Sample records for safety authority efsa

  1. Power learning or path dependency? Investigating the roots of the European Food Safety Authority.

    PubMed

    Roederer-Rynning, Christilla; Daugbjerg, Carsten

    2010-01-01

    A key motive for establishing the European Food Safety Authority (EFSA) was restoring public confidence in the wake of multiplying food scares and the BSE crisis. Scholars, however, have paid little attention to the actual political and institutional logics that shaped this new organization. This article explores the dynamics underpinning the making of EFSA. We examine the way in which learning and power shaped its organizational architecture. It is demonstrated that the lessons drawn from the past and other models converged on the need to delegate authority to an external agency, but diverged on its mandate, concretely whether or not EFSA should assume risk management responsibilities. In this situation of competitive learning, power and procedural politics conditioned the mandate granted to EFSA. The European Commission, the European Parliament and the European Council shared a common interest in preventing the delegation of regulatory powers to an independent EU agency in food safety policy.

  2. Scientific Method and the Regulation of Health and Nutritional Claims by the European Food Safety Authority

    ERIC Educational Resources Information Center

    Hoad, Darren

    2011-01-01

    The protection of European consumers from the false or misleading scientific and nutritional claims of food manufacturers took a step forward with the recent opinions of the European Food Safety Authority (EFSA). As a risk assessment agency, the EFSA recently assessed and rejected a vast number of food claim forcing the withdrawal of many claims…

  3. Safety Assessment of Food and Feed from GM Crops in Europe: Evaluating EFSA's Alternative Framework for the Rat 90-day Feeding Study.

    PubMed

    Hong, Bonnie; Du, Yingzhou; Mukerji, Pushkor; Roper, Jason M; Appenzeller, Laura M

    2017-07-12

    Regulatory-compliant rodent subchronic feeding studies are compulsory regardless of a hypothesis to test, according to recent EU legislation for the safety assessment of whole food/feed produced from genetically modified (GM) crops containing a single genetic transformation event (European Union Commission Implementing Regulation No. 503/2013). The Implementing Regulation refers to guidelines set forth by the European Food Safety Authority (EFSA) for the design, conduct, and analysis of rodent subchronic feeding studies. The set of EFSA recommendations was rigorously applied to a 90-day feeding study in Sprague-Dawley rats. After study completion, the appropriateness and applicability of these recommendations were assessed using a battery of statistical analysis approaches including both retrospective and prospective statistical power analyses as well as variance-covariance decomposition. In the interest of animal welfare considerations, alternative experimental designs were investigated and evaluated in the context of informing the health risk assessment of food/feed from GM crops.

  4. Genotoxicity testing approaches for the safety assessment of substances used in food contact materials prior to their authorization in the European Union.

    PubMed

    Bolognesi, Claudia; Castoldi, Anna F; Crebelli, Riccardo; Barthélémy, Eric; Maurici, Daniela; Wölfle, Detlef; Volk, Katharina; Castle, Laurence

    2017-06-01

    Food contact materials are all materials and articles intended to come directly or indirectly into contact with food. Before being included in the positive European "Union list" of authorized substances (monomers, other starting substances and additives) for plastic food contact materials, the European Food Safety Authority (EFSA) must assess their safety "in use". If relevant for risk, the safety of the main impurities, reaction and degradation products originating from the manufacturing process is also evaluated. Information on genotoxicity is always required irrespective of the extent of migration and the resulting human exposure, in view of the theoretical lack of threshold for genotoxic events. The 2008 EFSA approach, requiring the testing of food contact materials in three in vitro mutagenicity tests, though still acceptable, is now superseded by the 2011 EFSA Scientific Committee's recommendation for only two complementary tests including a bacterial gene mutation test and an in vitro micronucleus test, to detect two main genetic endpoints (i.e., gene mutations and chromosome aberrations). Follow-up of in vitro positive results depends on the type of genetic effect and on the substance's systemic availability. In this study, we provide an analysis of the data on genotoxicity testing gathered by EFSA on food contact materials for the period 1992-2015. We also illustrate practical examples of the approaches that EFSA took when evaluating "non standard" food contact chemicals (e.g., polymeric additives, oligomer or other reaction mixtures, and nanosubstances). Additionally, EFSA's experience gained from using non testing methods and/or future possibilities in this area are discussed. Environ. Mol. Mutagen. 58:361-374, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  5. Why the European Food Safety Authority was right to reject health claims for probiotics.

    PubMed

    Katan, M B

    2012-06-01

    Probiotics are microbes that are claimed to promote health and well-being when added to foods. However, the European Food Safety Authority (EFSA) has so far advised negatively about health claims for probiotics. Companies and scientists have protested against these rejections, sometimes in vigorous language. I argue that EFSA could not have acted differently, given EU regulations and the lack of convincing evidence for some of the claimed effects of probiotics on human health and well-being. One EU regulation that makes it hard to demonstrate the benefits of probiotics is the prohibition of medical claims, i.e. claims that a food prevents or cures a disease. If this prohibition did not exist, manufacturers of nutritional treatments might circumvent the costly procedures required for drugs, and market their products to ill people without thorough proof that they are effective and safe. However, the prohibition is also a legal fiction, because promotion of health and prevention of disease is largely the same thing. EFSA has recently indicated that it will allow health claims based on the ability of probiotics to reduce infections. To a certain extent, this abolishes the distinction between health claims and medical claims. It remains to be seen if probiotics producers can convince EFSA that their products prevent or cure infections and other diseases in humans.

  6. Risk assessment of pesticides and other stressors in bees: Principles, data gaps and perspectives from the European Food Safety Authority.

    PubMed

    Rortais, Agnès; Arnold, Gérard; Dorne, Jean-Lou; More, Simon J; Sperandio, Giorgio; Streissl, Franz; Szentes, Csaba; Verdonck, Frank

    2017-06-01

    Current approaches to risk assessment in bees do not take into account co-exposures from multiple stressors. The European Food Safety Authority (EFSA) is deploying resources and efforts to move towards a holistic risk assessment approach of multiple stressors in bees. This paper describes the general principles of pesticide risk assessment in bees, including recent developments at EFSA dealing with risk assessment of single and multiple pesticide residues and biological hazards. The EFSA Guidance Document on the risk assessment of plant protection products in bees highlights the need for the inclusion of an uncertainty analysis, other routes of exposures and multiple stressors such as chemical mixtures and biological agents. The EFSA risk assessment on the survival, spread and establishment of the small hive beetle, Aethina tumida, an invasive alien species, is provided with potential insights for other bee pests such as the Asian hornet, Vespa velutina. Furthermore, data gaps are identified at each step of the risk assessment, and recommendations are made for future research that could be supported under the framework of Horizon 2020. Finally, the recent work conducted at EFSA is presented, under the overarching MUST-B project ("EU efforts towards the development of a holistic approach for the risk assessment on MUltiple STressors in Bees") comprising a toolbox for harmonised data collection under field conditions and a mechanistic model to assess effects from pesticides and other stressors such as biological agents and beekeeping management practices, at the colony level and in a spatially complex landscape. Future perspectives at EFSA include the development of a data model to collate high quality data to calibrate and validate the model to be used as a regulatory tool. Finally, the evidence collected within the framework of MUST-B will support EFSA's activities on the development of a holistic approach to the risk assessment of multiple stressors in bees. In

  7. Antimicrobial resistance monitoring projects for zoonotic and indicator bacteria of animal origin: common aspects and differences between EASSA and EFSA.

    PubMed

    Moyaert, Hilde; de Jong, Anno; Simjee, Shabbir; Thomas, Valérie

    2014-07-16

    Resistance monitoring programmes are essential to generate data for inclusion in the scientific risk assessment of the potential for transmission of antimicrobial-resistant bacteria or their resistance determinants from food-producing animals to humans. This review compares the technical specifications on monitoring of antimicrobial resistance in zoonotic Salmonella, Campylobacter and indicator Escherichia coli and Enterococcus as performed by the European Food Safety Authority (EFSA) with veterinary pharmaceutical industry's European Antimicrobial Susceptibility Surveillance in Animals (EASSA) programme. The authors conclude that most of EFSA's recent monitoring recommendations have been covered by EASSA since the start of the latter programme in 1998. The major difference between the two programmes is the classification into 'susceptible' versus 'resistant'. While EFSA categorises all isolates with an MIC value above the epidemiological cut-off value as 'resistant', EASSA differentiates between 'percentage decreased susceptible' and 'percentage clinical resistant' strains by applying both epidemiological cut-off values and clinical breakpoints. Because there is still a need to further improve harmonisation among individual EU Member State activities, Animal Health Industry welcomes EFSA's initiative to further improve the quality of resistance monitoring as it is of utmost importance to apply standardised collection procedures and harmonised susceptibility testing, when monitoring antimicrobial resistance across Europe. Copyright © 2014 Elsevier B.V. All rights reserved.

  8. Possible health impacts of Bt toxins and residues from spraying with complementary herbicides in genetically engineered soybeans and risk assessment as performed by the European Food Safety Authority EFSA.

    PubMed

    Then, Christoph; Bauer-Panskus, Andreas

    2017-01-01

    MON89788 was the first genetically engineered soybean worldwide to express a Bt toxin. Under the brand name Intacta, Monsanto subsequently engineered a stacked trait soybean using MON89788 and MON87701-this stacked soybean expresses an insecticidal toxin and is, in addition, tolerant to glyphosate. After undergoing risk assessment by the European Food Safety Authority (EFSA), the stacked event was authorised for import into the EU in June 2012, including for use in food and feed. This review discusses the health risks associated with Bt toxins present in these genetically engineered plants and the residues left from spraying with the complementary herbicide. We have compared the opinion published by EFSA [1] with findings from other publications in the scientific literature. It is evident that there are several issues that EFSA did not consider in detail and which will need further assessment: (1) There are potential combinatorial effects between plant components and other impact factors that might enhance toxicity. (2) It is known that Bt toxins have immunogenic properties; since soybeans naturally contain many allergens, these immunogenic properties raise specific questions. (3) Fully evaluated and reliable protocols for measuring the Bt concentration in the plants are needed, in addition to a comprehensive set of data on gene expression under varying environmental conditions. (4) Specific attention should be paid to the herbicide residues and their interaction with Bt toxins. The case of the Intacta soybeans highlights several regulatory problems with Bt soybean plants in the EU. Moreover, many of the issues raised also concern other genetically engineered plants that express insecticidal proteins, or are engineered to be resistant to herbicides, or have those two types of traits combined in stacked events. It remains a matter of debate whether the standards currently applied by the risk assessor, EFSA, and the risk manager, the EU Commission, meet the standards

  9. Eating nanomaterials: cruelty-free and safe? the EFSA guidance on risk assessment of nanomaterials in food and feed.

    PubMed

    Sauer, Ursula G

    2011-12-01

    Nanomaterials are increasingly being added to food handling and packaging materials, or directly, to human food and animal feed. To ensure the safety of such engineered nanomaterials (ENMs), in May 2011, the European Food Safety Authority (EFSA) published a guidance document on Risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. It states that risk assessment should be performed by following a step-wise procedure. Whenever human or animal exposure to nanomaterials is expected, the general hazard characterisation scheme requests information from in vitro genotoxicity, toxicokinetic and repeated dose 90-day oral toxicity studies in rodents. Numerous prevailing uncertainties with regard to nanomaterial characterisation and their hazard and risk assessment are addressed in the guidance document. This article discusses the impact of these knowledge gaps on meeting the goal of ensuring human safety. The EFSA's guidance on the risk assessment of ENMs in food and animal feed is taken as an example for discussion, from the point of view of animal welfare, on what level of uncertainty should be considered acceptable for human safety assessment of products with non-medical applications, and whether animal testing should be considered ethically acceptable for such products.

  10. Criticism of EFSA's scientific opinion on combinatorial effects of 'stacked' GM plants.

    PubMed

    Bøhn, Thomas

    2018-01-01

    Recent genetically modified plants tend to include both insect resistance and herbicide tolerance traits. Some of these 'stacked' GM plants have multiple Cry-toxins expressed as well as tolerance to several herbicides. This means that non-target organisms in the environment (biodiversity) will be co-exposed to multiple stressors simultaneously. A similar co-exposure may happen to consumers through chemical residues in the food chain. EFSA, the responsible unit for minimizing risk of harm in European food chains, has expressed its scientific interest in combinatorial effects. However, when new data showed how two Cry-toxins acted in combination (added toxicity), and that the same Cry-toxins showed combinatorial effects when co-exposed with Roundup (Bøhn et al., 2016), EFSA dismissed these new peer-reviewed results. In effect, EFSA claimed that combinatorial effects are not relevant for itself. EFSA was justifying this by referring to a policy question, and by making invalid assumptions, which could have been checked directly with the lead-author. With such approach, EFSA may miss the opportunity to improve its environmental and health risk assessment of toxins and pesticides in the food chain. Failure to follow its own published requests for combinatorial effects research, may also risk jeopardizing EFSA's scientific and public reputation. Copyright © 2017. Published by Elsevier Ltd.

  11. What is a health benefit? An evaluation of EFSA opinions on health benefits with reference to probiotics.

    PubMed

    Binnendijk, K H; Rijkers, G T

    2013-09-01

    Probiotics are microorganisms that have a beneficial effect on the health of the host. However, before these effects can be referred to as beneficial to human health, such claims need to be evaluated by regulatory institutes such as the European Food Safety Authority (EFSA). The EFSA Panel on Dietetic Products, Nutrition and allergies (NDA) has published their opinions regarding health claims including probiotics, most of which were rejected in the past years. Using the EFSA database, the NDA dossiers published between 2005 and 2013 were analysed to provide an overview on what grounds certain health effects were accepted as beneficial and others not. The NDA Panel distinguishes between claims that are definitely beneficial, possibly beneficial or non-beneficial to human health. Overall, 78% of all analysed health claims are considered by the NDA Panel as (possibly) beneficial to human health, in particular the gut health effects. Since, in many cases, the scientific substantiation of a particular health claim was deemed insufficient, most applications were turned down. For future health claim applications concerning probiotics to be successful, they should include specific statements on what exactly the microorganism affects, and the scientific substantiation of the particular health claim should be based on the targeted (general) population.

  12. EFSA's scientific activities and achievements on the risk assessment of genetically modified organisms (GMOs) during its first decade of existence: looking back and ahead.

    PubMed

    Devos, Yann; Aguilera, Jaime; Diveki, Zoltán; Gomes, Ana; Liu, Yi; Paoletti, Claudia; du Jardin, Patrick; Herman, Lieve; Perry, Joe N; Waigmann, Elisabeth

    2014-02-01

    Genetically modified organisms (GMOs) and derived food and feed products are subject to a risk analysis and regulatory approval before they can enter the market in the European Union (EU). In this risk analysis process, the role of the European Food Safety Authority (EFSA), which was created in 2002 in response to multiple food crises, is to independently assess and provide scientific advice to risk managers on any possible risks that the use of GMOs may pose to human and animal health and the environment. EFSA's scientific advice is elaborated by its GMO Panel with the scientific support of several working groups and EFSA's GMO Unit. This review presents EFSA's scientific activities and highlights its achievements on the risk assessment of GMOs for the first 10 years of its existence. Since 2002, EFSA has issued 69 scientific opinions on genetically modified (GM) plant market registration applications, of which 62 for import and processing for food and feed uses, six for cultivation and one for the use of pollen (as or in food), and 19 scientific opinions on applications for marketing products made with GM microorganisms. Several guidelines for the risk assessment of GM plants, GM microorganisms and GM animals, as well as on specific issues such as post-market environmental monitoring (PMEM) were elaborated. EFSA also provided scientific advice upon request of the European Commission on safeguard clause and emergency measures invoked by EU Member States, annual PMEM reports, the potential risks of new biotechnology-based plant breeding techniques, evaluations of previously assessed GMOs in the light of new scientific publications, and the use of antibiotic resistance marker genes in GM plants. Future challenges relevant to the risk assessment of GMOs are discussed. EFSA's risk assessments of GMO applications ensure that data are analysed and presented in a way that facilitates scientifically sound decisions that protect human and animal health and the environment.

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

    PubMed

    Pöting, A; Schauzu, M

    2010-06-01

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

  14. Reply to the EFSA (2016) on the relevance of recent publications (Hofmann et al. 2014, 2016) on environmental risk assessment and management of Bt-maize events (MON810, Bt11 and 1507).

    PubMed

    Kruse-Plass, Maren; Hofmann, Frieder; Kuhn, Ulrike; Otto, Mathias; Schlechtriemen, Ulrich; Schröder, Boris; Vögel, Rudolf; Wosniok, Werner

    2017-01-01

    In this commentary, we respond to a report of the EFSA GMO Panel (EFSA EFSA Supp Publ, 1) that criticises the outcomes of two studies published in this journal (Hofmann et al. Environ Sci Eur 26: 24, 2; Environ Sci Eur 28: 14, 3). Both publications relate to the environmental risk assessment and management of Bt-maize, including maize events MON810, Bt11 and maize 1507. The results of Hofmann et al. (Environ Sci Eur 26: 24, 2), using standardised pollen mass filter deposition measurements, indicated that the EFSA Panel model had underestimated pollen deposition and, hence, exposure of non-target organisms to Bt-maize pollen. The results implied a need for safety buffer distances in the kilometre range for protected nature reserve areas instead of the 20-30 m range recommended by the EFSA Panel. As a result, the EFSA Panel revised their model (EFSA EFSA J 13: 4127, 4), adopting the slope of the empirical data from Hofmann et al. The intercept, however, was substantially reduced to less than 1% at one point by introducing further assumptions based on the estimates of mainly panel members, citing possible 'uncertainty'. Hofmann et al. (Environ Sci Eur 28: 14, 3) published extensive empirical data regarding pollen deposition on leaves. These results were part of a larger 3-year study involving detailed measurements of pollen release, dispersal and deposition over the maize flowering period. The data collected in situ confirmed the previous predictions of Hofmann et al. (Environ Sci Eur 26: 24, 2). Mean levels and observed variability of pollen deposition on maize and four lepidopteran host plants exceeded the assumptions and disagreed with the conclusions of the EFSA Panel. The EFSA Panel reacted in a report (EFSA EFSA Supp Publ, 1) criticising the methods and outcomes of the two published studies of Hofmann et al. while reaffirming their original recommendations. We respond here point-by-point, showing that the critique is not justified. Based on our results on

  15. Health safety issues of synthetic food colorants.

    PubMed

    Amchova, Petra; Kotolova, Hana; Ruda-Kucerova, Jana

    2015-12-01

    Increasing attention has been recently paid to the toxicity of additives used in food. The European Parliament and the Council published the REGULATION (EC) No. 1333/2008 on food additives establishing that the toxicity of food additives evaluated before 20th January 2009 must be re-evaluated by European Food Safety Authority (EFSA). The aim of this review is to survey current knowledge specifically on the toxicity issues of synthetic food colorants using official reports published by the EFSA and other available studies published since the respective report. Synthetic colorants described are Tartrazine, Quinoline Yellow, Sunset Yellow, Azorubine, Ponceau 4R, Erythrosine, Allura Red, Patent Blue, Indigo Carmine, Brilliant Blue FCF, Green S, Brilliant Black and Brown HT. Moreover, a summary of evidence on possible detrimental effects of colorant mixes on children's behaviour is provided and future research directions are outlined. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Acute tier-1 and tier-2 effect assessment approaches in the EFSA Aquatic Guidance Document: are they sufficiently protective for insecticides?

    PubMed

    van Wijngaarden, René P A; Maltby, Lorraine; Brock, Theo C M

    2015-08-01

    The objective of this paper is to evaluate whether the acute tier-1 and tier-2 methods as proposed by the Aquatic Guidance Document recently published by the European Food Safety Authority (EFSA) are appropriate for deriving regulatory acceptable concentrations (RACs) for insecticides. The tier-1 and tier-2 RACs were compared with RACs based on threshold concentrations from micro/mesocosm studies (ETO-RAC). A lower-tier RAC was considered as sufficiently protective, if less than the corresponding ETO-RAC. ETO-RACs were calculated for repeated (n = 13) and/or single pulsed applications (n = 17) of 26 insecticides to micro/mesocosms, giving a maximum of 30 insecticide × application combinations (i.e. cases) for comparison. Acute tier-1 RACs (for 24 insecticides) were lower than the corresponding ETO-RACs in 27 out of 29 cases, while tier-2 Geom-RACs (for 23 insecticides) were lower in 24 out of 26 cases. The tier-2 SSD-RAC (for 21 insecticides) using HC5 /3 was lower than the ETO-RAC in 23 out of 27 cases, whereas the tier-2 SSD-RAC using HC5 /6 was protective in 25 out of 27 cases. The tier-1 and tier-2 approaches proposed by EFSA for acute effect assessment are sufficiently protective for the majority of insecticides evaluated. Further evaluation may be needed for insecticides with more novel chemistries (neonicotinoids, biopesticides) and compounds that show delayed effects (insect growth regulators). © 2014 Society of Chemical Industry.

  17. The importance of data collection for timely and accurate risk assessment

    NASA Astrophysics Data System (ADS)

    Gilsenan, MB

    2017-09-01

    The European Food Safety Authority (EFSA) is responsible for food safety risk assessments at EU level. It provides independent scientific advice on risks associated with the food chain to support EU risk management decisions. Since its establishment, EFSA has amassed a wealth of data to underpin its risk assessments, such as food consumption data, monitoring data and experimental data. Increasing transparency of its risk assessments is a core objective of EFSA. EFSA aims to enhance the quality and transparency of its outputs by giving insofar as possible access to data and methods underpinning its scientific outputs. This paper provides an overview of the role of EFSA, its core data collections and their regulatory framework, as well as data quality and standardisation aspects. Finally, the paper elaborates on EFSA’s 2020 strategy in relation to data, and describes EFSA scientific data warehouse and Knowledge Junction in this regard.

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

    PubMed

    Gürtler, R

    2010-06-01

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

  19. Evaluating EFSA protection goals for honey bees (Apis mellifera): what do they mean for pollination?

    PubMed

    Croft, Simon; Brown, Mike; Wilkins, Selwyn; Hart, Andy; Smith, Graham C

    2018-06-20

    In recent years there has been growing concern regarding the sudden and unexplained failure of honeybee (Apis mellifera) colonies. Several factors have been suggested including pesticides. In an effort to regulate their impact guidance has been published by the European Food Safety Authority (EFSA) recommending that the magnitude of effects on exposed colonies should not exceed 7% reduction in colony size after 2 brood cycles. However, fears have been raised regarding the practicality of measuring such a loss in the field. It is also unclear how this protection goal relates to maintaining the ecosystem services provided by bees, which we argue should be a primary objective for regulators. Here, we evaluate what these protection goals mean in relation to ecosystems performance using a computational colony model incorporating mechanisms to simulate both lethal and sub-lethal pesticide effects. To these simulations we apply a testing regime similar to that commonly used in field trials to produce standard assessment metrics. By relating these measures to losses in forager activity we aim to identify which could be used as effective indicators of reduced ecoservice and to quantify acceptable limits below which performance can be maintained. Our findings show that loss of colony size is the best indicator of reduced ecoservice. Metrics which focus on specific colony functions such as increased brood or forager mortality are ineffective indicators for all types of simulated pesticide effects. At the levels of colony loss recommended by EFSA, using our default parameterisation, we predict a loss of ecosystems performance of 3-4%. However, based on an extensive sensitivity analysis it is clear that this estimate is subject to substantial uncertainty with losses under alternative parameterisations of up to 14%. Nevertheless, our model provides a valuable framework for assessing protection goals, allowing regulators to test relevant impacts and quantify their magnitude. This

  20. Hydration and chemical ingredients in sport drinks: food safety in the European context.

    PubMed

    Urdampilleta, Aritz; Gómez-Zorita, Saioa; Soriano, José M; Martínez-Sanz, José M; Medina, Sonia; Gil-Izquierdo, Angel

    2015-05-01

    Before, during and after physical activity, hydration is a limiting factor in athletic performance. Therefore, adequate hydration provides benefits for health and performance of athletes. Besides, hydration is associated to the intake of carbohydrates, protein, sodium, caffeine and other substances by different dietary aids, during the training and/or competition by athletes. These requirements have led to the development of different products by the food industry, to cover the nutritional needs of athletes. Currently in the European context, the legal framework for the development of products, substances and health claims concerning to sport products is incomplete and scarce. Under these conditions, there are many products with different ingredients out of European Food Safety Authority (EFSA) control where claims are wrong due to no robust scientific evidence and it can be dangerous for the health. Further scientific evidence should be constructed by new clinical trials in order to assist to the Experts Commitees at EFSA for obtaining robust scientific opinions concerning to the functional foods and the individual ingredients for sport population. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  1. Use of published research in paediatric nutrition for the scientific substantiation of health claims referring to children's development and health.

    PubMed

    Valtueña Martínez, Silvia; Agostoni, Carlo

    2013-10-01

    The European Food Safety Authority (EFSA) provides policy makers with scientific and technical advice in relation to food safety and human nutrition in an independent and transparent way, and communicates such advice to the general public. Requirements for the scientific substantiation of health claims referring to children's development and health are the same as for other health claims. However, children (particularly infants) have peculiarities which should be taken into account, because these may impair the extrapolation of results to other groups. Health claims used in commercial communications should be authorized only after a scientific assessment of the highest possible standard by EFSA. EFSA's negative opinions on rejected claims should not be read as a criticism to research studies published in paediatric nutrition but rather highlight their limitations in relation to the substantiation of specific health claims made on foods. ©2013 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  2. New York Metropolitan Transportation Authority safety investigation

    DOT National Transportation Integrated Search

    1993-06-01

    The Federal Transit Administration (FTA) conducted an intensive investigation of passenger and employee safety on the New York Metropolitan Transportation Authority (MTA) and its operating elements. The investigation stressed the system safety concep...

  3. Comprehensive European dietary exposure model (CEDEM) for food additives.

    PubMed

    Tennant, David R

    2016-05-01

    European methods for assessing dietary exposures to nutrients, additives and other substances in food are limited by the availability of detailed food consumption data for all member states. A proposed comprehensive European dietary exposure model (CEDEM) applies summary data published by the European Food Safety Authority (EFSA) in a deterministic model based on an algorithm from the EFSA intake method for food additives. The proposed approach can predict estimates of food additive exposure provided in previous EFSA scientific opinions that were based on the full European food consumption database.

  4. Design and analysis of field studies with bees: A critical review of the draft EFSA guidance.

    PubMed

    Bakker, Frank

    2016-07-01

    The specific protection goal, primary assessment endpoints, acceptable effect thresholds, and experimental design proposed in the European Food Safety Authority (EFSA) update of the bee guidance document are subjected to critical review. It is concluded that the negligible effect criteria were established without sufficient regulatory definition and without convincing scientific argumentation. For the assessment endpoints, effects on hive strength lack temporal definition and the reduction to numbers of bees is inappropriate to evaluate effects. Restricting mortality assessments to homing failure is not theoretically justified and specific criteria were incorrectly derived. The combination of acute effect estimates with models for chronic stressors is biased risk assessment and a temporal basis for the acceptability of effects is missing. Effects on overwintering success cannot be experimentally assessed using the proposed criteria. The experimental methodology proposed is inappropriate and the logistical consequences, in particular those related to replication and land use are such that field studies are no longer a feasible option for the risk assessment. It may be necessary to explore new lines of thought for the set-up of field studies and to clearly separate experimentation from monitoring. Integr Environ Assess Manag 2016;12:422-428. © 2015 SETAC. © 2015 SETAC.

  5. Safety assessment of plant food supplements (PFS).

    PubMed

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

    2011-12-01

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

  6. [Assessment of allergenicity of genetically modified food crops].

    PubMed

    Schauzu, M; Pöting, A; Rubin, D; Lampen, A

    2012-03-01

    The placing on the European Union's market of genetically modified crops requires authorization by the European Commission which is based on the proof that the derived foods are as safe as their conventional counterparts. The assessment of potential allergenicity is part of the necessary investigations recommended in the updated Guidance Document of the Scientific Panel on Genetically Modified Organisms (GMO) of the European Food Safety Authority (EFSA), which is based on internationally agreed recommendations. All genetically modified crops which so far have been authorized in the European Union were evaluated by the EFSA GMO Panel which considered it unlikely that their overall allergenicity has been altered.

  7. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... is suitably equipped and organized to carry out the State's highway safety program. (b) Authority... safety and projects administered by other State and local agencies; (3) Maintain or have ready access to information contained in State highway safety data systems, including crash, citation, adjudication, emergency...

  8. 23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... is suitably equipped and organized to carry out the State's highway safety program. (b) Authority... safety and projects administered by other State and local agencies; (3) Maintain or have ready access to information contained in State highway safety data systems, including crash, citation, adjudication, emergency...

  9. Genome Sequence of Lactobacillus plantarum 19L3, a Strain Proposed as a Starter Culture for Slovenská Bryndza Ovine Cheese

    PubMed Central

    Džunková, Mária; Moya, Andrés; Tomáška, Martin; Kološta, Miroslav; Kmet, Vladimir

    2014-01-01

    The genome sequence of Lactobacillus plantarum isolated from ovine cheese is presented here. This bacterium is proposed as a starter strain, named 19L3, for Slovenská bryndza cheese, a traditional Slovak cheese fulfilling European Food Safety Authority (EFSA) requirements. PMID:24762933

  10. [Recommendations for inspections of the French nuclear safety authority].

    PubMed

    Rousse, C; Chauvet, B

    2015-10-01

    The French nuclear safety authority is responsible for the control of radiation protection in radiotherapy since 2002. Controls are based on the public health and the labour codes and on the procedures defined by the controlled health care facility for its quality and safety management system according to ASN decision No. 2008-DC-0103. Inspectors verify the adequacy of the quality and safety management procedures and their implementation, and select process steps on the basis of feedback from events notified to ASN. Topics of the inspection are communicated to the facility at the launch of a campaign, which enables them to anticipate the inspectors' expectations. In cases where they are not physicians, inspectors are not allowed to access information covered by medical confidentiality. The consulted documents must therefore be expunged of any patient-identifying information. Exchanges before the inspection are intended to facilitate the provision of documents that may be consulted. Finally, exchange slots between inspectors and the local professionals must be organized. Based on improvements achieved by the health care centres and on recommendations from a joint working group of radiotherapy professionals and the nuclear safety authority, changes will be made in the control procedure that will be implemented when developing the inspection program for 2016-2019. Copyright © 2015. Published by Elsevier SAS.

  11. 76 FR 63988 - Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ...-0097] Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits AGENCY: Federal Motor... public comment on data and information concerning the Pre-Authorization Safety Audits (PASAs) for two motor carriers that applied to participate in the Agency's long-haul pilot program to test and...

  12. Transgenic maize event TC1507: Global status of food, feed, and environmental safety

    PubMed Central

    Baktavachalam, Gajendra B; Delaney, Bryan; Fisher, Tracey L; Ladics, Gregory S; Layton, Raymond J; Locke, Mary EH; Schmidt, Jean; Anderson, Jennifer A; Weber, Natalie N; Herman, Rod A; Evans, Steven L

    2015-01-01

    Maize (Zea mays) is a widely cultivated cereal that has been safely consumed by humans and animals for centuries. Transgenic or genetically engineered insect-resistant and herbicide-tolerant maize, are commercially grown on a broad scale. Event TC1507 (OECD unique identifier: DAS-Ø15Ø7–1) or the Herculex®# I trait, an insect-resistant and herbicide-tolerant maize expressing Cry1F and PAT proteins, has been registered for commercial cultivation in the US since 2001. A science-based safety assessment was conducted on TC1507 prior to commercialization. The safety assessment addressed allergenicity; acute oral toxicity; subchronic toxicity; substantial equivalence with conventional comparators, as well as environmental impact. Results from biochemical, physicochemical, and in silico investigations supported the conclusion that Cry1F and PAT proteins are unlikely to be either allergenic or toxic to humans. Also, findings from toxicological and animal feeding studies supported that maize with TC1507 is as safe and nutritious as conventional maize. Maize with TC1507 is not expected to behave differently than conventional maize in terms of its potential for invasiveness, gene flow to wild and weedy relatives, or impact on non-target organisms. These safety conclusions regarding TC1507 were acknowledged by over 20 regulatory agencies including United States Environment Protection Agency (US EPA), US Department of Agriculture (USDA), Canadian Food Inspection Agency (CFIA), and European Food Safety Authority (EFSA) before authorizing cultivation and/or food and feed uses. A comprehensive review of the safety studies on TC1507, as well as some benefits, are presented here to serve as a reference for regulatory agencies and decision makers in other countries where authorization of TC1507 is or will be pursued. PMID:26018138

  13. Transgenic maize event TC1507: Global status of food, feed, and environmental safety.

    PubMed

    Baktavachalam, Gajendra B; Delaney, Bryan; Fisher, Tracey L; Ladics, Gregory S; Layton, Raymond J; Locke, Mary Eh; Schmidt, Jean; Anderson, Jennifer A; Weber, Natalie N; Herman, Rod A; Evans, Steven L

    2015-01-01

    Maize (Zea mays) is a widely cultivated cereal that has been safely consumed by humans and animals for centuries. Transgenic or genetically engineered insect-resistant and herbicide-tolerant maize, are commercially grown on a broad scale. Event TC1507 (OECD unique identifier: DAS-Ø15Ø7-1) or the Herculex®(#) I trait, an insect-resistant and herbicide-tolerant maize expressing Cry1F and PAT proteins, has been registered for commercial cultivation in the US since 2001. A science-based safety assessment was conducted on TC1507 prior to commercialization. The safety assessment addressed allergenicity; acute oral toxicity; subchronic toxicity; substantial equivalence with conventional comparators, as well as environmental impact. Results from biochemical, physicochemical, and in silico investigations supported the conclusion that Cry1F and PAT proteins are unlikely to be either allergenic or toxic to humans. Also, findings from toxicological and animal feeding studies supported that maize with TC1507 is as safe and nutritious as conventional maize. Maize with TC1507 is not expected to behave differently than conventional maize in terms of its potential for invasiveness, gene flow to wild and weedy relatives, or impact on non-target organisms. These safety conclusions regarding TC1507 were acknowledged by over 20 regulatory agencies including United States Environment Protection Agency (US EPA), US Department of Agriculture (USDA), Canadian Food Inspection Agency (CFIA), and European Food Safety Authority (EFSA) before authorizing cultivation and/or food and feed uses. A comprehensive review of the safety studies on TC1507, as well as some benefits, are presented here to serve as a reference for regulatory agencies and decision makers in other countries where authorization of TC1507 is or will be pursued.

  14. Safety review of Washington Metropolitan Area Transit Authority (WMATA) metrorail operations

    DOT National Transportation Integrated Search

    1997-09-01

    A recent series of accidents and incidents at the Washington Metropolitan Area Transit Authority (WMATA) have raised concerns about the Authority's commitment to safety as its top priority. In January 1996, a train operator was killed at an end-of-th...

  15. Approaches for grouping of pesticides into cumulative assessment groups for risk assessment of pesticide residues in food.

    PubMed

    Colnot, Thomas; Dekant, Wolfgang

    2017-02-01

    The European Food Safety Authority (EFSA) is developing approaches to cumulative risk assessment of pesticides by assigning individual pesticides to cumulative assessment groups (CAGs). For assignment to CAGs, EFSA recommended to rely on adverse effects on the specific target system. Contractors to EFSA have proposed to allocate individual pesticides into CAGs relying on NOAELs for effects on target organs. This manuscript evaluates the assignments by applying EFSAs criteria to the CAGs "Toxicity to the nervous system" and "Toxicity to the thyroid hormone system (gland or hormones)". Assignment to the CAG "Toxicity to the nervous system" based, for example, on neurochemical effects like choline esterase inhibition is well supported, whereas assignment to the CAG "Toxicity to the thyroid hormone system (gland or hormones)" has been based in the examined case studies on non-reproducible effects seen in single studies or on observations that are not adverse. Therefore, a more detailed effects evaluation is required to assign a pesticide to a CAG for a target organ where many confounders regarding effects are present. Relative potency factors in cumulative risk assessment should be based on benchmark doses from studies in one species with identical study design and human relevance of effects on specific target organs should be analyzed to define minimal margins of exposure. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  16. 78 FR 28897 - Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ...] Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the... CFR 2.104, 2.105, 2.300, 2.309, 2.313, 2.318, and 2.321, notice is hereby given that an Atomic Safety... comprised of the following administrative judges: Alex S. Karlin, Chairman, Atomic Safety and Licensing...

  17. Approaches in the risk assessment of genetically modified foods by the Hellenic Food Safety Authority.

    PubMed

    Varzakas, Theodoros H; Chryssochoidis, G; Argyropoulos, D

    2007-04-01

    Risk analysis has become important to assess conditions and take decisions on control procedures. In this context it is considered a prerequisite in the evaluation of GM food. Many consumers worldwide worry that food derived from genetically modified organisms (GMOs) may be unhealthy and hence regulations on GMO authorisations and labelling have become more stringent. Nowadays there is a higher demand for non-GM products and these products could be differentiated from GM products using the identity preservation system (IP) that could apply throughout the grain processing system. IP is the creation of a transparent communication system that encompasses HACCP, traceability and related systems in the supply chain. This process guarantees that certain characteristics of the lots of food (non-GM origin) are maintained "from farm to fork". This article examines the steps taken by the Hellenic Food Safety Authority to examine the presence of GMOs in foods. The whole integrated European legislation framework currently in place still needs to be implemented in Greece. Penalties should be enforced to those who import, process GMOs without special licence and do not label those products. Similar penalties should be enforced to those companies that issue false certificates beyond the liabilities taken by the food enterprises for farmers' compensation. We argue that Greece has no serious reasons to choose the use of GMOs due to the fact that the structural and pedologic characteristics of the Greek agriculture favour the biological and integrated cultivation more. Greece is not in favour of the politics behind coexistence of conventional and GM plants and objects to the use of GMOs in the food and the environment because the processor has a big burden in terms of money, time and will suffer a great deal in order to prove that their products are GMO free or that any contamination is adventitious or technically unavoidable. Moreover, Greece owns a large variety of genetic

  18. Regulatory forum opinion piece*: supporting the need for international harmonization of safety assessments for food flavoring substances.

    PubMed

    Konishi, Yoichi; Hayashi, Shim-Mo; Fukushima, Shoji

    2014-08-01

    The advancement of technology and the growth of international commerce underscore the need for global harmonization of regulatory safety requirements and their assessment pertaining to consumer products such as drugs, medical devices, and food. This need is particularly relevant when safety requirements involve time-intensive and costly animal safety studies. Here we present the current regulatory requirements in Europe, the United States, and Japan for flavoring substances (FSs) used in foods and point out significant differences relevant to the international standardization for safety assessments that in our opinion need to be addressed and overcome. The safety assessments that are carried out for FSs in various countries are influenced by divergent definitions of FS, by the information required and available for regulatory submission, and by different regulatory procedures, including the use of decision tree approaches. The European Food Safety Authority (EFSA), the Expert Panel of the U.S. Flavor and Extract Manufacturers Association (FEMA), and the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) are making efforts to improve and harmonize the safety assessment of FSs. The application of in silico methods such as quantitative structure-activity relationships and read-across strategies relying on expert input are useful as a first-step screening of the assessment. Application of the Threshold of Toxicological Concern (TTC) approach permits conclusions that are compatible with the risk assessment approaches currently used by international advisory committees. The Japanese Regulatory Authority, on the other hand, does not yet consider in silico methods but still requires in vivo and in vitro genotoxicity test data as well as repeat-dose 90-day toxicity data in at least one species, to be submitted as the first step in the safety assessment of FSs. With this article, we echo requests that have

  19. DARHT: INTEGRATION OF AUTHORIZATION BASIS REQUIREMENTS AND WORKER SAFETY

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

    D. A. MC CLURE; C. A. NELSON; R. L. BOUDRIE

    2001-04-01

    This document describes the results of consensus agreements reached by the DARHT Safety Planning Team during the development of the update of the DARHT Safety Analysis Document (SAD). The SAD is one of the Authorization Basis (AB) Documents required by the Department prior to granting approval to operate the DARHT Facility. The DARHT Safety Planning Team is lead by Mr. Joel A. Baca of the Department of Energy Albuquerque Operations Office (DOE/AL). Team membership is drawn from the Department of Energy Albuquerque Operations Office, the Department of Energy Los Alamos Area Office (DOE/LAAO), and several divisions of the Los Alamosmore » National Laboratory. Revision 1 of the DARHT SAD had been written as part of the process for gaining approval to operate the Phase 1 (First Axis) Accelerator. Early in the planning stage for the required update of the SAD for the approval to operate both Phase 1 and Phase 2 (First Axis and Second Axis) DARHT Accelerator, it was discovered that a conflict existed between the Laboratory approach to describing the management of facility and worker safety.« less

  20. Adverse outcome pathways | Science Inventory | US EPA

    EPA Pesticide Factsheets

    The Systems Toxicology Unit of the European Commission Joint Research Centre (JRC) is strongly committed to development and uptake of AOPs. In coordination with the OECD, the JRC and EPA have collaborated closely in the development of training and outreach materials related to the development and application of AOPs. The European Food Safety Authority (EFSA) has requested that the JRC provide eight training courses, each 2 days in duration, to EFSA over a 2.5 year period. Given EPA’s expertise in the development of AOPs and the AOP-wiki, as well as EPA’s experience in training others on the AOP concepts and best practices in this rapidly moving arena, the JRC has engaged EPA expertise in this training activity, which reaches groups of 30-40 participants from regulatory authorities and academic institutes across Europe. Not Applicable

  1. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  2. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  3. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  4. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  5. 10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

  6. Barriers to Safety Event Reporting in an Academic Radiology Department: Authority Gradients and Other Human Factors.

    PubMed

    Siewert, Bettina; Swedeen, Suzanne; Brook, Olga R; Eisenberg, Ronald L; Hochman, Mary

    2018-05-15

    Purpose To investigate barriers to reporting safety concerns in an academic radiology department and to evaluate the role of human factors, including authority gradients, as potential barriers to safety concern reporting. Materials and Methods In this institutional review board-approved, HIPAA-compliant retrospective study, an online questionnaire link was emailed four times to all radiology department staff members (n = 648) at a tertiary care institution. Survey questions included frequency of speaking up about safety concerns, perceived barriers to speaking up, and the annual number of safety concerns that respondents were unsuccessful in reporting. Respondents' sex, role in the department, and length of employment were recorded. Statistical analysis was performed with the Fisher exact test. Results The survey was completed by 363 of the 648 employees (56%). Of those 363 employees, 182 (50%) reported always speaking up about safety concerns, 134 (37%) reported speaking up most of the time, 36 (10%) reported speaking up sometimes, seven (2%) reported rarely speaking up, and four (1%) reported never speaking up. Thus, 50% of employees spoke up about safety concerns less than 100% of the time. The most frequently reported barriers to speaking up included high reporting threshold (69%), reluctance to challenge someone in authority (67%), fear of disrespect (53%), and lack of listening (52%). Conclusion Of employees in a large academic radiology department, 50% do not attain 100% reporting of safety events. The most common human barriers to speaking up are high reporting threshold, reluctance to challenge authority, fear of disrespect, and lack of listening, which suggests that existing authority gradients interfere with full reporting of safety concerns. © RSNA, 2018.

  7. Assessment of an extended dataset of in vitro human dermal absorption studies on pesticides to determine default values, opportunities for read-across and influence of dilution on absorption.

    PubMed

    Aggarwal, M; Fisher, P; Hüser, A; Kluxen, F M; Parr-Dobrzanski, R; Soufi, M; Strupp, C; Wiemann, C; Billington, R

    2015-06-01

    Dermal absorption is a key parameter in non-dietary human safety assessments for agrochemicals. Conservative default values and other criteria in the EFSA guidance have substantially increased generation of product-specific in vitro data and in some cases, in vivo data. Therefore, data from 190 GLP- and OECD guideline-compliant human in vitro dermal absorption studies were published, suggesting EFSA defaults and criteria should be revised (Aggarwal et al., 2014). This follow-up article presents data from an additional 171 studies and also the combined dataset. Collectively, the data provide consistent and compelling evidence for revision of EFSA's guidance. This assessment covers 152 agrochemicals, 19 formulation types and representative ranges of spray concentrations. The analysis used EFSA's worst-case dermal absorption definition (i.e., an entire skin residue, except for surface layers of stratum corneum, is absorbed). It confirmed previously proposed default values of 6% for liquid and 2% for solid concentrates, irrespective of active substance loading, and 30% for all spray dilutions, irrespective of formulation type. For concentrates, absorption from solvent-based formulations provided reliable read-across for other formulation types, as did water-based products for solid concentrates. The combined dataset confirmed that absorption does not increase linearly beyond a 5-fold increase in dilution. Finally, despite using EFSA's worst-case definition for absorption, a rationale for routinely excluding the entire stratum corneum residue, and ideally the entire epidermal residue in in vitro studies, is presented. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  8. Claimed effects, outcome variables and methods of measurement for health claims proposed under European Community Regulation 1924/2006 in the framework of protection against oxidative damage and cardiovascular health.

    PubMed

    Martini, D; Rossi, S; Biasini, B; Zavaroni, I; Bedogni, G; Musci, M; Pruneti, C; Passeri, G; Ventura, M; Di Nuzzo, S; Galli, D; Mirandola, P; Vitale, M; Dei Cas, A; Bonadonna, R C; Del Rio, D

    2017-06-01

    The high number of negative opinions from the European Food Safety Authority (EFSA) to the requests for authorization of health claims is largely due to the design of human intervention studies, including the inappropriate choice of outcome variables (OVs) and of their methods of measurement (MMs). The present manuscript reports the results of an investigation aimed to collect, collate and critically analyse the information in relation to claimed effects, OVs and MMs, in the context of protection against oxidative damage and cardiovascular health compliant with Regulation 1924/2006. Claimed effects, OVs and the related MMs were collected from EFSA Guidance documents and applications for authorization of health claims under Articles 13.5 and 14. The OVs and their MMs were evaluated only if the claimed effect was sufficiently defined and was considered beneficial by EFSA. The collection, collation and critical analysis of the relevant scientific literature consisted in the definition of the keywords, the PubMed search strategies and the creation of databases of references. The critical analysis of the OVs and their MMs was performed on the basis of the literature review and was aimed at defining the appropriateness of OVs and MMs in the context of the specific claimed effects. The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for health claims, as well as to the stakeholders for the proper design of human intervention studies aimed to substantiate such health claims. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

  9. Claimed effects, outcome variables and methods of measurement for health claims proposed under European Community Regulation 1924/2006 in the area of blood glucose and insulin concentrations.

    PubMed

    Martini, Daniela; Biasini, Beatrice; Zavaroni, Ivana; Bedogni, Giorgio; Musci, Marilena; Pruneti, Carlo; Passeri, Giovanni; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Dei Cas, Alessandra; Bonadonna, Riccardo C; Del Rio, Daniele

    2018-04-01

    Most requests for authorization to bear health claims under Articles 13(5) and 14 related to blood glucose and insulin concentration/regulation presented to the European Food Safety Authority (EFSA) receive a negative opinion. Reasons for such decisions are mainly ascribable to poor substantiation of the claimed effects. In this scenario, a project was carried out aiming at critically analysing the outcome variables (OVs) and methods of measurement (MMs) to be used to substantiate health claims, with the final purpose to improve the quality of applications provided by stakeholders to EFSA. This manuscript provides a position statement of the experts involved in the project, reporting the results of an investigation aimed to collect, collate and critically analyse the information relevant to claimed effects (CEs), OVs and MMs related to blood glucose and insulin levels and homoeostasis compliant with Regulation 1924/2006. The critical analysis of OVs and MMs was performed with the aid of the pertinent scientific literature and was aimed at defining their appropriateness (alone or in combination with others) to support a specific CE. The results can be used to properly select OVs and MMs in a randomized controlled trial, for an effective substantiation of the claims, using the reference method(s) whenever available. Moreover, results can help EFSA in updating the guidance for the scientific requirements of health claims.

  10. Integrated data collection on zoonoses in the European Union, from animals to humans, and the analyses of the data.

    PubMed

    Ammon, Andrea; Makela, Pia

    2010-05-30

    The European Community (EC) has been collecting for 15 years data on zoonoses and agents thereof that integrate the information from human cases and their occurrence in food and animals. The current data collection covers 11 zoonotic agents: Salmonella, Campylobacter, Listeria, verotoxigenic E. coli (VTEC), Yersinia spp., Brucella, Mycobacterium bovis, Trichinella and Echinoccoccus, as well as rabies and food-borne outbreaks. The European Food Safety Authority (EFSA) is assigned the tasks of examining the data collected and publishing the Community Summary Report. This Report is prepared in close collaboration with the European Centre for Disease Prevention and Control (ECDC) responsible for the surveillance of the communicable diseases in humans, and with EFSA's Zoonoses Collaboration Centre (ZCC, in the Technical University of Denmark). Member States report the data on animals, feed, food and food-borne outbreaks to EFSA's web-based reporting system and the data on the human cases are reported to ECDC's web-application for The European Surveillance System (TESSy). The flow and analysis of data are described as well as an outline of the future plans to improve the comparability of the data. Copyright 2010 Elsevier B.V. All rights reserved.

  11. Reflections on bird and mammal risk assessment for plant protection products in the European Union: Past, present, and future.

    PubMed

    Brooks, Amy C; Fryer, Mike; Lawrence, Alan; Pascual, Juan; Sharp, Rachel

    2017-03-01

    The use of plant protection products on agricultural crops can result in exposure of birds and mammals to toxic chemicals. In the European Union, the risks from such exposures are assessed under the current (2009) guidance document from the European Food Safety Authority (EFSA), designed to increase the realism of the theoretical risk assessments in comparison to its predecessor (SANCO/4145/2000). Since its adoption over 7 yr ago, many plant protection products have been evaluated successfully using the 2009 EFSA guidance document. However, there are still significant areas of improvement recommended for future revisions of this guidance. The present Focus article discusses experiences to date with the current scheme, including levels of conservatism in input parameters and interpretation by regulatory authorities together with proposals for how the guidance document could be improved when it is revised in the not too distant future. Several areas for which further guidance is recommended have been identified, such as the derivation of ecologically relevant bird and mammal reproductive endpoints and the use of modeling approaches to contextualize risk assessments. Areas where existing databases could be improved were also highlighted, including the collation of relevant focal species across Europe and expansion of the residue database for food items. To produce a realistic and useable guidance document in the future, it is strongly recommended that there is open and constructive communication between industry, regulatory authorities, and the EFSA. Such collaboration would also encourage harmonization between member states, thus reducing workloads for both industry and regulatory authorities. Environ Toxicol Chem 2017;36:565-575. © 2017 SETAC. © 2017 SETAC.

  12. Taxonomy of Probiotic Microorganisms

    NASA Astrophysics Data System (ADS)

    Felis, Giovanna E.; Dellaglio, Franco; Torriani, Sandra

    When referring to probiotics, one refers to probiotic strains, i.e., the microbial individuals, sub-cultures of billion of almost identical cells ideally derived from the same mother cell. Therefore, beneficial effects attributed to probiotics are ascribed in fact to specific strains. However, these strains have to be, by law, clearly identified at the species level (Pineiro and Stanton, 2007). In fact, probiotics have to be safe for consumption, and the evaluation of QPS - qualified presumption of safety - status by the European Food Safety Authority (EFSA) (Opinion, 2007) is discussed for species, not for single strains.

  13. Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims Proposed Under European Community Regulation 1924/2006 in the Framework of Maintenance of Skin Function

    PubMed Central

    Cortelazzi, Chiara; Zavaroni, Ivana; Bedogni, Giorgio; Musci, Marilena; Pruneti, Carlo; Passeri, Giovanni; Ventura, Marco; Galli, Daniela; Vitale, Marco; Bonadonna, Riccardo C.; Di Nuzzo, Sergio; De Felici, Maria Beatrice

    2017-01-01

    Evidence suggests a protective role for several nutrients and foods in the maintenance of skin function. Nevertheless, all the requests for authorization to use health claims under Article 13(5) in the framework of maintenance of skin function presented to the European Food Safety Authority (EFSA) have received a negative opinion. Reasons for such failures are mainly due to an insufficient substantiation of the claimed effects, including the choice of inappropriate outcome variables (OVs) and methods of measurement (MMs). The present paper reports the results of an investigation aimed at collecting, collating and critically analyzing the information with relation to claimed effects (CEs), OVs and MMs related to skin health compliance with Regulation 1924/2006. CEs, OVs and MMs were collected from both the EFSA Guidance document and from the authorization requests of health claims under Article 13(5). The critical analysis of OVs and MMs was based on a literature review, and was aimed at defining their appropriateness (alone or in combination with others) in the context of a specific CE. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the claims. PMID:29271939

  14. Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims Proposed Under European Community Regulation 1924/2006 in the Framework of Maintenance of Skin Function.

    PubMed

    Martini, Daniela; Angelino, Donato; Cortelazzi, Chiara; Zavaroni, Ivana; Bedogni, Giorgio; Musci, Marilena; Pruneti, Carlo; Passeri, Giovanni; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Dei Cas, Alessandra; Bonadonna, Riccardo C; Di Nuzzo, Sergio; De Felici, Maria Beatrice; Del Rio, Daniele

    2017-12-22

    Evidence suggests a protective role for several nutrients and foods in the maintenance of skin function. Nevertheless, all the requests for authorization to use health claims under Article 13(5) in the framework of maintenance of skin function presented to the European Food Safety Authority (EFSA) have received a negative opinion. Reasons for such failures are mainly due to an insufficient substantiation of the claimed effects, including the choice of inappropriate outcome variables (OVs) and methods of measurement (MMs). The present paper reports the results of an investigation aimed at collecting, collating and critically analyzing the information with relation to claimed effects (CEs), OVs and MMs related to skin health compliance with Regulation 1924/2006. CEs, OVs and MMs were collected from both the EFSA Guidance document and from the authorization requests of health claims under Article 13(5). The critical analysis of OVs and MMs was based on a literature review, and was aimed at defining their appropriateness (alone or in combination with others) in the context of a specific CE. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the claims.

  15. RNAi-based GM plants: food for thought for risk assessors.

    PubMed

    Ramon, Matthew; Devos, Yann; Lanzoni, Anna; Liu, Yi; Gomes, Ana; Gennaro, Andrea; Waigmann, Elisabeth

    2014-12-01

    RNA interference (RNAi) is an emerging technology that offers new opportunities for the generation of new traits in genetically modified (GM) plants. Potential risks associated with RNAi-based GM plants and issues specific to their risk assessment were discussed during an international scientific workshop (June 2014) organized by the European Food Safety Authority (EFSA). Selected key outcomes of the workshop are reported here. © 2014 Society for Experimental Biology, Association of Applied Biologists and John Wiley & Sons Ltd.

  16. [Contaminants from food packaging : New developments in risk assessment].

    PubMed

    Pfaff, Karla; Wölfle, Detlef; Luch, Andreas

    2017-07-01

    Diverse materials intended for contact with food are important sources of food contamination. Harmonised European regulations including whitelists (so-called "positive lists") of substances along with migration limits and restrictions exist for plastics and regenerated cellulose films only. The European Food Safety Authority (EFSA) is responsible for the risk assessment of substances prior to their authorization and inclusion into the positive lists. In 2016 the EFSA issued an opinion on recent developments in the risk assessment of substances migrating into food for public consideration. Also migration related to non-intentionally added substances (NIASs), e. g. impurities, degradations products or oligomers, may be relevant for risk assessment. For substances migrating in quantities up to 50 ppb the requested data are restricted to genotoxicity testing based on a tiered approach for toxicological data requirements. In the case of higher migration levels (>50 ppb) experimental animal studies are also requested. Along with an evaluation of the available information, toxicological data on structurally similar substances may be used for the assessment if sufficiently justified with the aim to reduce animal studies as far as possible. For the risk assessment of NIASs it is possible to apply in silico methods in the absence of experimental toxicological data. Additionally, new technologies such as the use of nanomaterials, active and intelligent packaging and recycled plastics are challenging tasks in EFSA's risk assessment in accordance with the regulations by the European Commission.

  17. Claimed effects, outcome variables and methods of measurement for health claims on foods proposed under European Community Regulation 1924/2006 in the area of appetite ratings and weight management.

    PubMed

    Martini, Daniela; Biasini, Beatrice; Rossi, Stefano; Zavaroni, Ivana; Bedogni, Giorgio; Musci, Marilena; Pruneti, Carlo; Passeri, Giovanni; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Dei Cas, Alessandra; Bonadonna, Riccardo C; Del Rio, Daniele

    2018-06-01

    All the requests for authorisation to bear health claims under Articles 13(5) and 14 in the context of appetite ratings and weight management have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of the insufficient substantiation of the claimed effects (CEs). This manuscript results from an investigation aimed to collect, collate and critically analyse the information related to outcome variables (OVs) and methods of measurement (MMs) in the context of appetite ratings and weight management compliant with Regulation 1924/2006. Based on the literature review, the appropriateness of OVs and MMs was evaluated for specific CEs. This work might help EFSA in the development of updated guidance addressed to stakeholders interested in bearing health claims in the area of weight management. Moreover, it could drive the applicants during the design of randomised controlled trials aimed to substantiate such claims.

  18. 75 FR 3946 - Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-25

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-438-CP, 50-439-CP; ASLBP No. 10-896-01-CP-BD01] Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission dated December 29, 1972, published in the Federal Register, 37 FR 28,710 (1972), and the...

  19. Safety evaluation report on Tennessee Valley Authority: Browns Ferry nuclear performance plan

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

    Not Available

    1989-10-01

    This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Plant and in supporting documents has been prepared by the US Nuclear Regulatory commission staff. The Browns Ferry Nuclear Plant consists of three boiling-water reactors at a site in Limestone County, Alabama. The plan addresses the plant-specific concerns requiring resolution before the startup of Unit 2. The staff will inspect implementation of those TVA programs that address these concerns. Where systems are common to Units 1 and 2 or to Units 2more » and 3, the staff safety evaluations of those systems are included herein. 85 refs.« less

  20. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...; (2) To the contracting officer's knowledge, the Government has not provided advance notice so that... competition without SAFETY Act protections or the subject technology would be sold to the Government only with SAFETY Act protections. (b) Contracting officers shall not authorize offers contingent upon obtaining a...

  1. Drinking Water Intake Is Associated with Higher Diet Quality among French Adults

    PubMed Central

    Gazan, Rozenn; Sondey, Juliette; Maillot, Matthieu; Guelinckx, Isabelle; Lluch, Anne

    2016-01-01

    This study aimed to examine the association between drinking water intake and diet quality, and to analyse the adherence of French men and women to the European Food Safety Authority 2010 Adequate Intake (EFSA AI). A representative sample of French adults (≥18) from the Individual and National Survey on Food Consumption (INCA2) was classified, by sex, into small, medium, and large drinking water consumers. Diet quality was assessed with several nutritional indices (mean adequacy ratio (MAR), mean excess ratio (MER), probability of adequate intakes (PANDiet), and solid energy density (SED)). Of the total sample, 72% of men and 46% of women were below the EFSA AI. This percentage of non-adherence decreased from the small to the large drinking water consumers (from 95% to 34% in men and from 81% to 9% in women). For both sexes, drinking water intake was associated with higher diet quality (greater MAR and PANDiet). This association remained significant independently of socio-economic status for women only. Low drinking water consumers did not compensate with other sources (beverages and food moisture) and a high drinking water intake was not a guarantee for reaching the EFSA AI, meaning that increasing consumption of water should be encouraged in France. PMID:27809236

  2. Lack of genotoxicity in vivo for food color additive Allura Red AC.

    PubMed

    Bastaki, Maria; Farrell, Thomas; Bhusari, Sachin; Pant, Kamala; Kulkarni, Rohan

    2017-07-01

    Allura Red AC is an approved food color additive internationally with INS number 129, in the United States as food color subject to batch certification "Food, Drug, and Cosmetic" (FD&C) Red No. 40, and in Europe as food color additive with E number 129. In their evaluation of the color (2013), the European Food Safety Authority (EFSA) expressed concerns of potential genotoxicity, based primarily on one genotoxicity study that was not conducted according to Guidelines. The present in vivo genotoxicity study was conducted according to OECD Guidelines in response to EFSA's request for additional data. The animal species and strain, and the tissues examined were selected specifically to address the previously reported findings. The results show clear absence of genotoxic activity for Allura Red AC, in the bone marrow micronucleus assay and the Comet assay in the liver, stomach, and colon. These data addressed EFSA's concerns for genotoxicity. The Joint WHO/FAO Committee on Food Additives (JECFA) (2016) also reviewed the study and concluded that there is no genotoxicity concern for Allura Red AC. Negative findings in parallel genotoxicity studies on Tartrazine and Ponceau 4R (published separately) are consistent with lack of genotoxicity for azo dyes used as food colors. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Lack of genotoxicity in vivo for food color additive Tartrazine.

    PubMed

    Bastaki, Maria; Farrell, Thomas; Bhusari, Sachin; Pant, Kamala; Kulkarni, Rohan

    2017-07-01

    Tartrazine is approved as a food color additive internationally with INS number 102, in the United States as food color subject to batch certification "Food, Drug, and Cosmetic" (FD&C) Yellow No. 5, and in Europe as food color additive with E number 102. In their evaluation of the color (2013), the European Food Safety Authority (EFSA) expressed concerns of potential genotoxicity, based primarily on one genotoxicity study that was not conducted according to Guidelines. The present in vivo genotoxicity study was conducted according to OECD Guidelines in response to EFSA's request for additional data. The animal species and strain, and the tissues examined were selected specifically to address the previously reported findings. The results of this study show clear absence of genotoxic activity for Tartrazine, in the bone marrow micronucleus assay and the Comet assay in the liver, stomach, and colon. These data addressed EFSA's concerns for genotoxicity. The Joint WHO/FAO Committee on Food Additives (JECFA) (2016) also reviewed these data and concluded that there is no genotoxicity concern for Tartrazine. Negative findings in parallel genotoxicity studies on Allura Red AC and Ponceau 4R (published separately) are consistent with lack of genotoxicity for azo dyes used as food colors. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Drinking Water Intake Is Associated with Higher Diet Quality among French Adults.

    PubMed

    Gazan, Rozenn; Sondey, Juliette; Maillot, Matthieu; Guelinckx, Isabelle; Lluch, Anne

    2016-10-31

    This study aimed to examine the association between drinking water intake and diet quality, and to analyse the adherence of French men and women to the European Food Safety Authority 2010 Adequate Intake (EFSA AI). A representative sample of French adults (≥18) from the Individual and National Survey on Food Consumption (INCA2) was classified, by sex, into small, medium, and large drinking water consumers. Diet quality was assessed with several nutritional indices (mean adequacy ratio (MAR), mean excess ratio (MER), probability of adequate intakes (PANDiet), and solid energy density (SED)). Of the total sample, 72% of men and 46% of women were below the EFSA AI. This percentage of non-adherence decreased from the small to the large drinking water consumers (from 95% to 34% in men and from 81% to 9% in women). For both sexes, drinking water intake was associated with higher diet quality (greater MAR and PANDiet). This association remained significant independently of socio-economic status for women only. Low drinking water consumers did not compensate with other sources (beverages and food moisture) and a high drinking water intake was not a guarantee for reaching the EFSA AI, meaning that increasing consumption of water should be encouraged in France.

  5. Transport temperatures observed during the commercial transportation of animals.

    PubMed

    Fiore, Gianluca; Hofherr, Johann; Natale, Fabrizio; Mainetti, Sergio; Ruotolo, Espedito

    2012-01-01

    Current temperature standards and those proposed by the European Food Safety Authority (EFSA) were compared with the actual practices of commercial transport in the European Union. Temperature and humidity records recorded for a year on 21 vehicles over 905 journeys were analysed. Differences in temperature and humidity recorded by sensors at four different positions in the vehicles exceeded 10°C between the highest and lowest temperatures in nearly 7% of cases. The number and position of temperature sensors are important to ensure the correct representation of temperature conditions in the different parts of a vehicle. For all journeys and all animal categories, a relatively high percentage of beyond threshold temperatures can be observed in relation to the temperature limits of 30°C and 5°C. Most recorded temperature values lie within the accepted tolerance of ±5°C stipulated in European Community Regulation (EC) 1/2005. The temperature thresholds proposed by EFSA would result in a higher percentage of non-compliant conditions which are more pronounced at the lower threshold, compared to the thresholds laid down in Regulation (EC) 1/2005. With respect to the different animal categories, the non-compliant temperature occurrences were more frequent in pigs and sheep, in particular with regard to the thresholds proposed by EFSA.

  6. Cumulative dietary exposure to a selected group of pesticides of the triazole group in different European countries according to the EFSA guidance on probabilistic modelling.

    PubMed

    Boon, Polly E; van Donkersgoed, Gerda; Christodoulou, Despo; Crépet, Amélie; D'Addezio, Laura; Desvignes, Virginie; Ericsson, Bengt-Göran; Galimberti, Francesco; Ioannou-Kakouri, Eleni; Jensen, Bodil Hamborg; Rehurkova, Irena; Rety, Josselin; Ruprich, Jiri; Sand, Salomon; Stephenson, Claire; Strömberg, Anita; Turrini, Aida; van der Voet, Hilko; Ziegler, Popi; Hamey, Paul; van Klaveren, Jacob D

    2015-05-01

    The practicality was examined of performing a cumulative dietary exposure assessment according to the requirements of the EFSA guidance on probabilistic modelling. For this the acute and chronic cumulative exposure to triazole pesticides was estimated using national food consumption and monitoring data of eight European countries. Both the acute and chronic cumulative dietary exposures were calculated according to two model runs (optimistic and pessimistic) as recommended in the EFSA guidance. The exposures obtained with these model runs differed substantially for all countries, with the highest exposures obtained with the pessimistic model run. In this model run, animal commodities including cattle milk and different meat types, entered in the exposure calculations at the level of the maximum residue limit (MRL), contributed most to the exposure. We conclude that application of the optimistic model run on a routine basis for cumulative assessments is feasible. The pessimistic model run is laborious and the exposure results could be too far from reality. More experience with this approach is needed to stimulate the discussion of the feasibility of all the requirements, especially the inclusion of MRLs of animal commodities which seem to result in unrealistic conclusions regarding their contribution to the dietary exposure. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Total and inorganic arsenic in fish samples from Norwegian waters.

    PubMed

    Julshamn, Kaare; Nilsen, Bente M; Frantzen, Sylvia; Valdersnes, Stig; Maage, Amund; Nedreaas, Kjell; Sloth, Jens J

    2012-01-01

    The contents of total arsenic and inorganic arsenic were determined in fillet samples of Northeast Artic cod, herring, mackerel, Greenland halibut, tusk, saithe and Atlantic halibut. In total, 923 individual fish samples were analysed. The fish were mostly caught in the open sea off the coast of Norway, from 40 positions. The determination of total arsenic was carried out by inductively coupled plasma mass spectrometry following microwave-assisted wet digestion. The determination of inorganic arsenic was carried out by high-performance liquid chromatography-ICP-MS following microwave-assisted dissolution of the samples. The concentrations found for total arsenic varied greatly between fish species, and ranged from 0.3 to 110 mg kg(-1) wet weight. For inorganic arsenic, the concentrations found were very low (<0.006 mg kg(-1)) in all cases. The obtained results question the assumptions made by the European Food Safety Authority (EFSA) on the inorganic arsenic level in fish used in the recent EFSA opinion on arsenic in food.

  8. Claimed effects, outcome variables and methods of measurement for health claims on foods related to the gastrointestinal tract proposed under regulation (EC) 1924/2006.

    PubMed

    Biasini, Beatrice; Marchi, Laura; Angelino, Donato; Bedogni, Giorgio; Zavaroni, Ivana; Pruneti, Carlo; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Dei Cas, Alessandra; Bonadonna, Riccardo C; Passeri, Giovanni; Ventura, Marco; Del Rio, Daniele; Martini, Daniela

    2018-01-29

    Most of the requests of authorisation to the use of health claims pursuant to Regulation EC 1924/2006 related to the gastrointestinal (GI) tract have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of an insufficient substantiation of the claimed effect (CE). The present manuscript refers to the collection, collation and critical analysis of outcome variables (OVs) and methods of measurement (MMs) related to the GI tract compliant with Regulation 1924/2006. The critical evaluation of OVs and MMs was based on the literature review, with the final aim of defining their appropriateness in the context of a specific CE. The results obtained are relevant for the choice of the best OVs and MMs to be used in randomised controlled trials aimed to substantiate the claims on the GI tract. Moreover, the results can be used by EFSA for updating the guidance for the scientific requirements of such health claims.

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

    PubMed Central

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

    2002-01-01

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

  10. Safe Physical Activity Environments--To What Extent Are Local Government Authorities Auditing the Safety of Grassed Sporting Grounds?

    ERIC Educational Resources Information Center

    Otago, Leonie; Swan, Peter; Donaldson, Alex; Payne, Warren; Finch, Caroline

    2009-01-01

    Physical activity (PA) participation is influenced by the safety of the settings in which it is undertaken. This study describes the grounds assessment practices of Local Government Authorities (LGAs) in Victoria, Australia to ensure the safety of grassed sporting grounds. It also makes recommendations for improving these practices to maximise the…

  11. Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

    PubMed

    Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

    2015-09-01

    Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

  12. Safety evaluation report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan

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

    Not Available

    1991-01-01

    This safety evaluation report (SER) was prepared by the US Nuclear Regulatory Commission (NRC) staff and represents the second and last supplement (SSER 2) to the staff's original SER published as Volume 3 of NUREG-1232 in April 1989. Supplement 1 of Volume 3 of NUREG-1232 (SSER 1) was published in October 1989. Like its predecessors, SSER 2 is composed of numerous safety evaluations by the staff regarding specific elements contained in the Browns Ferry Nuclear Performance Plan (BFNPP), Volume 3 (up to and including Revision 2), submitted by the Tennessee Valley Authority (TVA) for the Browns Ferry Nuclear Plant (BFN).more » The Browns Ferry Nuclear Plant consists of three boiling-water reactors (BWRs) at a site in Limestone County, Alabama. The BFNPP describes the corrective action plans and commitments made by TVA to resolve deficiencies with its nuclear programs before the startup of Unit 2. The staff has inspected and will continue to inspect TVA's implementation of these BFNPP corrective action plans that address staff concerns about TVA's nuclear program. SSER 2 documents the NRC staff's safety evaluations and conclusions for those elements of the BFNPP that were not previously addressed by the staff or that remained open as a result of unresolved issues identified by the staff in previous SERs and inspections.« less

  13. Index to Nuclear Safety: a technical progress review by chronology, permuted title, and author, Volume 18 (1) through Volume 22 (6)

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

    Cottrell, W.B.; Passiakos, M.

    This index to Nuclear Safety covers articles published in Nuclear Safety, Volume 18, Number 1 (January-February 1977) through Volume 22, Number 6 (November-December 1981). The index is divided into three section: a chronological list of articles (including abstracts), a permuted-title (KWIC) index, and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. Over 300 technical articles published in Nuclear Safety in the last 5 years are listed in this index.

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

    PubMed

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

    2013-10-01

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

  15. Monitoring of polycyclic aromatic hydrocarbons (PAH) in food supplements containing botanicals and other ingredients on the Dutch market.

    PubMed

    Martena, M J; Grutters, M M P; De Groot, H N; Konings, E J M; Rietjens, I M C M

    2011-01-01

    Food supplements can contain polycyclic aromatic hydrocarbons (PAH). The European Food Safety Authority (EFSA) has defined 16 priority PAH that are both genotoxic and carcinogenic and identified eight priority PAH (PAH8) or four of these (PAH4) as good indicators of the toxicity and occurrence of PAH in food. The current study aimed to determine benzo[a]pyrene and other EFSA priority PAH in different categories of food supplements containing botanicals and other ingredients. From 2003 to 2008, benzo[a]pyrene exceeded the limit of quantification (LOQ) in 553 (44%) of 1258 supplements with a lower-bound mean of 3.37 µg kg(-1). In 2008 and 2009, benzo[a]pyrene and 12 other EFSA priority PAH were determined in 333 food supplements. Benzo[a]pyrene exceeded the LOQ in 210 (63%) food supplements with a lower-bound mean of 5.26 µg kg(-1). Lower-bound mean levels for PAH4 and PAH8(-indeno[1,2,3-cd]pyrene) were 33.5 and 40.5 µg kg(-1), respectively. Supplements containing resveratrol, Ginkgo biloba, St. John's wort and propolis showed relatively high PAH4 levels in 2008 and 2009. Before 2008, supplements with these ingredients and also dong quai, green tea or valerian contained relatively high benzo[a]pyrene levels. On average, PAH4 intake resulting from food supplement use will be at the lower end of the range of contributions of main food groups to PAH4 exposure, although individual food supplements can contribute significantly to PAH4 exposure. Regular control of EFSA indicator PAH levels in food supplements may prove a way forward to reduce further the intake of PAH from food.

  16. Attitudes and beliefs on the establishment of a national food safety authority in Cyprus. A population-based survey.

    PubMed

    Hadjigeorgiou, Andreas; Talias, Michael A; Soteriades, Elpidoforos S; Philalithis, Anastasios; Psaroulaki, Anna; Gikas, Achilleas; Tselentis, Yiannis

    2014-04-01

    Cyprus does not have a National Food Safety Authority (NFSA), but a multi-level, fragmented system with responsibilities divided among different ministries and governmental agencies, frequently impeding efforts to effectively manage food risks by duplication and overlapping of responsibilities. A population-based survey was carried out to determine the beliefs and attitudes of interested parties concerning the establishment of a NFSA in Cyprus. Information was collected using a random stratified sampling design and a structured questionnaire. A total of 868 questionnaires were collected (704 from regular consumers, 154 from food businesses' representatives, and 10 from public services' directors or acting head officers). About 11% of food businesses' representatives and 45% of consumers reported that they did not know which public authorities are responsible for food control. Moreover, 2 out of 10 (17%) of responders from public agencies, 70% from food businesses and 91% from consumers, although not aware of ongoing efforts to establish a food safety authority in Cyprus (currently under consideration), were supportive of the idea [8 out of 10 (83%) of responders from public services, 93% from food businesses, and 89% of consumers]. Finally, 7 out of 10 (67%) from the public agencies and 84% of representatives from food businesses agreed with the separation of risk assessment from risk management activities. Public opinion in Cyprus as well as public agencies and food businesses' representatives support the establishment of a single independent national food safety authority in Cyprus based on the European paradigm including the division of risk activities. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. Index to Nuclear Safety. A technical progress review by chronology, permuted title, and author. Vol. 11, No. 1--Vol. 17, No. 6

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

    Cottrell, W.B.; Klein, A.

    1977-02-23

    This index to Nuclear Safety covers articles in Nuclear Safety Vol. 11, No. 1 (Jan.-Feb. 1970), through Vol. 17, No. 6 (Nov.-Dec. 1976). The index includes a chronological list of articles (including abstract) followed by KWIC and Author Indexes. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. The index lists over 350 technical articles in the last six years of publication.

  18. A new food frequency questionnaire to assess chocolate and cocoa consumption.

    PubMed

    Vicente, Filipa; Saldaña-Ruíz, Sandra; Rabanal, Manel; Rodríguez-Lagunas, María J; Pereira, Paula; Pérez-Cano, Francisco J; Castell, Margarida

    2016-01-01

    Cocoa has been highlighted as a food with potential benefits to human health because of its polyphenol content. However, few studies show the contribution of cocoa and chocolate products in polyphenol intake. The aim of this work was to develop a food frequency questionnaire (FFQ) for evaluating the intake of food products containing cocoa (C-FFQ). A sample of 50 university students was recruited to complete the 90-item questionnaire, a validated questionnaire (called here European Food Safety Authority [EFSA]-Q) as well as a 24-hour dietary recall (24 HDR). Spearman correlation test, Bland-Altman plots, and quintile classification analysis were conducted together with the Wilcoxon test and descriptive statistics. Significant correlations between the C-FFQ and the EFSA-Q for the most common cocoa/chocolate products were observed (P < 0.05), as well as between data from the C-FFQ and 24 HDR (P < 0.05). However, a number of cocoa/chocolate products frequently consumed by the participants were detected by the C-FFQ and 24 HDR which were not included in the EFSA-Q. According to the C-FFQ, chocolate bars were the main source of cocoa in university students, but dairy products also provided an important amount of cocoa. The developed C-FFQ questionnaire can be considered as a valid option for assessing the consumption frequency of cocoa/chocolate-derived products, thereby allowing the evaluation of cocoa polyphenol intake in further studies. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. Safety Evaluation Report on Tennessee Valley Authority: Browns Ferry Nuclear Performance Plan: Browns Ferry Unit 2 restart

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

    Not Available

    1989-04-01

    This safety evaluation report (SER) on the information submitted by the Tennessee Valley Authority (TVA) in its Nuclear Performance Plan, through Revision 2, for the Browns Ferry Nuclear Power Station and in supporting documents has been prepared by the US Nuclear Regulatory Commission staff. The plan addresses the plant-specific concerns requiring resolution before startup of Unit 2. The staff will inspect implementation of those programs. Where systems are common to Units 1 and 2 or to Units 2 and 3, the staff safety evaluations of those systems are included herein. 3 refs.

  20. Efficacy and safety testing of mycotoxin-detoxifying agents in broilers following the European Food Safety Authority guidelines.

    PubMed

    Osselaere, A; Devreese, M; Watteyn, A; Vandenbroucke, V; Goossens, J; Hautekiet, V; Eeckhout, M; De Saeger, S; De Baere, S; De Backer, P; Croubels, S

    2012-08-01

    Contamination of feeds with mycotoxins is a worldwide problem and mycotoxin-detoxifying agents are used to decrease their negative effect. The European Food Safety Authority recently stated guidelines and end-points for the efficacy testing of detoxifiers. Our study revealed that plasma concentrations of deoxynivalenol and deepoxy-deoxynivalenol were too low to assess efficacy of 2 commercially available mycotoxin-detoxifying agents against deoxynivalenol after 3 wk of continuous feeding of this mycotoxin at concentrations of 2.44±0.70 mg/kg of feed and 7.54±2.20 mg/kg of feed in broilers. This correlates with the poor absorption of deoxynivalenol in poultry. A safety study with 2 commercially available detoxifying agents and veterinary drugs showed innovative results with regard to the pharmacokinetics of 2 antibiotics after oral dosing in the drinking water. The plasma and kidney tissue concentrations of oxytetracycline were significantly higher in broilers receiving a biotransforming agent in the feed compared with control birds. For amoxicillin, the plasma concentrations were significantly higher for broilers receiving an adsorbing agent in comparison to birds receiving the biotransforming agent, but not to the control group. Mycotoxin-detoxifying agents can thus interact with the oral bioavailability of antibiotics depending on the antibiotic and detoxifying agent, with possible adverse effects on the health of animals and humans.

  1. 47 CFR 0.392 - Authority delegated.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 1 2011-10-01 2011-10-01 false Authority delegated. 0.392 Section 0.392 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public Safety and Homeland Security Bureau § 0.392 Authority delegated. The Chief, Public Safety and Homeland...

  2. 47 CFR 0.392 - Authority delegated.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Authority delegated. 0.392 Section 0.392 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public Safety and Homeland Security Bureau § 0.392 Authority delegated. The Chief, Public Safety and Homeland...

  3. Authorization basis supporting documentation for plutonium finishing plant

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

    King, J.P., Fluor Daniel Hanford

    1997-03-05

    The identification and definition of the authorization basis for the Plutonium Finishing Plant (PFP) facility and operations are essential for compliance to DOE Order 5480.21, Unreviewed Safety Questions. The authorization basis, as defined in the Order, consists of those aspects of the facility design basis, i.e., the structures, systems and components (SSCS) and the operational requirements that are considered to be important to the safety of operations and are relied upon by DOE to authorize operation of the facility. These facility design features and their function in various accident scenarios are described in WHC-SD-CP-SAR-021, Plutonium Finishing Plant Final Safety Analysismore » Report (FSAR), Chapter 9, `Accident Analysis.` Figure 1 depicts the relationship of the Authorization Basis to its components and other information contained in safety documentation supporting the Authorization Basis. The PFP SSCs that are important to safety, collectively referred to as the `Safety Envelope` are discussed in various chapters of the FSAR and in WHC-SD-CP-OSR-010, Plutonium Finishing Plant Operational Safety Requirements. Other documents such as Criticality Safety Evaluation Reports (CSERS) address and support some portions of the Authorization Basis and Safety Envelope.« less

  4. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  5. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  6. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  7. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  8. 49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

  9. Is an ecosystem services-based approach developed for setting specific protection goals for plant protection products applicable to other chemicals?

    PubMed

    Maltby, Lorraine; Jackson, Mathew; Whale, Graham; Brown, A Ross; Hamer, Mick; Solga, Andreas; Kabouw, Patrick; Woods, Richard; Marshall, Stuart

    2017-02-15

    Clearly defined protection goals specifying what to protect, where and when, are required for designing scientifically sound risk assessments and effective risk management of chemicals. Environmental protection goals specified in EU legislation are defined in general terms, resulting in uncertainty in how to achieve them. In 2010, the European Food Safety Authority (EFSA) published a framework to identify more specific protection goals based on ecosystem services potentially affected by plant protection products. But how applicable is this framework to chemicals with different emission scenarios and receptor ecosystems? Four case studies used to address this question were: (i) oil refinery waste water exposure in estuarine environments; (ii) oil dispersant exposure in aquatic environments; (iii) down the drain chemicals exposure in a wide range of ecosystems (terrestrial and aquatic); (iv) persistent organic pollutant exposure in remote (pristine) Arctic environments. A four-step process was followed to identify ecosystems and services potentially impacted by chemical emissions and to define specific protection goals. Case studies demonstrated that, in principle, the ecosystem services concept and the EFSA framework can be applied to derive specific protection goals for a broad range of chemical exposure scenarios. By identifying key habitats and ecosystem services of concern, the approach offers the potential for greater spatial and temporal resolution, together with increased environmental relevance, in chemical risk assessments. With modifications including improved clarity on terminology/definitions and further development/refinement of the key concepts, we believe the principles of the EFSA framework could provide a methodical approach to the identification and prioritization of ecosystems, ecosystem services and the service providing units that are most at risk from chemical exposure. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights

  10. Drug packaging in 2014: authorities should direct more efforts towards medication safety.

    PubMed

    2015-05-01

    In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety. Although pharmaceutical companies and drug regulatory agencies seem to be taking more account of the risk of accidental poisoning in children, the level of protection remains low overall in the absence of stringent measures on the part of the authorities. New drugs too often have poor-quality or even dangerous packaging at the time of their market introduction. And the packaging quality of older drugs is disturbing. Pharmaceutical companies no longer invest in the packaging of these products, and agencies often fail to take advantage of the opportunities provided by their reassessment to improve the situation. The inappropriate labelling of certain injectable drugs remains a source of medication errors, sometimes resulting in very serious consequences. In 2014, signs of progress in the packaging of several drugs show that its role in medication safety is better appreciated. But the persistence of dangers in the pharmaceuticals market, created by "unfinished", overly complex or poor-quality packaging, raises the question of the responsibility of pharmaceutical companies and agencies for past and present accidents.

  11. The need for strategic development of safety sciences.

    PubMed

    Busquet, Francois; Hartung, Thomas

    2017-01-01

    The practice of risk assessment and regulation of substances has largely developed as a patchwork of circumstantial additions to a nowadays more or less shared international toolbox. The dominant drivers from the US and Europe have pursued remarkably different approaches in the use of these tools for regulation, i.e., a more risk-based approach in the US and a more precautionary approach in Europe. We argue that there is need for scientific developments not only for the tools but also for their application, i.e., a need for Regulatory Science or, perhaps better, Safety Science. While some of this is emerging on the US side as strategic reports, e.g., from the National Academies, the NIH and the regulatory agencies, especially the EPA and the FDA, such strategic developments beyond technological developments are largely lacking in Europe or have started only recently at EFSA, ECHA or within the flagship project EU-ToxRisk. This article provides a rationale for the creation of a European Safety Sciences Institute (ESSI) based on regulatory and scientific needs, political context and current EU missions. Moreover, the possible modus operandi of ESSI will be described along with possible working formats as well as anticipated main tasks and duties. This mirrors the triple alliance on the American side (US EPA, NIH and FDA) in revamping regulatory sciences. Moreover, this could fit the political agenda of the European Commission for better implementation of existing EU legislation rather than creating new laws.

  12. Towards a harmonized approach for risk assessment of genotoxic carcinogens in the European Union.

    PubMed

    Crebelli, Riccardo

    2006-01-01

    The EU Scientific Committees have considered in the past the use of matematical models for human cancer risk estimation not adequately supported by the available scientific knowledge. Therefore, the advice given to risk managers was to reduce the exposure as far as possible, following the as low as reasonably achievable (ALARA) principle. However, ALARA does not allow to set priorities for risk management, as it does not take into consideration carcinogenic potency and level of human exposure. For this reason the European Food Safety Authority (EFSA) has identified as a priority task the development of a transparent, scientically justifiable and harmonized approach for risk assessment of genotoxic carcinogens. This approach, proposed at the end of 2005, is based on the definition of the (MOE), i.e. the relationship between a given point of the dose reponse curve in the animal and human exposure. As point of comparison EFSA recommends the BMDL10, i.e. the lower limit of the confidence interval of the Benchmark Dose associated with an incidence of 10% of induced tumors. Based on current scientific knowkedge, EFSA concluded that a MOE of 10000 or greater is associated with a low risk and low priority for risk management actions. The approach proposed does not replace the ALARA. It should find application on food contaminants, process by-product, and other substances unintentionally present in food. On the other hand, it is not intended to provide a tool for the definition of tolerable intake levels for genotoxic carcinogens deliberately added to food.

  13. Highway Safety Program Manual: Volume 14: Pedestrian Safety.

    ERIC Educational Resources Information Center

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

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

  14. Highway Safety Program Manual: Volume 3: Motorcycle Safety.

    ERIC Educational Resources Information Center

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

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

  15. [Isoflavone-containing dietary supplements].

    PubMed

    Lehmann, Leane; Soukup, Sebastian T; Gerhäuser, Clarissa; Vollmer, Günter; Kulling, Sabine E

    2017-03-01

    Isoflavones (IFs) from soy and other legumes have weak estrogenic properties. Isolated IFs are available as dietary supplements and advertised to alleviate symptoms of menopause. The present chapter provides an overview of the occurrence, the chemical structure of IFs and their metabolites, the market situation and reviews the current evidence on the efficacy and safety of IF-containing dietary supplements.The biological effectiveness of IFs is attributable to the activation of the estrogen receptor (ER). Studies on the influence of IFs on endogenous estrogen levels in women show inconsistent results. So far, the European Food Safety Authority (EFSA) has rejected all submitted health claims for IFs due to insufficient scientific evidence for any of the postulated health effects. Based on the results of their recent risk assessment, the EFSA concluded that the available human studies did not support the hypothesis of adverse effects of isolated IFs on the human mammary gland, uterus or thyroid in healthy postmenopausal women. However, the assessment does not allow a general statement on the safety of IF-containing dietary supplements. Studies in animal models are often not comparable with the complex interactions in humans due to differences in the metabolism of IFs, in the developmental stage at time of consumption and in the temporarily restricted uptake of IFs during certain stages of life. So far, for none of the advertised functions is unequivocal scientific evidence available. On the basis of available data, potential unwanted side effects cannot be fully excluded. This holds particularly true for women with undiagnosed diseases, especially for those with undetected precancerous lesions in the mammary gland.

  16. Detection of biogenic amines and microbial safety assessment of novel Meju fermented with addition of Nelumbo nucifera, Ginkgo biloba, and Allium sativum.

    PubMed

    Shukla, Shruti; Lee, Jong Suk; Bajpai, Vivek K; Nile, Shivraj Hariram; Huh, Yun Suk; Han, Young-Kyu; Kim, Myunghee

    2018-04-10

    Meju, a cooked and fermented soy bean based food product, is used as a major ingredient in Korean traditional fermented foods such as Doenjang. We developed a novel type of Meju using single and combined extracts of Allium sativum (garlic clove), Nelumbo nucifera (lotus leaves), and Ginkgo biloba (ginkgo leaves) at 1% and 10% concentrations to improve the safety of Meju-based fermented products. Biogenic amines (BAs) in protein-rich fermented food products pose considerable toxical risks. The objective of this study was to investigate the effects of adding selected plant extracts in Meju samples during fermentation. Nine BAs, including tryptamine, 2-phenylethylamine, putrescine, cadaverine, agmatine, histamine, tyramine, spermidine and spermine, were isolated from Meju samples after sample derivatization with dansyl chloride and analyzed by high performance liquid chromatography. As a result, all tested Meju samples with added plant extracts showed total BAs levels in the range of 20.12 ± 2.03 to 118.42 ± 10.68 mg/100 g, which were below the safety limit set by various regulatory authorities (USFDA/KFDA/EFSA). However, among all tested Meju samples, LOM10 (Meju fermented with Nelumbo nucifera at 10% concentration) showed higher levels of BAs content than others either due to batch-to-batch variability or reduced beneficial microorganisms and/or due to increase in BA forming microorganisms. Also, none of the samples showed the aflatoxin level above the detection limit. Furthermore, all the tested Meju samples improved microbial safety as confirmed by the complete absence of Salmonella species and Staphylococcus aureus. However, some of the Meju samples showed the presence of coliforms (in range of 1.6 × 10 0 -1.1 × 10 3  CFU/g), which is under regulatory limits. These results suggested that the use of plant extracts in Meju during fermentation have potential to improve microbial and toxicological safety of Meju products. Copyright © 2018

  17. Water and beverage consumption among children aged 4-13 years in France: analyses of INCA 2 (Étude Individuelle Nationale des Consommations Alimentaires 2006-2007) data.

    PubMed

    Vieux, Florent; Maillot, Matthieu; Constant, Florence; Drewnowski, Adam

    2016-09-01

    To examine the consumption of plain water among children in France and compare total water intakes with guidelines issued by the European Food Safety Authority (EFSA). Nationally representative data were used to assess food, beverage and water consumption by sex, age group (4-8 years, 9-13 years), income-to-poverty ratio, eating occasion and location. Beverages were classified into nine groups: water (tap or bottled), milk, 100 % fruit juice, sodas, fruit drinks, hot beverages, sports drinks and flavoured waters. Total water volume in relation to energy intake (litres/kcal) was also examined. INCA 2 study (Étude Individuelle Nationale des Consommations Alimentaires 2006-2007). French children (n 835) aged 4-13 years. Total water intakes were accounted for by plain water (34 %), beverages (26 %) and food moisture (40 %). Plain water could be tap (18 %) or bottled (16 %). Older children drank more plain water than did younger children and boys drank more plain water than did girls. No socio-economic gradient for plain water consumption was observed. About 90 % of children did not meet the EFSA water intake recommendations. The daily water shortfall ranged from 367 to 594 ml/d. Water-to-energy ratio was 0·75-0·77 litres/1000 kcal (4184 kJ). Children drank milk at breakfast and plain water during lunch and dinner. Caloric beverages provided 10 % of dietary energy; consumption patterns varied by eating location. Total water intakes among young children in France were below EFSA-recommended levels. Analyses of beverage consumption patterns by eating occasion and location can help identify ways to increase water consumption among children.

  18. 16 CFR 1500.2 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Authority. 1500.2 Section 1500.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND ENFORCEMENT REGULATIONS § 1500.2 Authority. Authority under the...

  19. Transgenesis affects endogenous soybean allergen levels less than traditional breeding.

    PubMed

    Hill, Ryan C; Fast, Brandon J; Herman, Rod A

    2017-10-01

    The regulatory body that oversees the safety assessment of genetically modified (GM) crops in the European Union, the European Food Safety Authority (EFSA), uniquely requires that endogenous allergen levels be quantified as part of the compositional characterization of GM versions of crops, such as soybean, that are considered to be major allergenic foods. The value of this requirement for assessing food safety has been challenged for multiple reasons including negligible risk of altering allergen levels compared with traditional non-GM breeding. Scatter plots comparing the mean endogenous allergen levels in non-GM soybean isoline grain with the respective levels in GM grain or concurrently grown non-GM commercial reference varieties clearly show that transgenesis causes less change compared with traditional breeding. This visual assessment is confirmed by the quantitative fit of the line of identity (y = x) to the datasets. The current science on allergy does not support the requirement for quantifying allergen levels in GM crops to support safety assessment. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  1. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  2. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  3. 16 CFR 1700.2 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Authority. 1700.2 Section 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of 1970 is...

  4. 49 CFR Appendix to Subpart H of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Non-North America-Domiciled...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Evaluation Criteria for Non-North America-Domiciled Motor Carriers Appendix to Subpart H of Part 385... Special Rules for New Entrant Non-North America-Domiciled Carriers Pt. 385, Subpt. H, App. Appendix to Subpart H of Part 385—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Non-North...

  5. State Regulatory Authority (SRA) Coordination of Safety, Security, and Safeguards of Nuclear Facilities: A Framework for Analysis

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

    Mladineo, Stephen V.; Frazar, Sarah L.; Kurzrok, Andrew J.

    This paper will explore the development of a framework for conducting an assessment of safety-security-safeguards integration within a State. The goal is to examine State regulatory structures to identify conflicts and gaps that hinder management of the three disciplines at nuclear facilities. Such an analysis could be performed by a State Regulatory Authority (SRA) to provide a self-assessment or as part of technical cooperation with either a newcomer State, or to a State with a fully developed SRA.

  6. 10 CFR 60.31 - Construction authorization.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Construction authorization. 60.31 Section 60.31 Energy... REPOSITORIES Licenses Construction Authorization § 60.31 Construction authorization. Upon review and... authorize construction if it determines: (a) Safety. That there is reasonable assurance that the types and...

  7. 10 CFR 60.31 - Construction authorization.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Construction authorization. 60.31 Section 60.31 Energy... REPOSITORIES Licenses Construction Authorization § 60.31 Construction authorization. Upon review and... authorize construction if it determines: (a) Safety. That there is reasonable assurance that the types and...

  8. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  9. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  10. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  11. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  12. 49 CFR 451.3 - Action by Approval Authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

  13. [Genetically modified food and allergies - an update].

    PubMed

    Niemann, Birgit; Pöting, Annette; Braeuning, Albert; Lampen, Alfonso

    2016-07-01

    Approval by the European Commission is mandatory for placing genetically modified plants as food or feed on the market in member states of the European Union (EU). The approval is preceded by a safety assessment based on the guidance of the European Food Safety Authority EFSA. The assessment of allergenicity of genetically modified plants and their newly expressed proteins is an integral part of this assessment process. Guidance documents for the assessment of allergenicity are currently under revision. For this purpose, an expert workshop was conducted in Brussels on June 17, 2015. There, methodological improvements for the assessment of coeliac disease-causing properties of proteins, as well as the use of complex models for in vitro digestion of proteins were discussed. Using such techniques a refinement of the current, proven system of allergenicity assessment of genetically modified plants can be achieved.

  14. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... this part. The Food Safety Inspection Service and its officers and employees shall not be liable in...

  15. Water and beverage consumption patterns among 4 to 13-year-old children in the United Kingdom.

    PubMed

    Vieux, Florent; Maillot, Matthieu; Constant, Florence; Drewnowski, Adam

    2017-05-19

    The UK government has announced a tax on sugar-sweetened beverages. The aim of this study was to assess consumption patterns for plain drinking water relative to sugary beverages among UK children. Dietary intake data for 845 children aged 4-13 years came from the nationally representative cross-sectional National Diet and Nutrition Survey, 2008-2011. Beverage categories were drinking water (tap or bottled), milk, 100% fruit juices, soda, fruit drinks, tea, coffee, sports drinks, flavored waters, and liquid supplements. Consumption patterns were examined by age group, gender, household incomes, time and location of consumption, region and seasonality. Total water consumption from drinking water, beverages, and foods, and the water-to-calorie ratios (L/kcal) were compared to the EFSA (European Food Safety Authority) adequate intake standards. Total water intake (1338 ml/d) came from plain water (19%), beverages (48%), and food moisture (33%). Plain drinking water provided 258 g/d (241 g/d for children aged 4-8 years; 274 g/d for 9-13 years), mostly (83.8%) from tap. Water and beverages supplied 901 g /d of water. Tap water consumption increased with income and was highest in the South of England. The consumption of bottled water, soda, tea and coffee increased with age, whereas milk consumption declined. About 88.7% of children did not meet EFSA adequate intake standards. The daily water shortfall ranged from 322 ml/d to 659 ml/d. Water-to-calorie ratio was 0.845 L/1000 kcal short of desirable levels of 1.0-1.5 L/1000 kcal. Total water intake were at 74.8% of EFSA reference values. Drinking water consumption among children in the UK was well below US and French estimates.

  16. Handling of thermal paper: Implications for dermal exposure to bisphenol A and its alternatives.

    PubMed

    Bernier, Meghan R; Vandenberg, Laura N

    2017-01-01

    Bisphenol A (BPA) is an endocrine disrupting chemical used in a wide range of consumer products including photoactive dyes used in thermal paper. Recent studies have shown that dermal absorption of BPA can occur when handling these papers. Yet, regulatory agencies have largely dismissed thermal paper as a major source of BPA exposure. Exposure estimates provided by agencies such as the European Food Safety Authority (EFSA) are based on assumptions about how humans interact with this material, stating that 'typical' exposures for adults involve only one handling per day for short periods of time (<1 minute), with limited exposure surfaces (three fingertips). The objective of this study was to determine how individuals handle thermal paper in one common setting: a cafeteria providing short-order meals. We observed thermal paper handling in a college-aged population (n = 698 subjects) at the University of Massachusetts' dining facility. We find that in this setting, individuals handle receipts for an average of 11.5 min, that >30% of individuals hold thermal paper with more than three fingertips, and >60% allow the paper to touch their palm. Only 11% of the participants we observed were consistent with the EFSA model for time of contact and dermal surface area. Mathematical modeling based on handling times we measured and previously published transfer coefficients, concentrations of BPA in paper, and absorption factors indicate the most conservative estimated intake from handling thermal paper in this population is 51.1 ng/kg/day, similar to EFSA's estimates of 59 ng/kg/day from dermal exposures. Less conservative estimates, using published data on concentrations in thermal paper and transfer rates to skin, indicate that exposures are likely significantly higher. Based on our observational data, we propose that the current models for estimating dermal BPA exposures are not consistent with normal human behavior and should be reevaluated.

  17. Recent advances in the risk assessment of melamine and cyanuric acid in animal feed

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

    Dorne, Jean Lou, E-mail: jean-lou.dorne@efsa.europa.eu; Doerge, Daniel R.; Vandenbroeck, Marc

    Melamine can be present at low levels in food and feed mostly from its legal use as a food contact material in laminates and plastics, as a trace contaminant in nitrogen supplements used in animal feeds, and as a metabolite of the pesticide cyromazine. The mechanism of toxicity of melamine involves dose-dependent formation of crystals with either endogenous uric acid or a structural analogue of melamine, cyanuric acid, in renal tubules resulting in potential acute kidney failure. Co-exposure to melamine and cyanuric acid in livestock, fish, pets and laboratory animals shows higher toxicity compared with melamine or cyanuric acid alone.more » Evidence for crystal formation between melamine and other structural analogs i.e. ammelide and ammeline is limited. Illegal pet food adulterations with melamine and cyanuric acid and adulteration of milk with melamine resulted in melamine–cyanuric acid crystals, kidney damage and deaths of cats and dogs and melamine–uric acid stones, hospitalisation and deaths of children in China respectively. Following these incidents, the tolerable daily intake for melamine was re-evaluated by the U.S. Food and Drug Administration, the World Health Organisation, and the Scientific Panel on Contaminants in the Food Chain of the European Food Safety Authority (EFSA). This review provides an overview of toxicology, the adulteration incidents and risk assessments for melamine and its structural analogues. Particular focus is given to the recent EFSA risk assessment addressing impacts on animal and human health of background levels of melamine and structural analogues in animal feed. Recent research and future directions are discussed. - Highlights: ► Melamine in food and feed. ► Forms crystals in kidney with uric acid or cyanuric acid. ► Toxicity higher with cyanuric acid. ► Recent EFSA risk assessment. ► Animal and human health.« less

  18. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  19. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  20. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  1. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

  2. Safety in the Chemical Laboratory: Developing Departmental Safety Procedures.

    ERIC Educational Resources Information Center

    Renfrew, Malcolm M., Ed.; Palladino, George F.

    1980-01-01

    Presents rationale and guidelines for development of Safety Standard Operating Procedures (Safety SOP) specific for local conditions. Includes an outline of a Safety SOP developed for a department primarily focused on undergraduate education with a wide variety of expertise from common laborer to PhD with 20 years experience. (Author/JN)

  3. 77 FR 28451 - Unsatisfactory Safety Rating; Revocation of Operating Authority Registration; Technical Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-14

    ... carrier for failure to comply with safety fitness requirements; if the Agency determines that a motor carrier is ``Unfit'' based on its Safety Fitness Determination procedures, the Agency must revoke the... failure to comply with safety fitness requirements. See 49 U.S.C. 13905(f)(1)(B) and (3). The implementing...

  4. The Peroxidation of Leukocytes Index Ratio Reveals the Prooxidant Effect of Green Tea Extract

    PubMed Central

    Manafikhi, Husseen; Raguzzini, Anna; Longhitano, Yaroslava; Reggi, Raffaella; Zanza, Christian

    2016-01-01

    Despite tea increased plasma nonenzymatic antioxidant capacity, the European Food Safety Administration (EFSA) denied claims related to tea and its protection from oxidative damage. Furthermore, the Supplement Information Expert Committee (DSI EC) expressed some doubts on the safety of green tea extract (GTE). We performed a pilot study in order to evaluate the effect of a single dose of two capsules of a GTE supplement (200 mg × 2) on the peroxidation of leukocytes index ratio (PLIR) in relation to uric acid (UA) and ferric reducing antioxidant potential (FRAP), as well as the sample size to reach statistical significance. GTE induced a prooxidant effect on leukocytes, whereas FRAP did not change, in agreement with the EFSA and the DSI EC conclusions. Besides, our results confirm the primary role of UA in the antioxidant defences. The ratio based calculation of the PLIR reduced the sample size to reach statistical significance, compared to the resistance to an exogenous oxidative stress and to the functional capacity of oxidative burst. Therefore, PLIR could be a sensitive marker of redox status. PMID:28101300

  5. The Peroxidation of Leukocytes Index Ratio Reveals the Prooxidant Effect of Green Tea Extract.

    PubMed

    Peluso, Ilaria; Manafikhi, Husseen; Raguzzini, Anna; Longhitano, Yaroslava; Reggi, Raffaella; Zanza, Christian; Palmery, Maura

    2016-01-01

    Despite tea increased plasma nonenzymatic antioxidant capacity, the European Food Safety Administration (EFSA) denied claims related to tea and its protection from oxidative damage. Furthermore, the Supplement Information Expert Committee (DSI EC) expressed some doubts on the safety of green tea extract (GTE). We performed a pilot study in order to evaluate the effect of a single dose of two capsules of a GTE supplement (200 mg × 2) on the peroxidation of leukocytes index ratio (PLIR) in relation to uric acid (UA) and ferric reducing antioxidant potential (FRAP), as well as the sample size to reach statistical significance. GTE induced a prooxidant effect on leukocytes, whereas FRAP did not change, in agreement with the EFSA and the DSI EC conclusions. Besides, our results confirm the primary role of UA in the antioxidant defences. The ratio based calculation of the PLIR reduced the sample size to reach statistical significance, compared to the resistance to an exogenous oxidative stress and to the functional capacity of oxidative burst. Therefore, PLIR could be a sensitive marker of redox status.

  6. Note on evaluating safety performance of road infrastructure to motivate safety competition.

    PubMed

    Han, Sangjin

    2016-01-01

    Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

  7. Update on food safety of monosodium l-glutamate (MSG).

    PubMed

    Henry-Unaeze, Helen Nonye

    2017-12-01

    This evidence-based safety review of the flavor enhancer monosodium l-glutamate (MSG) was triggered by its global use and recent studies expressing some safety concerns. This article obtained information through search of evidence-based scientific databases, especially the US National Library of Medicine NIH. (A) MSG is a water-soluble salt of glutamate, a non-essential amino acid, normally synthesized in the body and prevalent in protein foods. (B) MSG is utilized world-wide for its "umami" taste and flavor enhancement qualities, (C) the human body does not discriminate between glutamate present in food and that added as seasoning, (D) glutamate metabolism is compartmentalized in the human body without reported ethnic differences, (E) glutamate does not passively cross biological membranes, (F) food glutamate is completely metabolized by gut cells as energy source and serves as key substrate for other important metabolites in the liver, (G) normal food use of MSG is dose-dependent and self-limiting without elevation in plasma glutamate, (H) the recent EFSA acceptable daily intake (30mg/kg body weight/day) is not attainable when MSG is consumed at normal dietary level, (I) scientists have not been able to consistently elicit reactions in double-blind studies with 'sensitive' individuals using MSG or placebo in food. Based on the above observations (A-I), high quality MSG is safe for all life-cycle stages without respect to ethnic origin or culinary background. MSG researchers are advised to employ appropriate scientific methodologies, consider glutamate metabolism and its normal food use before extrapolating pharmacological rodent studies to humans. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. The Strategy for Safety: Preventing Crises through Safety Audits

    ERIC Educational Resources Information Center

    Schwartz, Sara Goldsmith

    2013-01-01

    In this article the author demonstrates the importance of school safety audits and describes what schools should focus on in a safety audit. Ultimately, each school should determine its own safety audit strategy based on its unique circumstances, including the type of community within which it is located, the age of the students it serves, and the…

  9. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... Authority. The Administrator shall perform, for and under the supervision of the Secretary, such duties as...

  10. 16 CFR § 1700.2 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Authority. § 1700.2 Section § 1700.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS POISON PREVENTION PACKAGING § 1700.2 Authority. Authority under the Poison Prevention Packaging Act of...

  11. 2016 Traffic Safety Culture Index

    MedlinePlus

    ... for Traffic Safety. For media inquiries, contact: Tamra Johnson 202-942-2079 TRJohnson@national.aaa.com Authors ... for Traffic Safety. For media inquiries, contact: Tamra Johnson 202-942-2079 TRJohnson@national.aaa.com Authors ...

  12. [Do residents and nurses communicate safety relevant concerns? : simulation study on the influence of the authority gradient].

    PubMed

    St Pierre, M; Scholler, A; Strembski, D; Breuer, G

    2012-10-01

    Due to the negative impact on decision-making too steep authority gradients in teams represent a risk factor for patient safety. As residents and nursing staff may fear sanctions they may be reluctant to forward critical information to or challenge planned actions of attending physicians. In the setting of a simulation course it was investigated whether and to what extent team members would challenge decisions of familiar attending physicians. In each case where participants did not voice an opinion the underlying motives for the behavior were investigated. A total of 59 physicians and 18 nursing staff participated in the scenario. During a rapid sequence induction they were confronted with 7 critical situations created by the attending physician who had been instructed by the simulation team. Recommendations of the German Society of Anaesthesiology were ignored as well as clinical standard operating procedures (SOPs) and two potentially fatal drug administrations were ordered. An attempt was made to determine whether team members were aware of the safety threat at all and if so how they would solve the resulting conflicts. The level of verbal challenge was scored. During debriefing participants were asked to verbalize the motives which they thought might account for their silence or level of challenge. In situations where non-verbal conflict resolution was possible 65% of the participants pursued that strategy whereas 35% voiced an opinion. Situations necessitating verbal intervention were identified in 66% but 72% of the participants chose to remain silent. Team members decided to challenge the attending physician in only 28% of the situations. In 35% their statement was oblique, in 25% the problem was addressed but not further pursued and only in 40% did participants show crisp advocacy and assertiveness and initiated discussion. Asked why they had refrained from challenging the attending physician 37% had no answer, in 35% of situations participants observed a

  13. Post-authorization safety surveillance of a liquid pentavalent vaccine in Guatemalan children.

    PubMed

    Asturias, Edwin J; Contreras-Roldan, Ingrid L; Ram, Malathi; Garcia-Melgar, Ana J; Morales-Oquendo, Vilma; Hartman, Katharina; Rauscher, Martina; Moulton, Lawrence H; Halsey, Neal A

    2013-12-02

    Combination vaccines have improved the efficiency of delivery of new vaccines in low and middle-income countries. Post-authorization monitoring of adverse events (AEs) after vaccination with a liquid pentavalent DTwP-HepB-Hib combination vaccine was conducted in Guatemalan infants. A prospective observational safety study of the incidence of medical attended events (MAEs) and serious adverse events (SAEs) in children who received pentavalent and oral polio vaccines at 2, 4 and 6 months of age was conducted in two clinics at the Institute of Guatemala. Parents were contacted by telephone after each dose. All outpatient, emergency department visits, and hospitalizations were monitored. A self-controlled analysis was conducted to determine if there was evidence of increased risk of MAEs or SAEs following vaccines as compared to control time windows. Of 3000 recruited infants, 2812 (93.7%) completed the third dose and 2805 (93.5%) completed follow-up. Ten AEs in eight infants, of which four SAEs in four infants, were classified as related to the vaccine. Thirteen deaths were reported due to common illnesses of infancy, and none were judged to be related to the vaccine. The mortality rate (4.4 per 1000) was lower than expected for the population. The incidence-rate-ratio for healthcare visits was lower in post-vaccination time windows than for control windows; after the first vaccine dose, the rate ratios for the risk periods of 0-1, 2-6, and 7-30 days post-vaccination were 0.3, 0.5, and 0.7, respectively (all statistically significantly different from the reference value of 1.0 for the 31-60 day control period). The liquid pentavalent vaccine was associated with lower rates of health care visits and not associated with increases in SAEs or hospitalizations. Systems can be set up in low to middle income countries to capture all health care visits to monitor the safety of new vaccines. Copyright © 2013 Elsevier Ltd. All rights reserved.

  14. Vitamin B12 determination in milk, whey and different by-products of ricotta cheese production by ultra performance liquid chromatography coupled with tandem mass spectrometry

    PubMed Central

    Repossi, Adele; Zironi, Elisa; Gazzotti, Teresa; Serraino, Andrea; Pagliuca, Giampiero

    2017-01-01

    Vitamin B12 (cobalamin) is a metal complex composed of a central cobalt ion bonded to six ligands. It is essential for major biological functions such as protein, fat and carbohydrate metabolism, the maintenance of the central nervous system, and the formation of red blood cells. Since mammals cannot synthesize cobalamin, dietary intake represents the only natural source for humans. Dairy products can provide significant levels of cobalamin; moreover, the European Food Safety Authority (EFSA) panel has set the recommended intake at 4 μg/day for adults. Vitamin B12 content was determined in milk and several matrices related to the process of transformation of the residual whey from Parmigiano Reggiano cheese-making to obtain ricotta cheese. In addition, vitamin B12 degradation during ricotta cheese shelf-life was studied. The analyses were performed using an ultra performance liquid chromatography-tandem mass spectrometry method. Results show that vitamin B12 amount in ricotta from dairy and experimental cheese-making brings respectively 1/8 to 1/4 of the adequate intake in adults established by EFSA. In addition, shelf-life experiment shows that cobalamine is fairly rapidly degraded in ricotta: light effect seems to be significant, even if the light exposure is short. The use of photoprotective packaging material increases B12 shelf-life in the early stage of storage. PMID:29564230

  15. Role of Young Child Formulae and Supplements to Ensure Nutritional Adequacy in U.K. Young Children

    PubMed Central

    Vieux, Florent; Brouzes, Chloé M. C.; Maillot, Matthieu; Briend, André; Hankard, Régis; Lluch, Anne; Darmon, Nicole

    2016-01-01

    The European Food Safety Authority (EFSA) states that young child formulae (YCFs) “cannot be considered as a necessity to satisfy the nutritional requirements” of children aged 12–36 months. This study quantifies the dietary changes needed to ensure nutritional adequacy in U.K. young children who consume YCFs and/or supplements and in those who do not. Dietary data from 1147 young children (aged 12–18 months) were used to identify, using linear programming models, the minimum changes needed to ensure nutritional adequacy: (i) by changing the quantities of foods initially consumed by each child (repertoire-foods); and (ii) by introducing new foods (non-repertoire-foods). Most of the children consumed neither YCFs, nor supplements (61.6%). Nutritional adequacy with repertoire-foods alone was ensured for only one child in this group, against 74.4% of the children consuming YCFs and supplement. When access to all foods was allowed, smaller food changes were required when YCFs and supplements were initially consumed than when they were not. In the total sample, the main dietary shifts needed to ensure nutritional adequacy were an increase in YCF and a decrease in cow’s milk (+226 g/day and −181 g/day, respectively). Increasing YCF and supplement consumption was the shortest way to cover the EFSA nutrient requirements of U.K. children. PMID:27598195

  16. Role of Young Child Formulae and Supplements to Ensure Nutritional Adequacy in U.K. Young Children.

    PubMed

    Vieux, Florent; Brouzes, Chloé M C; Maillot, Matthieu; Briend, André; Hankard, Régis; Lluch, Anne; Darmon, Nicole

    2016-09-02

    The European Food Safety Authority (EFSA) states that young child formulae (YCFs) "cannot be considered as a necessity to satisfy the nutritional requirements" of children aged 12-36 months. This study quantifies the dietary changes needed to ensure nutritional adequacy in U.K. young children who consume YCFs and/or supplements and in those who do not. Dietary data from 1147 young children (aged 12-18 months) were used to identify, using linear programming models, the minimum changes needed to ensure nutritional adequacy: (i) by changing the quantities of foods initially consumed by each child (repertoire-foods); and (ii) by introducing new foods (non-repertoire-foods). Most of the children consumed neither YCFs, nor supplements (61.6%). Nutritional adequacy with repertoire-foods alone was ensured for only one child in this group, against 74.4% of the children consuming YCFs and supplement. When access to all foods was allowed, smaller food changes were required when YCFs and supplements were initially consumed than when they were not. In the total sample, the main dietary shifts needed to ensure nutritional adequacy were an increase in YCF and a decrease in cow's milk (+226 g/day and -181 g/day, respectively). Increasing YCF and supplement consumption was the shortest way to cover the EFSA nutrient requirements of U.K. children.

  17. 75 FR 63774 - Pipeline Safety: Safety of On-Shore Hazardous Liquid Pipelines

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Pipelines AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of... Gas Pipeline Safety Act of 1968, Public Law 90-481, delegated to DOT the authority to develop...

  18. State safety oversight program : audit of the tri-state oversight committee and the Washington metropolitan area transit authority, final audit report, March 4, 2010.

    DOT National Transportation Integrated Search

    2010-03-04

    The Federal Transit Administration (FTA) conducted an on-site audit of the safety program implemented by the Washington Metropolitan Area Transit Authority (WMATA) and overseen by the Tri-State Oversight Committee (TOC) between December 14 and 17, 20...

  19. MICROBIOLOGICAL SAFETY BIBLIOGRAPHY

    DTIC Science & Technology

    More than a thousand articles on biological safety in infectious disease laboratories are listed for the use of supervisors responsible for the safety of laboratory personnel. An author index is included.

  20. The moderating role of safety-specific trust on the relation between safety-specific leadership and safety citizenship behaviors.

    PubMed

    Conchie, Stacey M; Donald, Ian J

    2009-04-01

    The authors examined whether safety-specific trust moderates or mediates the relationship between safety-specific transformational leadership and subordinates' safety citizenship behavior. Data from 139 subordinate-supervisor dyads were collected from the United Kingdom construction industry and analyzed using hierarchical regression models. Results showed that safety-specific trust moderated rather than mediated the effects of safety-specific transformational leaders on subordinates' behavior. Specifically, in conditions of high and moderate safety-specific trust, leaders had a significant effect on subordinates' safety citizenship behavior. However, in conditions of low safety-specific trust, leaders did not significantly influence subordinates' safety citizenship behavior. The implications of these findings for general safety theory and practice are discussed.

  1. 47 CFR 95.1107 - Authorized locations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1107 Authorized locations. The operation of a wireless medical telemetry transmitter under this part is authorized anywhere within a health...

  2. 47 CFR 95.1107 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1107 Section 95.1107 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1107 Authorized locations. The...

  3. 47 CFR 95.1203 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1203 Section 95.1203 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Medical Device Radiocommunication Service (MedRadio) § 95.1203 Authorized locations. MedRadio...

  4. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  5. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  6. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  7. 9 CFR 592.10 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Administration § 592.10 Authority. The Administrator shall perform, for and under the supervision of th...

  8. Safety Evaluations of Bifidobacterium bifidum BGN4 and Bifidobacterium longum BORI.

    PubMed

    Kim, Min Jeong; Ku, Seockmo; Kim, Sun Young; Lee, Hyun Ha; Jin, Hui; Kang, Sini; Li, Rui; Johnston, Tony V; Park, Myeong Soo; Ji, Geun Eog

    2018-05-09

    putrescine, commonly found in living cells, at levels similar to or lower than that found in other foods (e.g., spinach, ketchup, green pea, sauerkraut, and sausage). B. bifidum BGN4 showed higher resistance to gentamicin than the European Food Safety Authority (EFSA) cut-off. However, this paper shows the gentamicin resistance of B. bifidum BGN4 was not transferred via conjugation with L. acidophilus ATCC 4356, the latter of which is highly susceptible to gentamicin. The entire genomic sequence of B. bifidum BGN4 has been published in GenBank (accession no.: CP001361.1), documenting the lack of retention of plasmids capable of transferring an antibiotic-resistant gene. Moreover, there was little genetic mutation between the first and 25th generations of B. bifidum BGN4. Tetracycline-resistant genes are prevalent among B. longum strains; B. longum BORI has a tet (W) gene on its chromosome DNA and has also shown resistance to tetracycline. However, this research shows that its tetracycline resistance was not transferred via conjugation with L. fermentum AGBG1, the latter of which is highly sensitive to tetracycline. These findings support the continuous use of B. bifidum BGN4 and B. longum BORI as probiotics, both of which have been reported as safe by several clinical studies, and have been used in food supplements for many years.

  9. 49 CFR 392.9a - Operating authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Operating authority. 392.9a Section 392.9a Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS DRIVING OF COMMERCIAL MOTOR...

  10. 33 CFR 147.5 - Delegation of authority.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Delegation of authority. 147.5 Section 147.5 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OUTER CONTINENTAL SHELF ACTIVITIES SAFETY ZONES § 147.5 Delegation of authority. The authority to...

  11. 33 CFR 147.5 - Delegation of authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Delegation of authority. 147.5 Section 147.5 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OUTER CONTINENTAL SHELF ACTIVITIES SAFETY ZONES § 147.5 Delegation of authority. The authority to...

  12. 47 CFR 80.1103 - Equipment authorization.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES... for Ship Stations § 80.1103 Equipment authorization. (a) All equipment specified in § 80.1101 must be...

  13. 47 CFR 95.1505 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1505 Section 95.1505 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... locations. Operation of DSRCS On-Board Units is authorized anywhere CB station operation is permitted under...

  14. Nutrition issues in Codex: health claims, nutrient reference values and WTO agreements: a conference report.

    PubMed

    Aggett, Peter J; Hathcock, John; Jukes, David; Richardson, David P; Calder, Philip C; Bischoff-Ferrari, Heike; Nicklas, Theresa; Mühlebach, Stefan; Kwon, Oran; Lewis, Janine; Lugard, Maurits J F; Prock, Peter

    2012-03-01

    Codex documents may be used as educational and consensus materials for member governments. Also, the WTO SPS Agreement recognizes Codex as the presumptive international authority on food issues. Nutrient bioavailability is a critical factor in determining the ability of nutrients to provide beneficial effects. Bioavailability also influences the quantitative dietary requirements that are the basis of nutrient intake recommendations and NRVs. Codex, EFSA and some national regulatory authorities have established guidelines or regulations that will permit several types of health claims. The scientific basis for claims has been established by the US FDA and EFSA, but not yet by Codex. Evidence-based nutrition differs from evidence-based medicine, but the differences are only recently gaining recognition. Health claims on foods may provide useful information to consumers, but many will interpret the information to mean that they can rely upon the food or nutrient to eliminate a disease risk. NRVs are designed to provide a quantitative basis for comparing the nutritive values of foods, helping to illustrate how specific foods fit into the overall diet. The INL-98 and the mean of adult male and female values provide NRVs that are sufficient when used as targets for individual intakes by most adults. WTO recognizes Codex as the primary international authority on food issues. Current regulatory schemes based on recommended dietary allowances are trade restrictive. A substantial number of decisions by the EFSA could lead to violation of WTO agreements.

  15. 36 CFR 1004.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 3 2014-07-01 2014-07-01 false Authorized emergency vehicles. 1004.3 Section 1004.3 Parks, Forests, and Public Property PRESIDIO TRUST VEHICLES AND TRAFFIC SAFETY § 1004.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when...

  16. 36 CFR 1004.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Authorized emergency vehicles. 1004.3 Section 1004.3 Parks, Forests, and Public Property PRESIDIO TRUST VEHICLES AND TRAFFIC SAFETY § 1004.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when...

  17. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690). ...

  18. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690). ...

  19. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690). ...

  20. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. Drug-Free Workplace Act of 1988 (Pub. L. 100-690). ...

  1. [The system of the quality control and the safety of baby food, the prospects of its development].

    PubMed

    Georgieva, O V; Konovalova, L S; Kon', I Ya

    In the article there is considered the substantiation of raise demands to the chemical composition of children’s food and indices of their safety, with taking into account the immaturity of metabolic and physiological processes and limitations of “depot” of nutrients in babies. Based on research results of leading experts in the field of children’s nutritiology and according to the recommendations of the Codex Alimentarius of the Commission of FAO/WHO, ESPGHAN Committee on Nutrition, the EFSA recommendations and EUDirectives there were specified requirements for the ingredient composition, content of essential components and indices of the nutritional value of substitutes for human milk and functional products for the nutrition of infants of the first year of life. There are shown stages of the development of the Russian system of hygienic requirements for baby food, and the direction of its harmonization with international and European standards, particularly for substitutes for human milk and products of dietary therapeutic and dietary preventive nutrition for babies. There are considered aspects of the introduction ofproducts and weaning food dishes into the food ration of infants. There is presented the classification ofproducts of children’s food and the assortment of each group of weaning foods. There is provided the modern legislative framework in the field of the quality and safety for infant nutrition. There was shown the difference between domestic legislation and regulatory framework of the EurAsEC Customs Union of the European countries in the field offood products safety for children older three years. There are presented proposals on the creation of the single regulatory base within the framework of the EurAsEC Customs Union for control the quality and safety of all the baby foods.

  2. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 36 Parks, Forests, and Public Property 1 2014-07-01 2014-07-01 false Authorized emergency vehicles... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or suspected...

  3. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Authorized emergency vehicles... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or suspected...

  4. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 36 Parks, Forests, and Public Property 1 2012-07-01 2012-07-01 false Authorized emergency vehicles... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or suspected...

  5. 36 CFR 4.3 - Authorized emergency vehicles.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Authorized emergency vehicles... INTERIOR VEHICLES AND TRAFFIC SAFETY § 4.3 Authorized emergency vehicles. (a) The operator of an authorized emergency vehicle, when responding to an emergency or when pursuing or apprehending an actual or suspected...

  6. Liquefied natural gas (LNG) safety

    NASA Technical Reports Server (NTRS)

    Ordin, P. M.

    1977-01-01

    Bibliography, assembled from computer search of NASA Aerospace Safety Data Bank, including title of report, author, abstract, source, description of figures, key references, and key words or subject terms. Publication is indexed by key subjects and by authors. Items are relevant to design engineers and safety specialists.

  7. 16 CFR 1101.71 - Delegation of authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Delegation of authority. 1101.71 Section... INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Delegation of Authority to Information Group § 1101.71 Delegation of authority. (a) Delegation. Pursuant to section 27(b)(9) of the CPSA...

  8. Heavy metal concentrations in cocoa beans (Theobroma cacao L.) originating from East Luwu, South Sulawesi, Indonesia

    NASA Astrophysics Data System (ADS)

    Assa, A.; Noor, A.; Yunus, M. R.; Misnawi; Djide, M. N.

    2018-03-01

    Concentrations of some heavy metals (Pb, Cu, Cd, As and Hg) were assessed for cocoa beans (Theobroma cacao L) originating from East Luwu, South Sulawesi, Indonesia after five-day fermentation. Consisting of PB 123, BR 25, and MCC 02 cocoa clones, the spectrophotometric analysis showed that concentrations of Pb, Cd, As and Hg in the cocoa beans over the three clones was below the detection limits of 0.100; 0.050, 0.010 and 0.005 mg/kg. For Cu, they were 19.343; 10.391, and 18.594 mg/kg respectively, but still below the maximum critical levels, established by the European Food Safety Authority (EFSA). Concentrations of those five heavy metals in the bean shells were found to be parallel to those in the cocoa beans, except for Pb.

  9. The ascent of the blessed: regulatory issues on health effects and health claims for probiotics in Europe and the rest of the world.

    PubMed

    Dronkers, T M G; Krist, L; Van Overveld, F J; Rijkers, G T

    2018-05-25

    The outcome of the first series of health claim applications for probiotics in Europe as evaluated by the European Food Safety Authority (EFSA) has, up to 2013 almost completely yielded negative results. All recent applications also have been rejected, including the latest on prevention of mastitis in breastfeeding mothers. In other developed countries, such as Switzerland, Japan and Canada, the health effects of probiotics, for which scientific evidence has been provided, can be communicated to potential consumers. The number of clinical trials with probiotics over recent years shows a trend to level off or even decline. At the same time, clinical research into the role of (gut) microbiota in a wide variety of diseases and conditions is booming. Ultimately, this may offer new indications for gut microbiota management by probiotics, prebiotics or other food supplements.

  10. 48 CFR 23.502 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 23.502 Authority. 41 U.S.C. chapter 81, Drug-Free Workplace. [79 FR 24208, Apr...

  11. Foodborne and waterborne pathogenic bacteria in selected Organisation for Economic Cooperation and Development (OECD) countries.

    PubMed

    Curtis, Dennis; Hill, Arthur; Wilcock, Anne; Charlebois, Sylvain

    2014-10-01

    The World Ranking Food Safety Performance reports by Charlebois in 2008 and 2010 importantly stimulated international discussion and encouraged efforts to establish realistic international benchmarks for food safety performance among Organisation for Economic Cooperation and Development (OECD) countries. This paper presents the international incidence of 5 common foodborne pathogens and describes the challenges of comparing international data. Data were compiled from surveillance authorities in the countries, such as the Natl. Notifiable Diseases Surveillance System of Australia; the Canadian Notifiable Diseases Surveillance System; the European Food Safety Authority, EFSA; the Ministry of Health, Labour and Welfare of Japan; New Zealand Food Safety Authority; and the U.S. Center for Disease Control and Prevention. The highest average rates in cases per 100000 people over the 12-y period from 2000 to 2011 for Campylobacter spp. (237.47), Salmonella spp. (67.08), Yersinia spp. (12.09), Verotoxigenic/Shiga toxin producing Escherichia coli (3.38), and Listeria monocytogenes (1.06) corresponded, in order, to New Zealand, Belgium, Finland, Canada, and Denmark. Comparatively, annual average rates for these 5 pathogens showed an increase over the 12-y period in 28%, 17%, 14%, 50%, and 6% of the countries for which data were available. Salmonella spp. showed a decrease in 56% of the countries, while incidence of L. monocytogenes was constant in most countries (94%). Variable protocols for monitoring incidence of pathogens among OECD countries remain. Nevertheless, there is evidence of sufficient standardization of monitoring protocols such as the European Surveillance System, which has contributed to reduce this gap. © 2014 Institute of Food Technologists®

  12. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  13. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  14. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  15. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120 Authority of applicant. Proof of the authority of any...

  16. 47 CFR 87.147 - Authorization of equipment.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorization of equipment. 87.147 Section 87.147 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES Technical Requirements § 87.147 Authorization of equipment. (a) Certification may be...

  17. 47 CFR 95.1109 - Equipment authorization requirement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Equipment authorization requirement. 95.1109 Section 95.1109 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO... be authorized under the certification procedure prior to marketing or use in accordance with the...

  18. 47 CFR 95.1109 - Equipment authorization requirement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Equipment authorization requirement. 95.1109 Section 95.1109 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO... be authorized under the certification procedure prior to marketing or use in accordance with the...

  19. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.105 Exemption authority. (a) The head of an...

  20. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.105 Exemption authority. (a) The head of an...

  1. Transsexualism and Flight Safety

    DTIC Science & Technology

    1987-05-08

    Security Classification) Transsexualism and Flight Safety 12. PERSONAL AUTHOR(S) Clements, Thomas I. and Wicks, Roland E. 13a. TYPE OF REPORT 13b. TIME... transsexual pilot with questionable judgment affecting flight safety is reported. The definition, etiology, and presenting symptoms are discussed. Three...involve all the phases of therapy and can be significant. Though the transsexual tends to have more episodes of anxiety and depression than the norm

  2. 48 CFR 23.102 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.102 Authorities. (a) Executive Order 13423 of January 24, 2007, Strengthening Federal Environmental, Energy, and Transportation Management. (b...

  3. 48 CFR 23.102 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Sustainable Acquisition Policy 23.102 Authorities. (a) Executive Order 13423 of January 24, 2007, Strengthening Federal Environmental, Energy, and Transportation Management. (b...

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

    PubMed

    van der Wal, P

    1982-02-01

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

  5. 29 CFR 1926.1418 - Authority to stop operation.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 8 2011-07-01 2011-07-01 false Authority to stop operation. 1926.1418 Section 1926.1418 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Cranes and Derricks in...

  6. Validation of the TrichinEasy® digestion system for the detection of Anisakidae larvae in fish products.

    PubMed

    Cammilleri, Gaetano; Chetta, Michele; Costa, Antonella; Graci, Stefania; Collura, Rosaria; Buscemi, Maria Drussilla; Cusimano, Maria; Alongi, Angelina; Principato, Deborah; Giangrosso, Giuseppe; Vella, Antonio; Ferrantelli, Vincenzo

    2016-03-01

    Anisakis and other parasites belonging to the Anisakidae family are organisms of interest for human health, because of their high zoonotic potential. Parasites belonging to this family can cause Anisakiasis, a parasitological disease caused by the ingestion of raw, infested fish products. Furthermore, evidence from the EFSA (European Food Safety Authority; EFSA 2010) has highlighted the allergological potential of nematodes belonging to the Anisakis genre. The detection and identification of Anisakidae larvae in fish products requires an initial visual inspection of the fish sample, as well as other techniques such as candling, UV illumination and artificial digestion. The digestion method consists of the simulation of digestive mechanics, which is made possible by the utilization of HCl and pepsin, according to EC Regulation 2075/2005. In this study, a new Anisakidae larvae detection method using a mechanical digestion system called Trichineasy® was developed. A total of 142 fish samples, belonging to 14 different species, were examined to validate the method. A reaction mixture with 100 g of sample, 10 g of pepsin (1:10000 NF) and 50 ml of 10% HCl at 36 ± 1°C for 20 minutes was evaluated to be the best condition for the digestion of fish samples. These parameters have also allowed the detection of viable larvae after digestion. The results confirm this instrumentation as a valuable and safe tool for the detection of Anisakidae larvae in fishery products.

  7. Glyceria maxima as new test species for the EU risk assessment for herbicides: a microcosm study.

    PubMed

    Mohr, S; Schott, J; Hoenemann, L; Feibicke, M

    2015-03-01

    In its recent guidance document on tiered risk assessment for plant protection products for aquatic organisms, the European Food Safety Authority (EFSA) proposed to use Glyceria maxima as monocotyledonous grass species for the testing of special herbicide groups. However, published toxicity data for this species is very limited and there is no test guideline for Glyceria sp. For this reason a microcosm study was conducted in order to gain experience on the degree of sensitivity of G. maxima to the herbicidal substances clodinafop-propargyl (grass herbicide) and fluroxypyr (auxin) in comparison to the already established test organism water milfoil Myriophyllum spicatum and the duckweed species Landoltia punctata. Five concentrations without replicates were tested for each test substance using 10 microcosms and three microcosms served as controls. The experiment was run for 8 weeks. Morphological endpoints were used to determine growth and EC50 values. The results show that M. spicatum was most sensitive to fluroxypyr (37 days EC50 for roots: 62 µg/L) and G. maxima most sensitive to clodinafop-propargyl (22 days EC50 for total shoot length: 48 µg/L) whereas the duckweed species was considerable less sensitive. Hence, G. maxima turns out to be a good candidate for testing grass specific herbicides, supporting its inclusion as an additional macrophyte test for the risk assessment of herbicides as proposed by the EFSA.

  8. 48 CFR 23.402 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Use of Recovered Materials and Biobased Products 23.402 Authorities. (a) The... Federal Environmental, Energy, and Transportation Management. (d) The Energy Policy Act of 2005, Public...

  9. 48 CFR 23.402 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Use of Recovered Materials and Biobased Products 23.402 Authorities. (a) The... Federal Environmental, Energy, and Transportation Management. (d) The Energy Policy Act of 2005, Public...

  10. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... July 31, 2001, Energy Efficient Standby Power Devices. (f) Executive Order 13423 of January 24, 2007... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities...

  11. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Authority to settle. 3.514 Section 3.514 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY... exclusive authority to settle any issue or case without the consent of the ALJ. ...

  12. 42 CFR 3.514 - Authority to settle.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Authority to settle. 3.514 Section 3.514 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY... exclusive authority to settle any issue or case without the consent of the ALJ. ...

  13. 78 FR 72666 - First Responder Network Authority Board Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-03

    ... Network Authority Board Meeting AGENCY: National Telecommunications and Information Administration, U.S... Authority. SUMMARY: The Board of the First Responder Network Authority (FirstNet) will convene open public... single nationwide, interoperable public safety broadband network. The FirstNet Board is responsible for...

  14. Comparison of beverage consumption in adult populations from three different countries: do the international reference values allow establishing the adequacy of water and beverage intakes?

    PubMed

    Nissensohn, Mariela; Fuentes Lugo, Daniel; Serra-Majem, Lluis

    2016-07-13

    Recommendations of adequate total water intake (aTWI) have been proposed by the European Food Safety Agency (EFSA) and the Institute of Medicine (IOM)of the United States of America. However, there are differences in the approach used to support them: IOM recommendation is based on average intakes observed in NHANES III (Third National Health and Nutrition Examination Survey) and EFSA recommendation on a combination of observed intakes from 13 different European countries. Despite these recommendations of aTWI, the currently available scientifi c evidence is not sufficient to establish a cut-off value that would prevent disease, reduce the risk for chronic diseases or improve health status. To compare the average daily consumption of fluids (water and other beverages) in selective samples of population from Mexico, US and Spain, evaluating the quantity of fluid intake and understanding the contribution of each fluid type to the total fl uid intake. We also aim to determine if they reached adequate intake (AI) values, as defi ned by three different criteria: IOM, EFSA and water density. Three studies were compared: from Mexico, the National Health and Nutrition Survey conducted in 2012 (NHNS 2012); from US, the NHANES III 2005-2010 and from Spain the ANIBES study leaded in 2013. Different categories of beverages were used to establish the pattern of energy intake for each country. Only adult population was selected. TWI of each study was compared with EFSA and IOM AI recommendations, as well as applying the criterion of water density (mL/kcal). The American study obtained the higher value of total kcal/day from food and beverages (2,437 ± 13). Furthermore, the percentage of daily energy intake coming from beverages was, for American adults, 21%. Mexico was slightly behind with 19% and Spain ANIBES study registered only 12%. ANIBES showed signifi cantly low AI values for the overall population, but even more alarming in the case of males. Only 12% of men, in

  15. 48 CFR 923.7001 - Nuclear safety.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Nuclear safety. 923.7001... Efficiency, Renewable Energy Technologies, and Occupational Safety Programs 923.7001 Nuclear safety. The DOE regulates the nuclear safety of its major facilities under its own statutory authority derived from the...

  16. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Ozone-Depleting Substances 23.801 Authorities. (a) Title VI of the Clean Air Act... Environmental, Energy, and Transportation Management. (d) Executive Order 13514 of October 5, 2009, Federal...

  17. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities. (a) Resource Conservation and Recovery Act (RCRA) (42 U.S.C. 6901, et seq.). (b) National Energy...

  18. 48 CFR 23.801 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Ozone-Depleting Substances 23.801 Authorities. (a) Title VI of the Clean Air Act... Environmental, Energy, and Transportation Management. (d) Executive Order 13514 of October 5, 2009, Federal...

  19. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities. (a) Resource Conservation and Recovery Act (RCRA) (42 U.S.C. 6901, et seq.). (b) National Energy...

  20. 48 CFR 23.702 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Contracting for Environmentally Preferable Products and Services 23.702 Authorities. (a) Resource Conservation and Recovery Act (RCRA) (42 U.S.C. 6901, et seq.). (b) National Energy...

  1. Unstoppable The Gap Between Public Safety and Traffic Safety in the Age of Driverless Cars

    DTIC Science & Technology

    2017-03-01

    themselves, what will the increase in traffic safety cost society in terms of public safety? • What can public safety and homeland security...industry. Safer products are more marketable products, and companies that work with law enforcement for the benefit of public safety may have an...secondary public safety benefit of crime suppression. Reasonable suspicion to stop a vehicle would be an infrequent occurrence, and the legal authority

  2. 42 CFR 3.416 - Authority to settle.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Authority to settle. 3.416 Section 3.416 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY... subpart limits the authority of the Secretary to settle any issue or case or to compromise any penalty. ...

  3. 42 CFR 3.416 - Authority to settle.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Authority to settle. 3.416 Section 3.416 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY... subpart limits the authority of the Secretary to settle any issue or case or to compromise any penalty. ...

  4. The dental safety net in Connecticut.

    PubMed

    Beazoglou, Tryfon; Heffley, Dennis; Lepowsky, Steven; Douglass, Joanna; Lopez, Monica; Bailit, Howard

    2005-10-01

    Many poor, medically disabled and geographically isolated populations have difficulty accessing private-sector dental care and are considered underserved. To address this problem, public- and voluntary-sector organizations have established clinics and provide care to the underserved. Collectively, these clinics are known as "the dental safety net." The authors describe the dental safety net in Connecticut and examine the capacity and efficiency of this system to provide care to the noninstitutionalized underserved population of the state. The authors describe Connecticut's dental safety net in terms of dentists, allied health staff members, operatories, patient visits and patients treated per dentist per year. The authors compare the productivity of safety-net dentists with that of private practitioners. They also estimate the capacity of the safety net to treat people enrolled in Medicaid and the State Children's Health Insurance Program. The safety net is made up of dental clinics in community health centers, hospitals, the dental school and public schools. One hundred eleven dentists, 38 hygienists and 95 dental assistants staff the clinics. Safety-net dentists have fewer patient visits and patients than do private practitioners. The Connecticut safety-net system has the capacity to treat about 28.2 percent of publicly insured patients. The dental safety net is an important community resource, and greater use of allied dental personnel could substantially improve the capacity of the system to care for the poor and other underserved populations.

  5. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  6. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  7. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  8. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  9. 10 CFR 76.81 - Authorized use of radioactive material.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Authorized use of radioactive material. 76.81 Section 76.81 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.81 Authorized use of radioactive material. Unless otherwise authorized by law, the Corporation...

  10. Laboratory Safety in the Biology Lab.

    ERIC Educational Resources Information Center

    Ritch, Donna; Rank, Jane

    2001-01-01

    Reports on a research project to determine if students possess and comprehend basic safety knowledge. Shows a significant increase in the amount of safety knowledge gained when students are exposed to various topics in laboratory safety and are held accountable for learning the information as required in a laboratory safety course. (Author/MM)

  11. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested to...

  12. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested to...

  13. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested to...

  14. 9 CFR 590.10 - Authority.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Authority. 590.10 Section 590.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... permit experimentation so that new procedures, equipment, and processing techniques may be tested to...

  15. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 7 2012-10-01 2012-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  16. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 7 2014-10-01 2014-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  17. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 7 2013-10-01 2013-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  18. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

  19. 49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority... 49 Transportation 7 2010-10-01 2010-10-01 false Delegation to the Directors of Office of Aviation...

  20. Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

    PubMed

    Furlan, Giovanni

    2012-08-01

    Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically

  1. Procedure-Authoring Tool Improves Safety on Oil Rigs

    NASA Technical Reports Server (NTRS)

    2014-01-01

    Dark, cold, and dangerous environments are plentiful in space and on Earth. To ensure safe operations in difficult surroundings, NASA relies heavily on procedures written well ahead of time. Houston-based TRACLabs Inc. worked with Ames Research Center through the SBIR program to create an electronic procedure authoring tool, now used by NASA and companies in the oil and gas industry.

  2. 47 CFR 95.101 - What the license authorizes.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false What the license authorizes. 95.101 Section 95.101 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES General Mobile Radio Service (GMRS) § 95.101 What the license authorizes. (a) A...

  3. 47 CFR 95.101 - What the license authorizes.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false What the license authorizes. 95.101 Section 95.101 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES General Mobile Radio Service (GMRS) § 95.101 What the license authorizes. (a) A...

  4. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b, 8262g...

  5. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b, 8262g...

  6. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b, 8262g...

  7. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b, 8262g...

  8. 48 CFR 23.201 - Authorities.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Energy and Water Efficiency and Renewable Energy 23.201 Authorities. (a) Energy... U.S.C. 6901, et seq.). (b) National Energy Conservation Policy Act (42 U.S.C. 8253, 8259b, 8262g...

  9. 12 CFR 1777.2 - Preservation of other authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Preservation of other authority. 1777.2 Section 1777.2 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE OVERSIGHT, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SAFETY AND SOUNDNESS PROMPT CORRECTIVE ACTION § 1777.2 Preservation of other authority...

  10. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Exemption authority. 23.105 Section 23.105 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND...

  11. 48 CFR 23.105 - Exemption authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Exemption authority. 23.105 Section 23.105 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION SOCIOECONOMIC PROGRAMS ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND...

  12. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Authority to affix Seal. 803.3 Section 803.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD OFFICIAL SEAL § 803.3 Authority to affix Seal. (a) The Seal shall be in the custody and control of the...

  13. 49 CFR 803.3 - Authority to affix Seal.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Authority to affix Seal. 803.3 Section 803.3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD OFFICIAL SEAL § 803.3 Authority to affix Seal. (a) The Seal shall be in the custody and control of the...

  14. Safety and health concerns in forestry operations

    Treesearch

    Robert B. Rummer

    1997-01-01

    The author discusses several safety models, including the "Three E?s": engineering, education, and enforcement; the Heinrich-Lateiner model; the organizational model; and the behavioral safety model. Rummer encourages approaching safety from a broader perspective, enabling the industry to track changes in all aspects and to keep leading the safety target....

  15. 77 FR 67342 - First Responder Network Authority Board Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... Network Authority Board Meeting AGENCY: National Telecommunications and Information Administration, U.S... Responder Network Authority (FirstNet). DATES: The meetings will be held on December 11, 2012; April 23... safety broadband network. The FirstNet Board is responsible for making strategic decisions regarding...

  16. 14 CFR 431.33 - Safety organization.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Safety organization. 431.33 Section 431.33... Launch and Reentry of a Reusable Launch Vehicle § 431.33 Safety organization. (a) An applicant shall maintain a safety organization and document it by identifying lines of communication and approval authority...

  17. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

  18. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

  19. 47 CFR 90.20 - Public Safety Pool.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

  20. 47 CFR 95.1303 - Authorized locations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Authorized locations. 95.1303 Section 95.1303 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... efforts in order to resolve or mitigate any potential interference problem with the Arecibo Observatory...

  1. 47 CFR 95.1303 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1303 Section 95.1303 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... efforts in order to resolve or mitigate any potential interference problem with the Arecibo Observatory...

  2. 47 CFR 95.1003 - Authorized locations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Authorized locations. 95.1003 Section 95.1003 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... reasonable efforts in order to resolve or mitigate any potential interference problem with the Arecibo...

  3. 47 CFR 95.1003 - Authorized locations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Authorized locations. 95.1003 Section 95.1003 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO... reasonable efforts in order to resolve or mitigate any potential interference problem with the Arecibo...

  4. Safety Education--An Essential Element of Technical Training

    ERIC Educational Resources Information Center

    Glazener, Everett R.; Comstock, Thomas W.

    1978-01-01

    After tracing the background of the safety movement, provisions of recent safety legislation, and the ecological and environmental impact of industrial processes, the author stresses the need for safety education in technical education programs to prepare future employees for industrial safety requirements. (MF)

  5. Cholesterol-lowering properties of different pectin types in mildly hyper-cholesterolemic men and women.

    PubMed

    Brouns, F; Theuwissen, E; Adam, A; Bell, M; Berger, A; Mensink, R P

    2012-05-01

    Viscous fibers typically reduce total cholesterol (TC) by 3-7% in humans. The cholesterol-lowering properties of the viscous fiber pectin may depend on its physico-chemical properties (viscosity, molecular weight (MW) and degree of esterification (DE)), but these are not typically described in publications, nor required by European Food Safety Authority (EFSA) with respect to its generic pectin cholesterol-lowering claim. Here, different sources and types of well-characterized pectin were evaluated in humans. Cross-over studies were completed in mildly hyper-cholesterolemic persons receiving either 15 g/day pectin or cellulose with food for 4 weeks. Relative low-density lipoprotein (LDL) cholesterol (LDL-C) lowering was as follows: citrus pectin DE-70=apple pectin DE-70 (7-10% reduction versus control)>apple pectin DE-35=citrus pectin DE-35>OPF (orange pulp fiber) DE-70 and low-MW pectin DE-70>citrus DE-0. In a subsequent 3-week trial with 6 g/day pectin, citrus DE-70 and high MW pectin DE-70 reduced LDL-C 6-7% versus control (without changes in TC). In both studies, high DE and high MW were important for cholesterol lowering. Source may also be important as citrus and apple DE-70 pectin were more effective than OPF DE-70 pectin. Pectin did not affect inflammatory markers high-sensitivity C-reactive protein (hsCRP) nor plasma homocysteine. Pectin source and type (DE and MW) affect cholesterol lowering. The EFSA pectin cholesterol-lowering claim should require a minimum level of characterization, including DE and MW.

  6. [Safety monitoring of cell-based medicinal products (CBMPs)].

    PubMed

    Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

    2015-11-01

    Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

  7. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

  8. 31 CFR 560.528 - Aircraft safety.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

  9. Commonwealth of Virginia, Department of Transportation Safety, transportation safety plan for the period July 1, 1981-June 30, 1982.

    DOT National Transportation Integrated Search

    1981-01-01

    Senate Bill 85, passed by the General Assembly in 1978, renamed the Highway Safety Division of Virginia the Department of Transportation Safety (VDTS) and authorized it to participate in the evaluation of current safety measures in all modes of trans...

  10. School Bus Fleet Safety: Planning and Development.

    ERIC Educational Resources Information Center

    Bieber, Robert M.

    1984-01-01

    To ensure worker safety, fleet safety managers need professional staffs, good access to top management, and sufficient authority to discharge their duties. Safety programs should include careful driver hiring; training, including orientation, testing, and practice; comprehensive accident reporting; and cooperative compliance programs with…

  11. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...— (i) For offers contingent upon SAFETY Act designation, a pre-qualification designation notice or a block designation; or (ii) For offers contingent upon SAFETY Act certification, a block certification... contingent upon SAFETY Act designation or certification before contract award. 50.205-3 Section 50.205-3...

  12. Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims on Foods Related to Vision Proposed Under Regulation (EC) 1924/2006.

    PubMed

    Martini, Daniela; Innocenti, Augusto; Cosentino, Chiara; Bedogni, Giorgio; Angelino, Donato; Biasini, Beatrice; Zavaroni, Ivana; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Dei Cas, Alessandra; Bonadonna, Riccardo C; Passeri, Giovanni; Pruneti, Carlo; Del Rio, Daniele

    2018-02-14

    Adequate visual function has a strong impact on the quality of life of people. Several foods and food components have been hypothesized to play a role in the maintenance of normal visual function and in the prevention of eye diseases. Some of these foods/food components have been the object of a request of authorization for use of health claims under Articles 13(5) or 14 of the Regulation (EC) 1924/2006. Most of these requests have received a negative opinion from the European Food Safety Authority (EFSA) due to the choice of inappropriate outcome variables (OVs) and/or methods of measurement (MMs) applied in the studies used to substantiate the claims. This manuscript refers to the collection, collation and critical analysis of OVs and MMs related to vision. Guidance document and requests for authorization of health claims were used to collect OVs and MMs related to vision. A literature review was performed to critically analyse OVs and MMs, with the aim of defining their appropriateness in the context of a specific claimed effect related to vision. The results highlight the importance of adequate choices of OVs and MMs for an effective substantiation of claims related to visual function.

  13. Stakeholders' perception of the nutrition and health claim regulation.

    PubMed

    de Boer, Alie; Bast, Aalt

    2015-05-01

    In 2007, the Nutrition and Health Claim Regulation (NHCR) entered into force, which required scientific substantiation of health claims. In the field of antioxidants, most proposed claims were negatively assessed by the European Food Safety Authority (EFSA). This study reviews the perception of the NHCR of 14 Dutch stakeholders to unravel the grounds for disproving the putative health claims. Most claims are shown to be refused based on the quality of scientific substantiation, due to usage of scientific methods on which no consensus has been reached and the differences in expectations and requirements. Three themes exemplify the need for improvement in applying the NHCR: (i) enforcement; (ii) methodology; and (iii) perceived impact of the NHCR. With highly diverging perceptions of stakeholders, the current effectiveness of the NHCR can be questioned. The views of different stakeholders on these themes help to focus the discussion on the NCHR in capturing health effects.

  14. 29 CFR 2201.3 - Delegation of authority and responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Section 2201.3 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION REGULATIONS IMPLEMENTING THE FREEDOM OF INFORMATION ACT § 2201.3 Delegation of authority and responsibilities. (a) The Chairman delegates to the Chief FOIA Officer the authority to act upon all requests for...

  15. 47 CFR 90.515 - Change or cancellation of authorization without hearing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... hearing. 90.515 Section 90.515 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND... cancellation of authorization without hearing. Every application for authority to engage in developmental... authorization issued pursuant thereto will be accepted with the express understanding of the applicant that it...

  16. 29 CFR 1954.3 - Exercise of Federal discretionary authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Exercise of Federal discretionary authority. 1954.3 Section 1954.3 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... § 1954.3 Exercise of Federal discretionary authority. (a)(1) When a State plan is approved under section...

  17. 47 CFR 95.1109 - Equipment authorization requirement.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Section 95.1109 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1109 Equipment authorization requirement. (a) Wireless medical telemetry devices operating under this part must...

  18. 78 FR 55064 - First Responder Network Authority Board Special Review Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... Network Authority Board Special Review Committee Meeting AGENCY: National Telecommunications and... Responder Network Authority Special Review Committee. SUMMARY: The First Responder Network Authority (First... nationwide, interoperable public safety broadband network. The FirstNet Board is responsible for making...

  19. Another Approach to Enhance Airline Safety: Using Management Safety Tools

    NASA Technical Reports Server (NTRS)

    Lu, Chien-tsug; Wetmore, Michael; Przetak, Robert

    2006-01-01

    The ultimate goal of conducting an accident investigation is to prevent similar accidents from happening again and to make operations safer system-wide. Based on the findings extracted from the investigation, the "lesson learned" becomes a genuine part of the safety database making risk management available to safety analysts. The airline industry is no exception. In the US, the FAA has advocated the usage of the System Safety concept in enhancing safety since 2000. Yet, in today s usage of System Safety, the airline industry mainly focuses on risk management, which is a reactive process of the System Safety discipline. In order to extend the merit of System Safety and to prevent accidents beforehand, a specific System Safety tool needs to be applied; so a model of hazard prediction can be formed. To do so, the authors initiated this study by reviewing 189 final accident reports from the National Transportation Safety Board (NTSB) covering FAR Part 121 scheduled operations. The discovered accident causes (direct hazards) were categorized into 10 groups Flight Operations, Ground Crew, Turbulence, Maintenance, Foreign Object Damage (FOD), Flight Attendant, Air Traffic Control, Manufacturer, Passenger, and Federal Aviation Administration. These direct hazards were associated with 36 root factors prepared for an error-elimination model using Fault Tree Analysis (FTA), a leading tool for System Safety experts. An FTA block-diagram model was created, followed by a probability simulation of accidents. Five case studies and reports were provided in order to fully demonstrate the usefulness of System Safety tools in promoting airline safety.

  20. A multiplex real-time PCR assay for the identification and differentiation of Salmonella enterica serovar Typhimurium and monophasic serovar 4,[5],12:i:-.

    PubMed

    Prendergast, Deirdre M; Hand, Darren; Nί Ghallchóir, Eadaoin; McCabe, Evonne; Fanning, Seamus; Griffin, Margaret; Egan, John; Gutierrez, Montserrat

    2013-08-16

    Salmonella enterica subsp. enterica serovar 4,[5],12:i:- is considered to be a monophasic variant of Salmonella Typhimurium and is increasingly associated with human infections. The use of PCR for the unequivocal identification of strains identified by conventional serotyping as 4,[5],12:i:- has been recommended by the European Food Safety Authority (EFSA), in particular the conventional multiplex PCR developed by Tennant et al. (2010). An alternative protocol for the identification and differentiation of S. Typhimurium and S. Typhimurium-like strains, including its monophasic variants, based on a multiplex real-time PCR assay was developed in our laboratory. A panel of 206 Salmonella strains was used to validate our multiplex real-time PCR against the conventional multiplex PCR recommended by EFSA, i.e. 43 Salmonella strains of serovars other than Typhimurium and 163 routine isolates determined by slide agglutination serotyping to have an incomplete antigenic formula compatible with the S. Typhimurium formula 4,[5],12:i:1,2. Both methods correctly identified the 43 Salmonella strains as non S. Typhimurium. Among the 163 isolates of undetermined serovar by conventional serotyping, both PCR protocols identified 54 isolates as S. Typhimurium, 101 as monophasic S. Typhimurium and 8 as non-S. Typhimurium. Twenty isolates phenotypically lacking the phase-2 H antigen were positive for the fljB.1,2 gene. These strains have been recently described in the literature by other workers and have been referred to as "inconsistent" variants of S. Typhimurium. Antimicrobial resistance and phage typing were also performed on the S. Typhimurium isolates, including monophasic variants, and approximately half of the isolates identified as monophasic S. Typhimurium by our multiplex real-time PCR protocol were DT193 with the resistance pattern ASSuT. There was 100% concordance between the conventional PCR and the multiplex real-time PCR method developed in this study which proved that

  1. Low-dose effect of developmental bisphenol A exposure on sperm count and behaviour in rats.

    PubMed

    Hass, U; Christiansen, S; Boberg, J; Rasmussen, M G; Mandrup, K; Axelstad, M

    2016-07-01

    Bisphenol A is widely used in food contact materials and other products and is detected in human urine and blood. Bisphenol A may affect reproductive and neurological development; however, opinion of the European Food Safety Authority (EFSA) on bisphenol A (EFSA J, 13, 2015 and 3978) concluded that none of the available studies were robust enough to provide a point of departure for setting a tolerable daily intake for bisphenol A. In the present study, pregnant Wistar rats (n = 17-21) were gavaged from gestation day 7 to pup day 22 with bisphenol A doses of 0, 25 μg, 250 μg, 5 mg or 50 mg/kg bw/day. In the offspring, growth, sexual maturation, weights and histopathology of reproductive organs, oestrus cyclicity and sperm counts were assessed. Neurobehavioural development was investigated using a behavioural testing battery including tests for motor activity, sweet preference, anxiety and spatial learning. Decreased sperm count was found at the lowest bisphenol A dose, that is 25 μg/kg/day, but not at the higher doses. Reproductive organ weight and histology were not affected and no behavioural effects were seen in male offspring. In the female offspring, exposure to 25 μg/kg bw/day bisphenol A dose resulted in increased body weight late in life and altered spatial learning in a Morris water maze, indicating masculinization of the brain. Decreased intake of sweetened water was seen in females from the highest bisphenol A dose group, also a possible sign of masculinization. The other investigated endpoints were not significantly affected. In conclusion, the present study using a robust experimental study design, has shown that developmental exposure to 25 μg/kg bw/day bisphenol A can cause adverse effects on fertility (decreased sperm count), neurodevelopment (masculinization of spatial learning in females) and lead to increased female body weight late in life. These results suggest that the new EFSA temporary tolerable daily intake of 4 μg/kg bw

  2. 77 FR 27442 - Recruitment of First Responder Network Authority Board of Directors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ... First Responder Network Authority Board of Directors AGENCY: National Telecommunications and Information... First Responder Network Authority (FirstNet). The Act created FirstNet as an independent authority within NTIA that will establish a single nationwide, interoperable public safety broadband network. The...

  3. Fluid consumption, total water intake and first morning urine osmolality in Spanish adolescents from Zaragoza: data from the HELENA study.

    PubMed

    Iglesia, I; Santaliestra-Pasías, A M; Bel-Serrat, S; Sadalla-Collese, T; Miguel-Berges, M L; Moreno, L A

    2016-05-01

    The objective of the study is to describe the hydration status and to assess the main food- and/or fluid intake-associated factors in healthy adolescents. A total of 194 adolescents from the city of Zaragoza aged 12.5-17.5 years (99 males) participating in the 'Healthy Lifestyle in Europe by Nutrition in Adolescence' (HELENA) cross-sectional study were included. First morning urine was collected, and osmolality was determined by freezing point depression osmometer. A self-reported computer-based 24-h dietary recall was applied the same day of the urine collection. Analysis of variance, Kruskal-Wallis procedure or Pearson's χ(2) analyses was used to examine the group associations. Seventy-one percent of adolescents did not meet the European Food Safety Agency (EFSA) recommendations for average total water intake (TWI), and 68% had high first morning urine osmolality values. TWI and the proportion of those meeting EFSA reference values significantly (P<0.05) decreased with increased osmolality. Males who met the EFSA recommendations consumed significantly (P<0.05) more plain water (1035.13 vs 582.68 ml) and dairy drinks (368.13 vs 226.68 ml) than those who did not. In females, the consumption of water (1359.41 vs 620.44 ml) and sugar-sweetened beverages (214.61 vs 127.42 ml) was significantly higher in those meeting the EFSA recommendations than in those who did not. First morning urine osmolality was associated with vegetables (unstandardized β: -0.6; 95% confidence interval (CI): -1.02 and -0.18) and fruits intake (β: -0.41; 95% CI: -0.63 and -0.19) in males and with dairy drinks (β: -0.39; 95% CI: -0.76 and -0.02) and fruits (β: -0.41; 95% CI: -0.73 and -0.10) in females. There was a high prevalence of inadequate TWI and high urine osmolality among these Spanish adolescents. Lower urine osmolality was associated with higher consumption of vegetables in males, dairy drinks in females and fruits in both males and females.

  4. Safety climate in OHSAS 18001-certified organisations: antecedents and consequences of safety behaviour.

    PubMed

    Fernández-Muñiz, Beatriz; Montes-Peón, José Manuel; Vázquez-Ordás, Camilo José

    2012-03-01

    The occupational health and safety standard OHSAS 18001 has gained considerable acceptance worldwide, and firms from diverse sectors and of varying sizes have implemented it. Despite this, very few studies have analysed safety management or the safety climate in OHSAS 18001-certified organisations. The current work aims to analyse the safety climate in these organisations, identify its dimensions, and propose and test a structural equation model that will help determine the antecedents and consequences of employees' safety behaviour. For this purpose, the authors carry out an empirical study using a sample of 131 OHSAS 18001-certified organisations located in Spain. The results show that management's commitment, and particularly communication, have an effect on safety behaviour and on safety performance, employee satisfaction, and firm competitiveness. These findings are particularly important for management since they provide evidence about the factors that should be encouraged to reduce risks and improve performance in this type of organisation. Copyright © 2011 Elsevier Ltd. All rights reserved.

  5. 10 CFR 35.50 - Training for Radiation Safety Officer.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

  6. 10 CFR 35.50 - Training for Radiation Safety Officer.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

  7. 10 CFR 35.50 - Training for Radiation Safety Officer.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

  8. 10 CFR 35.50 - Training for Radiation Safety Officer.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

  9. 78 FR 76191 - Operational Tests and Inspections for Compliance With Maximum Authorized Train Speeds and Other...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-16

    ... Tests and Inspections for Compliance With Maximum Authorized Train Speeds and Other Speed Restrictions... safety advisory; Operational tests and inspections for compliance with maximum authorized train speeds and other speed restrictions. SUMMARY: FRA is issuing Safety Advisory 2013-08 to stress to railroads...

  10. Safety equipment list for the 241-SY-101 RAPID mitigation project

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

    MORRIS, K.L.

    1999-06-29

    This document provides the safety classification for the safety (safety class and safety RAPID Mitigation Project. This document is being issued as the project SEL until the supporting authorization basis documentation, this document will be superseded by the TWRS SEL (LMHC 1999), documentation istlralized. Upon implementation of the authorization basis significant) structures, systems, and components (SSCS) associated with the 241-SY-1O1 which will be updated to include the information contained herein.

  11. Promoting a Culture of Safety as a Patient Safety Strategy

    PubMed Central

    Weaver, Sallie J.; Lubomksi, Lisa H.; Wilson, Renee F.; Pfoh, Elizabeth R.; Martinez, Kathryn A.; Dy, Sydney M.

    2015-01-01

    Developing a culture of safety is a core element of many efforts to improve patient safety and care quality. This systematic review identifies and assesses interventions used to promote safety culture or climate in acute care settings. The authors searched MEDLINE, CINAHL, PsycINFO, Cochrane, and EMBASE to identify relevant English-language studies published from January 2000 to October 2012. They selected studies that targeted health care workers practicing in inpatient settings and included data about change in patient safety culture or climate after a targeted intervention. Two raters independently screened 3679 abstracts (which yielded 33 eligible studies in 35 articles), extracted study data, and rated study quality and strength of evidence. Eight studies included executive walk rounds or interdisciplinary rounds; 8 evaluated multicomponent, unit-based interventions; and 20 included team training or communication initiatives. Twenty-nine studies reported some improvement in safety culture or patient outcomes, but measured outcomes were highly heterogeneous. Strength of evidence was low, and most studies were pre–post evaluations of low to moderate quality. Within these limits, evidence suggests that interventions can improve perceptions of safety culture and potentially reduce patient harm. PMID:23460092

  12. 49 CFR 501.5 - Exercise of authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 6 2013-10-01 2013-10-01 false Exercise of authority. 501.5 Section 501.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ORGANIZATION AND DELEGATION OF POWERS AND DUTIES § 501.5 Exercise of...

  13. 49 CFR 501.5 - Exercise of authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 6 2012-10-01 2012-10-01 false Exercise of authority. 501.5 Section 501.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ORGANIZATION AND DELEGATION OF POWERS AND DUTIES § 501.5 Exercise of...

  14. 49 CFR 501.5 - Exercise of authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 6 2014-10-01 2014-10-01 false Exercise of authority. 501.5 Section 501.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ORGANIZATION AND DELEGATION OF POWERS AND DUTIES § 501.5 Exercise of...

  15. 49 CFR 501.5 - Exercise of authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 6 2011-10-01 2011-10-01 false Exercise of authority. 501.5 Section 501.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ORGANIZATION AND DELEGATION OF POWERS AND DUTIES § 501.5 Exercise of...

  16. 49 CFR 501.5 - Exercise of authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 6 2010-10-01 2010-10-01 false Exercise of authority. 501.5 Section 501.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ORGANIZATION AND DELEGATION OF POWERS AND DUTIES § 501.5 Exercise of...

  17. Patient safety goals for the proposed Federal Health Information Technology Safety Center.

    PubMed

    Sittig, Dean F; Classen, David C; Singh, Hardeep

    2015-03-01

    The Office of the National Coordinator for Health Information Technology is expected to oversee creation of a Health Information Technology (HIT) Safety Center. While its functions are still being defined, the center is envisioned as a public-private entity focusing on promotion of HIT related patient safety. We propose that the HIT Safety Center leverages its unique position to work with key administrative and policy stakeholders, healthcare organizations (HCOs), and HIT vendors to achieve four goals: (1) facilitate creation of a nationwide 'post-marketing' surveillance system to monitor HIT related safety events; (2) develop methods and governance structures to support investigation of major HIT related safety events; (3) create the infrastructure and methods needed to carry out random assessments of HIT related safety in complex HCOs; and (4) advocate for HIT safety with government and private entities. The convening ability of a federally supported HIT Safety Center could be critically important to our transformation to a safe and effective HIT enabled healthcare system. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  18. Vaccine Safety Resources for Nurses

    PubMed Central

    Shimabukuro, Tom T.; Hibbs, Beth F.; Moro, Pedro L.; Broder, Karen R.; Vellozzi, Claudia

    2015-01-01

    Overview Nurses are on the front lines of health care delivery, and many of them routinely administer immunizations. The authors describe the Centers for Disease Control and Prevention’s (CDC) vaccine safety monitoring systems, explaining how nurses can access inquiry channels and other immunization information resources. Examples of recent vaccine safety inquiries are also provided. PMID:26222474

  19. 10 CFR 810.7 - Generally authorized activities.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... determined that the following activities are generally authorized, provided no sensitive nuclear technology... continuing programs, to enhance the operational safety of an existing civilian nuclear power plant in a... off-site population posed by a civilian nuclear power plant in such a country; provided the Department...

  20. 10 CFR 810.7 - Generally authorized activities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... determined that the following activities are generally authorized, provided no sensitive nuclear technology... continuing programs, to enhance the operational safety of an existing civilian nuclear power plant in a... off-site population posed by a civilian nuclear power plant in such a country; provided the Department...

  1. 9 CFR 592.120 - Authority of applicant.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority of applicant. 592.120 Section 592.120 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Application for Service § 592.120...

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

    PubMed

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

    2015-01-01

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

  3. OSHA Laboratory Standard: Driving Force for Laboratory Safety!

    ERIC Educational Resources Information Center

    Roy, Kenneth R.

    2000-01-01

    Discusses the Occupational Safety and Health Administration's (OSHA's) Laboratory Safety Standards as the major driving force in establishing and maintaining a safe working environment for teachers and students. (Author)

  4. Melatonin is synthesised by yeast during alcoholic fermentation in wines.

    PubMed

    Rodriguez-Naranjo, M Isabel; Gil-Izquierdo, Angel; Troncoso, Ana M; Cantos-Villar, Emma; Garcia-Parrilla, M Carmen

    2011-06-15

    Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone produced in the pineal gland. Its biological properties are related to the circadian rhythm. Recently, the European Food Safety Authority (EFSA) accepted the health claim related to melatonin and the alleviation of subjective feelings of jet lag. This molecule has been detected in some foods. In this work, 13 grape varieties were studied; 7 monovarietal wines were produced in an experimental winery under strictly controlled conditions and were sampled in different steps. The grape varieties used to make the wines were: Cabernet Sauvignon, Merlot, Syrah, Tempranillo, Tintilla de Rota, Palomino Fino and Alpha red. Liquid chromatography tandem mass spectrometry (LC-MS/MS) unequivocally confirmed the presence of melatonin in wines. The main contribution of this paper is the results that clearly show that melatonin is synthesised during the winemaking process, specifically after the alcoholic fermentation. Indeed, melatonin is absent in grapes and musts and is formed during alcoholic fermentation. Copyright © 2010 Elsevier Ltd. All rights reserved.

  5. The effect of plant sterol-enriched turkey meat on cholesterol bio-accessibility during in vitro digestion and Caco-2 cell uptake.

    PubMed

    Grasso, S; Harrison, S M; Monahan, F J; Brayden, D; Brunton, N P

    2018-03-01

    This study evaluated the effect of a plant sterol-enriched turkey product on cholesterol bio-accessibility during in vitro digestion and cholesterol uptake by Caco-2 monolayers. Turkey products, one plant sterol-enriched (PS) and one plant sterol-free (C), were produced in an industrial pilot plant. Before simulated digestion, matrices were spiked with cholesterol (1:5 weight ratio of cholesterol to plant sterol). Plant sterols were included at a concentration equivalent to the minimum daily intake recommended by the European Food Safety Authority (EFSA) for cholesterol lowering. After simulated digestion, the percentage of cholesterol micellarization and uptake by Caco-2 cells in the presence of PS meat were measured. Compared to C meat, PS meat significantly inhibited cholesterol micellarization on average by 24% and Caco-2 cell accumulation by 10%. This study suggests that plant sterols in meat can reduce cholesterol uptake by intestinal epithelia and it encourages efforts to make new PS-based functional foods.

  6. 31 CFR 538.519 - Aircraft and maritime safety.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Aircraft and maritime safety. 538.519..., Authorizations, and Statements of Licensing Policy § 538.519 Aircraft and maritime safety. Specific licenses may... aircraft, and to ensure the safety of ocean-going maritime traffic in international waters. ...

  7. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 4 2011-10-01 2011-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

  8. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 4 2014-10-01 2014-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

  9. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 4 2012-10-01 2012-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

  10. 46 CFR 115.910 - Passenger Ship Safety Certificate.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 4 2013-10-01 2013-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

  11. 20 CFR 726.115 - Revocation of authorization to self-insure.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED BLACK LUNG BENEFITS; REQUIREMENTS FOR COAL MINE OPERATOR'S INSURANCE Authorization of Self-Insurers § 726.115 Revocation of authorization to... regulations in this part, or with any lawful order or communication of the Office, or the failure or...

  12. 20 CFR 726.115 - Revocation of authorization to self-insure.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED BLACK LUNG BENEFITS; REQUIREMENTS FOR COAL MINE OPERATOR'S INSURANCE Authorization of Self-Insurers § 726.115 Revocation of authorization to... regulations in this part, or with any lawful order or communication of the Office, or the failure or...

  13. 9 CFR 590.620 - Authority of applicant.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority of applicant. 590.620 Section 590.620 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Exempted Egg...

  14. 12 CFR 1253.9 - Preservation of authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Preservation of authority. 1253.9 Section 1253.9 Banks and Banking FEDERAL HOUSING FINANCE AGENCY ENTERPRISES PRIOR APPROVAL FOR ENTERPRISE....S.C. 4541), and this regulation and other issuances in no way restricts— (1) The safety and...

  15. 9 CFR 590.620 - Authority of applicant.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Authority of applicant. 590.620 Section 590.620 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Exempted Egg...

  16. Phytonutrient intakes in relation to European fruit and vegetable consumption patterns observed in different food surveys.

    PubMed

    Tennant, David R; Davidson, Julia; Day, Andrea J

    2014-10-14

    Fruit and vegetables make an important contribution to health, partly due to the composition of phytonutrients, such as carotenoids and polyphenols. The aim of the present study was to quantify the intake of fruit and vegetables across different European countries using food consumption data of increasing complexity: food balance sheets (FBS); the European Food Safety Authority (EFSA) Comprehensive Database; individual food consumption data from the UK National Diet and Nutrition Survey (NDNS). Across Europe, the average consumption of fruit and vegetables ranged from 192 to 824 g/d (FBS data). Based on EFSA data, nine out of fourteen countries consumed < 400 g/d (recommended by the WHO), although even in the highest-consuming countries such as Spain, 36 % did not reach the target intake. In the UK, the average consumption of fruit and vegetables was 310 g/d (NDNS data). Generally, phytonutrient intake increased in accordance with fruit and vegetable intake across all European countries with the exception of lycopene (from tomatoes), which appeared to be higher in some countries that consumed less fruit and vegetables. There were little differences in the average intake of flavanols, flavonols and lycopene in those who did or did not meet the 400 g/d recommendation in the UK. However, average intakes of carotenoid, flavanone, anthocyanidin and ellagic acid were higher in those who consumed >400 g/d of fruit and vegetables compared with those who did not. Overall, intakes of phytonutrients are highly variable, suggesting that while some individuals obtain healthful amounts, there may be others who do not gain all the potential benefits associated with phytonutrients in the diet.

  17. Expert opinion as 'validation' of risk assessment applied to calf welfare.

    PubMed

    Bracke, Marc B M; Edwards, Sandra A; Engel, Bas; Buist, Willem G; Algers, Bo

    2008-07-14

    Recently, a Risk Assessment methodology was applied to animal welfare issues in a report of the European Food Safety Authority (EFSA) on intensively housed calves. Because this is a new and potentially influential approach to derive conclusions on animal welfare issues, a so-called semantic-modelling type 'validation' study was conducted by asking expert scientists, who had been involved or quoted in the report, to give welfare scores for housing systems and for welfare hazards. Kendall's coefficient of concordance among experts (n = 24) was highly significant (P < 0.001), but low (0.29 and 0.18 for housing systems and hazards respectively). Overall correlations with EFSA scores were significant only for experts with a veterinary or mixed (veterinary and applied ethological) background. Significant differences in welfare scores were found between housing systems, between hazards, and between experts with different backgrounds. For example, veterinarians gave higher overall welfare scores for housing systems than ethologists did, probably reflecting a difference in their perception of animal welfare. Systems with the lowest scores were veal calves kept individually in so-called "baby boxes" (veal crates) or in small groups, and feedlots. A suckler herd on pasture was rated as the best for calf welfare. The main hazards were related to underfeeding, inadequate colostrum intake, poor stockperson education, insufficient space, inadequate roughage, iron deficiency, inadequate ventilation, poor floor conditions and no bedding. Points for improvement of the Risk Assessment applied to animal welfare include linking information, reporting uncertainty and transparency about underlying values. The study provides novel information on expert opinion in relation to calf welfare and shows that Risk Assessment applied to animal welfare can benefit from a semantic modelling approach.

  18. Beverage Consumption Habits among the European Population: Association with Total Water and Energy Intakes

    PubMed Central

    Nissensohn, Mariela; Sánchez-Villegas, Almudena; Galan, Pilar; Turrini, Aida; Arnault, Nathalie; Mistura, Lorenza; Ortiz-Andrellucchi, Adriana; Szabo de Edelenyi, Fabien; D’Addezio, Laura; Serra-Majem, Lluis

    2017-01-01

    Background: Fluid and water intake have received limited attention in epidemiological studies. The aim of this study was to compare the average daily consumption of foods and beverages in adults of selective samples of the European Union (EU) population in order to understand the contribution of these to the total water intake (TWI), evaluate if the EU adult population consumes adequate amounts of total water (TW) according to the current guidelines, and to illustrate the real water intake in Europe. Methods: Three national European dietary surveys have been selected: Spain used the Anthropometry, Intake, and Energy Balance Study (ANIBES) population database, Italy analyzed data from the Italian National Food Consumption Survey (INRAN-SCAI 2005-06), and French data came from the NutriNet-Santé database. Mean daily consumption was used to compare between individuals. TWI was compared with European Food Safety Authority (EFSA) reference values for adult men and women. Results: On average, in Spain, TWI was 1.7 L (SE 22.9) for men and 1.6 L (SE 19.4) for women; Italy recorded 1.7 L (SE 16.9) for men and 1.7 L (SE 14.1) for women; and France recorded 2.3 L (SE 4.7) for men and 2.1 L (SE 2.4) for women. With the exception of women in France, neither men nor women consumed sufficient amounts of water according to EFSA reference values. Conclusions: This study highlights the need to formulate appropriate health and nutrition policies to increase TWI in the EU population. The future of beverage intake assessment requires the use of new instruments, techniques, and the application of the new available technologies. PMID:28406441

  19. 14 CFR 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... authority to take action regarding “liquidated damage” assessments under the Contract Work Hours and Safety Standards Act, and associated labor statutes. (a) Delegation of authority. The Director, Industrial...

  20. 31 CFR 538.519 - Aircraft and maritime safety.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft and maritime safety. 538.519..., Authorizations, and Statements of Licensing Policy § 538.519 Aircraft and maritime safety. Specific licenses may... technology to insure the safety of civil aviation and safe operation of U.S.-origin commercial passenger...

  1. 10 CFR 2.1316 - Authority and role of NRC staff.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Authority and role of NRC staff. 2.1316 Section 2.1316... License Transfer Applications § 2.1316 Authority and role of NRC staff. (a) During the pendency of any hearing under this subpart, consistent with the NRC staff's findings in its Safety Evaluation Report (SER...

  2. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  3. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  4. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  5. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  6. 49 CFR 451.13 - Action by approval authority-approval by design type.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

  7. Bricks-and-mortar and patient safety culture.

    PubMed

    Brandis, Susan; Schleimer, Stephanie; Rice, John

    2017-06-19

    Purpose Building a new hospital requires a major investment in capital infrastructure. The purpose of this paper is to investigate the impact of bricks-and-mortar on patient safety culture before and two years after the move of a large tertiary hospital to a greenfield site. The difference in patient safety perceptions between clinical and non-clinical staff is also explored. Design/methodology/approach This research uses data collected from the same workforce across two time periods (2013 and 2015) in a large Australian healthcare service. Validated surveys of patient safety culture ( n=306 and 246) were analysed using descriptive and inferential statistics. Findings Using two-way analysis of variance, the authors found that perceived patient safety culture remains unchanged for staff despite a major relocation and upgrade of services and different perceptions of patient safety culture between staff groups remains the same throughout change. Practical implications A dramatic change in physical context, such as moving an entire hospital, made no measurable impact on perceived patient safety culture by major groups of staff. Improving patient safety culture requires more than investment in buildings and infrastructure. Understanding differences in professional perspectives of patient safety culture may inform organisational management approaches, and enhance the targeting of specific strategies. Originality/value The authors believe this to be the first empirically based paper that investigates the impact of a large investment into hospital capital and a subsequent relocation of services on clinical and non-clinical staff perceptions of patient safety culture.

  8. 10 CFR 35.415 - Safety precautions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Safety precautions. 35.415 Section 35.415 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Manual Brachytherapy § 35.415 Safety precautions. (a... his or her designee, and an authorized user as soon as possible if the patient or human research...

  9. 10 CFR 35.410 - Safety instruction.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Safety instruction. 35.410 Section 35.410 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Manual Brachytherapy § 35.410 Safety instruction. In... designee, and an authorized user if the patient or the human research subject has a medical emergency or...

  10. 76 FR 52231 - Restrictions on Operators Employing Former Flight Standards Service Aviation Safety Inspectors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-22

    ... Standards Service Aviation Safety Inspectors AGENCY: Federal Aviation Administration (FAA), DOT. ACTION... responsible for the oversight of, a Flight Standards Service Aviation Safety Inspector, and had direct... . SUPPLEMENTARY INFORMATION: Authority for This Rulemaking The FAA's authority to issue rules on aviation safety...

  11. Regulation of Health Policy: Patient Safety and the States

    DTIC Science & Technology

    2005-05-01

    the consumer perspective about patient safety. Advances in Patient Safety: Vol 1 420 Note See e.g., Public Citizen, Inc. v. U.S. Dept. of Health ...405 Regulation of Health Policy: Patient Safety and the States Joanna Weinberg, Lee H. Hilborne, Quang-Tuyen Nguyen Abstract In its 1999...regulating patient safety. The authors suggest that State patient safety regulation illustrates ongoing tensions in U.S. health policy, and conclude that

  12. Nuclear Safety Information Center, Its Products and Services

    ERIC Educational Resources Information Center

    Buchanan, J. R.

    1970-01-01

    The Nuclear Safety Information Center (NSIC) serves as a focal point for the collection, analysis and dissemination of information related to safety problems encountered in the design, analysis, and operation of nuclear facilities. (Author/AB)

  13. Alcohol/safety public information materials catalog. Number 5

    DOT National Transportation Integrated Search

    1981-06-01

    Author's abstract: The Alcohol/Safety Public Information Materials Catalog is designed for use by persons developing public information programs on alcohol and highway safety. It lists materials produced for campaigns along with journal articles and ...

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

    PubMed

    2010-01-21

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

  15. The roles and functions of safety professionals in Taiwan: Comparing the perceptions of safety professionals and safety educators.

    PubMed

    Wu, Tsung-Chih

    2011-10-01

    The perspectives of both internal and external members have to be considered when developing safety curricula. This study discusses perceptional differences between safety educators (SEs) and safety professionals (SPs) regarding the function of SPs. The findings will serve as a reference framework for the establishment of core safety competencies and the development of safety curricula for SPs. 248 respondents, including both SEs and SPs, completed self-administered questionnaires, which included the 45-item safety function scale (SFS). Nine factors were extracted from the scale using exploratory factor analysis (EFA), namely inspection and research, regulatory tasks, emergency procedures and settlement of damage, management and financial affairs, culture change, problem identification and analysis, developing and implementing solutions, knowledge management, and training and communications. Descriptive statistical results indicated that SPs and SEs hold differing views on the rank of the frequency of safety functions. MANOVA results indicated that SPs' perceptions of developing and implementing solutions, training and communications, inspection and research, and management and financial affairs were significantly higher than that of SEs. On the other hand, SE's perceptions regarding participation in regulatory tasks were significantly higher than those of SPs. Based on these results, the author suggests that a clear communication channel should be established between universities and industry to reduce the gap between the perceptions of SEs and SPs. The results of the study are statistically and practically significant. In addition to serving as a reference for the development of safety curricula, the results are also conducive to the establishment of SP roles and functions. Ultimately the development of more suitable safety curricula would open up employment competition for students who graduate from safety-related programs. SPs, on the other hand, can correctly

  16. Safety First!

    ERIC Educational Resources Information Center

    Longfield, Judith

    2006-01-01

    In this article, the author relates how a hands-on chemistry investigation provided her the inspiration to develop an effective safety lesson for her third grade chemistry class. She began the lesson by demonstrating the use of pH indicator paper to show that ordinary household (white) vinegar was an acid. With the students, she wondered aloud…

  17. Maintenance of safety behaviors via response-produced stimuli.

    PubMed

    Angelakis, Ioannis; Austin, Jennifer L

    2015-11-01

    Animal studies suggest that safety behaviors may be maintained by internally or externally produced safety signals, which function as positive reinforcers. We designed two experiments to test this phenomenon with humans. Participants played a computerized game in which they could earn or lose treasures by clicking on a map. In baseline, losses could be postponed by pressing a pedal that also produced a blue bar at the bottom of the screen. During test conditions, no losses were programmed, and pedal presses turned the bar from yellow to blue (Test 1) or blue to yellow (Test 2). In Experiment 2, new participants were exposed to the same conditions but were given information about the safety of the test environment. In both experiments, participants engaged in high rates of pedal pressing when presses were followed by blue bars, suggesting the bar functioned as a safety signal. We discuss how these findings may relate to safety behaviors commonly observed in certain mental health disorders. © The Author(s) 2015.

  18. Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims on Foods Related to Vision Proposed Under Regulation (EC) 1924/2006

    PubMed Central

    Bedogni, Giorgio; Biasini, Beatrice; Zavaroni, Ivana; Ventura, Marco; Galli, Daniela; Mirandola, Prisco; Vitale, Marco; Bonadonna, Riccardo C.; Passeri, Giovanni

    2018-01-01

    Adequate visual function has a strong impact on the quality of life of people. Several foods and food components have been hypothesized to play a role in the maintenance of normal visual function and in the prevention of eye diseases. Some of these foods/food components have been the object of a request of authorization for use of health claims under Articles 13(5) or 14 of the Regulation (EC) 1924/2006. Most of these requests have received a negative opinion from the European Food Safety Authority (EFSA) due to the choice of inappropriate outcome variables (OVs) and/or methods of measurement (MMs) applied in the studies used to substantiate the claims. This manuscript refers to the collection, collation and critical analysis of OVs and MMs related to vision. Guidance document and requests for authorization of health claims were used to collect OVs and MMs related to vision. A literature review was performed to critically analyse OVs and MMs, with the aim of defining their appropriateness in the context of a specific claimed effect related to vision. The results highlight the importance of adequate choices of OVs and MMs for an effective substantiation of claims related to visual function. PMID:29443929

  19. Carcinogenicity of glyphosate: why is New Zealand's EPA lost in the weeds?

    PubMed

    Douwes, Jeroen; 't Mannetje, Andrea; McLean, Dave; Pearce, Neil; Woodward, Alistair; Potter, John D

    2018-03-23

    In 2015, the International Agency for Research on Cancer (IARC) concluded that glyphosate is "probably carcinogenic to humans". The New Zealand Environmental Protection Authority (NZEPA) rejected this and commissioned a new report, concluding that glyphosate was unlikely to be genotoxic or carcinogenic to humans. The NZEPA has argued that the difference arose because IARC is a "hazard-identification authority", whereas NZEPA is a "regulatory body that needs to cast the net more widely". We conclude that the NZEPA process for evaluating the carcinogenicity of glyphosate was flawed and the post hoc justification invalid: there is no mention of risk assessment or "net-benefit approach" in the NZEPA report; and there is no discussion of current New Zealand glyphosate exposures. Further, the NZEPA report quotes heavily from the European Food Safety Authority (EFSA) report, which is itself markedly flawed, and like the NZEPA report, relies heavily on industry-funded and industry-manipulated reviews. Given the scientific flaws in both reports we urge that: the NZEPA report be withdrawn; the NZEPA respond to the concerns raised and for a reassessment to be conducted; and clearer process and better understanding of science be used to inform any future review of hazardous substances in New Zealand.

  20. "Aspartame: A review of genotoxicity data".

    PubMed

    Kirkland, David; Gatehouse, David

    2015-10-01

    Aspartame is a methyl ester of a dipeptide of aspartic acid and phenylalanine. It is 200× sweeter than sucrose and is approved for use in food products in more than 90 countries around the world. Aspartame has been evaluated for genotoxic effects in microbial, cell culture and animal models, and has been subjected to a number of carcinogenicity studies. The in vitro and in vivo genotoxicity data available on aspartame are considered sufficient for a thorough evaluation. There is no evidence of induction of gene mutations in a series of bacterial mutation tests. There is some evidence of induction of chromosomal damage in vitro, but this may be an indirect consequence of cytotoxicity. The weight of evidence from in vivo bone marrow micronucleus, chromosomal aberration and Comet assays is that aspartame is not genotoxic in somatic cells in vivo. The results of germ cell assays are difficult to evaluate considering limited data available and deviations from standard protocols. The available data therefore support the conclusions of the European Food Safety Authority (EFSA) that aspartame is non-genotoxic. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. Bisphenol A and Bisphenol S release in milk under household conditions from baby bottles marketed in Italy.

    PubMed

    Russo, Giacomo; Barbato, Francesco; Cardone, Eleonora; Fattore, Margherita; Albrizio, Stefania; Grumetto, Lucia

    2018-02-01

    A simple and sensitive validated analytical method based on liquid chromatography coupled to tandem fluorescence (FD) and ultraviolet (UV) spectrophotometry was applied to monitor the presence of bisphenol A and bisphenol S in plastic baby bottles marketed in Italy. The limits of detection (LOD) were 3.75 ng mL -1 and 80.00 ng mL -1 , and those of quantification (LOQ) were 12.51 ng mL -1 and 260.00 ng mL -1 for BPA (FD detection) and for BPS (UV detection), respectively. BPA was found in only four samples, two samples undergone to microwave heating and two samples undergone to bottle warmer heating either at 40°C or at 80°C. Although the quantities of leached BPA were well below the reference dose for daily intake established by the European Food Safety Authority (EFSA) (4.0 µg kg -1 bw/day), the release of BPA and BPS from these plastic materials should be carefully considered by the government authorities to increase people's awareness on this issue and to protect the most vulnerable population group.

  2. Worker Health and Safety: An Area of Conflicts

    ERIC Educational Resources Information Center

    Ashford, Nicholas A.

    1975-01-01

    The article outlines four basic conflicts concerning occupational health and safety, discusses the nature and dimensions of health and safety problems, examines the generation of information and its diffusion, and deals briefly with some economic issues. (Author)

  3. Car manufacturers and global road safety: a word frequency analysis of road safety documents.

    PubMed

    Roberts, I; Wentz, R; Edwards, P

    2006-10-01

    The World Bank believes that the car manufacturers can make a valuable contribution to road safety in poor countries and has established the Global Road Safety Partnership (GRSP) for this purpose. However, some commentators are sceptical. The authors examined road safety policy documents to assess the extent of any bias. Word frequency analyses of road safety policy documents from the World Health Organization (WHO) and the GRSP. The relative occurrence of key road safety terms was quantified by calculating a word prevalence ratio with 95% confidence intervals. Terms for which there was a fourfold difference in prevalence between the documents were tabulated. Compared to WHO's World report on road traffic injury prevention, the GRSP road safety documents were substantially less likely to use the words speed, speed limits, child restraint, pedestrian, public transport, walking, and cycling, but substantially more likely to use the words school, campaign, driver training, and billboard. There are important differences in emphasis in road safety policy documents prepared by WHO and the GRSP. Vigilance is needed to ensure that the road safety interventions that the car industry supports are based on sound evidence of effectiveness.

  4. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  5. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  6. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  7. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

  8. 49 CFR 451.16 - Action by approval authority-individual approval.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.16 Action by approval authority-individual approval. (a) The...

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

    PubMed

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

    2015-09-01

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

  10. 7 CFR 2.51 - Deputy Under Secretary for Food Safety.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

  11. 7 CFR 2.51 - Deputy Under Secretary for Food Safety.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 1 2014-01-01 2014-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

  12. 7 CFR 2.51 - Deputy Under Secretary for Food Safety.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 1 2012-01-01 2012-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

  13. 7 CFR 2.51 - Deputy Under Secretary for Food Safety.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 1 2013-01-01 2013-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

  14. 7 CFR 2.51 - Deputy Under Secretary for Food Safety.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

  15. Infusing Reliability Techniques into Software Safety Analysis

    NASA Technical Reports Server (NTRS)

    Shi, Ying

    2015-01-01

    Software safety analysis for a large software intensive system is always a challenge. Software safety practitioners need to ensure that software related hazards are completely identified, controlled, and tracked. This paper discusses in detail how to incorporate the traditional reliability techniques into the entire software safety analysis process. In addition, this paper addresses how information can be effectively shared between the various practitioners involved in the software safety analyses. The author has successfully applied the approach to several aerospace applications. Examples are provided to illustrate the key steps of the proposed approach.

  16. Radiation Protection, Safety and Security Issues in Ghana.

    PubMed

    Boadu, Mary; Emi-Reynolds, Geoffrey; Amoako, Joseph Kwabena; Akrobortu, Emmanuel; Hasford, Francis

    2016-11-01

    Although the use of radioisotopes in Ghana began in 1952, the Radiation Protection Board of Ghana was established in 1993 and served as the national competent authority for authorization and inspection of practices and activities involving radiation sources until 2015. The law has been superseded by an Act of Parliament, Act 895 of 2015, mandating the Nuclear Regulatory Authority of Ghana to take charge of the regulation of radiation sources and their applications. The Radiation Protection Institute in Ghana provided technical support to the regulatory authority. Regulatory and service activities that were undertaken by the Institute include issuance of permits for handling of a radiation sources, authorization and inspection of radiation sources, radiation safety assessment, safety assessment of cellular signal towers, and calibration of radiation-emitting equipment. Practices and activities involving application of radiation are brought under regulatory control in the country through supervision by the national competent authority.

  17. 14 CFR § 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... Hours and Safety Standards Act, and associated labor statutes. (a) Delegation of authority. The Director, Industrial Relations Office, is hereby delegated the authority to act for the Administrator in all matters...

  18. 31 CFR 586.515 - Payments for services rendered by the Government of the FRY (S&M) to aircraft authorized...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Government of the FRY (S&M) to aircraft authorized; aircraft and maritime safety. 586.515 Section 586.515... services rendered by the Government of the FRY (S&M) to aircraft authorized; aircraft and maritime safety... maritime traffic in international waters. ...

  19. 31 CFR 315.7 - Authorized forms of registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 2 2012-07-01 2012-07-01 false Authorized forms of registration. 315.7 Section 315.7 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued... omitted. Examples: Tenth National Bank, trustee of Pension Fund of Safety Manufacturing Company, U/A with...

  20. 31 CFR 315.7 - Authorized forms of registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 2 2013-07-01 2013-07-01 false Authorized forms of registration. 315.7 Section 315.7 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued... omitted. Examples: Tenth National Bank, trustee of Pension Fund of Safety Manufacturing Company, U/A with...

  1. 31 CFR 315.7 - Authorized forms of registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance: Treasury 2 2014-07-01 2014-07-01 false Authorized forms of registration. 315.7 Section 315.7 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued... omitted. Examples: Tenth National Bank, trustee of Pension Fund of Safety Manufacturing Company, U/A with...

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

    ERIC Educational Resources Information Center

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

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

  3. Behavior-Based Safety and Occupational Risk Management

    ERIC Educational Resources Information Center

    Geller, E. Scott

    2005-01-01

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

  4. Training in quality and safety: the current landscape.

    PubMed

    Karasick, Andrew S; Nash, David B

    2015-01-01

    The current US health care environment requires and encourages the development and implementation of training programs focusing on quality improvement and patient safety. This article offers a new resource that details the basic characteristics of such physician-inclusive training programs. Specifically, program type, objectives, eligibility, cost, training length, and modality are aggregated and displayed to provide health care professionals with a new tool to facilitate individual education in the field of quality improvement and patient safety. © The Author(s) 2014.

  5. Towards an Inclusive Occupational Health and Safety For Informal Workers.

    PubMed

    Lund, Francie; Alfers, Laura; Santana, Vilma

    2016-08-01

    Large numbers of workers worldwide work informally. Yet the discipline and practice of occupational health and safety covers largely only formal workers, in formal work places. A comprehensive approach would have to take into account specific hazards faced by those in different occupations, working in "atypical" work places. Local authorities exert significant influence in the provision of infrastructure that impacts on health and safety, such as water and sanitation. Examples from Brazil and Ghana show that positive interventions are possible so long as informal workers are recognized as contributing to the economy. A more inclusive occupational health and safety is most likely to happen in contexts where informal workers have an organized voice and where there are responsive health and safety personnel who understand that the world of work has changed. Some policy interventions that impact on healthy and safe work will need to involve multiple stakeholders and institutions. © The Author(s) 2016.

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

    ERIC Educational Resources Information Center

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

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

  7. Teen worker safety training: methods used, lessons taught, and time spent.

    PubMed

    Zierold, Kristina M

    2015-05-01

    Safety training is strongly endorsed as one way to prevent teens from performing dangerous tasks at work. The objective of this mixed methods study was to characterize the safety training that teenagers receive on the job. From 2010 through 2012, focus groups and a cross-sectional survey were conducted with working teens. The top methods of safety training reported were safety videos (42 percent) and safety lectures (25 percent). The top lessons reported by teens were "how to do my job" and "ways to spot hazards." Males, who were more likely to do dangerous tasks, received less safety training than females. Although most teens are getting safety training, it is inadequate. Lessons addressing safety behaviors are missing, training methods used are minimal, and the time spent is insignificant. More research is needed to understand what training methods and lessons should be used, and the appropriate safety training length for effectively preventing injury in working teens. In addition, more research evaluating the impact of high-quality safety training compared to poor safety training is needed to determine the best training programs for teens. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  8. 31 CFR 360.6 - Authorized forms of registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 2 2013-07-01 2013-07-01 false Authorized forms of registration. 360.6 Section 360.6 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued... Pension Fund of Safety Manufacturing Company, U/A with the company, dated March 31, 1996, 12-3456789...

  9. 31 CFR 360.6 - Authorized forms of registration.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 31 Money and Finance:Treasury 2 2011-07-01 2011-07-01 false Authorized forms of registration. 360.6 Section 360.6 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued... Pension Fund of Safety Manufacturing Company, U/A with the company, dated March 31, 1996, 12-3456789...

  10. 31 CFR 360.6 - Authorized forms of registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 2 2012-07-01 2012-07-01 false Authorized forms of registration. 360.6 Section 360.6 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued... Pension Fund of Safety Manufacturing Company, U/A with the company, dated March 31, 1996, 12-3456789...

  11. 31 CFR 353.7 - Authorized forms of registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance: Treasury 2 2014-07-01 2014-07-01 false Authorized forms of registration. 353.7 Section 353.7 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued... limited term, their names may be omitted. Examples: Tenth National Bank, trustee of Pension Fund of Safety...

  12. 31 CFR 353.7 - Authorized forms of registration.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 31 Money and Finance:Treasury 2 2013-07-01 2013-07-01 false Authorized forms of registration. 353.7 Section 353.7 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued... limited term, their names may be omitted. Examples: Tenth National Bank, trustee of Pension Fund of Safety...

  13. 31 CFR 360.6 - Authorized forms of registration.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 31 Money and Finance: Treasury 2 2014-07-01 2014-07-01 false Authorized forms of registration. 360.6 Section 360.6 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued... Pension Fund of Safety Manufacturing Company, U/A with the company, dated March 31, 1996, 12-3456789...

  14. 31 CFR 353.7 - Authorized forms of registration.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 31 Money and Finance:Treasury 2 2012-07-01 2012-07-01 false Authorized forms of registration. 353.7 Section 353.7 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued... limited term, their names may be omitted. Examples: Tenth National Bank, trustee of Pension Fund of Safety...

  15. Safety Alerts: An Observational Study in Portugal.

    PubMed

    Soares, Sara; Roque, Fátima; Teixeira Rodrigues, António; Figueiras, Adolfo; Herdeiro, Maria Teresa

    2015-09-01

    The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefore sought to analyze all safety alerts published by the Portuguese National Authority of Medicines and Health Products I.P. (INFARMED). We conducted an observational study of all alerts published on the INFARMED website from January 2002 through December 2014. From the data included in the alerts, the following information was abstracted: active substance name (and trade name), event that led to the alert, and the resulting safety measures. Active substances were classified according to the Anatomical Therapeutic Chemical (ATC) code. A total of 562 alerts were published, and 304 were eligible for inclusion. The musculoskeletal system was the ATC code with more alerts (n = 53), followed by the nervous system (n = 42). Communication of the information and recommendations to the health care professionals and the public in general was the most frequent safety measure (n = 128), followed by changes in the Summary of the Product Characteristics and package information leaflet (n = 66). During the study period, 26 marketing authorizations were temporarily suspended and 10 were revoked. The knowledge of the alerts published during the postmarketing period is very useful to the health care professionals for improving prescription and use of medicines and to the scientific community for the development of new researches. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

  16. 49 CFR 450.11 - Application for delegation of authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 6 2014-10-01 2014-10-01 false Application for delegation of authority. 450.11 Section 450.11 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS GENERAL Procedure for Delegation to...

  17. 49 CFR 450.11 - Application for delegation of authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 6 2013-10-01 2013-10-01 false Application for delegation of authority. 450.11 Section 450.11 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS GENERAL Procedure for Delegation to...

  18. 49 CFR 450.11 - Application for delegation of authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 6 2011-10-01 2011-10-01 false Application for delegation of authority. 450.11 Section 450.11 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS GENERAL Procedure for Delegation to...

  19. 49 CFR 450.11 - Application for delegation of authority.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 6 2010-10-01 2010-10-01 false Application for delegation of authority. 450.11 Section 450.11 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS GENERAL Procedure for Delegation to...

  20. 49 CFR 450.11 - Application for delegation of authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 6 2012-10-01 2012-10-01 false Application for delegation of authority. 450.11 Section 450.11 Transportation Other Regulations Relating to Transportation (Continued) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS GENERAL Procedure for Delegation to...

  1. The development of a methodology for transportation safety planning in Virginia.

    DOT National Transportation Integrated Search

    1980-01-01

    Senate Bill 85, passed by the General Assembly in 1978, renamed the former Highway Safety Division of Virginia the Department of Transportation Safety (VDTS) and authorized it to assume control over safety activities in all modes of transportation. T...

  2. 77 FR 64450 - Hazardous Materials: Incorporation of Certain Special Permits and Competent Authorities Into...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... varies from the regulations provided an equivalent level of safety is maintained. An approval is a... materials regulations (HMR) provided an equivalent level of safety is maintained. A competent authority (CA... drums. Transportation of spent bleaching earth. Requalification of non-DOT specification cylinders in...

  3. Y-12 PLANT NUCLEAR SAFETY HANDBOOK

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

    Wachter, J.W. ed.; Bailey, M.L.; Cagle, T.J.

    1963-03-27

    Information needed to solve nuclear safety problems is condensed into a reference book for use by persons familiar with the field. Included are a glossary of terms; useful tables; nuclear constants; criticality calculations; basic nuclear safety limits; solution geometries and critical values; metal critical values; criticality values for intermediate, heterogeneous, and interacting systems; miscellaneous and related information; and report number, author, and subject indexes. (C.H.)

  4. GSFC Safety and Mission Assurance Organization

    NASA Technical Reports Server (NTRS)

    Kelly, Michael P.

    2010-01-01

    This viewgraph presentation reviews NASA Goddard Space Flight Center's approach to safety and mission assurance. The contents include: 1) NASA GSFC Background; 2) Safety and Mission Assurance Directorate; 3) The Role of SMA-D and the Technical Authority; 4) GSFC Mission assurance Requirements; 5) GSFC Systems Review Office (SRO); 6) GSFC Supply Chain Management Program; and 7) GSFC ISO9001/AS9100 Status Brief.

  5. Achievements and Perspectives of the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management

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

    Louvat, D.; Lacoste, A.C.

    The Joint Convention on the Safety of Spent Fuel management and on the Safety of Radioactive Waste Management is the first legal instrument to directly address the safety of spent fuel and radioactive waste management on a global scale. The Joint Convention entered into force in 2001. This paper describes its process and its main achievements to date. The perspectives to establish of a Global Waste Safety Regime based on the Joint Convention are also discussed. (authors)

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

    Verstraete, Frans, E-mail: Frans.Verstraete@ec.europa.eu

    Directive 2002/32/EC of 7 May 2002 of the European Parliament and of the Council on undesirable substances in animal feed is the framework for the EU action on undesirable substances in feed. This framework Directive provides: ⁎that products intended for animal feed may enter for use in the Union from third countries, be put into circulation and/or used in the Union only if they are sound, genuine and of merchantable quality and therefore when correctly used do not represent any danger to human health, animal health or to the environment or could adversely affect livestock production. ⁎that in order tomore » protect animal and public health and the environment, maximum levels for specific undesirable substances shall be established where necessary. ⁎for mandatory consultation of a scientific body (EFSA) for all provisions which may have an effect upon public health or animal health or on the environment. ⁎that products intended for animal feed containing levels of an undesirable substance that exceed the established maximum level may not be mixed for dilution purposes with the same, or other, products intended for animal feed and may not be used for the production of compound feed. Based on the provisions and principles laid down in this framework Directive, maximum levels for a whole range of undesirable substances have been established at EU level. During the discussions in view of the adoption of Directive 2002/32/EC, the European Commission made the commitment to review all existing provisions on undesirable substances on the basis of updated scientific risk assessments. Following requests of the European Commission, the Panel on Contaminants in the Food Chain (CONTAM) from the European Food Safety Authority (EFSA) has completed a series of 30 risk assessments undertaken over the last 5 years on undesirable substances in animal feed reviewing the possible risks for animal and human health due to the presence of these substances in animal feed. EU

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

    PubMed

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

    2014-01-01

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

  8. [History of the evaluation of medicines aiming for marketing authorization].

    PubMed

    Caulin, C

    2008-01-01

    The European Directive on Medicines Evaluation and Marketing Authorization were issued in 1975. For more than 30 years, Marketing Authorization criteria have been defined as pharmaceutical and biological quality, therapeutic efficacy, and safety. The application comes from the pharmaceutical company and must include the full data on drug development. French procedures have always included practical assessment of the drug by health practitioners: clinicians, pharmacists, biologists, and specialists in biostatistics.

  9. Reported Dietary Intake and Food Sources of Zinc, Selenium, and Vitamins A, E and C in the Spanish Population: Findings from the ANIBES Study.

    PubMed

    Olza, Josune; Aranceta-Bartrina, Javier; González-Gross, Marcela; Ortega, Rosa M; Serra-Majem, Lluis; Varela-Moreiras, Gregorio; Gil, Ángel

    2017-07-06

    Zinc, selenium, and the vitamins A, E and C, all have specific biological functions that are involved mainly in the antioxidant defence system, which has important implications for the development of chronic diseases. We aimed to assess the reported intake of those six nutrients, as well as the food that contributes to their sources of intakes. Data were obtained from the Spanish ANIBES ("Anthropometry, Intake and Energy Balance in Spain") study, n = 2009 (9-75 years old). The analyses were performed in the whole population and in the plausible energy reporters after a misreporting analysis according to the European Food and Safety Authority (EFSA) protocol. A validated, photo-based three-day food record was used to collect the data. Mean (max-min) reported intake for the whole population of zinc was 8.1 ± 0.1 mg/day, (2.3-27.3 mg/day), selenium 75 ± 1 µg/day, (14-265 µg/day), vitamin A 668 µg RE/day (2-11,017 µg RE/day), retinol 364 ± 18 µg/day (0-10,881 µg/day), carotenes 1735 ± 35 µg/day (13-13,962 µg/day), vitamin E 7.0 ± 0.1 mg α-TE/day (0.7-55.2 mg α-TE/day) and vitamin C 84.4 ± 1.4 mg/day (5.0-802.7 mg/day). The main source intakes for zinc were meat and meat products, for selenium cereals and grains, for vitamin E oils and fat, and for vitamin A and C vegetables. There is an elevated percentage of the Spanish ANIBES population not meeting the EFSA recommended intakes for all analysed micronutrients: zinc (83%), vitamin A (60%), vitamin E (80%), vitamin C (36%) and selenium (25%).

  10. Handling of thermal paper: Implications for dermal exposure to bisphenol A and its alternatives

    PubMed Central

    Bernier, Meghan R.

    2017-01-01

    Bisphenol A (BPA) is an endocrine disrupting chemical used in a wide range of consumer products including photoactive dyes used in thermal paper. Recent studies have shown that dermal absorption of BPA can occur when handling these papers. Yet, regulatory agencies have largely dismissed thermal paper as a major source of BPA exposure. Exposure estimates provided by agencies such as the European Food Safety Authority (EFSA) are based on assumptions about how humans interact with this material, stating that ‘typical’ exposures for adults involve only one handling per day for short periods of time (<1 minute), with limited exposure surfaces (three fingertips). The objective of this study was to determine how individuals handle thermal paper in one common setting: a cafeteria providing short-order meals. We observed thermal paper handling in a college-aged population (n = 698 subjects) at the University of Massachusetts’ dining facility. We find that in this setting, individuals handle receipts for an average of 11.5 min, that >30% of individuals hold thermal paper with more than three fingertips, and >60% allow the paper to touch their palm. Only 11% of the participants we observed were consistent with the EFSA model for time of contact and dermal surface area. Mathematical modeling based on handling times we measured and previously published transfer coefficients, concentrations of BPA in paper, and absorption factors indicate the most conservative estimated intake from handling thermal paper in this population is 51.1 ng/kg/day, similar to EFSA’s estimates of 59 ng/kg/day from dermal exposures. Less conservative estimates, using published data on concentrations in thermal paper and transfer rates to skin, indicate that exposures are likely significantly higher. Based on our observational data, we propose that the current models for estimating dermal BPA exposures are not consistent with normal human behavior and should be reevaluated. PMID:28570582

  11. Guiding principles of safety as a basis for developing a pharmaceutical safety culture.

    PubMed

    Edwards, Brian; Olsen, Axel K; Whalen, Matthew D; Gold, Marla J

    2007-05-01

    Despite the best efforts of industry and regulatory authorities, the trust of society in the process of medicine development and communication of pharmaceutical risk has ebbed away. In response the US government has called for a culture of compliance while the EU regulators talk of a 'culture of scientific excellence'. However, one of the fundamental problems hindering progress to rebuilding trust based on a pharmaceutical safety culture is the lack of agreement and transparency between all stakeholders as to what is meant by a 'Safety of Medicines'. For that reason, we propose 'Guiding Principles of Safety for Pharmaceuticals' are developed analogous to the way that Chemical Safety has been tackled. A logical starting point would be to examine the Principles outlined by the US Institute of Medicine although we acknowledge that these Principles require further extensive debate and definition. Nevertheless, the Principles should take centre stage in the reform of pharmaceutical development required to restore society's trust.

  12. Bibliography on Liquefied Natural Gas (LNG) safety

    NASA Technical Reports Server (NTRS)

    Ordin, P. M.

    1976-01-01

    Approximately 600 citations concerning safety of liquefied natural gas and liquid methane are presented. Each entry includes the title, author, abstract, source, description of figures, key references, and major descriptors for retrieving the document. An author index is provided as well as an index of descriptors.

  13. 2006 Missouri traffic safety compendium

    DOT National Transportation Integrated Search

    2006-01-01

    The purpose of this publication is to provide the Missouri State Highway Patrol, the Missouri Department of Transportation, : Highway Safety Division, and other State and local authorities with information on Missouri's traffic crash problems. : It i...

  14. 2004 Missouri traffic safety compendium

    DOT National Transportation Integrated Search

    2004-01-01

    The purpose of this publication is to provide the Missouri State Highway Patrol, the Missouri Department of : Transportation, Highway Safety Division, and other State and local authorities with information on Missouri's traffic : crash problems. It i...

  15. 2007 Missouri traffic safety compendium

    DOT National Transportation Integrated Search

    2007-01-01

    The purpose of this publication is to provide the Missouri State Highway Patrol, the Missouri Department of Transportation, : Highway Safety Division, and other State and local authorities with information on Missouri's traffic crash problems. : It i...

  16. 2009 Missouri traffic safety compendium

    DOT National Transportation Integrated Search

    2009-01-01

    The purpose of this publication is to provide the Missouri State Highway Patrol, the Missouri Department of Transportation, : Highway Safety Division, and other State and local authorities with information on Missouri's traffic crash problems. : It i...

  17. 2010 Missouri traffic safety compendium

    DOT National Transportation Integrated Search

    2010-01-01

    The purpose of this publication is to provide the Missouri State Highway Patrol, the Missouri Department of Transportation, : Highway Safety Division, and other State and local authorities with information on Missouri's traffic crash problems. : It i...

  18. 2003 Missouri traffic safety compendium

    DOT National Transportation Integrated Search

    2003-01-01

    The purpose of this publication is to provide the Missouri State Highway Patrol, the Missouri Department of : Transportation, Highway Safety Division, and other State and local authorities with information on Missouri's traffic : crash problems. It i...

  19. 2005 Missouri traffic safety compendium

    DOT National Transportation Integrated Search

    2005-01-01

    The purpose of this publication is to provide the Missouri State Highway Patrol, the Missouri Department of Transportation, : Highway Safety Division, and other State and local authorities with information on Missouri's traffic crash problems. : It i...

  20. 2008 Missouri traffic safety compendium

    DOT National Transportation Integrated Search

    2008-01-01

    The purpose of this publication is to provide the Missouri State Highway Patrol, the Missouri Department of Transportation, : Highway Safety Division, and other State and local authorities with information on Missouri's traffic crash problems. : It i...

  1. Systems Engineering Technical Authority: A Path to Mission Success

    NASA Technical Reports Server (NTRS)

    Andary, James F.; So, Maria M.; Breindel, Barry

    2008-01-01

    The systems engineering of space missions to study planet Earth has been an important focus of the National Aeronautics and Space Administration (NASA) since its inception. But all space missions are becoming increasingly complex and this fact, reinforced by some major mishaps, has caused NASA to reevaluate their approach to achieving safety and mission success. A new approach ensures that there are adequate checks and balances in place to maximize the probability of safety and mission success. To this end the agency created the concept of Technical Authority which identifies a key individual accountable and responsible for the technical integrity of a flight mission as well as a project-independent reporting path. At the Goddard Space Flight Center (GSFC) this responsibility ultimately begins with the Mission Systems Engineer (MSE) for each satellite mission. This paper discusses the Technical Authority process and then describes some unique steps that are being taken at the GSFC to support these MSEs in meeting their responsibilities.

  2. Safety Assessment of Talc as Used in Cosmetics.

    PubMed

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

    2015-01-01

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

  3. The Relationship Between the Learning and Patient Safety Climates of Clinical Departments and Residents' Patient Safety Behaviors.

    PubMed

    Silkens, Milou E W M; Arah, Onyebuchi A; Wagner, Cordula; Scherpbier, Albert J J A; Heineman, Maas Jan; Lombarts, Kiki M J M H

    2018-05-15

    Improving residents' patient safety behavior should be a priority in graduate medical education to ensure the safety of current and future patients. Supportive learning and patient safety climates may foster this behavior. This study examined the extent to which residents' self-reported patient safety behavior can be explained by the learning climate and patient safety climate of their clinical departments. The authors collected learning climate data from clinical departments in the Netherlands that used the web-based Dutch Residency Educational Climate Test between September 2015 and October 2016. They also gathered data on those departments' patient safety climate and on residents' self-reported patient safety behavior. They used generalized linear mixed models and multivariate general linear models to test for associations in the data. In total, 1,006 residents evaluated 143 departments in 31 teaching hospitals. Departments' patient safety climate was associated with residents' overall self-reported patient safety behavior (regression coefficient (b) = 0.33; 95% confidence interval (CI) = 0.14 - 0.52). Departments' learning climate was not associated with residents' patient safety behavior (b = 0.01; 95% CI = -0.17 - 0.19), although it was with their patient safety climate (b = 0.73; 95% CI = 0.69 - 0.77). Departments should focus on establishing a supportive patient safety climate to improve residents' patient safety behavior. Building a supportive learning climate might help to improve the patient safety climate and, in turn, residents' patient safety behavior.

  4. Road Infrastructure Safety Management in Poland

    NASA Astrophysics Data System (ADS)

    Budzynski, Marcin; Jamroz, Kazimierz; Kustra, Wojciech; Michalski, Lech; Gaca, Stanislaw

    2017-10-01

    stretch, road section, junction, etc.). The objective of the methods is to help road authorities to take rational decisions in the area of road safety and road infrastructure safety and understand the consequences occurring in the particular phases of road life cycle. To help with assessing the impact of a road project on the safety of related roads, a method was developed for long-term forecasts of accidents and accident cost estimation as well as a risk classification to identify risks that are not acceptable risks. With regard to road safety audits and road safety inspection, a set of principles was developed to identify risks and the basic classification of mistakes and omissions. This work has added to the Polish experience of preparing and implementing such tools within the competent road authorities.

  5. The Impact of Language and Culture Diversity in Occupational Safety.

    PubMed

    De Jesus-Rivas, Mayra; Conlon, Helen Acree; Burns, Candace

    2016-01-01

    Occupational health nursing plays a critical part in improving the safety of foreign labor workers. The development and implementation of safety training programs do not always regularly take into account language barriers, low literacy levels, or cultural elements. This oversight can lead to more injuries and fatalities among this group. Despite established health and safety training programs, a significant number of non-native English speakers are injured or killed in preventable, occupation-related accidents. Introducing safety programs that use alternative teaching strategies such as pictograms, illustrations, and hands-on training opportunities will assist in addressing challenges for non-English laborers. Occupational health nursing has an opportunity to provide guidance on this subject and assist businesses in creating a safer and more productive work environment. © 2015 The Author(s).

  6. 78 FR 65429 - Pipeline Safety: Request for Special Permit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-31

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2010-0041] Pipeline Safety: Request for Special Permit AGENCY: Pipeline and Hazardous Materials...-0041 Williams Gas Pipeline 49 CFR 192.150........ To authorize the extension Company, LLC (WGP). of a...

  7. 14 CFR 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... authority to take action regarding “liquidated damage” assessments under the Contract Work Hours and Safety... nonconstruction contracts as they are subject to the Conract Work Hours and Safety Standards Act, in regards to...

  8. 14 CFR 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... authority to take action regarding “liquidated damage” assessments under the Contract Work Hours and Safety... nonconstruction contracts as they are subject to the Conract Work Hours and Safety Standards Act, in regards to...

  9. Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval.

    PubMed

    Giezen, Thijs J; Mantel-Teeuwisse, Aukje K; Straus, Sabine M J M; Egberts, Toine C G; Blackburn, Stella; Persson, Ingemar; Leufkens, Hubert G M

    2009-01-01

    Since November 2005, an EU Risk Management Plan (EU-RMP) has had to be submitted as part of a marketing application for all new chemical entities in the EU. In the EU-RMP, the safety profile of the medicine has to be described and pharmacovigilance activities should be proposed to study further safety concerns during use of the drug in the real-world setting. These activities include, for example, collection of spontaneously reported adverse events and post-authorization safety studies (PASS). Since the submission of an EU-RMP is a relatively new requirement, there is limited knowledge on the quality and completeness of the study protocols of PASS at the time of approval and there are no data on the influence of certain drug characteristics on the proposed pharmacovigilance activities. To examine the types of proposed pharmacovigilance activities in a sample of EU-RMPs, describe and evaluate the methodology of PASS, identify problems and propose remedies, and compare characteristics between biologicals and small molecules. Eighteen EU-RMPs (nine for biologicals, nine for small molecules) given a positive decision regarding the marketing application by the Committee for Medicinal Products for Human Use between November 2005 and May 2007 were included in this descriptive cohort study. The EU-RMPs were selected over time and different therapeutic areas. Classification of the safety concerns ('important identified risks', 'important potential risks', 'important missing information' within the EU-RMP was studied. For PASS, data source (registry, population-based database, sponsor-owned clinical trial database), source of study population to be included in PASS and comprehensiveness of study protocol (full protocol, limited protocol, study synopsis, short description, commitment without further information) were studied. Compared to small molecules, safety concerns for biologicals were less frequently classified as important identified risks (relative risk [RR] 0.6; 95

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

    PubMed

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

    2014-01-01

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

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

    DTIC Science & Technology

    1990-03-23

    Trade Commission (FrC), under its own legislative authority to protect consumers against false and deceptive advertising , can take enforcement action...vides to the public about the safety of its products, federal enforcement actions taken against lawn care pesticide safety advertising claims, and...in reassessing the risks of these pesticides. FIFRA also authorizes EPA to take enforcement action against advertising claims made by pesticide

  12. 18 CFR 12.4 - Staff administrative responsibility and supervisory authority.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS AND PROJECT WORKS General Provisions § 12.4 Staff administrative responsibility and supervisory authority. (a) Administrative responsibility. The Director of the Office of Energy Projects is...

  13. 18 CFR 12.4 - Staff administrative responsibility and supervisory authority.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS AND PROJECT WORKS General Provisions § 12.4 Staff administrative responsibility and supervisory authority. (a) Administrative responsibility. The Director of the Office of Energy Projects is...

  14. 18 CFR 12.4 - Staff administrative responsibility and supervisory authority.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT SAFETY OF WATER POWER PROJECTS AND PROJECT WORKS General Provisions § 12.4 Staff administrative responsibility and supervisory authority. (a) Administrative responsibility. The Director of the Office of Energy Projects...

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

    PubMed

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

    2015-09-01

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

  16. 2002 Missouri traffic safety compendium

    DOT National Transportation Integrated Search

    2002-01-01

    The purpose of this publication is to provide the Missouri State Highway Patrol, the Missouri Division of Highway : Safety, and other State and local authorities with information on Missouri's traffic crash problems. It is one in a : series which is ...

  17. Determination of Inorganic Arsenic in a Wide Range of Food Matrices using Hydride Generation - Atomic Absorption Spectrometry.

    PubMed

    de la Calle, Maria B; Devesa, Vicenta; Fiamegos, Yiannis; Vélez, Dinoraz

    2017-09-01

    The European Food Safety Authority (EFSA) underlined in its Scientific Opinion on Arsenic in Food that in order to support a sound exposure assessment to inorganic arsenic through diet, information about distribution of arsenic species in various food types must be generated. A method, previously validated in a collaborative trial, has been applied to determine inorganic arsenic in a wide variety of food matrices, covering grains, mushrooms and food of marine origin (31 samples in total). The method is based on detection by flow injection-hydride generation-atomic absorption spectrometry of the iAs selectively extracted into chloroform after digestion of the proteins with concentrated HCl. The method is characterized by a limit of quantification of 10 µg/kg dry weight, which allowed quantification of inorganic arsenic in a large amount of food matrices. Information is provided about performance scores given to results obtained with this method and which were reported by different laboratories in several proficiency tests. The percentage of satisfactory results obtained with the discussed method is higher than that of the results obtained with other analytical approaches.

  18. Potential use of an arthropod database to support the non-target risk assessment and monitoring of transgenic plants.

    PubMed

    Romeis, Jörg; Meissle, Michael; Alvarez-Alfageme, Fernando; Bigler, Franz; Bohan, David A; Devos, Yann; Malone, Louise A; Pons, Xavier; Rauschen, Stefan

    2014-12-01

    Worldwide, plants obtained through genetic modification are subject to a risk analysis and regulatory approval before they can enter the market. An area of concern addressed in environmental risk assessments is the potential of genetically modified (GM) plants to adversely affect non-target arthropods and the valued ecosystem services they provide. Environmental risk assessments are conducted case-by-case for each GM plant taking into account the plant species, its trait(s), the receiving environments into which the GM plant is to be released and its intended uses, and the combination of these characteristics. To facilitate the non-target risk assessment of GM plants, information on arthropods found in relevant agro-ecosystems in Europe has been compiled in a publicly available database of bio-ecological information during a project commissioned by the European Food Safety Authority (EFSA). Using different hypothetical GM maize case studies, we demonstrate how the information contained in the database can assist in identifying valued species that may be at risk and in selecting suitable species for laboratory testing, higher-tier studies, as well as post-market environmental monitoring.

  19. Cause-effect relationships in nutritional intervention studies for health claims substantiation: guidance for trial design.

    PubMed

    Navas-Carretero, Santiago; Martinez, J Alfredo

    2015-07-01

    The growing worldwide interest on functional food research has been accompanied by increasing regulatory guidelines in this area, with the aim of ensuring that any claimed effect in foods, beyond their nutritional role, is based on scientific unequivocal evidence. In order to assess the cause-effect relationship between the regular consumption of a food or a food component and the beneficial outcome for the consumer, an appropriate study design is required. Previous knowledge and research on the specific claimed food or product may be an adequate basis for defining a hypothesis and accurate objectives. Other key factors to take into account are based on the outcomes studied, the length of the trial, sample size and type, as well as the transparency on reporting the results obtained. Based on the Consolidated Standards on Reporting Trials statement (CONSORT), together with the specific guidelines published by the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies, the present article aims at summarizing key questions conducting to the most appropriate study design for solid health claim substantiation.

  20. OSHA safety requirements and the general duty clause.

    PubMed

    Mills, Anne C; Chillock, Cynthia A; Edelman, Harold; Mills, Shannon E

    2005-03-01

    Dental offices and clinics are subject to the same general safety requirements as other workplaces. Current guidelines, inspections, education, and training focus on infectious disease as the major workplace hazard for dental health care personnel (DHCP). However, the Occupational Safety and Health Administration has cited an increasing variety and number of general safety hazards during inspections of dental offices. A review of the general safety requirements for personal protective equipment and fire safety as they relate to DHCP follows. The authors discuss the responsibility of both employers and employees to perform workplace hazard evaluation and to implement education, engineering controls, and work practice controls to minimize their exposure to recognized and emerging workplace hazards.

  1. Revisiting the safety of aspartame.

    PubMed

    Choudhary, Arbind Kumar; Pretorius, Etheresia

    2017-09-01

    Aspartame is a synthetic dipeptide artificial sweetener, frequently used in foods, medications, and beverages, notably carbonated and powdered soft drinks. Since 1981, when aspartame was first approved by the US Food and Drug Administration, researchers have debated both its recommended safe dosage (40 mg/kg/d) and its general safety to organ systems. This review examines papers published between 2000 and 2016 on both the safe dosage and higher-than-recommended dosages and presents a concise synthesis of current trends. Data on the safe aspartame dosage are controversial, and the literature suggests there are potential side effects associated with aspartame consumption. Since aspartame consumption is on the rise, the safety of this sweetener should be revisited. Most of the literature available on the safety of aspartame is included in this review. Safety studies are based primarily on animal models, as data from human studies are limited. The existing animal studies and the limited human studies suggest that aspartame and its metabolites, whether consumed in quantities significantly higher than the recommended safe dosage or within recommended safe levels, may disrupt the oxidant/antioxidant balance, induce oxidative stress, and damage cell membrane integrity, potentially affecting a variety of cells and tissues and causing a deregulation of cellular function, ultimately leading to systemic inflammation. © The Author(s) 2017. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  2. Integration into Civil Airspace Airworthiness and Safety

    DTIC Science & Technology

    2003-09-02

    Integration into Civil Airspace Airworthiness and Safety 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER......into civil airspace lPurpose : n to explore and propose French process and means for integrating UAV into civil airspace. lMethod based on : n first

  3. Debate on vaccines and autoimmunity: Do not attack the author, yet discuss it methodologically.

    PubMed

    Bragazzi, Nicola Luigi; Watad, Abdulla; Amital, Howard; Shoenfeld, Yehuda

    2017-10-09

    Since Jenner, vaccines and vaccinations have stirred a hot, highly polarized debate, leading to contrasting positions and feelings, ranging from acritical enthusiasm to blind denial. On the one hand, we find anti-vaccination movements which divulge and disseminate misleading information, myths, prejudices, and even frauds, with the main aim of denying that vaccination practices represent a major public health measure, being effective in controlling infectious diseases and safeguarding the wellbeing of entire communities. Recently, the authors of many vaccine safety investigations are being personally criticized rather than the actual science being methodologically assessed and critiqued. Unfortunately, this could result in making vaccine safety science a "hazardous occupation". Critiques should focus on the science and not on the authors and on the scientists that publish reasonably high-quality science suggesting a problem with a given vaccine. These scientists require adequate professional protection so there are not disincentives to publish and to carry out researches in the field. The issues for vaccine safety are not dissimilar to other areas such as medical errors and drug safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. TeamSTEPPS Improves Operating Room Efficiency and Patient Safety.

    PubMed

    Weld, Lancaster R; Stringer, Matthew T; Ebertowski, James S; Baumgartner, Timothy S; Kasprenski, Matthew C; Kelley, Jeremy C; Cho, Doug S; Tieva, Erwin A; Novak, Thomas E

    2016-09-01

    The objective was to evaluate the effect of TeamSTEPPS on operating room efficiency and patient safety. TeamSTEPPS consisted of briefings attended by all health care personnel assigned to the specific operating room to discuss issues unique to each case scheduled for that day. The operative times, on-time start rates, and turnover times of all cases performed by the urology service during the initial year with TeamSTEPPS were compared to the prior year. Patient safety issues identified during postoperative briefings were analyzed. The mean case time was 12.7 minutes less with TeamSTEPPS (P < .001). The on-time first-start rate improved by 21% with TeamSTEPPS (P < .001). The mean room turnover time did not change. Patient safety issues declined from an initial rate of 16% to 6% at midyear and remained stable (P < 0.001). TeamSTEPPS was associated with improved operating room efficiency and diminished patient safety issues in the operating room. © The Author(s) 2015.

  5. Safety Assessment of Dialkyl Sulfosuccinate Salts as Used in Cosmetics.

    PubMed

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

    2016-11-01

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

  6. School Safety in a Post-Sandy Hook World

    ERIC Educational Resources Information Center

    Trump, Kenneth S.

    2014-01-01

    In this report the author, who is a school safety expert, provides information about school safety in a post-Sandy Hook world. He presents the following: (1) Continuum of Threats and Responses; (2) The role social media plays; (3) Reliable Best Practices; (4) Policy and Funding--Climate and Context; (5) Policy and Funding--Things to Avoid; and (6)…

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

    ERIC Educational Resources Information Center

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

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

  8. School Security and Safety.

    ERIC Educational Resources Information Center

    Licht, Kenneth F.

    The author contends that safety and accident prevention should be given primary consideration in a school system's risk management program. He argues that accidents and losses are symptoms of defects in the management system. Two classes of loss discussed are (1) accidental -- injury/loss resulting from unintended events; and (2) purposeful --…

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

    ERIC Educational Resources Information Center

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

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

  10. Occupational Safety and Health Systems: A Three-Country Comparison.

    ERIC Educational Resources Information Center

    Singleton, W. T.

    1983-01-01

    This article compares the occupational safety and health systems of Switzerland, the United Kingdom, and the United States, looking at the origins of their legislation and its effects on occupational safety and health, with a view to determining what lessons may emerge, particularly for developing countries. (Author/SSH)

  11. Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.

    PubMed

    Engel, Pierre; Almas, Mariana Ferreira; De Bruin, Marieke Louise; Starzyk, Kathryn; Blackburn, Stella; Dreyer, Nancy Ann

    2017-04-01

    To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages. During the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. To the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines. © 2016 The British Pharmacological Society.

  12. Model-Driven Development of Safety Architectures

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh; Whiteside, Iain

    2017-01-01

    We describe the use of model-driven development for safety assurance of a pioneering NASA flight operation involving a fleet of small unmanned aircraft systems (sUAS) flying beyond visual line of sight. The central idea is to develop a safety architecture that provides the basis for risk assessment and visualization within a safety case, the formal justification of acceptable safety required by the aviation regulatory authority. A safety architecture is composed from a collection of bow tie diagrams (BTDs), a practical approach to manage safety risk by linking the identified hazards to the appropriate mitigation measures. The safety justification for a given unmanned aircraft system (UAS) operation can have many related BTDs. In practice, however, each BTD is independently developed, which poses challenges with respect to incremental development, maintaining consistency across different safety artifacts when changes occur, and in extracting and presenting stakeholder specific information relevant for decision making. We show how a safety architecture reconciles the various BTDs of a system, and, collectively, provide an overarching picture of system safety, by considering them as views of a unified model. We also show how it enables model-driven development of BTDs, replete with validations, transformations, and a range of views. Our approach, which we have implemented in our toolset, AdvoCATE, is illustrated with a running example drawn from a real UAS safety case. The models and some of the innovations described here were instrumental in successfully obtaining regulatory flight approval.

  13. Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics.

    PubMed

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

    2016-07-01

    The Cosmetic Ingredient Review Expert Panel assessed the safety of 34 microbial polysaccharide gums for use in cosmetics, finding that these ingredients are safe in cosmetic formulations in the present practices of use and concentration. The microbial polysaccharide gums named in this report have a variety of reported functions in cosmetics, including emulsion stabilizer, film former, binder, viscosity-increasing agent, and skin-conditioning agent. The Panel reviewed available animal and clinical data in making its determination of safety. © The Author(s) 2016.

  14. 78 FR 20619 - First Responder Network Authority Board Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... Network Authority (FirstNet). DATES: The meeting will be held on June 4, 2013, from 8:30 a.m. to 11:30 a.m.... SUPPLEMENTARY INFORMATION: This notice informs the public that the FirstNet Board has scheduled a meeting on... the nationwide public safety broadband network. For information on the conference, please visit http...

  15. 20 CFR 726.115 - Revocation of authorization to self-insure.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Revocation of authorization to self-insure. 726.115 Section 726.115 Employees' Benefits EMPLOYMENT STANDARDS ADMINISTRATION, DEPARTMENT OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED BLACK LUNG BENEFITS; REQUIREMENTS FOR COAL...

  16. 20 CFR 726.111 - Notice of authorization to self-insure.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Notice of authorization to self-insure. 726.111 Section 726.111 Employees' Benefits EMPLOYMENT STANDARDS ADMINISTRATION, DEPARTMENT OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED BLACK LUNG BENEFITS; REQUIREMENTS FOR COAL...

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

    ERIC Educational Resources Information Center

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

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

  18. Environment/Health/Safety (EHS): Databases

    Science.gov Websites

    Hazard Documents Database Biosafety Authorization System CATS (Corrective Action Tracking System) (for findings 12/2005 to present) Chemical Management System Electrical Safety Ergonomics Database (for new Learned / Best Practices REMS - Radiation Exposure Monitoring System SJHA Database - Subcontractor Job

  19. Safety Precautions in Fiber Arts.

    ERIC Educational Resources Information Center

    Hamilton, Marcia

    1979-01-01

    The author discusses the potential hazards of working with fibers, dyes, and wax in textile art projects: bacteria, dust, poisons, allergies, and fumes. Safety precautions for working with dyes are listed. This article is one of seven in this issue on fiber arts. (SJL)

  20. Assessing Explosives Safety Risks, Deviations, And Consequences

    DTIC Science & Technology

    2009-07-31

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

  1. Neighbourhood social trust and youth perceptions of safety during daily activities.

    PubMed

    Flynn, Kalen; Richmond, Therese S; Branas, Charles C; Wiebe, Douglas J

    2017-10-07

    Exposure to adverse neighbourhood conditions can negatively impact adolescent well-being and perceived safety. However, the impact of neighbourhood social trust on perceived safety is largely unknown. We studied 139 adolescent men to investigate how their perceptions of safety varied as a function of social trust levels in the neighbourhoods they traversed; neighbourhoods that were not necessarily their own. Adolescents mapped their minute-by-minute activities over a recent day and rated their perceived safety on a 10-point scale during in-person interviews. Neighbourhood social trust was measured via a citywide random sample survey. Mixed effects regression showed that, compared with their safety perceptions when in areas of low social trust, older adolescents were 73% more likely to feel unsafe when in areas of medium social trust, and 89% more likely to feel unsafe when in areas of high social trust. Inverse relationships between neighbourhood social trust and adolescents' perceived safety highlight the complex interplay between youth, environmental contexts and safety. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  2. Perinatal Safety: From Concept to Nursing Practice

    PubMed Central

    Kennedy, Holly Powell

    2010-01-01

    Communication and teamwork problems are leading causes of documented preventable adverse outcomes in perinatal care. An essential component of perinatal safety is the organizational culture in which clinicians work. Clinicians’ individual and collective authority to question the plan of care and take action to change the direction of a clinical situation in the patient’s best interest can be viewed as their “agency for safety.” However, collective agency for safety and commitment to support nurses in their advocacy role is missing in many perinatal care settings. This paper draws from Organizational Accident Theory, High Reliability Theory, and Symbolic Interactionism to describe the nurse’s role in maintaining safety during labor and birth in acute care settings, and suggests actions for supporting the perinatal nurse at individual, group, and systems levels to achieve maximum safety in perinatal care. PMID:20147827

  3. Perinatal safety: from concept to nursing practice.

    PubMed

    Lyndon, Audrey; Kennedy, Holly Powell

    2010-01-01

    Communication and teamwork problems are leading causes of documented preventable adverse outcomes in perinatal care. An essential component of perinatal safety is the organizational culture in which clinicians work. Clinicians' individual and collective authority to question the plan of care and take action to change the direction of a clinical situation in the patient's best interest can be viewed as their "agency for safety." However, collective agency for safety and commitment to support nurses in their role of advocacy is missing in many perinatal care settings. This article draws from Organizational Accident Theory, High Reliability Theory, and Symbolic Interactionism to describe the nurse's role in maintaining safety during labor and birth in acute care settings and suggests actions for supporting the perinatal nurse at individual, group, and systems levels to achieve maximum safety in perinatal care.

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

    PubMed

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

    2016-11-01

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

  5. Method of operator safety assessment for underground mobile mining equipment

    NASA Astrophysics Data System (ADS)

    Działak, Paulina; Karliński, Jacek; Rusiński, Eugeniusz

    2018-01-01

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

  6. Dams and Levees: Safety Risks

    NASA Astrophysics Data System (ADS)

    Carter, N. T.

    2017-12-01

    The nation's flood risk is increasing. The condition of U.S. dams and levees contributes to that risk. Dams and levee owners are responsible for the safety, maintenance, and rehabilitation of their facilities. Dams-Of the more than 90,000 dams in the United States, about 4% are federally owned and operated; 96% are owned by state and local governments, public utilities, or private companies. States regulate dams that are not federally owned. The number of high-hazard dams (i.e., dams whose failure would likely result in the loss of human life) has increased in the past decade. Roughly 1,780 state-regulated, high-hazard facilities with structural ratings of poor or unsatisfactory need rehabilitation. Levees-There are approximately 100,000 miles of levees in the nation; most levees are owned and maintained by municipalities and agricultural districts. Few states have levee safety programs. The U.S. Army Corps of Engineers (Corps) inspects 15,000 miles of levees, including levees that it owns and local levees participating in a federal program to assist with certain post-flood repairs. Information is limited on how regularly other levees are inspected. The consequence of a breach or failure is another aspect of risk. State and local governments have significant authority over land use and development, which can shape the social and economic impacts of a breach or failure; they also lead on emergency planning and related outreach. To date, federal dam and levee safety efforts have consisted primarily of (1) support for state dam safety standards and programs, (2) investments at federally owned dams and levees, and (3) since 2007, creation of a national levee database and enhanced efforts and procedures for Corps levee inspections and assessments. In Public Law 113-121, enacted in 2014, Congress (1) directed the Corps to develop voluntary guidelines for levee safety and an associated hazard potential classification system for levees, and (2) authorized support for the

  7. 77 FR 71454 - Notice of Atomic Safety And Licensing Board Reconstitution, Tennessee Valley Authority (Watts Bar...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-30

    ... accordance with the NRC E-Filing rule. See 10 CFR 2.302 et seq. Issued at Rockville, Maryland this 16th day of November 2012. E. Roy Hawkens, Chief Administrative Judge, Atomic Safety and Licensing Board Panel...

  8. 78 FR 56611 - Safety Zone, Shallowbag Bay; Manteo, NC; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security... as follows: PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 0 1. The authority citation... representative, unless the Captain of the Port previously announced via Marine Safety Radio Broadcast on VHF...

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

    ERIC Educational Resources Information Center

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

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

  10. Of Brains and Safety: Neuroscience for 5-Year-Olds

    ERIC Educational Resources Information Center

    Cynkar, Donna; Rutledge-Gorman, Mark

    2004-01-01

    Spring is the traditional time in Maplewood Elementary School Kindergarten when science instruction receives particular emphasis. It is also a time of promoting greater safety awareness as children increase their outdoor activities on the longer, warmer days. In May 2003, the authors planned to make a link between neuroscience and safety in a…

  11. Error reduction, patient safety and institutional ethics committees.

    PubMed

    Meaney, Mark E

    2004-01-01

    Institutional ethics committees remain largely absent from the literature on error reduction and patient safety. In this paper, the author endeavors to fill the gap. As noted in the Hastings Center's recent report, "Promoting Patient Safety," the occurrence of medical error involves complex web of multiple factors. Human misstep is certainly one such factor, but not the only one. This paper builds on the Hastings Center's report in arguing that institutional ethics committees ought to play an integral role in the transformation of a "culture of blame" to a "culture of safety" in healthcare delivery.

  12. Caught in a tightening fire safety net.

    PubMed

    Baillie, Jonathan

    2008-06-01

    How the Regulatory Reform (Fire Safety) Order 2005 has shifted responsibility for hospital fire safety from local fire authorities to so-called "responsible persons", and the implications for senior management/board-level personnel, as well as for hospital fire officers, fire wardens and department managers charged with implementation, was expertly examined by a leading expert in fire law at May's National Association of Healthcare Fire Officers (NAHFO) 2008 conference in Nottingham. Jonathan Baillie reports.

  13. Hawaii State Plan for Occupational Safety and Health. Final rule.

    PubMed

    2012-09-21

    This document announces the Occupational Safety and Health Administration's (OSHA) decision to modify the Hawaii State Plan's ``final approval'' determination under Section 18(e) of the Occupational Safety and Health Act (the Act) and to transition to ``initial approval'' status. OSHA is reinstating concurrent federal enforcement authority over occupational safety and health issues in the private sector, which have been solely covered by the Hawaii State Plan since 1984.

  14. State of the Art: Recent Legislation on Workers' Health and Safety.

    ERIC Educational Resources Information Center

    Parmeggiani, L.

    1982-01-01

    Reviews present trends in occupational health and safety legislation. Discusses the role of the state, the development of workers' participation, trends in the organization of occupational health services, and methods and objectives of occupational safety and health. (Author/JOW)

  15. Where the Safety Rubber Meets the Shop Floor: A Confirmatory Model of Management Influence on Workplace Safety.

    DOT National Transportation Integrated Search

    1997-03-01

    The role of management in establishing a safe work environment remains a topic that receives less attention in the literature than it deserves. Many authors have focused on safety programs and associated indications of program effects. Prescriptive a...

  16. Most common road safety engineering deficiencies in South Eastern Europe as a part of safe system approach

    NASA Astrophysics Data System (ADS)

    Jovanov, D.; Vollpracht, H. J.; Beles, H.; Popa, V.; Tolea, B. A.

    2017-10-01

    Most common road safety engineering deficiencies identified by the authors in South Eastern Europe, including Romania, have been collected together and presented in this paper as a part of road safety unbreakably connected to the safe system approach (driver-vehicle-road). In different South Eastern Europe countries Road Safety Audit (RSA), Road Safety Inspection (RSI), as well as Black Spot Management (BSM) was introduced and practical implementation experience enabled the authors to analyze the road safety problems. Typical road safety engineering deficiencies have been presented in 8 different subsections, based on PIARC (World Road Association) RSA approach. This paper presents collected common road safety problems with relevant illustrations (real pictures) with associated accident risks.

  17. Safety Assessment of Nitrocellulose and Collodion as Used in Cosmetics.

    PubMed

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

    2016-07-01

    The Cosmetic Ingredient Review Expert Panel (the Panel) assessed the safety of nitrocellulose and collodion as used in cosmetics, concluding that these ingredients are safe in the present practices of use and concentration in cosmetic formulations. Both ingredients are used almost exclusively in nail product formulations. The maximum concentration of use of nitrocellulose in nail polish and enamels is 22%; for collodion, the maximum reported concentration of use in nail polish and enamel is 14%. The Panel reviewed available animal and clinical data in making its determination of safety. © The Author(s) 2016.

  18. Safety and design in airplane construction

    NASA Technical Reports Server (NTRS)

    Teichmann, Alfred

    1934-01-01

    The author gives a survey of the principles of stress analysis and design of airplane structures, and discusses the fundamental strength specifications and their effect on the stress analysis as compared with the safety factors used in other branches of engineering.

  19. The Impact of Market Orientation on Patient Safety Climate Among Hospital Nurses.

    PubMed

    Weng, Rhay-Hung; Chen, Jung-Chien; Pong, Li-Jung; Chen, Li-Mei; Lin, Tzu-Chi

    2016-03-01

    Improving market orientation and patient safety have become the key concerns of nursing management. For nurses, establishing a patient safety climate is the key to enhancing nursing quality. This study explores how market orientation affects the climate of patient safety among hospital nurses. We proposed adopting a cross-sectional research design and using questionnaires to collect responses from nurses working in two Taiwanese hospitals. Three-hundred and forty-three valid samples were obtained. Multiple regression and path analyses were conducted to test the study. Market orientation was defined as the combination of customer orientation, competitor orientation, and interfunctional coordination. Customer orientation directly affects the climate of patient safety. Although the findings only supported Hypothesis 1, competitor orientation and interfunctional coordination positively affected the patient safety climate through the mediating effects of hospital support for staff. Health care managers could encourage nurses to adopt customer-oriented perspectives to enhance their nursing care. In addition, to enhance competitor orientation, interfunctional coordination, and the patient safety climate, hospital managers could strengthen their support for staff members. © The Author(s) 2014.

  20. Post-authorization safety study of Clottafact® , a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study.

    PubMed

    Négrier, C; Rothschild, C; Borg, J-Y; Lambert, T; Claeyssens, S; Sanhes, L; Stieltjes, N; Bertrand, A; André, M-H; Sié, P; Gruel, Y; Tellier, Z

    2016-11-01

    A new fibrinogen concentrate Clottafact ® was developed according to European guidelines on plasma-derived products. A post-authorization safety study was set up in 2009 as part of the risk management plan. This was a non-interventional, prospective, non-comparative, multicenter study of the use of fibrinogen concentrate for congenital afibrinogenemia in real-life medical practice in France. The analysis was descriptive and performed on 3 subgroups: prophylaxis vs. on-demand treatment, age (<6, <12 and ≥12) and severity of the deficiency. Fourteen patients [1-78 years] were included in 7 centres and followed for 1 year. Twenty-one adverse drug reactions (ADRs) classically reported with fibrinogen (pallor, chills, cough, vomiting, headache, urticaria and erythematous rash) were reported in 5 of 14 patients. Two ADRs were serious: an anaphylactic shock and a subclavian venous thrombosis with a favourable outcome without sequelae. In the nine patients under prophylaxis, 365 of 367 infusions were considered as successful (99·5%) and 2 as failures. For the five patients treated on-demand, the efficacy was rated as excellent for 27 of 48 infusions and good for the 21 others. This study confirms that the benefit/risk balance for this fibrinogen concentrate is favourable. © 2016 International Society of Blood Transfusion.

  1. A multilevel model of patient safety culture: cross-level relationship between organizational culture and patient safety behavior in Taiwan's hospitals.

    PubMed

    Chen, I-Chi; Ng, Hui-Fuang; Li, Hung-Hui

    2012-01-01

    As health-care organizations endeavor to improve their quality of care, there is a growing recognition of the importance of establishing a culture of patient safety. The main objective of this study was to investigate the cross-level influences of organizational culture on patient safety behavior in Taiwan's hospitals. The authors measured organizational culture (bureaucratic, supportive and innovative culture), patient safety culture and behavior from 788 hospital workers among 42 hospitals in Taiwan. Multilevel analysis was applied to explore the relationship between organizational culture (group level) and patient safety behavior (individual level). Patient safety culture had positive impact on patient safety behavior in Taiwan's hospitals. The results also indicated that bureaucratic, innovative and supportive organizational cultures all had direct influence on patient safety behavior. However, only supportive culture demonstrated significant moderation effect on the relationship between patient safety culture and patient safety behavior. Furthermore, organizational culture strength was shown correlated negatively with patient safety culture variability. Overall, organizational culture plays an important role in patient safety activities. Safety behaviors of hospital staff are partly influenced by the prevailing cultural norms in their organizations and work groups. For management implications, constructed patient priority from management commitment to leadership is necessary. For academic implications, research on patient safety should consider leadership, group dynamics and organizational learning. These factors are important for understanding the barriers and the possibilities embedded in patient safety. Copyright © 2011 John Wiley & Sons, Ltd.

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

    PubMed

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

    2014-02-01

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

  3. Firearms safety program

    USGS Publications Warehouse

    ,

    2005-01-01

    The USGS provides appropriate firearms safety training for any employee or USGS volunteer who uses, handles, carries, or stores a firearm as part of his or her official duties. An employee or volunteer can be authorized to carry a firearm while on official duty once he or she has completed specified training requirements and a certificate of need and qualification inquiry. Knowledge of details for firearms storage, security, and transport is also necessary.

  4. 33 CFR 96.490 - What further obligations exist for an organization if the Coast Guard terminates its authorization?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Authorization of Recognized... companies and vessels must do to have their safety management systems transferred to another organization...

  5. Very short duration operations : safety guidebook.

    DOT National Transportation Integrated Search

    2012-01-01

    Texas has the most roadway mileage of any state in the nation, and maintenance is a major : function of the Texas Department of Transportation (TxDOT). The safety of workers and : motorists is a major concern and the Federal Highway Authority recogni...

  6. 33 CFR 96.470 - How does the Coast Guard terminate an organization's authorization?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Authorization of Recognized Organizations To Act on Behalf of the U.S. § 96.470...

  7. IRQN award paper: Operational rounds: a practical administrative process to improve safety and clinical services in radiology.

    PubMed

    Donnelly, Lane F; Dickerson, Julie M; Lehkamp, Todd W; Gessner, Kevin E; Moskovitz, Jay; Hutchinson, Sally

    2008-11-01

    As part of a patient safety program in the authors' department of radiology, operational rounds have been instituted. This process consists of radiology leaders' visiting imaging divisions at the site of imaging and discussing frontline employees' concerns about patient safety, the quality of care, and patient and family satisfaction. Operational rounds are executed at a time to optimize the number of attendees. Minutes that describe the issues identified, persons responsible for improvement, and updated improvement plan status are available to employees online. Via this process, multiple patient safety and other issues have been identified and remedied. The authors believe that the process has improved patient safety, the quality of care, and the efficiency of operations. Since the inception of the safety program, the mean number of days between serious safety events involving radiology has doubled. The authors review the background around such walk rounds, describe their particular program, and give multiple illustrative examples of issues identified and improvement plans put in place.

  8. 20 CFR 726.114 - Period of authorization as self-insurer; reauthorization.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Period of authorization as self-insurer; reauthorization. 726.114 Section 726.114 Employees' Benefits EMPLOYMENT STANDARDS ADMINISTRATION, DEPARTMENT OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED BLACK LUNG BENEFITS; REQUIREMENTS FOR...

  9. Safety considerations for outpatient electroconvulsive therapy.

    PubMed

    Reti, Irving M; Walker, Melinda; Pulia, Kathy; Gallegos, Jesus; Jayaram, Geetha; Vaidya, Punit

    2012-03-01

    As electroconvulsive therapy (ECT) requires general anesthesia and is associated with both cognitive and non-cognitive side effects, careful consideration must be given to the safety aspects of providing ECT on an outpatient basis. Drawing upon published literature and their clinical experience administering outpatient ECT, the authors propose best practices for safely providing ECT to outpatients. They review criteria for selecting patients for outpatient ECT as well as treatment and programmatic issues. The authors highlight the importance of educating referring clinicians as well as patients and their families about factors involved in the safe delivery of ECT for outpatients. Fiscal considerations and the drive toward reduced length of stay are prompting insurers and caregivers to choose outpatient over inpatient ECT. For each patient, such a choice merits a careful analysis of the risks of outpatient ECT, as well as the implementation of measures to ensure patient safety.

  10. NASA Expendable Launch Vehicle (ELV) Payload Safety Review Process

    NASA Technical Reports Server (NTRS)

    Starbus, Calvert S.; Donovan, Shawn; Dook, Mike; Palo, Tom

    2007-01-01

    Issues addressed by this program: (1) Complicated roles and responsibilities associated with multi-partner projects (2) Working relationships and communications between all organizations involved in the payload safety process (3) Consistent interpretation and implementation of safety requirements from one project to the rest (4) Consistent implementation of the Tailoring Process (5) Clearly defined NASA decision-making-authority (6) Bring Agency-wide perspective to each ElV payload project. Current process requires a Payload Safety Working Group (PSWG) for eac payload with representatives from all involved organizations.

  11. [Procedure for the marketing authorization of an antibacterial agent].

    PubMed

    López Navas, Antonio; García-Escribano Ráez, Nuria; Flores Juberías, Ángela; Suárez Gea, María Luisa

    2014-10-01

    The marketing authorization of a new medicinal product is the first step before being placed on the market, and includes the full investigation programme. In order to ensure their quality, safety and efficacy, medicinal products are closely regulated from their initial phases of investigation to their use in clinical practice. For registration purposes, the results of all the clinical and preclinical studies, along with quality data and the description of the manufacturing process should be submitted. All information collected is presented for review by the competent authority. The European Medicines Agency regulates the registration of medicines in Europe, and national agencies in each EU member state are responsible for the assessment of the marketing authorisation application. To facilitate the development of clinical programmes, there is a common framework for the evaluation of an antibacterial, which includes guidelines and an addendum, detailing the specific requirements that must be carried out in clinical trials to assess the efficacy and safety for most of the infections. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  12. Enlisting health departments in highway safety programs

    DOT National Transportation Integrated Search

    1983-02-01

    Author's abstract: This report documents the manner and degree of health agency involvement in motor vehicle injury prevention activities. It describes not only the existing cooperative activities between state highway safety and health agencies, but...

  13. 12 CFR 1777.1 - Authority, purpose, scope, and implementation dates.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ...)), and section 309(k) of the Federal National Mortgage Association Charter Act (12 U.S.C. 1723a(k... 12 Banks and Banking 9 2013-01-01 2013-01-01 false Authority, purpose, scope, and implementation... Housing Enterprises Financial Safety and Soundness Act (1992 Act) (12 U.S.C. 4513, 4631, 4632, and 4636...

  14. 12 CFR 1777.1 - Authority, purpose, scope, and implementation dates.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...)), and section 309(k) of the Federal National Mortgage Association Charter Act (12 U.S.C. 1723a(k... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Authority, purpose, scope, and implementation... Housing Enterprises Financial Safety and Soundness Act (1992 Act) (12 U.S.C. 4513, 4631, 4632, and 4636...

  15. 12 CFR 1777.1 - Authority, purpose, scope, and implementation dates.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...)), and section 309(k) of the Federal National Mortgage Association Charter Act (12 U.S.C. 1723a(k... 12 Banks and Banking 10 2014-01-01 2014-01-01 false Authority, purpose, scope, and implementation... Housing Enterprises Financial Safety and Soundness Act (1992 Act) (12 U.S.C. 4513, 4631, 4632, and 4636...

  16. 12 CFR 1777.1 - Authority, purpose, scope, and implementation dates.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ...)), and section 309(k) of the Federal National Mortgage Association Charter Act (12 U.S.C. 1723a(k... 12 Banks and Banking 9 2012-01-01 2012-01-01 false Authority, purpose, scope, and implementation... Housing Enterprises Financial Safety and Soundness Act (1992 Act) (12 U.S.C. 4513, 4631, 4632, and 4636...

  17. 12 CFR 1777.1 - Authority, purpose, scope, and implementation dates.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...)), and section 309(k) of the Federal National Mortgage Association Charter Act (12 U.S.C. 1723a(k... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Authority, purpose, scope, and implementation... Housing Enterprises Financial Safety and Soundness Act (1992 Act) (12 U.S.C. 4513, 4631, 4632, and 4636...

  18. Extending Safety Culture Development through Communication - 12366

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

    Sneve, M.K.; Kiselev, M.; Shandala, N.K.

    2012-07-01

    The Norwegian Radiation Protection Authority has been implementing a regulatory support program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective is the enhancement of safety culture. The project outputs have included appropriate regulatory threat assessments, to determine the hazardous activities which are most in need of enhanced regulatory supervision; and development of the norms, standards and regulatory procedures, necessary to address the often abnormal conditions at nuclear legacy sites. Project outputs have been prepared and subsequently confirmed asmore » official regulatory documents of the Russian Federation. The continuing program of work focuses on practical application of the enhanced regulatory framework as applied to legacy sites, including safe management of radioactive wastes arising in the process of site remediation. One of the lessons learnt from this practical application is the importance of effective communication at all levels: - between managers and shop workers; - between different operators - e.g. waste producers and waste disposal organisations; - between operators and regulators; - between nuclear safety regulators, radiation protection regulators and other pollution and safety regulators; - between scientists, policy makers and wider stakeholders; and - between all of those mentioned above. A key message from this work is that it is not just an issue of risk communication; rather all aspects of communication can contribute to safety culture enhancement to support effective and efficient risk management, including the role of regulatory supervision. (authors)« less

  19. An examination of the impact of five grade crossing safety factors on driver decision making

    DOT National Transportation Integrated Search

    2014-04-01

    The authors applied signal detection theory to model the impact : of five grade-crossing safety factors to understand their impact : on driver decision making. The safety factors were improving : commercial motor vehicle (CMV) driver safety through f...

  20. Rail transportation : Federal Railroad Administration's safety programs

    DOT National Transportation Integrated Search

    1998-05-20

    Federal Railroad Administration (FRA) enforces federal railroad safety statutes under a delegation of authority from the Secretary of Transportation. FRA's mission is to protect railroad employees and the public by ensuring the safe operation of frei...

  1. Improving Safety through Human Factors Engineering.

    PubMed

    Siewert, Bettina; Hochman, Mary G

    2015-10-01

    Human factors engineering (HFE) focuses on the design and analysis of interactive systems that involve people, technical equipment, and work environment. HFE is informed by knowledge of human characteristics. It complements existing patient safety efforts by specifically taking into consideration that, as humans, frontline staff will inevitably make mistakes. Therefore, the systems with which they interact should be designed for the anticipation and mitigation of human errors. The goal of HFE is to optimize the interaction of humans with their work environment and technical equipment to maximize safety and efficiency. Special safeguards include usability testing, standardization of processes, and use of checklists and forcing functions. However, the effectiveness of the safety program and resiliency of the organization depend on timely reporting of all safety events independent of patient harm, including perceived potential risks, bad outcomes that occur even when proper protocols have been followed, and episodes of "improvisation" when formal guidelines are found not to exist. Therefore, an institution must adopt a robust culture of safety, where the focus is shifted from blaming individuals for errors to preventing future errors, and where barriers to speaking up-including barriers introduced by steep authority gradients-are minimized. This requires creation of formal guidelines to address safety concerns, establishment of unified teams with open communication and shared responsibility for patient safety, and education of managers and senior physicians to perceive the reporting of safety concerns as a benefit rather than a threat. © RSNA, 2015.

  2. Blood transfusion safety: a new philosophy.

    PubMed

    Franklin, I M

    2012-12-01

    Blood transfusion safety has had a chequered history, and there are current and future challenges. Internationally, there is no clear consensus for many aspects of the provision of safe blood, although pan-national legislation does provide a baseline framework in the European Union. Costs are rising, and new safety measures can appear expensive, especially when tested against some other medical interventions, such as cancer treatment and vaccination programmes. In this article, it is proposed that a comprehensive approach is taken to the issue of blood transfusion safety that considers all aspects of the process rather than considering only new measures. The need for an agreed level of safety for specified and unknown risks is also suggested. The importance of providing care and support for those inadvertently injured as a result of transfusion problems is also made. Given that the current blood safety decision process often uses a utilitarian principle for decision making--through the calculation of Quality Adjusted Life Years--an alternative philosophy is proposed. A social contract for blood safety, based on the principles of 'justice as fairness' developed by John Rawls, is recommended as a means of providing an agreed level of safety, containing costs and providing support for any adverse outcomes. © 2012 The Author. Transfusion Medicine © 2012 British Blood Transfusion Society.

  3. Health and safety in clinical laboratories in developing countries: safety considerations.

    PubMed

    Ejilemele, A A; Ojule, A C

    2004-01-01

    Clinical laboratories are potentially hazardous work areas. Health and safety in clinical laboratories is becoming an increasingly important subject as a result of the emergence of highly infectious diseases such as hepatitis and HIV. This is even more so in developing countries where health and safety have traditionally been regarded as low priority issues, considering the more important health problems confronting the health authorities in these countries. We conducted a literature search using the medical subheadings titles on the INTERNET over a period of twenty years and summarized our findings. This article identifies hazards in the laboratories and highlights measures to make the laboratory a safer work place. It also emphasizes the mandatory obligations of employers and employees towards the attainment of acceptable safety standards in clinical laboratories in Third World countries in the face of the current HIV/AIDS epidemic in many of these developing countries especially in the sub-Saharan Africa while accommodating the increasing work load in these laboratories. Both the employer and the employee have major roles to play in the maintenance of a safe working environment. This can be achieved if measures discussed are incorporated into everyday laboratory practice.

  4. 75 FR 45697 - Safety Advisory Notice: Personal Electronic Device Related Distractions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... the Federal safety authority for the transportation of hazardous materials by air, rail, highway, and... transportation of hazardous materials. In light of PHMSA's vital safety mission, we issue this advisory bulletin... hazardous materials transportation. Issued in Washington, DC, on July 27, 2010. Magdy El-Sibaie, Associate...

  5. Occupational Safety and Health in Peru.

    PubMed

    Cruz, Ismael; Huerta-Mercado, Raul

    2015-01-01

    Peru is a country located on the Pacific coast of South America with a population of more than 30 million inhabitants. In the past 10 years, Peru has had a steady economic growth. Peru is predominantly an extractive industry country, but the manufacturing and construction sectors are booming. It is in this context that regulations have been implemented to protect the safety and health of workers. One of the most important regulations is the Law on Safety and Health at Work, which has been recently promulgated. Regulations are complemented by training and education in occupational safety and health. The measures are yet to be fully implemented thus a positive effect in reducing accidents and occupational diseases at work has not yet been seen. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  6. Developing a smartphone based warning system application to enhance the safety at work zones : final report.

    DOT National Transportation Integrated Search

    2016-05-01

    Collisions in the work zone have always been a contributing factor to compromising safety on urban roadways. The National Highway Traffic Safety Administration (NHTSA) and the State Transportation Authorities have implemented many safety countermeasu...

  7. 77 FR 65892 - Patient Safety Organizations: Voluntary Relinquishment From PDR Secure, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-31

    ... Organizations: Voluntary Relinquishment From PDR Secure, LLC AGENCY: Agency for Healthcare Research and Quality... Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information... Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission...

  8. The intake of inorganic arsenic from long grain rice and rice-based baby food in Finland - low safety margin warrants follow up.

    PubMed

    Rintala, Eeva-Maria; Ekholm, Päivi; Koivisto, Pertti; Peltonen, Kimmo; Venäläinen, Eija-Riitta

    2014-05-01

    We evaluated total and inorganic arsenic levels in long grain rice and rice based baby foods on Finnish market. Inorganic arsenic was analysed with an HPLC-ICP-MS system. The total arsenic concentration was determined with an ICP-MS method. In this study, the inorganic arsenic levels in long grain rice varied from 0.09 to 0.28mg/kg (n=8) and the total arsenic levels from 0.11 to 0.65mg/kg. There was a good correlation between the total and inorganic arsenic levels in long grain rice at a confidence level of 95%. The total arsenic levels of rice-based baby foods were in the range 0.02 - 0.29mg/kg (n=10), however, the level of inorganic arsenic could only be quantitated in four samples, on average they were 0.11mg/kg. Our estimation of inorganic arsenic intake from long grain rice and rice-based baby food in Finland indicate that in every age group the intake is close to the lowest BMDL0.1 value 0.3μg/kg bw/day set by EFSA. According to our data, the intake of inorganic arsenic should be more extensively evaluated. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  9. Development of a safety communication and recognition program for construction.

    PubMed

    Sparer, Emily H; Herrick, Robert F; Dennerlein, Jack T

    2015-05-01

    Leading-indicator-based (e.g., hazard recognition) incentive programs provide an alternative to controversial lagging-indicator-based (e.g., injury rates) programs. We designed a leading-indicator-based safety communication and recognition program that incentivized safe working conditions. The program was piloted for two months on a commercial construction worksite and then redesigned using qualitative interview and focus group data from management and workers. We then ran the redesigned program for six months on the same worksite. Foremen received detailed weekly feedback from safety inspections, and posters displayed worksite and subcontractor safety scores. In the final program design, the whole site, not individual subcontractors, was the unit of analysis and recognition. This received high levels of acceptance from workers, who noted increased levels of site unity and team-building. This pilot program showed that construction workers value solidarity with others on site, demonstrating the importance of health and safety programs that engage all workers through a reliable and consistent communication infrastructure. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  10. School and Community Transportation Safety Awareness.

    ERIC Educational Resources Information Center

    Pederson, Patricia J.

    1994-01-01

    A comprehensive school bus safety program designed and implemented in Euclid (Ohio) involves participation by students, drivers, parents, and the community. This article was originally submitted in application for, and the author received, a 1993 Pinnacle of Achievement Award from the Association of School Business Officials. (MLF)

  11. 20 CFR 726.101 - Who may be authorized to self-insure.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Who may be authorized to self-insure. 726.101 Section 726.101 Employees' Benefits EMPLOYMENT STANDARDS ADMINISTRATION, DEPARTMENT OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED BLACK LUNG BENEFITS; REQUIREMENTS FOR COAL MINE OPERATOR...

  12. 40 CFR 1620.6 - Authority to adjust, determine, compromise, and settle.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Authority to adjust, determine, compromise, and settle. 1620.6 Section 1620.6 Protection of Environment CHEMICAL SAFETY AND HAZARD... Chairperson or any other lawful designee can only be made after a legal review is conducted by an attorney...

  13. 40 CFR 1620.6 - Authority to adjust, determine, compromise, and settle.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 33 2014-07-01 2014-07-01 false Authority to adjust, determine, compromise, and settle. 1620.6 Section 1620.6 Protection of Environment CHEMICAL SAFETY AND HAZARD... Chairperson or any other lawful designee can only be made after a legal review is conducted by an attorney...

  14. 40 CFR 1620.6 - Authority to adjust, determine, compromise, and settle.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 34 2013-07-01 2013-07-01 false Authority to adjust, determine, compromise, and settle. 1620.6 Section 1620.6 Protection of Environment CHEMICAL SAFETY AND HAZARD... Chairperson or any other lawful designee can only be made after a legal review is conducted by an attorney...

  15. Development of a novel scoring system for identifying emerging chemical risks in the food chain.

    PubMed

    Oltmanns, J; Licht, O; Bitsch, A; Bohlen, M-L; Escher, S E; Silano, V; MacLeod, M; Serafimova, R; Kass, G E N; Merten, C

    2018-02-21

    The European Food Safety Authority (EFSA) is responsible for risk assessment of all aspects of food safety, including the establishment of procedures aimed at the identification of emerging risks to food safety. Here, a scoring system was developed for identifying chemicals registered under the European REACH Regulation that could be of potential concern in the food chain using the following parameters: (i) environmental release based on maximum aggregated tonnages and environmental release categories; (ii) biodegradation in the environment; (iii) bioaccumulation and in vivo and in vitro toxicity. The screening approach was tested on 100 data-rich chemicals registered under the REACH Regulation at aggregated volumes of at least 1000 tonnes per annum. The results show that substance-specific data generated under the REACH Regulation can be used to identify potential emerging risks in the food chain. After application of the screening procedure, priority chemicals can be identified as potentially emerging risk chemicals through the integration of exposure, environmental fate and toxicity. The default approach is to generate a single total score for each substance using a predefined weighting scenario. However, it is also possible to use a pivot table approach to combine the individual scores in different ways that reflect user-defined priorities, which enables a very flexible, iterative definition of screening criteria. Possible applications of the approaches are discussed using illustrative examples. Either approach can then be followed by in-depth evaluation of priority substances to ensure the identification of substances that present a real emerging chemical risk in the food chain.

  16. Migration of antioxidants from polylactic acid films: A parameter estimation approach and an overview of the current mass transfer models.

    PubMed

    Samsudin, Hayati; Auras, Rafael; Mishra, Dharmendra; Dolan, Kirk; Burgess, Gary; Rubino, Maria; Selke, Susan; Soto-Valdez, Herlinda

    2018-01-01

    Migration studies of chemicals from contact materials have been widely conducted due to their importance in determining the safety and shelf life of a food product in their packages. The US Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA) require this safety assessment for food contact materials. So, migration experiments are theoretically designed and experimentally conducted to obtain data that can be used to assess the kinetics of chemical release. In this work, a parameter estimation approach was used to review and to determine the mass transfer partition and diffusion coefficients governing the migration process of eight antioxidants from poly(lactic acid), PLA, based films into water/ethanol solutions at temperatures between 20 and 50°C. Scaled sensitivity coefficients were calculated to assess simultaneously estimation of a number of mass transfer parameters. An optimal experimental design approach was performed to show the importance of properly designing a migration experiment. Additional parameters also provide better insights on migration of the antioxidants. For example, the partition coefficients could be better estimated using data from the early part of the experiment instead at the end. Experiments could be conducted for shorter periods of time saving time and resources. Diffusion coefficients of the eight antioxidants from PLA films were between 0.2 and 19×10 -14 m 2 /s at ~40°C. The use of parameter estimation approach provided additional and useful insights about the migration of antioxidants from PLA films. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. The carcinogenic effects of aspartame: The urgent need for regulatory re-evaluation.

    PubMed

    Soffritti, Morando; Padovani, Michela; Tibaldi, Eva; Falcioni, Laura; Manservisi, Fabiana; Belpoggi, Fiorella

    2014-04-01

    Aspartame (APM) is an artificial sweetener used since the 1980s, now present in >6,000 products, including over 500 pharmaceuticals. Since its discovery in 1965, and its first approval by the US Food and Drugs Administration (FDA) in 1981, the safety of APM, and in particular its carcinogenicity potential, has been controversial. The present commentary reviews the adequacy of the design and conduct of carcinogenicity bioassays on rodents submitted by G.D. Searle, in the 1970s, to the FDA for market approval. We also review how experimental and epidemiological data on the carcinogenic risks of APM, that became available in 2005 motivated the European Commission (EC) to call the European Food and Safety Authority (EFSA) for urgent re-examination of the available scientific documentation (including the Searle studies). The EC has further requested that, if the results of the evaluation should suggest carcinogenicity, major changes must be made to the current APM specific regulations. Taken together, the studies performed by G.D. Searle in the 1970s and other chronic bioassays do not provide adequate scientific support for APM safety. In contrast, recent results of life-span carcinogenicity bioassays on rats and mice published in peer-reviewed journals, and a prospective epidemiological study, provide consistent evidence of APM's carcinogenic potential. On the basis of the evidence of the potential carcinogenic effects of APM herein reported, a re-evaluation of the current position of international regulatory agencies must be considered an urgent matter of public health. © 2014 Wiley Periodicals, Inc.

  18. Food safety educational intervention positively influences college students' food safety attitudes, beliefs, knowledge, and self-reported practices.

    PubMed

    Yarrow, Linda; Remig, Valentina M; Higgins, Mary Meck

    2009-01-01

    In this study, the authors evaluated college students' food safety attitudes, beliefs, knowledge, and self-reported practices and explored whether these variables were positively influenced by educational intervention. Students (n=59), were mostly seniors, health or non-health majors, and responsible for meal preparation. Subjects completed a food safety questionnaire (FSQ) prior to educational intervention, which consisted of three interactive modules. Subjects completed module pre-, post-, and post-posttests. The FSQ was also administered after exposure to intervention and five weeks later to determine changes in food safety attitudes, beliefs, knowledge, and self-reported practices. Students' FSQ attitude scores increased from 114 to 122 (p < or = .001); FSQ belief and knowledge scores improved from 86 to 98 (p < or = .001) and from 11 to 13 (p < or = .001), respectively. Food safety knowledge was also measured by module pre- and posttests, and improved significantly after intervention for all students, with health majors having the greatest increase. Intervention resulted in improved food safety self-reported practices for health majors only. The educational intervention appeared effective in improving food safety beliefs and knowledge. For health majors, attitudes and some self-reported practices improved. For all areas, the strongest effects were seen in health majors.

  19. 78 FR 17099 - Safety Zone; BWRC Southwest Showdown 2, Parker, AZ

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

    ...The Coast Guard is establishing a temporary safety zone within the Lake Moolvalya region of the navigable waters of the Colorado River in Parker, Arizona for the Blue Water Resort and Casino Southwest Showdown. This temporary safety zone is necessary to provide for the safety of the participants, crew, spectators, participating vessels, and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port or his designated representative.

  20. Generation III reactors safety requirements and the design solutions

    NASA Astrophysics Data System (ADS)

    Felten, P.

    2009-03-01

    Nuclear energy's public acceptance, and hence its development, depends on its safety. As a reactor designer, we will first briefly remind the basic safety principles of nuclear reactors' design. We will then show how the industry, and in particular Areva with its EPR, made design evolution in the wake of the Three Miles Island accident in 1979. In particular, for this new generation of reactors, severe accidents are taken into account beyond the standard design basis accidents. Today, Areva's EPR meets all so-called "generation III" safety requirements and was licensed by several nuclear safety authorities in the world. Many innovative solutions are integrated in the EPR, some of which will be introduced here.

  1. 15 CFR 270.325 - Notice of authority to enter and inspect property where building components, materials, artifacts...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence... pursuant to the Act, any member of a Team, or any other person authorized by the Director to support a Team... property to be inspected and to carry out the duties of the Team; (2) During reasonable hours, inspect any...

  2. 15 CFR 270.325 - Notice of authority to enter and inspect property where building components, materials, artifacts...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence... pursuant to the Act, any member of a Team, or any other person authorized by the Director to support a Team... property to be inspected and to carry out the duties of the Team; (2) During reasonable hours, inspect any...

  3. 15 CFR 270.325 - Notice of authority to enter and inspect property where building components, materials, artifacts...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence... pursuant to the Act, any member of a Team, or any other person authorized by the Director to support a Team... property to be inspected and to carry out the duties of the Team; (2) During reasonable hours, inspect any...

  4. 15 CFR 270.325 - Notice of authority to enter and inspect property where building components, materials, artifacts...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence... pursuant to the Act, any member of a Team, or any other person authorized by the Director to support a Team... property to be inspected and to carry out the duties of the Team; (2) During reasonable hours, inspect any...

  5. 15 CFR 270.325 - Notice of authority to enter and inspect property where building components, materials, artifacts...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Collection and Preservation of Evidence... pursuant to the Act, any member of a Team, or any other person authorized by the Director to support a Team... property to be inspected and to carry out the duties of the Team; (2) During reasonable hours, inspect any...

  6. 48 CFR 1850.102 - Delegation of and limitations of exercise of authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Delegation of and limitations of exercise of authority. 1850.102 Section 1850.102 Federal Acquisition Regulations System... SAFETY ACT Extraordinary Contractual Actions 1850.102 Delegation of and limitations of exercise of...

  7. 48 CFR 1850.102 - Delegation of and limitations of exercise of authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Delegation of and limitations of exercise of authority. 1850.102 Section 1850.102 Federal Acquisition Regulations System... SAFETY ACT Extraordinary Contractual Actions 1850.102 Delegation of and limitations of exercise of...

  8. 48 CFR 1850.102 - Delegation of and limitations of exercise of authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Delegation of and limitations of exercise of authority. 1850.102 Section 1850.102 Federal Acquisition Regulations System... SAFETY ACT Extraordinary Contractual Actions 1850.102 Delegation of and limitations of exercise of...

  9. Future challenges to microbial food safety.

    PubMed

    Havelaar, Arie H; Brul, Stanley; de Jong, Aarieke; de Jonge, Rob; Zwietering, Marcel H; Ter Kuile, Benno H

    2010-05-30

    Despite significant efforts by all parties involved, there is still a considerable burden of foodborne illness, in which micro-organisms play a prominent role. Microbes can enter the food chain at different steps, are highly versatile and can adapt to the environment allowing survival, growth and production of toxic compounds. This sets them apart from chemical agents and thus their study from food toxicology. We summarize the discussions of a conference organized by the Dutch Food and Consumer Products Safety Authority and the European Food Safety Authority. The goal of the conference was to discuss new challenges to food safety that are caused by micro-organisms as well as strategies and methodologies to counter these. Management of food safety is based on generally accepted principles of Hazard Analysis Critical Control Points and of Good Manufacturing Practices. However, a more pro-active, science-based approach is required, starting with the ability to predict where problems might arise by applying the risk analysis framework. Developments that may influence food safety in the future occur on different scales (from global to molecular) and in different time frames (from decades to less than a minute). This necessitates development of new risk assessment approaches, taking the impact of different drivers of change into account. We provide an overview of drivers that may affect food safety and their potential impact on foodborne pathogens and human disease risks. We conclude that many drivers may result in increased food safety risks, requiring active governmental policy setting and anticipation by food industries whereas other drivers may decrease food safety risks. Monitoring of contamination in the food chain, combined with surveillance of human illness and epidemiological investigations of outbreaks and sporadic cases continue to be important sources of information. New approaches in human illness surveillance include the use of molecular markers for

  10. Safety Assurances at Space Test Centres: Lessons Learned

    NASA Astrophysics Data System (ADS)

    Alarcon Ruiz, Raul; O'Neil, Sean; Valls, Rafel Prades

    2010-09-01

    The European Space Agency’s(ESA) experts in quality, cleanliness and contamination control, safety, test facilities and test methods have accumulated valuable experience during the performance of dedicated audits of space test centres in Europe over a period of 10 years. This paper is limited to a summary of the safety findings and provides a valuable reference to the lessons learned, identifying opportunities for improvement in the areas of risk prevention measures associated to the safety of all test centre personnel, the test specimen, the test facilities and associated infrastructure. Through the analysis of the audit results the authors present what are the main lessons learned, and conclude how an effective safety management system will contribute to successful test campaigns and have a positive impact on the cost and schedule of space projects.

  11. Influenza vaccines: Evaluation of the safety profile

    PubMed Central

    Trombetta, Claudia Maria; Gianchecchi, Elena; Montomoli, Emanuele

    2018-01-01

    ABSTRACT The safety of vaccines is a critical factor in maintaining public trust in national vaccination programs. Vaccines are recommended for children, adults and elderly subjects and have to meet higher safety standards, since they are administered to healthy subjects, mainly healthy children. Although vaccines are strictly monitored before authorization, the possibility of adverse events and/or rare adverse events cannot be totally eliminated. Two main types of influenza vaccines are currently available: parenteral inactivated influenza vaccines and intranasal live attenuated vaccines. Both display a good safety profile in adults and children. However, they can cause adverse events and/or rare adverse events, some of which are more prevalent in children, while others with a higher prevalence in adults. The aim of this review is to provide an overview of influenza vaccine safety according to target groups, vaccine types and production methods. PMID:29297746

  12. Nurses' role in medication safety.

    PubMed

    Choo, Janet; Hutchinson, Alison; Bucknall, Tracey

    2010-10-01

    To explore the nurse's role in the process of medication management and identify the challenges associated with safe medication management in contemporary clinical practice. Medication errors have been a long-standing factor affecting consumer safety. The nursing profession has been identified as essential to the promotion of patient safety. A review of literature on medication errors and the use of electronic prescribing in medication errors. Medication management requires a multidisciplinary approach and interdisciplinary communication is essential to reduce medication errors. Information technologies can help to reduce some medication errors through eradication of transcription and dosing errors. Nurses must play a major role in the design of computerized medication systems to ensure a smooth transition to such as system. The nurses' roles in medication management cannot be over-emphasized. This is particularly true when designing a computerized medication system. The adoption of safety measures during decision making that parallel those of the aviation industry safety procedures can provide some strategies to prevent medication error. Innovations in information technology offer potential mechanisms to avert adverse events in medication management for nurses. © 2010 The Authors. Journal compilation © 2010 Blackwell Publishing Ltd.

  13. 33 CFR 96.420 - What authority may an organization ask for under this regulation?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Authorization of Recognized Organizations To Act on Behalf of the U.S. § 96.420...

  14. Industrial requirements in food safety.

    PubMed

    Vincent, P M

    1990-01-01

    The principles of establishing industrial requirements in food safety are described, taking risk potentials all along the food chain into their respective account. Regulations will, in the future, lead to increased autocontrol in production. The rapid changes in food technology require constant adaptation to new problems, to keep the global quality of food at a high level. Regulatory authorities will, in the new European market, concentrate on enforcement of 'essential requirements' while industrialists will follow good manufacturing practices. Open dialogue between the latter, the former and the scientific community is highly desirable since mutual knowledge of the problem will help maintain a high level of food safety, for the benefit of everybody.

  15. Predictors of Safety Training Transfer Support as In-Role Behavior of Occupational Health and Safety Professionals

    ERIC Educational Resources Information Center

    Freitas, Ana Cristina; Silva, Sílvia Agostinho; Santos, Catarina Marques

    2017-01-01

    Purpose: The purpose of this study is to identify individual and contextual influences on in-house safety trainers' role orientation toward the transfer of training (TT). Design/methodology/approach: The authors tested a model where felt-responsibility for TT mediates the influence of job resources (i.e. autonomy, access to resources, access to…

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

    PubMed

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

    2011-10-01

    Using the Job Demands-Resources model (JD-R) as a theoretical framework, this study investigated the relationship between risk perception as a job demand and psychological safety climate as a job resource with regard to job satisfaction in safety critical organizations. In line with the JD-R model, it was hypothesized that high levels of risk perception is related to low job satisfaction and that a positive perception of safety climate is related to high job satisfaction. In addition, it was hypothesized that safety climate moderates the relationship between risk perception and job satisfaction. Using a sample of Norwegian offshore workers (N = 986), all three hypotheses were supported. In summary, workers who perceived high levels of risk reported lower levels of job satisfaction, whereas this effect diminished when workers perceived their safety climate as positive. Follow-up analyses revealed that this interaction was dependent on the type of risks in question. The results of this study supports the JD-R model, and provides further evidence for relationships between safety-related concepts and work-related outcomes indicating that organizations should not only develop and implement sound safety procedures to reduce the effects of risks and hazards on workers, but can also enhance other areas of organizational life through a focus on safety. © 2011 The Authors. Scandinavian Journal of Psychology © 2011 The Scandinavian Psychological Associations.

  17. 48 CFR 250.102 - Delegation of and limitations on exercise of authority.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 3 2014-10-01 2014-10-01 false Delegation of and limitations on exercise of authority. 250.102 Section 250.102 Federal Acquisition Regulations System DEFENSE... AND THE SAFETY ACT Extraordinary Contractual Actions 250.102 Delegation of and limitations on exercise...

  18. 48 CFR 250.102 - Delegation of and limitations on exercise of authority.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 3 2013-10-01 2013-10-01 false Delegation of and limitations on exercise of authority. 250.102 Section 250.102 Federal Acquisition Regulations System DEFENSE... AND THE SAFETY ACT Extraordinary Contractual Actions 250.102 Delegation of and limitations on exercise...

  19. 48 CFR 250.102 - Delegation of and limitations on exercise of authority.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 3 2012-10-01 2012-10-01 false Delegation of and limitations on exercise of authority. 250.102 Section 250.102 Federal Acquisition Regulations System DEFENSE... AND THE SAFETY ACT Extraordinary Contractual Actions 250.102 Delegation of and limitations on exercise...

  20. 48 CFR 250.102 - Delegation of and limitations on exercise of authority.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 3 2011-10-01 2011-10-01 false Delegation of and limitations on exercise of authority. 250.102 Section 250.102 Federal Acquisition Regulations System DEFENSE... AND THE SAFETY ACT Extraordinary Contractual Actions 250.102 Delegation of and limitations on exercise...