risk assessment's toxicity studies-the implications.

    Science.gov (United States)

    Tweedale, Anthony C

    2017-01-01

    Industry provides essentially all the data for most (pre-market) chemical risk assessments (RA); academics study a chemical once it is marketed. For two randomly-chosen high production chemicals, despite new European Union mandates to evaluate all data, just 13% of the herbicide bentazon and 15% of the flame-retardant hexabromocyclododecane's published toxicity studies were found in their pre-market RA, and a systematic review on bentazon concludes it has greater hazards than indicated in its RA. More important, for both, academia's toxicity studies were designated as lower quality than industries were, despite showing hazards at lower doses. The accuracy of industry's test methods is analyzed and found to be replicable but insensitive, thus inaccurate. The synthetic pharmaceutical industry originated them, and by 1983 the Organization for Economic Cooperation & Development mandated their test guidelines (TG) methods be accepted for any new study for pre-market RA. For existing studies, industry's "Klimisch" criterion is universally used to evaluate quality, but it only states that TG studies produce the best data. However, no TG can answer the realistic exposure effect hypotheses of academics; therefore, crucially in pre-market RA, tens of thousands of published experimental findings (increasingly at low dose) are ignored to determine the safe dose. Few appreciate this, so scientific debate on the most accurate elements of toxicity tests is urgently indicated. Copyright © 2016 John Wiley & Sons, Ltd.

  10. Safety assessment of genetically modified foods

    NARCIS (Netherlands)

    Kleter, G.A.; Noordam, M.Y.

    2016-01-01

    The cultivation of genetically modified (GM) crops has steadily increased since their introduction to the market in the mid-1990s. Before these crops can be grown and sold they have to obtain regulatory approval in many countries, the process of which includes a pre-market safety assessment. The foo

  11. A critical first assessment of the new pre-market approval regime for new psychoactive substances (NPS) in New Zealand.

    Science.gov (United States)

    Wilkins, Chris

    2014-10-01

    New Zealand has recently attempted to address the underlying drivers of the escalating new psychoactive substances (NPS) ('legal highs') problem by establishing the world's first pre-market approval regulatory regime for NPS. NPS products which can be shown with clinical trial data to pose a 'low risk' of harm will be approved for legal manufacture and sale. This paper critically assesses the new regime, drawing on experience of the pharmaceutical sector and legal BZP market. A number of characteristics of the recreational use of NPS may not be well addressed by standard medical clinical trials, including binge use, polydrug use, use by vulnerable groups and high-risk modes of administration. The overt advertising and covert promotion of approved NPS products on the internet may make them fairly visible to young people. The black market for unapproved NPS may be difficult to suppress given that unapproved NPS will be physically identical to approved NPS. If the legal market for NPS encourages the use of NPS, alcohol and other drugs there may be an increase in drug-related harm. Alternatively, if the legal NPS market reduces the use of more harmful drugs, there may be a considerable public health benefit. The clinical trials required for NPS products should address the characteristics of recreational NPS use. Enforcement resources and technical solutions are required to clearly distinguish legal NPS products. The impact the new NPS regime has on other drug use is a key issue and demands further study. © 2014 Society for the Study of Addiction.

  12. Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; pharmaceutical GMP inspection reports, medical device quality system evaluation reports, and certain medical device premarket evaluation reports--FDA. Proposed rule.

    Science.gov (United States)

    1998-04-10

    The Food and Drug Administration (FDA) is proposing to amend its regulations pursuant to an international agreement that is expected to be concluded between the United States and the European Community (EC) (Ref. 1). Under the terms of that agreement, FDA may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by equivalent EC Member State regulatory authorities and medical device quality system evaluation reports and certain medical device premarket evaluation reports provided by equivalent conformity assessment bodies. FDA is taking this action to enhance its ability to ensure the safety and efficacy of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The agency is requesting comments on the proposed rule.

  13. Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.

    Science.gov (United States)

    Yang, Brian W; Iorio, Matthew L; Day, Charles S

    2017-03-15

    The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation.

  14. [Agricultural biotechnology safety assessment].

    Science.gov (United States)

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

    2015-01-01

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

  15. Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

    Science.gov (United States)

    Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

    2016-01-01

    Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

  16. FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.

    Science.gov (United States)

    Jenson, Desmond; Lester, Joelle; Berman, Micah L

    2016-05-01

    Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process.

  17. Safety Assessment of Probiotics

    Science.gov (United States)

    Lahtinen, Sampo J.; Boyle, Robert J.; Margolles, Abelardo; Frias, Rafael; Gueimonde, Miguel

    Viable microbes have been a natural part of human diet throughout the history of mankind. Today, different fermented foods and other foods containing live microbes are consumed around the world, including industrialized countries, where the diet has become increasingly sterile during the last decades. By definition, probiotics are viable microbes with documented beneficial effects on host health. Probiotics have an excellent safety record, both in humans and in animals. Despite the wide and continuously increasing consumption of probiotics, adverse events related to probiotic use are extremely rare. Many popular probiotic strains such as lactobacilli and bifidobacteria can be considered as components of normal healthy intestinal microbiota, and thus are not thought to pose a risk for the host health - in contrast, beneficial effects on health are commonly reported. Nevertheless, the safety of probiotics is an important issue, in particular in the case of new potential probiotics which do not have a long history of safe use, and of probiotics belonging to species for which general assumption of safety cannot be made. Furthermore, safety of probiotics in high-risk populations such as critically ill patients and immunocompromized subjects deserves particular attention, as virtually all reported cases of bacteremia and fungemia associated with probiotic use, involve subjects with underlying diseases, compromised immune system or compromised intestinal integrity.

  18. Topaz II preliminary safety assessment

    Science.gov (United States)

    Marshall, Albert C.; Standley, Vaughn; Voss, Susan S.; Haskin, Eric

    1993-01-01

    The Strategic Defense Initiative Organization (SDIO) decided to investigate the possibility of launching a Russian Topaz II space nuclear power system. A preliminary safety assessment was conducted to determine whether or not a space mission could be conducted safely and within budget constraints. As part of this assessment, a safety policy and safety functional requirements were developed to guide both the safety assessment and future Topaz II activities. A review of the Russian flight safety program was conducted and documented. Our preliminary safety assessment included a top level event tree, neutronic analysis of normal and accident configurations, an evaluation of temperature coefficients of reactivity, a reentry and disposal analysis, and analysis of postulated launch abort impact accidents, and an analysis of postulated propellant fire and explosion accidents. Based on the assessment, it appears that it will be possible to safely launch the Topaz II system in the U.S. with some possible system modifications. The principal system modifications will probably include design changes to preclude water flooded criticality and to assure intact reentry.

  19. LNG Safety Assessment Evaluation Methods

    Energy Technology Data Exchange (ETDEWEB)

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

    2015-05-01

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

  20. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Science.gov (United States)

    2013-06-14

    ... HUMAN SERVICES Food and Drug Administration Content of Premarket Submissions for Management of... Administration (FDA) is announcing the availability of the draft guidance entitled ``Content of Premarket... draft guidance document entitled ``Content of Premarket Submissions for Management of Cybersecurity...

  1. Integrated Safety Assessment for Assuring Acceptable Level of Nuclear Safety

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Kwang Sik; Choi, Young Sung [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2008-05-15

    The discussions on regulatory goal of assuring an acceptable level of nuclear safety at nuclear facilities have been made among regulators worldwide so far. Several meetings were held and documents have been also prepared on safety goal, safety objectives, regulatory safety goals and so on. In 2008, the Greenbook 'The regulatory goal of assuring nuclear safety' was published by OECD/NEA CNRA (Committee on Nuclear Regulatory Activities) task group consisting of experts from OECD/NEA member countries. In Korea, similar efforts have been made and some practices have been already implemented in regulatory activities although they are not explicitly shown up. This paper reviews discussions made so far on the safety objectives or goals of regulation, and presents some examples adopted for integrated safety assessment in Korea. Some suggestions for future directions on this discourse are made.

  2. Medical devices; exemption from premarket notification; class II devices; wheelchair elevator. Final order.

    Science.gov (United States)

    2013-03-04

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

  3. Assessment of potential adjuvanticity of Cry proteins

    DEFF Research Database (Denmark)

    Joshi, Saurabh S; Barnett, Brian; Doerrer, Nancy G

    2016-01-01

    the potential immuno-adjuvant effects of Cry proteins. These studies had limitations in study design. The studies used animal models with extremely high doses of Cry proteins, which when given using the ig route were co-administered with an adjuvant. Although the presumption exists that Cry proteins may have......, the history of safe use of Cry proteins in foods, safety of the Bt donor organisms, and pre-market weight-of-evidence-based safety assessments for GM crops....

  4. Health Technology Assessment and patient safety

    Directory of Open Access Journals (Sweden)

    Andrew Mulcahy

    2005-12-01

    Full Text Available

    Health Technology Assessment (HTA is a process used to evaluate the clinical effectiveness and costeffectiveness of health technologies by a systematic review of clinical, economic, and utilization research.

    Despite widespread investment in patient safety technologies in the U.K., U.S., and elsewhere, little HTA has been done to establish the clinical or cost-effectiveness of these technologies. The HTA and patient safety literature suggests there are four categories of patient safety HTA, including HTA for existing safety technologies, underutilized safety technologies, emerging safety technologies, as well as safety aspects of technologies with a non-safety primary purpose.

    Recent HTA and other research, including a 2002 evidencebased evaluation of patient safety technologies from the U.S. Agency for Health Research and Quality, provide an important foundation for a more comprehensive approach to patient safety HTA. However, HTA programs must address prioritization, methodology, and dissemination challenges introduced by patient safety technologies before significant progress can Te made.

  5. Food Safety Assessment and Programming.

    Science.gov (United States)

    Gilmore, Gary D.; And Others

    1994-01-01

    A 1990 Wisconsin extension survey (n=1,549) was followed up in 1993 (n=1,135). In 1993, the top three concerns about food safety were food-borne illnesses, government role, and pesticides/chemicals; in 1990, they were pesticides, drugs in food, and manufacturing standards. In both surveys, preferred information sources were radio, television, and…

  6. Food and feed safety assessment

    NARCIS (Netherlands)

    Kuiper, H.A.; Paoletti, Claudia

    2015-01-01

    The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the

  7. Safety Sound interpretive site designation environmental assessment

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The purpose of this environmental assessment is to analyze the impacts of designating a 70 acre parcel of the Alaska Maritime National Wildlife Refuge as the Safety...

  8. Drug Safety Assessment:An Urgent Task

    Institute of Scientific and Technical Information of China (English)

    Guo Haiyan; Zhao Baohua

    2002-01-01

    @@ A CAS scientist has pointed out at an international symposium that it is important for China to step up its efforts in drug safety assessment to address a hidden peril in China's pharmaceuticals industry.

  9. PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

    DEFF Research Database (Denmark)

    Hulstaert, F.; Neyt, M.; Vinck, I.

    2012-01-01

    Objectives: High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT...... Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. Results: In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus...

  10. Review of the regulation and safety assessment of food substances in various countries and jurisdictions.

    Science.gov (United States)

    Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

    2013-01-01

    This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods.

  11. Fire safety assessment of tunnel structures

    DEFF Research Database (Denmark)

    Gkoumas, Konstantinos; Giuliani, Luisa; Petrini, Francesco

    2011-01-01

    durability provisions, commitment to environmental aspects, issues of sustainability and safety assurance, for their whole lifecycle. The design for safety of tunnel infrastructures is a multifaceted process, since there are many aspects that need to be accounted for, regarding different aspects (e...... for upgrading fire safety provisions and tunnel management are also important for existing tunnels. In this study, following a brief introduction of issues regarding the above mentioned aspects, the structural performance of a steel rib for a tunnel infrastructure subject to fire is assessed by means...

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

    Energy Technology Data Exchange (ETDEWEB)

    EVANS, C B

    2004-12-21

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

  13. Safety assessment of genetically modified foods.

    Science.gov (United States)

    Taylor, S L

    2001-12-01

    The development of novel foods produced through agricultural biotechnology is a complex three-stage process: gene discovery, line selection, and product advancement to commercialization. The safety of genetically modified foods is an integral part of the overall developmental process throughout all of the stages. In the discovery stage, the safety of the gene, its source, and the gene products must be considered. If any questions arise at this stage, these questions must be answered later in the developmental process. During the line selection stage, the genetically modified seed progresses through a variety of greenhouse and field trials. At this stage, the biological and agronomic equivalence of the genetically modified crop to its traditional counterpart must be compared. While the evaluations made during this stage are not specifically directed toward a safety assessment, many potential products with unusual characteristics are eliminated during this stage of development. However, the elimination of products with unusual agronomic or biological characteristics enhances the likelihood that a safe product will be generated. Finally, in the pre-commercialization stage, the genetically modified product undergoes a detailed safety assessment process. This process focuses on the safety of the gene products associated with the introduced gene and any other likely toxicological or anti-nutrient factors associated with the source of the novel gene and the crop to which it was introduced. The safety of the genetically modified product for both food and feed uses is considered. Thus far, all of the genetically modified products brought into the marketplace have been subjected to such an intensive safety assessment. The safety assessment data have been reviewed by regulatory authorities around the world. The current generation of genetically modified products are quite safe for human and feed animal consumption.

  14. Indirect Lightning Safety Assessment Methodology

    Energy Technology Data Exchange (ETDEWEB)

    Ong, M M; Perkins, M P; Brown, C G; Crull, E W; Streit, R D

    2009-04-24

    Lightning is a safety hazard for high-explosives (HE) and their detonators. In the However, the current flowing from the strike point through the rebar of the building The methodology for estimating the risk from indirect lighting effects will be presented. It has two parts: a method to determine the likelihood of a detonation given a lightning strike, and an approach for estimating the likelihood of a strike. The results of these two parts produce an overall probability of a detonation. The probability calculations are complex for five reasons: (1) lightning strikes are stochastic and relatively rare, (2) the quality of the Faraday cage varies from one facility to the next, (3) RF coupling is inherently a complex subject, (4) performance data for abnormally stressed detonators is scarce, and (5) the arc plasma physics is not well understood. Therefore, a rigorous mathematical analysis would be too complex. Instead, our methodology takes a more practical approach combining rigorous mathematical calculations where possible with empirical data when necessary. Where there is uncertainty, we compensate with conservative approximations. The goal is to determine a conservative estimate of the odds of a detonation. In Section 2, the methodology will be explained. This report will discuss topics at a high-level. The reasons for selecting an approach will be justified. For those interested in technical details, references will be provided. In Section 3, a simple hypothetical example will be given to reinforce the concepts. While the methodology will touch on all the items shown in Figure 1, the focus of this report is the indirect effect, i.e., determining the odds of a detonation from given EM fields. Professor Martin Uman from the University of Florida has been characterizing and defining extreme lightning strikes. Using Professor Uman's research, Dr. Kimball Merewether at Sandia National Laboratory in Albuquerque calculated the EM fields inside a Faraday-cage type

  15. Savannah River Site reactor safety assessment. Draft

    Energy Technology Data Exchange (ETDEWEB)

    Woody, N.D.; Brandyberry, M.D. [eds.] [Westinghouse Savannah River Co., Aiken, SC (United States); Baker, W.H.; Brandyberry, M.D.; Kearnaghan, D.P.; O`Kula, K.R.; Woody, N.D. [Westinghouse Savannah River Co., Aiken, SC (United States); Amos, C.N.; Weingardt, J.J. [Science Applications International Corp., San Diego, CA (United States)

    1991-02-28

    This report gives the results of a Savannah River Site (SRS) Production Reactor risk assessment. Measures of adverse consequences to health and safety resulting from representations of severe accidents in SRS reactors are presented. In addition, the report gives a summary of the methods employed to represent these accidents and to assess the resultant consequences. The report is issued to provide timely information to the US Department of Energy (DOE) on the risk of operation of SRS reactors, for insights into severe accident phenomena that contribute to this risk, and in support of improved bases for other Site programs in Heavy Water Reactor safety.

  16. Industrial irradiator radiation safety program assessments

    Science.gov (United States)

    Smith, Mark A.

    2000-03-01

    Considerable attention is typically given to radiation safety in the design of irradiators and initially establishing the program. However, one component that may not receive enough attention is applying the continuous improvement philosophy to the radiation safety program. Periodic total program assessments of radiation safety can ensure that the design and implementation of the program continues to be applicable to the operations. The first step in the process must be to determine what is to be covered in the program assessment. While regulatory compliance audits are a component, the most useful evaluation will extend beyond looking only at compliance and determine whether the radiation safety program is the most appropriate for the particular operation. Several aspects of the irradiator operation, not all of which may routinely be considered "radiation safety", per se, should be included: Design aspects of the irradiator and operating system, system controls, and maintenance procedures, as well as the more traditional radiation safety program components such as surveys, measurements and training.

  17. DOE/EM Criticality Safety Needs Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Westfall, Robert Michael [ORNL; Hopper, Calvin Mitchell [ORNL

    2011-02-01

    The issue of nuclear criticality safety (NCS) in Department of Energy Environmental Management (DOE/EM) fissionable material operations presents challenges because of the large quantities of material present in the facilities and equipment that are committed to storage and/or material conditioning and dispositioning processes. Given the uncertainty associated with the material and conditions for many DOE/EM fissionable material operations, ensuring safety while maintaining operational efficiency requires the application of the most-effective criticality safety practices. In turn, more-efficient implementation of these practices can be achieved if the best NCS technologies are utilized. In 2002, DOE/EM-1 commissioned a survey of criticality safety technical needs at the major EM sites. These needs were documented in the report Analysis of Nuclear Criticality Safety Technology Supporting the Environmental Management Program, issued May 2002. Subsequent to this study, EM safety management personnel made a commitment to applying the best and latest criticality safety technology, as described by the DOE Nuclear Criticality Safety Program (NCSP). Over the past 7 years, this commitment has enabled the transfer of several new technologies to EM operations. In 2008, it was decided to broaden the basis of the EM NCS needs assessment to include not only current needs for technologies but also NCS operational areas with potential for improvements in controls, analysis, and regulations. A series of NCS workshops has been conducted over the past years, and needs have been identified and addressed by EM staff and contractor personnel. These workshops were organized and conducted by the EM Criticality Safety Program Manager with administrative and technical support by staff at Oak Ridge National Laboratory (ORNL). This report records the progress made in identifying the needs, determining the approaches for addressing these needs, and assimilating new NCS technologies into EM

  18. Safety assessment of plant food supplements (PFS)

    NARCIS (Netherlands)

    Berg, van den S.J.P.L.; Serra-Majem, L.; Coppens, P.; Rietjens, I.

    2011-01-01

    Botanicals and botanical preparations, including plant food supplements (PFS), are widely used in Western diets. The growing use of PFS is accompanied by an increasing concern because the safety of these PFS is not generally assessed before they enter the market. Regulatory bodies have become more a

  19. Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

    Science.gov (United States)

    Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

    2017-01-01

    The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P < .001). Radiologic devices are largely approved by multireader, multicenter studies, the recommended standard for assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  20. Safety assessment of high consequence robotics system

    Energy Technology Data Exchange (ETDEWEB)

    Robinson, D.G.; Atcitty, C.B.

    1996-08-01

    This paper outlines the use of a failure modes and effects analysis for the safety assessment of a robotic system being developed at Sandia National Laboratories. The robotic system, the weigh and leak check system, is to replace a manual process for weight and leakage of nuclear materials at the DOE Pantex facility. Failure modes and effects analyses were completed for the robotics process to ensure that safety goals for the systems have been met. Due to the flexible nature of the robot configuration, traditional failure modes and effects analysis (FMEA) were not applicable. In addition, the primary focus of safety assessments of robotics systems has been the protection of personnel in the immediate area. In this application, the safety analysis must account for the sensitivities of the payload as well as traditional issues. A unique variation on the classical FMEA was developed that permits an organized and quite effective tool to be used to assure that safety was adequately considered during the development of the robotic system. The fundamental aspects of the approach are outlined in the paper.

  1. Safety assessment of probiotics for human use

    Science.gov (United States)

    Akkermans, Louis MA; Haller, Dirk; Hammerman, Cathy; Heimbach, James; Hörmannsperger, Gabriele; Huys, Geert; Levy, Dan D; Lutgendorff, Femke; Mack, David; Phothirath, Phoukham; Solano-Aguilar, Gloria; Vaughan, Elaine

    2010-01-01

    The safety of probiotics is tied to their intended use, which includes consideration of potential vulnerability of the consumer or patient, dose and duration of consumption, and both the manner and frequency of administration. Unique to probiotics is that they are alive when administered, and unlike other food or drug ingredients, possess the potential for infectivity or in situ toxin production. Since numerous types of microbes are used as probiotics, safety is also intricately tied to the nature of the specific microbe being used. The presence of transferable antibiotic resistance genes, which comprises a theoretical risk of transfer to a less innocuous member of the gut microbial community, must also be considered. Genetic stability of the probiotic over time, deleterious metabolic activities, and the potential for pathogenicity or toxicogenicity must be assessed depending on the characteristics of the genus and species of the microbe being used. Immunological effects must be considered, especially in certain vulnerable populations, including infants with undeveloped immune function. A few reports about negative probiotic effects have surfaced, the significance of which would be better understood with more complete understanding of the mechanisms of probiotic interaction with the host and colonizing microbes. Use of readily available and low cost genomic sequencing technologies to assure the absence of genes of concern is advisable for candidate probiotic strains. The field of probiotic safety is characterized by the scarcity of studies specifically designed to assess safety contrasted with the long history of safe use of many of these microbes in foods. PMID:21327023

  2. Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

    Science.gov (United States)

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

    2011-11-01

    Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required ≥1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. The aim was to evaluate the extent to which regulators and industry have addressed the risk of safety issues for HIV drugs based on prior experience with other drugs in the same class and whether doing so impacts development time of these drugs. HIV drugs receiving ≥1 DHPC in the Netherlands between January 1999 and December 2008 were identified. Each drug with a DHPC ('index' drug) was paired with subsequently approved HIV drug(s) in the same class (Anatomical Therapeutic Chemical [ATC] 4th level) ['follow-on' drugs]. Characteristics of safety issues were extracted from the DHPCs of the 'index' drugs. European Public Assessment Reports (EPARs) were reviewed regarding whether the safety issues had been considered during development and approval. Consideration of previously identified safety issues in 'follow-on' drug applications was assessed regarding attention paid to adverse drug reaction (ADR) symptoms in pre-marketing studies, Summary of Product Characteristics (SmPC) and postmarketing commitments, and whether size of the safety population was in accordance with Regulatory guidelines. 'Index' drugs were also paired with drugs in the same class already on the market ('older' drugs). For 'older' drugs, we identified whether the safety issue led to appropriate changes in the current SmPC (January 2011) compared with the SmPC at the time of marketing authorization. Clinical development time was assessed using time from first patent application to market authorization as proxy, and comparison was made between 'index' and 'follow-on' drugs. For 9 (43%) of the 21 centrally authorized HIV drugs, 11 serious safety issues that required a DHPC were identified. Two drugs were excluded from our

  3. Animal-Free Chemical Safety Assessment

    Directory of Open Access Journals (Sweden)

    George D Loizou

    2016-07-01

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

  4. Animal-Free Chemical Safety Assessment.

    Science.gov (United States)

    Loizou, George D

    2016-01-01

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

  5. Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials.

    Science.gov (United States)

    Avigan, Mark I; Bjornsson, Einar S; Pasanen, Markku; Cooper, Charles; Andrade, Raul J; Watkins, Paul B; Lewis, James H; Merz, Michael

    2014-11-01

    A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in clinical trials. There was agreement that in order to achieve this goal the systematic acquisition of protocol-specified clinical measures and lab specimens from all study subjects is crucial. In addition, standard DILI terms that address the diverse clinical and pathologic signatures of DILI were considered essential. There was a strong consensus that clinical and lab analyses necessary for the evaluation of cases of acute liver injury should be consistent with the US Food and Drug Administration (FDA) guidance on pre-marketing risk assessment of DILI in clinical trials issued in 2009. A recommendation that liver injury case review and management be guided by clinicians with hepatologic expertise was made. Of note, there was agreement that emerging DILI signals should prompt the systematic collection of candidate pharmacogenomic, proteomic and/or metabonomic biomarkers from all study subjects. The use of emerging standardized clinical terminology, CRFs and graphic tools for data review to enable harmonization across clinical trials was strongly encouraged. Many of the recommendations made in the breakout session are in alignment with those made in the other parallel sessions on methodology to assess clinical liver safety data, causality assessment for suspected DILI, and liver safety assessment in special populations (hepatitis B, C, and oncology trials). Nonetheless, a few outstanding issues remain for future consideration.

  6. Safety Factors in Pesticide Risk Assessment

    DEFF Research Database (Denmark)

    Elmegaard, N.; Jagers op Akkerhuis, G. A. J. M.

    Foreword It has become common practice to protect the environment from hazardous chemicals by use of risk assessment to establish environmental concentration at which only limited damage to the ecosystem can be expected. The methods and tools applied in the risk assessment need constant evaluation...... to secure that the methodology is adequate. As new knowledge surfaces the risk assessment procedures develops. The present report is a contribution to the development of safety factors used to account for the uncertainty when · extrapolating from the results of test with a single species in the laboratory...... factors used in pesticide risk assessment: the variability in species sensitivities, and the relationship between acute LC50's and chronic NOEC's....

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2007-07-01

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

  8. Physical quality and safety assessment of selected varieties of local ...

    African Journals Online (AJOL)

    Physical quality and safety assessment of selected varieties of local paddy and milled rice ... sampled from all major rice growing districts of Uganda were assessed for quality and safety. ... EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT

  9. Safety Factors in Pesticide Risk Assessment

    DEFF Research Database (Denmark)

    Elmegaard, N.; Jagers op Akkerhuis, G. A. J. M.

    Foreword It has become common practice to protect the environment from hazardous chemicals by use of risk assessment to establish environmental concentration at which only limited damage to the ecosystem can be expected. The methods and tools applied in the risk assessment need constant evaluation...... to many species in real ecosystems · extrapolating from acute to chronic or long term effects. The project was co-funded by the Environmental Protection Agency and The National Environmental Research Institute Summary In this report two factors are studied which have implications for the size of safety...... factors used in pesticide risk assessment: the variability in species sensitivities, and the relationship between acute LC50's and chronic NOEC's....

  10. SIMPATO-The safety impact assessment tool of interactive

    NARCIS (Netherlands)

    Noort, M. van; Bakri, T.; Fahrenkrog, F.; Dobberstein, J.

    2015-01-01

    One step in the development of safety oriented Advanced Driver Assistance Systems (ADAS) is an ex ante assessment of the expected safety impacts. This requires a careful analysis combining models and data from various sources. This paper describes the Safety IMPact Assessment Tool, called SIMPATO, t

  11. Safety Assessment and Countermeasures of Genetically Modified Food

    Directory of Open Access Journals (Sweden)

    2013-05-01

    Full Text Available With the rapid development of science-biotechnology, the safety of genetically modified organisms has become some of the most controversial issues in our society. This study aims to review the safety assessment and countermeasures of Genetically Modified (GM foods. Firstly, the research status and the main contents of GM foods safety assessment are discussed. What’s more, the countermeasures of GM foods safety assessment are proposed. This study tries to summarize and discuss the safety assessment of GM foods.

  12. Safety assessment of smoke flavouring primary products by the European Food Safety Authority

    NARCIS (Netherlands)

    Theobald, A.; Arcella, D.; Carere, A.; Croera, C.; Engel, K.H.; Gott, D.; Gurtler, R.; Meier, D.; Pratt, I.; Rietjens, I.M.C.M.; Simon, R.; Walker, R.

    2012-01-01

    This paper summarises the safety assessments of eleven smoke flavouring primary products evaluated by the European Food Safety Authority (EFSA). Data on chemical composition, content of polyaromatic hydrocarbons and results of genotoxicity tests and subchronic toxicity studies are presented and

  13. 78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

    Science.gov (United States)

    2013-03-04

    ... HUMAN SERVICES Food and Drug Administration Pulse Oximeters--Premarket Notification Submissions... availability of the guidance entitled ``Pulse Oximeters--Premarket Notification Submissions .'' This guidance document pertains to non-invasive pulse oximeters intended for prescription use to measure arterial...

  14. Assessing Hmong farmers' safety and health.

    Science.gov (United States)

    de Castro, A B; Krenz, Jennifer; Neitzel, Richard L

    2014-05-01

    This pilot project investigated agricultural-related safety and health issues among Hmong refugees working on family-operated farms. Novel approaches, namely participatory rural appraisal and photovoice, were used to conduct a qualitative occupational hazard assessment with a group of Hmong farmers in Washington State. These two methods were useful in gathering participants' own perspectives about priority concerns. Several identified problems were related to musculoskeletal disorders, handling and operating heavy machinery, heat and cold stress, respiratory exposures, pest management, and socioeconomic and language concerns. Findings from this study provide insight into the work-related challenges that Hmong refugee farmers encounter and can serve as a basis for occupational health professionals to develop interventions to assist this underserved group.

  15. Environmental Restoration Disposal Facility (Project W-296) Safety Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Armstrong, D.L.

    1994-08-01

    This Safety Assessment is based on information derived from the Conceptual Design Report for the Environmental Restoration Disposal Facility (DOE/RL 1994) and ancillary documentation developed during the conceptual design phase of Project W-296. The Safety Assessment has been prepared to support the Solid Waste Burial Ground Interim Safety Basis document. The purpose of the Safety Assessment is to provide an evaluation of the design to determine if the process, as proposed, will comply with US Department of Energy (DOE) Limits for radioactive and hazardous material exposures and be acceptable from an overall health and safety standpoint. The evaluation considered affects on the worker, onsite personnel, the public, and the environment.

  16. Safety Assessment in Installation of Precast Concrete

    Directory of Open Access Journals (Sweden)

    Yashrri S.N.

    2014-03-01

    Full Text Available This study was carried out to identify the safety aspects and the level of safety during the installation process in construction sites. A questionnaire survey and interviews were done to provide data on safety requirements in precast concrete construction. All of the interviews and the research questionnaire survey were conducted among contractors that are registered as class 1 to class 7 with the Construction Industry Development Board (CIDB and class A to class G with Pusat Khidmat Kontraktor (PKK in Penang. Returned questionnaires were analysed with the use of simple percentages and the Likert Scale analysis method to identify safety aspects of precast construction. The results indicate that the safety aspect implemented by companies involved in the precast construction process is at a good level in the safety aspect during bracing, propping, welding and grouting processes and at a very good level of safety in general aspects and safety aspects during lifting processes.

  17. 21 CFR 170.103 - Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Withdrawal without prejudice of a premarket... ADDITIVES Premarket Notifications § 170.103 Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). A manufacturer or supplier may withdraw an FCN without prejudice to...

  18. Geosphere process report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Skagius, Kristina (ed.) (Kemakta Konsult AB, Stockholm (Sweden))

    2010-11-15

    This report documents geosphere processes identified as relevant to the long-term safety of a KBS-3 repository, and forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  19. Constantly evolving safety assessment protocols for GM foods.

    Science.gov (United States)

    Sesikeran, B; Vasanthi, Siruguri

    2008-01-01

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

  20. Safety management practices and safety behaviour: assessing the mediating role of safety knowledge and motivation.

    Science.gov (United States)

    Vinodkumar, M N; Bhasi, M

    2010-11-01

    Safety management practices not only improve working conditions but also positively influence employees' attitudes and behaviours with regard to safety, thereby reducing accidents in workplace. This study measured employees' perceptions on six safety management practices and self-reported safety knowledge, safety motivation, safety compliance and safety participation by conducting a survey using questionnaire among 1566 employees belonging to eight major accident hazard process industrial units in Kerala, a state in southern part of India. The reliability and unidimesionality of all the scales were found acceptable. Path analysis using AMOS-4 software showed that some of the safety management practices have direct and indirect relations with the safety performance components, namely, safety compliance and safety participation. Safety knowledge and safety motivation were found to be the key mediators in explaining these relationships. Safety training was identified as the most important safety management practice that predicts safety knowledge, safety motivation, safety compliance and safety participation. These findings provide valuable guidance for researchers and practitioners for identifying the mechanisms by which they can improve safety of workplace.

  1. [Patient safety in antibiotics administration: Risk assessment].

    Science.gov (United States)

    Maqueda Palau, M; Pérez Juan, E

    To determine the level of risk in the preparation and administration of antibiotics frequently used in the Intensive Care Unit using a risk matrix. A study was conducted using situation analysis and literature review of databases, protocols and good practice guidelines on intravenous therapy, drugs, and their administration routes. The most used antibiotics in the ICU registered in the ENVIN-HELICS program from 1 April to 30 June 2015 were selected. In this period, 257 patients received antimicrobial treatment and 26 antibiotics were evaluated. Variables studied: A risk assessment of each antibiotic using the scale Risk Assessment Tool, of the National Patient Safety Agency, as well as pH, osmolarity, type of catheter recommended for administration, and compatibility and incompatibility with other antibiotics studied. Almost two-thirds (65.3%) of antibiotics had more than 3 risk factors (represented by a yellow stripe), with the remaining 34.7% of antibiotics having between 0 and 2 risk factors (represented by a green stripe). There were no antibiotics with 6 or more risk factors (represented by a red stripe). Most drugs needed reconstitution, additional dilution, and the use of part of the vial to administer the prescribed dose. More than half of the antibiotics studied had a moderate risk level; thus measures should be adopted in order to reduce it. The risk matrix is a useful tool for the assessment and detection of weaknesses associated with the preparation and administration of intravenous antibiotics. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  2. ITER plasma safety interface models and assessments

    Energy Technology Data Exchange (ETDEWEB)

    Uckan, N.A. [Oak Ridge National Lab., TN (United States); Bartels, H-W. [ITER San Diego Joint Work Site, La Jolla, CA (United States); Honda, T. [Hitachi Ltd., Ibaraki (Japan). Hitachi Research Lab.; Putvinski, S. [ITER San Diego Joint Work Site, La Jolla, CA (United States); Amano, T. [National Inst. for Fusion Science, Nagoya (Japan); Boucher, D.; Post, D.; Wesley, J. [ITER San Diego Joint Work Site, La Jolla, CA (United States)

    1996-12-31

    Physics models and requirements to be used as a basis for safety analysis studies are developed and physics results motivated by safety considerations are presented for the ITER design. Physics specifications are provided for enveloping plasma dynamic events for Category I (operational event), Category II (likely event), and Category III (unlikely event). A safety analysis code SAFALY has been developed to investigate plasma anomaly events. The plasma response to ex-vessel component failure and machine response to plasma transients are considered.

  3. Systematic assessment of laser safety in otolaryngology

    Science.gov (United States)

    Oswal, V. H.

    2001-01-01

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

  4. Safety assessment and detection methods of genetically modified organisms.

    Science.gov (United States)

    Xu, Rong; Zheng, Zhe; Jiao, Guanglian

    2014-01-01

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

  5. Safety Assessment of Dialkyl Malates as Used in Cosmetics.

    Science.gov (United States)

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

    2015-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 6 dialkyl malate compounds used in cosmetics. These ingredients function mostly as skin-conditioning agents-emollients. The Panel reviewed relevant animal and human data related to the ingredients along with a previous safety assessment of malic acid. The similar structure, properties, functions, and uses of these ingredients enabled grouping them and using the available toxicological data to assess the safety of the entire group. The Panel concluded that these dialkyl maleate compounds are safe in the present practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

  6. Safety Assessment of Synthetic Fluorphlogopite as Used in Cosmetics.

    Science.gov (United States)

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

    2015-01-01

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

  7. Radionuclide transport report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This document compiles radionuclide transport calculations of a KBS-3 repository for the safety assessment SR-Site. The SR-Site assessment supports the licence application for a final repository at Forsmark, Sweden

  8. Fire safety assessment of tunnel structures

    DEFF Research Database (Denmark)

    Gkoumas, Konstantinos; Giuliani, Luisa; Petrini, Francesco

    2011-01-01

    .g. structural and non structural, organizational, human behavior). This is even more truth for the fire safety design of such structures. Fire safety in tunnels is challenging because of the particular environment, bearing in mind also that a fire can occur in different phases of the tunnel’s lifecycle. Plans...... of nonlinear analyses for different fire exposures....

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

    NARCIS (Netherlands)

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

    2016-01-01

    Background: By assessing patient safety culture, healthcare providers can identify areas for improvement in patient safety culture. To achieve this, these assessment outcomes have to be relevant and presented clearly. The aim of our study was to explore healthcare professionals’ views on the feedbac

  10. A Computer Program for Assessing Nuclear Safety Culture Impact

    Energy Technology Data Exchange (ETDEWEB)

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

    2014-10-15

    Through several accidents of NPP including the Fukushima Daiichi in 2011 and Chernobyl accidents in 1986, a lack of safety culture was pointed out as one of the root cause of these accidents. Due to its latent influences on safety performance, safety culture has become an important issue in safety researches. Most of the researches describe how to evaluate the state of the safety culture of the organization. However, they did not include a possibility that the accident occurs due to the lack of safety culture. Because of that, a methodology for evaluating the impact of the safety culture on NPP's safety is required. In this study, the methodology for assessing safety culture impact is suggested and a computer program is developed for its application. SCII model which is the new methodology for assessing safety culture impact quantitatively by using PSA model. The computer program is developed for its application. This program visualizes the SCIs and the SCIIs. It might contribute to comparing the level of the safety culture among NPPs as well as improving the management safety of NPP.

  11. Fuzzy synthetic assessment of building fire safety system

    Institute of Scientific and Technical Information of China (English)

    YANG Gao-shang; PENG Li-min

    2005-01-01

    A multistage assessment index set is chosen based on the analysis of building fire safety system, whereby the weight of each index is determined through an analy tie.hierarchy process; a fuzzy synthetic assessment model for the building fire safety system is constructed, and the quantified result was obtained by using hierarchy parameter judgment. This fuzzy synthetic assessment method can quantify assessment result of the building fire safety system, so thatthe fire precautions may be accurately adopted, and the serious potential risk may be avoided. The application shows that this method possesses both objectivity and feasibility.

  12. Safety Assessment of Genetically Modified Foods

    OpenAIRE

    TAYLOR Steve L.

    2001-01-01

    The development of novel foods produced through agricultural biotechnology is a complex three-stage process: gene discovery, line selection, and product advancement to commercialization. The safety of genetically modified foods is an integral part of the overall developmental process throughout all of the stages. In the discovery stage, the safety of the gene, its source, and the gene products must be considered. If any questions arise at this stage, these questions must be answered later in ...

  13. SAFETY CULTURE ASSESSMENT – OPTIMIZATION OF EXISTING PRACTICE

    Directory of Open Access Journals (Sweden)

    Mirela Valenta Grebenšek

    2015-12-01

    Full Text Available Improving aviation safety has always been a priority for the aviation industry. While in recent decades the reliability of machinery and computers dramatically improved the reliability of the people and the organizational aspect of safety did not change much. Many of air accident investigations have shown that one of the causal factors, which increase the probability and severity of accidents, is exactly poor safety culture. The purpose of this paper is to present the concept of safety culture assessment and the overview and review of different methods of measuring the safety culture in aviation. This research provides the suggestion that by use of different methods of assessment (evaluation of the results, more credible insight into the level of safety culture in the organization can be obtained. It also provides an understanding of how measurement systems in order to guide future performance can be used proactively.

  14. FDA'S food ingredient approval process: Safety assurance based on scientific assessment.

    Science.gov (United States)

    Rulis, Alan M; Levitt, Joseph A

    2009-02-01

    Fifty years ago, the Food and Drug Administration (FDA) began implementing new provisions of the Federal Food, Drug, and Cosmetic Act aimed at assuring the safety of new food additives before they enter the marketplace. Today, the agency's procedures for premarket evaluation of food additive safety have evolved into a scientifically rigorous, sound and dependable system whose objective and independent evaluations by FDA scientists assure that new food additives are safe for their intended uses before they arrive on the consumer's plate. Although controversy often surrounds food additives in the popular media and culture, and science-based challenges to FDA's decisions do arise, the agency's original safety judgments successfully withstand these challenges time and again. This article reviews the basic components of the FDA's decision-making process for evaluating the safety of new food additives, and identifies characteristics of this process that are central to assuring that FDA's decisions are marked by scientific rigor and high integrity, and can continue to be relied on by consumers.

  15. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

    Science.gov (United States)

    Rathi, Vinay K; Krumholz, Harlan M; Masoudi, Frederick A; Ross, Joseph S

    2015-08-11

    The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. In 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer

  16. LNG vehicle technology, economics, and safety assessment

    Science.gov (United States)

    Powars, Charles A.; Moyer, Carl B.; Lowell, Douglas D.

    1994-02-01

    Liquid natural gas (LNG) is an attractive transportation fuel because of its high heating value and energy density (i.e., Btu/lb. and Btu/gal.), clean burning characteristics, relatively low cost ($/Btu), and domestic availability. This research evaluated LNG vehicle and refueling system technology, economics, and safety. Prior and current LNG vehicle projects were studied to identify needed technology improvements. Life-cycle cost analyses considered various LNG vehicle and fuel supply options. Safety records, standards, and analysis methods were reviewed. The LNG market niche is centrally fueled heavy-duty fleet vehicles with high fuel consumption. For these applications, fuel cost savings can amortize equipment capital costs.

  17. Assessment of patient safety culture: what tools for medical students?

    Science.gov (United States)

    Chaneliere, M; Jacquet, F; Occelli, P; Touzet, S; Siranyan, V; Colin, C

    2016-09-29

    The assessment of patient safety culture refers mainly to surveys exploring the perceptions of health professionals in hospitals. These surveys have less relevance when considering the assessment of the patient safety culture of medical students, especially at university or medical school. They are indeed not fully integrated in care units and constitute a heterogeneous population. This work aimed to find appropriate assessment tools of the patient safety culture of medical students. Systematic review of the literature. Surveys related to a care unit were excluded. A typology of the patient safety culture of medical students was built from the included surveys. Eighteen surveys were included. In our typology of patient safety culture of medical students (15 dimensions), the number of dimensions explored by survey (n) ranged from 1 to 12, with 6 "specialized" tools (n ≤ 4) and 12 "global" tools (N ≥ 5). These surveys have explored: knowledge about patient safety, acknowledgment of the inevitability of human error, the lack of skills as the main source of errors, the errors reporting systems, disclosure of medical errors to others health professionals or patients, teamwork and patient involvement to improve safety in care. We recommend using Wetzel's survey for making an overall assessment of the patient safety culture of medical students at university. In a specific purpose-e.g. to assess an educational program on medical error disclosure-the authors recommend to determine which dimensions of patient safety will be taught, to select the best assessment tool. Learning on patient safety should however be considered beyond the university. International translations of tools are required to create databases allowing comparative studies.

  18. Assessing propensity to learn from safety-related events

    NARCIS (Netherlands)

    Drupsteen, L.; Wybo, J.L.

    2015-01-01

    Most organisations aim to use experience from the past to improve safety, for instance through learning from safety-related incidents and accidents. Whether an organisation is able to learn successfully can however only be determined afterwards. So far, there are no proactive measures to assess whet

  19. Eimpact: Impact assessment of in-vehicle safety systems

    NARCIS (Netherlands)

    Malone, K.; Wilmink, I.; Noort, M. van; Klunder, G.

    2007-01-01

    eIMPACT, a project in the EU's Sixth Framework Programme for Information Society Technologies and Media, assesses the socio-economic effects of Intelligent Vehicle Safety Systems (IVSS), their impact on traffic safety and efficiency. It addresses policy options and the views of the different stakeho

  20. Safety assessment of 6-hydroxyindole as used in cosmetics.

    Science.gov (United States)

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

    2014-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 6-hydroxyindole, which functions as an oxidative hair dye ingredient. The Panel considered relevant animal and human data provided in this safety assessment and concluded that 6-hydroxyindole is safe for use in oxidative hair dye formulations.

  1. Ports and Waterways Safety Assessment: Tampa Bay

    Science.gov (United States)

    2003-01-01

    draft mariner proficiency. Most are compliant with Standards for Training, Certification, and Watchkeeping ( STCW ) and IMO. Mariners on U.S. vessels...Generally the vessels that have high maintenance standards have high mariner proficiency. Trends: STCW and IMO are having some positive...fire and shipboard drills. Mandatory pilotage for most vessels arriving in Tampa. STCW . International Safety Management Code (ISM Code

  2. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Science.gov (United States)

    2011-02-18

    ... guidance for industry entitled ``Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.'' The draft guidance is intended to assist the pharmaceutical industry and other investigators... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Clinical...

  3. 76 FR 78930 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket...

    Science.gov (United States)

    2011-12-20

    ... Drug Administration (FDA) is announcing the availability of the guidance entitled ``Enforcement Policy... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and...

  4. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Science.gov (United States)

    2013-03-04

    ... Notification; Class II Devices; Wheelchair Elevator AGENCY: Food and Drug Administration, HHS. ACTION: Final... requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known... another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices,...

  5. Predictive and External Validity of a Pre-Market Study to Determine the Most Effective Pictorial Health Warning Label Content for Cigarette Packages.

    Science.gov (United States)

    Huang, Li-Ling; Thrasher, James F; Reid, Jessica L; Hammond, David

    2016-05-01

    Studies examining cigarette package pictorial health warning label (HWL) content have primarily used designs that do not allow determination of effectiveness after repeated, naturalistic exposure. This research aimed to determine the predictive and external validity of a pre-market evaluation study of pictorial HWLs. Data were analyzed from: (1) a pre-market convenience sample of 544 adult smokers who participated in field experiments in Mexico City before pictorial HWL implementation (September 2010); and (2) a post-market population-based representative sample of 1765 adult smokers in the Mexican administration of the International Tobacco Control Policy Evaluation Survey after pictorial HWL implementation. Participants in both samples rated six HWLs that appeared on cigarette packs, and also ranked HWLs with four different themes. Mixed effects models were estimated for each sample to assess ratings of relative effectiveness for the six HWLs, and to assess which HWL themes were ranked as the most effective. Pre- and post-market data showed similar relative ratings across the six HWLs, with the least and most effective HWLs consistently differentiated from other HWLs. Models predicting rankings of HWL themes in post-market sample indicated: (1) pictorial HWLs were ranked as more effective than text-only HWLs; (2) HWLs with both graphic and "lived experience" content outperformed symbolic content; and, (3) testimonial content significantly outperformed didactic content. Pre-market data showed a similar pattern of results, but with fewer statistically significant findings. The study suggests well-designed pre-market studies can have predictive and external validity, helping regulators select HWL content. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  6. Ensuring the quality of occupational safety risk assessment.

    Science.gov (United States)

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

    2013-03-01

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

  7. Safety assessment of the liquid-fed ceramic melter process

    Energy Technology Data Exchange (ETDEWEB)

    Buelt, J.L.; Partain, W.L.

    1980-08-01

    As part of its development program for the solidification of high-level nuclear waste, Pacific Northwest Laboratory assessed the safety issues for a complete liquid-fed ceramic melter (LFCM) process. The LFCM process, an adaption of commercial glass-making technology, is being developed to convert high-level liquid waste from the nuclear fuel cycle into glass. This safety assessment uncovered no unresolved or significant safety problems with the LFCM process. Although in this assessment the LFCM process was not directly compared with other solidification processes, the safety hazards of the LFCM process are comparable to those of other processes. The high processing temperatures of the glass in the LFCM pose no additional significant safety concerns, and the dispersible inventory of dried waste (calcine) is small. This safety assessment was based on the nuclear power waste flowsheet, since power waste is more radioactive than defense waste at the time of solidification, and all accident conditions for the power waste would have greater radiological consequences than those for defense waste. An exhaustive list of possible off-standard conditions and equipment failures was compiled. These accidents were then classified according to severity of consequence and type of accident. Radionuclide releases to the stack were calculated for each group of accidents using conservative assumptions regarding the retention and decontamination features of the process and facility. Two recommendations that should be considered by process designers are given in the safety assessment.

  8. Microbial safety assessment of recreation water at Lake Nabugabo ...

    African Journals Online (AJOL)

    EJIRO

    Key words: Lake Nabugabo, microbial safety assessment, recreation water, water quality. INTRODUCTION .... bacteria of faecal origin. Lake Nabugabo ..... Waters of Tanzania. J. Biol. Life Sci. 4: 63-82. Ogutu-Ohwayo R (2002). The Effects of ...

  9. Use of agent based simulation for traffic safety assessment

    CSIR Research Space (South Africa)

    Conradie, Dirk CU

    2008-07-01

    Full Text Available This paper describes the development of an agent based Computational Building Simulation (CBS) tool, termed KRONOS that is being used to work on advanced research questions such as traffic safety assessment and user behaviour in buildings...

  10. Safety studies on Korean fusion DEMO plant using Integrated Safety Assessment Methodology: Part 2

    Energy Technology Data Exchange (ETDEWEB)

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

    2015-10-15

    Highlights: • The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant. • The concepts of Integrated Safety Assessment Methodology (ISAM) that can be applied in addressing regulatory requirements and recognizing safety issues for K-DEMO were emphasized. • Phenomena Identification Ranking Table (PIRT) and Objective Provision Tree (OPT) were performed and updated. • This work is expected to contribute on the conceptual design of safety features for K-DEMO to design engineers and the guidance for regulatory requirements to licensers. - Abstract: The purpose of this paper is to investigate safety issues using Integrated Safety Assessment Methodology (ISAM) proposed by Generation IV Forum Risk and Safety Working Group (RSWG) for Korean fusion DEMO plant (K-DEMO). In ongoing nuclear energy research such as Generation IV fission power plant (GEN-IV), new methodology based on Technology-Neutral Framework (TNF) has been applied for safety assessment. In this methodology, design and regulatory requirements for safety of nuclear power plants are considered simultaneously. The design based on regulatory requirements can save resource, time, and manpower while maintaining high level safety. ISAM is one of the options to apply TNF in K-DEMO. We have performed safety studies for K-DEMO using Phenomena Identification and Ranking Table (PIRT) and Objective Provision Tree (OPT) which are constitutive part of ISAM. Considering the design phase of K-DEMO, the current study focused on PIRT and OPT for K-DEMO. Results have been reviewed and updated by Korean fusion advisory group after considering the views of specialists from domestic universities, industries, and national institutes in South Korea.

  11. Safety Assessment - Swedish Nuclear Power Plants

    Energy Technology Data Exchange (ETDEWEB)

    Kjellstroem, B. [Luleaa Univ. of Technology (Sweden)

    1996-12-31

    After the reactor accident at Three Mile Island, the Swedish nuclear power plants were equipped with filtered venting of the containment. Several types of accidents can be identified where the filtered venting has no effect on the radioactive release. The probability for such accidents is hopefully very small. It is not possible however to estimate the probability accurately. Experiences gained in the last years, which have been documented in official reports from the Nuclear Power Inspectorate indicate that the probability for core melt accidents in Swedish reactors can be significantly larger than estimated earlier. A probability up to one in a thousand operating years can not be excluded. There are so far no indications that aging of the plants has contributed to an increased accident risk. Maintaining the safety level with aging nuclear power plants can however be expected to be increasingly difficult. It is concluded that the 12 Swedish plants remain a major threat for severe radioactive pollution of the Swedish environment despite measures taken since 1980 to improve their safety. Closing of the nuclear power plants is the only possibility to eliminate this threat. It is recommended that until this is done, quantitative safety goals, same for all Swedish plants, shall be defined and strictly enforced. It is also recommended that utilities distributing misleading information about nuclear power risks shall have their operating license withdrawn. 37 refs.

  12. Safety assessment of modified terephthalate polymers as used in cosmetics.

    Science.gov (United States)

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

    2014-01-01

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

  13. Selected Component Failure Rate Values from Fusion Safety Assessment Tasks

    Energy Technology Data Exchange (ETDEWEB)

    Cadwallader, Lee Charles

    1998-09-01

    This report is a compilation of component failure rate and repair rate values that can be used in magnetic fusion safety assessment tasks. Several safety systems are examined, such as gas cleanup systems and plasma shutdown systems. Vacuum system component reliability values, including large vacuum chambers, have been reviewed. Values for water cooling system components have also been reported here. The report concludes with the examination of some equipment important to personnel safety, atmospheres, combustible gases, and airborne releases of radioactivity. These data should be useful to system designers to calculate scoping values for the availability and repair intervals for their systems, and for probabilistic safety or risk analysts to assess fusion systems for safety of the public and the workers.

  14. Selected component failure rate values from fusion safety assessment tasks

    Energy Technology Data Exchange (ETDEWEB)

    Cadwallader, L.C.

    1998-09-01

    This report is a compilation of component failure rate and repair rate values that can be used in magnetic fusion safety assessment tasks. Several safety systems are examined, such as gas cleanup systems and plasma shutdown systems. Vacuum system component reliability values, including large vacuum chambers, have been reviewed. Values for water cooling system components have also been reported here. The report concludes with the examination of some equipment important to personnel safety, atmospheres, combustible gases, and airborne releases of radioactivity. These data should be useful to system designers to calculate scoping values for the availability and repair intervals for their systems, and for probabilistic safety or risk analysts to assess fusion systems for safety of the public and the workers.

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

    Science.gov (United States)

    Ancel, Ersin; Shih, Ann T.

    2014-01-01

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

  16. Safety Assessment of Pentaerythrityl Tetraesters as Used in Cosmetics.

    Science.gov (United States)

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

    2015-09-01

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

  17. Savannah River Site K-Reactor Probabilistic Safety Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Brandyberry, M.D.; Bailey, R.T.; Baker, W.H.; Kearnaghan, D.P.; O`Kula, K.R.; Wittman, R.S.; Woody, N.D. [Westinghouse Savannah River Co., Aiken, SC (United States); Amos, C.N.; Weingardt, J.J. [Science Applications International Corp. (United States)

    1992-12-01

    This report gives the results of a Savannah River Site (SRS) K-Reactor Probabilistic Safety Assessment (PSA). Measures of adverse consequences to health and safety resulting from representations of severe accidents in SRS reactors are presented. In addition, the report gives a summary of the methods employed to represent these accidents and to assess the resultant consequences. The report is issued to provide useful information to the U. S. Department of Energy (DOE) on the risk of operation of SRS reactors, for insights into severe accident phenomena that contribute to this risk, and in support of improved bases for other DOE programs in Heavy Water Reactor safety.

  18. Safety culture assessment in community pharmacy: development, face validity, and feasibility of the Manchester Patient Safety Assessment Framework

    National Research Council Canada - National Science Library

    Ashcroft, D M; Morecroft, C; Parker, D; Noyce, P R

    2005-01-01

    To develop a framework that could be used by community pharmacies to self-assess their current level of safety culture maturity, which has high face validity and is both acceptable and feasible for use in this setting...

  19. Safety culture assessment in community pharmacy: development, face validity, and feasibility of the Manchester Patient Safety Assessment Framework

    OpenAIRE

    Ashcroft, D; Morecroft, C; D. Parker; Noyce, P

    2005-01-01

    Objective: To develop a framework that could be used by community pharmacies to self-assess their current level of safety culture maturity, which has high face validity and is both acceptable and feasible for use in this setting.

  20. Research on advanced system safety assessment procedures (4)

    Energy Technology Data Exchange (ETDEWEB)

    Suzuki, Kazuhiko; Shimada, Yukiyasu [Okayama Univ. (Japan)

    2001-03-01

    The past research reports in the area of safety engineering proposed the Computer-aided HAZOP system to be applied to Nuclear Reprocessing Facilities. Automated HAZOP system has great advantage compared with human analysts in terms of accuracy of the results, and time required to conduct HAZOP studies. This report surveys the literature on risk assessment and safety design based on the concept of independent protection layers (IPLs). Furthermore, to improve HAZOP System, tool is proposed to construct the basic model and the internal state model. Such HAZOP system is applied to analyze two kinds of processes, where the ability of the proposed system is verified. In addition, risk assessment support system is proposed to integrate safety design environment and assessment result to be used by other plants as well as to enable the underline plant to use other plants' information. This technique can be implemented using web-based safety information systems. (author)

  1. LANL Safety Conscious Work Environment (SCWE) Self-Assessment

    Energy Technology Data Exchange (ETDEWEB)

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

    2014-01-29

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2014-10-15

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

  3. Innovations in Post-Marketing Safety Research

    NARCIS (Netherlands)

    Stefánsdóttir, G.

    2012-01-01

    Safety surveillance is important during the entire life cycle of a drug. Pre-marketing trials have been shown to be ineffective in establishing the full safety profile of the drug, mainly due to their relatively small sample size and characteristics of the patients, which are usually younger and hea

  4. Innovations in Post-Marketing Safety Research

    NARCIS (Netherlands)

    Stefánsdóttir, G.

    2012-01-01

    Safety surveillance is important during the entire life cycle of a drug. Pre-marketing trials have been shown to be ineffective in establishing the full safety profile of the drug, mainly due to their relatively small sample size and characteristics of the patients, which are usually younger and

  5. Computer Aided Safety Assessment(CASA) Tool for ISS Payloads

    Science.gov (United States)

    Hochstein, Jason; Festa, Fabrizio

    2010-09-01

    In an effort to streamline the processes established by the partners of the International Space Station(ISS) to certify the safety of hardware and experiments destined for the Station, the European Space Agency’s(ESA) ISS System Safety Team is developing the Computer Aided Safety Assessment(CASA) tool suite. These software tools guide payload developers through the creation process of two types of standard payload hazard reports via a series of questions following a predetermined logic. The responses provided by the user are used by the CASA system to complete the majority of each hazard report requisite for payload flight safety reviews, employing consistent, approved descriptions of most hazards, hazard causes, controls and verification methods. Though some manual inputs will still be required to complete these reports, working with CASA will considerably reduce the amount of time necessary to review the documentation by agency safety authorities.

  6. Emerging frontier technologies for food safety analysis and risk assessment

    Institute of Scientific and Technical Information of China (English)

    DONG Yi-yang; LIU Jia-hui; WANG Sai; CHEN Qi-long; GUO Tian-yang; ZHANG Li-ya; JIN Yong; SU Hai-jia; TAN Tian-wei

    2015-01-01

    Access to security and safe food is a basic human necessity and essential for a sustainable world. To perform hi-end food safety analysis and risk assessment with state of the art technologies is of utmost importance thereof. With applications as exempliifed by microlfuidic immunoassay, aptasensor, direct analysis in real time, high resolution mass spectrometry, benchmark dose and chemical speciifc adjustment factor, this review presents frontier food safety analysis and risk assess-ment technologies, from which both food quality and public health wil beneift undoubtedly in a foreseeable future.

  7. A Methodology To Incorporate The Safety Culture Into Probabilistic Safety Assessments

    Energy Technology Data Exchange (ETDEWEB)

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

    2015-10-15

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

  8. Safety assessment of platform loadout procedures based on unascertained measures

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    Safety assessment of offshore platforms is an urgent task. Such assessments are now focusing on the structure,maintenance, and retirement of a platform. Some methods employed have many shortcomings. For example, they cannot make the reliability adequately explicable. Therefore, a mathematical tool, the unascertained measure, was introduced. First, the basic knowledge of the unascertained sets was introduced briefly. Second, the unascertained measure was defined and credible identification was set up. The method has been introduced into the fields for safety assessment of a jacket loadout procedure.Engineering practices showed that it can complete the safety assessment systematically and scientifically without any assumption. The work should have significance in theory and practice for offshore engineering.

  9. Safety assessment of existing highway bridges and viaducts

    NARCIS (Netherlands)

    Maljaars, J.; Steenbergen, R.; Abspoel, L.; Kolstein, M.H.

    2012-01-01

    The assessment of the structural safety of existing br idges and viaducts becomes increasingly important in many countries owing to an increase in traffic loads. Most existing standards, however, are developed for the design of new structures. For this reason, an assessment method for determining th

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

    Science.gov (United States)

    Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

    2012-07-01

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

  11. Safety culture assessment in community pharmacy: development, face validity, and feasibility of the Manchester Patient Safety Assessment Framework.

    Science.gov (United States)

    Ashcroft, D M; Morecroft, C; Parker, D; Noyce, P R

    2005-12-01

    To develop a framework that could be used by community pharmacies to self-assess their current level of safety culture maturity, which has high face validity and is both acceptable and feasible for use in this setting. An iterative review process in which the framework was developed and evaluated through a series of 10 focus groups with a purposive sample of 67 community pharmacists and support staff in the UK. Development of the framework and qualitative process feedback on its acceptability, face validity, and feasibility for use in community pharmacies. Using this process, a version of the Manchester Patient Safety Assessment Framework (MaPSAF) was developed that is suitable for application to community pharmacies. The participants were able to understand the concepts, recognised differences between the five stages of safety culture maturity, and concurred with the descriptions from personal experience. They also indicated that they would be willing to use the framework but recognised that staff would require protected time in order to complete the assessment. In practice the MaPSAF is likely to have a number of uses including raising awareness about patient safety and illustrating any differences in perception between staff, stimulating discussion about the strengths and weaknesses of patient safety culture within the pharmacy, identifying areas for improvement, and evaluating patient safety interventions and tracking changes over time. This will support the development of a mature safety culture in community pharmacies.

  12. Safety Assessment of Foods Derived from Genetically Modified Microorganisms

    OpenAIRE

    Schlundt, J.

    2011-01-01

    Microorganisms have a long history of use in food production, e.g. in the production of sausages, cheeses, etc. Roughly one quarter of all food products rely on microbiological processes, and the safe use of microorganisms for food production is essential. The transfer of novel traits to food microorganisms through recombinant gene technology will result in new potential food safety issues. This requires the elaboration of criteria for safety assessment of foods derived from genetic microorga...

  13. Safety Assessment of Galactomannans as Used in Cosmetics.

    Science.gov (United States)

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

    2015-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 16 galactomannans as used in cosmetics. These ingredients are legume polysaccharides that function mostly as hair/skin-conditioning agents and viscosity-increasing agents in cosmetic products. Their substantial molecular sizes suggest that skin penetration of these ingredients would be unlikely. The Panel concluded that these galactomannans are safe in the present practices of use and concentration described in this safety assessment. © The Author(s) 2015.

  14. Safety assessment of ammonium hectorites as used in cosmetics.

    Science.gov (United States)

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

    2013-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 4 ammonium hectorite compounds used in cosmetics: disteardimonium hectorite, dihydrogenated tallow benzylmonium hectorite, stearalkonium hectorite, and quaternium-18 hectorite. These ingredients function in cosmetics mainly as nonsurfactant suspending agents. The Panel reviewed available animal and human data and concluded that these ammonium hectorite compounds were safe as cosmetic ingredients in the practices of use and concentration as given in this safety assessment.

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

    Science.gov (United States)

    Haslberger, Alexander G

    2006-05-03

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

  16. Assessment of safety culture maturity in a hospital setting.

    Science.gov (United States)

    Law, Madelyn P; Zimmerman, Rosanne; Baker, G Ross; Smith, Teresa

    2010-01-01

    The Manchester Patient Safety Culture Assessment Tool (MaPSCAT) was used to examine the levels of safety culture maturity in four programs across one large healthcare organization. The MaPSCAT is based on a theoretical framework that was developed in the United Kingdom through extensive literature reviews and expert input. It provides a view of safety culture on 10 dimensions (continuous improvement, priority given to safety, system errors and individual responsibility, recording incidents, evaluating incidents, learning and effecting change, communication, personnel management, staff education and teamwork) at five progressive levels of safety maturity. These levels are pathological ("Why waste our time on safety?"), reactive ("We do something when we have an incident"), bureaucratic ("We have systems in place to manage safety"), proactive ("We are always on alert for risks") and generative ("Risk management is an integral part of everything we do"). This article highlights the use of a new tool, the results of a study completed with this tool and how the results can be used to advance safety culture.

  17. Safety assessment of trans-tympanic photobiomodulation.

    Science.gov (United States)

    Moon, Tae-Hyun; Lee, Min Young; Jung, Jae Yun; Ahn, Jin-Chul; Chang, So-Young; Chung, Phil-Sang; Rhee, Chung-Ku; Kim, Yoon-Hwan; Suh, Myung-Whan

    2016-02-01

    We evaluated functional and morphological changes after trans-tympanic laser application using several different powers of photobiomodulation (PBM). The left (L) ears of 17 rats were irradiated for 30 min daily over 14 days using a power density of 909.1 (group A, 5040 J), 1136.4 (group B, 6300 J), and 1363.6 (group C, 7560 J) mW/cm(2). The right (N) ears served as controls. The safety of PBM was determined by endoscopic findings, auditory brainstem response (ABR) thresholds, and histological images of hair cells using confocal microscopy, and light microscopic images of the external auditory canal (EAC) and tympanic membrane (TM). Endoscopic findings revealed severe inflammation in the TM of C group; no other group showed damage in the TM. No significant difference in ABR threshold was found in the PBM-treated groups (excluding the group with TM damage). Confocal microscopy showed no histological difference between the AL and AN, or BL and BN groups. However, light microscopy showed more prominent edema, inflammation, and vascular congestion in the TM of BL ears. This study found a dose-response relationship between laser power parameters and TM changes. These results will be useful for defining future allowance criteria for trans-tympanic laser therapies.

  18. A proposal of safety indicators aggregation to assess the safety management effectiveness of nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Carvalho, Jose Antonio B.; Saldanha, Pedro L.C. [Comissao Nacional de Energia Nuclear (CNEN), Rio de Janeiro, RJ (Brazil). Coordenacao-Geral de Reatores e Ciclo Combustivel], e-mail: jantonio@cnen.gov.br, e-mail: saldanha@cnen.gov.br; Melo, Paulo F.F. Frutuoso e [Coordenacao dos Programas de Pos-graduacao de Engenharia (COPPE/UFRJ), Rio de Janeiro, RJ (Brazil). Programa de Engenharia Nuclear], e-mail: frutuoso@con.ufrj.br

    2009-07-01

    Safety management has changed with the evolution of management methods, named Quality Systems, moving from Quality Control, where the focus was the product, passing through Quality Assurance, which takes care of the whole manufacturing process and reaching the Total Quality Management, where policies and goals are established. Nowadays, there is a trend towards Management Systems, which integrate all different aspects related to the management of an organization (safety, environment, security, quality, costs and, etc), but it is necessary to have features to establish and assure that safety overrides the remaining aspects. The most usual way to reach this goal is to establish a policy where safety is a priority, but its implementation and the assessment of its effectiveness are no so simple. Nuclear power plants usually have over a hundred safety indicators in many processes dedicated to prevent and detect problems, although a lot of them do not evaluate these indicators in an integrated manner or point out degradation trends of organizational aspects, which can affect the plant safety. This work develops an aggregation of proactive and reactive safety indicators in order to evaluate the effectiveness of nuclear power plant safety management and to detect, at early stages, signs of process degradation or activities used to establish, maintain and assure safety conditions. The aggregation integrates indicators of the usual processes and is based on the manner the management activities have been developed in the last decades, that is: Planning, Doing, Checking and Acting - known as PDCA cycle - plus a fifth element related to the capability of those who perform safety activities. The proposed aggregation is in accordance to Brazilian standards and international recommendations and constitutes a friendly link between the top management level and the daily aspects of the organization. (author)

  19. Safety Assessment of Alkyl Esters as Used in Cosmetics.

    Science.gov (United States)

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

    2015-09-01

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

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

    Science.gov (United States)

    Pöting, A; Schauzu, M

    2010-06-01

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

  1. Psychometric model for safety culture assessment in nuclear research facilities

    Energy Technology Data Exchange (ETDEWEB)

    Nascimento, C.S. do, E-mail: claudio.souza@ctmsp.mar.mil.br [Centro Tecnológico da Marinha em São Paulo (CTMSP), Av. Professor Lineu Prestes 2468, 05508-000 São Paulo, SP (Brazil); Andrade, D.A., E-mail: delvonei@ipen.br [Instituto de Pesquisas Energéticas e Nucleares (IPEN/CNEN – SP), Av. Professor Lineu Prestes 2242, 05508-000 São Paulo, SP (Brazil); Mesquita, R.N. de, E-mail: rnavarro@ipen.br [Instituto de Pesquisas Energéticas e Nucleares (IPEN/CNEN – SP), Av. Professor Lineu Prestes 2242, 05508-000 São Paulo, SP (Brazil)

    2017-04-01

    Highlights: • A psychometric model to evaluate ‘safety climate’ at nuclear research facilities. • The model presented evidences of good psychometric qualities. • The model was applied to nuclear research facilities in Brazil. • Some ‘safety culture’ weaknesses were detected in the assessed organization. • A potential tool to develop safety management programs in nuclear facilities. - Abstract: A safe and reliable operation of nuclear power plants depends not only on technical performance, but also on the people and on the organization. Organizational factors have been recognized as the main causal mechanisms of accidents by research organizations through USA, Europe and Japan. Deficiencies related with these factors reveal weaknesses in the organization’s safety culture. A significant number of instruments to assess the safety culture based on psychometric models that evaluate safety climate through questionnaires, and which are based on reliability and validity evidences, have been published in health and ‘safety at work’ areas. However, there are few safety culture assessment instruments with these characteristics (reliability and validity) available on nuclear literature. Therefore, this work proposes an instrument to evaluate, with valid and reliable measures, the safety climate of nuclear research facilities. The instrument was developed based on methodological principles applied to research modeling and its psychometric properties were evaluated by a reliability analysis and validation of content, face and construct. The instrument was applied to an important nuclear research organization in Brazil. This organization comprises 4 research reactors and many nuclear laboratories. The survey results made possible a demographic characterization and the identification of some possible safety culture weaknesses and pointing out potential areas to be improved in the assessed organization. Good evidence of reliability with Cronbach's alpha

  2. Interim process report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Sellin, Patrick (ed.)

    2004-08-01

    This report is a documentation of buffer processes identified as relevant to the long-term safety of a KBS-3 repository. The report is part of the interim reporting of the safety assessment SR-Can, see further the Interim main report. The final SR-Can reporting will support SKB's application to build an Encapsulation plant for spent nuclear fuel and is to be produced in 2006. The purpose of this report is to document the scientific knowledge of the processes to a level required for an adequate treatment in the safety assessment. The documentation is thus from a scientific point of not exhaustive since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. The purpose is further to determine the handling of each process in the safety assessment and to demonstrate how uncertainties are taken care of, given the suggested handling. The process documentation in the SR 97 version of the Process report is a starting point for this SR-Can interim version. As further described in the Interim main report, the list of relevant processes has been reviewed and slightly extended by comparison to other databases. Furthermore, the backfill has been included as a system part of its own, rather than being described together with the buffer as in SR 97. Apart from giving an interim account of the documentation and handling of buffer processes in SR-Can, this report is meant to serve as a template for the forthcoming documentation of processes occurring in other parts of the repository system. A complete list of processes can be found in the Interim FEP report for the safety assessment SR-Can. All material presented in this document is preliminary in nature and will possibly be updated as the SR-Can project progresses.

  3. Safety assessment of gamma-cyclodextrin.

    Science.gov (United States)

    Munro, I C; Newberne, P M; Young, V R; Bär, A

    2004-06-01

    Gamma-cyclodextrin (gamma-CD) is a cyclic alpha-(1,4)-linked oligosaccharide consisting of eight glucose molecules. Like other cyclodextrins, gamma-CD can form inclusion complexes with a variety of organic molecules because the inner side of the torus-like molecule is less polar than the outer side. In foods, gamma-CD may be used as a carrier for flavors, vitamins, polyunsaturated fatty acids, and other ingredients. It also has useful properties as a stabilizer in different food systems. The daily intake from all its intended uses in food at highest feasible concentrations has been estimated at 4.1g/person/day for consumers of gamma-CD containing foods. The present review summarizes the safety data of gamma-CD. The toxicity studies consist of standard genotoxicity tests, subchronic rat studies with oral and intravenous administration of gamma-CD for up to 3 months, a subchronic (3-month) toxicity study in dogs, a (1-year) oral toxicity study in rats, and embryotoxicity/teratogenicity studies in rats and rabbits. In the studies with oral administration, gamma-CD was given at dietary concentrations of up to 20%. All these studies demonstrated that gamma-CD is well tolerated and elicits no toxicological effects. Metabolic studies in rats showed that gamma-CD is rapidly and essentially completely digested by salivary and pancreatic amylase. Therefore, the metabolism of gamma-CD closely resembles that of starch and linear dextrins. A human study with ingestion of single doses of 8 g gamma-CD or 8 g maltodextrin did not reveal a difference in gastrointestinal tolerance of these two products. An interaction of ingested gamma-CD with the absorption of fat-soluble vitamins or other lipophilic nutrients is not to be expected because the formation of inclusion complexes is a reversible process, gamma-CD is readily digested in the small intestine, and studies with beta-CD, a non-digestible cyclodextrin, have shown that the bioavailability of vitamins (A, D, and E) is not

  4. Data report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report compiles, documents, and qualifies input data identified as essential for the long-term safety assessment of a KBS-3 repository, and forms an important part of the reporting of the safety assessment project SR-Site. The input data concern the repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock, and the biosphere in the proximity of the repository. The input data also concern external influences acting on the system, in terms of climate related data. Data are provided for a selection of relevant conditions and are qualified through traceable standardised procedures

  5. A Framework for Assessment of Aviation Safety Technology Portfolios

    Science.gov (United States)

    Jones, Sharon M.; Reveley, Mary S.

    2014-01-01

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

  6. Mathematical Safety Assessment Approaches for Thermal Power Plants

    Directory of Open Access Journals (Sweden)

    Zong-Xiao Yang

    2014-01-01

    Full Text Available How to use system analysis methods to identify the hazards in the industrialized process, working environment, and production management for complex industrial processes, such as thermal power plants, is one of the challenges in the systems engineering. A mathematical system safety assessment model is proposed for thermal power plants in this paper by integrating fuzzy analytical hierarchy process, set pair analysis, and system functionality analysis. In the basis of those, the key factors influencing the thermal power plant safety are analyzed. The influence factors are determined based on fuzzy analytical hierarchy process. The connection degree among the factors is obtained by set pair analysis. The system safety preponderant function is constructed through system functionality analysis for inherence properties and nonlinear influence. The decision analysis system is developed by using active server page technology, web resource integration, and cross-platform capabilities for applications to the industrialized process. The availability of proposed safety assessment approach is verified by using an actual thermal power plant, which has improved the enforceability and predictability in enterprise safety assessment.

  7. Safety Assessment of Talc as Used in Cosmetics.

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2008-12-15

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

  9. Comparative safety assessment of plant-derived foods.

    Science.gov (United States)

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

    2008-02-01

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

  10. Dynamic Vehicle Impact for Safety Assessment of Bridges

    DEFF Research Database (Denmark)

    Kirkegaard, Poul Henning; Nielsen, Søren R. K.; Enevoldsen, I.

    In this paper the dynamic amplification of vehicle load at minor highway bridges is considered for safety assessment of the load carrying capacity of bridges. The considered case is the most critical for bridges, i.e. the simultaneous passage of two heavy trucks. A short description...

  11. Assessing the Food Safety Knowledge of University of Maine Students

    Science.gov (United States)

    Ferk, Chelsea C.; Calder, Beth L.; Camire, Mary Ellen

    2016-01-01

    Foodborne illness is a global public health issue. Young adults may work in foodservice while they are university students, and their habits may later shape the practices and well-being of their children. The objective of this study was to establish baseline data and assess the food safety knowledge of 18- to 26-year-old Univ. of Maine students.…

  12. A review of international sources for road safety measures assessment.

    NARCIS (Netherlands)

    Yannis, G. Weijermars, W. & Kauppila, J.

    2012-01-01

    The efficiency assessment of road safety measures is considered to be an extremely useful tool in decision making; in particular, cost-benefit and cost-effectiveness analyses are carried out in several countries, in a more or less systematic way. The objective of this paper is to present findings fr

  13. Comparative safety assessment of plant-derived foods

    NARCIS (Netherlands)

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

    2008-01-01

    The second generation of genetically modified (GM) plants that are moving towards the market are characterized by modifications that may be more complex and traits that more often are to the benefit of the consumer. These developments will have implications for the safety assessment of the resulting

  14. Probabilistic Safety Assessment of Waste from PyroGreen Processes

    Energy Technology Data Exchange (ETDEWEB)

    Ju, Hee Jae; Ham, In hye; Hwang, Il Soon [Seoul National University, Seoul (Korea, Republic of)

    2016-05-15

    The main object of PyroGreen processes is decontaminating SNFs into intermediate level waste meeting U.S. WIPP contact-handled (CH) waste characteristics to achieve long-term radiological safety of waste disposal. In this paper, radiological impact of PyroGreen waste disposal is probabilistically assessed using domestic input parameters for safety assessment of disposal. PyroGreen processes is decontamination technology using pyro-chemical process developed by Seoul National University in collaboration with KAERI, Chungnam University, Korea Hydro-Nuclear Power and Yonsei University. Advanced Korean Reference Disposal System (A-KRS) design for vitrified waste is applied to develop safety assessment model using GoldSim software. The simulation result shows that PyroGreen vitrified waste is expected to satisfy the regulatory dose limit criteria, 0.1 mSv/yr. With small probability, however, radiological impact to public can be higher than the expected value after 2E5-year. Although the result implies 100 times safety margin even in that case, further study will be needed to assess the sensitivity of other input parameters which can affect the radiological impact for long-term.

  15. Safety assessment of utilization of the RSG-GAS reactor

    Energy Technology Data Exchange (ETDEWEB)

    Kuntoro, I.; Hastowo, H.; Taryo, T. [Center for Research Reactor Technology Delopment (P2TRR), National Nuclear Energy Agency (BATAN), Serpong (Indonesia)

    2000-10-01

    The indonesia Multipurpose Reactor G.A. Siwabessy (RSG-GAS) is operated to serve the utilization in the field of experiments, radioisotope production and material research. Based on design specification, the reactor can actually be operated at the power of 30 MW thermal. Based on considerations of efficiency and of most users requirements, the reactor is mostly operated at the power of about 15 MW thermal, to produce a primary radioisotope, a highly enriched uranium (HEU) target containing about 2 grams of U-235 is irradiated in the reactor core for 5 days weekly. Furthermore, there are some other targets principally possessing gamma-neutron reaction to be irradiated in the reactor core. For material research, four beam tubes available in the reactor core are applied, while one other beam tube is utilized for iodine production facility. To guarantee the safe operation and optimum utilization, a safety procedure was established. Prior to irradiation of a new experiment in the reactor core, a safety assessment should be carried out. This report deals with the safety procedures and safety analysis work connoted in the RSG-GAS reactor. An example of safety assessment is also presented. (author)

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

    Energy Technology Data Exchange (ETDEWEB)

    Heimdahl, Olaf E. R. (Naval Air Warfare Center, China Lake, CA); LaHoud, Paul (Athens, AL); 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.

  17. Environment, Safety and Health Progress Assessment of the Hanford Site

    Energy Technology Data Exchange (ETDEWEB)

    1992-05-01

    This report documents the result of the US Department of Energy (DOE) Environment, Safety and Health (ES&H) Progress Assessment of the Hanford Site, in Richland, Washington. The assessment, which was conducted from May 11 through May 22, 1992, included a selective-review of the ES&H management systems and programs of the responsible DOE Headquarters Program Offices the DOE Richland Field Office, and the site contractors. The ES&H Progress Assessments are part of the Secretary of Energy`s continuing effort to institutionalize line management accountability and the self-assessment process throughout DOE and its contractor organizations. The purpose of the Hanford Site ES&H Progress Assessment is to provide the Secretary with an independent assessment of the adequacy and effectiveness of the DOE and contractor management structures, resources, and systems to address ES&H problems and requirements. They are not intended to be comprehensive compliance assessments of ES&H activities. The point of reference for assessing programs at the Hanford Site was, for the most part, the Tiger Team Assessment of the Hanford Site, which was conducted from May 21 through July 18, 1990. A summary of issues and progress in the areas of environment, safety and health, and management is included.

  18. Epidemiological designs for vaccine safety assessment: methods and pitfalls.

    Science.gov (United States)

    Andrews, Nick

    2012-09-01

    Three commonly used designs for vaccine safety assessment post licensure are cohort, case-control and self-controlled case series. These methods are often used with routine health databases and immunisation registries. This paper considers the issues that may arise when designing an epidemiological study, such as understanding the vaccine safety question, case definition and finding, limitations of data sources, uncontrolled confounding, and pitfalls that apply to the individual designs. The example of MMR and autism, where all three designs have been used, is presented to help consider these issues.

  19. Safety Assessment of PEGylated oils as used in cosmetics.

    Science.gov (United States)

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

    2014-01-01

    PEGylated oil is a terminology used to describe cosmetic ingredients that are the etherification and esterification products of glycerides and fatty acids with ethylene oxide. The Cosmetic Ingredient Review Expert Panel (Panel) considered the safety of PEGylated oils, which function primarily as surfactants in cosmetic products. The Panel reviewed relevant animal and human data provided in this safety assessment and concluded that the 130 chemically related PEGylated oils were safe as cosmetic ingredients in the present practices of use and concentration when formulated to be nonirritating.

  20. Safety Assessment of Dimethicone Crosspolymers as Used in Cosmetics.

    Science.gov (United States)

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

    2014-05-26

    The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 62 dimethicone crosspolymer ingredients as used in cosmetics. These ingredients function mostly as absorbents, bulking agents, film formers, hair-conditioning agents, emollient skin-conditioning agents, slip modifiers, surface modifiers, and nonaqueous viscosity-increasing agents. The Panel reviewed available animal and human data related to these polymers and addressed the issue of residual monomers. The Panel concluded that these dimethicone crosspolymer ingredients are safe in the practices of use and concentration as given in this safety assessment.

  1. Safety Assessment of Alkyl Ethylhexanoates as Used in Cosmetics.

    Science.gov (United States)

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

    2015-01-01

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

  2. Interim main report of the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Hedin, Allan (ed.) [and others

    2004-08-01

    This document is an interim report on the safety assessment SR-Can (SR in the acronym stands for Safety Report and Can is short for canister). The final SR-Can report will support SKB's application to build an Encapsulation plant for spent nuclear fuel and is to be produced in 2006. The purpose of the present interim report is to demonstrate the methodology for safety assessment so that it can be reviewed before it is used in a license application. The assessment relates to the KBS-3 disposal concept in which copper canisters with a cast iron insert containing spent nuclear fuel are surrounded by bentonite clay and deposited at approximately 500 m depth in saturated, granitic rock. Preliminary data from the Forsmark site, presently being investigated by SKB as one of the candidate for a KBS-3 repository are used to some extent as examples. However, the collected data are yet too sparse to allow an evaluation of safety for this site. An important aim of this report is to demonstrate the proper handling of requirements on the safety assessment in applicable regulations. Therefore, regulations issued by the Swedish Nuclear Power Inspectorate and the Swedish Radiation Protection Authority are duplicated in an Appendix. The principal acceptance criterion requires that 'the annual risk of harmful effects after closure does not exceed 10{sup -6} for a representative individual in the group exposed to the greatest risk'. 'Harmful effects' refer to cancer and hereditary effects. Following the introductory chapter 1, this report outlines the methodology for the SR-Can assessment in chapter 2, and presents in chapters 3, 4 and 5 the initial state of the system and the plans and methods for handling external influences and internal processes, respectively. Function indicators are introduced in chapter 6 and a preliminary evaluation of these is given in chapter 7. The material presented in the first seven chapters is utilised in the scenario selection

  3. Fire safety assessment and upgrading of existing traffic tunnels

    Directory of Open Access Journals (Sweden)

    Diederichs U.

    2013-09-01

    Full Text Available Many traffic tunnels in the European Union need records of their conservation and safety status, including fire performance. Besides other countries the German road transport authorities plan to enhance the safety of their tunnels. As an example, the results of investigations performed with a two-tube tunnel in Northern Germany, which has been examined to assess fire safety, is reported. It turned out, that the older tube, which got fire protection boards on the ceilings and the wall crowns, fully fits the demands according to the current rules. The later tube needs an upgrading to avoid catastrophic impairment of air and car traffic in the vicinity of the tunnels. For the retrofitting a number of protection materials are in the market. The execution of the measure requires smart planning as to reach the strived goal.

  4. Model summary report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Vahlund, Fredrik

    2006-10-15

    This document is the model summary report for the safety assessment SR-Can. In the report, the quality assurance measures conducted for the assessment codes are presented together with the chosen methodology. In the safety assessment SR-Can, a number of different computer codes are used. In order to better understand how these codes are related Assessment Model Flowcharts, AMFs, have been produced within the project. From these, it is possible to identify the different modelling tasks and consequently also the different computer codes used. A large number of different computer codes are used in the assessment of which some are commercial while others are developed especially for the current assessment project. QA requirements must on the one hand take this diversity into account and on the other hand be well defined. In the methodology section of the report the following requirements are defined: It must be demonstrated that the code is suitable for its purpose; It must be demonstrated that the code has been properly used; and, It must be demonstrated that the code development process has followed appropriate procedures and that the code produces accurate results. Although the requirements are identical for all codes, the measures used to show that the requirements are fulfilled will be different for different codes (for instance due to the fact that for some software the source-code is not available for review). Subsequent to the methodology section, each assessment code is presented and it is shown how the requirements are met.

  5. A study on safety assessment methodology for a vitrification plant

    Energy Technology Data Exchange (ETDEWEB)

    Seo, Y. C.; Lee, G. S.; Choi, Y. C.; Kim, G. H. [Yonsei Univ., Seoul (Korea, Republic of)

    2002-03-15

    In this study, the technical and regulatory status of radioactive waste vitrification technologies in foreign and domestic plants is investigated and analyzed, and then significant factors are suggested which must be contained in the final technical guideline or standard for the safety assessment of vitrification plants. Also, the methods to estimate the stability of vitrified waste forms are suggested with property analysis of them. The contents and scope of the study are summarized as follows : survey of the status on radioactive waste vitrification technologies in foreign and domestic plants, survey of the characterization methodology for radioactive waste form, analysis of stability for vitrified waste forms, survey and analysis of technical standards and regulations concerned with them in foreign and domestic plants, suggestion of significant factors for the safety assessment of vitrification plants, submission of regulated technical standard on radioactive waste vitrification plats.

  6. Portable Nanoparticle-Based Sensors for Food Safety Assessment.

    Science.gov (United States)

    Bülbül, Gonca; Hayat, Akhtar; Andreescu, Silvana

    2015-12-05

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

  7. Radiation safety assessment and development of environmental radiation monitoring technology

    CERN Document Server

    Choi, B H; Kim, S G

    2002-01-01

    The Periodic Safety Review(PSR) of the existing nuclear power plants is required every ten years according to the recently revised atomic energy acts. The PSR of Kori unit 1 and Wolsong unit 1 that have been operating more than ten years is ongoing to comply the regulations. This research project started to develop the techniques necessary for the PSR. The project developed the following four techniques at the first stage for the environmental assessment of the existing plants. 1) Establishment of the assessment technology for contamination and accumulation trends of radionuclides, 2) alarm point setting of environmental radiation monitoring system, 3) Development of Radiation Safety Evaluation Factor for Korean NPP, and 4) the evaluation of radiation monitoring system performance and set-up of alarm/warn set point. A dynamic compartment model to derive a relationship between the release rates of gas phase radionuclides and the concentrations in the environmental samples. The model was validated by comparing ...

  8. Application of formal safety assessment in planning VTS

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    To ensure that limited resources are allocated more effectively to reduce marine risks, formal safety assessment (FSA), a proactive method, is introduced in planning a vessel traffic system (VTS). Based on the data of Wuhan port, some new solutions based on risk-indices are put forward. The weighted number of traffic accidents is predicted after the future weighted vessel traffic volume is estimated by analyzing the trend of trade development. To analyze risk acceptability, the as-low-as-reasonably-practica...

  9. Guide for the Development of Safety Assessment Report (SAR)

    Science.gov (United States)

    1987-08-01

    smoke grenade and associated launchers. c. Describe operating environments and specific skills for safe operation, maintenance, or disposal. 2 4. Describe...as a result of the design or use of the system. AttaOh OTSG Health Hazard Assesment (AR 40-10). 5. Conclusions and -ecommendations. a. State whethvr...FOR THE j XM52 SMOKE GENERATOR MAY 1984 CONCURRED BY; CONCURRED BY: D-2 SUBJECT: Safety Assessment Report for XM52 Smoke Generator 1.0 INTRODUCTION

  10. Nanotechnology in food science: Functionality, applicability, and safety assessment

    OpenAIRE

    Xiaojia He; Huey-Min Hwang

    2016-01-01

    Rapid development of nanotechnology is expected to transform many areas of food science and food industry with increasing investment and market share. In this article, current applications of nanotechnology in food systems are briefly reviewed. Functionality and applicability of food-related nanotechnology are highlighted in order to provide a comprehensive view on the development and safety assessment of nanotechnology in the food industry. While food nanotechnology offers great potential be...

  11. CP-50 calibration facility radiological safety assessment document

    Energy Technology Data Exchange (ETDEWEB)

    Chilton, M.W.; Hill, R.L.; Eubank, B.F.

    1980-03-01

    The CP-50 Calibration Facility Radiological Safety Assessment document, prepared at the request of the Nevada Operations Office of the US Department of Energy to satisfy provisions of ERDA Manual Chapter 0531, presents design features, systems controls, and procedures used in the operation of the calibration facility. Site and facility characteristics and routine and non-routine operations, including hypothetical incidents or accidents are discussed and design factors, source control systems, and radiation monitoring considerations are described.

  12. 78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

    Science.gov (United States)

    2013-03-04

    ... chairs (which are different from wheelchairs) continue to require submission of 510(k)s. FDA is... known as stairway chair lifts. These devices are used to assist in the transfer of a person with a... stairway chair lifts, class II devices, from premarket notification and establishes conditions for...

  13. 78 FR 4094 - Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices

    Science.gov (United States)

    2013-01-18

    ... Approval for Two Class III Preamendments Devices AGENCY: Food and Drug Administration, HHS. ACTION... the following two class III preamendments devices: Hip joint metal/metal semi- constrained, with a... class III (premarket approval). Under section 513 of the FD&C Act, devices that were in...

  14. 21 CFR 807.100 - FDA action on a premarket notification.

    Science.gov (United States)

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL...) After review of a premarket notification, FDA will: (1) Issue an order declaring the device to be... information, including clinical data if deemed necessary by the Commissioner, that demonstrates that...

  15. 77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

    Science.gov (United States)

    2012-06-01

    ...: Powered Patient Transport AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... premarket notification requirements for powered patient transport devices commonly known as stairlifts...: Richard Keller, on behalf of Bruno Independent Living Aids, Inc., for powered patient transport...

  16. Criticality safety assessment of tank 241-C-106 remediation

    Energy Technology Data Exchange (ETDEWEB)

    Waltar, A.E., Westinghouse Hanford

    1996-07-19

    A criticality safety assessment was performed in support of Project 320 for the retrieval of waste from tank 241-C-106 to tank 241-AY-102. The assessment was performed by a multi-disciplined team consisting of expertise covering the range of nuclear engineering, plutonium and nuclear waste chemistry,and physical mixing hydraulics. Technical analysis was performed to evaluate the physical and chemical behavior of fissile material in neutralized Hanford waste as well as modeling of the fluid dynamics for the retrieval activity. The team has not found evidence of any credible mechanism to attain neutronic criticality in either tank and has concluded that a criticality accident is incredible.

  17. Learning Safety Assessment from Accidents in a University Environment

    DEFF Research Database (Denmark)

    Jensen, Niels; Jørgensen, Sten Bay

    2013-01-01

    This contribution describes how a chemical engineering department started learning from accidents during experimental work and ended up implementing an industrially inspired system for risk assessment of new and existing experimental setups as well as a system for assessing potential risk from...... the chemicals used in the experimental work. These experiences have led to recent developments which focus increasingly on the a theoretical basis for modeling and reasoning on safety as well as operational aspects within a common framework. Presently this framework is being extended with barrier concepts both...

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

    Science.gov (United States)

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

    2002-04-01

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

  19. Ames Laboratory integrated safety management self-assessment report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-10-01

    The implementation of Integrated Safety Management (ISM) at Ames Laboratory began with the signing of the ISM Implementation Charter on February 24, 1997 (see Appendix A). The first step toward implementation of ISM at Ames Laboratory is the performance of a Self-Assessment (SA). In preparation for the SA, a workshop on ISM was provided to the Laboratory`s Environment, Safety, and Health (ES&H) Coordinators, Safety Review Committee members, and the Environment, Safety, Health and Assurance (ESH&A) staff. In addition, a briefing was given to the Laboratory`s Executive Council and Program Directors. Next, an SA Team was organized. The Team was composed of four Ames Laboratory and four Department of Energy-Chicago Operations Office (DOE-CH) staff members. The purpose of this SA was to determine the current status of ES&H management within Ames Laboratory, as well as to identify areas which need to be improved during ISM implementation. The SA was conducted by reviewing documents, interviewing Ames Laboratory management and staff, and performing walkthroughs of Laboratory areas. At the conclusion of this SA, Ames Laboratory management was briefed on the strengths, weaknesses, and the areas of improvement which will assist in the implementation of ISM.

  20. Model summary report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Vahlund, Fredrik; Zetterstroem Evins, Lena (Swedish Nuclear Fuel and Waste Management Co., Stockholm (Sweden)); Lindgren, Maria (Kemakta Konsult AB, Stockholm (Sweden))

    2010-12-15

    This document is the model summary report for the safety assessment SR-Site. In the report, the quality assurance (QA) measures conducted for assessment codes are presented together with the chosen QA methodology. In the safety assessment project SR-Site, a large number of numerical models are used to analyse the system and to show compliance. In order to better understand how the different models interact and how information are transferred between the different models Assessment Model Flowcharts, AMFs, are used. From these, different modelling tasks can be identify and the computer codes used. As a large number of computer codes are used in the assessment the complexity of these differs to a large extent, some of the codes are commercial while others are developed especially for the assessment at hand. QA requirements must on the one hand take this diversity into account and on the other hand be well defined. In the methodology section of the report the following requirements are defined for all codes: - It must be demonstrated that the code is suitable for its purpose. - It must be demonstrated that the code has been properly used. - It must be demonstrated that the code development process has followed appropriate procedures and that the code produces accurate results. - It must be described how data are transferred between the different computational tasks. Although the requirements are identical for all codes in the assessment, the measures used to show that the requirements are fulfilled will be different for different types of codes (for instance due to the fact that for some software the source-code is not available for review). Subsequent to the methodology section, each assessment code is presented together with a discussion on how the requirements are met

  1. Development and assessment of best estimate integrated safety analysis code

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Bub Dong; Lee, Young Jin; Hwang, Moon Kyu (and others)

    2007-03-15

    Improvement of the integrated safety analysis code MARS3.0 has been carried out and a multi-D safety analysis application system has been established. Iterative matrix solver and parallel processing algorithm have been introduced, and a LINUX version has been generated to enable MARS to run in cluster PCs. MARS variables and sub-routines have been reformed and modularised to simplify code maintenance. Model uncertainty analyses have been performed for THTF, FLECHT, NEPTUN, and LOFT experiments as well as APR1400 plant. Participations in international cooperation research projects such as OECD BEMUSE, SETH, PKL, BFBT, and TMI-2 have been actively pursued as part of code assessment efforts. The assessment, evaluation and experimental data obtained through international cooperation projects have been registered and maintained in the T/H Databank. Multi-D analyses of APR1400 LBLOCA, DVI Break, SLB, and SGTR have been carried out as a part of application efforts in multi-D safety analysis. GUI based 3D input generator has been developed for user convenience. Operation of the MARS Users Group (MUG) was continued and through MUG, the technology has been transferred to 24 organisations. A set of 4 volumes of user manuals has been compiled and the correction reports for the code errors reported during MARS development have been published.

  2. Knowledge representation in safety assessment: improving transparency and traceability

    Energy Technology Data Exchange (ETDEWEB)

    Lemos, F.L. de [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN-MG), Belo Horizonte, MG (Brazil); Sullivan, T. [Brookhaven National Laboratory (BNL), Upton, NY (United States); Ross, T. [University of New Mexico (UNM), Albuquerque, NM (United States); Guimaraes, L.N.F. [Instituto de Estudos Avancados (IEAv/CTA), Sao Jose dos Campos, SP (Brazil)

    2011-07-01

    Transparency and traceability are key factors for confidence building, acceptability, and quality enhancement of the safety assessment, and safety case for a radioactive waste disposal facility. In order to facilitate analysis and promote discussions, all of the information used to make decisions should be readily available to stake holders. The information should convey a good understanding of the intermediate decisions processes, allowing examination of alternatives and 'what if questions'. In an ideal situation all stake holders, including scientists and the public, should be able to follow the path of a certain parameter, from the beginning where it was defined, its assumptions and uncertainties, throughout the calculations until the final results of the safety assessment. One of the main challenges, to achieving such a transparency and traceability, is that stake holders are a very diverse audience, with very different backgrounds. This could require preparation of various versions of the same documentation, which would be impractical. While the linguistic information is of crucial importance to understanding the reasoning, it is very difficult to convey the supporting conditions, and consequent uncertainties for the selection of parameters values. Even scientists involved in the process can become confused due to the overwhelming amount of information that is used to support parameter value selection. The amount of details makes it difficult to track the decisions, which lead to the selection of a certain parameter, throughout the calculations. This paper presents a methodology to represent the linguistic information used in the safety assessment in terms of mathematical expressions by using the fuzzy sets and fuzzy logic tools. This methodology aims to help information to be readily available while keeping, as much as possible, the original meaning of the linguistic expressions and, consequently, to be available at any time as a quick reference

  3. International symposium on engineering under uncertainty : safety assessment and management

    CERN Document Server

    Bhattacharya, Gautam; ISEUSAM - 2012

    2013-01-01

    International Symposium on Engineering under Uncertainty: Safety Assessment and Management (ISEUSAM - 2012) is organized by Bengal Engineering and Science University, India during the first week of January 2012 at Kolkata.The primary aim of ISEUSAM 2012 is to provide a platform to facilitate the discussion for a better understanding and management of uncertainty and risk, encompassing various aspects of safety and reliability of engineering systems. The conference received an overwhelming response from national as well as international scholars, experts and delegates from different parts of the world.  Papers were received from authors of several countries including Australia, Canada, China, Germany, Italy, UAE, UK and USA, besides India. More than two hundred authors have shown their interest in the symposium. The Proceedings presents ninety two high quality papers which address issues of uncertainty encompassing various fields of engineering, i.e. uncertainty analysis and modelling, structural reliability...

  4. Nanotechnology in food science: Functionality, applicability, and safety assessment

    Directory of Open Access Journals (Sweden)

    Xiaojia He

    2016-10-01

    Full Text Available Rapid development of nanotechnology is expected to transform many areas of food science and food industry with increasing investment and market share. In this article, current applications of nanotechnology in food systems are briefly reviewed. Functionality and applicability of food-related nanotechnology are highlighted in order to provide a comprehensive view on the development and safety assessment of nanotechnology in the food industry. While food nanotechnology offers great potential benefits, there are emerging concerns arising from its novel physicochemical properties. Therefore, the safety concerns and regulatory policies on its manufacturing, processing, packaging, and consumption are briefly addressed. At the end of this article, the perspectives of nanotechnology in active and intelligent packaging applications are highlighted.

  5. Safety assessment driving radioactive waste management solutions (SADRWMS Methodology) implemented in a software tool (SAFRAN)

    Energy Technology Data Exchange (ETDEWEB)

    Kinker, M., E-mail: M.Kinker@iaea.org [International Atomic Energy Agency (IAEA), Vienna (Austria); Avila, R.; Hofman, D., E-mail: rodolfo@facilia.se [FACILIA AB, Stockholm (Sweden); Jova Sed, L., E-mail: jovaluis@gmail.com [Centro Nacional de Seguridad Nuclear (CNSN), La Habana (Cuba); Ledroit, F., E-mail: frederic.ledroit@irsn.fr [IRSN PSN-EXP/SSRD/BTE, (France)

    2013-07-01

    In 2004, the International Atomic Energy Agency (IAEA) organized the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) to examine international approaches to safety assessment for predisposal management of radioactive waste. The initial outcome of the SADRWMS Project was achieved through the development of flowcharts which could be used to improve the mechanisms for applying safety assessment methodologies to predisposal management of radioactive waste. These flowcharts have since been incorporated into DS284 (General Safety Guide on the Safety Case and Safety Assessment for Predisposal Management of Radioactive Waste), and were also considered during the early development stages of the Safety Assessment Framework (SAFRAN) Tool. In 2009 the IAEA presented DS284 to the IAEA Waste Safety Standards Committee, during which it was proposed that the graded approach to safety case and safety assessment be illustrated through the development of Safety Reports for representative predisposal radioactive waste management facilities and activities. To oversee the development of these reports, it was agreed to establish the International Project on Complementary Safety Reports: Development and Application to Waste Management Facilities (CRAFT). The goal of the CRAFT project is to develop complementary reports by 2014, which the IAEA could then publish as IAEA Safety Reports. The present work describes how the DS284 methodology and SAFRAN Tool can be applied in the development and review of the safety case and safety assessment to a range of predisposal waste management facilities or activities within the Region. (author)

  6. Safety Assessment of Vehicles with Ensemble FLC Based FCAS

    Directory of Open Access Journals (Sweden)

    S. Paul Sathiyan

    2016-08-01

    Full Text Available This research work proposes a new Ensemble Fuzzy Logic Controller for Forward Collision Avoidance System (EFLC-FCAS which assists driving in rural, inter urban and highway operating zones. This system is intended to sense the obstacle / lead vehicle in the same lane of travel and apply brake automatically to reduce the potential of rear end collision thus ensuring safety. Article also covers the assessment procedure developed for assessing FCAS. Driver assistance virtual simulation software, CarMaker along with Matlab / Simulink is used for validating the performance of the proposed controller. Test results have shown a positive influence on the performance of the proposed controller for the test procedures recommended by the assessing agencies.

  7. Findings From the National Machine Guarding Program: Safety Climate, Hazard Assessment, and Safety Leadership in Small Metal Fabrication Businesses.

    Science.gov (United States)

    Parker, David L; Yamin, Samuel; Xi, Min; Gordon, Robert; Most, Ivan; Stanley, Rod

    2017-09-19

    This manuscript assesses safety climate data from the National Machine Guarding Program (NMGP)-a nationwide intervention to improve machine safety. Baseline safety climate surveys were completed by 2161 employees and 341 owners or managers at 115 businesses. A separate onsite audit of safety management practices and machine guarding equipment was conducted at each business. Safety climate measures were not correlated with machine guarding or safety management practices. The presence of a safety committee was correlated with higher scores on the safety management audit when contrasted with those without one. The presence of a safety committee is easily assessed and provides a basis on which to make recommendations with regard to how it functions. Measures of safety climate fail to provide actionable information. Future research on small manufacturing firms should emphasize the presence of an employee-management safety committee.This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0.

  8. Safety assessment of cyclomethicone, cyclotetrasiloxane, cyclopentasiloxane, cyclohexasiloxane, and cycloheptasiloxane.

    Science.gov (United States)

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

    2011-12-01

    Cyclomethicone (mixture) and the specific chain length cyclic siloxanes (n = 4-7) reviewed in this safety assessment are cyclic dimethyl polysiloxane compounds. These ingredients have the skin/hair conditioning agent function in common. Minimal percutaneous absorption was associated with these ingredients and the available data do not suggest skin irritation or sensitization potential. Also, it is not likely that dermal exposure to these ingredients from cosmetics would cause significant systemic exposure. The Cosmetic Ingredient Review Expert Panel concluded that these ingredients are safe in the present practices of use and concentration.

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

    Science.gov (United States)

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

    2016-10-01

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

  10. An assessment of food hygiene and safety at farmers' markets.

    Science.gov (United States)

    Worsfold, D; Worsfold, P M; Griffith, C J

    2004-04-01

    Farmers' markets are becoming a more significant part of the food-retailing sector. A survey of farmers' markets was conducted to assess aspects of food hygiene and safety. The views of the public using the markets were also examined. The range of farm products was wide and the methods utilised varied. The markets were usually temporary outdoor events with few facilities. Traders had received elementary food hygiene training and rated their hygiene standards highly. Less than half had risk management procedures in place, most did not perceive their produce as high-risk. They believed consumers to be mainly interested in food quality and to regard food safety issues highly. Consumers shopped at the markets because of the quality of the products sold. Their overall satisfaction with the markets was high and they raised no concerns about food safety. Given the restricted facilities at farmers' markets and the early phase of implementation of hygiene management systems by market traders, it may be precautionary to restrict the sale of farm products at farmers markets to those that are regarded as low-risk.

  11. Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA)

    DEFF Research Database (Denmark)

    Leuschner, R. G. K.; Robinson, T. P.; Hugas, M.;

    2010-01-01

    Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA) to notified biological agents aiming at simplifying risk assessments across different scientific Panels and Units. The aim of this review is to outline the implementation...... and value of the QPS assessment for EFSA and to explain its principles such as the unambiguous identity of a taxonomic unit, the body of knowledge including potential safety concerns and how these considerations lead to a list of biological agents recommended for QPS which EFSA keeps updated through...

  12. Geosphere process report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Skagius, Kristina [Kemakta Konsult AB, Stockholm (SE)] (ed.)

    2006-09-15

    This report documents geosphere processes identified as relevant to the long-term safety of a KBS- repository, and forms an important part of the reporting of the safety assessment SR-Can. The detailed assessment methodology, including the role of the process report in the assessment, is described in the SR-Can Main report. The following excerpts describe the methodology, and clarify the role of this process report in the assessment. The repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock and the biosphere in the proximity of the repository, will evolve over time. Future states of the system will depend on the initial state of the system, a number of radiation related, thermal, hydraulic, mechanical, chemical and biological processes acting within the repository system over time, and external influences acting on the system. A methodology in ten steps has been developed for SR-Can described below. Identification of factors to consider (FEP processing): This step consists of identifying all the factors that need to be included in the analysis. Experience from earlier safety assessments and KBS-specific and international databases of relevant features, events and processes influencing long-term safety are utilised. Based on the results of the FEP processing, an SR-Can FEP catalogue, containing FEPs to be handled in SR-Can, has been established. The initial state of the system is described based on the design specifications of the KBS repository, a descriptive model of the repository site and a site-specific layout of the repository. The initial state of the fuel and the engineered components is that immediately after deposition, as described in the SR-Can Initial state report. The initial state of the geosphere and the biosphere is that of the natural system prior to excavation, as described in the site descriptive models. The repository layouts adapted to the sites are provided in underground

  13. Geosphere process report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Skagius, Kristina [Kemakta Konsult AB, Stockholm (SE)] (ed.)

    2006-09-15

    This report documents geosphere processes identified as relevant to the long-term safety of a KBS- repository, and forms an important part of the reporting of the safety assessment SR-Can. The detailed assessment methodology, including the role of the process report in the assessment, is described in the SR-Can Main report. The following excerpts describe the methodology, and clarify the role of this process report in the assessment. The repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock and the biosphere in the proximity of the repository, will evolve over time. Future states of the system will depend on the initial state of the system, a number of radiation related, thermal, hydraulic, mechanical, chemical and biological processes acting within the repository system over time, and external influences acting on the system. A methodology in ten steps has been developed for SR-Can described below. Identification of factors to consider (FEP processing): This step consists of identifying all the factors that need to be included in the analysis. Experience from earlier safety assessments and KBS-specific and international databases of relevant features, events and processes influencing long-term safety are utilised. Based on the results of the FEP processing, an SR-Can FEP catalogue, containing FEPs to be handled in SR-Can, has been established. The initial state of the system is described based on the design specifications of the KBS repository, a descriptive model of the repository site and a site-specific layout of the repository. The initial state of the fuel and the engineered components is that immediately after deposition, as described in the SR-Can Initial state report. The initial state of the geosphere and the biosphere is that of the natural system prior to excavation, as described in the site descriptive models. The repository layouts adapted to the sites are provided in underground

  14. Risk assessment for safety laboratories in Politeknik Negeri Medan

    Science.gov (United States)

    Viyata Sundawa, Bakti; Hutajulu, Elferida; Sirait, Regina; Banurea, Waldemar; Indrayadi; Mulyadi, Sangap

    2017-09-01

    International Labour Organization (ILO) estimated 2.34 million people die each year because accidents and diseases in workplace. It also impact to economic losses in some countries. It need to do safety and healthy in working environment especially in laboratory. Identification of potential hazards and risks must be done in Telecommunication Laboratory Politeknik Negeri Medan. Therefore, this study was assessed 5 of potential hazards and risks in our laboratory by Likert Scale. This object was divided into 2 assessment namely likelihood of hazards and severity of consequences. Collecting data is taken from questionnaire who involved 100 students at random academic level. The result showed The highest score is chemical hazards 73.2% in likelihood of hazards and electrical hazards 85% in severity of consequences. This condition is classified as “high” state. Big attention must be given to “high” state because it can help us to determine mitigate action.

  15. Corrosion calculations report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report is a compilation of the quantitative assessments of corrosion of the copper canisters in a KBS-3 repository. The calculations are part of the safety assessment SR-Site that is the long-term safety assessment to support the license application for building a final repository for spent nuclear fuel at Forsmark, Sweden. The safety assessment methodology gives the frame for the structured and documented approach to assess all conceivable corrosion processes. The quantitative assessments are done in different ways depending on the nature of the process and on the implications for the long-term safety. The starting point for the handling of the corrosion processes is the description of all known corrosion processes for copper with the current knowledge base and applied to the specific system and geology. Already at this stage some processes are excluded for further analysis, for example if the repository environment is not a sufficient prerequisite for the process to occur. The next step is to identify processes where the extent of corrosion could be bounded, e.g. by a mass balance approach. For processes where a mass balance is not limiting, the mass transport of corrodants (or corrosion products) is taken into account. A simple approach would be just to calculate the diffusive transport of corrodants through the bentonite, but generally the transport resistance for the interface between groundwater in a rock fracture intersecting the deposition hole and the bentonite buffer is more important. In SR-Site, the concept of equivalent flowrate, Q{sub eq}, is used. This assessment is done integrated with the evaluation of the geochemical and hydrogeological evolution of the repository. For most of the corrosion processes analysed, the corrosion depth is much smaller than the copper shell thickness, even for the assessment time of 106 years. Several processes give corrosion depths less than 100 mum, but no process give corrosion depths larger than a few

  16. Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems.

    Science.gov (United States)

    Walter, Jessica R; Hayman, Emily; Tsai, Shelun; Ghobadi, Comeron W; Xu, Shuai

    2016-06-01

    Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation. The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015. Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days). Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials. Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices.

  17. Plant natural variability may affect safety assessment data.

    Science.gov (United States)

    Batista, Rita; Oliveira, Margarida

    2010-12-01

    Before market introduction, genetic engineered (GE) food products, like any other novel food product, are subjected to extensive assessment of their potential effects on human health. In recent years, a number of profiling technologies have been explored aiming to increase the probability of detecting any unpredictable unintended effect and, consequently improving the efficiency of GE food safety assessment. These techniques still present limitations associated with the interpretation of the observed differences with respect to their biological relevance and toxicological significance. In order to address this issue, in this study, we have performed 2D-gel electrophoresis of five different ears of five different MON810 maize plants and of other five of the non-transgenic near-isogenic line. We have also performed 2D-gel electrophoresis of the pool of the five protein extractions of MON810 and control lines. We have notice that, in this example, the exclusive use of data from 2D-electrophoresed pooled samples, to compare these two lines, would be insufficient for an adequate safety evaluation. We conclude that, when using "omics" technologies, it is extremely important to eliminate all potential differences due to factors not related to the ones under study, and to understand the role of natural plant-to-plant variability in the encountered differences.

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

    Science.gov (United States)

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

    2010-09-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

  1. Safety assessment for a KBS-3H spent nuclear fuel repository at Olkiluoto. Complementary evaluations of safety

    Energy Technology Data Exchange (ETDEWEB)

    Neall, Fiona; Pastina, Barbara; Snellman, Margit; Smith, Paul; Gribi, P.; Johnson, Lawrence

    2008-12-15

    The KBS-3H design is a variant of the more general KBS-3 method for the geological disposal of spent nuclear fuel in Finland and Sweden. In the KBS-3H design, multiple assemblies containing spent fuel are emplaced horizontally in parallel, approximately 300 m long, slightly inclined deposition drifts. The copper canisters, each with a surrounding layer of bentonite clay, are placed in perforated steel shells prior to deposition in the drifts; the assembly is called the 'supercontainer'. The other KBS-3 variant is the KBS-3V design, in which the copper canisters are emplaced vertically in individual deposition holes surrounded by bentonite clay but without steel supercontainer shells. SKB and Posiva have conducted a Research, Development and Demonstration programme over the period 2002-2007 with the overall aim of establishing whether KBS-3H represents a feasible alternative to KBS-3V. As part of this programme, the long-term safety of a KBS-3H repository has been assessed in the KBS-3H safety studies. In order to focus the safety studies, the Olkiluoto site in the municipality of Eurajoki, which is the proposed site for a spent fuel repository in Finland, was used as a hypothetical site for a KBS-3H repository. The present report is part of a portfolio of reports discussing the long-term safety of the KBS-3H repository. The overall outcome of the KBS-3H safety studies is documented in the summary report, 'Safety assessment for a KBS-3H repository for spent nuclear fuel at Olkiluoto'. The purpose and scope of the KBS-3H complementary evaluations of safety report is provided in Posiva's Safety Case Plan, which is based on Regulatory Guide YVL 8.4 and on international guidelines on complementary lines of argument to long-term safety that are considered an important element of a post-closure safety case for geological repositories. Complementary evaluations of safety require the use of evaluations, evidence and qualitative supporting arguments

  2. 21 CFR 190.6 - Requirement for premarket notification.

    Science.gov (United States)

    2010-04-01

    ... (HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint... receipt of a notification made under section 413 of the Federal Food, Drug, and Cosmetic Act (the act)...

  3. Assessment of the long-term safety for SFR

    Energy Technology Data Exchange (ETDEWEB)

    Greis Dahlberg, Christina; Vahlund, Frederik [Svensk Kaernbraenslehantering AB, Stockholm (Sweden)

    2015-07-01

    During operation and decommissioning of the Swedish nuclear facilities, radioactive waste is generated that must be disposed of. Besides waste from the nuclear facilities, some waste derives from other activities such as industry, research, medical care, etc. Short-lived low- and intermediate-level waste from these activities is disposed of in the final repository for short-lived radioactive waste, SFR, in Forsmark. The facility, which has been in operation since 1988, is owned and operated by Svensk Karnbranslehantering AB, SKB. The existing facility has neither sufficient space nor a license to receive decommissioning waste. SFR must therefore be extended so that shortlived low- and intermediate-level decommissioning waste from the nuclear facilities can also be received. The need for additional capacity has been accentuated by the closure of two reactors in Barseback. These reactors cannot be dismantled until the SFR facility has been extended. The existing repository is built to receive, and after closure serve as a passive repository for, low- and intermediate-level radioactive waste. The disposal rooms are situated in the bedrock beneath the sea floor, covered by about 60 metres of rock. The repository has been designed so that it can be abandoned after closure without requiring further measures to maintain its function. The extension of SFR, is done at the -120 m level immediately adjacent to, and within the same depth range as, the existing facility. The basic function of the existing SFR and of the extended one will be the same. However, a clear difference is the design of the tunnel and the rock vault that are required to permit transport and storage of whole reactor pressure vessels. The application for a license to build this extension includes an assessment of the long-term safety (post-closure safety) of the facility. The safety assessment also contains an updated assessment of the long-term safety of the existing facility. The safety assessment for

  4. Planning report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-06-01

    This document is a planning report for SKB's next assessment of long-term safety for a KBS 3 repository. The assessment, SR-Can, is to be finished by the end of 2005 and will be used for SKB's application to build an Encapsulation plant for spent nuclear fuel. Apart from outlining the methodology, the report discusses the handling in SR-Can of a number of important issues regarding the near field, the geosphere, the biosphere, the climatic evolution etc. The Swedish nuclear safety and radiation protection authorities have recently issued regulations concerning the final disposal of nuclear waste. The principal compliance criterion states that the annual risk of harmful effects must not exceed 10{sup -6} for a representative individual in the group exposed to the greatest risk. There are also a number of requirements on methodological aspects of the safety assessment as well as on the contents of a safety report. The regulations are reproduced in an Appendix to this report. The primary safety function of the KBS 3 system is to completely isolate the spent nuclear fuel within copper canisters over the entire assessment period, which will be one million years in SR-Can. Should a canister be damaged, the secondary safety function is to retard any releases from the canisters. The main steps of the assessment are the following: 1. Qualitative system description, FEP processing: This step consists of defining a system boundary and of describing the system on a format suitable for the safety assessment. Databases of relevant features, events and processes influencing long-term safety are structured and used as one starting point for the assessment. 2. Initial state descriptions. 3. Process descriptions: In this step all identified processes within the system boundary involved in the long-term evolution of the system are described in detail. 4. Description of boundary conditions: This step is a broad description of the evolution of the boundaries of the system

  5. Planning report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-06-01

    This document is a planning report for SKB's next assessment of long-term safety for a KBS 3 repository. The assessment, SR-Can, is to be finished by the end of 2005 and will be used for SKB's application to build an Encapsulation plant for spent nuclear fuel. Apart from outlining the methodology, the report discusses the handling in SR-Can of a number of important issues regarding the near field, the geosphere, the biosphere, the climatic evolution etc. The Swedish nuclear safety and radiation protection authorities have recently issued regulations concerning the final disposal of nuclear waste. The principal compliance criterion states that the annual risk of harmful effects must not exceed 10{sup -6} for a representative individual in the group exposed to the greatest risk. There are also a number of requirements on methodological aspects of the safety assessment as well as on the contents of a safety report. The regulations are reproduced in an Appendix to this report. The primary safety function of the KBS 3 system is to completely isolate the spent nuclear fuel within copper canisters over the entire assessment period, which will be one million years in SR-Can. Should a canister be damaged, the secondary safety function is to retard any releases from the canisters. The main steps of the assessment are the following: 1. Qualitative system description, FEP processing: This step consists of defining a system boundary and of describing the system on a format suitable for the safety assessment. Databases of relevant features, events and processes influencing long-term safety are structured and used as one starting point for the assessment. 2. Initial state descriptions. 3. Process descriptions: In this step all identified processes within the system boundary involved in the long-term evolution of the system are described in detail. 4. Description of boundary conditions: This step is a broad description of the evolution of the boundaries of the system

  6. A Geospatial Mixed Methods Approach to Assessing Campus Safety

    Science.gov (United States)

    Hites, Lisle S.; Fifolt, Matthew; Beck, Heidi; Su, Wei; Kerbawy, Shatomi; Wakelee, Jessica; Nassel, Ariann

    2013-01-01

    Background: While there is no panacea for alleviating campus safety concerns, safety experts agree that one of the key components to an effective campus security plan is monitoring the environment. Despite previous attempts to measure campus safety, quantifying perceptions of fear, safety, and risk remains a challenging issue. Since perceptions of…

  7. Research on safety assessment of gas explosion hazard in heading face based on BP neural network

    Institute of Scientific and Technical Information of China (English)

    TIAN Shui-cheng; ZHU Li-jun; CHEN Yong-gang; WANG Li

    2005-01-01

    According to hazard theory and the principle of selecting assessment index,combining the causes and mechanism of gas explosion, established assessment index system of gas explosion in heading face. Based on the method of gray clustering, principle of BP neural network and characters of gas explosion in heading face, safety assessment procedural diagram of BP neural network on gas explosion hazard in heading face is designed. Meanwhile, concrete heading face of the gas explosion hazard is assessed by safety assessment method of BP neural network and grades of comprehensive safety assessment are got. The static and dynamic safety assessment can be achieved by this method. It is practical to improve safety management and to develop safety assessment technology in coalmine.

  8. Developmental toxicity testing for safety assessment: new approaches and technologies.

    Science.gov (United States)

    Knudsen, Thomas B; Kavlock, Robert J; Daston, George P; Stedman, Donald; Hixon, Mary; Kim, James H

    2011-10-01

    The ILSI Health and Environmental Sciences Institute's Developmental and Reproductive Toxicology Technical Committee held a 2-day workshop entitled "Developmental Toxicology-New Directions" in April 2009. The fourth session of this workshop focused on new approaches and technologies for the assessment of developmental toxicology. This session provided an overview of the application of genomics technologies for developmental safety assessment, the use of mouse embryonic stem cells to capture data on developmental toxicity pathways, dynamical cell imaging of zebrafish embryos, the use of computation models of development pathways and systems, and finally, high-throughput in vitro approaches being utilized by the EPA ToxCast program. Issues discussed include the challenges of anchoring in vitro predictions to relevant in vivo endpoints and the need to validate pathway-based predictions with targeted studies in whole animals. Currently, there are 10,000 to 30,000 chemicals in world-wide commerce in need of hazard data for assessing potential health risks. The traditional animal study designs for assessing developmental toxicity cannot accommodate the evaluation of this large number of chemicals, requiring that alternative technologies be utilized. Though a daunting task, technologies are being developed and utilized to make that goal reachable. © 2011 Wiley Periodicals, Inc.

  9. Initial state report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Pers, Karin (ed.) [Kemakta Konsult AB, Stockholm (Sweden)

    2006-10-15

    A comprehensive description of the initial state of the engineered parts of the repository system is one of the main bases for the safety assessment. There is no obvious definition of the time of the initial state. For the engineered part of their repository system, the time of deposition is a natural starting point and the initial state in SR-Can is, therefore, defined as the state at the time of deposition for the engineered barrier system. The initial state of the engineered parts of the repository system is largely obtained from the design specifications of the repository, including allowed tolerances or allowance for deviations. Also the manufacturing, excavation and control methods have to be described in order to adequately discuss and handle hypothetical initial states outside the allowed limits in the design specifications. It should also be noted that many parts of the repository system are as yet not finally designed, there can be many changes in the future. The design and technical solutions presented here are representative of the current stage of development. The repository system is based on the KBS-3 method, in which copper canisters with a cast iron insert containing spent nuclear fuel are surrounded by bentonite clay and deposited at 400-700 m depth in saturated granitic rock. The facility design comprises rock caverns, tunnels, deposition positions etc. Deposition tunnels are linked by tunnels for transport and communication and shafts for ventilation. One ramp and five shafts connect the surface facility to the underground repository. The ramp is used for heavy and bulky transports and the shafts are for utility systems and for transport of excavated rock, backfill and staff. For the purposes of the safety assessment, the engineered parts of the repository system have been sub-divided into a number of components or sub-systems. These are: The fuel, (also including cavities in the canister since strong interactions between the two occur if the

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

    Science.gov (United States)

    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.

  11. Safety indices and their application to nuclear waste management safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Voss, J.W.

    1979-04-01

    Thirteen indices have been examined to determine their potential applicability to operational waste management safety assessment. Two waste streams are presented on a normalized basis. These are the packaged spent fuel from the once-through fuel cycle and solidified high-level waste from a coprocessed UO/sub 2/--PuO/sub 2/ fuel cycle. Seven of the indices are then calculated for a hypothetical surface storage scenario of the two wastes. The indices are examined on a consistent basis to identify any biases built into them, and to determine the sensitivities of each to various waste situations. The two waste streams are then compared on the basis of the indices to extend the understanding of the analysis techniques. The results of the analysis fall into two categories, index evaluation and fuel cycle waste comparison. Only five of the indices are determined to be applicable to operational waste management safety assessment. The remainder are rejected either because they require very detailed input data; they are specifically designed for geologic isolation; they are extremely controversial in their application; or because they are particularly sensitive to a few specific radionuclides. The waste stream comparison yields three results: (1) the solidified high-level waste from the coprocessed UO/sub 2/--PuO/sub 2/ fuel cycle may be potentially less hazardous than the packaged spent fuel from the once-through fuel cycle; (2) the removal of actinides, and especially plutonium, from spent fuel may reduce the potent hazard associated with the waste; and (3) after one million years of decay, the packaged spent fuel and solidified high-level waste are nearly the same on a hazard potential basis.

  12. Unified methodology for fire safety assessment and optimal design

    Energy Technology Data Exchange (ETDEWEB)

    Shetty, N.K.; Deaves, D.M.; Gierlinski, J.T. [WS Atkins Consultants Ltd., Epsom (United Kingdom); Dogliani, M. [Registro Italiano Navale, Genova (Italy)

    1996-12-31

    The paper presents a unified, fully-probabilistic approach to fire safety assessment and optimal design of fire protection on offshore topside structures. The methodology has been developed by integrating Quantitative Risk Analysis (QRA) techniques with the modern methods of Structural System Reliability Analysis (SRA) and Reliability Based Design Optimization (RBDO). The integration has been achieved by using platform-specific extended event-trees which model in detail the escalation paths leading to the failure of Temporary Refuge (TR), Escape, Evacuation and Rescue (EER) systems or structural collapse of the topside. Probabilities of events for which historical data are not generally available are calculated using structural reliability methods. The optimization of fire protection is performed such that the total expected cost of the protection system and the cost of failure of the platform (loss of life, loss of asset, environmental damage) is minimized while satisfying reliability constraints.

  13. Safety Assessment of Boron Nitride as Used in Cosmetics.

    Science.gov (United States)

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

    2015-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of boron nitride which functions in cosmetics as a slip modifier (ie, it has a lubricating effect). Boron nitride is an inorganic compound with a crystalline form that can be hexagonal, spherical, or cubic; the hexagonal form is presumed to be used in cosmetics. The highest reported concentration of use of boron nitride is 25% in eye shadow formulations. Although boron nitride nanotubes are produced, boron nitride is not listed as a nanomaterial used in cosmetic formulations. The Panel reviewed available chemistry, animal data, and clinical data and concluded that this ingredient is safe in the present practices of use and concentration in cosmetic formulations.

  14. Probabilistic safety assessment of components; Probabilistische Sicherheitsanalyse von Komponenten

    Energy Technology Data Exchange (ETDEWEB)

    Roos, E.; Schuler, X.; Wackenhut, G.; Lammert, R. [Stuttgart Univ. (Germany). MPA

    2008-07-01

    For safety relevant reactor components precaution against damage due to operational or accident loads has to be guaranteed. These procedures and requirements are regulated within the nuclear standards, for instance by comparing strength and fracture mechanical characteristics of the used reactor materials. Numerical assessments do not allow to quantify the consequences of input parameter uncertainties. If these assessments are performed taking into account the possible scatter of material characteristics, geometric dimensions and loads the failure probabilities and the respective uncertainties may be quantified. It is possible to integrate postulated flaw sizes and to evaluate the consequences of operational measures. This procedure is based on the exact knowledge of the relevant parameter scatter and the consequences on the used methodology, and thus on the result of the calculation. The contribution presents the used reliability theory. The failure probability at welded joints is calculated for the example of a feed water line and the existing safety margin is analysed. [German] Fuer sicherheitstechnisch relevante Bauteile ist Vorsorge gegen Schaeden durch betriebliche und Stoerfallbelastungen zu gewaehrleisten. Dies erfolgt nach den in den kerntechnischen Regelwerken enthaltenen Verfahren und Anforderungen, z.B. im Vergleich mit den Festigkeits- und bruchmechanischen Kennwerten (Gewaehrleistungswerte) der eingesetzten Werkstoffe. Dabei koennen mit den rechnerischen Nachweisen die Auswirkungen von Unsicherheiten bei den Eingangsparametern nicht quantitativ bewertet werden. Werden die Nachweise unter Beruecksichtigung von moeglichen Streuungen in den Werkstoffkennwerten, den geometrischen Abmessungen sowie den Belastungen durchgefuehrt, sind die Versagenswahrscheinlichkeiten und damit die jeweilig hervorgerufenen Unsicherheiten quantifizierbar. Darueber hinaus koennen (postulierte) Fehlergroessen einbezogen und die Auswirkung von betrieblichen Massnahmen bewertet

  15. Earthquake safety assessment of concrete arch and gravity dams

    Institute of Scientific and Technical Information of China (English)

    Lin Gao; Hu Zhiqiang

    2005-01-01

    Based on research studies currently being carried out at Dalian University of Technology, some important aspects for the earthquake safety assessment of concrete dams are reviewed and discussed. First, the rate-dependent behavior of concrete subjected to earthquake loading is examined, emphasizing the properties of concrete under cyclic and biaxial loading conditions. Second, a modified four-parameter Hsieh-Ting-Chen viscoplastic consistency model is developed to simulate the rate-dependent behavior of concrete. The earthquake response of a 278m high arch dam is analyzed, and the results show that the strain-rate effects become noticeable in the inelastic range. Third, a more accurate non-smooth Newton algorithm for the solution of three-dimensional frictional contact problems is developed to study the joint opening effects of arch dams during strong earthquakes. Such effects on two nearly 300m high arch dams have been studied. It was found that the canyon shape has great influence on the magnitude and distribution of the joint opening along the dam axis. Fourth, the scaled boundary finite element method presented by Song and Wolf is employed to study the dam-reservoir-foundation interaction effects of concrete dams. Particular emphases were placed on the variation of foundation stiffness and the anisotropic behavior of the foundation material on the dynamic response of concrete dams. Finally, nonlinear modeling of concrete to study the damage evolution of concrete dams during strong earthquakes is discussed. An elastic-damage mechanics approach for damage prediction of concrete gravity dams is described as an example. These findings are helpful in understanding the dynamic behavior of concrete dams and promoting the improvement of seismic safety assessment methods.

  16. Analysis on evaluation ability of nonlinear safety assessment model of coal mines based on artificial neural network

    Institute of Scientific and Technical Information of China (English)

    SHI Shi-liang; LIU Hai-bo; LIU Ai-hua

    2004-01-01

    Based on the integration analysis of goods and shortcomings of various methods used in safety assessment of coal mines, combining nonlinear feature of mine safety sub-system, this paper establishes the neural network assessment model of mine safety, analyzes the ability of artificial neural network to evaluate mine safety state, and lays the theoretical foundation of artificial neural network using in the systematic optimization of mine safety assessment and getting reasonable accurate safety assessment result.

  17. STUDYING OF SAFETY CLIMATE ASSESSMENT: A CASE STUDY AT STEEL INDUSTRY

    Directory of Open Access Journals (Sweden)

    Hassan DARVISH

    2011-01-01

    Full Text Available Evolution of safety climate used as a practical means has determined and assessed potential problems relevant to safety issues in an organization and can be used in individuals’ performance and work efficiency and decreasing rate of incidents ;as well as; guidance to provide safety organization policy and comparison of safety performance in different organizations. The study wants to determine and prepare safety climate profile and application of its results in improving safety situation. In this study, applied tools presented by Loughborough University are used to evaluate safety climate in one of steel industries and data is collected through questionnaire, group discussions or purposeful interviews and observations, and safety climate score was obtained in 17 scopes. Calculating the score of each safety climate domain and preparing the profile indicated there is the average rate (4.89 2 in the safety climate of the industry.

  18. FEP report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report documents the analysis and processing of features, events and processes, FEPs, that has been carried out within the safety assessment SR-Site, and forms an important part of the reporting of the project. The main part of the work was conducted within the earlier safety assessment SR-Can, which was a preparatory stage for the SR-Site assessment. The overall objective of the FEP analysis and processing in both SR-Can and SR-Site included development of a database of features, events and processes, an SKB FEP database, in a format that facilitates both a systematic analysis of FEPs and documentation of that FEP analysis, as well as facilitating revisions and updates to be made in connection with new safety assessments. The primary objective in SR-Site was to establish an SR-Site FEP catalogue within the framework of the SKB FEP database. This FEP catalogue was required to contain all FEPs that needed to be handled in SR-Site and is an update of the corresponding SR-Can FEP catalogue that was established for the SR-Can assessment. The starting point for the handling of FEPs in SR-Site was the SR-Can version of the SKB FEP database and associated SR-Can reports. The SR-Can version of the SKB FEP database includes the SR-Can FEP catalogue, as well as the sources for the identification of FEPs in SR-Can, namely the SR 97 processes and variables, Project FEPs in the NEA International FEP database version 1.2 and matrix interactions in the Interaction matrices developed for a deep repository of the KBS-3 type. Since the completion of the FEP work within SR-Can, an updated electronic version, version 2.1, of the NEA FEP database has become available. Compared with version 1.2 of the NEA FEP database, version 2.1 contains FEPs from two more projects. As part of SR-Site, all new Project FEPs in version 2.1 of the NEA FEP database have been mapped according to the methodology adopted in SR-Can resulting in an SR-Site version of the SKB FEP database. The SKB FEP

  19. EURO medi CAT: Safety of medication use in pregnancy

    NARCIS (Netherlands)

    Jordan, S.; Charlton, R.A.; Tingay, K.; Thayer, D.S.; Davies, G.I.; Morgan, M.; Tucker, D.; Watkins, A.; Wiesel, A.; Gini, R.; Pierini, A.; Garne, E.; Nybo, A.-M.; Puccini, A.; Neville, A.J.; Bos, Jens; De Jong-Van Den Berg, L.T.W.; De Vries, C.S.; Dolk, H.

    2015-01-01

    Objective / Background 1) animal studies are seriously limited in their ability to predict human teratogenesis. 2) pregnant women are excluded from pre-marketing clinical trials in humans. Aims In EURO medi CAT we aim to build a European system for reproductive safety evaluation: To identify systema

  20. 78 FR 14912 - International Aviation Safety Assessment (IASA) Program Change

    Science.gov (United States)

    2013-03-08

    ... date, countries have not been removed from the category listing for inactivity, even though the safety... country can be rated in the IASA program and before a carrier subject to that country's aviation safety... found that the country meets ICAO Standards for safety oversight of civil aviation. Category 2...

  1. Fuel and canister process report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Werme, Lars; Lilja, Christina (eds.)

    2010-12-15

    This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  2. MATILDA: A Military Laser Range Safety Tool Based on Probabilistic Risk Assessment (PRA) Techniques

    Science.gov (United States)

    2014-08-01

    AFRL-RH-FS-TR-2014-0035 MATILDA: A Military Laser Range Safety Tool Based on Probabilistic Risk Assessment (PRA) Techniques Paul...the Government’s approval or disapproval of its ideas or findings. MATILDA: A Military Laser Range Safety Tool Based on Probabilistic Risk Assessment... Probabilistic Risk Assessment (PRA) techniques to perform laser safety and hazard analysis for high output lasers in outdoor environments has become

  3. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines

    NARCIS (Netherlands)

    Pane, J. (Josep); P.M. Coloma (Preciosa); K.M.C. Verhamme (Katia); M.C.J.M. Sturkenboom (Miriam); Rebollo, I. (Irene)

    2017-01-01

    textabstractRecent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our obje

  4. Overview of resulting tools, guidelines, and instruments. IN-SAFETY Workpackage 3: New models, tools and guidelines for road safety assessment, Deliverable 3.4.

    OpenAIRE

    Dijkstra, A. Bald, S. Benz, T. & Gaitanidou, E. (eds.)

    2009-01-01

    Road safety will most probably be influenced by introducing Advanced Driver Assistance Systems (ADAS) or Intelligent Vehicle Safety Systems (IVSS). The effects of these systems on road safety can be assessed in different ways. This document gives a short overview of methodologies which allow for assessing road safety effects (Chapter 2), This Deliverable gives an overview of the outcome of work package 3 of IN-SAFETY. Two methodologies have basically been applied: • simulation model • risk an...

  5. Safety assessment of dairy microorganisms: the Lactobacillus genus.

    Science.gov (United States)

    Bernardeau, Marion; Vernoux, Jean Paul; Henri-Dubernet, Ségolène; Guéguen, Micheline

    2008-09-01

    genes to other bacteria. However, as a general rule, lactobacilli have a high natural resistance to many antibiotics, especially vancomycin, that is not transferable. Safety assessment requirements for Lactobacillus strains of technological interest should be limited to an antibiotic profile and a study to determine whether any antibiotic resistance(s) of medical interest detected is (or are) transferable. This agrees with the recent EFSA proposal suggesting attribution of a QPS status for 32 selected species of lactobacilli.

  6. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  7. Safety assessment of ammonia as a transport fuel

    DEFF Research Database (Denmark)

    Duijm, N.J.; Markert, Frank; Paulsen, Jette Lundtang

    2005-01-01

    of transport of ammonia to the refuelling stations and safety of the activities at the refuelling station (unloading and refuelling). Comparisons are made between the safety of using ammonia and the safety of otherexisting or alternative fuels. The conclusion is that the hazards in relation to ammonia need......This report describes the safety study performed as part of the EU supported project “Ammonia Cracking for Clean Electric Power Technology” The study addresses the following activities: safety of operation of the ammonia-powered vehicle under normal andaccident (collision) conditions, safety...... to be controlled by a combination of technical and regulatory measures. The most important requirements are: - Advanced safety systems in the vehicle -Additional technical measures and regulations are required to avoid releases in maintenance workshops and unauthorised maintenance on the fuel system. - Road...

  8. Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials

    DEFF Research Database (Denmark)

    Klokker, Louise; Tugwell, Peter; Furst, Daniel E

    2016-01-01

    in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. METHODS: The safety...

  9. (Q)SAR modeling and safety assessment in regulatory review.

    Science.gov (United States)

    Kruhlak, N L; Benz, R D; Zhou, H; Colatsky, T J

    2012-03-01

    The ability to predict clinical safety based on chemical structures is becoming an increasingly important part of regulatory decision making. (Quantitative) structure-activity relationship ((Q)SAR) models are currently used to evaluate late-arising safety concerns and possible nonclinical effects of a drug and its related compounds when adequate safety data are absent or equivocal. Regulatory use will likely increase with the standardization of analytical approaches, more complete and reliable data collection methods, and a better understanding of toxicity mechanisms.

  10. EARLY EVALUATION OF NEW HEALTH TECHNOLOGIES: THE CASE FOR PREMARKET STUDIES THAT HARMONIZE REGULATORY AND COVERAGE PERSPECTIVES.

    Science.gov (United States)

    Levin, Leslie

    2015-01-01

    With an increasing awareness that active engagement between policy decision makers, HTA agencies, regulators and payers with industry in the premarket space is needed, a disruptive comprehensive approach is described which moves the evidentiary process exclusively into this space. Single harmonized studies pre-market to address regulatory and coverage needs and expectations are more likely to be efficient and less costly and position evidence to drive rather than test innovation. An example of such a process through the MaRS EXCITE program in Ontario, Canada, now undergoing proof of concept, is briefly discussed. Other examples of dialogue between decision makers and industry pre-market are provided though these are less robust than a comprehensive evidentiary approach.

  11. A hierarchical network modeling method for railway tunnels safety assessment

    Science.gov (United States)

    Zhou, Jin; Xu, Weixiang; Guo, Xin; Liu, Xumin

    2017-02-01

    Using network theory to model risk-related knowledge on accidents is regarded as potential very helpful in risk management. A large amount of defects detection data for railway tunnels is collected in autumn every year in China. It is extremely important to discover the regularities knowledge in database. In this paper, based on network theories and by using data mining techniques, a new method is proposed for mining risk-related regularities to support risk management in railway tunnel projects. A hierarchical network (HN) model which takes into account the tunnel structures, tunnel defects, potential failures and accidents is established. An improved Apriori algorithm is designed to rapidly and effectively mine correlations between tunnel structures and tunnel defects. Then an algorithm is presented in order to mine the risk-related regularities table (RRT) from the frequent patterns. At last, a safety assessment method is proposed by consideration of actual defects and possible risks of defects gained from the RRT. This method cannot only generate the quantitative risk results but also reveal the key defects and critical risks of defects. This paper is further development on accident causation network modeling methods which can provide guidance for specific maintenance measure.

  12. Dynamic safety assessment of natural gas stations using Bayesian network.

    Science.gov (United States)

    Zarei, Esmaeil; Azadeh, Ali; Khakzad, Nima; Aliabadi, Mostafa Mirzaei; Mohammadfam, Iraj

    2017-01-05

    Pipelines are one of the most popular and effective ways of transporting hazardous materials, especially natural gas. However, the rapid development of gas pipelines and stations in urban areas has introduced a serious threat to public safety and assets. Although different methods have been developed for risk analysis of gas transportation systems, a comprehensive methodology for risk analysis is still lacking, especially in natural gas stations. The present work is aimed at developing a dynamic and comprehensive quantitative risk analysis (DCQRA) approach for accident scenario and risk modeling of natural gas stations. In this approach, a FMEA is used for hazard analysis while a Bow-tie diagram and Bayesian network are employed to model the worst-case accident scenario and to assess the risks. The results have indicated that the failure of the regulator system was the worst-case accident scenario with the human error as the most contributing factor. Thus, in risk management plan of natural gas stations, priority should be given to the most probable root events and main contribution factors, which have identified in the present study, in order to reduce the occurrence probability of the accident scenarios and thus alleviate the risks.

  13. Final Safety Assessment of Coal Tar as Used in Cosmetics

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2008-07-01

    Coal Tar is a semisolid by-product obtained in the destructive distillation of bituminous coal, which functions in cosmetic products as a cosmetic biocide and denaturant-antidandruff agent is also listed as a function, but this is considered an over-the-counter (OTC) drug use. In 2002, Coal Tar was reported to the Food and Drug Administration (FDA) to be used in four formulations, all of which appear to be OTC drug products. Coal Tar is monographed by the FDA as Category I (safe and effective) OTC drug ingredient for use in the treatment of dandruff, seborrhoea, and psoriasis. Coal Tar is absorbed through the skin of animals and humans and is systemically distributed. Although the Cosmetic Ingredient Review (CIR) Expert Panel believes that Coal Tar use as an antidandruff ingredient in OTC drug preparations is adequately addressed by the FDA regulations, the Panel also believes that the appropriate concentration of use of Coal Tar in cosmetic formulations should be that level that does not have a biological effect in the user. Additional data needed to make a safety assessment include product types in which Coal Tar is used (other than as an OTC drug ingredient), use concentrations, and the maximum concentration that does not induce a biological effect in users.

  14. On the fundamentals of nuclear reactor safety assessment. Inherent threats and their implications

    Energy Technology Data Exchange (ETDEWEB)

    Hyvaerinen, J. [Finnish Centre for Radiation and Nuclear Safety, Helsinki (Finland). Nuclear Safety Dept.

    1996-12-01

    The thesis addresses some fundamental questions related to implementation and assessment of nuclear safety. The safety principles and assessment methods are described, followed by descriptions of selected novel technical challenges to nuclear safety. The novel challenges encompass a wide variety of technical issues, thus providing insights on the limitations of conventional safety assessment methods. Study of the limitations suggests means to improve nuclear reactor design criteria and safety assessment practices. The novel safety challenges discussed are (1) inherent boron dilution in PWRs, (2) metallic insulation performance with respect to total loss of emergency cooling systems in a loss-of-coolant accident, and (3) horizontal steam generator heat transfer performance at natural circulation conditions. (50 refs.).

  15. Liquefied Gaseous Fuels Safety and Environmental Control Assessment Program: second status report

    Energy Technology Data Exchange (ETDEWEB)

    None

    1980-10-01

    This document is arranged in three volumes and reports on progress in the Liquefied Gaseous Fuels (LGF) Safety and Environmental Control Assessment Program made in fiscal Year (FY)-1979 and early FY-1980. Volume 3 contains reports from 6 government contractors on LPG, anhydrous ammonia, and hydrogen energy systems. Report subjects include: simultaneous boiling and spreading of liquefied petroleum gas (LPG) on water; LPG safety research; state-of-the-art of release prevention and control technology in the LPG industry; ammonia: an introductory assessment of safety and environmental control information; ammonia as a fuel, and hydrogen safety and environmental control assessment.

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

    Science.gov (United States)

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

    2014-01-01

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

  17. Safety barriers for motorways : shoulder and bridge safety barriers and impact attenuators surveyed and assessed.

    NARCIS (Netherlands)

    Schoon, C.C. Heijer, T. Pol, W.H.M. van de & Jordaan, D.J.R.

    1986-01-01

    The various types and practical qualities of deformable and non-deformable safety barriers are listed. The main conclusions drawn from tests based on several safety criteria are : various types of deformable barriers (steel guide rails) perform well when hit by cars; various types of deformable barr

  18. Assessing the relationship between patient safety culture and EHR strategy.

    Science.gov (United States)

    Ford, Eric W; Silvera, Geoffrey A; Kazley, Abby S; Diana, Mark L; Huerta, Timothy R

    2016-07-11

    Purpose - The purpose of this paper is to explore the relationship between hospitals' electronic health record (EHR) adoption characteristics and their patient safety cultures. The "Meaningful Use" (MU) program is designed to increase hospitals' adoption of EHR, which will lead to better care quality, reduce medical errors, avoid unnecessary cost, and promote a patient safety culture. To reduce medical errors, hospital leaders have been encouraged to promote safety cultures common to high-reliability organizations. Expecting a positive relationship between EHR adoption and improved patient safety cultures appears sound in theory, but it has yet to be empirically demonstrated. Design/methodology/approach - Providers' perceptions of patient safety culture and counts of patient safety incidents are explored in relationship to hospital EHR adoption patterns. Multi-level modeling is employed to data drawn from the Agency for Healthcare Research and Quality's surveys on patient safety culture (level 1) and the American Hospital Association's survey and healthcare information technology supplement (level 2). Findings - The findings suggest that the early adoption of EHR capabilities hold a negative association to the number of patient safety events reported. However, this relationship was not present in providers' perceptions of overall patient safety cultures. These mixed results suggest that the understanding of the EHR-patient safety culture relationship needs further research. Originality/value - Relating EHR MU and providers' care quality attitudes is an important leading indicator for improved patient safety cultures. For healthcare facility managers and providers, the ability to effectively quantify the impact of new technologies on efforts to change organizational cultures is important for pinpointing clinical areas for process improvements.

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

    DEFF Research Database (Denmark)

    Pilegaard, Kirsten

    The Qualified Presumption of Safety (QPS) approach, initially developed for the assessment of microorganisms referred to EFSA and added to the food chain is equally applicable to the assessment of botanicals or botanical preparations. Using the principles to establish the suitability of a botanical...... preparation for QPS status, it has been possible to develop a structured assessment scheme that provides a practical method for assessing botanicals and botanical preparations for which an adequate body of knowledge exists and therefore without the need for further testing. Reiterative applications...... in the development of a comprehensive, systematic and transparent methodology. The Scientific Committee recommends its use as an extension of the 2009 EFSA guidance for the safety assessment of botanicals and botanical preparations intended to be used in food supplements....

  20. SAFETY

    CERN Document Server

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  1. Assessing patient safety culture in hospitals across countries

    NARCIS (Netherlands)

    Wagner, C.; Smits, M.; Sorra, J.; Huang, C.C.

    2013-01-01

    OBJECTIVE: It is believed that in order to reduce the number of adverse events, hospitals have to stimulate a more open culture and reflective attitude towards errors and patient safety. The objective is to examine similarities and differences in hospital patient safety culture in three countries: t

  2. Assessing patient safety culture in hospitals across countries.

    NARCIS (Netherlands)

    Wagner, C.; Smits, M.; Sorra, J.; Huang, C.C.

    2013-01-01

    Objective: It is believed that in order to reduce the number of adverse events, hospitals have to stimulate a more open culture and reflective attitude towards errors and patient safety. The objective is to examine similarities and differences in hospital patient safety culture in three countries: t

  3. Safety assessment of ammonia as a transport fuel

    Energy Technology Data Exchange (ETDEWEB)

    Duijm, N.J.; Markert, F.; Lundtang paulsen, Jette

    2005-02-01

    This report describes the safety study performed as part of the EU supported project 'Ammonia Cracking for Clean Electric Power Technology' The study addresses the following activities: safety of operation of the ammonia-powered vehicle under normal and accident (collision) conditions, safety of transport of ammonia to the refuelling stations and safety of the activities at the refuelling station (unloading and refuelling). Comparisons are made between the safety of using ammonia and the safety of other existing or alternative fuels. The conclusion is that the hazards in relation to ammonia need to be controlled by a combination of technical and regulatory measures. The most important requirements are: - Advanced safety systems in the vehicle - Additional technical measures and regulations are required to avoid releases in maintenance workshops and unauthorised maintenance on the fuel system - Road transport of ammonia to refuelling stations in refrigerated form - Sufficient safety zones between refuelling stations and residential or otherwise public areas. When these measures are applied, the use of ammonia as a transport fuel wouldnt cause more risks than currently used fuels (using current practice). (au)

  4. The application of transcriptomics in the comparative safety assessment of (GMO-derived) plant products

    NARCIS (Netherlands)

    Kok, E.J.

    2008-01-01

    National and international organizations have discussed current approaches to the safety assessment of complex (plant) food products in general and the safety assessment of GMO-derived food products in particular. One of the recommendations of different expert meetings was that the new analytical te

  5. Interim FEP report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Skagius, Kristina (ed.) [Kemakta Konsult AB, Stockholm (Sweden)

    2004-08-01

    This report describes the work with identification and structuring of features, events and processes (FEPs) that has been carried out within the scope of the SR-Can safety assessment up to the time of the interim reporting of the project. The overall objective of the work is to develop a database of features, events and processes in a format that would facilitate both a systematic analysis of FEPs and documentation of the FEP analysis as well as facilitate revisions and updates to be made in connection with new safety assessments. This overall objective also includes the development of procedures for a systematic FEP analysis as well as to apply these procedures in order to arrive at an SR-Can version of the FEP database. The work started by implementing the content of the SR 97 Process report into a database format suitable for import and processing of FEP information from other sources. The SR 97 version of the database was systematically audited against the NEA database with Project FEPs, version 1.2. In addition, an earlier audit of the SR 97 process report against the interaction matrices developed for a deep repository of the KBS-3 type was revisited and updated. Relevant FEPs from the audit were sorted into three main categories in the SR-Can database i) FEPs related to the initial states of the repository system, ii) FEPs related to internal processes of the repository system, and iii) FEPs related to external impacts on the repository system. These groups of FEPs were further processed for making decisions on how to handle these FEPs in the assessment. Biosphere processes were not included in the SR 97 Process report and there is thus not the same basis for updating these descriptions as for the engineered barriers and the geosphere. All biosphere FEPs from the audit have therefore been compiled in a single category in the database, but remain to be further handled. FEPs were also categorised as irrelevant or as being related to methodology on a general

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

    Directory of Open Access Journals (Sweden)

    Christos A. Damalas

    2011-05-01

    Full Text Available Pesticides are widely used in agricultural production to prevent or control pests, diseases, weeds, and other plant pathogens in an effort to reduce or eliminate yield losses and maintain high product quality. Although pesticides are developed through very strict regulation processes to function with reasonable certainty and minimal impact on human health and the environment, serious concerns have been raised about health risks resulting from occupational exposure and from residues in food and drinking water. Occupational exposure to pesticides often occurs in the case of agricultural workers in open fields and greenhouses, workers in the pesticide industry, and exterminators of house pests. Exposure of the general population to pesticides occurs primarily through eating food and drinking water contaminated with pesticide residues, whereas substantial exposure can also occur in or around the home. Regarding the adverse effects on the environment (water, soil and air contamination from leaching, runoff, and spray drift, as well as the detrimental effects on wildlife, fish, plants, and other non-target organisms, many of these effects depend on the toxicity of the pesticide, the measures taken during its application, the dosage applied, the adsorption on soil colloids, the weather conditions prevailing after application, and how long the pesticide persists in the environment. Therefore, the risk assessment of the impact of pesticides either on human health or on the environment is not an easy and particularly accurate process because of differences in the periods and levels of exposure, the types of pesticides used (regarding toxicity and persistence, and the environmental characteristics of the areas where pesticides are usually applied. Also, the number of the criteria used and the method of their implementation to assess the adverse effects of pesticides on human health could affect risk assessment and would possibly affect the characterization

  7. A study of assessment of patient safety climate in tertiary care hospitals.

    Science.gov (United States)

    Chakravarty, Abhijit; Sahu, Anupam; Biswas, Manash; Chatterjee, Kaustuv; Rath, Subrata

    2015-04-01

    Medical errors are being detected with increasing frequency in healthcare environment, in many cases leading to patient harm. Measurement and improvement of patient safety climate has been identified as a strategic effort towards addressing this vital issue. Safety Attitude Questionnaire (SAQ), validated by previous research was administered to 300 respondents in three tertiary care hospitals of India, the respondents representing various categories of healthcare workers and variations in safety scale score was analyzed by various statistical tools. No variation was observed in the Patient Safety Index score among the study hospitals. However, significant variations were observed among different categories of healthcare workers across dimensions of Teamwork, Perception of Management and Stress Recognition. Multiple Regression models identified Teamwork and Perception of Management to have significant correlation with Patient Safety Index Score. Patient Safety Climate can be effectively assessed and such assessment utilized for focused improvement efforts towards safety in healthcare organizations.

  8. Patient safety culture in teaching hospitals in Iran: assessment by the hospital survey on patient safety culture (HSOPSC

    Directory of Open Access Journals (Sweden)

    Mohammad Zakaria Kiaei

    2016-04-01

    Full Text Available Introduction: Patient safety culture is an important part of improvement in the safety of health care. Knowing its present status is required for development of safety culture. The present study aimed to evaluate the current status of Patient safety culture in hospitals of three central provinces of Iran. Method: The present cross-sectional study was performed in teaching hospitals of Tehran, Alborz, and Qazvin provinces. The standard HSOPSC questionnaire was used for evaluation of the patient safety culture from the viewpoint of 522(Qazvin: 200, Tehran: 312, Alborz: 40 individuals who were randomly selected as workers of the hospitals. The collected data were analyzed using Chi-square and ANOVA tests. Results:The mean positive response to 12 aspects of the patient safety was 62.9%. “Organizational learning” had the highest proportion of positive response (71.18% and “Handoffs & Transitions” had the lowest (54.49%. There was a statistically significant difference in scores of “Teamwork within Units”(p=0.006(,”Manager Expectations & actions promoting”(p=0.014,”organizational learning and continuous improvement”(p=0.001, “Management support”(p=0.007, “Feedback and communication”(p=0.012, and “Communication openness”(p=0.003 among the provinces, respectively. Conclusion: We performed a full assessment of the patient safety culture in the studied provinces. Organizational learning was satisfactory in the hospitals. The studied hospitals need arrangement of safety-based programs and supports of senior administrators to perform more sophisticated efforts and improve the patient safety culture.

  9. Safety inspections - the role of TS : risks, their assessment and the role of safety systems

    CERN Document Server

    Béjar-Alonso, Isabel; CERN. Geneva. TS Department

    2008-01-01

    In 2007 the DG decided a new approach for safety at CERN. This had as consequence the creation of a new unit, the safety service provider, in the TS department. The organization and the services that this unit provides to CERN will be described and the achievements since the creation of the unit will be summarized. Some important personnel safety systems, on their side have been the responsibility of the TS Department for many years. Their importance has grown with the arrival of LHC and their complexity and impact on operation has increased. Their role as well as the importance of an appropriate regulatory framework shall be discussed.

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

    Energy Technology Data Exchange (ETDEWEB)

    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

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

    Energy Technology Data Exchange (ETDEWEB)

    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

  12. 78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-03-21

    ... Assist System. P120008, FDA-2012-M-1176 Abbott Laboratories.. ARCHITECT AFP Assay, November 28, 2012. ARCHITECT AFP Calibrators and ARCHITECT AFP Controls. II. Electronic Access Persons with access to...

  13. 77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-03-16

    ...% sodium October 11, 2011. Pharmaceuticals, Inc. hyaluronate). P110022, FDA-2011-M-0786 Roche Diagnostics... November 30, 2011. kit. P110025, FDA-2011-M-0917 Roche Diagnostics ELECSYS anti-HBC IGM December 14, 2011...

  14. 76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2011-08-04

    .... Applicant Trade name Approval date P050050 FDA-2011-M-0323....... Small Bone Scandinavian total ankle May 27, 2009. Innovations, Inc. replacement system. P060004(S1) FDA-2011-M-0256... Carl Zeiss Meditec,...

  15. 75 FR 36099 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2010-06-24

    ... Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d.../S11 Boston TAXUS LIBERTE LONG July 13, FDA-2009-M-0369 Scientific PACLITAXEL ELUING STENT 2009...

  16. 77 FR 2071 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-01-13

    ..., 2011. P110020, FDA-2011-M-0601...... Roche Molecular COBAS 4800 BRAF V600 MUTATION August 17, 2011. Systems, Inc.. TEST. P110012, FDA-2011-M-0630...... Abbott Molecular, VYSIS ALK BREAK APART FISH PROBE August 26, 2011. Inc.. KIT; VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT...

  17. 77 FR 35690 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-06-14

    ...-0208, FDA- 2012-M-0209, FDA-2012-M-0210, FDA-2012-M-0221, and FDA-2012-M-0250] Medical Devices... BSD Medical BSD-2000 November 18, 2011. Corporation. Hyperthermia System. H100004, FDA-2011-M-0919..., 2012. Associates, Inc. Endoprosthesis. P100039, FDA-2012-M-0075 Siemens Healthcare ADVIA Centaur...

  18. 75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2010-07-02

    ... LEFT VENTRICULAR ASSIST 20, 2010 SYSTEM (LVAS) H080002 Medtronic, MEDTRONIC MELODY January FDA-2010-M-0063 Inc. TRANSCATHETER PULMONARY 25, 2010 VALVE (MODEL PB10) AND MEDTRONIC ENSEMBLE TRANSCATHETER... PREMOUNTED STENT SYSTEM 2010 Corp. P090006 Medtronic COMPLETE SE VASCULAR March 17, FDA-2010-M-0158 Vascular...

  19. 76 FR 31965 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2011-06-02

    ... THERAPY DEFIBRILLATORS. FDA-2011-M-0034 P100021 Medtronic Vascular. MEDTRONIC VASCULAR December 16, 2010. ENDURANT STENT GRAFT SYSTEM. FDA-2011-M-0040 P100010 Medtronic Cryocath, ARCTIC FRONT December 17, 2010. LP.... EXPANDABLE RENAL STENT SYSTEM. FDA-2011-M-0056 P090013 Medtronic, Inc..... REVO MRI SURESCAN IPG February 8...

  20. Safety assessment of DHA-rich microalgae from Schizochytrium sp.

    Science.gov (United States)

    Hammond, B G; Mayhew, D A; Holson, J F; Nemec, M D; Mast, R W; Sander, W J

    2001-04-01

    Schizochytrium sp. (DRM) contains oil rich in highly unsaturated fatty acids (PUFAs). Docosahexaenoic acid (DHA) is the most abundant PUFA component of the oil (approx. 35% w/w). DHA-rich extracted oil from Schizochytrium sp. is intended for use as a nutritional ingredient in foods. As part of a comprehensive safety assessment program, the developmental toxicity of DRM was assessed in Sprague-Dawley derived rats [25/group, provided DRM in the diet at 0.6, 6, and 30% on gestation days (GD) 6-15] and in New Zealand White (NZW) rabbits (22/group, dosed with DRM at levels of 180, 600, and 1800 mg/kg/day by oral gavage on GD 6-19). Fish oil was used as a negative control at dose levels to provide an equivalent amount of fat to that received by the high-dose DRM rabbits. Maternal food consumption, body weights, and clinical signs were recorded at regular intervals throughout these studies. Animals were sacrificed on GD 20 (rats) and GD 29 (rabbits) and examined for implant status, fetal weight, sex, and morphologic development. No clinical signs of toxicity were observed. Maternal exposure to DRM during organogenesis did not adversely affect the frequency of postimplantation loss, mean fetal body weight/litter, or external, visceral, or skeletal malformations in either the rat or the rabbit. In the rats, neither maternal nor developmental toxicity was observed at any dietary concentration of DRM. Thus, 22 g/ kg/day(1) of DRM administered in the feed to pregnant rats during organogenesis was the NOEL (no-observed-effect level) for both maternal and developmental toxicity. In rabbits, no maternal toxicity was expressed at DRM dose levels of 180 and 600 mg/kg/day. As a possible consequence of the high-fat content of the fish oil and DRM, reductions in food consumption and body weight gain and a slight increase in abortions occurred in the fish oil control and 1800 mg/kg/day DRM groups. Developmental toxicity was not observed at any DRM dose level. Based on the results of

  1. Safety

    CERN Multimedia

    2003-01-01

    Please note that the safety codes A9, A10 AND A11 (ex annexes of SAPOCO/42) entitled respectively "Safety responsibilities in the divisions" "The safety policy committee (SAPOCO) and safety officers' committees" and "Administrative procedure following a serious accident or incident" are available on the web at the following URLs: Code A9: http://edms.cern.ch/document/337016/LAST_RELEASED Code A10: http://edms.cern.ch/document/337019/LAST_RELEASED Code A11: http://edms.cern.ch/document/337026/LAST_RELEASED Paper copies can also be obtained from the TIS divisional secretariat, e-mail: tis.secretariat@cern.ch. TIS Secretariat

  2. FEP report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Skagius, Kristina [Kemakta Konsult AB, Stockholm (Sweden)

    2006-11-15

    This report documents the analysis and processing of features, events and processes, FEPs, that has been carried out within the safety assessment SR-Can, and forms an important part of the reporting of the project. The SR-Can project is a preparatory stage for the SR-Site assessment, and the report from that project will be used in support of SKB's application to build a final repository. The overall objective of the FEP analysis and processing included development of a database of features, events and processes, an SKB FEP database, in a format that facilitates both a systematic analysis of FEPs and documentation of that FEP analysis, as well as facilitating revisions and updates to be made in connection with new safety assessments. The overall objective also extended to the development of procedures for such a systematic FEP analysis as well as the application of those procedures in order to establish an SR-Can FEP catalogue within the framework of the SKB FEP database. The work started by implementing the content of the SR 97 Process Report into a database format suitable for import and processing of FEP information from other sources. The SR 97 version of the database was systematically audited against the NEA database with Project FEPs, version 1.2. In addition, an earlier audit of the SR 97 process report against the interaction matrices developed for a deep repository of the KBS-3 type was revisited and updated. Relevant FEPs identified through the audit process were sorted into three main categories i) FEPs related to the initial states of the repository system, ii) FEPs related to internal processes of the repository system, and iii) FEPs related to external impacts on the repository system. This resulted in additions to the SR 97 list of processes and to the lists of initial state FEPs and external factors to be addressed in further processing. The further processing of the initial state FEPs revealed that those FEPs that are not covered by the

  3. Safety culture assessment among laboratory personnel of a petrochemical company

    Directory of Open Access Journals (Sweden)

    M. Shekari

    2014-05-01

    .Conclusion: Strong and positive safety culture among laboratory personnel would prevent incidence of many occupational accidents. In another word, it would help organizations to facilitate access to higher standards.

  4. Safety Assessment of PowerBeam Flywheel Technology

    Energy Technology Data Exchange (ETDEWEB)

    Starbuck, J Michael [ORNL; Hansen, James Gerald [ORNL

    2009-11-01

    The greatest technical challenge facing the developer of vehicular flywheel systems is the issue of safety. The PowerBeam flywheel system concept, developed by HyKinesys Inc., employs a pair of high aspect ratio, counter-rotating flywheels to provide surge power for hybrid vehicle applications. The PowerBeam approach to safety is to design flywheels conservatively so as to avoid full rotor burst failure modes. A conservative point design was sized for use in a mid-size sedan such as a Chevrolet Malibu. The PowerBeam rotor rims were designed with a steel tube covered by a carbon fiber reinforced composite tube. ORNL conducted rotor design analyses using both nested ring and finite element analysis design codes. The safety factor of the composite material was 7, while that of the steel was greater than 3. The design exceeded the PNGV recommendation for a safety factor of at least 4 for composite material to prevent flywheel burst.

  5. Function and safety assessment of Lactococus lactis subsp. lactis ...

    African Journals Online (AJOL)

    STORAGESEVER

    2008-11-19

    Nov 19, 2008 ... antibiotic sensitivity and safety were also examined. The serum total cholesterol, ... Staphylococcus aureus ATCC 25923 (obtained from the Micro- biological Laboratory of Life ... Aliquots were removed prior to inoculation to ...

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

    Science.gov (United States)

    Wreathall, J; Nemeth, C

    2004-06-01

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

  7. Ranking the types of intersections for assessing the safety of pedestrians using TOPSIS method

    Directory of Open Access Journals (Sweden)

    Călin ŞERBU

    2014-11-01

    Full Text Available Every year, more than 1500 accidents with pedestrian occur in the intersections in Romania. The number of accidents involving pedestrians in roundabouts intersections type increased approximately three times in 2013 compared to 2009 in Romania. This alarming increase led to the need of assessing the safety of pedestrians in intersections with or without safety systems. The safety systems for pedestrians and drivers include: the road marking, the pedestrian crossings marking, signal intersections with road signs, traffic lights or pedestrian safety barriers. We propose to assess the types of intersections with TOPSIS method.

  8. Bayesian Network Assessment Method for Civil Aviation Safety Based on Flight Delays

    Directory of Open Access Journals (Sweden)

    Huawei Wang

    2013-01-01

    Full Text Available Flight delays and safety are the principal contradictions in the sound development of civil aviation. Flight delays often come up and induce civil aviation safety risk simultaneously. Based on flight delays, the random characteristics of civil aviation safety risk are analyzed. Flight delays have been deemed to a potential safety hazard. The change rules and characteristics of civil aviation safety risk based on flight delays have been analyzed. Bayesian networks (BN have been used to build the aviation operation safety assessment model based on flight delay. The structure and parameters learning of the model have been researched. By using BN model, some airline in China has been selected to assess safety risk of civil aviation. The civil aviation safety risk of BN model has been assessed by GeNIe software. The research results show that flight delay, which increases the safety risk of civil aviation, can be seen as incremental safety risk. The effectiveness and correctness of the model have been tested and verified.

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

    Science.gov (United States)

    Aminbakhsh, Saman; Gunduz, Murat; Sonmez, Rifat

    2013-09-01

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

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

    Science.gov (United States)

    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.

  11. Safety assessment of a nuclear power plant building subjected to an aircraft crash

    Energy Technology Data Exchange (ETDEWEB)

    Thai, Duc-Kien; Kim, Seung-Eock, E-mail: sekim@sejong.ac.kr

    2015-11-15

    Highlights: • Numerical analysis of a nuclear auxiliary building under aircraft crash is conducted. • The analysis result of impact force is verified using the Riera function. • The safety assessment is performed with regard to different impact scenarios. • Discussions and conclusions on safety of the nuclear building are presented. - Abstract: This paper presents a safety assessment of a nuclear building subjected to an aircraft crash using numerical analysis. For impact simulation, the reinforced concrete (RC) Primary Auxiliary Building (PAB) of the Korea Standard Nuclear Power Plant (KSNP) is fully modeled and an aircraft model of a Boeing 767-400 is used. The Riera function is used to verify the analysis result of impact force–time history. The IRIS test is used to verify the structural behavior of the RC wall under impact loading. The safety assessment of the building is performed with regard to different impact scenarios. The safety of the nuclear building under aircraft crash, including (1) global structural safety, (2) local structural safety, and (3) vibration safety are evaluated and discussed. The results show that the global and local structural safety of the PAB is ensured in all impact scenarios. However, the vibration safety of the building is not ensured. In accordance, the regulatory guide of United States Nuclear Regulatory Commission (U.S. NRC), shutdown of the nuclear power plant is required.

  12. The application of transcriptomics in the comparative safety assessment of (GMO-derived) plant products

    OpenAIRE

    Kok, E.J.

    2008-01-01

    National and international organizations have discussed current approaches to the safety assessment of complex (plant) food products in general and the safety assessment of GMO-derived food products in particular. One of the recommendations of different expert meetings was that the new analytical techniques, in particular the ‘omics’ approaches, need to be explored for their potential to improve the analysis and thereby the toxicological and nutritional assessment of complex (GMO-derived) pla...

  13. Buffer and backfill process report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Sellin, Patrik (comp.)

    2006-09-15

    This document compiles information on processes in the buffer and deposition tunnel backfill relevant for long-term safety of a KBS-repository. It supports the safety assessment SR-Can, which is a preparatory step for a safety assessment that will support the licence application for a final repository in Sweden. The purpose of the process reports is to document the scientific knowledge of the processes to a level required for an adequate treatment of the processes in the safety assessment. The documentation is not exhaustive from a scientific point of view, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. However, it must be sufficiently detailed to motivate, by arguments founded on scientific understanding, the treatment of each process in the safety assessment. The purpose is further to determine how to handle each process in the safety assessment at an appropriate degree of detail, and to demonstrate how uncertainties are taken care of, given the suggested handling.

  14. Assessment of Safety Condition in One of the Teaching Hospitals in Kermanshah (2015: A Case Study

    Directory of Open Access Journals (Sweden)

    Masod Ghanbari Kakavand

    2016-09-01

    Full Text Available Background & Aims of the Study: Many working conditions-related stress factors that can produce injuries and illnesses are important in hospital environments. So, the health and safety of nurses and patients from workplace-induced injuries and illnesses is important. In this study, we have assessed the safety condition of one of the teaching hospitals in Kermanshah (2015. Materials and Methods: This descriptive and cross-sectional study was conducted in one of the teaching hospital of Kermanshah University of medical sciences. For this aim a checklist was prepared based on the Occupational Safety and Health Administration's standards and Part 3 of the manual of National Building Regulations. These checklists comprised (The final checklist had 239 questions of 9 dimensions various sections of safety including; fire safety, building safety, electrical safety, emergency exit routes safety, heating and cooling equipment safety, operating room and laundry room and salty home safety. Eventually, using SPSS 16 and descriptive statistics, data were analyzed. Results: According to the results of this study, 66.6% of the units had poor safety and 33.4% of them were moderately safe. As well as, only ICU and CCU unit, heating and cooling equipment and operational room showed moderate compliance with safety requirements and other sections were poorly complied. Conclusion: The results of this study showed that safety conditions of hospital were not at favorable level. These poor safety statues can jeopardize patients and hospital personnel. Thus some interventions such as improvement of working conditions, compliance with safety acts and implementation of health, safety and environmental management system would be necessary.

  15. FEP report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Skagius, Kristina [Kemakta Konsult AB, Stockholm (Sweden)

    2006-11-15

    This report documents the analysis and processing of features, events and processes, FEPs, that has been carried out within the safety assessment SR-Can, and forms an important part of the reporting of the project. The SR-Can project is a preparatory stage for the SR-Site assessment, and the report from that project will be used in support of SKB's application to build a final repository. The overall objective of the FEP analysis and processing included development of a database of features, events and processes, an SKB FEP database, in a format that facilitates both a systematic analysis of FEPs and documentation of that FEP analysis, as well as facilitating revisions and updates to be made in connection with new safety assessments. The overall objective also extended to the development of procedures for such a systematic FEP analysis as well as the application of those procedures in order to establish an SR-Can FEP catalogue within the framework of the SKB FEP database. The work started by implementing the content of the SR 97 Process Report into a database format suitable for import and processing of FEP information from other sources. The SR 97 version of the database was systematically audited against the NEA database with Project FEPs, version 1.2. In addition, an earlier audit of the SR 97 process report against the interaction matrices developed for a deep repository of the KBS-3 type was revisited and updated. Relevant FEPs identified through the audit process were sorted into three main categories i) FEPs related to the initial states of the repository system, ii) FEPs related to internal processes of the repository system, and iii) FEPs related to external impacts on the repository system. This resulted in additions to the SR 97 list of processes and to the lists of initial state FEPs and external factors to be addressed in further processing. The further processing of the initial state FEPs revealed that those FEPs that are not covered by the

  16. Assessment of the impact of scheduled postmarketing safety summary analyses on regulatory actions.

    Science.gov (United States)

    Sekine, S; Pinnow, E E; Wu, E; Kurtzig, R; Hall, M; Dal Pan, G J

    2016-07-01

    In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities.

  17. Implications of Monte Carlo Statistical Errors in Criticality Safety Assessments

    Energy Technology Data Exchange (ETDEWEB)

    Pevey, Ronald E.

    2005-09-15

    Most criticality safety calculations are performed using Monte Carlo techniques because of Monte Carlo's ability to handle complex three-dimensional geometries. For Monte Carlo calculations, the more histories sampled, the lower the standard deviation of the resulting estimates. The common intuition is, therefore, that the more histories, the better; as a result, analysts tend to run Monte Carlo analyses as long as possible (or at least to a minimum acceptable uncertainty). For Monte Carlo criticality safety analyses, however, the optimization situation is complicated by the fact that procedures usually require that an extra margin of safety be added because of the statistical uncertainty of the Monte Carlo calculations. This additional safety margin affects the impact of the choice of the calculational standard deviation, both on production and on safety. This paper shows that, under the assumptions of normally distributed benchmarking calculational errors and exact compliance with the upper subcritical limit (USL), the standard deviation that optimizes production is zero, but there is a non-zero value of the calculational standard deviation that minimizes the risk of inadvertently labeling a supercritical configuration as subcritical. Furthermore, this value is shown to be a simple function of the typical benchmarking step outcomes--the bias, the standard deviation of the bias, the upper subcritical limit, and the number of standard deviations added to calculated k-effectives before comparison to the USL.

  18. 21 CFR 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.

    Science.gov (United States)

    2010-04-01

    ... secret or confidential commercial or financial information under § 20.61. (3) Any adverse reaction report... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Confidentiality of data and information in a premarket approval application (PMA) file. 814.9 Section 814.9 Food and Drugs FOOD AND DRUG...

  19. Assessment of Patient Safety Culture in Primary Health Care Settings in Kuwait

    OpenAIRE

    Maha Mohamed Ghobashi; Hanan Abdel Ghani El-ragehy; Hanan Mosleh Ibrahim; Fatma Abdullah Al-Doseri

    2014-01-01

    Background Patient safety is critical component of health care quality. We aimed to assess the awareness of primary healthcare staff members about patient safety culture and explore the areas of deficiency and opportunities for improvement concerning this issue.Methods: This descriptive cross sectional study surveyed 369 staff members in four primary healthcare centers in Kuwait using self-administered “Hospital Survey on Patient Safety Culture” adopted questionnaire. The total number of resp...

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

    Science.gov (United States)

    Kurozumi, Ryota; Yamamoto, Toru; Fujisawa, Shoichiro

    2015-01-01

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

  1. Automating the aviation command safety assessment survey as an Enterprise Information System (EIS)

    OpenAIRE

    Held, Jonathan S.; Mingo, Fred J.

    1999-01-01

    The Aviation Command Safety Assessment (ACSA) is a questionnaire survey methodology developed to evaluate a Naval Aviation Command's safety climate, culture, and safety program effectiveness. This survey was a manual process first administered in the fall of 1996. The primary goal of this thesis is to design, develop, and test an Internet-based, prototype model for administering this survey using new technologies that allow automated survey submission and analysis. The result of this thesis i...

  2. Image processing for safety assessment in civil engineering.

    Science.gov (United States)

    Ferrer, Belen; Pomares, Juan C; Irles, Ramon; Espinosa, Julian; Mas, David

    2013-06-20

    Behavior analysis of construction safety systems is of fundamental importance to avoid accidental injuries. Traditionally, measurements of dynamic actions in civil engineering have been done through accelerometers, but high-speed cameras and image processing techniques can play an important role in this area. Here, we propose using morphological image filtering and Hough transform on high-speed video sequence as tools for dynamic measurements on that field. The presented method is applied to obtain the trajectory and acceleration of a cylindrical ballast falling from a building and trapped by a thread net. Results show that safety recommendations given in construction codes can be potentially dangerous for workers.

  3. Crane Safety Assessment Method Based on Entropy and Cumulative Prospect Theory

    Directory of Open Access Journals (Sweden)

    Aihua Li

    2017-01-01

    Full Text Available Assessing the safety status of cranes is an important problem. To overcome the inaccuracies and misjudgments in such assessments, this work describes a safety assessment method for cranes that combines entropy and cumulative prospect theory. Firstly, the proposed method transforms the set of evaluation indices into an evaluation vector. Secondly, a decision matrix is then constructed from the evaluation vectors and evaluation standards, and an entropy-based technique is applied to calculate the index weights. Thirdly, positive and negative prospect value matrices are established from reference points based on the positive and negative ideal solutions. Thus, this enables the crane safety grade to be determined according to the ranked comprehensive prospect values. Finally, the safety status of four general overhead traveling crane samples is evaluated to verify the rationality and feasibility of the proposed method. The results demonstrate that the method described in this paper can precisely and reasonably reflect the safety status of a crane.

  4. Assessment of Primary Production of Horticultural Safety Management Systems of Mushroom Farms in South Africa.

    Science.gov (United States)

    Dzingirayi, Garikayi; Korsten, Lise

    2016-07-01

    Growing global consumer concern over food safety in the fresh produce industry requires producers to implement necessary quality assurance systems. Varying effectiveness has been noted in how countries and food companies interpret and implement food safety standards. A diagnostic instrument (DI) for global fresh produce industries was developed to measure the compliancy of companies with implemented food safety standards. The DI is made up of indicators and descriptive grids for context factors and control and assurance activities to measure food safety output. The instrument can be used in primary production to assess food safety performance. This study applied the DI to measure food safety standard compliancy of mushroom farming in South Africa. Ten farms representing almost half of the industry farms and more than 80% of production were independently assessed for their horticultural safety management system (HSMS) compliance via in-depth interviews with each farm's quality assurance personnel. The data were processed using Microsoft Office Excel 2010 and are represented in frequency tables. The diagnosis revealed that the mushroom farming industry had an average food safety output. The farms were implementing an average-toadvanced HSMS and operating in a medium-risk context. Insufficient performance areas in HSMSs included inadequate hazard analysis and analysis of control points, low specificity of pesticide assessment, and inadequate control of suppliers and incoming materials. Recommendations to the industry and current shortcomings are suggested for realization of an improved industry-wide food safety assurance system.

  5. Hospitals safety from disasters in I.R.iran: the results from assessment of 224 hospitals.

    Science.gov (United States)

    Ardalan, Ali; Kandi, Maryam; Talebian, Mohammad Taghi; Khankeh, Hamidreza; Masoumi, Gholamreza; Mohammadi, Reza; Maleknia, Samaneh; Miadfar, Jafar; Mobini, Atieh; Mehranamin, Sara

    2014-02-28

    Iran's hospitals have been considerably affected by disasters during last decade. To address this, health system of I.R.Iran has taken an initiative to assess disaster safety of the hospitals using an adopted version of Hospital Safety Index (HSI). This article presents the results of disaster safety assessment in 224 Iran's hospitals. A self-assessment approach was applied to assess the disaster safety in 145 items categorized in 3 components including structural, non-structural and functional capacity. For each item, safety level was categorized to 3 levels: not safe (0), average safe (1) and high safe (2). A raw score was tallied for each safety component and its elements by a simple sum of all the corresponding scores. All scores were normalized on a 100 point scale. Hospitals were classified to three safety classes according to their normalized total score: low (≤34.0), average (34.01-66.0) and high (>66.0). The average score of all safety components were 32.4 out of 100 (± 12.7 SD). 122 hospitals (54.5%) were classified as low safe and 102 hospitals (45.5%) were classified as average safe. No hospital was placed in the high safe category. Average safety scores out of 100 were 27.3 (±14.2 SD) for functional capacity, 36.0 (±13.9 SD) for non-structural component and 36.0 (±19.0 SD) for structural component. Neither the safety classes nor the scores of safety components were significantly associated with types of hospitals in terms of affiliation, function and size (P>0.05). To enhance the hospitals safety for disaster in Iran, we recommend: 1) establishment of a national committee for hospital safety in disasters; 2) supervision on implementation of the safety standards in construction of new hospitals; 3) enhancement of functional readiness and safety of non-structural components while structural retrofitting of the existing hospitals is being taken into consideration, whenever is cost-effective; 4) considering the disaster safety status as the criteria

  6. Assessment of Native Languages for Food Safety Training Programs for Meat Industry Employees

    Science.gov (United States)

    Olsen, Sherrlyn S.; Cordray, Joseph C.; Sapp, Stephen; Sebranek, Joseph G.; Anderson, Barbara; Wenger, Matt

    2012-01-01

    Challenges arise when teaching food safety to culturally diverse employees working in meatpacking and food manufacturing industries. A food safety training program was developed in English, translated into Spanish, and administered to 1,265 adult learners. Assessments were conducted by comparing scores before and immediately following training.…

  7. Probability distributions of dose conversion factors for radionuclides used in a long-term safety assessment

    NARCIS (Netherlands)

    Laheij GMH; Uijt de Haag PAM

    1993-01-01

    The research presented in this report forms part of the PROSA (PRObabilistic Safety Assessment) project. PROSA aims to determine the radiological effects on humans and the characteristics relevant to safety of disposal concepts for radioactive waste in rocksalt formations. This report describes

  8. Assessment of Food Safety Knowledge of High School and Transition Teachers of Special Needs Students

    Science.gov (United States)

    Pivarnik, Lori F.; Patnoad, Martha S.; Richard, Nicole Leydon; Gable, Robert K.; Hirsch, Diane Wright; Madaus, Joseph; Scarpati, Stan; Carbone, Elena

    2009-01-01

    Adolescents with disabilities require access to general education and life skills instruction. Knowledge of food safety for this audience is important for health and valuable for work placement. The objective was to implement a survey to assess high school and transition special education teachers in RI, CT, and MA for food safety knowledge and…

  9. Calibration of partial factors in the safety assessment of existing concrete slab bridges for shear failure

    NARCIS (Netherlands)

    Steenbergen, R.D.J.M.; De Boer, A.; Van der Veen, C.

    2012-01-01

    The assessment of the structural safety of existing bridges and viaducts becomes increasingly important in many countries due to the age of the structures and an increase in traffic loads. Many structures need to be reassessed in order to find out whether the safety requirements are met. Most existi

  10. ANALYSIS OF SEQUENTIAL FAILURES FOR ASSESSMENT OF RELIABILITY AND SAFETY OF MANUFACTURING SYSTEMS. (R828541)

    Science.gov (United States)

    Assessment of reliability and safety of a manufacturing system with sequential failures is an important issue in industry, since the reliability and safety of the system depend not only on all failed states of system components, but also on the sequence of occurrences of those...

  11. Assessment of Native Languages for Food Safety Training Programs for Meat Industry Employees

    Science.gov (United States)

    Olsen, Sherrlyn S.; Cordray, Joseph C.; Sapp, Stephen; Sebranek, Joseph G.; Anderson, Barbara; Wenger, Matt

    2012-01-01

    Challenges arise when teaching food safety to culturally diverse employees working in meatpacking and food manufacturing industries. A food safety training program was developed in English, translated into Spanish, and administered to 1,265 adult learners. Assessments were conducted by comparing scores before and immediately following training.…

  12. Assessment of Food Safety Knowledge of High School and Transition Teachers of Special Needs Students

    Science.gov (United States)

    Pivarnik, Lori F.; Patnoad, Martha S.; Richard, Nicole Leydon; Gable, Robert K.; Hirsch, Diane Wright; Madaus, Joseph; Scarpati, Stan; Carbone, Elena

    2009-01-01

    Adolescents with disabilities require access to general education and life skills instruction. Knowledge of food safety for this audience is important for health and valuable for work placement. The objective was to implement a survey to assess high school and transition special education teachers in RI, CT, and MA for food safety knowledge and…

  13. Safety assessment of menaquinone-7 for use in human nutrition

    Directory of Open Access Journals (Sweden)

    Basavaias Ravishankar

    2015-03-01

    Full Text Available Vitamin K occurs widely in foods and has been shown to have a beneficial effect on the cardiovascular system, as well as anticancer, anti-inflammatory, and antiosteoporosis properties. A previous study indicates that long-chain menaquinone-7 may be more bioavailable than vitamin K and short-chain menaquinones. In the present study, acute, subacute toxicity and genotoxicity assays were carried out to evaluate the safety of oral menaquinone-7 in albino Wistar rats. Oral administration of menaquinone-7, at a concentration of 2000 mg/kg, did not cause toxic symptoms in either male or female rats. A subacute toxicity study also proved the safety and tolerance of prolonged treatment (for 90 days with menaquinone-7 in rats, as evidenced by biochemical, hematological, and urine parameters as well as by histopathological analysis. Genotoxicity and mutagenicity studies were performed by comet, micronucleus, and Ames tests on Salmonella typhimurium strains, which showed cellular safety and nonmutagenicity of menaquinone-7. The results indicate the safety of menaquinone-7 for human consumption.

  14. Flibe use in fusion reactors -- An initial safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Cadwallader, L.C.; Longhurst, G.R.

    1999-03-01

    This report is an initial effort to identify and evaluate safety issues associated with the use of Flibe (LiF-BeF{sub 2}) as a molten salt coolant for nuclear fusion power plant applications. Flibe experience in the Molten Salt Reactor Experiment is briefly reviewed. Safety issues identified include chemical toxicity, radiological issues resulting from neutron activation, and the operational concerns of handling a high temperature coolant. Beryllium compounds and fluorine pose be toxicological concerns. Some controls to protect workers are discussed. Since Flibe has been handled safely in other applications, its hazards appear to be manageable. Some safety issues that require further study are pointed out. Flibe salt interaction with strong magnetic fields should be investigated. Evolution of Flibe constituents and activation products at high temperature (i.e., will Fluorine release as a gas or remain in the molten salt) is an issue. Aerosol and tritium release from a Flibe spill requires study, as does neutronics analysis to characterize radiological doses. Tritium migration from Flibe into the cooling system is also a safety concern. Investigation of these issues will help determine the extent to which Flibe shows promise as a fusion power plant coolant or plasma-facing material.

  15. Flibe Use in Fusion Reactors - An Initial Safety Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Cadwallader, Lee Charles; Longhurst, Glen Reed

    1999-04-01

    This report is an initial effort to identify and evaluate safety issues associated with the use of Flibe (LiF-BeF2) as a molten salt coolant for nuclear fusion power plant applications. Flibe experience in the Molten Salt Reactor Experiment is briefly reviewed. Safety issues identified include chemical toxicity, radiological issues resulting from neutron activation, and the operational concerns of handling a high temperature coolant. Beryllium compounds and fluorine pose be toxicological concerns. Some controls to protect workers are discussed. Since Flibe has been handled safely in other applications, its hazards appear to be manageable. Some safety issues that require further study are pointed out. Flibe salt interaction with strong magnetic fields should be investigated. Evolution of Flibe constituents and activation products at high temperature (i.e., will Fluorine release as a gas or remain in the molten salt) is an issue. Aerosol and tritium release from a Flibe spill requires study, as does neutronics analysis to characterize radiological doses. Tritium migration from Flibe into the cooling system is also a safety concern. Investigation of these issues will help determine the extent to which Flibe shows promise as a fusion power plant coolant or plasma-facing material.

  16. Assessing the safety of routes in a regional network.

    NARCIS (Netherlands)

    Dijkstra, A.

    2013-01-01

    In The Netherlands, the concept ‘Sustainable Safety’ is the leading vision in road safety policy and research. The main goal of a sustainably safe road transport system is to reduce the annual number of road crash casualties to a fraction of the current levels. An important requirement that follows

  17. Learning Safety Assessment from Accidents in a University Environment

    DEFF Research Database (Denmark)

    Jensen, Niels; Jørgensen, Sten Bay

    2013-01-01

    the chemicals used in the experimental work. These experiences have led to recent developments which focus increasingly on the a theoretical basis for modeling and reasoning on safety as well as operational aspects within a common framework. Presently this framework is being extended with barrier concepts both...

  18. 76 FR 45453 - New Car Assessment Program (NCAP); Safety Labeling

    Science.gov (United States)

    2011-07-29

    .... Second, the company said the visual presentation of the overall vehicle score should make clear to... maximum possible safety rating; (2) refers to frontal impact crash tests, side impact crash tests, and... rating system to reflect new side impact test dummies, new injury criteria, the inclusion of nearly...

  19. Ports and Waterways Safety Assessment: Long Island Sound

    Science.gov (United States)

    2005-05-04

    DeMoustes Keyspan Energy Mr. James Divan Riverhead Police Department Ms. Maureen Dolan Citizen’s Campaign for the Environment Capt. Donald Fromm ...Harbor Master LT Andrea Logman USCG Group/Marine Safety Office Long Island Sound Ms. Leah Lopez Schmalz Save the Sound Col. Eric Nelson

  20. Ports and Waterways Safety Assessment: San Diego Workshop Report

    Science.gov (United States)

    2003-03-01

    o International conventions (SOLAS, STCW , etc.) • Recreational Vessels: o Recreational vessel safety checks by Coast Guard Auxiliary and Power...discussed. Existing Mitigations: • STCW training requirements. • ISO requirements. • Coast Guard licensing standards. • Commercial vessel in-house

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

    Science.gov (United States)

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

    2017-06-01

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

  2. Overview of resulting tools, guidelines, and instruments. IN-SAFETY Workpackage 3: New models, tools and guidelines for road safety assessment, Deliverable 3.4.

    NARCIS (Netherlands)

    Dijkstra, A. Bald, S. Benz, T. & Gaitanidou, E. (eds.)

    2009-01-01

    Road safety will most probably be influenced by introducing Advanced Driver Assistance Systems (ADAS) or Intelligent Vehicle Safety Systems (IVSS). The effects of these systems on road safety can be assessed in different ways. This document gives a short overview of methodologies which allow for ass

  3. Preliminary nuclear safety assessment of the NEPST (Topaz 2) space reactor program

    Science.gov (United States)

    Marshall, A. C.

    The United States (US) Strategic Defense Initiative Organization (SDIO) decided to investigate the possibility of launching a Russian Topaz 2 space nuclear power system. A preliminary nuclear safety assessment was conducted to determine whether or not a space mission could be conducted safely and within budget constraints. As part of this assessment, a safety policy and safety functional requirements were developed to guide both the safety assessment and future Topaz 2 activities. A review of the Russian flight safety program was conducted and documented. Our preliminary nuclear safety assessment included a number of deterministic analyses, such as the following: neutronic analysis of normal and accident configurations, an evaluation of temperature coefficients of reactivity, a reentry and disposal analysis, an analysis of postulated launch abort impact accidents, and an analysis of postulated propellant fire and explosion accidents. Based on the assessment to date, it appears that it will be possible to safely launch the Topaz 2 system in the US with a modification to preclude water flooded criticality. A full scale safety program is now underway.

  4. Assessment of policy issues in nuclear safety regulation according to circumstantial changes

    Energy Technology Data Exchange (ETDEWEB)

    Chang, Soon Heung; Lee, Byong Ho; Baek, Won Pil; Lee, Kwang Gu; Huh, Gyun Young; Hahn, Young Tae [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

    2000-03-15

    The objective of the work is to assess various issues in nuclear safety regulation in consideration of circumstantial changes. Emphasis is given to the safety of operating NPPs. It is concluded that the Periodic Safety Review (PSR) should be implemented in Korea as soon as possible, in harmonization with the regulation for life extension of NPPs. The IAEA guidelines, including 10 year intervals and 11 safety factors, should be used as the basic guidelines. The approach to improve regulatory effectiveness is also reviewed and a transition to 'knowledge-based regulation' is suggested.

  5. The safety and regulation of natural products used as foods and food ingredients.

    Science.gov (United States)

    Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J

    2011-10-01

    The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements.

  6. SAFETY ANALYSIS AND RISK ASSESSMENT FOR BRIDGES HEALTH MONITORING WITH MONTE CARLO METHODS

    OpenAIRE

    2016-01-01

    With the increasing requirements of building safety in the past few decades, healthy monitoring and risk assessment of structures is of more and more importance. Especially since traffic loads are heavier, risk Assessment for bridges are essential. In this paper we take advantage of Monte Carlo Methods to analysis the safety of bridge and monitoring the destructive risk. One main goal of health monitoring is to reduce the risk of unexpected damage of artificial objects

  7. Safety Assessment of Alkyl PEG Sulfosuccinates as Used in Cosmetics.

    Science.gov (United States)

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

    2015-09-01

    The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of alkyl polyethylene glycol (PEG) sulfosuccinates, which function in cosmetics mostly as surfactants/cleansing agents. Although these ingredients may cause ocular and skin irritation, dermal penetration is unlikely because of the substantial polarity and molecular size of these ingredients. The Panel considered the negative oral carcinogenicity and reproductive and developmental toxicity data on chemically related laureths (PEG lauryl ethers) and negative repeated dose toxicity and skin sensitization data on disodium laureth sulfosuccinate supported the safety of these alkyl PEG sulfosuccinates in cosmetic products, but. The CIR Expert Panel concluded that the alkyl PEG sulfosuccinates are safe in the present practices of use and concentration when formulated to be nonirritating.

  8. Probabilistic safety assessment in the chemical and nuclear industries

    CERN Document Server

    Fullwood, Ralph R

    2000-01-01

    Probabilistic Safety Analysis (PSA) determines the probability and consequences of accidents, hence, the risk. This subject concerns policy makers, regulators, designers, educators and engineers working to achieve maximum safety with operational efficiency. Risk is analyzed using methods for achieving reliability in the space program. The first major application was to the nuclear power industry, followed by applications to the chemical industry. It has also been applied to space, aviation, defense, ground, and water transportation. This book is unique in its treatment of chemical and nuclear risk. Problems are included at the end of many chapters, and answers are in the back of the book. Computer files are provided (via the internet), containing reliability data, a calculator that determines failure rate and uncertainty based on field experience, pipe break calculator, event tree calculator, FTAP and associated programs for fault tree analysis, and a units conversion code. It contains 540 references and many...

  9. Efficiency assessment of coal mine safety input by data envelopment analysis

    Institute of Scientific and Technical Information of China (English)

    TONG Lei; DING Ri-jia

    2008-01-01

    In recent years improper allocation of safety input has prevailed in coal mines in China, which resulted in the frequent accidents in coal mining operation. A comprehensive assessment of the input efficiency of coal mine safety should lead to im-proved efficiency in the use of funds and management resources. This helps government and enterprise managers better understand how safety inputs are used and to optimize allocation of resources. Study on coal mine's efficiency assessment of safety input was conducted in this paper. A C2R model with non-Archimedean infinitesimal vector based on output is established after consideration of the input characteristics and the model properties. An assessment of an operating mine was done using a specific set of input and output criteria. It is found that the safety input was efficient in 2002 and 2005 and was weakly efficient in 2003. However, the effi-ciency was relatively low in both 2001 and 2004. The safety input resources can be optimized and adjusted by means of projection theory. Such analysis shows that, on average in 2001 and 2004, 45% of the expended funds could have been saved. Likewise, 10% of the safety management and technical staff could have been eliminated and working hours devoted to safety could have been reduced by 12%. These conditions could have given the same results.

  10. Ports and Waterways Safety Assessment Workshop Report: Narragansett Bay

    Science.gov (United States)

    2004-09-08

    STCW , SOLAS, etc. standards. • Navigation safety equipment (GPS, radar, etc.). • Single-hull barges 2004-05 phase-out schedule. They are...required of crews. • ISM Code; STCW . Simulator training gets better and is used much more. • Mandatory pilotage. • ATB units are all double hulled...knowledgeable / experienced. Trends: • STCW and Responsible Carrier Program have improved the tug/barge fleet. • F/V fleet improving by attrition and

  11. Ports and Waterways Safety Assessment Workshop Report for Aleutian Islands

    Science.gov (United States)

    2006-07-25

    Code and Standards for Training, Certification and Watchkeeping ( STCW ) • Enforcement of regulations by USCG • Pressure put on owners by insurance...discussed Existing Mitigations: • STCW compliance • OPA 90 compliance • Little to no communication / language problems, majority of operators are...Require mandatory inspections of commercial fishing vessels >26 feet (8) • Encourage voluntary STCW Basic Safety Training classes (7) • Require crew

  12. Quantitative Assessment of Statistical Reviews of Patient Safety Research Articles.

    Science.gov (United States)

    Daniels, Jeffrey R; Dexter, Franklin; Espy, Jennifer L; Brull, Sorin J

    2017-06-06

    For 8.5 consecutive years, all patient safety articles of a journal underwent statistical review before publication. We sought to establish the prevalence of statistical themes in the statistical reviews, consideration of contemporary statistical methods, and their associations with time to journal receipt of authors' revision. An initial set of statistical themes was created using the statistical editor's notes. For example, for the statistical theme of "CONSORT checklist," the search term needed was "CONSORT." A complete (exhaustive) list of additional themes was obtained inductively. Among the 273 subsequent reviews for manuscripts that were ultimately accepted, the number of paragraphs that included a theme of a statistical method was only weakly associated with longer revision times (Kendall τ = 0.139 ± 0.039, P = 0.0004). Among the total 3274 paragraphs of statistical reviews, 72.2% did not include a theme of a statistical method (e.g., the editor instead asked the authors to clarify what statistical method had been used) (95% confidence interval [CI] = 70.6%-73.7%, P paragraphs of statistical review comments, only 16.0% included a contemporary theme (95% CI = 13.7%-18.6%). The revised versions of patient safety articles, which are eventually to be accepted for publication, have many statistical limitations especially in the reporting (writing) of basic statistical methods and results. The results suggest a need for education of patient safety investigators to include statistical writing.

  13. [Safety assessment of nanomaterials in reproductive developmental field].

    Science.gov (United States)

    Yamashita, Kohei; Yoshioka, Yasuo

    2012-01-01

    A diverse array of nanomaterials (NMs) such as amorphous nanosilica and carbon nanotubes have become widespread in use due to the development of nanotechnology. NMs are already being applied in universal fields because they have unique physicochemical properties. On the other hand, the increasing use of NMs has raised public concern about their potential risks to human health. In particular, recent reports indicated that carbon nanotubes induced mesothelioma-like lesions in mice, in a way similar to those induced by crocidolite asbestos. However, current knowledge of the potential risk of nanomaterials is considered insufficient. Because NMs have the potential to improve the quality of human life, it is essential to ensure the safety of NMs and provide information for designing NMs with safety. Especially, few studies have examined the effect of NMs on maintenance of pregnancy. Similar to the cases of thalidomide, a lot of evidence shows that fetuses are affected more than adults by a variety of environmental toxins because of physiological immaturity. Therefore it is essential to examine the effect of NMs on fetuses and pregnancies. Here we introduce the potential risk of amorphous nanosilica, most widely used NMs in food and the cosmetics field, to induce fetotoxicity and useful information for developing NMs with safety.

  14. Implementation of a risk assessment tool based on a probabilistic safety assessment developed for radiotherapy practices

    Energy Technology Data Exchange (ETDEWEB)

    Paz, A.; Godinez, V.; Lopez, R., E-mail: abpaz@cnsns.gob.m [Comision Nacional de Seguridad Nuclear y Salvaguardias, Dr. Barragan No. 779, Col. Narvarte, 03020 Mexico D. F. (Mexico)

    2010-10-15

    The present work describes the implementation process and main results of the risk assessment to the radiotherapy practices with Linear Accelerators (Linac), with cobalt 60, and with brachytherapy. These evaluations were made throughout the risk assessment tool for radiotherapy practices SEVRRA (risk evaluation system for radiotherapy), developed at the Mexican National Commission in Nuclear Safety and Safeguards derived from the outcome obtained with the Probabilistic Safety Analysis developed at the Ibero-American Regulators Forum for these radiotherapy facilities. The methodology used is supported by risk matrices method, a mathematical tool that estimates the risk to the patient, radiation workers and public from mechanical failures, mis calibration of the devices, human mistakes, and so. The initiating events are defined as those undesirable events that, together with other failures, can produce a delivery of an over-dose or an under-dose of the medical prescribed dose, to the planned target volume, or a significant dose to non prescribed human organs. Initiating events frequency and reducer of its frequency (actions intended to avoid the accident) are estimated as well as robustness of barriers to those actions, such as mechanical switches, which detect and prevent the accident from occurring. The spectrum of the consequences is parameterized, and the actions performed to reduce the consequences are identified. Based on this analysis, a software tool was developed in order to simplify the evaluations to radiotherapy installations and it has been applied as a first step forward to some Mexican installations, as part of a national implementation process, the final goal is evaluation of all Mexican facilities in the near future. The main target and benefits of the SEVRRA implementation are presented in this paper. (Author)

  15. Safety Assessment Methodologies and Their Application in Development of Near Surface Waste Disposal Facilities--ASAM Project

    Energy Technology Data Exchange (ETDEWEB)

    Batandjieva, B.; Metcalf, P.

    2003-02-25

    Safety of near surface disposal facilities is a primary focus and objective of stakeholders involved in radioactive waste management of low and intermediate level waste and safety assessment is an important tool contributing to the evaluation and demonstration of the overall safety of these facilities. It plays significant role in different stages of development of these facilities (site characterization, design, operation, closure) and especially for those facilities for which safety assessment has not been performed or safety has not been demonstrated yet and the future has not been decided. Safety assessments also create the basis for the safety arguments presented to nuclear regulators, public and other interested parties in respect of the safety of existing facilities, the measures to upgrade existing facilities and development of new facilities. The International Atomic Energy Agency (IAEA) has initiated a number of research coordinated projects in the field of development and improvement of approaches to safety assessment and methodologies for safety assessment of near surface disposal facilities, such as NSARS (Near Surface Radioactive Waste Disposal Safety Assessment Reliability Study) and ISAM (Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities) projects. These projects were very successful and showed that there is a need to promote the consistent application of the safety assessment methodologies and to explore approaches to regulatory review of safety assessments and safety cases in order to make safety related decisions. These objectives have been the basis of the IAEA follow up coordinated research project--ASAM (Application of Safety Assessment Methodologies for Near Surface Disposal Facilities), which will commence in November 2002 and continue for a period of three years.

  16. Climate and climate-related issues for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    The purpose of this report is to document current scientific knowledge on climate and climate-related conditions, relevant to the long-term safety of a KBS-3 repository, to a level required for an adequate treatment in the safety assessment SR-Site. The report also presents a number of dedicated studies on climate and selected climate-related processes of relevance for the assessment of long term repository safety. Based on this information, the report presents a number of possible future climate developments for Forsmark, the site selected for building a repository for spent nuclear fuel in Sweden (Figure 1-1). The presented climate developments are used as basis for the selection and analysis of SR-Site safety assessment scenarios in the SR-Site main report /SKB 2011/. The present report is based on research conducted and published by SKB as well as on research reported in the general scientific literature

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

    Science.gov (United States)

    Delaney, Bryan

    2015-12-01

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

  18. Safety assessment of nylon as used in cosmetics.

    Science.gov (United States)

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

    2014-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of nylon polymers, which function in cosmetics primarily as bulking and opacifying agents. The Panel reviewed relevant animal and human data related to these large polymers and determined that they are not likely to penetrate the skin. Whatever residual monomers may be present were not present at a sufficient level to cause any reactions in test subjects at the maximum ingredient use concentration. Accordingly, the Panel concluded that these ingredients are safe in the present practices of use and concentration.

  19. Federal Radiological Monitoring and Assessment Center Health and Safety Manual

    Energy Technology Data Exchange (ETDEWEB)

    FRMAC Health and Safety Working Group

    2012-03-20

    This manual is a tool to provide information to all responders and emergency planners and is suggested as a starting point for all organizations that provide personnel/assets for radiological emergency response. It defines the safety requirements for the protection of all emergency responders. The intent is to comply with appropriate regulations or provide an equal level of protection when the situation makes it necessary to deviate. In the event a situation arises which is not addressed in the manual, an appropriate management-level expert will define alternate requirements based on the specifics of the emergency situation. This manual is not intended to pertain to the general public.

  20. Safety Assessment of Ethanolamides as Used in Cosmetics.

    Science.gov (United States)

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

    2015-01-01

    The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) rereviewed the safety of 28 ethanolamides and found them safe in the present practices of use and concentration when they are formulated to be nonirritating, and that these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed. Most of the ethanolamides are reported to function in cosmetics as hair-conditioning agents, skin-conditioning agents, and surfactant-foam boosters. The Panel reviewed available animal and clinical data, as well as information from previous CIR reports. © The Author(s) 2015.

  1. Environment, Safety and Health progress assessment of the Idaho National Engineering Laboratory (INEL)

    Energy Technology Data Exchange (ETDEWEB)

    1993-08-01

    The ES&H Progress Assessments are part of the Department`s continuous improvement process throughout DOE and its contractor organizations. The purpose of the INEL ES&H Progress Assessment is to provide the Department with concise independent information on the following: (1) change in culture and attitude related to ES&H activities; (2) progress and effectiveness of the ES&H corrective actions resulting from previous Tiger Team Assessments; (3) adequacy and effectiveness of the ES&H self-assessment programs of the DOE line organizations and the site management and operating contractor; and (4) effectiveness of DOE and contractor management structures, resources, and systems to effectively address ES&H problems. It is not intended that this Progress Assessment be a comprehensive compliance assessments of ES&H activities. The points of reference for assessing programs at the INEL were, for the most part, the 1991 INEL Tiger Team Assessment, the INEL Corrective Action Plan, and recent appraisals and self-assessments of INEL. Horizontal and vertical reviews of the following programmatic areas were conducted: Management: Corrective action program; self-assessment; oversight; directives, policies, and procedures; human resources management; and planning, budgeting, and resource allocation. Environment: Air quality management, surface water management, groundwater protection, and environmental radiation. Safety and Health: Construction safety, worker safety and OSHA, maintenance, packaging and transportation, site/facility safety review, and industrial hygiene.

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

    Science.gov (United States)

    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.

  3. Final report of the safety assessment of Urea.

    Science.gov (United States)

    2005-01-01

    alone or with other agents in treatment of diseased skin. Overall, there are few reports of sensitization among the many clinical studies that report use of Urea in treatment of diseased skin. The Cosmetic Ingredient Review (CIR) Expert Panel determined the data provided in this report to be sufficient to assess the safety of Urea. The Panel did note that Urea can cause uncoiling of DNA, a property used in many DNA studies, but concluded that this in vitro activity is not linked to any in vivo genotoxic activity. Although noting that formulators should be aware that Urea can increase the percutaneous absorption of other chemicals, the CIR Expert Panel concluded that Urea is safe as used in cosmetic products.

  4. Microbiological quality and safety assessment of lettuce production in Brazil.

    Science.gov (United States)

    Ceuppens, Siele; Hessel, Claudia Titze; de Quadros Rodrigues, Rochele; Bartz, Sabrina; Tondo, Eduardo César; Uyttendaele, Mieke

    2014-07-02

    The microbiological quality and safety of lettuce during primary production in Brazil were determined by enumeration of hygiene indicators Escherichia coli, coliforms and enterococci and detection of enteric pathogens Salmonella and E. coli O157:H7 in organic fertilizers, soil, irrigation water, lettuce crops, harvest boxes and worker's hands taken from six different lettuce farms throughout the crop growth cycle. Generic E. coli was a suitable indicator for the presence of Salmonella and E. coli O157:H7, while coliforms and enterococci were not. Few pathogens were detected: 5 salmonellae and 2 E. coli O157:H7 from 260 samples, of which only one was lettuce and the others were manure, soil and water. Most (5/7) pathogens were isolated from the same farm and all were from organic production. Statistical analysis revealed the following environmental and agro-technical risk factors for increased microbial load and pathogen prevalence in lettuce production: high temperature, flooding of lettuce fields, application of contaminated organic fertilizer, irrigation with water of inferior quality and large distances between the field and toilets. Control of the composting process of organic fertilizers and the irrigation water quality appear most crucial to improve and/or maintain the microbiological quality and safety during the primary production of lettuce.

  5. Establishment of database for radiation exposure and safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Choi, G. S.; Kim, J. H. [Science Culture Research Institute, Seoul (Korea, Republic of)

    2005-12-15

    The nuclear electric energy in our country plays a major role for the national industrial development as well as for the secure living of the peoples. It is, however, considered as a socially dreadful elements because of the radiation materials exposed into the environment. In effect, the DB is intended to serve for the reference to the epidemical study upon the low-level radiation exposure involving the nuclear facilities, radio-isotope business enterprises, and the related workers at the radiation sites. In connection with the development of nuclear energy, the low-level radiation, associated with the radioisotope materials exposed into our environment out of nuclear facilities, is believed to possibly raise significant hazardous effects toward human persons. Therefor, it is necessary to take a positive counter measures by means of comprehensive quantitative estimates on its possibilities. In consequence, the low-level radiation effects do not bring about the immediate hazard cases, however, appear to possibly pose the lately caused diseases such as cancer cause, life reduction, and creation of mutation, etc. Therefore, it is intended to set up the social security with the secure safety, by conducting an advanced safety study on the low-level radiation.

  6. OCCUPATIONAL SAFETY AND RISK ASSESSMENT IN THE MINING INDUSTRY

    Directory of Open Access Journals (Sweden)

    Slobodan Radosavljević

    2008-12-01

    Full Text Available Global dynamics of the technological changes creates a need for modern approaches while evaluating and analysing the risk in the mining industry. Analysing and managing technical systems in the mining industry is a key factor concerning the quality of their functioning. Dependability, safety, and maintenance management based on the risk analysis can contribute substantially to the overall effectiveness and efficiency of the mining technological systems. Besides applying adequate technology, organizing and harmonizing the system links among various structures and standardization is of the great importance in achieving business goals. The choice and use of the optimal solutions in the analysis ought to recognize, anticipate, forestall, reduce, and minimize the risk and possible destructive applications. The mining industry production practice recognizes the need for the strategy of organizational and process redesigning as well as raising this issue to the level of the other managing functions of the company. A realistic view of the present state in the risk analysis shows the need for the rapid transformation in the mining industry. The study puts forward a proposal for the possible approaches and improvement relating to the following and implementing modern, standardized world trends, (models and methods concerning the analysis of the technical and occupational safety risk in some of the basic processes in the mining industry.

  7. The School Assessment for Environmental Typology (SAfETy): An Observational Measure of the School Environment.

    Science.gov (United States)

    Bradshaw, Catherine P; Milam, Adam J; Furr-Holden, C Debra M; Johnson, Sarah Lindstrom

    2015-12-01

    School safety is of great concern for prevention researchers, school officials, parents, and students, yet there are a dearth of assessments that have operationalized school safety from an organizational framework using objective tools and measures. Such a tool would be important for deriving unbiased assessments of the school environment, which in turn could be used as an evaluative tool for school violence prevention efforts. The current paper presents a framework for conceptualizing school safety consistent with Crime Prevention through Environmental Design (CPTED) model and social disorganization theory, both of which highlight the importance of context as a driver for adolescents' risk for involvement in substance use and violence. This paper describes the development of a novel observational measure, called the School Assessment for Environmental Typology (SAfETy), which applies CPTED and social disorganizational frameworks to schools to measure eight indicators of school physical and social environment (i.e., disorder, trash, graffiti/vandalism, appearance, illumination, surveillance, ownership, and positive behavioral expectations). Drawing upon data from 58 high schools, we provide preliminary data regarding the validity and reliability of the SAfETy and describe patterns of the school safety indicators. Findings demonstrate the reliability and validity of the SAfETy and are discussed with regard to the prevention of violence in schools.

  8. Assessing Knowledge Retention of an Immersive Serious Game vs. a Traditional Education Method in Aviation Safety.

    Science.gov (United States)

    Chittaro, Luca; Buttussi, Fabio

    2015-04-01

    Thanks to the increasing availability of consumer head-mounted displays, educational applications of immersive VR could now reach to the general public, especially if they include gaming elements (immersive serious games). Safety education of citizens could be a particularly promising domain for immersive serious games, because people tend not to pay attention to and benefit from current safety materials. In this paper, we propose an HMD-based immersive game for educating passengers about aviation safety that allows players to experience a serious aircraft emergency with the goal of surviving it. We compare the proposed approach to a traditional aviation safety education method (the safety card) used by airlines. Unlike most studies of VR for safety knowledge acquisition, we do not focus only on assessing learning immediately after the experience but we extend our attention to knowledge retention over a longer time span. This is a fundamental requirement, because people need to retain safety procedures in order to apply them when faced with danger. A knowledge test administered before, immediately after and one week after the experimental condition showed that the immersive serious game was superior to the safety card. Moreover, subjective as well as physiological measurements employed in the study showed that the immersive serious game was more engaging and fear-arousing than the safety card, a factor that can contribute to explain the obtained superior retention, as we discuss in the paper.

  9. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

    Science.gov (United States)

    Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

    2017-01-01

    Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features

  10. Including social impact assessment in food safety governance

    NARCIS (Netherlands)

    Dreyer, M.; Renn, O.; Cope, S.F.; Frewer, L.J.

    2010-01-01

    This paper applies the concepts of social impact assessment (SIA) to the SAFE FOODS risk analysis model highlighting the role that concern assessment, defined as a structured and systematic inclusion of (also wider) social concerns into risk governance, could play in the integration of SIA in food s

  11. Three Reflections on Assessing Safety Training Needs: A Case Study

    Science.gov (United States)

    Sleezer, Catherine M.; Kelsey, Kathleen D.; Wood, Thomas E.

    2008-01-01

    Needs assessment plays an important role in training and human performance improvement efforts, but the literature contains little research on this topic. This study extended previous research on the Performance Analysis for Training (PAT) model of needs assessment by examining its implementation to determine environmental and occupational health…

  12. The TESS database. Use in product safety assessment.

    Science.gov (United States)

    Litovitz, T

    1998-01-01

    The Toxic Exposure Surveillance System or TESS is a comprehensive poisoning surveillance database maintained by the American Association of Poison Control Centers. It now includes data on more than 20.3 million human poison exposures reported to US poison centres. TESS data are submitted by 67 of the 75 US poison control centres, covering 87% of the US population. Reports to US poison centres included in TESS originate both from the general public and from health professionals (12.9%) and include both patients managed at home or at the site of the exposure (73.6%) and those managed in hospitals, emergency departments, or other healthcare facilities (22.8%). TESS data are used by the pharmaceutical industry to monitor or defend product safety, by regulatory agencies proposing new regulations or considering new approvals or over-the-counter switches, and by clinical researchers attempting to characterise toxicity profiles or determine treatment protocols. TESS is a key component of an effective post-marketing surveillance programme, allowing early identification of previously unsuspected hazards, and early changes in formulations, labelling, or packaging when needed, thereby minimising injuries, deaths and product liability. Deaths, severe outcomes and comparisons of poisoning outcomes and hospitalisation rates between products or product categories are used to identify safety outliers. TESS data for each case of poisoning include identification of the substances implicated (including brand and formulation where known), patient age, outcome, specific clinical effects, exposure route, reason for the exposure (unintentional, suicidal, therapeutic error, etc.), antidotes used and the level of healthcare intervention utilised. Pharmaceuticals are implicated in 42% of TESS poisoning cases. About 53% of all cases of poisoning occur in children under 6 years of age. Of the more than 2.1 million cases reported to TESS in 1996, 123,095 (5.7%) were therapeutic errors and 32

  13. Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose

    Directory of Open Access Journals (Sweden)

    Sara Raposo

    2013-01-01

    Full Text Available It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion. The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53. EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.

  14. Safety assessment and biological effects of a new cold processed SilEmulsion for dermatological purpose.

    Science.gov (United States)

    Raposo, Sara; Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C; Urbano, Manuela; Ribeiro, Helena M

    2013-01-01

    It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.

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

    Science.gov (United States)

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

    2004-07-01

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

  16. A Study on Methodologies for Assessing Safety Critical Network's Risk Impact on Nuclear Power Plant

    Energy Technology Data Exchange (ETDEWEB)

    Lim, T. J.; Park, S. K.; Seo, S. J. [Soongsil Univ., Seoul (Korea, Republic of)

    2007-04-15

    The objectives of this project is to establish methodologies for assessing safety-critical network's risk impact on nuclear power plant by developing reliability analysis models for the safety-critical network. It is essential to develop reliability analysis models for safety-critical network, and it is very important to adapt the model to the current methodologies for assessing risk impact on nuclear power plants. Major outputs of the first year study are preliminary models for assessing reliability of safety-critical communication networks and those of the second year study are methodologies for assessing safety-critical network's risk impact on nuclear power plant.

  17. Safety assessment and caloric value of partially hydrolyzed guar gum.

    Science.gov (United States)

    Finley, John W; Soto-Vaca, Adriana; Heimbach, James; Rao, T P; Juneja, Lekh Raj; Slavin, Joanne; Fahey, George C

    2013-02-27

    Guar gum and partially hydrolyzed guar gum (PHGG) are food ingredients that have been available for many years. PHGG is the partially hydrolyzed product from guar gum obtained from the Indian cluster bean (Cyanopsis tetragonolopus). The gum (CAS Registry No. 9000-30-0) is composed of galactomannan, a gel-forming polysaccharide with a molecular weight ranging from 200 to 300 kDa. The intact and partially hydrolyzed forms have multiple food applications. The intact material can be used to control the viscosity, stability, and texture of foods. PHGG is highly soluble and has little physical impact on foods. Both forms are indigestible but are excellent sources of fermentable dietary fiber. The caloric value of intact guar gum is accepted as 2.0, whereas the caloric value of PHGG has not been firmly established. It is the goal of this paper to review the chemistry, safety, in vivo effects, and caloric value of PHGG.

  18. Safety assessment of alkyl benzoates as used in cosmetics.

    Science.gov (United States)

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

    2012-01-01

    The functions of alkyl benzoates in cosmetics include fragrance ingredients, skin-conditioning agents--emollient, skin-conditioning agents--miscellaneous, preservatives, solvents, and plasticizers. The Cosmetic Ingredient Review Expert Panel reviewed the relevant animal and human data and noted gaps in the available safety data for some of the alkyl benzoates. Similar structure activity relationships, biologic functions, and cosmetic product usage allowed the available data of many of the alkyl benzoates to be extended to the entire group. Carcinogenicity data were not available, but available data indicated that these alkyl benzoate cosmetic ingredients are not genotoxic. Also benzoic acid and tested component alcohols were not reproductive or developmental toxicants, are not genotoxic in almost all assays, and are not carcinogenic. These ingredients were determined to be safe in the present practices of use and concentration.

  19. Use of A Shatter Test Vessel to Assess Propellant Safety

    Institute of Scientific and Technical Information of China (English)

    Clive WOODLEY; Peter HENNING

    2015-01-01

    At low temperatures,gun propellant grains may become brittle and this can lead to fracture or shatter of the grains during gun firing.Should this event occur then it will result in an increase in the burning surface of the propellant and will give rise to a change in ballistic performance.Also,if the resultant over pressure is sufficient,a breech failure may result.Understanding the propensity of a grain to fracture or shatter is therefore important in determining its safety in use.This document describes a test that may be used to derive knowledge and to quantify the physical behaviour of a gun propellant grain at the low temperatures at which fracture or shatter is most likely to occur.

  20. Safety and efficiency of emergency department assessment of chest discomfort

    Science.gov (United States)

    Christenson, Jim; Innes, Grant; McKnight, Douglas; Boychuk, Barb; Grafstein, Eric; Thompson, Christopher R.; Rosenberg, Frances; Anis, Aslam H.; Gin, Ken; Tilley, Jessica; Wong, Hubert; Singer, Joel

    2004-01-01

    Background Most Canadian emergency departments use an unstructured, individualized approach to patients with chest pain, without data to support the safety and efficiency of this practice. We sought to determine the proportions of patients with chest discomfort in emergency departments who either had acute coronary syndrome (ACS) and were inappropriately discharged from the emergency department or did not have ACS and were held for investigation. Methods Consecutive consenting patients aged 25 years or older presenting with chest discomfort to 2 urban tertiary care emergency departments between June 2000 and April 2001 were prospectively enrolled unless they had a terminal illness, an obvious traumatic cause, a radiographically identifiable cause, severe communication problems or no fixed address in British Columbia or they would not be available for follow-up by telephone. At 30 days we assigned predefined explicit outcome diagnoses: definite ACS (acute myocardial infarction [AMI] or definite unstable angina) or no ACS. Results Of 1819 patients, 241 (13.2%) were assigned a 30-day diagnosis of AMI and 157 (8.6%), definite unstable angina. Of these 398 patients, 21 (5.3%) were discharged from the emergency department without a diagnosis of ACS and without plans for further investigation. The clinical sensitivity for detecting ACS was 94.7% (95% confidence interval [CI] 92.5%– 96.9%) and the specificity 73.8% (95% CI 71.5%– 76.0%). Of the patients without ACS or an adverse event, 71.1% were admitted to hospital or held in the emergency department for more than 3 hours. Interpretation The current individualized approach to evaluation and disposition of patients with chest discomfort in 2 Canadian tertiary care emergency departments misses 5.3% of cases of ACS while consuming considerable health care resources for patients without coronary disease. Opportunities exist to improve both safety and efficiency. PMID:15184334

  1. Assessment of patient safety culture among healthcare providers at a teaching hospital in Cairo, Egypt.

    Science.gov (United States)

    Aboul-Fotouh, A M; Ismail, N A; Ez Elarab, H S; Wassif, G O

    2012-04-01

    A previous study in Cairo, Egypt highlighted the need to improve the patient safety culture among health-care providers at Ain Shams University hospitals. This descriptive cross-sectional study assessed healthcare providers' perceptions of patient safety culture within the organization and determined factors that played a role in patient safety culture. A representative sample of 510 physicians, nurses, pharmacists, technicians and labourers in different departments answered an Arabic version of the Agency of Healthcare Research and Quality hospital survey for patient safety culture. The highest mean composite positive score among the 12 dimensions was for the organizational learning for continuous improvement (78.2%), followed by teamwork (58.1%). The lowest mean score was for the dimension of non-punitive response to error (19.5%). Patient safety culture still has many areas for improvement that need continuous evaluation and monitoring to attain a safe environment both for patients and health-care providers.

  2. Surgical team member assessment of the safety of surgery practice in 38 South Carolina hospitals.

    Science.gov (United States)

    Singer, Sara J; Jiang, Wei; Huang, Lyen C; Gibbons, Lorri; Kiang, Mathew V; Edmondson, Lizabeth; Gawande, Atul A; Berry, William R

    2015-06-01

    We assessed surgical team member perceptions of multiple dimensions of safe surgical practice in 38 South Carolina hospitals participating in a statewide initiative to implement surgical safety checklists. Primary data were collected using a novel 35-item survey. We calculated the percentage of 1,852 respondents with strongly positive, positive, and neutral/negative responses about the safety of surgical practice, compared results by hospital and professional discipline, and examined how readiness, teamwork, and adherence related to staff perception of care quality. Overall, 78% of responses were positive about surgical safety at respondent's hospitals, but in each survey dimension, from 16% to 40% of responses were neutral/negative, suggesting significant opportunity to improve surgical safety. Respondents not reporting they would feel safe being treated in their operating rooms varied from 0% to 57% among hospitals. Surgeons responded more positively than nonsurgeons. Readiness, teamwork, and practice adherence related directly to staff perceptions of patient safety (p < .001).

  3. Statistical analysis used in the nutritional assessment of novel food using the proof of safety.

    Science.gov (United States)

    Hothorn, Ludwig A; Oberdoerfer, Regina

    2006-03-01

    The safety assessment of Novel Food, including GM biotechnology-derived crops, starts with the comparison of the Novel Food with a traditional counterpart that is generally accepted as safe based on a history of human food use. Substantial equivalence is established if no meaningful difference from the conventional counterpart was found, leading to the conclusion that the Novel Food is as safe and nutritious as its traditional counterpart. In general, the non-significance of p value is used for the proof of safety. From a statistical perspective, the problems connected with such an approach are demonstrated, namely that quite different component-specific false negative error rates result. As an alternative, the proof of safety is discussed with the inherently related definition of safety thresholds. Moreover, parametric and non-parametric confidence intervals for the difference and the ratio to control (conventional line) are described in detail. Finally, the treatment of multiple components for a global proof of safety is explained.

  4. Data report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Vahlund, Fredrik [Swedish Nuclear Fuel and Waste Management Co., Stockholm (Sweden); Andersson, Johan [JA Streamflow AB, Aelvsjoe (Sweden); Loefgren, Martin [Kemakta Konsult AB, Stockholm (Sweden)

    2006-11-15

    This report is the data report derived within the project SR-Can. The purpose of the data report is to present input data, with uncertainty estimates, for the SR-Can assessment calculations. Data presented in the report have been derived using standardised procedures following a methodology which is presented in the initial part of the report. In this part, a template is presented that has been used when assessing input data in supporting documents as illustrated in subsequent chapters of the data report. By using the template, decisions by the SR-Can team are separated from expert input. This increases the traceability of assessment decisions. The data report supplies assessment data for all parts of the repository system, the fuel, the canister, the buffer and backfill and the geosphere. For the geosphere, many of the data are based on information obtained during the site investigation programme.

  5. Feasibility studies of safety assessment methods for programmable automation systems. Final report of the AVV project

    Energy Technology Data Exchange (ETDEWEB)

    Haapanen, P.; Maskuniitty, M.; Pulkkinen, U. [VTT Automation, Espoo (Finland); Heikkinen, J.; Korhonen, J.; Tuulari, E. [VTT Electronics, Espoo (Finland)

    1995-10-01

    Feasibility studies of two different groups of methodologies for safety assessment of programmable automation systems has been executed at the Technical Research Centre of Finland (VTT). The studies concerned the dynamic testing methods and the fault tree (FT) and failure mode and effects analysis (FMEA) methods. In order to get real experience in the application of these methods, an experimental testing of two realistic pilot systems were executed and a FT/FMEA analysis of a programmable safety function accomplished. The purpose of the studies was not to assess the object systems, but to get experience in the application of methods and assess their potentials and development needs. (46 refs., 21 figs.).

  6. Modeling and Analysis on Radiological Safety Assessment of Low- and Intermediate Level Radioactive Waste Repository

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Youn Myoung; Jung, Jong Tae; Kang, Chul Hyung (and others)

    2008-04-15

    Modeling study and analysis for technical support for the safety and performance assessment of the low- and intermediate level (LILW) repository partially needed for radiological environmental impact reporting which is essential for the licenses for construction and operation of LILW has been fulfilled. Throughout this study such essential area for technical support for safety and performance assessment of the LILW repository and its licensing as gas generation and migration in and around the repository, risk analysis and environmental impact during transportation of LILW, biosphere modeling and assessment for the flux-to-dose conversion factors for human exposure as well as regional and global groundwater modeling and analysis has been carried out.

  7. Modeling and Analysis on Radiological Safety Assessment of Low- and Intermediate Level Radioactive Waste Repository

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Youn Myoung; Jung, Jong Tae; Kang, Chul Hyung (and others)

    2008-04-15

    Modeling study and analysis for technical support for the safety and performance assessment of the low- and intermediate level (LILW) repository partially needed for radiological environmental impact reporting which is essential for the licenses for construction and operation of LILW has been fulfilled. Throughout this study such essential area for technical support for safety and performance assessment of the LILW repository and its licensing as gas generation and migration in and around the repository, risk analysis and environmental impact during transportation of LILW, biosphere modeling and assessment for the flux-to-dose conversion factors for human exposure as well as regional and global groundwater modeling and analysis has been carried out.

  8. Climate considerations in long-term safety assessments for nuclear waste repositories.

    Science.gov (United States)

    Näslund, Jens-Ove; Brandefelt, Jenny; Liljedahl, Lillemor Claesson

    2013-05-01

    For a deep geological repository for spent nuclear fuel planned in Sweden, the safety assessment covers up to 1 million years. Climate scenarios range from high-end global warming for the coming 100 000 years, through deep permafrost, to large ice sheets during glacial conditions. In contrast, in an existing repository for short-lived waste the activity decays to low levels within a few tens of thousands of years. The shorter assessment period, 100 000 years, requires more focus on climate development over the coming tens of thousands of years, including the earliest possibility for permafrost growth and freezing of the engineered system. The handling of climate and climate change in safety assessments must be tailor-made for each repository concept and waste type. However, due to the uncertain future climate development on these vast time scales, all safety assessments for nuclear waste repositories require a range of possible climate scenarios.

  9. Climate Considerations in Long-Term Safety Assessments for Nuclear Waste Repositories

    Energy Technology Data Exchange (ETDEWEB)

    Naeslund, Jens-Ove; Brandefelt, Jenny; Claesson Liljedahl, Lillemor [Svensk Kaernbraenslehantering AB, Stockholm (Sweden)], E-mail: jens-ove.naslund@skb.se

    2013-05-15

    For a deep geological repository for spent nuclear fuel planned in Sweden, the safety assessment covers up to 1 million years. Climate scenarios range from high-end global warming for the coming 100 000 years, through deep permafrost, to large ice sheets during glacial conditions. In contrast, in an existing repository for short-lived waste the activity decays to low levels within a few tens of thousands of years. The shorter assessment period, 100 000 years, requires more focus on climate development over the coming tens of thousands of years, including the earliest possibility for permafrost growth and freezing of the engineered system. The handling of climate and climate change in safety assessments must be tailor-made for each repository concept and waste type. However, due to the uncertain future climate development on these vast time scales, all safety assessments for nuclear waste repositories require a range of possible climate scenarios.

  10. Approaches to the safety assessment of engineered nanomaterials (ENM) in food

    NARCIS (Netherlands)

    Cockburn, A.; Bradford, R.; Buck, N.; Kampers, F.W.H.

    2012-01-01

    A systematic, tiered approach to assess the safety of engineered nanomaterials (ENMs) in foods is presented. The ENM is first compared to its non-nano form counterpart to determine if ENM-specific assessment is required. Of highest concern from a toxicological perspective are ENMs which have potenti

  11. Complementary Safety Margin Assessment f the Nuclear Installations of the research reactor in Petten, Netherlands

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-02-15

    On March 11, 2011, a large part of the Japanese eastern coastal area was devastated by an earthquake, followed by an immense tsunami. As a result, thousands of people were killed, injured or made homeless. In the days that followed, the situation was further complicated because of the failing nuclear reactors on the Fukushima coast. The local environment suffered from radioactive releases, requiring evacuation zones, and generating international concerns about nuclear safety. In the wake of this disaster the European Union decided to assess safety on all operating nuclear reactors in its member states. This safety evaluation initiated by the European Union focusses on extreme natural hazards, beyond the standard safety evaluations which regularly have to be performed to demonstrate the safety of a nuclear power plant. Consequences of these extreme hazards for the research reactor in Petten, Netherlands, have been evaluated based on available safety analyses, supplemented by engineering judgement. In this way, the robustness of the existing plant has been assessed and possible measures to further increase the safety margins have been identified. This document presents the results of the Complementary Safety margin Assessment (CSA) performed for the 'Onderzoekslocatie Petten'. The distinct difference between this report and former risk analysis reports in general and the existing Safety Report of the Petten reactor is that the maximum resistance of the plant against redefined and more challenging events has been investigated, whereas traditionally the plant design is investigated against certain events that are determined on a historical basis. This different approach requires different analyses and studies, which in turn presents new insights into the robustness of the plant. The main purpose of this report is to answer the questions posed by the Ministry of Economic Affairs, Agriculture and Innovation. It was decided to write at the same time a report in

  12. Safety Assessment for a Side-by-side Offloading Mooring System

    Institute of Scientific and Technical Information of China (English)

    Liping Sun; Qiang He; Shangmao Ai

    2011-01-01

    In order to improve the safety properties of an offloading system with side-by-side (SBS) mooring in which the FPSO is moored by a yoke system in the field of BZ25-1,it is necessary to analyze those properties.According to the experience of similar projects,tow strategies of different offloading arrangements were discussed by using the 3-D radiation/diffraction theory and quasi-static time domain method to assess their respective safety properties.Through the safety assessment analysis of different arrangement comparisons,various ways to improve the safety properties of offloading systems with side-by-side mooring were verified by analyzing the tension in the mooring lines and the fender deflection.Through comparison it can be concluded that by enlarging the key factors properly,including the size of the fenders and the hawsers as well as the number of hawsers,a better satiety performance can be achieved.

  13. Preliminary Assessment of Operational Hazards and Safety Requirements for Airborne Trajectory Management (ABTM) Roadmap Applications

    Science.gov (United States)

    Cotton, William B.; Hilb, Robert; Koczo, Stefan, Jr.; Wing, David J.

    2016-01-01

    A set of five developmental steps building from the NASA TASAR (Traffic Aware Strategic Aircrew Requests) concept are described, each providing incrementally more efficiency and capacity benefits to airspace system users and service providers, culminating in a Full Airborne Trajectory Management capability. For each of these steps, the incremental Operational Hazards and Safety Requirements are identified for later use in future formal safety assessments intended to lead to certification and operational approval of the equipment and the associated procedures. Two established safety assessment methodologies that are compliant with the FAA's Safety Management System were used leading to Failure Effects Classifications (FEC) for each of the steps. The most likely FEC for the first three steps, Basic TASAR, Digital TASAR, and 4D TASAR, is "No effect". For step four, Strategic Airborne Trajectory Management, the likely FEC is "Minor". For Full Airborne Trajectory Management (Step 5), the most likely FEC is "Major".

  14. Is Scores Derived from the Most Internationally Applied Patient Safety Culture Assessment Tool Correct?

    OpenAIRE

    Javad Moghri; Ali Akbari Sari; Mehdi Yousefi; Hasan Zahmatkesh; Ranjbar Mohammad Ezzatabadi; Pejman Hamouzadeh; Satar Rezaei; Jamil Sadeghifar

    2013-01-01

    Abstract Background Hospital Survey on Patient Safety Culture, known as HSOPS, is an internationally well known and widely used tool for measuring patient safety culture in hospitals. It includes 12 dimensions with positive and negative wording questions. The distribution of these questions in different dimensions is uneven and provides the risk of acquiescence bias. The aim of this study was to assess the questionnaire against this bias. Methods Three hundred nurses were assigned into study ...

  15. 3D GIS BASED EVALUATION OF THE AVAILABLE SIGHT DISTANCE TO ASSESS SAFETY OF URBAN ROADS

    OpenAIRE

    Bassani, M.; Grasso, N.; Piras, M.

    2015-01-01

    The available sight distance (ASD) in front of the driver to detect possible conflicts with unexpected obstacles is fundamental for traffic safety. In the last 20 years, road design software (RDS) has been continuously updated with dedicated modules to estimate ASD, thus assessing the quality of project from a safety point of view. Unfortunately, the evaluation of ASD still represents an issue in the case of existing road, and the object of discussion in the research community. To avoid probl...

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

    Science.gov (United States)

    Zelkin, Natalie; Henriksen, Stephen

    2011-01-01

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

  17. Safety assessment guidance in the International Atomic Energy Agency RADWASS Program

    Energy Technology Data Exchange (ETDEWEB)

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

    1995-12-31

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

  18. Safety assessment of envisaged systems for automotive hydrogen supply and utilization

    Energy Technology Data Exchange (ETDEWEB)

    Landucci, Gabriele [Dipartimento di Ingegneria Chimica, Chimica Industriale e Scienza dei Materiali, Universita di Pisa, via Diotisalvi n.2, 56126 Pisa (Italy); Tugnoli, Alessandro; Cozzani, Valerio [Dipartimento di Ingegneria Chimica, Mineraria e delle Tecnologie Ambientali, Alma Mater Studiorum - Universita di Bologna, via Terracini n.28, 40131 Bologna (Italy)

    2010-02-15

    A novel consequence-based approach was applied to the inherent safety assessment of the envisaged hydrogen production, distribution and utilization systems, in the perspective of the widespread hydrogen utilization as a vehicle fuel. Alternative scenarios were assessed for the hydrogen system chain from large scale production to final utilization. Hydrogen transportation and delivery was included in the analysis. The inherent safety fingerprint of each system was quantified by a set of Key Performance Indicators (KPIs). Rules for KPIs aggregation were considered for the overall assessment of the system chains. The final utilization stage resulted by large the more important for the overall expected safety performance of the system. Thus, comparison was carried out with technologies proposed for the use of other low emission fuels, as LPG and natural gas. The hazards of compressed hydrogen-fueled vehicles resulted comparable, while reference innovative hydrogen technologies evidenced a potentially higher safety performance. Thus, switching to the inherently safer technologies currently under development may play an important role in the safety enhancement of hydrogen vehicles, resulting in a relevant improvement of the overall safety performance of the entire hydrogen system. (author)

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

    Science.gov (United States)

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

    2008-05-01

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

  20. Food fermentation: a safety and nutritional assessment. Joint FAO/WHO Workshop on Assessment of Fermentation as a Household Technology for Improving Food Safety.

    OpenAIRE

    Motarjemi, Y.; Nout, M. J.

    1996-01-01

    An assessment of the food-safety and nutritional aspects of lactic acid fermentation for the preparation of weaning food at the household level was carried out during a Joint FAO/WHO Workshop held in Pretoria, South Africa, in December 1995. In particular, lactic acid fermentation was evaluated as a part of food preparation processes involving other operations such as soaking, cooking, and the germination of cereal grains. The use of germinated cereals is of particular interest since they can...

  1. Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

    Science.gov (United States)

    Tarricone, Rosanna; Torbica, Aleksandra; Ferré, Francesca; Drummond, Mike

    2014-10-01

    Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.

  2. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  3. Diagnostic endoscopic ultrasonography: Assessment of safety and prevention of complications

    Institute of Scientific and Technical Information of China (English)

    Christian Jenssen; Maria Victoria Alvarez-Sánchez; Bertrand Napoléon; Siegbert Faiss

    2012-01-01

    Endoscopic ultrasonography (EUS) has gained wide acceptance as an important,minimally invasive diagnostic tool in gastroenterology,pulmonology,visceral surgery and oncology.This review focuses on data regarding risks and complications of non-interventional diagnostic EUS and EUS-guided fine-needle biopsy (EUSFNB).Measures to improve the safety of EUS und EUSFNB will be discussed.Due to the specific mechanical properties of echoendoscopes in EUS,there is a low but noteworthy risk of perforation.To minimize this risk,endoscopists should be familiar with the specific features of their equipment and their patients' specific anatomical situations (e.g.,tumor stenosis,diverticula).Most diagnostic EUS complications occur during EUSFNB.Pain,acute pancreatitis,infection and bleeding are the primary adverse effects,occurring in 1% to 2% of patients.Only a few cases of needle tract seeding and peritoneal dissemination have been reported.The mortality associated with EUS and EUS-FNB is 0.02%.The risks associated with EUS-FNB are affected by endoscopist experience and target lesion.EUS-FNB of cystic lesions is associated with an increased risk of infection and hemorrhage.Peri-interventional antibiotics are recommended to prevent cyst infection.Adequate education and training,as well consideration of contraindications,are essential to minimize the risks of EUS and EUS-FNB.Restricting EUS-FNB only to patients in whom the cytopathological results may be expected to change the course of management is the best way of reducing the number of complications.

  4. Assessment of Patient Safety Culture in a Selected Number of Pharmacies Affiliated to Mashhad University of Medical Sciences Using the Pharmacy Survey on Patient Safety Culture (SOPS)

    OpenAIRE

    Sara Jamili; Hossein Ebrahimipour; Elaheh Hooshmand; Habibollah Esmaeli; Ali Vafaee Najar

    2016-01-01

    Introduction: Patient safety culture plays a pivotal role in the improvement of patient safety level in health centers. This study aimed to assess patient safety culture in the pharmacies affiliated to Mashhad University of Medical Sciences, Iran using a standard questionnaire developed by the American Agency for Healthcare Research and Quality (AHRQ). Materials and Methods This analytic, descriptive, cross-sectional study was conducted on 108 pharmacists and pharmacy technicians in Mashha...

  5. Impact of workplace mistreatment on patient safety risk and nurse-assessed patient outcomes.

    Science.gov (United States)

    Laschinger, Heather K Spence

    2014-05-01

    The aim of this study was to investigate the impact of subtle forms of workplace mistreatment (bullying and incivility) on Canadian nurses' perceptions of patient safety risk and, ultimately, nurse-assessed quality and prevalence of adverse events. Workplace mistreatment is known to have detrimental effects on job performance and in nursing may threaten patient care quality. A total of 336 nurses from acute care settings across Ontario responded to a questionnaire that was mailed to their home address in early 2013, with a response rate of 52%. Bullying and incivility from nurses, physicians, and supervisors have significant direct and indirect effects on nurse-assessed adverse events (R = 0.03-0.06) and perceptions of patient care quality (R = 0.04-0.07), primarily through perceptions of increased patient safety risk. Bullying and workplace incivility have unfavorable effects on nurse-assessed patient quality through their effect on perceptions of patient safety risk.

  6. Current Status and Applications of Integrated Safety Assessment and Simulation Code System for ISA

    Directory of Open Access Journals (Sweden)

    J.M. Izquierdo

    2017-03-01

    Full Text Available This paper reviews current status of the unified approach known as integrated safety assessment (ISA, as well as the associated SCAIS (simulation codes system for ISA computer platform. These constitute a proposal, which is the result of collaborative action among the Nuclear Safety Council (CSN, University of Madrid (UPM, and NFQ Solutions S.L, aiming to allow independent regulatory verification of industry quantitative risk assessments. The content elaborates on discussions of the classical treatment of time in conventional probabilistic safety assessment (PSA sequences and states important conclusions that can be used to avoid systematic and unacceptable underestimation of the failure exceedance frequencies. The unified ISA method meets this challenge by coupling deterministic and probabilistic mutual influences. The feasibility of the approach is illustrated with some examples of its application to a real size plant.

  7. A study on the methodology of probabilistic safety assessment for KALIMER

    Energy Technology Data Exchange (ETDEWEB)

    Jeong, Kwan Seong; Kwon, Young Min; Lee, Yong Bum; Jeong, Hae Yong; Yang, Joon Eon; Ha, Kyu Suk; Hahn, Do Hee [Korea Atomic Energy Research Institute, Taejeon (Korea)

    2002-03-01

    Existing Probabilistic Safety Assessment(PSA) is a method for Light Water Reactor or Pressurized Heavy Water Reactor. Because KALIMER is different from these reactor, the new methodology of PSA need to be developed. In this paper, the PSA of Power Reactor Inherently Safety Module(PRISM) is analyzed, and Initiating Event such as Experiential Assessment, Logical Assessment and Failure Mode Effect Analysis(FMEA) is reviewed. Also, Pipe Damage Frequency Method is suggested for KALIMER. And the Reliability Physical method of Passive System, which is a chief safety system of KALIMER, is reviewed and its applicability is investigated. Finally, for the Preliminary PSA of KALIMER, Intermediate Heat Transfer System is analyzed. 23 refs., 10 figs., 13 tabs. (Author)

  8. Climate and climate-related issues for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Naeslund, Jens-Ove (comp.)

    2006-11-15

    The purpose of this report is to document current scientific knowledge of the climate-related conditions and processes relevant to the long-term safety of a KBS-3 repository to a level required for an adequate treatment in the safety assessment SR-Can. The report also includes a concise background description of the climate system. The report includes three main chapters: A description of the climate system (Chapter 2); Identification and discussion of climate-related issues (Chapter 3); and, A description of the evolution of climate-related conditions for the safety assessment (Chapter 4). Chapter 2 includes an overview of present knowledge of the Earth climate system and the climate conditions that can be expected to occur in Sweden on a 100,000 year time perspective. Based on this, climate-related issues relevant for the long-term safety of a KBS-3 repository are identified. These are documented in Chapter 3 'Climate-related issues' to a level required for an adequate treatment in the safety assessment. Finally, in Chapter 4, 'Evolution of climate-related conditions for the safety assessment' an evolution for a 120,000 year period is presented, including discussions of identified climate-related issues of importance for repository safety. The documentation is from a scientific point of view not exhaustive, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of a safety assessment. As further described in the SR-Can Main Report and in the Features Events and Processes report, the content of the present report has been audited by comparison with FEP databases compiled in other assessment projects. This report follows as far as possible the template for documentation of processes regarded as internal to the repository system. However, the term processes is not used in this report, instead the term issue has been used. Each issue includes a set of processes together resulting in the

  9. Comparative assessment of nanomaterial definitions and safety evaluation considerations.

    Science.gov (United States)

    Boverhof, Darrell R; Bramante, Christina M; Butala, John H; Clancy, Shaun F; Lafranconi, Mark; West, Jay; Gordon, Steve C

    2015-10-01

    Nanomaterials continue to bring promising advances to science and technology. In concert have come calls for increased regulatory oversight to ensure their appropriate identification and evaluation, which has led to extensive discussions about nanomaterial definitions. Numerous nanomaterial definitions have been proposed by government, industry, and standards organizations. We conducted a comprehensive comparative assessment of existing nanomaterial definitions put forward by governments to highlight their similarities and differences. We found that the size limits used in different definitions were inconsistent, as were considerations of other elements, including agglomerates and aggregates, distributional thresholds, novel properties, and solubility. Other important differences included consideration of number size distributions versus weight distributions and natural versus intentionally-manufactured materials. Overall, the definitions we compared were not in alignment, which may lead to inconsistent identification and evaluation of nanomaterials and could have adverse impacts on commerce and public perceptions of nanotechnology. We recommend a set of considerations that future discussions of nanomaterial definitions should consider for describing materials and assessing their potential for health and environmental impacts using risk-based approaches within existing assessment frameworks. Our intent is to initiate a dialogue aimed at achieving greater clarity in identifying those nanomaterials that may require additional evaluation, not to propose a formal definition. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  10. Interim data report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Vahlund, Fredrik [Swedish Nuclear Fuel and Waste Management Co., Stockholm (Sweden); Andersson, Johan [JA Streamflow AB, Aelvsjoe (Sweden)

    2004-08-01

    This document is the interim data report in the project SR-Can. The purpose of the data report is to present input data, with uncertainty estimates, for the SR-Can assessment calculations. Besides input data, the report also describes the standardised procedures used when deriving the input data and the corresponding uncertainty estimates. However, in the present interim version of the report (written in the initial stage of the project when site characterisation has yet not been completed) the standardised procedures have not been possible to apply for most of the data and, in order to present a compilation of the data used in the assessment, much of the input data is presented without following the standardised procedures. This will however be changed for the final version of the SR-Can data report, in order to show the methodology that will be used in the final version one example of how input data will be presented is included (migration data for buffer) . The recommended input data for the assessment calculations are, for the interim version, mainly based on SR 97 Beberg data, these are merely presented without any background or uncertainty discussion (this is presented in the SR 97 data report)

  11. Structural Safety Assessment of Existing Multiarch Tunnel: A Case Study

    Directory of Open Access Journals (Sweden)

    Jinxing Lai

    2017-01-01

    Full Text Available Structural health assessment is one of the key activities in maintaining the performance of a tunnel during its service life. Due to the development of modern detection technology, comprehensive structural health assessment system is being established for operating tunnels. To evaluate the actual operational state of Shitigou tunnel, overall detection of the liner crack, tunnel seepage, and liner void was conducted by employing the modern detection technology, such as crack width monitoring technology, concrete strength monitoring technology, and electromagnetic wave nondestructive monitoring technology. Through the statistical analysis of the detection results, the distribution characteristic, development law, and damage grade of structural defects were obtained. Tunnel liner cracks are mainly located on the middle wall; serious water leakage is encountered on the side wall, middle wall, and vault; the strength of foundation and liner structure of left tunnel does not meet the design requirement; the liner voids are mostly located at the tunnel entrance section, especially, on the tunnel vault; and the proportion of influence factors of structural defects should be considered. The research results presented for this study can serve as references for effective design and health assessment of existing multiarch tunnel projects.

  12. Explosion approach for external safety assessment: a case study

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, D. Michael; Halford, Ann [Germanischer Lloyd, Loughborough (United Kingdom); Mendes, Renato F. [PETROBRAS S.A., Rio de Janeiro, RJ (Brazil)

    2009-07-01

    Several questions related to the potential for explosions are explored as this became an important subject during an enterprise risk analysis. The understanding of explosions underwent a substantial evolution in the final 20 years of the 20{sup th} century following international research projects in Europe involving several research institutes, as well gas and oil companies. This led to the development of techniques that could be used to assess the potential consequences of explosions on oil, gas and petrochemical facilities. This paper presents an overview of the potential for explosions in communities close to industrial sites or pipelines right of way (RoW), where the standard explosion assessment methods cannot be applied. With reference to experimental studies, the potential for confined explosions in buildings and Vapor Cloud Explosions is explored. Vapor Cloud Explosion incidents in rural or urban areas are also discussed. The method used for incorporating possible explosion and fire events in risk studies is also described using a case study. Standard explosion assessment methodologies and a revised approach are compared as part of an on going evaluation of risk (author)

  13. Planning the Unplanned Experiment: Towards Assessing the Efficacy of Standards for Safety-Critical Software

    Science.gov (United States)

    Graydon, Patrick J.; Holloway, C. M.

    2015-01-01

    Safe use of software in safety-critical applications requires well-founded means of determining whether software is fit for such use. While software in industries such as aviation has a good safety record, little is known about whether standards for software in safety-critical applications 'work' (or even what that means). It is often (implicitly) argued that software is fit for safety-critical use because it conforms to an appropriate standard. Without knowing whether a standard works, such reliance is an experiment; without carefully collecting assessment data, that experiment is unplanned. To help plan the experiment, we organized a workshop to develop practical ideas for assessing software safety standards. In this paper, we relate and elaborate on the workshop discussion, which revealed subtle but important study design considerations and practical barriers to collecting appropriate historical data and recruiting appropriate experimental subjects. We discuss assessing standards as written and as applied, several candidate definitions for what it means for a standard to 'work,' and key assessment strategies and study techniques and the pros and cons of each. Finally, we conclude with thoughts about the kinds of research that will be required and how academia, industry, and regulators might collaborate to overcome the noted barriers.

  14. Formal safety assessment and application of the navigation simulators for preventing human error in ship operations

    Institute of Scientific and Technical Information of China (English)

    2005-01-01

    The International Maritime Organization (IMO) has encouraged its member countries to introduce Formal Safety Assessment (FSA) for ship operations since the end of the last century. FSA can be used through certain formal assessing steps to generate effective recommendations and cautions to control marine risks and improve the safety of ships. On the basis of the brief introduction of FSA, this paper describes the ideas of applying FSA to the prevention of human error in ship operations. It especially discusses the investigation and analysis of the information and data using navigation simulators and puts forward some suggestions for the introduction and development of the FSA research work for safer ship operations.

  15. Handling of future human actions in the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Moren, Lena

    2006-10-15

    This report documents the future human actions (FHA) considered in the long-term safety analysis of a KBS-3 repository. The report is one of the supporting documents to the safety assessment SR-Can. The purpose of this report is to provide an account of: General considerations concerning FHA; The methodology applied in SR-Can to assess FHA; The aspects of FHA that need to be considered in the evaluation of their impact on a deep geological repository; and The selection of representative scenarios for illustrative consequence analysis.

  16. Assessment of Traffic Safety State of Ship Based on Unascertained Measure

    Institute of Scientific and Technical Information of China (English)

    DUAN Ai-yuan; ZHAO Yao

    2007-01-01

    Using the theory and method of unascertained measure, an unascertained measure model and the related confidence rule are established to assess the safety state of ship. Thus, the dangerous factors in the hull system can be identified, and the accident possibility, loss, and injury degree can be forcasted. An application result shows that the the proposed method is effective in assessment of the traffic safety of ships, and it is more simple in computation than the fuzzy synthetic evaluation method. The proposed method can provide a scientific basis for realizing shipping transportation security and formulating preventive measures.

  17. Project SAFE. Update of the SFR-1 safety assessment. Phase 1

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan [ed.] [Golder Associates AB (Sweden); Riggare, P. [ed.] [Swedish Nuclear Fuel and Waste Management Co., Stockholm (Sweden); Skagius, K. [ed.] [Kemakta Konsult AB, Stockholm (Sweden)

    1998-10-01

    SFR-1 is a facility for disposal of low-level radioactive operational waste from the nuclear power plants in Sweden. Low-level radioactive waste from industry, medicine, and research is also disposed in SFR-1. The facility is situated in bedrock beneath the Baltic Sea, 1 km off the coast near the Forsmark nuclear power plant. SFR-1 was built between the years 1983 and 1988. An assessment of the long-term performance of the facility was included in the vast documentation that was a part of the application for an operational license. The assessment was presented in the form of a final safety report. In the operational licence for SFR-1 it is stated that renewed safety assessments should be carried out at least each ten years. In order to meet this demand SKB has launched a special project, SAFE (Safety Assessment of Final Disposal of Operational Radioactive Waste). The aim of the project is to update the safety analysis and to prepare a safety report that will be presented to the Swedish authorities not later than year 2000. Project SAFE is divided into three phases. The first phase is a prestudy, and the results of the prestudy are given in this report. The aim of the prestudy is to identify issues where additional studies would improve the basis for the updated safety analysis as well as to suggest how these studies should be carried out. The work has been divided into six different topics, namely the inventory, the near field, the far field, the biosphere, radionuclide transport calculations and scenarios. For each topic the former safety reports and regulatory reviews are scrutinised and needs for additional work is identified. The evaluations are given in appendices covering the respective topics. The main report is a summary of the appendices with a more stringent description of the repository system and the processes that are of interest and therefore should be addressed in an updated safety assessment. However, it should be pointed out that one of the

  18. Tools to prevent process safety events at university research facility - chemical risk assessment and experimental set-up risk assessment

    DEFF Research Database (Denmark)

    Jensen, Niels; Jørgensen, Sten Bay

    2014-01-01

    The article discusses the two forms developed to examine the hazards of the chemicals to be used in the experiments in the experimental setup in the Department of Chemical and Biochemical Engineering of the Technical University of Denmark. A system for the safety assessment of new experimental...

  19. Study of a Comprehensive Assessment Method for Coal Mine Safety Based on a Hierarchical Grey Analysis

    Institute of Scientific and Technical Information of China (English)

    LIU Ya-jing; MAO Shan-jun; LI Mei; YAO Ji-ming

    2007-01-01

    Coal mine safety is a complex system, which is controlled by a number of interrelated factors and is difficult to estimate. This paper proposes an index system of safety assessment based on correlated factors involved in coal mining and a comprehensive evaluation model that combines the advantages of the AHP and a grey clustering method to guarantee the accuracy and objectivity of weight coefficients. First, we confirmed the weight of every index using the AHP, then did a general safety assessment by means of a grey clustering method. This model analyses the status of mining safety both qualitatively and quantitatively. It keeps management and technical groups informed of the situation of the coal production line in real time, which aids in making correct decisions based on practical safety issues. A case study in the application of the model is presented. The results show that the method is applicable and realistic with regard to the core of a coal mine's safety management. Consequently, the safe production of a mine and the awareness of advanced safe production management is accelerated.

  20. Liquefied Gaseous Fuels Safety and Environmental Control Assessment Program: second status report

    Energy Technology Data Exchange (ETDEWEB)

    1980-10-01

    The Assistant Secretary for Environment has responsibility for identifying, characterizing, and ameliorating the environmental, health, and safety issues and public concerns associated with commercial operation of specific energy systems. The need for developing a safety and environmental control assessment for liquefied gaseous fuels was identified by the Environmental and Safety Engineering Division as a result of discussions with various governmental, industry, and academic persons having expertise with respect to the particular materials involved: liquefied natural gas, liquefied petroleum gas, hydrogen, and anhydrous ammonia. This document is arranged in three volumes and reports on progress in the Liquefied Gaseous Fuels (LGF) Safety and Environmental Control Assessment Program made in Fiscal Year (FY)-1979 and early FY-1980. Volume 1 (Executive Summary) describes the background, purpose and organization of the LGF Program and contains summaries of the 25 reports presented in Volumes 2 and 3. Annotated bibliographies on Liquefied Natural Gas (LNG) Safety and Environmental Control Research and on Fire Safety and Hazards of Liquefied Petroleum Gas (LPG) are included in Volume 1.

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

    DEFF Research Database (Denmark)

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

    2004-01-01

    modifications. First, the paper reviews test methods developed for the risk assessment of chemicals, including food additives and pesticides, discussing which of these methods are suitable for the assessment of recombinant proteins and whole foods. Second, the paper presents a systematic approach to combine......This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group I of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics...... of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safety assessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use...

  2. An assessment of patient safety in acupuncture process under EMR support.

    Science.gov (United States)

    Li, Yi-Chang; Hung, Ming-Chien; Hsiao, Shih-Jung; Tsai, Kuen-Daw; Chang, Mei-Man

    2011-12-01

    With the facilitating roles of IT, this study is to investigate the safety issues of the acupuncture process in the current practices under EMR support. A self-administered questionnaire survey was conducted in 80 Chinese medicine practice hospitals and clinics in Taiwan. Concerns over patient safety during the acupuncture process were raised, such as an inconsistency between the practice and prescription and a lack of monitoring patient's condition during the treatment. Confirming the physicians' prescription and documenting patients' reaction for patient record management are needed to add to the EMR system for patient safety while performing acupuncture. The results of this study can be used by the government or medical institutes to assess the work flow and set up standards of EMRs design for their acupuncture treatment to ensure patient safety and to enhance healthcare quality.

  3. Characterization and improvement of the nuclear safety culture through self-assessment

    Energy Technology Data Exchange (ETDEWEB)

    Levin, H.A. [Synergy Consulting Services Corp., Great Falls, VA (United States); McGehee, R.B. [Wise Carter Child & Caraway, Jackson, MS (United States); Cottle, W.T. [Houston Lighting & Power, Wadsworth, TX (United States)

    1996-12-31

    Organizational culture has a powerful influence on overall corporate performance. The ability to sustain superior results in ensuring the public`s health and safety is predicated on an organization`s deeply embedded values and behavioral norms and how these affect the ability to change and seek continuous improvement. The nuclear industry is developing increased recognition of the relationship of culture to nuclear safety performance as a critical element of corporate strategy. This paper describes a self-assessment methodology designed to characterize and improve the nuclear safety culture, including processes for addressing employee concerns. This methodology has been successfully applied on more than 30 occasions in the last several years, resulting in measurable improvements in safety performance and quality and employee motivation, productivity, and morale. Benefits and lessons learned are also presented.

  4. Development of Seismic Safety Assessment Technology for Containment Structure

    Energy Technology Data Exchange (ETDEWEB)

    Jang, J.B.; Suh, Y.P.; Lee, J.R. [Korea Electric Power Research Institute, Taejon (Korea)

    2002-07-01

    This final report is made based on the research results of seismic analysis and seismic margin assessment field, carried out during 3rd stage ('01.4.1{approx}'02.3.31) under financial support of MOST(Ministry of Science and Technology). The objective of this research is to develop the soil - structure interaction analysis technique with high reliability, the main research subjects, performed during 3rd stage are as follows. 1) Preparation of user's guide manual for SSI analysis with high accuracy. 2) Sensitivity analysis of effective shear strain and seismic input motion. 3) Database construction of Hualien earthquake recorded data. (author). 21 refs., 27 figs., 2 tabs.

  5. Development of Seismic Safety Assessment Technology for Containment Structure

    Energy Technology Data Exchange (ETDEWEB)

    Jang, J.B.; Suh, Y.P.; Lee, J.R. [Korea Electric Power Research Institute, Taejon (Korea)

    2002-07-01

    This final report is made based on the research results of seismic analysis and seismic margin assessment field, carried out during 3rd stage ('01.4.1{approx}'02.3.31) under financial support of MOST(Ministry of Science and Technology). The objective of this research is to develop the soil - structure interaction analysis technique with high reliability, the main research subjects, performed during 3rd stage are as follows. 1) Preparation of user's guide manual for SSI analysis with high accuracy. 2) Sensitivity analysis of effective shear strain and seismic input motion. 3) Database construction of Hualien earthquake recorded data. (author). 21 refs., 27 figs., 2 tabs.

  6. The application of fracture mechanics to the safety assessment of transport casks for radioactive materials

    Energy Technology Data Exchange (ETDEWEB)

    Zencker, U.; Mueller, K.; Droste, B.; Roedel, R.; Voelzke, H. [Bundesanstalt fuer Materialforschung und -pruefung (BAM), Berlin (Germany)

    2004-07-01

    BAM is the German responsible authority for the mechanical and thermal design safety assessment of packages for the transport of radioactive materials. The assessment has to cover the brittle fracture safety proof of package components made of potentially brittle materials. This paper gives a survey of the regulatory and technical requirements for such an assessment according to BAM's new ''Guidelines for the Application of Ductile Cast Iron for Transport and Storage Casks for Radioactive Materials''. Based on these guidelines higher stresses than before can become permissible, but it is necessary to put more effort into the safety assessment procedure. The fundamentals of such a proof with the help of the methods of fracture mechanics are presented. The recommended procedure takes into account the guidelines of the IAEA Advisory Material which are based on the prevention of crack initiation. Examples of BAM's research and safety assessment practices are given. Recommendations for further developments towards package designs with higher acceptable stress levels will be concluded.

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

    Science.gov (United States)

    Graydon, Patrick J.; Holloway, C. Michael

    2015-01-01

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

  8. A safety assessment methodology applied to CNS/ATM-based air traffic control system

    Energy Technology Data Exchange (ETDEWEB)

    Vismari, Lucio Flavio, E-mail: lucio.vismari@usp.b [Safety Analysis Group (GAS), School of Engineering at University of Sao Paulo (Poli-USP), Av. Prof. Luciano Gualberto, Trav.3, n.158, Predio da Engenharia de Eletricidade, Sala C2-32, CEP 05508-900, Sao Paulo (Brazil); Batista Camargo Junior, Joao, E-mail: joaocamargo@usp.b [Safety Analysis Group (GAS), School of Engineering at University of Sao Paulo (Poli-USP), Av. Prof. Luciano Gualberto, Trav.3, n.158, Predio da Engenharia de Eletricidade, Sala C2-32, CEP 05508-900, Sao Paulo (Brazil)

    2011-07-15

    In the last decades, the air traffic system has been changing to adapt itself to new social demands, mainly the safe growth of worldwide traffic capacity. Those changes are ruled by the Communication, Navigation, Surveillance/Air Traffic Management (CNS/ATM) paradigm , based on digital communication technologies (mainly satellites) as a way of improving communication, surveillance, navigation and air traffic management services. However, CNS/ATM poses new challenges and needs, mainly related to the safety assessment process. In face of these new challenges, and considering the main characteristics of the CNS/ATM, a methodology is proposed at this work by combining 'absolute' and 'relative' safety assessment methods adopted by the International Civil Aviation Organization (ICAO) in ICAO Doc.9689 , using Fluid Stochastic Petri Nets (FSPN) as the modeling formalism, and compares the safety metrics estimated from the simulation of both the proposed (in analysis) and the legacy system models. To demonstrate its usefulness, the proposed methodology was applied to the 'Automatic Dependent Surveillance-Broadcasting' (ADS-B) based air traffic control system. As conclusions, the proposed methodology assured to assess CNS/ATM system safety properties, in which FSPN formalism provides important modeling capabilities, and discrete event simulation allowing the estimation of the desired safety metric.

  9. Closing the Gap and Raising the Bar: Assessing Board Competency in Quality and Safety.

    Science.gov (United States)

    McGaffigan, Patricia A; Ullem, Beth Daley; Gandhi, Tejal K

    2017-06-01

    Despite recognition of the important role that governance and executive leaders play in ensuring patient safety and quality, little research has examined leaders' involvement in these areas beyond surveys that assess higher-level knowledge and understanding of patient and workforce safety concepts. A survey was sent to a convenience sample of board members and CEOs, as well as unpaired safety and quality leaders (SQLs). The survey included approximately 36 questions asking board members and other non-CEO executives their knowledge, understanding, and board activities related to safety and quality, and SQLs their perceptions of their own boards' knowledge, understanding, and activities related to safety and quality. An analysis of the responses of each of the three groups was conducted to assess baseline ratings, as well as to examine similarities and differences. Overall, similar patterns of self-reported knowledge, understanding, and activities related to safety and quality were evident between the board and CEO groups across virtually all areas examined in this survey, although groups were unpaired. Differences of varying degree were found at the level of individual survey items between board members' and CEOs' responses. SQL ratings were generally lower than the ratings of both board members and CEOs. This survey reveals specific areas of focus for improving governance and leadership practices at board meetings, as well as several areas where knowledge and understanding of safety and quality were variable. Further research and consensus would be beneficial to identify best practices for board education and governance activities to drive quality and safety. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.

  10. Final report of the safety assessment of niacinamide and niacin.

    Science.gov (United States)

    2005-01-01

    . Niacinamide and Niacin at 2 mg/ml were negative in a chromosome aberration test in Chinese hamster ovary cells, but did produce large structural chromosome aberrations at 3 mg/ml. Niacinamide induced sister chromatid exchanges in Chinese hamster ovary cells, but Niacin did not. Under certain circumstances, Niacinamide can cause an increase in unscheduled DNA synthesis in human lymphocytes treated with UV or a nitrosoguanidine compound. Niacinamide itself was not carcinogenic when administered (1%) in the drinking water of mice. No data on the carcinogenic effect of Niacin were available. Niacinamide can moderate the induction of tumors by established carcinogens. Niacinamide in combination with streptozotocin (a nitrosourea compound) or with heliotrine (a pyrrolizidine alkaloid), produced pancreatic islet tumors. On the other hand, Niacinamide reduced the renal adenomas produced by streptozotocin; and intestinal and bladder tumors induced by a preparation of bracken fern. Niacinamide evaluated in in vitro test systems did affect development, but Niacinamide reduced the reproductive/developmental toxicity of 2-aminonicotinamide-amino-1,3,4-thiadiazole hydrochloride and urethane. Clinical testing of Niacinamide produced no stinging sensation at concentrations up to 10%, use tests produced no irritation at concentrations up to 5%, and a 21-day cumulative irritation test at concentrations up to 5% resulted in no irritancy. Niacinamide was not a sensitizer, nor was it a photosensitizer. The CIR Expert Panel considered that Niacinamide and Niacin are sufficiently similar from a toxicologic standpoint to combine the available data and reach a conclusion on the safety of both as cosmetic ingredients. Overall, these ingredients are non-toxic at levels considerably higher than would be experienced in cosmetic products. Clinical testing confirms that these ingredients are not significant skin irritants, sensitizers or photosensitizers. While certain formulations were marginal to slight

  11. Final report on the safety assessment of polyethylene.

    Science.gov (United States)

    2007-01-01

    , was a mild irritant when tested as a solid material in the eyes of rabbits. Rabbit eyes treated with a solution containing 13% Polyethylene beads produced minimal irritation and no corneal abrasions. No genotoxicity was found in bacterial assays. No chemical carcinogenicity has been seen in implantation studies, although particles from Polyethylene implants can induce so-called solid-state carcinogenicity, which is a physical reaction to an implanted material. Occupational case reports of ocular irritation and systemic sclerosis in workers exposed to Polyethylene have been difficult to interpret because such workers are also exposed to other irritants. Clinical testing of intrauterine devices made of Polyethylene failed to conclusively identify statistically significant adverse effects, although squamous metaplasia was observed. The Cosmetic Ingredient Review (CIR) Expert Panel did not expect significant dermal absorption and systemic exposure to large Polyethylene polymers used in cosmetics. The Panel was concerned that information on impurities, including residual catalyst and reactants from the polymerization process, was not available. The Panel considered that the monomer unit in Polyethylene polymerization is ethylene. In the United States, ethylene is 99.9% pure. The other 0.1% includes ethane, propylene, carbon dioxide, carbon monoxide, sulfur, hydrogen, acetylene, water, and oxygen. The Panel believed that the concentration of these impurities in any final polymer would be so low as to not raise toxicity issues. Safety tests of cosmetic-grade Polyethylene have consistently failed to identify any toxicity associated with residual catalyst. Although it was reported that one process used to cross-link Polyethylene with an organic peroxide, this process is not currently used. In addition, cosmetic-grade Polyethylene is not expected to contain toxic hexanes. The Panel was concerned that the only genotoxicity data available was nonmammalian, but taking this

  12. Safety Assessment of a Metal Cask under Aircraft Engine Crash

    Directory of Open Access Journals (Sweden)

    Sanghoon Lee

    2016-04-01

    Full Text Available The structural integrity of a dual-purpose metal cask currently under development by the Korea Radioactive Waste Agency (KORAD was evaluated, through numerical simulations and a model test, under high-speed missile impact reflecting targeted aircraft crash conditions. The impact conditions were carefully chosen through a survey on accident cases and recommendations from literature. In the impact scenario, a missile flying horizontally hits the top side of the cask, which is freestanding on a concrete pad, with a velocity of 150 m/s. A simplified missile simulating a commercial aircraft engine was designed from an impact load–time function available in literature. In the analyses, the dynamic behavior of the metal cask and the integrity of the containment boundary were assessed. The simulation results were compared with the test results for a 1:3 scale model. Although the dynamic behavior of the cask in the model test did not match exactly with the prediction from the numerical simulation, other structural responses, such as the acceleration and strain history during the impact, showed very good agreement. Moreover, the containment function of the cask survived the missile impact as expected from the numerical simulation. Thus, the procedure and methodology adopted in the structural numerical analyses were successfully validated.

  13. Safety assessment of essential and toxic metals in infant formulas.

    Science.gov (United States)

    Sipahi, Hande; Eken, Ayşe; Aydın, Ahmet; Şahin, Gönül; Baydar, Terken

    2014-01-01

    The aim of this study was to assess toxic metal (Cd, Pb and Al) contamination and levels of three essential trace elements (Mn, Cr and Co) in 63 infant formulas. In addition, the levels of these metals in the study samples were compared with the acceptable limits of toxic heavy metals and the recommended daily allowances (RDAs) of essential trace elements. According to our results, the toxic metal levels measured in the formulas were within the acceptable limits, with the exception of Al levels in 8 of the 63 samples. In 16 samples, Mn levels exceeded 600 μg/day, and the Cr content in 7 samples was higher than 5.5 μg/day, these amounts being the adequate intake levels for infants. Cobalt levels in 10 formulas were higher than the RDA. In view of these findings, which indicate that metal levels in infant formulas are generally much higher than those found in breast milk, breast milk should be preferred for infant feeding. Moreover, since infants are potentially more susceptible to metals, infant foods should be monitored regularly and checked for contamination by toxic metals as well as for levels of essential trace elements.

  14. Safety assessment of a metal cask under aircraft engine crash

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Sang Hoon [Dept. of Mechanical and Automotive Engineering, Keimyung University, Daegu (Korea, Republic of); Choi, Woo Seok; Seo, Ki Seog [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2016-04-15

    The structural integrity of a dual-purpose metal cask currently under development by the Korea Radioactive Waste Agency (KORAD) was evaluated, through numerical simulations and a model test, under high-speed missile impact reflecting targeted aircraft crash conditions. The impact conditions were carefully chosen through a survey on accident cases and recommendations from literature. In the impact scenario, a missile flying horizontally hits the top side of the cask, which is free standing on a concrete pad, with a velocity of 150 m/s. A simplified missile simulating a commercial aircraft engine was designed from an impact load-time function available in literature. In the analyses, the dynamic behavior of the metal cask and the integrity of the containment boundary were assessed. The simulation results were compared with the test results for a 1:3 scale model. Although the dynamic behavior of the cask in the model test did not match exactly with the prediction from the numerical simulation, other structural responses, such as the acceleration and strain history during the impact, showed very good agreement. Moreover, the containment function of the cask survived the missile impact as expected from the numerical simulation. Thus, the procedure and methodology adopted in the structural numerical analyses were successfully validated.

  15. Genetically modified crops: success, safety assessment, and public concern.

    Science.gov (United States)

    Singh, Om V; Ghai, Shivani; Paul, Debarati; Jain, Rakesh K

    2006-08-01

    With the emergence of transgenic technologies, new ways to improve the agronomic performance of crops for food, feed, and processing applications have been devised. In addition, ability to express foreign genes using transgenic technologies has opened up options for producing large quantities of commercially important industrial or pharmaceutical products in plants. Despite this high adoption rate and future promises, there is a multitude of concerns about the impact of genetically modified (GM) crops on the environment. Potential contamination of the environment and food chains has prompted detailed consideration of how such crops and the molecules that they produce can be effectively isolated and contained. One of the reasonable steps after creating a transgenic plant is to evaluate its potential benefits and risks to the environment and these should be compared to those generated by traditional agricultural practices. The precautionary approach in risk management of GM plants may make it necessary to monitor significant wild and weed populations that might be affected by transgene escape. Effective risk assessment and monitoring mechanisms are the basic prerequisites of any legal framework to adequately address the risks and watch out for new risks. Several agencies in different countries monitor the release of GM organisms or frame guidelines for the appropriate application of recombinant organisms in agro-industries so as to assure the safe use of recombinant organisms and to achieve sound overall development. We feel that it is important to establish an internationally harmonized framework for the safe handling of recombinant DNA organisms within a few years.

  16. Can we well assess the relative efficacy and tolerability of a new drug versus others at the time of marketing authorization using mixed treatment comparisons? A detailed illustration with escitalopram

    OpenAIRE

    Llorca, Pierre-Michel; Lançon, Christophe; Brignone, Mélanie; Painchault, Caroline; Rive, Benoit; Toumi, Mondher; François, Clément

    2015-01-01

    Objective: To assess the variation of relative efficacy and tolerability of an antidepressant versus others based on both pre-marketing (registration studies) and post-marketing studies versus pre-marketing studies only in patients with major depressive disorder.Methods: The relative efficacy and tolerability of antidepressants was assessed by mixed treatment comparisons (MTCs) using data acquired over two time periods: before registration of the reference drug escitalopram (1989–2002) and up...

  17. Diversity for security: case assessment for FPGA-based safety-critical systems

    Directory of Open Access Journals (Sweden)

    Kharchenko Vyacheslav

    2016-01-01

    Full Text Available Industrial safety critical instrumentation and control systems (I&Cs are facing more with information (in general and cyber, in particular security threats and attacks. The application of programmable logic, first of all, field programmable gate arrays (FPGA in critical systems causes specific safety deficits. Security assessment techniques for such systems are based on heuristic knowledges and the expert judgment. Main challenge is how to take into account features of FPGA technology for safety critical I&Cs including systems in which are applied diversity approach to minimize risks of common cause failure. Such systems are called multi-version (MV systems. The goal of the paper is in description of the technique and tool for case-based security assessment of MV FPGA-based I&Cs.

  18. Safety Assessment of Panax spp Root-Derived Ingredients as Used in Cosmetics.

    Science.gov (United States)

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

    2015-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 13 Panax spp root-derived ingredients as used in cosmetics. Panax "spp" indicates that multiple species within the genus are used in cosmetics, but not all species within that genus. Four species are being considered in this safety assessment. These ingredients function mostly as skin-conditioning agents-miscellaneous, fragrance ingredients, skin-conditioning agents-humectant, skin-conditioning agents-emollient, and cosmetic astringents. The Panel reviewed available data related to these ingredients and addressed the issue of pulegone, a constituent of these ingredients and other ingredients, such as peppermint oil. The Panel concluded that these Panax spp root-derived ingredients are safe in the practices of use and concentration as given in this safety assessment.

  19. Safety and efficacy assessment of standardized herbal formula PM012

    Directory of Open Access Journals (Sweden)

    Sohn Sung-Hwa

    2012-03-01

    Full Text Available Abstract Background This study was conducted to evaluate the efficacy of the herbal formula PM012 on an Alzheimer's disease model, human presenilin 2 mutant transgenic mice (hPS2m, and also to evaluate the toxicity of PM012 in Sprague-Dawely rats after 4 or 26 weeks treatment with repeated oral administration. Methods Spatial learning and memory capacities of hPS2m transgenic mice were evaluated using the Morris Water Maze. Simultaneously, PM012 was repeatedly administered orally to male and female SD rats (15/sex/group at doses of 0 (vehicle control, 500, 1,000 and 2,000 mg/kg/day for 4 or 26 weeks. To evaluate the recovery potential, 5 animals of each sex were assigned to vehicle control and 2,000 mg/kg/day groups during the 4-week recovery period. Results The results showed that PM012-treated hPS2m transgenic mice showed significantly reduced escape latency when compared with the hPS2m transgenic mice. The repeated oral administration of PM012 over 26 weeks in male and female rats induced an increase and increasing trend in thymus weight in the female treatment groups (main and recovery groups, but the change was judged to be toxicologically insignificant. In addition, the oral administration of the herbal medicine PM012 did not cause adverse effects as assessed by clinical signs, mortality, body weight, food and water consumption, ophthalmology, urinalysis, hematology, serum biochemistry, blood clotting time, organ weights and histopathology. The No Observed Adverse Effects Levels of PM012 was determined to be 2,000 mg/kg/day for both sexes, and the target organ was not identified. Conclusion These results suggest that PM012 has potential for use in the treatment of the Alzheimer's disease without serious adverse effects.

  20. A safety culture assessment by mixed methods at a public maternity and infant hospital in China

    Directory of Open Access Journals (Sweden)

    Listyowardojo TA

    2017-07-01

    Full Text Available Tita Alissa Listyowardojo,1 Xiaoling Yan,2,3 Stephen Leyshon,1 Bobbie Ray-Sannerud,1 Xin Yan Yu,4 Kai Zheng,4 Tao Duan2,3 1Life Sciences Program, Group Technology and Research, DNV GL, Hovik, Norway; 2Quality and Safety Department, Shanghai First Maternity and Infant Hospital, 3Tongji University School of Medicine, Shanghai, 4Healthcare Department, Business Assurance, DNV GL, Beijing, China Objective: To assess safety culture at a public maternity hospital in Shanghai, China, using a sequential mixed methods approach. The study was part of a bigger study looking at the application of the mixed methods approach to assess safety culture in health care in different organizations and countries.Methodology: A mixed methods approach was utilized by first distributing the Safety Attitudes Questionnaire measuring six safety culture dimensions and five independent items to all hospital staff (n=1482 working in 18 departments at a single hospital. Afterward, semistructured interviews were conducted using convenience sampling, where 48 hospital staff from nine departments at the same hospital were individually interviewed.Results: The survey received a response rate of 96%. The survey findings show significant differences between the hospital departments in almost all safety culture dimensions and independent items. Similarly, the interview findings revealed that there were different, competing priorities between departments perceived to result in a reduced quality of collaboration and bottlenecks in care delivery. Another major finding was that staff who worked more hours per week would perceive working conditions significantly more negatively. Issues related to working conditions were also the most common concerns discussed in the interviews, especially the issue on high workload. High workload was also reflected in the fact that 91.45% of survey respondents reported that they worked 40 hours or longer per week. Finally, interview findings complemented

  1. Safety Assessment of Low- and Intermediate-Level Waste Disposal at Vaalputs, South Africa

    Science.gov (United States)

    Kozak, M. W.; Beyleveld, C.; Carolissen, A.

    2006-12-01

    The South African Nuclear Energy Corporation (Necsa ) owns and operates the Vaalputs radioactive waste disposal site, which is South Africa's designated facility for the disposal of low-and intermediate level radioactive waste (LILW). The bulk of the currently authorized LILW disposal at Vaalputs was generated at the Koeberg Nuclear Power Station (KNPS) near Cape Town. However, Necsa has generated wastes associated with research and uranium enrichment that are currently in storage, which are intended for disposal at Vaalputs. In addition, South Africa is currently considering expansion of its nuclear power generating capabilities, both through construction of a second pressurized water reactor (PWR) and through the development of the Pebble Bed Modular Reactor (PBMR) design. The proposed change in waste characteristics warrants a safety review of the Vaalputs authorization for the disposal of LILW. As part of the safety review, an updated postclosure safety assessment is being conducted. This current safety assessment is being conducted according to an internationally accepted state-of-the-art safety assessment methodology (IAEA, 2004), and is defensible, transparent, and credible. A formal scenario-generation methodology is being applied, which has led to the identification of a number of site-specific scenarios for further consideration. Specific features of the site, the disposal facility design, and local behavior patterns were used to screen Features, Events, and Processes (FEPs) from consideration. Specific FEPs were chosen as initiating FEPs for scenarios to be considered in the safety assessment, based on a combination of reasonable likelihood and high consequence for the analysis. Scenarios identified by this process are A nominal scenario represents the intended design basis for the long-term function of the repository. A late-subsidence scenario is included, in which subsidence occurs after active institutional control measures cease, such that

  2. US Department of Energy Environment, Safety and Health Progress Assessment of the Nevada Test Site

    Energy Technology Data Exchange (ETDEWEB)

    1992-08-01

    This report documents the result of the US Department of Energy (DOE) Environment, Safety, and Health (ES&H) Progress Assessment of the Nevada Test Site (NTS), Nye County, Nevada. The assessment, which was conducted from July 20 through August 4, 1992, included a selective review of the ES&H management systems and progress of the responsible DOE Headquarters Program Offices; the DOE Nevada Field Office (NV); and the site contractors. The ES&H Progress Assessments are part of the Secretary of Energy`s continuing effort to institutionalize line management accountability and the self-assessment process throughout DOE and its contractor organizations. This report presents a summary of issues and progress in the areas of environment, safety and health, and management.

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

    Science.gov (United States)

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

    2016-04-01

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

  4. Health Technology Assessment: managing the introduction and use of medical devices in clinical practice in Italy.

    Science.gov (United States)

    Migliore, Antonio; Ratti, Marco; Cerbo, Marina; Jefferson, Tom

    2009-05-01

    Technology assumes a key role in current clinical practice. A number of innovative or improved products are constantly being launched on the market and offered directly to the users (i.e., clinicians) or even to the patients. However, in most cases, the regulation for admission to commerce is slower than the innovation process and may be inadequate for assessing the real clinical effectiveness and safety of medical devices in the premarket phase. Health Technology Assessment (HTA) can be used as a tool for the evaluation of clinical effectiveness, cost-effectiveness and risk to patients of medical devices. HTA products (e.g., periodic reports) may aid healthcare payers to make informed choices regarding the appropriate use, coverage and reimbursement of medical devices. We present the strengths and limitations of the first three Italian HTA reports we coauthored and critically explore some of the aspects related to the introduction, adoption and use of medical technologies in clinical practice.

  5. Final report on the safety assessment of phytantriol.

    Science.gov (United States)

    2007-01-01

    Phytantriol is an alcohol used in around 100 cosmetic products at concentrations ranging from 0.0002% to 1.0%, although uses at concentrations up to 3% are under development. Phytanriol is supplied at 95.2% and 96.0% purity. Impurities include water, sulphated ash, heavy metals, and a diastereomer of Phytantriol, 3,7,11,15-tetramethyl-1,2,3,4-tetrahydroxyhexadecane. Dermal penetration is low; skin permeability was calculated as log Kp = - 1.734. Oral LD50 values in mice and rats were reported to be > 5000 mg/kg. Ocular application of 100% Phytantriol did cause severe corneal damage in some animals, at 23% in diethyl phthalate only slight corneal opacity was seen, and at 10% transient opacity was seen, which resolved by 48 h. Phytantriol at 100% was a severe skin irritant in animal tests. Phytantriol at 3% and 10% in diethyl phthalate produced only slight erythema, which cleared by 48 h. Phytantriol, in the Longhorn egg chorioallantoic membrane assay, was found to have almost no irritation potential when tested at 3% concentration in corn oil. Phytantriol at 25% did produce sensitization in a maximization test, but concentrations of 1% and lower did not cause a sensitization response. Phytantriol is neither phototoxic nor photoallergenic. Phytantriol did not induce aberrations in cultured human lymphocytes, when tested within cytotoxicity limits, nor was it mutagenic in Ames tests, with or without metabolic activation. None of 101 human volunteers reacted initially or to challenge patches of 3% Phytantriol in corn oil. In another investigation of 227 volunteers induced and challenged with 3% Phytantriol in 70:30 ethyl alcohol/water, one person had a mild reaction to the first induction patch; this was the only positive reaction during the induction and challenge phases for all of the volunteers. Phytantriol had no adverse effects in any of 206 volunteer subjects in a repeat insult patch test at 5%. Although data were not available with which to assess reproductive

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

    NARCIS (Netherlands)

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

    2004-01-01

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

  7. 76 FR 39811 - International Center for Technology Assessment and the Center for Food Safety; Noxious Weed...

    Science.gov (United States)

    2011-07-07

    ... Assessment and the Center for Food Safety; Noxious Weed Status of Kentucky Bluegrass Genetically Engineered... engineered for tolerance to the herbicide glyphosate should not be listed as a Federal noxious weed and... noxious weeds. Our decision is based on our analysis of available scientific data, our weed risk...

  8. Risk assessment of medical devices: Evaluation of microbiological and toxicological safety

    Science.gov (United States)

    Dorpema, J. W.

    1995-02-01

    Safety assessment of medical devices includes sterilization and biological evaluation or biocompatibility testing. Sterilization by ETO gas is critised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program.

  9. Safety assessment of infrastructures using a new Bayesian Monte Carlo method

    NARCIS (Netherlands)

    Rajabalinejad, M.; Demirbilek, Z.

    2011-01-01

    A recently developed Bayesian Monte Carlo (BMC) method and its application to safety assessment of structures are described in this paper. We use a one-dimensional BMC method that was proposed in 2009 by Rajabalinejad in order to develop a weighted logical dependence between successive Monte Carlo s

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

    NARCIS (Netherlands)

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

    2004-01-01

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

  11. Assessment of the safety of aqueous extract of Aloe vera on ...

    African Journals Online (AJOL)

    Aghomotsegin

    2015-07-29

    Jul 29, 2015 ... Full Length Research Paper. Assessment of the ... safety of A. vera on blood parameters: packed cell volume (PCV), red blood cell count (RBC), haemoglobin ... Aloe vera is a stem-less or very short-stemmed succulent plant ...

  12. Quick assessment tool for assurance of structural safety in the building process

    NARCIS (Netherlands)

    Terwel, K.C.; Jansen, S.J.T.

    2014-01-01

    From forensic investigation it is known that many structural failures can be attributed to human errors and organizational factors. To provide project leaders with information on the current state of factors in the building process influencing structural safety, we developed a quick assessment tool.

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

    NARCIS (Netherlands)

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

    2004-01-01

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

  14. Buffer, backfill and closure process report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Sellin, Patrik (ed.)

    2010-11-15

    This report gives an account of how processes in buffer, deposition tunnel backfill and the closure important for the long-term evolution of a KBS-3 repository for spent nuclear fuel, will be documented in the safety assessment SR-Site

  15. Exposure data and risk indicators for safety performance assessment in Europe.

    NARCIS (Netherlands)

    Papadimitriou, E. Yannis, G. Bijleveld, F.D. & Cardoso, J.L.

    2013-01-01

    The objective of this paper is the analysis of the state-of-the-art in risk indicators and exposure data for safety performance assessment in Europe, in terms of data availability, collection methodologies and use. More specifically, the concepts of exposure and risk are explored, as well as the

  16. Review and assessments of potential environmental, health and safety impacts of MHD technology. Final draft

    Energy Technology Data Exchange (ETDEWEB)

    1978-01-01

    The purpose of this document is to develop an environmental, health and safety (EH and S) assessment and begin a site - specific assessment of these and socio - economic impacts for the magnetohydrodynamics program of the United States Department of Energy. This assessment includes detailed scientific and technical information on the specific EH and S issues mentioned in the MHD Environmental Development Plan. A review of current literature on impact-related subjects is also included. This document addresses the coal-fired, open-cycle MHD technology and reviews and assesses potential EH and S impacts resulting from operation of commercially-installed technology.

  17. A Level 1+ Probabilistic Safety Assessment of the High Flux Australian Reactor. Vol 3: Appendices

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-01-01

    The third volume of the Probabilistic Safety Assessment contains supporting information for the PSA as follows: Appendix C (continued) with details of the system analysis and reports for the system/top event models; Appendix D with results of the specific engineering analyses of internal initiating events; Appendix E, containing supporting data for the human performance assessment,; Appendix F with details of the estimation of the frequency of leaks at HIFAR and Appendix G, containing event sequence model and quantification results

  18. Assessment of Patient Safety Culture in Primary Health Care Settings in Kuwait

    Directory of Open Access Journals (Sweden)

    Maha Mohamed Ghobashi

    2014-01-01

    Full Text Available Background Patient safety is critical component of health care quality. We aimed to assess the awareness of primary healthcare staff members about patient safety culture and explore the areas of deficiency and opportunities for improvement concerning this issue.Methods: This descriptive cross sectional study surveyed 369 staff members in four primary healthcare centers in Kuwait using self-administered “Hospital Survey on Patient Safety Culture” adopted questionnaire. The total number of respondents was 276 participants (response rate = 74.79%.Results: Five safety dimensions with lowest positivity (less than 50% were identified and these are; the non – punitive response to errors, frequency of event reporting, staffing, communication openness, center handoffs and transitions with the following percentages of positivity 24%, 32%, 41%, 45% and 47% respectively. The dimensions of highest positivity were teamwork within the center’s units (82% and organizational learning (75%.Conclusion: Patient safety culture in primary healthcare settings in Kuwait is not as strong as improvements for the provision of safe health care. Well-designed patient safety initiatives are needed to be integrated with organizational policies, particularly the pressing need to address the bioethical component of medical errors and their disclosure, communication openness and emotional issues related to them and investing the bright areas of skillful organizational learning and strong team working attitudes.    

  19. Analysis on Occupants’ Satisfaction for Safety Performance Assessment in Low Cost Housing

    Directory of Open Access Journals (Sweden)

    Husin Husrul Nizam

    2014-01-01

    Full Text Available The delivery performance of the low cost housing is questioned since the occupants are prone towards safety hazards in the housing complex, such as structural instability and falling building fragments. Without defining the occupants’ requirements for the development of low cost housing, the prevailing safety factors are hard to be determined. This paper explores the rationale of safety performance assessment in the low cost housing by considering the occupants’ participation to achieve a better safety provision during occupancy period. Questionnaire survey was distributed to 380 occupants of the low cost housing in Kuala Lumpur and Selangor, Malaysia. The result shows that 80.8% of the respondents had expressed their dissatisfaction with the safety performance of the lift. By referring to the mode of ranking level, the most significant aspect rated by the respondents is Building Safety Features, with 51.6% respondents. The attained aspects can be fundamental parameters which can be considered in the future development of low cost housing.

  20. An Assessment of the VHTR Safety Distance Using the Reliability Physics Model

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Joeun; Kim, Jintae; Jae, Moosung [Hanyang University, Seoul (Korea, Republic of)

    2015-10-15

    In Korea planning the production of hydrogen using high temperature from nuclear power is in progress. To produce hydrogen from nuclear plants, supplying temperature above 800 .deg. C is required. Therefore, Very High Temperature Reactor (VHTR) which is able to provide about 950 .deg. C is suitable. In situation of high temperature and corrosion where hydrogen might be released easily, hydrogen production facility using VHTR has a danger of explosion. Moreover explosion not only has a bad influence upon facility itself but also on VHTR. Those explosions result in unsafe situation that cause serious damage. However, In terms of thermal-hydraulics view, long distance makes low efficiency Thus, in this study, a methodology for the safety assessment of safety distance between the hydrogen production facilities and the VHTR is developed with reliability physics model. Based on the standard safety criteria which is a value of 1 x 10{sup -6}, the safety distance between the hydrogen production facilities and the VHTR using reliability physics model are calculated to be a value of 60m - 100m. In the future, assessment for characteristic of VHTR, the capacity to resist pressure from outside hydrogen explosion and the overpressure for the large amount of detonation volume in detail is expected to identify more precise safety distance using this reliability physics model.

  1. Safety pharmacology in the nonclinical assessment of new medicinal products: definition, place, interest and difficulties.

    Science.gov (United States)

    Claude, Jean-Roger

    2002-04-01

    Until the year 2000 there was no internationally-accepted definition for the terms used in nonclinical pharmacology (primary, secondary pharmacodynamics, discovery, safety pharmacology, etc). Now, after ICH5 (San Diego, November 2000), a harmonisation of the nomenclature is adopted: safety pharmacology is defined as the studies that investigate the potential undesirable pharmacodynamic effects of a medicinal product on physiological functions in relationship to exposure. Consequently, safety pharmacology studies are a part of the safety assessment for a new product, in the same way than toxicological studies, and a basic battery of tests (core battery) has to be conducted prior to the first administration to humans. Safety pharmacology studies are of peculiar interest: they show a good predictive potential for humans, they do not require a large number of laboratory animals, long-term studies, large amount of products and they are more dynamic and more flexible than toxicological studies. Nevertheless, many difficulties occur for the implementation in industry, related to practical and/or scientific problems: location of the studies, routine activity for the pharmacologists, sometimes difficulties in the relationship between toxicologists and pharmacologists, adaptation to the GLP requirements, elaboration of an early relevant scientific programme, necessity to go to contract-labs or to academic research for unusual or for up to date methods, etc. To conclude, a retrospective timetable of the regulatory evolution for the last 10 years will be provided, as an illustration of the worldwide progress in the concept of 'harmonisation' for the assessment of new medicinal products.

  2. Safety performance assessment of food industry facilities using a fuzzy approach

    Directory of Open Access Journals (Sweden)

    F. Barreca

    2013-09-01

    Full Text Available The latest EU policies focus on the issue of food safety with a view to assuring adequate and standard quality levels for the food produced and/or consumed within the EC. To that purpose, the environment where agricultural products are manufactured and processed plays a crucial role in achieving food hygiene. As a consequence, it is of the utmost importance to adopt proper building solutions which meet health and hygiene requirements and to use suitable tools to measure the levels achieved. Similarly, it is necessary to verify and evaluate the level of safety and welfare of the workers in their working environment. The safety of the workers has not only an ethical and social value but also an economic implication, since possible accidents or environmental stressors are the major causes of the lower efficiency and productivity of workers. However, the technical solutions adopted in the manufacturing facilities in order to achieve adequate levels of safety and welfare of the workers are not always consistent with the solutions aimed at achieving adequate levels of food hygiene, even if both of them comply with sectoral rules which are often unconnected with each other. Therefore, it is fundamental to design suitable models of analysis that allow assessing buildings as a whole, taking into account both health and hygiene safety as well as the safety and welfare of workers. Hence, this paper proposes an evaluation model that, based on an established study protocol and on the application of a fuzzy logic procedure, allows evaluating the global safety level of a building. The proposed model allows to obtain a synthetic and global value of the building performance in terms of food hygiene and safety and welfare of the workers as well as to highlight possible weaknesses. Though the model may be applied in either the design or the operational phase of a building, this paper focuses on its application to certain buildings already operational in a specific

  3. A Level 1+ Probabilistic Safety Assessment of the High Flux Australian Reactor. Vol 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-01-01

    The Department of Industry, Science and Tourism selected PLG, an EQE International Company, to systematically and independently evaluate the safety of the High Flux Australian Reactor (HIFAR), located at Lucas Heights, New South Wales. PLG performed a comprehensive probabilistic safety assessment (PSA) to quantify the risks posed by operation of HIFAR . The PSA identified possible accident scenarios, estimated their likelihood of occurrence, and assigned each scenario to a consequence category; i.e., end state. The accident scenarios developed included the possible release of radioactive material from irradiated nuclear fuel and of tritium releases from reactor coolant. The study team developed a recommended set of safety criteria against which the results of the PSA may be judged. HIFAR was found to exceed one of the two primary safety objectives and two of the five secondary safety objectives. Reactor coolant leaks, earthquakes, and coolant pump trips were the accident initiators that contributed most to scenarios that could result in fuel overheating. Scenarios initiated by earthquakes were the reason the frequency criterion for the one primary safety objective was exceeded. Overall, the plant safety status has been shown to be generally good with no evidence of major safety-related problems from its operation. One design deficiency associated with the emergency core cooling system was identified that should be corrected as soon as possible. Additionally, several analytical issues have been identified that should be investigated further. The results from these additional investigations should be used to determine whether additional plant and procedural changes are required, or if further evaluations of postulated severe accidents are warranted. Supporting information can be found in Appendix A for the seismic analysis and in the Appendix B for selected other external events refs., 139 tabs., 85 figs. Prepared for Department of Industry, Science and Tourism

  4. An evaluation of conventional culture, invA PCR, and the real-time PCR iQ-Check kit as detection tools for Salmonella in naturally contaminated premarket and retail turkey.

    Science.gov (United States)

    Nde, Chantal W; Fakhr, Mohamed K; Doetkott, Curt; Logue, Catherine M

    2008-02-01

    This study was aimed at comparing the ability of conventional culture, the iQ-Check real-time PCR kit, and invA PCR to detect Salmonella in naturally contaminated premarket and retail turkey parts. Premarket (n = 120) turkey parts collected from a commercial turkey processing plant, and retail turkey parts (n = 138) were examined. Both PCR methods detected a significantly greater (P invA PCR for Salmonella detection in the premarket and retail parts, the indices of total agreement were 75.8% (95% CI: 67.2, 83.2) and 84.1% (95% CI: 76.9, 89.7), respectively. The rates of false positives (premarket: 31.9%, retail: 9.7%) and false negatives (premarket: 5.9%, retail: 9.7%) were determined between the culture method and the iQ-Check kit. When invA PCR was compared with the culture method, the rates of false positives (premarket: 37.7%, retail: 11.1%) and false negatives (premarket: 5.9%, retail: 18.3%) were obtained. The higher total agreement and the lower rates of both false positives and false negatives for the iQ-Check kit compared with invA PCR for both premarket and retail turkey parts corroborates the use of the iQ-Check kit as a screening tool for Salmonella in poultry meat.

  5. Leading safety performance indicators for resilience assessment of radiopharmaceuticals production process

    Energy Technology Data Exchange (ETDEWEB)

    Grecco, Claudio H.S.; Santos, Isaac J.A.L.; Carvalho, Paulo V.R., E-mail: grecco@ien.gov.b, E-mail: luquetti@ien.gov.b, E-mail: paulov@ien.gov.b [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil). Div. de Instrumentacao e Confiabilidade Humana; Vidal, Mario C.R., E-mail: mvidal@ergonomia.ufrj.b [Coordenacao dos Programas de Pos-Graduacao de Engenharia (PEP/COPPE/UFRJ), Rio de Janeiro, RJ (Brazil). Programa de Engenharia de Producao. Grupo de Ergonomia e Novas Tecnologias (GENTE)

    2011-07-01

    Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and imaging diagnosis. A Research Institute, located in Rio de Janeiro, produces three radiopharmaceuticals: the sodium iodate is used in the diagnosis of thyroid dysfunctions, the meta-iodo-benzyl guanidine is used in the diagnosis of cardiac diseases, and the fluorodeoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuro psychiatry. This paper presents a leading safety performance indicators framework to assess the resilience of radiopharmaceuticals production processes. The organizations that use resilience indicators will be able to pro actively evaluate and manage safety. (author)

  6. Modeling and Simulation Approaches for Cardiovascular Function and Their Role in Safety Assessment.

    Science.gov (United States)

    Collins, T A; Bergenholm, L; Abdulla, T; Yates, Jwt; Evans, N; Chappell, M J; Mettetal, J T

    2015-03-01

    Systems pharmacology modeling and pharmacokinetic-pharmacodynamic (PK/PD) analysis of drug-induced effects on cardiovascular (CV) function plays a crucial role in understanding the safety risk of new drugs. The aim of this review is to outline the current modeling and simulation (M&S) approaches to describe and translate drug-induced CV effects, with an emphasis on how this impacts drug safety assessment. Current limitations are highlighted and recommendations are made for future effort in this vital area of drug research.

  7. Qualification of Simulation Software for Safety Assessment of Sodium Cooled Fast Reactors. Requirements and Recommendations

    Energy Technology Data Exchange (ETDEWEB)

    Brown, Nicholas R. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Pointer, William David [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Sieger, Matt [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Flanagan, George F. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Moe, Wayne [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); HolbrookINL, Mark [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2016-04-01

    The goal of this review is to enable application of codes or software packages for safety assessment of advanced sodium-cooled fast reactor (SFR) designs. To address near-term programmatic needs, the authors have focused on two objectives. First, the authors have focused on identification of requirements for software QA that must be satisfied to enable the application of software to future safety analyses. Second, the authors have collected best practices applied by other code development teams to minimize cost and time of initial code qualification activities and to recommend a path to the stated goal.

  8. A concept of the assessment of Electric Vehicles’ Operational Safety (EVOS)

    Science.gov (United States)

    Łukjanow, S.; Zieliński, W.

    2016-09-01

    The Electric Vehicles’ Operational Safety (EVOS) is becoming an important issue due to the fact of the popularization of environment-friendly electrically driven vehicles. The expansion of new types of electric vehicles releasing by automotive companies may lead to yet unknown safety-related problems. The paper presents a three-level concept of examining and assessing the EVOS developed at PIMOT. The proposed criteria may be utilized at research works on electric vehicles, at the production of such vehicles and their components, and at the selection of vehicles, especially by transport companies.

  9. Radiological safety assessment of transporting radioactive waste to the Gyeongju disposal facility in Korea

    Energy Technology Data Exchange (ETDEWEB)

    Jeong, Jong Tae; Baik, Min Hoon; Kang, Mun Ja; Ahn, Hong Joo; Hwang, Doo Seong; Hong, Dae Seok; Jeong, Yong Hwan; Kim, Kyung Su [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2016-12-15

    A radiological safety assessment study was performed for the transportation of low level radioactive wastes which are temporarily stored in Korea Atomic Energy Research Institute (KAERI), Daejeon, Korea. We considered two kinds of wastes: (1) operation wastes generated from the routine operation of facilities; and (2) decommissioning wastes generated from the decommissioning of a research reactor in KAERI. The important part of the radiological safety assessment is related to the exposure dose assessment for the incident-free (normal) transportation of wastes, i.e., the radiation exposure of transport personnel, radiation workers for loading and unloading of radioactive waste drums, and the general public. The effective doses were estimated based on the detailed information on the transportation plan and on the radiological characteristics of waste packages. We also estimated radiological risks and the effective doses for the general public resulting from accidents such as an impact and a fire caused by the impact during the transportation. According to the results, the effective doses for transport personnel, radiation workers, and the general public are far below the regulatory limits. Therefore, we can secure safety from the viewpoint of radiological safety for all situations during the transportation of radioactive wastes which have been stored temporarily in KAERI.

  10. Assessing EM Patient Safety and Quality Improvement Milestones Using a Novel Debate Format.

    Science.gov (United States)

    Mamtani, Mira; Scott, Kevin R; DeRoos, Francis J; Conlon, Lauren W

    2015-11-01

    Graduate medical education is increasingly focused on patient safety and quality improvement; training programs must adapt their curriculum to address these changes. We propose a novel curriculum for emergency medicine (EM) residency training programs specifically addressing patient safety, systems-based management, and practice-based performance improvement, called "EM Debates." Following implementation of this educational curriculum, we performed a cross-sectional study to evaluate the curriculum through resident self-assessment. Additionally, a cross-sectional study to determine the ED clinical competency committee's (CCC) ability to assess residents on specific competencies was performed. Residents were overall very positive towards the implementation of the debates. Of those participating in a debate, 71% felt that it improved their individual performance within a specific topic, and 100% of those that led a debate felt that they could propose an evidence-based approach to a specific topic. The CCC found that it was easier to assess milestones in patient safety, systems-based management, and practice-based performance improvement (sub-competencies 16, 17, and 19) compared to prior to the implementation of the debates. The debates have been a helpful venue to teach EM residents about patient safety concepts, identifying medical errors, and process improvement.

  11. Radiological Safety Assessment of Transporting Radioactive Wastes to the Gyeongju Disposal Facility in Korea

    Directory of Open Access Journals (Sweden)

    Jongtae Jeong

    2016-12-01

    Full Text Available A radiological safety assessment study was performed for the transportation of low level radioactive wastes which are temporarily stored in Korea Atomic Energy Research Institute (KAERI, Daejeon, Korea. We considered two kinds of wastes: (1 operation wastes generated from the routine operation of facilities; and (2 decommissioning wastes generated from the decommissioning of a research reactor in KAERI. The important part of the radiological safety assessment is related to the exposure dose assessment for the incident-free (normal transportation of wastes, i.e., the radiation exposure of transport personnel, radiation workers for loading and unloading of radioactive waste drums, and the general public. The effective doses were estimated based on the detailed information on the transportation plan and on the radiological characteristics of waste packages. We also estimated radiological risks and the effective doses for the general public resulting from accidents such as an impact and a fire caused by the impact during the transportation. According to the results, the effective doses for transport personnel, radiation workers, and the general public are far below the regulatory limits. Therefore, we can secure safety from the viewpoint of radiological safety for all situations during the transportation of radioactive wastes which have been stored temporarily in KAERI.

  12. Research on vaccines during pregnancy: protocol design and assessment of safety.

    Science.gov (United States)

    Munoz, Flor M; Sheffield, Jeanne S; Beigi, Richard H; Read, Jennifer S; Swamy, Geeta K; Jevaji, Indira; Rasmussen, Sonja A; Edwards, Kathryn M; Fortner, Kimberly B; Patel, Shital M; Spong, Catherine Y; Ault, Kevin; Heine, R Philips; Nesin, Mirjana

    2013-09-13

    The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, entitled "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss study design and the assessment of safety in clinical trials conducted in pregnant women. A panel of experts was charged with developing guiding principles for the design of clinical trials and the assessment of safety of vaccines during pregnancy. Definitions and a grading system to evaluate local and systemic reactogenicity, adverse events, and other events associated with pregnancy and delivery were developed. The purpose of this report is to provide investigators interested in vaccine research in pregnancy with a basic set of tools to design and implement maternal immunization studies which may be conducted more efficiently using consistent definitions and grading of adverse events to allow the comparison of safety reports from different trials. These guidelines and safety assessment tools may be modified to meet the needs of each particular protocol based on evidence collected as investigators use them in clinical trials in different settings and share their findings and expertise.

  13. Human Reliability in Probabilistic Safety Assessments; Fiabilidad Humana en los Analisis Probabilisticos de Seguridad

    Energy Technology Data Exchange (ETDEWEB)

    Nunez Mendez, J.

    1989-07-01

    Nowadays a growing interest in environmental aspects is detected in our country. It implies an assessment of the risk involved in the industrial processes and installations in order to determine if those are into the acceptable limits. In these safety assessments, among which PSA (Probabilistic Safety Assessments), can be pointed out the role played by the human being in the system is one of the more relevant subjects (This relevance has been demonstrated in the accidents happened) . However, in Spain there aren't manuals specifically dedicated to asses the human contribution to risk in the frame of PSAs. This report aims to improve this situation providing: a) a theoretical background to help the reader in the understanding of the nature of the human error, b) a quid to carry out a Human Reliability Analysis and c) a selected overview of the techniques and methodologies currently applied in this area. (Author) 20 refs.

  14. Considerations on Applying the Method for Assessing the Level of Safety at Work

    Directory of Open Access Journals (Sweden)

    Costica Bejinariu

    2017-07-01

    Full Text Available The application of the method for assessing the level of safety at work starts with a document that contains the cover page, the description of the company (name, location, core business, organizational chart etc., description of the work system, a detailed list of its components, and a brief description of the assessment method. It continues with a Microsoft Excel document, which represents the actual application of the method and, finally, there is another document presenting conclusions, proposals, and prioritizations, which leads to the execution of the Prevention and Protection Plan. The present paper approaches the issue of developing the Microsoft Excel document, an essential part of the method for assessing the level of safety at work. The document is divided into a variable number of worksheets, showing the risk categories of general, specific, and management.

  15. Safety Assessment of Low-Contaminated Equipment Dismantling at Nuclear Power Plants

    Directory of Open Access Journals (Sweden)

    Egidijus Babilas

    2015-01-01

    Full Text Available The decommissioning of nuclear facilities requires adequate planning and demonstration that dismantling and decontamination activities can be conducted safely. Existing safety standards require that an appropriate safety assessment be performed to support the decommissioning plan for each facility (International Atomic Energy Agency, 2006. This paper presents safety assessment approach used in Lithuania during the development of the first dismantling and decontamination project for Ignalina NPP. The paper will mainly focus on the identification and assessment of the hazards raised due to dismantling and decontamination activities at Ignalina Nuclear Power Plant and on the assessment of the nonradiological and radiological consequences of the indicated most dangerous initiating event. The drop of heavy item was indicated as one of most dangerous initiating events for the discussed Ignalina Nuclear Power Plant dismantling and decontamination project. For the analysis of the nonradiological impact the finite element model for the load drop force calculation was developed. The radiological impact was evaluated in those accident cases which would lead to the worst radiological consequences. The assessments results show that structural integrity of the building and supporting columns of building structures will be maintained and radiological consequences are lower than the annual regulatory operator dose limit.

  16. Safety assessment for a KBS-3H spent nuclear fuel repository at Olkiluoto. Summary report

    Energy Technology Data Exchange (ETDEWEB)

    Smith, Paul; Neall, Fiona; Snellman, Margit; Pastina, Barbara; Nordman, Henrik; Johnson, Lawrence; Hjerpe, Thomas

    2008-03-15

    The KBS-3 method, based on multiple barriers, is the proposed spent fuel disposal method both in Sweden and Finland. KBS-3H and KBS-3V are the two design alternatives of the KBS-3 spent fuel disposal method. Posiva and SKB have conducted a joint research, demonstration and development (RDandD) programme in 2002-2007 with the overall aim of establishing whether KBS-3H represents a feasible alternative to the reference alternative KBS-3V. The overall objectives of the present phase covering the period 2004-2007 have been to demonstrate that the horizontal deposition alternative is technically feasible and to demonstrate that it fulfils the same long-term safety requirements as KBS-3V. The safety studies conducted as part of this programme include a safety assessment of a preliminary design of a KBS-3H repository for spent nuclear fuel located about 400 m underground at the Olkiluoto site, which is the proposed site for a spent fuel repository in Finland. This safety assessment is summarised in the present report. The scientific basis of the safety assessment includes around 30 years of scientific RandD and technical development in the Swedish and Finnish KBS-3V programmes. Much of this scientific basis is directly applicable to KBS-3H. This has allowed the KBS-3H safety studies to focus on those issues that are unique to this design alternative, identified in a systematic 'difference analysis' of KBS-3H and KBS-3V. This difference analysis has shown that the key differences in the evolution and performance of KBS-3H and KBS-3V relate mainly to the engineered barrier system and to the impact of local variations in the rate of groundwater inflow on buffer saturation along the KBS-3H deposition drifts. No features or processes specific to KBS-3H have been identified that could lead to a loss or substantial degradation of the safety functions of the engineered barriers over a million year time frame. Radionuclide release from the repository near field in the

  17. 76 FR 6087 - Draft Weapons Safety Assessment on the Use of Enhanced Weapons; Notice of Availability and...

    Science.gov (United States)

    2011-02-03

    ... Draft Weapons Safety Assessment on the Use of Enhanced Weapons; Notice of Availability and Request for... ``Weapons Safety Assessment'' (WSA). This guidance would be used by licensees and certificate holders applying to the NRC to obtain enhanced weapons under the NRC's proposed rule titled ``Enhanced Weapons...

  18. Environment, Safety and Health Self-Assessment Report Fiscal Year 2010

    Energy Technology Data Exchange (ETDEWEB)

    Robinson, Scott

    2011-03-23

    The Lawrence Berkeley National Laboratory (LBNL) Environment, Safety, and Health (ES&H) Self-Assessment Program was established to ensure that Integrated Safety Management (ISM) is implemented institutionally and by all divisions. The ES&H Self-Assessment Program, managed by the Office of Contractor Assurance (OCA), provides for an internal evaluation of all ES&H programs and systems at LBNL. The primary objective of the program is to ensure that work is conducted safely and with minimal negative impact to workers, the public, and the environment. Self-assessment follows the five core functions and guiding principles of ISM. Self-assessment is the mechanism used to promote the continuous improvement of the Laboratory's ES&H programs. The process is described in the Environment, Safety, and Health Assurance Plan (PUB-5344) and is composed of three types of self-assessments: Division ES&H Self-Assessment, ES&H Technical Assurance Program Assessment, and Division ES&H Peer Review. The Division ES&H Self-Assessment Manual (PUB-3105) provides the framework by which divisions conduct formal ES&H self-assessments to systematically identify program deficiencies. Issue-specific assessments are designed and implemented by the divisions and focus on areas of interest to division management. They may be conducted by teams and involve advance planning to ensure that appropriate resources are available. The ES&H Technical Assurance Program Manual (PUB-913E) provides the framework for systematic reviews of ES&H programs and processes. The ES&H Technical Assurance Program Assessment is designed to evaluate whether ES&H programs and processes are compliant with guiding regulations, are effective, and are properly implemented by LBNL divisions. The Division ES&H Peer Review Manual provides the framework by which division ISM systems are evaluated and improved. Peer Reviews are conducted by teams under the direction of senior division management and focus on higher

  19. Fuel and canister process report for the safety assessment SR-Can

    Energy Technology Data Exchange (ETDEWEB)

    Werme, Lars (ed.)

    2006-10-15

    This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Can. The detailed assessment methodology, including the role of the process report in the assessment, is described in the SR-Can Main report. The report is written by, and for, experts in the relevant scientific fields. It should though be possible for a generalist in the area of long-term safety assessments of geologic nuclear waste repositories to comprehend the contents of the report. The report is an important part of the documentation of the SR-Can project and an essential reference within the project, providing a scientifically motivated plan for the handling of geosphere processes. It is, furthermore, foreseen that the report will be essential for reviewers scrutinising the handling of geosphere issues in the SR-Can assessment. Several types of fuel will be emplaced in the repository. For the reference case with 40 years of reactor operation, the fuel quantity from boiling water reactors, BWR fuel, is estimated at 7,000 tonnes, while the quantity from pressurized water reactors, PWR fuel, is estimated at about 2,300 tonnes. In addition, 23 tonnes of mixed-oxide fuel (MOX) fuel of German origin from BWR and PWR reactors and 20 tonnes of fuel from the decommissioned heavy water reactor in Aagesta will be disposed of. To allow for future changes in the Swedish nuclear programme, the safety assessment assumes a total of 6,000 canister corresponding to 12,000 tonnes of fuel.

  20. Safety assessment and environmental impact assessment: Application to regulation of nuclear and radiation safety, with special consideration to Lepse related operations

    Energy Technology Data Exchange (ETDEWEB)

    Makarov, V.G. [Gosatomnadzor (Russian Federation); Smith, G.M.; Stone, D.M. [QuantiSci Ltd., Henley-on-Thames (United Kingdom)

    2000-11-01

    This report discusses the links between safety assessment and environmental impact assessment as applied to operations for unloading of spent nuclear fuel from the Lepse storage vessel. Regulatory responsibilities and regulatory requirements in these areas are under discussion and development in the Russian Federation and in other countries. The authors provide a briefing, based on inputs from Russian and western organisations, of their understanding of the situation at the time the work was done. They also make a variety of suggestions according to their perspectives. These suggestions should be relevant to the Lepse situation and to some other nuclear activities, bur do not represent the position of any particular organisation. Accordingly, this report is published by the SSI with the intention to promote discussion and interaction among relevant authorities.

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

    Energy Technology Data Exchange (ETDEWEB)

    Chernowski, John

    2009-02-27

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

  2. Implementation of external hazards in Probabilistic Safety Assessment for nuclear power plants

    Science.gov (United States)

    Kumar, Manorma; Klug, Joakim; Raimond, Emmanuel

    2015-04-01

    The paper will focus on the discussion on implementation of external hazards in the probabilistic safety assessment (PSA) methods for the extreme external hazards mainly focused on Seismic, Flooding, Meteorological Hazards (e.g. Storm, Extreme temperature, snow pack), Biological infestation, Lightening hazards, Accidental Aircraft crash and man- made hazards including natural external fire and external explosion. This will include discussion on identification of some good practices on the implementation of external hazards in Level 1 PSA, with a perspective of development of extended PSA and introduction of relevant modelling for external hazards in an existing Level 1 PSA. This paper is associated to the European project ASAMPSAE (www.asampsa.eu) which gathers more than 30 organizations (industry, research, safety control) from Europe, US and Japan and which aims at identifying some meaningful practices to extend the scope and the quality of the existing probabilistic safety analysis developed for nuclear power plants.

  3. Risk assessment by the occupational safety and health at work in the process of geological exploration

    Directory of Open Access Journals (Sweden)

    Staletović Novica M.

    2015-01-01

    Full Text Available This paper presents a model of risk assessment in terms of safety and health at work in the process of geological work/ drilling. Optimization model estimates OH & S risk for work place qualified driller, is in line with the provisions of the Mining and Geological exploration, the Law on Safety and Health at Work, the application of the requirements of ISO 31000 and criteria Kinny methods. Model estimates OH & S risks is the basis for the development and implementation of the management system of protection of health and safety at work according to BS OHSAS 18001: 2008 model is applied, checked and verified the approved exploration areas during execution and supervision applied geological exploration (of metals on the territory of the Republic of Serbia.

  4. Liquefied gaseous fuels safety and environmental control assessment program: third status report

    Energy Technology Data Exchange (ETDEWEB)

    1982-03-01

    This Status Report contains contributions from all contractors currently participating in the DOE Liquefied Gaseous Fuels (LG) Safety and Environmental Control Assessment Program and is presented in two principal sections. Section I is an Executive Summary of work done by all program participants. Section II is a presentation of fourteen individual reports (A through N) on specific LGF Program activities. The emphasis of Section II is on research conducted by Lawrence Livermore National Laboratory (Reports A through M). Report N, an annotated bibliography of literature related to LNG safety and environmental control, was prepared by Pacific Northwest Laboratory (PNL) as part of its LGF Safety Studies Project. Other organizations who contributed to this Status Report are Aerojet Energy Conversion Company; Applied Technology Corporation; Arthur D. Little, Incorporated; C/sub v/ International, Incorporated; Institute of Gas Technology; and Massachusetts Institute of Technology. Separate abstracts have been prepared for Reports A through N for inclusion in the Energy Data Base.

  5. Use of Foodomics for Control of Food Processing and Assessing of Food Safety.

    Science.gov (United States)

    Josić, D; Peršurić, Ž; Rešetar, D; Martinović, T; Saftić, L; Kraljević Pavelić, S

    Food chain, food safety, and food-processing sectors face new challenges due to globalization of food chain and changes in the modern consumer preferences. In addition, gradually increasing microbial resistance, changes in climate, and human errors in food handling remain a pending barrier for the efficient global food safety management. Consequently, a need for development, validation, and implementation of rapid, sensitive, and accurate methods for assessment of food safety often termed as foodomics methods is required. Even though, the growing role of these high-throughput foodomic methods based on genomic, transcriptomic, proteomic, and metabolomic techniques has yet to be completely acknowledged by the regulatory agencies and bodies. The sensitivity and accuracy of these methods are superior to previously used standard analytical procedures and new methods are suitable to address a number of novel requirements posed by the food production sector and global food market. © 2017 Elsevier Inc. All rights reserved.

  6. Organizational analysis and safety for utilities with nuclear power plants: perspectives for organizational assessment. Volume 2. [PWR; BWR

    Energy Technology Data Exchange (ETDEWEB)

    Osborn, R.N.; Olson, J.; Sommers, P.E.; McLaughlin, S.D.; Jackson, M.S.; Nadel, M.V.; Scott, W.G.; Connor, P.E.; Kerwin, N.; Kennedy, J.K. Jr.

    1983-08-01

    This two-volume report presents the results of initial research on the feasibility of applying organizational factors in nuclear power plant (NPP) safety assessment. Volume 1 of this report contains an overview of the literature, a discussion of available safety indicators, and a series of recommendations for more systematically incorporating organizational analysis into investigations of nuclear power plant safety. The six chapters of this volume discuss the major elements in our general approach to safety in the nuclear industry. The chapters include information on organizational design and safety; organizational governance; utility environment and safety related outcomes; assessments by selected federal agencies; review of data sources in the nuclear power industry; and existing safety indicators.

  7. Assessment of impact of construction materials on the ecological safety of home

    Directory of Open Access Journals (Sweden)

    Zhigulina Anna

    2017-01-01

    Full Text Available The article deals with the problems of creating environmentally friendly aerial environment within residential premises. The main sources causing air pollution of urban housing are determined and classified. The origins of air pollution sources of residential premises are adopted as the classifying criterion. The sources of contamination are defined and assessed. Particular attention is paid to the choice of environmentally friendly building materials. The methodology for assessing toxicity of industrial waste used in the production of housing materials is developed to assess the comfort and environmental safety of home. The idea of creating “Residential buldings ID” containing information on the construction materials used is introduced.

  8. Safety of Novel Microbes for Human Consumption: Practical Examples of Assessment in the European Union.

    Science.gov (United States)

    Brodmann, Theodor; Endo, Akihito; Gueimonde, Miguel; Vinderola, Gabriel; Kneifel, Wolfgang; de Vos, Willem M; Salminen, Seppo; Gómez-Gallego, Carlos

    2017-01-01

    Novel microbes are either newly isolated genera and species from natural sources or bacterial strains derived from existing bacteria. Novel microbes are gaining increasing attention for the general aims to preserve and modify foods and to modulate gut microbiota. The use of novel microbes to improve health outcomes is of particular interest because growing evidence points to the importance of gut microbiota in human health. As well, some recently isolated microorganisms have promise for use as probiotics, although in-depth assessment of their safety is necessary. Recent examples of microorganisms calling for more detailed evaluation include Bacteroides xylanisolvens, Akkermansia muciniphila, fructophilic lactic acid bacteria (FLAB), and Faecalibacterium prausnitzii. This paper discusses each candidate's safety evaluation for novel food or novel food ingredient approval according to European Union (EU) regulations. The factors evaluated include their beneficial properties, antibiotic resistance profiling, history of safe use (if available), publication of the genomic sequence, toxicological studies in agreement with novel food regulations, and the qualified presumptions of safety. Sufficient evidences have made possible to support and authorize the use of heat-inactivated B. xylanisolvens in the European Union. In the case of A. muciniphila, the discussion focuses on earlier safety studies and the strain's suitability. FLAB are also subjected to standard safety assessments, which, along with their proximity to lactic acid bacteria generally considered to be safe, may lead to novel food authorization in the future. Further research with F. prausnitzii will increase knowledge about its safety and probiotic properties and may lead to its future use as novel food. Upcoming changes in EUU Regulation 2015/2283 on novel food will facilitate the authorization of future novel products and might increase the presence of novel microbes in the food market.

  9. Safety of Novel Microbes for Human Consumption: Practical Examples of Assessment in the European Union

    Directory of Open Access Journals (Sweden)

    Theodor Brodmann

    2017-09-01

    Full Text Available Novel microbes are either newly isolated genera and species from natural sources or bacterial strains derived from existing bacteria. Novel microbes are gaining increasing attention for the general aims to preserve and modify foods and to modulate gut microbiota. The use of novel microbes to improve health outcomes is of particular interest because growing evidence points to the importance of gut microbiota in human health. As well, some recently isolated microorganisms have promise for use as probiotics, although in-depth assessment of their safety is necessary. Recent examples of microorganisms calling for more detailed evaluation include Bacteroides xylanisolvens, Akkermansia muciniphila, fructophilic lactic acid bacteria (FLAB, and Faecalibacterium prausnitzii. This paper discusses each candidate's safety evaluation for novel food or novel food ingredient approval according to European Union (EU regulations. The factors evaluated include their beneficial properties, antibiotic resistance profiling, history of safe use (if available, publication of the genomic sequence, toxicological studies in agreement with novel food regulations, and the qualified presumptions of safety. Sufficient evidences have made possible to support and authorize the use of heat-inactivated B. xylanisolvens in the European Union. In the case of A. muciniphila, the discussion focuses on earlier safety studies and the strain's suitability. FLAB are also subjected to standard safety assessments, which, along with their proximity to lactic acid bacteria generally considered to be safe, may lead to novel food authorization in the future. Further research with F. prausnitzii will increase knowledge about its safety and probiotic properties and may lead to its future use as novel food. Upcoming changes in EUU Regulation 2015/2283 on novel food will facilitate the authorization of future novel products and might increase the presence of novel microbes in the food market.

  10. Assessment of radiation safety awareness among nuclear medicine nurses: a pilot study

    Science.gov (United States)

    Yunus, N. A.; Abdullah, M. H. R. O.; Said, M. A.; Ch'ng, P. E.

    2014-11-01

    All nuclear medicine nurses need to have some knowledge and awareness on radiation safety. At present, there is no study to address this issue in Malaysia. The aims of this study were (1) to determine the level of knowledge and awareness on radiation safety among nuclear medicine nurses at Putrajaya Hospital in Malaysia and (2) to assess the effectiveness of a training program provided by the hospital to increase the knowledge and awareness of the nuclear medicine nurses. A total of 27 respondents attending a training program on radiation safety were asked to complete a questionnaire. The questionnaire consists 16 items and were categorized into two main areas, namely general radiation knowledge and radiation safety. Survey data were collected before and after the training and were analyzed using descriptive statistics and paired sample t-test. Respondents were scored out of a total of 16 marks with 8 marks for each area. The findings showed that the range of total scores obtained by the nuclear medicine nurses before and after the training were 6-14 (with a mean score of 11.19) and 13-16 marks (with a mean score of 14.85), respectively. Findings also revealed that the mean score for the area of general radiation knowledge (7.59) was higher than that of the radiation safety (7.26). Currently, the knowledge and awareness on radiation safety among the nuclear medicine nurses are at the moderate level. It is recommended that a national study be conducted to assess and increase the level of knowledge and awareness among all nuclear medicine nurses in Malaysia.

  11. Assessing elements of patient safety culture in Kermanshah health care and educational centers

    Directory of Open Access Journals (Sweden)

    Siros Kabodi

    2016-12-01

    Full Text Available Introduction: Annually, many accidents and preventable events happen for the patients hospitalized in treatment centers. Therefore, the related causing factors should be recognized in order to reduce the medical errors. Accordingly, the present study aimed to assess the relationship between patient’s safety culture elements and medical errors and also the ways to tackle them. Material and Method: This cross-sectional study was conducted among 380 employees working in the education and treatment centers affiliated with Kermanshah University of Medical Sciences in 2015. The hospital version of patient safety culture questionnaire was used for data collection. Data were analyzed by SPSS software, version 19 using different statistical tests including multivariate analysis of variance and Pearson’s correlation. Result: The patient safety culture was at an undesirable level in the study centers. Of the elements related to safety culture, the lowest positive scores belonged to ‘issues related to employees’, and ‘reporting’ with scores of 23% and 26%, respectively. On the other hand, ‘team working in the organizations’ (59% and ‘organizational learning’ (57% obtained the highest positive scores. Fifty-eight percent of the respondents did not report any errors. Conclusion: The results of present study emphasize on creating a desirable organizational atmosphere, the need for staff participation in various levels of decision making, and creating the culture of reporting errors in order to recognize the causing factors and to promote patient safety culture.

  12. Food safety systems in a small dairy factory: implementation, major challenges, and assessment of systems' performances.

    Science.gov (United States)

    Cusato, Sueli; Gameiro, Augusto H; Corassin, Carlos H; Sant'ana, Anderson S; Cruz, Adriano G; Faria, José de Assis F; de Oliveira, Carlos Augusto F

    2013-01-01

    The present study describes the implementation of a food safety system in a dairy processing plant located in the State of São Paulo, Brazil, and the challenges found during the process. In addition, microbiological indicators have been used to assess system's implementation performance. The steps involved in the implementation of a food safety system included a diagnosis of the prerequisites, implementation of the good manufacturing practices (GMPs), sanitation standard operating procedures (SSOPs), training of the food handlers, and hazard analysis and critical control point (HACCP). In the initial diagnosis, conformity with 70.7% (n=106) of the items analyzed was observed. A total of 12 critical control points (CCPs) were identified: (1) reception of the raw milk, (2) storage of the raw milk, (3 and 4) reception of the ingredients and packaging, (5) milk pasteurization, (6 and 7) fermentation and cooling, (8) addition of ingredients, (9) filling, (10) storage of the finished product, (11) dispatching of the product, and (12) sanitization of the equipment. After implementation of the food safety system, a significant reduction in the yeast and mold count was observed (pfood safety system were related to the implementation of actions established in the flow chart and to the need for constant training/adherence of the workers to the system. Despite this, the implementation of the food safety system was shown to be challenging, but feasible to be reached by small-scale food industries.

  13. Risk Assessment in the UK Health and Safety System: Theory and Practice

    Directory of Open Access Journals (Sweden)

    Karen Russ

    2010-09-01

    Full Text Available In the UK, a person or organisation that creates risk is required to manage and control that risk so that it is reduced 'So Far As Is Reasonably Practicable' (SFAIRP. How the risk is managed is to be determined by those who create the risk. They have a duty to demonstrate that they have taken action to ensure all risk is reduced SFAIRP and must have documentary evidence, for example a risk assessment or safety case, to prove that they manage the risks their activities create. The UK Health and Safety Executive (HSE does not tell organisations how to manage the risks they create but does inspect the quality of risk identification and management. This paper gives a brief overview of where responsibility for occupational health and safety lies in the UK, and how risk should be managed through risk assessment. The focus of the paper is three recent major UK incidents, all involving fatalities, and all of which were wholly avoidable if risks had been properly assessed and managed. The paper concludes with an analysis of the common failings of risk assessments and key actions for improvement.

  14. Characteristics and safety assessment of intractable proteins in genetically modified crops.

    Science.gov (United States)

    Bushey, Dean F; Bannon, Gary A; Delaney, Bryan F; Graser, Gerson; Hefford, Mary; Jiang, Xiaoxu; Lee, Thomas C; Madduri, Krishna M; Pariza, Michael; Privalle, Laura S; Ranjan, Rakesh; Saab-Rincon, Gloria; Schafer, Barry W; Thelen, Jay J; Zhang, John X Q; Harper, Marc S

    2014-07-01

    Genetically modified (GM) crops may contain newly expressed proteins that are described as "intractable". Safety assessment of these proteins may require some adaptations to the current assessment procedures. Intractable proteins are defined here as those proteins with properties that make it extremely difficult or impossible with current methods to express in heterologous systems; isolate, purify, or concentrate; quantify (due to low levels); demonstrate biological activity; or prove equivalency with plant proteins. Five classes of intractable proteins are discussed here: (1) membrane proteins, (2) signaling proteins, (3) transcription factors, (4) N-glycosylated proteins, and (5) resistance proteins (R-proteins, plant pathogen recognition proteins that activate innate immune responses). While the basic tiered weight-of-evidence approach for assessing the safety of GM crops proposed by the International Life Sciences Institute (ILSI) in 2008 is applicable to intractable proteins, new or modified methods may be required. For example, the first two steps in Tier I (hazard identification) analysis, gathering of applicable history of safe use (HOSU) information and bioinformatics analysis, do not require protein isolation. The extremely low level of expression of most intractable proteins should be taken into account while assessing safety of the intractable protein in GM crops. If Tier II (hazard characterization) analyses requiring animal feeding are judged to be necessary, alternatives to feeding high doses of pure protein may be needed. These alternatives are discussed here. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

  15. Mobile augmented reality in support of building damage and safety assessment

    Science.gov (United States)

    Kim, W.; Kerle, N.; Gerke, M.

    2016-02-01

    Rapid and accurate assessment of the state of buildings in the aftermath of a disaster event is critical for an effective and timely response. For rapid damage assessment of buildings, the utility of remote sensing (RS) technology has been widely researched, with focus on a range of platforms and sensors. However, RS-based approaches still have limitations to assess structural integrity and the specific damage status of individual buildings. Structural integrity refers to the ability of a building to hold the entire structure. Consequently, ground-based assessment conducted by structural engineers and first responders is still required. This paper demonstrates the concept of mobile augmented reality (mAR) to improve performance of building damage and safety assessment in situ. Mobile AR provides a means to superimpose various types of reference or pre-disaster information (virtual data) on actual post-disaster building data (real buildings). To adopt mobile AR, this study defines a conceptual framework based on the level of complexity (LOC). The framework consists of four LOCs, and for each of these, the data types, required processing steps, AR implementation and use for damage assessment are described. Based on this conceptualization we demonstrate prototypes of mAR for both indoor and outdoor purposes. Finally, we conduct a user evaluation of the prototypes to validate the mAR approach for building damage and safety assessment.

  16. Model summary report for the safety assessment SFR 1 SAR-08

    Energy Technology Data Exchange (ETDEWEB)

    2008-03-15

    This document is the model summary report for the safety assessment SFR 1 SAR-08. In the report, the quality assurance measures conducted for the assessment codes are presented together with the chosen methodology. In the safety assessment SFR1 SAR-08, a number of different computer codes are used. In order to better understand how these codes are related an Assessment Model Flowchart, AMF, has been produced within the project. From the AMF, it is possible to identify the different modelling tasks and consequently also the different computer codes used. A number of different computer codes are used in the assessment of which some are commercial while others are developed for assessment projects. QA requirements must on the one hand take this diversity into account and on the other hand be well defined. In the methodology section of the report the following requirements are defined: - It must be demonstrated that the code is suitable for its purpose. - It must be demonstrated that the code has been properly used. - It must be demonstrated that the code development process has followed appropriate procedures and that the code produces accurate results. Although the requirements are identical for all codes, the measures used to show that the requirements are fulfilled will be different for different codes (for instance due to the fact that for some software the source-code is not available for review). Subsequent to the methodology section, each assessment code is presented and it is shown how the requirements are met

  17. Examining the influence of urban definition when assessing relative safety of drinking-water in Nigeria.

    Science.gov (United States)

    Christenson, Elizabeth; Bain, Robert; Wright, Jim; Aondoakaa, Stephen; Hossain, Rifat; Bartram, Jamie

    2014-08-15

    Reducing inequalities is a priority from a human rights perspective and in water and public health initiatives. There are periodic calls for differential national and global standards for rural and urban areas, often justified by the suggestion that, for a given water source type, safety is worse in urban areas. For instance, initially proposed post-2015 water targets included classifying urban but not rural protected dug wells as unimproved. The objectives of this study were to: (i) examine the influence of urban extent definition on water safety in Nigeria, (ii) compare the frequency of thermotolerant coliform (TTC) contamination and prevalence of sanitary risks between rural and urban water sources of a given type and (iii) investigate differences in exposure to contaminated drinking-water in rural and urban areas. We use spatially referenced data from a Nigerian national randomized sample survey of five improved water source types to assess the extent of any disparities in urban-rural safety. We combined the survey data on TTC and sanitary risk with map layers depicting urban versus rural areas according to eight urban definitions. When examining water safety separately for each improved source type, we found no significant urban-rural differences in TTC contamination and sanitary risk for groundwater sources (boreholes and protected dug wells) and inconclusive findings for piped water and stored water. However, when improved and unimproved source types were combined, TTC contamination was 1.6 to 2.3 times more likely in rural compared to urban water sources depending on the urban definition. Our results suggest that different targets for urban and rural water safety are not justified and that rural dwellers are more exposed to unsafe water than urban dwellers. Additionally, urban-rural analyses should assess multiple definitions or indicators of urban to assess robustness of findings and to characterize a gradient that disaggregates the urban-rural dichotomy

  18. Application of REPAS Methodology to Assess the Reliability of Passive Safety Systems

    Directory of Open Access Journals (Sweden)

    Franco Pierro

    2009-01-01

    Full Text Available The paper deals with the presentation of the Reliability Evaluation of Passive Safety System (REPAS methodology developed by University of Pisa. The general objective of the REPAS is to characterize in an analytical way the performance of a passive system in order to increase the confidence toward its operation and to compare the performances of active and passive systems and the performances of different passive systems. The REPAS can be used in the design of the passive safety systems to assess their goodness and to optimize their costs. It may also provide numerical values that can be used in more complex safety assessment studies and it can be seen as a support to Probabilistic Safety Analysis studies. With regard to this, some examples in the application of the methodology are reported in the paper. A best-estimate thermal-hydraulic code, RELAP5, has been used to support the analyses and to model the selected systems. Probability distributions have been assigned to the uncertain input parameters through engineering judgment. Monte Carlo method has been used to propagate uncertainties and Wilks' formula has been taken into account to select sample size. Failure criterions are defined in terms of nonfulfillment of the defined design targets.

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

    Energy Technology Data Exchange (ETDEWEB)

    Belfadhel, M.B. [Canadian Nuclear Safety Commission, Waste and Geosciences Div., Ottawa, Ontario (Canada)]. E-mail: Benbelfadhelm@cnsc-ccsn.gc.ca; Bennett, D.G. [Galson Science Limited, Oakham (United Kingdom); Gonzales, A. [Iberdrola Ingeniera y Consultoria, Madrid (Spain); Metcalf, P. [International Atomic Energy Agency, Vienna (Austria); Nys, V. [Association Vincotte Nucleaire, Brussels (Belgium); Simeonov, G. [Nuclear Regulatory Agency, Sofia (Bulgaria); Zeleznik, N. [ARAO-Agency of Radwaste Management, Ljubljana (Slovenia)

    2006-07-01

    The IAEA successfully concluded a Coordinated Research Program (CRP) called ISAM, which focused on the development of an Improved Safety Assessment Methodology for near-surface radioactive waste disposal facilities (1997-2002). In November 2002, and as an extension of ISAM, the IAEA launched a new CRP called ASAM, designed to test the Application of the Safety Assessment Methodology by considering a range of near surface disposal facilities. The ASAM work programme is being implemented by three application working groups and two cross-cutting working groups. The application working groups are testing the applicability of the ISAM methodology by assessing an existing disposal facility in Hungary, a copper mine in South Africa, and a hypothetical facility containing heterogenous wastes, such as disused sealed sources. The first cross-cutting working group is addressing a number of technical issues that are common to all near-surface disposal facilities, while the second group, the Regulatory Review Working Group (RRWG) is developing guidance on how to gain confidence in safety assessments and safety cases, and on how to conduct regulatory reviews of safety assessments. This paper provides a brief overview of the work being conducted by the Regulatory Review Working Group. (author)

  20. Evaluation of experimental methods for assessing safety for ultrasound radiation force elastography.

    Science.gov (United States)

    Skurczynski, M J; Duck, F A; Shipley, J A; Bamber, J C; Melodelima, D

    2009-08-01

    Standard test tools have been evaluated for the assessment of safety associated with a prototype transducer intended for a novel radiation force elastographic imaging system. In particular, safety has been evaluated by direct measurement of temperature rise, using a standard thermal test object, and detection of inertial cavitation from acoustic emission. These direct measurements have been compared with values of the thermal index and mechanical index, calculated from acoustic measurements in water using standard formulae. It is concluded that measurements using a thermal test object can be an effective alternative to the calculation of thermal index for evaluating thermal hazard. Measurement of the threshold for cavitation was subject to considerable variability, and it is concluded that the mechanical index still remains the preferred standard means for assessing cavitation hazard.

  1. The safety assessment of food ingredients derived from plant cell, tissue and organ cultures: a review.

    Science.gov (United States)

    Murthy, Hosakatte Niranjana; Georgiev, Milen I; Park, So-Young; Dandin, Vijayalaxmi S; Paek, Kee-Yoeup

    2015-06-01

    Plant cell, tissue and organ cultures (PCTOC) have become an increasingly attractive alternative for the production of various high molecular weight molecules which are used as flavourings, fragrances, colouring agents and food additives. Although PCTOC products are cultivated in vitro in a contamination free environment, the raw material produced from PCTOC may contain many components apart from the target compound. In some cases, PCTOC raw materials may also carry toxins, which may be naturally occurring or accumulated during the culture process. Assessment of the safety of PCTOC products is, therefore, a priority of the biotech industries involved in their production. The safety assessment involves the evaluation of starting material, production process and the end product. Before commercialisation, PCTOC products should be evaluated for their chemical and biological properties, as well as for their toxicity. In this review, measures and general criteria for biosafety evaluation of PCTOC products are addressed and thoroughly discussed.

  2. Amended safety assessment of Hypericum perforatum-derived ingredients as used in cosmetics.

    Science.gov (United States)

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

    2014-01-01

    The Cosmetic Ingredient Review Expert Panel (Panel) has issued an amended safety assessment of 7 Hypericum perforatum-derived ingredients as used in cosmetics. A common name for this plant is St John wort. These ingredients function in cosmetics as skin-conditioning agents-miscellaneous and antimicrobial agents. The Panel reviewed relevant animal and human data related to the H perforatum-derived ingredients. Because formulators may use more than 1 botanical ingredient in a formulation, caution was urged to avoid levels of toxicological concern for constituent chemicals and impurities. The Panel concluded that H perforatum-derived ingredients were safe as cosmetic ingredients in the practices of use and concentration as described in this safety assessment.

  3. Food safety: importance of composition for assessing genetically modified cassava (Manihot esculenta Crantz).

    Science.gov (United States)

    van Rijssen, Fredrika W Jansen; Morris, E Jane; Eloff, Jacobus N

    2013-09-04

    The importance of food composition in safety assessments of genetically modified (GM) food is described for cassava ( Manihot esculenta Crantz) that naturally contains significantly high levels of cyanogenic glycoside (CG) toxicants in roots and leaves. The assessment of the safety of GM cassava would logically require comparison with a non-GM crop with a proven "history of safe use". This study investigates this statement for cassava. A non-GM comparator that qualifies would be a processed product with CG level below the approved maximum level in food and that also satisfies a "worst case" of total dietary consumption. Although acute and chronic toxicity benchmark CG values for humans have been determined, intake data are scarce. Therefore, the non-GM cassava comparator is defined on the "best available knowledge". We consider nutritional values for cassava and conclude that CG residues in food should be a priority topic for research.

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

    Science.gov (United States)

    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.

  5. Safety Assessment of Citric Acid, Inorganic Citrate Salts, and Alkyl Citrate Esters as Used in Cosmetics.

    Science.gov (United States)

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

    2014-05-26

    The CIR Expert Panel (Panel) assessed the safety of citric acid, 12 inorganic citrate salts, and 20 alkyl citrate esters as used in cosmetics, concluding that these ingredients are safe in the present practices of use and concentration. Citric acid is reported to function as a pH adjuster, chelating agent, or fragrance ingredient. Some of the salts are also reported to function as chelating agents, and a number of the citrates are reported to function as skin-conditioning agents but other functions are also reported. The Panel reviewed available animal and clinical data, but because citric acid, calcium citrate, ferric citrate, manganese citrate, potassium citrate, sodium citrate, diammonium citrate, isopropyl citrate, stearyl citrate, and triethyl citrate are generally recognized as safe direct food additives, dermal exposure was the focus for these ingredients in this cosmetic ingredient safety assessment.

  6. PROBABILISTIC SAFETY ASSESSMENT OF OPERATIONAL ACCIDENTS AT THE WASTE ISOLATION PILOT PLANT

    Energy Technology Data Exchange (ETDEWEB)

    Rucker, D.F.

    2000-09-01

    This report presents a probabilistic safety assessment of radioactive doses as consequences from accident scenarios to complement the deterministic assessment presented in the Waste Isolation Pilot Plant (WIPP) Safety Analysis Report (SAR). The International Council of Radiation Protection (ICRP) recommends both assessments be conducted to ensure that ''an adequate level of safety has been achieved and that no major contributors to risk are overlooked'' (ICRP 1993). To that end, the probabilistic assessment for the WIPP accident scenarios addresses the wide range of assumptions, e.g. the range of values representing the radioactive source of an accident, that could possibly have been overlooked by the SAR. Routine releases of radionuclides from the WIPP repository to the environment during the waste emplacement operations are expected to be essentially zero. In contrast, potential accidental releases from postulated accident scenarios during waste handling and emplacement could be substantial, which necessitates the need for radiological air monitoring and confinement barriers (DOE 1999). The WIPP Safety Analysis Report (SAR) calculated doses from accidental releases to the on-site (at 100 m from the source) and off-site (at the Exclusive Use Boundary and Site Boundary) public by a deterministic approach. This approach, as demonstrated in the SAR, uses single-point values of key parameters to assess the 50-year, whole-body committed effective dose equivalent (CEDE). The basic assumptions used in the SAR to formulate the CEDE are retained for this report's probabilistic assessment. However, for the probabilistic assessment, single-point parameter values were replaced with probability density functions (PDF) and were sampled over an expected range. Monte Carlo simulations were run, in which 10,000 iterations were performed by randomly selecting one value for each parameter and calculating the dose. Statistical information was then derived

  7. Review of GMO safety assessment studies: glyphosate residues in Roundup Ready crops is an ignored issue

    OpenAIRE

    2015-01-01

    Published version, also available at http://dx.doi.org/10.1186/s12302-015-0052-7 Background Genetically modified glyphosate-tolerant cultivar varieties have been a commercial success widely known as Roundup Ready plants. As new glyphosate-tolerant varieties are introduced to satisfy agriculture demand, it is relevant to review the scientific evidence that documents the quality and safety of such biotechnology. Assessments of genetically modified glyphosate-tolerant plants are partly ba...

  8. Probabilistic Assessment of the Design and Safety of HSLA-100 Steel Confinement Vessels

    Energy Technology Data Exchange (ETDEWEB)

    R.M. Dolin

    2003-03-03

    This probabilistic approach for assessing the design and safety of the HSLA-100 steel confinement vessel used for a DynEx test involved the probability of failure for several scenarios, in which a fragment may penetrate the vessel. The samples involve vessel thicknesses of 1 inch, 2 inches, and 5.25 inches--the combined thicknesses of the 2 inch containment vessel and the 3.25 inch safety vessel. Two simulation approaches were used for each scenario to assess the probability of failure. The Likelihood of Occurrence method simultaneously models all likely fragment events of a test, for which the net probability of failure is the sum of all the fragment events. The Stochastic Sampling method determines the probability of a fragment perforation on the basis of a logical model and takes the overall probability that an experiment results in failure as the maximum probability for any fragment event. With margin and safety assessments taken into account, it was concluded that the one and two inch thicknesses by themselves are inadequate for containing a DynEx test. The 5.25 inch thickness was determined to be safe by the Likelihood of Occurrence method and nearly adequate by the Stochastic Sampling simulation.

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

    Science.gov (United States)

    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.

  10. Spatial Analysis and Safety Assessment of Social and Economic Development of Small and Medium Cities

    Directory of Open Access Journals (Sweden)

    Elena Anatolyevna Orekhova

    2016-12-01

    Full Text Available The article discusses the spatial patterns of socio-economic development of small and medium-sized cities in the Volgograd region. We know that small and medium-sized cities as spatial socio-economic systems are not only the support frame of settlement, but the main “engine” of innovative impulses for the surrounding periphery. The scientific novelty of the study consists in the effort to implement a spatial approach to the assessment of the economic security of small and medium-sized cities (SCR. The content of the economic security of cities is determined by two system characteristics of the socio-economic system: economic activity (EA and quality of life (QL of the urban population, or SCR = F (EA; QL. For finding spatial patterns in GIS, great interest is in investigating the environment of each city by calculating the local statistical characteristics of geo-variability which allow assessing trends of spatial variation of the six components of security (human security, technosphere safety, environmental safety, etc., local variations in emissions and their values indicators Ki. The successful solution of these problems is possible with the use of tools of exploratory spatial data analysis (ESDA in ARCGIS, and in particular, the Voronoy maps. The spatial approach has allowed to perform an integrated assessment of the economic security and to evaluate safety risks in small and medium-sized cities of the Volgograd region with the security system of indicators.

  11. Biosphere modeling for safety assessment of high-level radioactive waste geological disposal

    Energy Technology Data Exchange (ETDEWEB)

    Baba, T.; Ishihara, Y.; Ishiguro, K. [Japan Nuclear Cycle Development Inst., Waste Management and Fuel Cycle Research Center, Tokai Works, Tokai, Ibaraki (Japan); Suzuki, Y. [Nuclear Energy System Incorporated, Tokyo (Japan); Naito, M. [Japan Nuclear Cycle Development Inst., Geological Isolation Research Project, Tokai, Ibaraki (Japan); Ikeda, T. [Japan Gas Corporation, Tokyo (Japan); Little, R. [QuantiSci Ltd, Henley-on-Thames, Oxon (United Kingdom)

    1999-11-01

    In the safety assessment of a high-level radioactive waste disposal system, it is required to estimate future radiological impacts on human beings. Consideration of living habits and the human environment in the future involves a large degree of uncertainty. To avoid endless speculation aimed at reducing such uncertainty, an approach is applied for identifying and justifying a 'reference biosphere' for use in safety assessment in Japan. Considering a wide range of Japanese geological environments, some specific reference biospheres' are developed using an approach consistent with the BIOMOVS II reference biosphere methodology. The models represent the components of the surface environment using compartments between which fluxes of materials (solid/water) and radionuclides are defined by transfer factors. A range of exposure pathways via which such radionuclides enter the food-chain, along with uptake and concentration factors, are also defined. The response to a step function of unit flux from the geosphere is determined for each model. The results show that it is reasonable to use steady-state biosphere responses to a unit-input flux to define nuclide-dependent factors for converting fluxes from the geosphere to doses. This simplifies safety assessment calculations, which then require only look-up tables for such flux to dose conversion rather than fully coupled biosphere models. (author)

  12. [Hazard assessment and occupational safety measures in surgery : Relevant knowledge on occupational medicine].

    Science.gov (United States)

    Darius, S; Meyer, F; Böckelmann, I

    2016-11-01

    Surgeons routinely work in an environment with occupational risks and hazards about which they are often uninformed. Based on the currently available scientific literature this review article describes the various hazards in the operating theater and their effects on personnel, particularly from the surgical perspective. A further aim of this article is to describe the occupational safety measures to reduce the burdens and to maintain the long-term health of personnel. Ultimately, surgeons should be equipped with the necessary knowledge for implementing hazard assessments according to the German Occupational Health and Safety Act. Surgeons are exposed to increased risks and hazards by working in awkward positions with a high risk for musculoskeletal pain and injuries. They are also commonly exposed to inhalational anesthetics, surgical smoke, radiation, noise and infectious agents. Furthermore, the mental and emotional stress associated with these activities is also high. Meaningful occupational safety measures for reduction of burdens are from a technical aspect the installation of effective air extraction systems, measures to reduce exposure to radiation and noise and the use of safer instruments to prevent needle stick injuries. Furthermore, individual occupational safety measures, such as the use of personal protective equipment (e.g. radiation protective clothing and double gloves) must be observed. The consistent implementation and also adherence to these described occupational safety measures and regulations can reduce the burden on operating theater personnel and contribute to maintaining health. Furthermore, periodic preventive healthcare controls and health checks by the company medical officer and individually initiated additional prevention measures can be a sensible augmentation to these safety measures.

  13. Assessment of Food Safety Knowledge, Attitudes and its Quality in Student Canteens at Duhok University, 2015

    Directory of Open Access Journals (Sweden)

    Haval Y. Yacoob Aldosky

    2016-10-01

    Full Text Available Maintaining and improving the health level of college students are important aspects for higher education, where the food security becomes the foundation of the health. The aim of this study was to assess the level of knowledge and attitudes about food safety and to evaluate the quality of food (Physical & Operational Standards in the student canteen at Duhok University. To achieve this goal, three questionnaires were developed. Concerning food safety knowledge and attitude for food handles (buying, storage and serving food data was collected using these self-questionnaires. The study was conducted on (319 respondents. The obtained data were analyzed and statistically tested. The results have shown that neither age nor education levels have significant impact on the food safety knowledge. However, significant difference between male and female was found for the age >41. For food quality evaluation, the results have also shown that canteen workers lack the physical and operational standards of food safety especially taste and healthy ways of food prepared. The analysis has shown that the positive attitudes of canteen owner toward food handlers were 66.25% for buying, 31.2% for storage and 42.5% for serving food. The overall positive attitude was 46.65% which is insufficient range. Overall respondents had poor food safety knowledge. There was a significant difference between the mean score of knowledge according to gender for group >41 years. In male only, the age has to impact on safety knowledge. While educational levels had no significant impact. The untrained employees who manage the university canteen made their attitudes toward storage and serving food unwelcome.

  14. Nuclear Safety Culture Assessment for a Newcomer Country: Case Study of Jordan

    Energy Technology Data Exchange (ETDEWEB)

    Khasawneh, Khalid; Park, Yun Woon [KAIST, Daejeon (Korea, Republic of)

    2016-05-15

    For countries initiating or considering to start their nuclear power programs; developing a successful safety culture is of a great challenge, owing to lack of experience and the sensitive nature of the nuclear industry in general. The Jordanian case was chosen since Jordan is in the early stages of its nuclear program and the establishment of an effective safety culture is crucial to guarantee the safe operation of its future nuclear facilities. It also should be noted that Fukushima accident has adversely affected the progress of the Jordanian nuclear program driven by the negative public opinion. The government shifts the policies toward enhancing the nuclear safety by enforcing the communication between the engaged parties and openness and transparency with public. In the wake of Fukushima accident the Jordanian government reassured the appropriate siting criteria and siting review, the leadership and the organizations commitment to nuclear safety by adopting advanced reactor technology, the consideration of modern operator accident mitigation strategies and the increased and close cooperation with IAEA and adherence to evolving international safety standards. The progress in the Jordanian nuclear power project in order to satisfy the IAEA requirements was quantified and ranked. A good progress was shown in some aspects, for example in the multicultural and multi-national elements and the establishment of an independent and effective regulatory body. However, some elements, concerning the understanding of the safety culture, management system of the regulatory body and the cultural assessment was not satisfied and an urgent need to focus on and enhance those aspects are required by the Jordanian government. Some elements, for example the leadership, communication and competence, have partial fulfillment of the IAEA requirements. However enhancing those aspects is required in the short and the mid-term in order to guarantee a well-established nuclear power

  15. Implementation of alternative test strategies for the safety assessment of engineered nanomaterials.

    Science.gov (United States)

    Nel, A E

    2013-12-01

    Nanotechnology introduces a new field that requires novel approaches and methods for hazard and risk assessment. For an appropriate scientific platform for safety assessment, nanoscale properties and functions of engineered nanomaterials (ENMs), including how the physicochemical properties of the materials relate to mechanisms of injury at the nano-bio interface, must be considered. Moreover, this rapidly advancing new field requires novel test strategies that allow multiple toxicants to be screened in robust, mechanism-based assays in which the bulk of the investigation can be carried out at the cellular and biomolecular level whilst maintaining limited animal use and is based on the contribution of toxicological pathways to the pathophysiology of disease. First, a predictive toxicological approach for the safety assessment of ENMs will be discussed against the background of a '21st-century vision' for using alternative test strategies (ATSs) to perform toxicological assessment of large numbers of untested chemicals, thereby reducing a backlog that could otherwise become a problem for nanotechnology. An ATS is defined here as an alternative to animal experiments or refinement/reduction alternative to traditional animal testing. Secondly, the approach of selecting pathways of toxicity to screen for the pulmonary hazard potential of carbon nanotubes and metal oxides will be discussed, as well as how to use these pathways to perform high-content or high-throughput testing and how the data can be used for hazard ranking, risk assessment, regulatory decision-making and 'safer-by-design' strategies. Finally, the utility and disadvantages of this predictive toxicological approach to ENM safety assessment, and how it can assist the 21st-century vision, will be addressed.

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

    Science.gov (United States)

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

    Science.gov (United States)

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

    2008-12-15

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

  18. Final Review of Safety Assessment Issues at Savannah River Site, August 2011

    Energy Technology Data Exchange (ETDEWEB)

    Napier, Bruce A.; Rishel, Jeremy P.; Bixler, Nathan E.

    2011-12-15

    At the request of Savannah River Nuclear Solutions (SRNS) management, a review team composed of experts in atmospheric transport modeling for environmental radiation dose assessment convened at the Savannah River Site (SRS) on August 29-30, 2011. Though the meeting was prompted initially by suspected issues related to the treatment of surface roughness inherent in the SRS meteorological dataset and its treatment in the MELCOR Accident Consequence Code System Version 2 (MACCS2), various topical areas were discussed that are relevant to performing safety assessments at SRS; this final report addresses these topical areas.

  19. Assessment of safety and health in the tea industry of Barak valley, Assam: a fuzzy logic approach.

    Science.gov (United States)

    Gupta, Rajat; Dey, Sanjoy Kumar

    2013-01-01

    Traditional safety and health system measurement procedures, practiced in various industries produce qualitative results with a degree of uncertainty. This paper presents a fuzzy-logic-based approach to developing a fuzzy model for assessing the safety and health status in the tea industry. For this, the overall safety and health status at a tea estate has been considered as a function of 4 inputs: occupational safety, occupational health, behavioral safety and competency. A set of fuzzy rules based on expert human judgment has been used to correlate different fuzzy inputs and output. Fuzzy set operations are used to calculate the safety and health status of the tea industry. Application of the developed model at a tea estate showed that the safety and health status belongs to the fuzzy class of good with a crisp value of 7.2.

  20. Non-animal approaches for consumer safety risk assessments: Unilever's scientific research programme.

    Science.gov (United States)

    Carmichael, Paul; Davies, Michael; Dent, Matt; Fentem, Julia; Fletcher, Samantha; Gilmour, Nicola; MacKay, Cameron; Maxwell, Gavin; Merolla, Leona; Pease, Camilla; Reynolds, Fiona; Westmoreland, Carl

    2009-12-01

    Non-animal based approaches to risk assessment are now routinely used for assuring consumer safety for some endpoints (such as skin irritation) following considerable investment in developing and applying new methods over the past 20 years. Unilever's research programme into non-animal approaches for safety assessment is currently focused on the application of new technologies to risk assessments in the areas of skin allergy, cancer and general toxicity (including inhalation toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biological and chemical processes that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement with EU-funded projects (e.g. Sens-it-iv, carcinoGENOMICS), participation in cross-industry collaborative research (e.g. COLIPA, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US 'Human Toxicology Project' consortium). 2009 FRAME.

  1. Safety assessment characteristics of pedestrian legform impactors in vehicle-front impact tests.

    Science.gov (United States)

    Matsui, Yasuhiro

    2014-12-01

    This study investigated the characteristics of safety assessment results of front-area vehicle impact tests carried out using the Transport Research Laboratory (TRL) legform impactor and a flexible legform impactor (FLEX legform impactor). Different types of vehicles (sedan, sport utility vehicle, high-roof K-car, and light cargo van) were examined. The impact locations in the study were the center of the bumper and an extremely stiff structure of the bumper (i.e., in front of the side member) of each tested vehicle. The measured injury criteria were normalized by injury assessment reference values of each legform impactor. The test results for center and side-member impacts indicated that there were no significant differences in ligament injury assessments derived from the normalized knee ligament injury measures between the TRL legform impactor and the FLEX legform impactor. Evaluations made using the TRL legform impactor and the FLEX legform impactor are thus similar in the vehicle safety investigation for knee ligament injury. Vehicle-center impact test results revealed that the tibia fracture assessments derived from the normalized tibia fracture measures did not significantly differ between the TRL legform impactor and the FLEX legform impactor. However, for an impact against an extremely stiff structure, there was a difference in the tibia fracture assessment between the FLEX legform impactor and the TRL legform impactor owing to their different sensor types.

  2. Safety assessment of personal care products/cosmetics and their ingredients.

    Science.gov (United States)

    Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

    2010-03-01

    We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However

  3. A State-of-the-Art Report on Technologies of a Safety Assessment and a Radioactivity Exposure Assessment for the Decommissioning Process of Nuclear Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Jeong, Kwan Seong; Kang, Young Ae; Lee, Dong Gyu; Lee, Kune Woo; Jung, Chong Hun

    2007-09-15

    This report is to provide the reference contents of research and development for technologies of radioactivity exposure and safety assessment for development of the decommissioning technology for nuclear facilities. This report consists of as follows: - Analyzing and discussing on state-of-the-art technologies of a radioactivity exposure assessment of a decommissioning for nuclear facilities - Analyzing and discussing on state-of-the-art technologies of a safety assessment of a decommissioning for nuclear facilities.

  4. Is Scores Derived from the Most Internationally Applied Patient Safety Culture Assessment Tool Correct?

    Directory of Open Access Journals (Sweden)

    Javad Moghri

    2013-09-01

    Full Text Available Background: Hospital Survey on Patient Safety Culture, known as HSOPS, is an internationally well known and widely used tool for measuring patient safety culture in hospitals. It includes 12 dimensions with positive and negative wording questions. The distribution of these questions in different dimensions is uneven and provides the risk of acquiescence bias. The aim of this study was to assess the questionnaire against this bias.Methods: Three hundred nurses were assigned into study and control groups randomly. Short form of HSOPS was distributed in the control group and totally reversed form of it was given to the study group. Percent positive scores and t-test were applied for data analysis. Statistical analyses were conducted using SPSS Version 16.Results: Finally a total of 272 nurses completed the questionnaire. All dimensions with positive wording items in both groups had higher scores compared with their negative worded format. The first dimension "organizational learning and continued improvement" which had the only statistically significant difference, got 16.2% less score in the study group comparing the other group. In addition six out of 18 differences in questions were statistically significant.Conclusion: The popular and widely used HSOPS is subject to acquiescence bias. The bias might lead to exaggerate the status of some patient safety culture composites. Balancing the number of positive and negative worded items in each composite could mitigate the mentioned bias and provide a more valid estimation of different elements of patient safety culture.

  5. SPATIAL ANALYSIS BASED HEALTH AND SAFETY RISK ASSESSMENT FOR LINEAR CONSTRUCTION PROJECTS

    Directory of Open Access Journals (Sweden)

    H. Atay

    2012-07-01

    Full Text Available This paper describes an on-going study that aims to develop a web-based spatial decision support system model for proactive health and safety management in linear construction projects. Currently, health and safety management is usually performed reactively instead of proactive management since hazard identification and risk assessment is mostly performed on paper based documents that are not effectively used at site. This leads to accidents and fatalities at construction sites. The proposed system automatically identifies the spatial risks according to the topographic and layout map of the site, project specification and health and safety regulations by means of spatial analysis. It enables the workers and management personnel to access the possible hazards and thematic risk map of any portion of the construction site for linear projects. Finally, the described approach provides the proposed mitigation measures for the identified hazards. The developed system is expected to raise awareness in H&S among workers and engineers, and increase participation of workers to health and safety management.

  6. Insights on in vitro models for safety and toxicity assessment of cosmetic ingredients.

    Science.gov (United States)

    Almeida, Andreia; Sarmento, Bruno; Rodrigues, Francisca

    2017-03-15

    According to the current European legislation, the safety assessment of each individual cosmetic ingredient of any formulation is the basis for the safety evaluation of a cosmetic product. Also, animal testing in the European Union is prohibited for cosmetic ingredients and products since 2004 and 2009, respectively. Additionally, the commercialization of any cosmetic products containing ingredients tested on animal models was forbidden in 2009. In consequence of these boundaries, the European Centre for the Validation of Alternative Methods (ECVAM) proposes a list of validated cell-based in vitro models for predicting the safety and toxicity of cosmetic ingredients. These models have been demonstrated as valuable and effective tools to overcome the limitations of animal in vivo studies. Although the use of in vitro cell-based models for the evaluation of absorption and permeability of cosmetic ingredients is widespread, a detailed study on the properties of these platforms and the in vitro-in vivo correlation compared with human data are required. Moreover, additional efforts must be taken to develop in vitro models to predict carcinogenicity, repeat dose toxicity and reproductive toxicity, for which no alternative in vitro methods are currently available. This review paper summarizes and characterizes the most relevant in vitro models validated by ECVAM employed to predict the safety and toxicology of cosmetic ingredients. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Spatial Analysis Based Health and Safety Risk Assessment for Linear Construction Projects

    Science.gov (United States)

    Atay, H.; Toz, G.

    2012-07-01

    This paper describes an on-going study that aims to develop a web-based spatial decision support system model for proactive health and safety management in linear construction projects. Currently, health and safety management is usually performed reactively instead of proactive management since hazard identification and risk assessment is mostly performed on paper based documents that are not effectively used at site. This leads to accidents and fatalities at construction sites. The proposed system automatically identifies the spatial risks according to the topographic and layout map of the site, project specification and health and safety regulations by means of spatial analysis. It enables the workers and management personnel to access the possible hazards and thematic risk map of any portion of the construction site for linear projects. Finally, the described approach provides the proposed mitigation measures for the identified hazards. The developed system is expected to raise awareness in H&S among workers and engineers, and increase participation of workers to health and safety management.

  8. Assessment of the culture of safety in public hospitals in Brazil 1

    Science.gov (United States)

    de Carvalho, Rhanna Emanuela Fontenele Lima; Arruda, Lidyane Parente; do Nascimento, Nayanne Karen Pinheiro; Sampaio, Renata Lopes; Cavalcante, Maria Lígia Silva Nunes; Costa, Ana Carolina Pinto

    2017-01-01

    ABSTRACT Objective: to assess the culture of safety in three public hospitals. Method: transversal study undertaken in three Brazilian public hospitals, with health professionals through applying the Safety Attitudes Questionnaire (SAQ). Scores greater than or equal to 75 were considered positive. Results: a total of 573 professionals participated in the study, including nurse technicians and auxiliary nurses 292 (51%), nurses 105 (18.3%), physicians 59 (10.3%), and other professionals 117 (20.4%). The mean of the SAQ varied between 65 and 69 in the three hospitals. Among the domains, however, 'Job satisfaction' presented a higher score, and the opposite was observed for the domain 'Perceptions of management'. The outsourced professionals presented a better perception of the culture of safety than did the statutory professionals. The professionals with higher education presented a better perception of the stressing factors than did the professionals educated to senior high school level. Conclusion: the level of the culture of safety found is below the ideal. The managerial actions are considered the main contributing factor to the culture's weakness; however, the professionals demonstrated themselves to be satisfied with the work. PMID:28301029

  9. Assessment of patient safety culture among personnel in the hospitals associated with Islamic Azad University in Tehran in 2013

    OpenAIRE

    Moussavi, Fatemeh; MOGHRI, Javad; Gholizadeh, Yavar; Karami, Atiyeh; Najjari, Sedigheh; Mehmandust, Reza; Asghari, Mehdi; Asghari, Habib

    2013-01-01

    Background: Patient safety is an essential element in the quality of healthcare, and a clear knowledge of its culture in healthcare organizations will lead to both improved healthcare and patient safety. The aim of this study was to assess the patient safety culture at Islamic Azad University hospitals in Tehran, Iran, in 2013. Methods: This cross-sectional study was conducted on clinical and diagnostic staff in all Islamic Azad University hospitals in Tehran in June 2013. The international “...

  10. An assessment of criticality safety at the Department of Energy Rocky Flats Plant, Golden, Colorado, July--September 1989

    Energy Technology Data Exchange (ETDEWEB)

    Mattson, Roger J.

    1989-09-01

    This is a report on the 1989 independent Criticality Safety Assessment of the Rocky Flats Plant, primarily in response to public concerns that nuclear criticality accidents involving plutonium may have occurred at this nuclear weapon component fabrication and processing plant. The report evaluates environmental issues, fissile material storage practices, ventilation system problem areas, and criticality safety practices. While no evidence of a criticality accident was found, several recommendations are made for criticality safety improvements. 9 tabs.

  11. An assessment of criticality safety at the Department of Energy Rocky Flats Plant, Golden, Colorado, July--September 1989

    Energy Technology Data Exchange (ETDEWEB)

    Mattson, Roger J.

    1989-09-01

    This is a report on the 1989 independent Criticality Safety Assessment of the Rocky Flats Plant, primarily in response to public concerns that nuclear criticality accidents involving plutonium may have occurred at this nuclear weapon component fabrication and processing plant. The report evaluates environmental issues, fissile material storage practices, ventilation system problem areas, and criticality safety practices. While no evidence of a criticality accident was found, several recommendations are made for criticality safety improvements. 9 tabs.

  12. [Genetically modified plants and food safety. State of the art and discussion in the European Union].

    Science.gov (United States)

    Schauzu, M

    2004-09-01

    Placing genetically modified (GM) plants and derived products on the European Union's (EU) market has been regulated by a Community Directive since 1990. This directive was complemented by a regulation specific for genetically modified and other novel foods in 1997. Specific labelling requirements have been applicable for GM foods since 1998. The law requires a pre-market safety assessment for which criteria have been elaborated and continuously adapted in accordance with the state of the art by national and international bodies and organisations. Consequently, only genetically modified products that have been demonstrated to be as safe as their conventional counterparts can be commercialized. However, the poor acceptance of genetically modified foods has led to a de facto moratorium since 1998. It is based on the lack of a qualified majority of EU member states necessary for authorization to place genetically modified plants and derived foods on the market. New Community Regulations are intended to end this moratorium by providing a harmonized and transparent safety assessment, a centralised authorization procedure, extended labelling provisions and a traceability system for genetically modified organisms (GMO) and derived food and feed.

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

    Directory of Open Access Journals (Sweden)

    Hanchen Jiang

    2014-01-01

    Full Text Available 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.

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

    Science.gov (United States)

    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.

  15. Study on assessment safety of geological disposal of high level radioactive waste

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-03-01

    Department of Environmental Safety Research of Japan Atomic Energy Research Institute has conducted the study on safety of geological disposal of high level radioactive waste. The long-term safety of the geological disposal is proposed to be secured by the multi barrier system which consists of engineered and natural barriers. Thus, in order to clarify the performance of the engineered barrier, we have studied on the long-term behaviors of waste forms, canister, overpack, back fill materials. We have developed a new waste form, i.e. ceramic waste form. And in order to clarify the performance of the natural barrier, we have studied on the hydrology, rock properties, geochemistry of actinides, sorption and fixation of radionuclides on and to rocks and/or minerals, alteration of minerals, dispersion behavior of radionuclides. Natural analogue studies and in-situ experiments have also been conducted. According to the methodology for the assessment established, the assessment model has been developed. (J.P.N.).

  16. Safety assessment of Bifidobacterium longum J DM301 based on complete genome sequences

    Institute of Scientific and Technical Information of China (English)

    Yan-Xia Wei; Zhuo-Yang Zhang; Chang Liu; Xiao-Kui Guo; Pradeep K Malakar

    2012-01-01

    AIM: To assess the safety of Bifidobacterium longum (B.longum) JDM301 based on complete genome sequences. METHODS: The complete genome sequences of JDM301 were determined using the GS 20 system. Putative virulence factors, putative antibiotic resistance genes and genes encoding enzymes responsible for harmful metabolites were identified by blast with virulence factors database, antibiotic resistance genes database and genes associated with harmful metabolites in previous reports. Minimum inhibitory concentration of 16 common antimicrobial agents was evaluated by E-test. RESULTS: JDM301 was shown to contain 36 genes associated with antibiotic resistance, 5 enzymes related to harmful metabolites and 162 nonspecific virulence factors mainly associated with transcriptional regulation, adhesion, sugar and amino acid transport. B. longum JDM301 was intrinsically resistant tocipro ciprofloxacin,amikacin, gentamicin and streptomycin and susceptible to vancomycin, amoxicillin, cephalothin, chloramphenicol, erythromycin, ampicillin, cefotaxime, rifampicin, imipenemandtrimethoprim and trimethoprim-sulphamethoxazol. JDM301.JDM301 was moderately resistant to bacitracin, while an earlier study showed that bifidobacteria were susceptible to this antibiotic. A tetracycline resistance gene with the risk of transfer was found in JDM301, which needs to be experimentally validated. CONCLUSION: The safety assessment of JDM301 using information derived from complete bacterial genome will contribute to a wider and deeper insight into the safety of probiotic bacteria.

  17. Connecting pre-marketing clinical research and medical practice : opinion-based study of core issues and possible changes in drug regulation

    NARCIS (Netherlands)

    Wieringa, N.F; Peschar, J.L.; Denig, P; de Graeff, P.A.; Vos, R

    2003-01-01

    Objectives: To identify core issues that contribute to the gap between pre-marketing clinical research and practice as seen from the perspective of medical practice, as well as possible changes and potential barriers for closing this gap. Methods: Interviews with 47 physicians and pharmacists who we

  18. Deep repository for long-lived low- and intermediate-level waste. Preliminary safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-11-01

    A preliminary safety assessment has been performed of a deep repository for long-lived low- and intermediate-level waste, SFL 3-5. The purpose of the study is to investigate the capacity of the facility to act as a barrier to the release of radionuclides and toxic pollutants, and to shed light on the importance of the location of the repository site. A safety assessment (SR 97) of a deep repository for spent fuel has been carried out at the same time. In SR 97, three hypothetical repository sites have been selected for study. These sites exhibit fairly different conditions in terms of hydrogeology, hydrochemistry and ecosystems. To make use of information and data from the SR 97 study, we have assumed that SFL 3-5 is co-sited with the deep repository for spent fuel. A conceivable alternative is to site SFL 3-5 as a completely separate repository. The focus of the SFL 3-5 study is a quantitative analysis of the environmental impact for a reference scenario, while other scenarios are discussed and analyzed in more general terms. Migration in the repository's near- and far-field has been taken into account in the reference scenario. Environmental impact on the three sites has also been calculated. The calculations are based on an updated forecast of the waste to be disposed of in SFL 3-5. The forecast includes radionuclide content, toxic metals and other substances that have a bearing on a safety assessment. The safety assessment shows how important the site is for safety. Two factors stand out as being particularly important: the water flow at the depth in the rock where the repository is built, and the ecosystem in the areas on the ground surface where releases may take place in the future. Another conclusion is that radionuclides that are highly mobile and long-lived, such as {sup 36}Cl and {sup 93}Mo , are important to take into consideration. Their being long-lived means that barriers and the ecosystems must be regarded with a very long time horizon.

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

    NARCIS (Netherlands)

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

    2010-01-01

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

  20. Safety and nutritional assessment of GM plants and derived food and feed: The role of animal feeding trials

    NARCIS (Netherlands)

    Haver, van E.; Alink, G.M.; Cockburn, A.; Kuiper, H.A.; Peijnenburg, A.A.C.M.

    2008-01-01

    In this report the various elements of the safety and nutritional assessment procedure for genetically modified (GM) plant derived food and feed are discussed, in particular the potential and limitations of animal feeding trials for the safety and nutritional testing of whole GM food and feed. The g

  1. Safety and nutritional assessment of GM plants and derived food and feed: The role of animal feeding trials

    NARCIS (Netherlands)

    Haver, van E.; Alink, G.M.; Cockburn, A.; Kuiper, H.A.; Peijnenburg, A.A.C.M.

    2008-01-01

    In this report the various elements of the safety and nutritional assessment procedure for genetically modified (GM) plant derived food and feed are discussed, in particular the potential and limitations of animal feeding trials for the safety and nutritional testing of whole GM food and feed. The

  2. Different sets of reliability data and success criteria in a probabilistic safety assessment for a plant producing nitroglycol.

    Science.gov (United States)

    Hauptmanns, Ulrich

    2009-03-15

    The lack of plant-specific reliability data for probabilistic safety assessments usually makes it necessary to use generic reliability data. Justifiably different assessments of plant behaviour (success criteria) lead to different models of plant systems. Both affect the numerical results of a probabilistic safety assessment. It is shown how these results change, if different sets of reliability data and different choices of success criteria for the safety system are employed. Differences in results may influence decisions taken on their basis and become especially important if compliance with a safety goal has to be proved, e.g. a safety integrity level. For the purpose of demonstration an accident sequence from a probabilistic safety assessment of a plant producing nitroglycol is used. The analysis relies on plant-specific reliability data so that it provides a good yardstick for comparing it with results obtained using generic data. The superiority of plant-specific data, which should of course be acquired, cannot be doubted. Nevertheless, plant safety can be improved even if generic data are used. However, the assignment to a safety integrity level may be affected by differences in both data and success criteria.

  3. Transferability of calibrated microsimulation model parameters for safety assessment using simulated conflicts.

    Science.gov (United States)

    Essa, Mohamed; Sayed, Tarek

    2015-11-01

    Several studies have investigated the relationship between field-measured conflicts and the conflicts obtained from micro-simulation models using the Surrogate Safety Assessment Model (SSAM). Results from recent studies have shown that while reasonable correlation between simulated and real traffic conflicts can be obtained especially after proper calibration, more work is still needed to confirm that simulated conflicts provide safety measures beyond what can be expected from exposure. As well, the results have emphasized that using micro-simulation model to evaluate safety without proper model calibration should be avoided. The calibration process adjusts relevant simulation parameters to maximize the correlation between field-measured and simulated conflicts. The main objective of this study is to investigate the transferability of calibrated parameters of the traffic simulation model (VISSIM) for safety analysis between different sites. The main purpose is to examine whether the calibrated parameters, when applied to other sites, give reasonable results in terms of the correlation between the field-measured and the simulated conflicts. Eighty-three hours of video data from two signalized intersections in Surrey, BC were used in this study. Automated video-based computer vision techniques were used to extract vehicle trajectories and identify field-measured rear-end conflicts. Calibrated VISSIM parameters obtained from the first intersection which maximized the correlation between simulated and field-observed conflicts were used to estimate traffic conflicts at the second intersection and to compare the results to parameters optimized specifically for the second intersection. The results show that the VISSIM parameters are generally transferable between the two locations as the transferred parameters provided better correlation between simulated and field-measured conflicts than using the default VISSIM parameters. Of the six VISSIM parameters identified as

  4. Assessing the stochastic variability of the Benefit-Cost ratio in roadway safety management.

    Science.gov (United States)

    Cafiso, Salvatore; D'Agostino, Carmelo

    2016-08-01

    Road Agencies set quantitative targets and adopt related road safety strategies within the priorities and the available resources at the time of an economic crisis. In this framework, benefit-cost analyses (BCA) are carried out to support the decision making process and alternative measures are ranked according to their expected benefit and benefit-cost ratio calculated using a Safety Performance Function (SPF) and Crash Modification Factors (CMFs) as predictors of future safety performances. Due to the variance of CMFs and crash frequency we are uncertain what the benefits of some future actions will be. The chance of making wrong decisions depends on the size of the standard deviation of the probability distribution of the considered stochastic variables. To deal with the uncertainty inherent in the decision making process, a reliability based assessment of benefits must be performed introducing a stochastic approach. In the paper the variability of the CMFs, the predicted number of crashes and the crash costs are taken into account in a reliability based BCA to address improvements and issues of an accurate probabilistic approach when compared to the deterministic results or other approximated procedures. A case study is presented comparing different safety countermeasures selected to reduce crash frequency and severity on sharp curves in motorways. These measures include retrofitting of old safety barriers, delineation systems and shoulder rumble strips. The methodology was applied using the Monte Carlo simulations to calculate the probability of failure of BCA statements. Results and comparisons with alternative approaches, like the one proposed in the HSM, are presented showing remarkable differences in the evaluation of outcomes which can be achieved.

  5. Assessment of enriched uranium storage safety issues at the Oak Ridge Y-12 Plant

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-08-01

    This document is an assessment of the technical safety issues pertaining to the storage of EU at the Oak Ridge Y-12 Plant. The purpose of the assessment is to serve as the basis for defining the technical standards for storage of EU at Y-12. A formal assessment of the Y-12 materials acceptance criteria for EU is currently being conducted by a task force cochaired by B. G. Eddy of DOE Oak Ridge Operations and S. 0. Cox of Y-12 Defense Programs. The mission of this technical assessment for storage is obviously dependent on results of the acceptance assessment. Clearly, the two efforts require coordination to avoid inconsistencies. In addition, both these Assessments must be consistent with the Environmental Assessment for EU storage at Y-12.1 Both the Storage Assessment and the Criteria for Acceptance must take cognizance of the fact that a portion of the EU to be submitted for storage in the future is expected to be derived from foreign sources and to include previously irradiated uranium containing significant levels of transuranics, radioactive daughter products, and unstable uranium isotopes that do not occur in the EU stream of the DOE weapons complex. National security considerations may dictate that these materials be accepted despite the fact that they fail to conform to the Acceptance Criteria. This document will attempt to address the complexities inherent in this situation.

  6. Liquefied Gaseous Fuels Safety and Environmental Control Assessment Program: second status report

    Energy Technology Data Exchange (ETDEWEB)

    None

    1980-10-01

    Volume 2 consists of 19 reports describing technical effort performed by Government Contractors in the area of LNG Safety and Environmental Control. Report topics are: simulation of LNG vapor spread and dispersion by finite element methods; modeling of negatively buoyant vapor cloud dispersion; effect of humidity on the energy budget of a liquefied natural gas (LNG) vapor cloud; LNG fire and explosion phenomena research evaluation; modeling of laminar flames in mixtures of vaporized liquefied natural gas (LNG) and air; chemical kinetics in LNG detonations; effects of cellular structure on the behavior of gaseous detonation waves under transient conditions; computer simulation of combustion and fluid dynamics in two and three dimensions; LNG release prevention and control; the feasibility of methods and systems for reducing LNG tanker fire hazards; safety assessment of gelled LNG; and a four band differential radiometer for monitoring LNG vapors.

  7. Safety Assessment of Ethanolamine and Ethanolamine Salts as Used in Cosmetics.

    Science.gov (United States)

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

    2015-09-01

    The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of ethanolamine and 12 salts of ethanolamine as used in cosmetics. Ethanolamine functions as a pH adjuster. The majority of the salts are reported to function as surfactants, and the others are reported to function as pH adjusters, hair fixatives, or preservatives. The Panel reviewed available animal and clinical data, as well as information from previous relevant CIR reports. Because data were not available for each individual ingredient and because the salts dissociate freely in water, the Panel extrapolated from those previous reports to support safety. The Panel concluded that these ingredients are safe in the present practices of use and concentrations (rinse-off products only) when formulated to be nonirritating, and these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed.

  8. An Assessment of "What does photon energy tell us about cellphone safety" by Dr. William Bruno

    CERN Document Server

    Leikind, Bernard

    2011-01-01

    Dr. Bruno asserts the well-known fact that cell phones radiate microwaves in the classical regime. This, he says, means that the photon energy is not relevant to assessing safety. Citing optical tweezers as an example of biologically relevant non-thermal effects of electromagnetic radiation, Bruno concludes that all other reports of non-thermal effects from microwaves are likely valid. He seeks safety thresholds based upon requiring that cell phone energy density be less than k_BT. This proposal and related ideas produce thresholds many orders of magnitude below present values. While Dr. Bruno is correct that cell phone microwave radiation is generally in the classical regime, he uses peculiar estimates (number of photons per cubic wavelength) that overstate the circumstance by more than 20 factors of ten. He misunderstands the operation of optical tweezers and ignores their significant thermal effects. He credulously accepts poorly supported claims of non-existent non-thermal effects. He mistakenly believes ...

  9. Health and safety: Preliminary comparative assessment of the Satellite Power System (SPS) and other energy alternatives

    Science.gov (United States)

    Habegger, L. J.; Gasper, J. R.; Brown, C.

    1980-01-01

    Data readily available from the literature were used to make an initial comparison of the health and safety risks of a fission power system with fuel reprocessing; a combined-cycle coal power system with a low-Btu gasifier and open-cycle gas turbine; a central-station, terrestrial, solar photovoltaic power system; the satellite power system; and a first-generation fusion system. The assessment approach consists of the identification of health and safety issues in each phase of the energy cycle from raw material extraction through electrical generation, waste disposal, and system deactivation; quantitative or qualitative evaluation of impact severity; and the rating of each issue with regard to known or potential impact level and level of uncertainty.

  10. Research on the development of advanced system safety assessment procedures (1)

    Energy Technology Data Exchange (ETDEWEB)

    Suzuki, Kazuhiko [Okayama Univ. (Japan)

    2002-02-01

    The past research reports in the area of safety engineering proposed the Computer-aided HAZOP system to be applied to Nuclear Reprocessing Facilities. Automated HAZOP system has great advantage compared with human analysts in terms of accuracy of the results, and time required to conduct HAZOP studies. This report surveys the literature on risk assessment and safety design based on the concept of independent protection layers (IPLs). Furthermore, to improve HAZOP System, counter measures information related to abnormal situation in plants are added to knowledge base in the system. As the result the HAZOP system can give appropriate measures information to protect accidents to uses. Such HAZOP system is applied to analyze the processes, where the ability of the proposed system is verified. (author)

  11. Safety assessment and detection method of genetically modified Chinese Kale (Brassica oleracea cv. alboglabra ).

    Science.gov (United States)

    Lin, Chih-Hui; Lu, Chien-Te; Lin, Hsin-Tang; Pan, Tzu-Ming

    2009-03-11

    Sporamins are tuberous storage proteins and account for 80% of soluble protein in sweet potato tubers with trypsin-inhibitory activity. The expression of sporamin protein in transgenic Chinese kale (line BoA 3-1) conferred insecticidal activity toward corn earworm [ Helicoverpa armigera (Hubner)] in a previous report. In this study, we present a preliminary safety assessment of transgenic Chinese kale BoA 3-1. Bioinformatic and simulated gastric fluid (SGF) analyses were performed to evaluate the allergenicity of sporamin protein. The substantial equivalence between transgenic Chinese kale and its wild-type host has been demonstrated by the comparison of important constituents. A reliable real-time polymerase chain reaction (PCR) detection method was also developed to control sample quality. Despite the results of most evaluations in this study being negative, the safety of sporamin in transgenic Chinese kale BoA 3-1 was uncluded because of the allergenic risk revealed by bioinformatic analysis.

  12. Development of a methodology for assessing the safety of embedded software systems

    Science.gov (United States)

    Garrett, C. J.; Guarro, S. B.; Apostolakis, G. E.

    1993-01-01

    A Dynamic Flowgraph Methodology (DFM) based on an integrated approach to modeling and analyzing the behavior of software-driven embedded systems for assessing and verifying reliability and safety is discussed. DFM is based on an extension of the Logic Flowgraph Methodology to incorporate state transition models. System models which express the logic of the system in terms of causal relationships between physical variables and temporal characteristics of software modules are analyzed to determine how a certain state can be reached. This is done by developing timed fault trees which take the form of logical combinations of static trees relating the system parameters at different point in time. The resulting information concerning the hardware and software states can be used to eliminate unsafe execution paths and identify testing criteria for safety critical software functions.

  13. The safety profile of the fluoroquinolones.

    Science.gov (United States)

    Bertino, J; Fish, D

    2000-07-01

    Premarketing trials showed the fluoroquinolone agents to have a favorable side-effect profile, with treatment-related adverse events comprising gastrointestinal, central nervous system, and dermatologic effects that were generally mild and reversible on cessation of treatment. However, postmarketing surveillance studies have identified severe adverse events, including severe anaphylaxis, QTc-interval prolongation, and potential cardiotoxicity, associated with 3 quinolone agents that either resulted in the removal of the agent from the market (temafloxacin and grepafloxacin) or significantly restricted its use due to substantial mortality and morbidity associated with liver toxicity (trovafloxacin). To date, there have been no such significant adverse events associated with the older fluoroquinolone agents, including ciprofloxacin, ofloxacin, norfloxacin, and levofloxacin. However, there are fewer data from postmarketing surveillance studies on the most recently approved agents, such as moxifloxacin and gatifloxacin, or agents awaiting approval, such as gemifloxacin. This paper examines safety data from the premarketing trials and postmarketing surveillance studies of fluoroquinolones available in the United States. A MEDLINE search was performed to identify all English-language studies published since 1980 concerning the safety profiles of the fluoroquinolones. The fluoroquinolone antibacterial agents offer broad-spectrum therapy in patients with a variety of infections. Given similar spectra of activity, the choice between quinolones may be based on differences in efficacy and safety or tolerability profiles. Most drug reactions involving these agents are minor and reversible on discontinuing treatment, but adverse effects can be associated with significant mortality and morbidity, as was seen in the case of trovafloxacin and temafloxacin.

  14. A combined deterministic and probabilistic procedure for safety assessment of components with cracks - Handbook.

    Energy Technology Data Exchange (ETDEWEB)

    Dillstroem, Peter; Bergman, Mats; Brickstad, Bjoern; Weilin Zang; Sattari-Far, Iradj; Andersson, Peder; Sund, Goeran; Dahlberg, Lars; Nilsson, Fred (Inspecta Technology AB, Stockholm (Sweden))

    2008-07-01

    SSM has supported research work for the further development of a previously developed procedure/handbook (SKI Report 99:49) for assessment of detected cracks and tolerance for defect analysis. During the operative use of the handbook it was identified needs to update the deterministic part of the procedure and to introduce a new probabilistic flaw evaluation procedure. Another identified need was a better description of the theoretical basis to the computer program. The principal aim of the project has been to update the deterministic part of the recently developed procedure and to introduce a new probabilistic flaw evaluation procedure. Other objectives of the project have been to validate the conservatism of the procedure, make the procedure well defined and easy to use and make the handbook that documents the procedure as complete as possible. The procedure/handbook and computer program ProSACC, Probabilistic Safety Assessment of Components with Cracks, has been extensively revised within this project. The major differences compared to the last revision are within the following areas: It is now possible to deal with a combination of deterministic and probabilistic data. It is possible to include J-controlled stable crack growth. The appendices on material data to be used for nuclear applications and on residual stresses are revised. A new deterministic safety evaluation system is included. The conservatism in the method for evaluation of the secondary stresses for ductile materials is reduced. A new geometry, a circular bar with a circumferential surface crack has been introduced. The results of this project will be of use to SSM in safety assessments of components with cracks and in assessments of the interval between the inspections of components in nuclear power plants

  15. Assessment of Integrated Pedestrian Protection Systems with Autonomous Emergency Braking (AEB) and Passive Safety Components.

    Science.gov (United States)

    Edwards, Mervyn; Nathanson, Andrew; Carroll, Jolyon; Wisch, Marcus; Zander, Oliver; Lubbe, Nils

    2015-01-01

    Autonomous emergency braking (AEB) systems fitted to cars for pedestrians have been predicted to offer substantial benefit. On this basis, consumer rating programs-for example, the European New Car Assessment Programme (Euro NCAP)-are developing rating schemes to encourage fitment of these systems. One of the questions that needs to be answered to do this fully is how the assessment of the speed reduction offered by the AEB is integrated with the current assessment of the passive safety for mitigation of pedestrian injury. Ideally, this should be done on a benefit-related basis. The objective of this research was to develop a benefit-based methodology for assessment of integrated pedestrian protection systems with AEB and passive safety components. The method should include weighting procedures to ensure that it represents injury patterns from accident data and replicates an independently estimated benefit of AEB. A methodology has been developed to calculate the expected societal cost of pedestrian injuries, assuming that all pedestrians in the target population (i.e., pedestrians impacted by the front of a passenger car) are impacted by the car being assessed, taking into account the impact speed reduction offered by the car's AEB (if fitted) and the passive safety protection offered by the car's frontal structure. For rating purposes, the cost for the assessed car is normalized by comparing it to the cost calculated for a reference car. The speed reductions measured in AEB tests are used to determine the speed at which each pedestrian in the target population will be impacted. Injury probabilities for each impact are then calculated using the results from Euro NCAP pedestrian impactor tests and injury risk curves. These injury probabilities are converted into cost using "harm"-type costs for the body regions tested. These costs are weighted and summed. Weighting factors were determined using accident data from Germany and Great Britain and an independently

  16. Ventilatory function assessment in safety pharmacology: optimization of rodent studies using normocapnic or hypercapnic conditions.

    Science.gov (United States)

    Goineau, Sonia; Rompion, Sonia; Guillaume, Philippe; Picard, Sandra

    2010-09-15

    Although the whole body plethysmography for unrestrained animals is the most widely used method to assess the respiratory risk of new drugs in safety pharmacology, non-appropriate experimental conditions may mask deleterious side effects of some substances. If stimulant or bronchodilatory effects can be easily evidenced in rodents under standard experimental conditions, i.e. normal air breathing and diurnal phase, drug-induced respiratory depression remains more difficult to detect. This study was aimed at comparing the responsiveness of Wistar rats, Duncan Hartley guinea-pigs or BALB/c mice to the respiratory properties of theophylline (50 or 100 mg/kg p.o.) or morphine (30 mg/kg i.p.) under varying conditions (100% air versus 5% CO2-enriched air, light versus dark day phase), in order to select the most appropriate experimental conditions to each species for safety airway investigations. Our results showed that under normocapnia the ventilatory depressant effects of morphine can be easily evidenced in mice, slightly observed in guinea-pigs and not detected in rats in any day phase. Slight hypercapnic conditions enhanced the responsiveness of rats to morphine but not that of guinea-pigs and importantly they did not blunt the airway responsiveness of rats to the stimulation and bronchodilation evoked by theophylline, the most widely used reference agent in safety pharmacology studies. In conclusion, hypercapnic conditions associated with the non-invasive whole body plethysmography should be considered for optimizing the assessment of both the ventilatory depressant potential of morphine-like substances or the respiratory stimulant effects of new drugs in the rat, the most extensively used species in rodent safety and toxicological investigations.

  17. Post-closure safety assessment of near surface disposal facilities for disused sealed radioactive sources

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Seunghee; Kim, Juyoul, E-mail: gracemi@fnctech.com

    2017-03-15

    Highlights: • Post-closure safety assessment of near surface disposal facility for DSRS was performed. • Engineered vault and rock-cavern type were considered for normal and well scenario. • {sup 14}C, {sup 226}Ra, {sup 241}Am were primary nuclides contributing large portion of exposure dose. • Near surface disposal of DSRSs containing {sup 14}C, {sup 226}Ra and {sup 241}Am should be restricted. - Abstract: Great attention has been recently paid to the post-closure safety assessment of low- and intermediate-level radioactive waste (LILW) disposal facility for disused sealed radioactive sources (DSRSs) around the world. Although the amount of volume of DSRSs generated from industry, medicine and research and education organization was relatively small compared with radioactive wastes from commercial nuclear power plants, some DSRSs can pose a significant hazard to human health due to their high activities and long half-lives, if not appropriately managed and disposed. In this study, post-closure safety assessment was carried out for DSRSs generated from 1991 to 2014 in Korea in order to ensure long-term safety of near surface disposal facilities. Two kinds of disposal options were considered, i.e., engineered vault type disposal facility and rock-cavern type disposal facility. Rock-cavern type disposal facility has been under operation in Gyeongju city, republic of Korea since August 2015 and engineered vault type disposal facility will be constructed until December 2020 in the vicinity of rock-cavern disposal facility. Assessment endpoint was individual dose to the member of critical group, which was modeled by GoldSim, which has been widely used as probabilistic risk analysis software based on Monte Carlo simulation in the area of safety assessment of radioactive waste facilities. In normal groundwater scenario, the maximum exposure dose was extremely low, approximately 1 × 10{sup −7} mSv/yr, for both disposal options and satisfied the regulatory limit

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

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report documents the future human actions, FHA, considered in the long-term safety analysis of a KBS-3 repository. The report is one of the supporting documents to the safety assessment SR-Site (see further the Main report /SKB 2011/). The purpose of this report is to provide an account of general considerations concerning FHA, the methodology applied in SR-Site to assess FHA, the aspects of FHA needed to be considered in the evaluation of their impact on a deep geological repository and to select and analyse representative scenarios for illustrative consequence analysis. The main focus of this report is a time period when institutional control has ceased to be effective, thereby permitting inadvertent intrusion. However, a brief discussion of the earlier period when the repository has been closed, sealed and continuously kept under institutional control is also provided. General The potential exposure to large quantities of radiotoxic material is an inescapable consequence of the deposition of spent nuclear fuel in a final repository, and consequently intrusion into the repository needs to be considered in repository design and safety assessment. In accordance with ICRP recommendations /ICRP 2000/, intrusion in the post-closure phase of institutional control and beyond is primarily prevented through the design of the repository. In addition to that there will presumably continue to be safeguards measures, preservation of information (record keeping) and possibly some sort of markers placed at the site. During the institutional control period, activities at the site have to be restricted or directed if they have the potential to interfere with or hinder surveillance of the site, but this does not necessarily rule out all forms of access to the area. Also the fact that the repository contains fissile materials is an important aspect. Control of safeguards measures will most likely be upheld by national as well as international agencies. Furthermore, the

  19. Application of Dynamic Probabilistic Safety Assessment Approach for Accident Sequence Precursor Analysis: Case Study for Steam Generator Tube Rupture

    National Research Council Canada - National Science Library

    Lee, Hansul; Kim, Taewan; Heo, Gyunyoung

    2017-01-01

    ...) analysis, and to propose a case study using the dynamic-probabilistic safety assessment (D-PSA) approach. The D-PSA approach can aid in the determination of high-risk/low-frequency accident scenarios from all potential scenarios...

  20. DECOVALEX III PROJECT. Thermal-Hydro-Mechanical Coupled Processes in Safety Assessments. Report of Task 4

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan [JA Streamflow AB, Aelvsjoe (Sweden)

    2005-02-15

    A part (Task 4) of the International DECOVALEX III project on coupled thermo-hydro-mechanical (T-H-M) processes focuses on T-H-M modelling applications in safety and performance assessment of deep geological nuclear waste repositories. A previous phase, DECOVALEX II, saw a need to improve such modelling. In order to address this need Task 4 of DECOVALEX III has: Analysed two major T-H-M experiments (Task 1 and Task 2) and three different Bench Mark Tests (Task 3) set-up to explore the significance of T-H-M in some potentially important safety assessment applications. Compiled and evaluated the use of T-H-M modelling in safety assessments at the time of the year 2000. Organised a forum a forum of interchange between PA-analysts and THM modelers at each DECOVALEX III workshop. Based on this information the current report discusses the findings and strives for reaching recommendations as regards good practices in addressing coupled T-H-M issues in safety assessments. The full development of T-H-M modelling is still at an early stage and it is not evident whether current codes provide the information that is required. However, although the geosphere is a system of fully coupled processes, this does not directly imply that all existing coupled mechanisms must be represented numerically. Modelling is conducted for specific purposes and the required confidence level should be considered. It is necessary to match the confidence level with the modelling objective. Coupled THM modelling has to incorporate uncertainties. These uncertainties mainly concern uncertainties in the conceptual model and uncertainty in data. Assessing data uncertainty is important when judging the need to model coupled processes. Often data uncertainty is more significant than the coupled effects. The emphasis on the need for THM modelling differs among disciplines. For geological radioactive waste disposal in crystalline and other similar hard rock formations DECOVALEX III shows it is essential to