Power learning or path dependency? Investigating the roots of the European Food Safety Authority.
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.
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…
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.
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.
Why the European Food Safety Authority was right to reject health claims for probiotics.
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.
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.
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
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
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.
Criticism of EFSA's scientific opinion on combinatorial effects of 'stacked' GM plants.
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.
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.
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.
[Safety assessment of foods derived from genetically modified plants].
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.
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
Health safety issues of synthetic food colorants.
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.
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.
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.
Evaluating EFSA protection goals for honey bees (Apis mellifera): what do they mean for pollination?
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
[Safety of food additives from a German and European point of view].
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.
Design and analysis of field studies with bees: A critical review of the draft EFSA guidance.
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.
Hydration and chemical ingredients in sport drinks: food safety in the European context.
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.
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.
Comprehensive European dietary exposure model (CEDEM) for food additives.
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.
Safety assessment of plant food supplements (PFS).
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.
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...
[Assessment of allergenicity of genetically modified food crops].
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.
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
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...
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...
Transgenic maize event TC1507: Global status of food, feed, and environmental safety
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
Transgenic maize event TC1507: Global status of food, feed, and environmental safety.
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.
[Recommendations for inspections of the French nuclear safety authority].
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.
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...
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.
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...
Adverse outcome pathways | Science Inventory | US EPA
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
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
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...
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
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
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.
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.
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...
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...
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...
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...
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...
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.
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.
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.
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.
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
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.
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.
[Contaminants from food packaging : New developments in risk assessment].
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.
RNAi-based GM plants: food for thought for risk assessors.
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.
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.
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.
Drinking Water Intake Is Associated with Higher Diet Quality among French Adults
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
Lack of genotoxicity in vivo for food color additive Allura Red AC.
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.
Lack of genotoxicity in vivo for food color additive Tartrazine.
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.
Drinking Water Intake Is Associated with Higher Diet Quality among French Adults.
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.
Transport temperatures observed during the commercial transportation of animals.
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.
Total and inorganic arsenic in fish samples from Norwegian waters.
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.
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.
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...
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...
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
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
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…
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
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.
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.
A new food frequency questionnaire to assess chocolate and cocoa consumption.
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.
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.
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
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
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.
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.
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.
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...
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...
Towards a harmonized approach for risk assessment of genotoxic carcinogens in the European Union.
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.
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
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...
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...
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...
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...
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...
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.
Drug packaging in 2014: authorities should direct more efforts towards medication safety.
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.
The need for strategic development of safety sciences.
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.
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…
[Isoflavone-containing dietary supplements].
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.
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…
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.
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
Transgenesis affects endogenous soybean allergen levels less than traditional breeding.
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.
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...
[Genetically modified food and allergies - an update].
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.
Water and beverage consumption patterns among 4 to 13-year-old children in the United Kingdom.
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.
Handling of thermal paper: Implications for dermal exposure to bisphenol A and its alternatives.
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.
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
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...
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...
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...
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...
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...
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...
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...
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.
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...
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...
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...
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...
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...
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)
The Peroxidation of Leukocytes Index Ratio Reveals the Prooxidant Effect of Green Tea Extract
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
The Peroxidation of Leukocytes Index Ratio Reveals the Prooxidant Effect of Green Tea Extract.
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.
Note on evaluating safety performance of road infrastructure to motivate safety competition.
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.
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...
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
Role of Young Child Formulae and Supplements to Ensure Nutritional Adequacy in U.K. Young Children
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
Role of Young Child Formulae and Supplements to Ensure Nutritional Adequacy in U.K. Young Children.
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.
2016 Traffic Safety Culture Index
... 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 ...
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.
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…
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...
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...
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...
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...
Update on food safety of monosodium l-glutamate (MSG).
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.
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...
MICROBIOLOGICAL SAFETY BIBLIOGRAPHY
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.
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...
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...
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.
Safety Evaluations of Bifidobacterium bifidum BGN4 and Bifidobacterium longum BORI.
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.
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
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.
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.
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...
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®
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.
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
Post-authorization safety surveillance of a liquid pentavalent vaccine in Guatemalan children.
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.
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...
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...
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...
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...
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...
[The system of the quality control and the safety of baby food, the prospects of its development].
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.
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...
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...
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...
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...
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). ...
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). ...
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). ...
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). ...
Transsexualism and Flight Safety
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
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...
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.
Glyceria maxima as new test species for the EU risk assessment for herbicides: a microcosm study.
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.
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...
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...
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...
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...
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...
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...
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...
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...
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
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...
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...
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...
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...
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...
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...
Unstoppable The Gap Between Public Safety and Traffic Safety in the Age of Driverless Cars
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
The dental safety net in Connecticut.
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.
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...
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. ...
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. ...
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...
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...
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...
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)
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...
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...
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...
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...
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...
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
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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. ...
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. ...
[Weighing use and safety of therapeutic agents and feed additives (author's transl)].
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.
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.
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.
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...
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...
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...
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...
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...
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...
Stakeholders' perception of the nutrition and health claim regulation.
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.
Safety and health concerns in forestry operations
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....
[Safety monitoring of cell-based medicinal products (CBMPs)].
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.
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...
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...
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...
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...
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...
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...
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...
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.
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...
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...
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...
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)
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. ...
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. ...
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...
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...
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...
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…
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...
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...
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...
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
Low-dose effect of developmental bisphenol A exposure on sperm count and behaviour in rats.
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
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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.
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...
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...
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.
Melatonin is synthesised by yeast during alcoholic fermentation in wines.
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.
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.
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.
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...
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...
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.
Safety Assessment of Synthetic Fluorphlogopite as Used in Cosmetics.
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.
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.
Expert opinion as 'validation' of risk assessment applied to calf welfare.
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.
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
Vaccine Safety Resources for Nurses
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
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...
Promoting a Culture of Safety as a Patient Safety Strategy
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
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)
Patient safety goals for the proposed Federal Health Information Technology Safety Center.
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.
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. ...
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...
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...
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...
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...
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
Carcinogenicity of glyphosate: why is New Zealand's EPA lost in the weeds?
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.
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...
"Aspartame: A review of genotoxicity data".
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.
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.
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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)
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 ...
Bricks-and-mortar and patient safety culture.
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.
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…
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...
Regulation of Health Policy: Patient Safety and the States
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
Maintenance of safety behaviors via response-produced stimuli.
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.
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...
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...
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...
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)
Radiation Protection, Safety and Security Issues in Ghana.
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.
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...
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...
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...
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...
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...
Safety Assessment of Pentaerythrityl Tetraesters as Used in Cosmetics.
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 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...
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...
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...
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...
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...
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...
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
Car manufacturers and global road safety: a word frequency analysis of road safety documents.
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.
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.
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.
Training in quality and safety: the current landscape.
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.
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…
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…
Towards an Inclusive Occupational Health and Safety For Informal Workers.
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.
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
Safety Alerts: An Observational Study in Portugal.
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.
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...
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. ...
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.…
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%).
Handling of thermal paper: Implications for dermal exposure to bisphenol A and its alternatives
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
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...
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...
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...
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...
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...
Teen worker safety training: methods used, lessons taught, and time spent.
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.
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...
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.)
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.
Safety assessment of Vitis vinifera (grape)-derived ingredients as used in cosmetics.
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.
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.
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)
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
Safety Assessment of Talc as Used in Cosmetics.
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.
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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.
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.
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.
The Impact of Language and Culture Diversity in Occupational Safety.
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).
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...
Guiding principles of safety as a basis for developing a pharmaceutical safety culture.
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.
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...
Lawn Care Pesticides. Risks Remain Uncertain While Prohibited Safety Claims Continue
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
[History of the evaluation of medicines aiming for marketing authorization].
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.
Safety assessment of modified terephthalate polymers as used in cosmetics.
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.
Integration into Civil Airspace Airworthiness and Safety
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
Safety Assessment of Alkyl Esters as Used in Cosmetics.
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.
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.
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 ...
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.
Revisiting the safety of aspartame.
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.
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.
TeamSTEPPS Improves Operating Room Efficiency and Patient Safety.
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.
Safety Assessment of Dialkyl Sulfosuccinate Salts as Used in Cosmetics.
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.
OSHA safety requirements and the general duty clause.
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.
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...
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...
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 --…
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)…
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…
Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics.
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.
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.…
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)
Assessing Explosives Safety Risks, Deviations, And Consequences
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
Environment/Health/Safety (EHS): Databases
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
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)
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 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...
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...
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...
Neighbourhood social trust and youth perceptions of safety during daily activities.
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.
Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics.
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.
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.
Perinatal Safety: From Concept to Nursing Practice
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
Perinatal safety: from concept to nursing practice.
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.
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...
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.
Debate on vaccines and autoimmunity: Do not attack the author, yet discuss it methodologically.
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.
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…
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…
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
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
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)
Caught in a tightening fire safety net.
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.
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...
Error reduction, patient safety and institutional ethics committees.
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.
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.
Safety Assessment of Nitrocellulose and Collodion as Used in Cosmetics.
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.
Hawaii State Plan for Occupational Safety and Health. Final rule.
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.
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.
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...
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...
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.
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...
The Impact of Market Orientation on Patient Safety Climate Among Hospital Nurses.
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.
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.
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...
,
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.
Safety considerations for outpatient electroconvulsive therapy.
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.
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...
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...
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.
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...
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.
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
Development of a novel scoring system for identifying emerging chemical risks in the food chain.
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.
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.
The carcinogenic effects of aspartame: The urgent need for regulatory re-evaluation.
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.
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.
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.
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...
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...
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...
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...
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)
Development of a safety communication and recognition program for construction.
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.
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...
Occupational Safety and Health in Peru.
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.
Health and safety in clinical laboratories in developing countries: safety considerations.
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.
Blood transfusion safety: a new philosophy.
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.
Improving Safety through Human Factors Engineering.
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.
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...
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.
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...
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...
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...
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...
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...
Beulke, Sabine; van Beinum, Wendy; Suddaby, Laura
2015-04-01
First-tier regulatory exposure assessments for pesticides assume that pesticide sorption is instantaneous and fully reversible. In European Union (EU) regulatory guidance, an increase in sorption over time ("aged sorption") can be considered at the higher tier to refine predicted environmental concentrations in groundwater. Research commissioned by the UK Chemicals Regulation Directorate (CRD), funded by the Department for Environment Food & Rural Affairs (Defra), formed the basis of a draft regulatory guidance document proposing 1) a protocol on how to measure aged sorption of parent compounds in laboratory studies, 2) procedures to fit kinetic models to the experimental data, 3) criteria to test the reliability of the parameters, and 4) procedures for use of the parameters in the groundwater exposure assessment. The draft guidance was revised after feedback from stakeholders and testing of the guidance was performed against real data sets by an independent consultancy. The Chemicals Regulation Directorate submitted the revised document to the European Food Safety Authority (EFSA) for scrutiny. This article gives an overview of the draft guidance and explains the reasoning behind the recommendations made. 2015 Crown Copyright; Published 2015 SETAC.
Caffeine intake and its sources: A review of national representative studies.
Verster, Joris C; Koenig, Juergen
2018-05-24
Aim of this review is to summarize current daily caffeine intake of children, adolescents, and adults, and trends in caffeine intake over the past decade. A literature search was conducted (1997-2015) which yielded 18 reports on nationally representative studies, describing caffeine consumption of over 275,000 children, adolescents and adults. The data revealed that mean total daily caffeine intake in children, adolescents, and adults is below caffeine intake recommendations such as those stated by Health Canada (2.5 mg/kg bw/day for children and adolescents, and 400 mg/day for adults) and the European Food Safety Authority, EFSA (3 mg/kg bw/day for children and adolescents, and 400 mg/day for adults). Total daily caffeine intake has remained stable in the last 10-15 years, and coffee, tea and soft drinks are the most important caffeine sources. Across all age groups, energy drinks contribute little to total caffeine intake. The highest potential for reducing daily caffeine intake is by limiting coffee consumption, and in some countries and age groups, by reducing tea and soft drink consumption.
Reboredo-Rodríguez, Patricia; Figueiredo-González, María; González-Barreiro, Carmen; Simal-Gándara, Jesús; Salvador, María Desamparados; Cancho-Grande, Beatriz; Fregapane, Giuseppe
2017-03-20
Virgin olive oil, the main fat of the Mediterranean diet, is per se considered as a functional food-as stated by the European Food Safety Authority (EFSA)-due to its content in healthy compounds. The daily intake of endogenous bioactive phenolics from virgin olive oil is variable due to the influence of multiple agronomic and technological factors. Thus, a good strategy to ensure an optimal intake of polyphenols through habitual diet would be to produce enriched virgin olive oil with well-known bioactive polyphenols. Different sources of natural biological active substances can be potentially used to enrich virgin olive oil (e.g., raw materials derived from the same olive tree, mainly olive leaves and pomaces, and/or other compounds from plants and vegetables, mainly herbs and spices). The development of these functional olive oils may help in prevention of chronic diseases (such as cardiovascular diseases, immune frailty, ageing disorders and degenerative diseases) and improving the quality of life for many consumers reducing health care costs. In the present review, the most relevant scientific information related to the development of enriched virgin olive oil and their positive human health effects has been collected and discussed.
Cano-Lamadrid, M; Marhuenda-Egea, F C; Hernández, F; Rosas-Burgos, E C; Burgos-Hernández, A; Carbonell-Barrachina, A A
2016-12-01
None of the health claims about pomegranate juices has been approved yet by European Food Safety Authority (EFSA). There is a general perception among consumers that organic foods are healthier, tastier, and more nutritive than the conventional products. The aim of this research was to study the differences in the biological activity between ready-for-consumption juices obtained from pomegranates fruits grown under conventional and organic agricultural practices. Antioxidant activity has been evaluated by three methods (DPPH • , ABTS + , and FRAP), together with the total contents of phenolics and punicalagin (HPLC-DAD); besides, the Ames test was used to evaluate the antimutagenic potential of the juices. Pomegranate juice, either from conventionally or organically grown fruits, was antimutagenic (mean of 51 and 90 % for Salmonella typhimurium TA100 and TA98, respectively) and it was capable of protecting DNA from both, base-pair or frame-shift type of mutations. In fact, the antimutagenicity of conventional pomegranate juice was higher than that achieved by the organic sample; this finding was linked to a higher punicalagin content (201 and 104 mg L -1 for conventional and organic juices, respectively).
Reboredo-Rodríguez, Patricia; Figueiredo-González, María; González-Barreiro, Carmen; Simal-Gándara, Jesús; Salvador, María Desamparados; Cancho-Grande, Beatriz; Fregapane, Giuseppe
2017-01-01
Virgin olive oil, the main fat of the Mediterranean diet, is per se considered as a functional food—as stated by the European Food Safety Authority (EFSA)—due to its content in healthy compounds. The daily intake of endogenous bioactive phenolics from virgin olive oil is variable due to the influence of multiple agronomic and technological factors. Thus, a good strategy to ensure an optimal intake of polyphenols through habitual diet would be to produce enriched virgin olive oil with well-known bioactive polyphenols. Different sources of natural biological active substances can be potentially used to enrich virgin olive oil (e.g., raw materials derived from the same olive tree, mainly olive leaves and pomaces, and/or other compounds from plants and vegetables, mainly herbs and spices). The development of these functional olive oils may help in prevention of chronic diseases (such as cardiovascular diseases, immune frailty, ageing disorders and degenerative diseases) and improving the quality of life for many consumers reducing health care costs. In the present review, the most relevant scientific information related to the development of enriched virgin olive oil and their positive human health effects has been collected and discussed. PMID:28335517
Perelló, Gemma; Vicente, Emilio; Castell, Victòria; Llobet, Juan M; Nadal, Martí; Domingo, José L
2015-01-01
This study aimed to analyse the concentrations of Al, Ba, Bi, Cu, Cr, Ge, Mn, Mo, Ni, Sb, Se, Sr and Zn in food samples collected in 2008 in Catalonia (Spain). The dietary intake of these 13 trace elements was subsequently estimated by different age-gender groups of the population: children, adolescents, adults and seniors. In general terms, fish and shellfish, cereals, and pulses were the food groups showing the highest levels for most elements. Higher dietary intakes were associated with male groups (adolescents, adults and seniors). However, none exceeded the tolerable levels. When exposure was estimated based on body weight, children were the group with the highest dietary intake. Notwithstanding, only the weekly intake of Al by children exceeded the recommendations of the European Food Safety Authority (EFSA). It is a consequence of the higher intake of cereals in relation to their respective body weights. In addition to the periodical food surveillance of toxic metals (As, Cd, Hg and Pb), it is also important to determine the levels of other trace elements in order to ensure that the dietary exposure by the Catalan population is under control.
Quo vadis? – Monitoring Campylobacter in Germany
Stingl, K.; Knüver, M.-T.; Vogt, P.; Buhler, C.; Krüger, N.-J.; Alt, K.; Tenhagen, B.-A.; Hartung, M.; Schroeter, A.; Ellerbroek, L.; Appel, B.; Käsbohrer, A.
2012-01-01
Campylobacter is a poorly recognized foodborne pathogen, leading the statistics of bacterially caused human diarrhoea in Europe during the last years. In this review, we present qualitative and quantitative German data obtained in the framework of specific monitoring programs and from routine surveillance. These also comprise recent data on antimicrobial resistances of food isolates. Due to the considerable reduction of in vitro growth capabilities of stressed bacteria, there is a clear discrepancy between the detection limit of Campylobacter by cultivation and its infection potential. Moreover, antimicrobial resistances of Campylobacter isolates established during fattening of livestock are alarming, since they constitute an additional threat to human health. The European Food Safety Authority (EFSA) discusses the establishment of a quantitative limit for Campylobacter contamination of broiler carcasses in order to achieve an appropriate level of protection for consumers. Currently, a considerable amount of German broiler carcasses would not comply with this future criterion. We recommend Campylobacter reduction strategies to be focussed on the prevention of fecal contamination during slaughter. Decontamination is only a sparse option, since the reduction efficiency is low and its success depends on the initial contamination concentration. PMID:24611125
Butler Ellis, M Clare; Kennedy, Marc C; Kuster, Christian J; Alanis, Rafael; Tuck, Clive R
2018-05-28
The BREAM (Bystander and Resident Exposure Assessment Model) (Kennedy et al. in BREAM: A probabilistic bystander and resident exposure assessment model of spray drift from an agricultural boom sprayer. Comput Electron Agric 2012;88:63-71) for bystander and resident exposure to spray drift from boom sprayers has recently been incorporated into the European Food Safety Authority (EFSA) guidance for determining non-dietary exposures of humans to plant protection products. The component of BREAM, which relates airborne spray concentrations to bystander and resident dermal exposure, has been reviewed to identify whether it is possible to improve this and its description of variability captured in the model. Two approaches have been explored: a more rigorous statistical analysis of the empirical data and a semi-mechanistic model based on established studies combined with new data obtained in a wind tunnel. A statistical comparison between field data and model outputs was used to determine which approach gave the better prediction of exposures. The semi-mechanistic approach gave the better prediction of experimental data and resulted in a reduction in the proposed regulatory values for the 75th and 95th percentiles of the exposure distribution.
Perales-García, Aránzazu; Estévez-Martínez, Isabel; Urrialde, Rafael
2016-07-12
Introduction: Hydration is defined as the water intake coming from food and beverages. Its study has become an area by itself, within the nutrition field. Meaning that in 2010 the European Food Safety Authority (EFSA) approved the water intake recommendations, but the study of this topic implies a rigorous methodology, which represents several issues. Objective: Showing as a glance the main methodological issues in hydration studies. Material and methods: Bibliographic revision of scientific literature. Results: The main methodological issues presented are: sample selection (investigation field and sample design), selection of the method to evaluate hydration status (dilution techniques, bioelectrical impedance, plasmatic and urinary indicators, changes in body composition, water losses and clinic symptoms) selection of the method to evaluate water intake (biomarker, questionnaires, informatics programs, smartphone use, 24-h register, dietary history and food frequency questionnaire), and the main sources of hydration. Conclusions: Hydration status should be understood as a routine model, with daily frequency, according to gender, age, physical activity and environmental conditions. Furthermore, the correct design of the methodology has a special importance in order to take into account all the aspects
[Procedure for the marketing authorization of an antibacterial agent].
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.
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.
Russo, Giacomo; Barbato, Francesco; Grumetto, Lucia
2017-12-01
Bisphenol A (BPA), a synthetic xenoestrogen widely used in various industrial fields, can be present, in its un-reacted form, as an additive in thermal paper. BPA is virtually ubiquitous in industrialized societies and humans are exposed to this chemical via dietary and non-dietary sources. Since in 2015 European Food Safety Authority (EFSA) indicated that thermal paper is the second source of BPA exposure after the food chain, some suppliers replaced BPA with its analogue Bisphenol S (BPS), speculatively supposed to be safer. In this work BPA and BPS concentration levels were determined in thermal paper receipts collected in Italy from 50 different sources by liquid chromatography coupled to tandem fluorescence and ultraviolet detection. BPA was found in 44 samples at mean concentration of 107.47μg/100mg of paper (from below Limits of Quantification (LOQ) to 1533.733μg/100mg of paper). BPS was found in 31 samples at mean concentration of 41.97μg/100mg of paper (from below the LOQ to 357.989μg/100mg of paper). 26 samples were positive to both BPA and BPS. The estimate daily intake (EDI) values of BPA and BPS occurring through dermal absorption were calculated for 70kg body weight individuals. For general population, they were 0.0625μg/day for BPA and 0.0244μg/day for BPS, based on the mean content of bisphenols found. For occupationally exposed individuals, they were 66.8μg/day for BPA and 15.6μg/day for BPS, based on the worst scenario. Such levels would produce a dermal intake below the Tolerable Day Intake established by EFSA (4μg/kg·bw/day); nevertheless, the occurrence of co-exposure to dietary and non-dietary sources should be considered in the health risk assessment, mainly for people frequently exposed to thermal paper contact for occupational reason. Copyright © 2017 Elsevier B.V. All rights reserved.
Is the chronic Tier-1 effect assessment approach for insecticides protective for aquatic ecosystems?
Brock, Theo Cm; Bhatta, Ranjana; van Wijngaarden, René Pa; Rico, Andreu
2016-10-01
We investigated the appropriateness of several methods, including those recommended in the Aquatic Guidance Document of the European Food Safety Authority (EFSA), for the derivation of chronic Tier-1 regulatory acceptable concentrations (RACs) for insecticides and aquatic organisms. The insecticides represented different chemical classes (organophosphates, pyrethroids, benzoylureas, insect growth regulators, biopesticides, carbamates, neonicotinoids, and miscellaneous). Chronic Tier-1 RACs derived using toxicity data for the standard species Daphnia magna, Chironomus spp., and/or Americamysis bahia, were compared with Tier-3 RACs derived from micro- and mesocosm studies on basis of the ecological threshold option (ETO-RACs). ETO-RACs could be derived for 31 insecticides applied to micro- and mesocosms in single or multiple applications, yielding a total number of 36 cases for comparison. The chronic Tier-1 RACs calculated according to the EFSA approach resulted in a sufficient protection level, except for 1 neonicotinoid (slightly underprotective) and for several pyrethroids if toxicity data for A. bahia were not included. This latter observation can be explained by 1) the fact that A. bahia is the most sensitive standard test species for pyrethroids, 2) the hydrophobic properties of pyrethroids, and 3) the fact that long-term effects observed in (epi) benthic arthropods may be better explained by exposure via the sediment than via overlying water. Besides including toxicity data for A. bahia, the protection level for pyrethroids can be improved by selecting both D. magna and Chironomus spp. as standard test species for chronic Tier-1 derivation. Although protective in the majority of cases, the conservativeness of the recommended chronic Tier-1 RACs appears to be less than an order of magnitude for a relatively large proportion of insecticides when compared with their Tier-3 ETO-RACs. This may leave limited options for refinement of the chronic effect assessment
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.
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...
77 FR 1975 - Safety Advisory: Unauthorized Marking of Compressed Gas Cylinders
Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-12
... Jackson Plaza, Ann Arbor, MI improperly requalified and marked high pressure compressed gas cylinders... DOT specification cylinders after its authority to requalifiy high pressure cylinders expired on... that Spears Fire & Safety continued to requalify and mark high pressure cylinders after their authority...
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.
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…
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.
Influenza vaccines: Evaluation of the safety profile
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
Industrial requirements in food safety.
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.
Future challenges to microbial food safety.
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
With Immigrants, Districts Balance Safety, Legalities
ERIC Educational Resources Information Center
Zehr, Mary Ann
2007-01-01
In this article, the author discusses attempts by schools to navigate stepped-up federal efforts to curb illegal immigration, protection of student privacy, and the safety of students during enforcement operations. In Albuquerque and Santa Fe, New Mexico, for example, school personnel are barred from putting information about a child's immigration…
Educating Veterinary Students in Food Safety.
ERIC Educational Resources Information Center
Genigeorgis, Constantin A.; And Others
1980-01-01
A survey of domestic and foreign schools of veterinary medicine is analyzed, revealing a general trend toward deemphasis and/or loss of identity in teaching food safety and regulated veterinary public health subjects. It is suggested that minimal standards need to be set for curricula of U.S. schools. (Author/MLW)
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-10
... duties imposed by the Occupational Safety and Health (OSH) Act of 1970 (29 U.S.C. 655, 656). Authority to...(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655(b)(1), 656(b)), the Federal... DEPARTMENT OF LABOR Occupational Safety and Health Administration Maritime Advisory Committee for...
Perry, Joe N; Barberi, Paolo; Bartsch, Detlef; Birch, A N E; Gathmann, Achim; Kiss, Jozsef; Manachini, Barbara; Nuti, Marco; Rauschen, Stefan; Schiemann, Joachim; Schuppener, Mechthild; Sweet, Jeremy; Tebbe, Christoph C; Veronesi, Fabio
2017-01-01
We respond to the paper of Kruse-Plass et al. (Environ Sci Eur 29:12, 2017), published in this journal, regarding the risk to non-target lepidopteran larvae exposed to pollen from one or more of three Bt maize events (MON810, Bt11 and 1507). We emphasise that what is important for environmental risk assessment is not the number of pollen grains per se, but the degree of exposure of a NT lepidopteran larva to Bt protein contained in maize pollen. The main text of this response deals with general issues which Kruse-Plass et al. have failed to understand; more detailed refutations of each of their claims are given in Additional file 1. Valid environmental risk assessment requires direct measurement of pollen on leaves at varying distances outside a source field(s); such measurements reflect the potential exposure experienced by an individual larva on a host plant. There are no new data in the Kruse-Plass et al. paper, or indeed any data directly quantifying pollen on actual host-plant leaves outside a maize field; only data gathered within or at the edge of maize crops were reported. Values quoted by Kruse-Plass et al. for deposition on host plants outside the field were estimates only. We reiterate the severe methodological criticisms made by EFSA [Relevance of a new scientific publication (Hofmann et al. 2016) for previous environmental risk assessment conclusions and risk management recommendations on the cultivation of Bt-maize events MON810, Bt11 and 1507. EFSA Supp Publ; EN-1070, 2016], which render this estimation procedure unreliable. Furthermore, criticisms of EFSA (EFSA J 2015(13):4127, 2015) and of EFSA [Relevance of a new scientific publication (Hofmann et al. 2016) for previous environmental risk assessment conclusions and risk management recommendations on the cultivation of Bt-maize events MON810, Bt11 and 1507. EFSA Supp Publ; EN-1070, 2016] made by Kruse-Plass et al. are shown in Additional file 1 to be without foundation. We therefore consider that
Nurses' role in medication safety.
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.
Thiel, Anette; Braun, William; Cary, Maurice G; Engelhardt, Jeffery A; Goodman, Dawn G; Hall, William C; Romeike, Annette; Ward, Jerrold M
2013-08-01
A 90-day feeding study in Han/Wistar rats with calcium lignosulphonate was evaluated by the EFSA. The study was considered to be inadequate due to potentially impaired health status of the animals based upon a high incidence of minimal lymphoid hyperplasia in mesenteric/mandibular lymph nodes and Peyer's patches, and minimal lymphoid cell infiltration in the liver in all animals. The EFSA Panel further disagreed with the conclusion that the treatment-related observation of foamy histiocytosis in mesenteric lymph nodes was non-adverse and asked whether this observation would progress to something more adverse over time. A PWG was convened to assess the sections of lymph nodes, Peyer's patches and liver. In addition, all lymphoid tissues were re-examined. The clinical pathology and animal colony health screening data were re-evaluated. The question whether the foamy histiocytosis could progress to an adverse finding with increasing exposure duration was addressed by read-across. In conclusion, the animals on the 90-day feeding study were in good health, the study was adequate for safety evaluation, and the foamy histiocytes in the mesenteric lymph nodes were not considered adverse, but rather an adaptive response that was considered unlikely to progress to an adverse condition with time. The NOAEL was re-affirmed to be 2000 mg/kgbw/d. Copyright © 2013 Elsevier Inc. All rights reserved.
Microbial bioinformatics for food safety and production
Alkema, Wynand; Boekhorst, Jos; Wels, Michiel
2016-01-01
In the production of fermented foods, microbes play an important role. Optimization of fermentation processes or starter culture production traditionally was a trial-and-error approach inspired by expert knowledge of the fermentation process. Current developments in high-throughput ‘omics’ technologies allow developing more rational approaches to improve fermentation processes both from the food functionality as well as from the food safety perspective. Here, the authors thematically review typical bioinformatics techniques and approaches to improve various aspects of the microbial production of fermented food products and food safety. PMID:26082168