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

A Safety Index and Method for Flightdeck Evaluation

NASA Technical Reports Server (NTRS)

Latorella, Kara A.

2000-01-01

If our goal is to improve safety through machine, interface, and training design, then we must define a metric of flightdeck safety that is usable in the design process. Current measures associated with our notions of "good" pilot performance and ultimate safety of flightdeck performance fail to provide an adequate index of safe flightdeck performance for design evaluation purposes. The goal of this research effort is to devise a safety index and method that allows us to evaluate flightdeck performance holistically and in a naturalistic experiment. This paper uses Reason's model of accident causation (1990) as a basis for measuring safety, and proposes a relational database system and method for 1) defining a safety index of flightdeck performance, and 2) evaluating the "safety" afforded by flightdeck performance for the purpose of design iteration. Methodological considerations, limitations, and benefits are discussed as well as extensions to this work.

16 CFR 1203.30 - Purpose, basis, and scope.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 1203.30 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS Certification § 1203.30 Purpose, basis, and scope. (a) Purpose. The... of compliance in the form specified. (b) Basis. Section 14(a)(1) of the Consumer Product Safety Act...

The in-depth safety assessment (ISA) pilot projects in Ukraine.

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

Kot, C. A.

1998-02-10

Ukraine operates pressurized water reactors of the Soviet-designed type, VVER. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs). After approval of the SARS by the Ukrainian Nuclear Regulatory Authority, the plants will be granted longer-term operating licenses. In September 1995, the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine issued a new contents requirement for the safety analysis reports of VVERs in Ukraine. It contains requirements in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. Themore » DBA requirements are an expanded version of the older SAR requirements. The last two requirements, on PRA and BDBA, are new. The US Department of Energy (USDOE), through the International Nuclear Safety Program (INSP), has initiated an assistance and technology transfer program to Ukraine to assist their nuclear power stations in developing a Western-type technical basis for the new SARS. USDOE sponsored In-Depth Safety Assessments (ISAs) have been initiated at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1. USDOE/INSP have structured the ISA program in such a way as to provide maximum assistance and technology transfer to Ukraine while encouraging and supporting the Ukrainian plants to take the responsibility and initiative and to perform the required assessments.« less

FY2017 Updates to the SAS4A/SASSYS-1 Safety Analysis Code

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

Fanning, T. H.

The SAS4A/SASSYS-1 safety analysis software is used to perform deterministic analysis of anticipated events as well as design-basis and beyond-design-basis accidents for advanced fast reactors. It plays a central role in the analysis of U.S. DOE conceptual designs, proposed test and demonstration reactors, and in domestic and international collaborations. This report summarizes the code development activities that have taken place during FY2017. Extensions to the void and cladding reactivity feedback models have been implemented, and Control System capabilities have been improved through a new virtual data acquisition system for plant state variables and an additional Block Signal for a variablemore » lag compensator to represent reactivity feedback for novel shutdown devices. Current code development and maintenance needs are also summarized in three key areas: software quality assurance, modeling improvements, and maintenance of related tools. With ongoing support, SAS4A/SASSYS-1 can continue to fulfill its growing role in fast reactor safety analysis and help solidify DOE’s leadership role in fast reactor safety both domestically and in international collaborations.« less

Light Water Reactor Sustainability Program Reactor Safety Technologies Pathway Technical Program Plan

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

Corradini, M. L.; Peko, D.; Farmer, M.

In the aftermath of the March 2011 multi-unit accident at the Fukushima Daiichi nuclear power plant (Fukushima), the nuclear community has been reassessing certain safety assumptions about nuclear reactor plant design, operations and emergency actions, particularly with respect to extreme events that might occur and that are beyond each plant’s current design basis. Because of our significant domestic investment in nuclear reactor technology (99 operating reactors in the fleet of commercial LWRs with five under construction), the United States has been a major leader internationally in these activities. The U.S. nuclear industry is voluntarily pursuing a number of additional safetymore » initiatives. The NRC continues to evaluate and, where deemed appropriate, establish new requirements for ensuring adequate protection of public health and safety in the occurrence of low probability events at nuclear plants; (e.g., mitigation strategies for beyond design basis events initiated by external events like seismic or flooding initiators). The DOE has also played a major role in the U.S. response to the Fukushima accident. Initially, DOE worked with the Japanese and the international community to help develop a more complete understanding of the Fukushima accident progression and its consequences, and to respond to various safety concerns emerging from uncertainties about the nature of and the effects from the accident. DOE R&D activities are focused on providing scientific and technical insights, data, analyses methods that ultimately support industry efforts to enhance safety. These activities are expected to further enhance the safety performance of currently operating U.S. nuclear power plants as well as better characterize the safety performance of future U.S. plants. In pursuing this area of R&D, DOE recognizes that the commercial nuclear industry is ultimately responsible for the safe operation of licensed nuclear facilities. As such, industry is considered the primary “end user” of the results from this DOE-sponsored work. The response to the Fukushima accident has been global, and there is a continuing multinational interest in collaborations to better quantify accident consequences and to incorporate lessons learned from the accident. DOE will continue to seek opportunities to facilitate collaborations that are of value to the U.S. industry, particularly where the collaboration provides access to vital data from the accident or otherwise supports or leverages other important R&D work. The purpose of the Reactor Safety Technology R&D is to improve understanding of beyond design basis events and reduce uncertainty in severe accident progression, phenomenology, and outcomes using existing analytical codes and information gleaned from severe accidents, in particular the Fukushima Daiichi events. This information will be used to aid in developing mitigating strategies and improving severe accident management guidelines for the current light water reactor fleet.« less

Light Water Reactor Sustainability Program: Reactor Safety Technologies Pathway Technical Program Plan

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

Corradini, M. L.

In the aftermath of the March 2011 multi-unit accident at the Fukushima Daiichi nuclear power plant (Fukushima), the nuclear community has been reassessing certain safety assumptions about nuclear reactor plant design, operations and emergency actions, particularly with respect to extreme events that might occur and that are beyond each plant’s current design basis. Because of our significant domestic investment in nuclear reactor technology (99 operating reactors in the fleet of commercial LWRs with five under construction), the United States has been a major leader internationally in these activities. The U.S. nuclear industry is voluntarily pursuing a number of additional safetymore » initiatives. The NRC continues to evaluate and, where deemed appropriate, establish new requirements for ensuring adequate protection of public health and safety in the occurrence of low probability events at nuclear plants; (e.g., mitigation strategies for beyond design basis events initiated by external events like seismic or flooding initiators). The DOE has also played a major role in the U.S. response to the Fukushima accident. Initially, DOE worked with the Japanese and the international community to help develop a more complete understanding of the Fukushima accident progression and its consequences, and to respond to various safety concerns emerging from uncertainties about the nature of and the effects from the accident. DOE R&D activities are focused on providing scientific and technical insights, data, analyses methods that ultimately support industry efforts to enhance safety. These activities are expected to further enhance the safety performance of currently operating U.S. nuclear power plants as well as better characterize the safety performance of future U.S. plants. In pursuing this area of R&D, DOE recognizes that the commercial nuclear industry is ultimately responsible for the safe operation of licensed nuclear facilities. As such, industry is considered the primary “end user” of the results from this DOE-sponsored work. The response to the Fukushima accident has been global, and there is a continuing multinational interest in collaborations to better quantify accident consequences and to incorporate lessons learned from the accident. DOE will continue to seek opportunities to facilitate collaborations that are of value to the U.S. industry, particularly where the collaboration provides access to vital data from the accident or otherwise supports or leverages other important R&D work. The purpose of the Reactor Safety Technology R&D is to improve understanding of beyond design basis events and reduce uncertainty in severe accident progression, phenomenology, and outcomes using existing analytical codes and information gleaned from severe accidents, in particular the Fukushima Daiichi events. This information will be used to aid in developing mitigating strategies and improving severe accident management guidelines for the current light water reactor fleet.« less

Evaluating the Safety of New Vaccines: Summary of a Workshop

PubMed Central

Ellenberg, Susan S.; Foulkes, Mary A.; Midthun, Karen; Goldenthal, Karen L.

2005-01-01

Public concerns about the safety of vaccines arise on a regular basis. In November 2000, a workshop titled “Evaluation of New Vaccines: How Much Safety Data?” was convened by US Public Health Service agencies, including the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, to discuss appropriate methods for evaluating the safety of new vaccines. Workshop presentations addressed the current standards and approaches for new vaccine evaluation and postlicensure surveillance, as well as public views about vaccine safety and alternative approaches that could be considered. The advantages and disadvantages of conducting large controlled trials before licensure or widespread use of a new vaccine were discussed. We summarize these presentations and discussions. PMID:15855455

Light Water Reactor Sustainability Program: Risk-Informed Safety Margins Characterization (RISMC) Pathway Technical Program Plan

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

Smith, Curtis; Rabiti, Cristian; Martineau, Richard

Safety is central to the design, licensing, operation, and economics of Nuclear Power Plants (NPPs). As the current Light Water Reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of Systems, Structures, and Components (SSCs) degradations or failures that initiate safety-significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very high degreemore » of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated, primarily based on “engineering judgment.”« less

Margin of Safety Definition and Examples Used in Safety Basis Documents and the USQ Process

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

Beaulieu, R. A.

The Nuclear Safety Management final rule, 10 CFR 830, provides an undefined term, margin of safety (MOS). Safe harbors listed in 10 CFR 830, Table 2, such as DOE-STD-3009 use but do not define the term. This lack of definition has created the need for the definition. This paper provides a definition of MOS and documents examples of MOS as applied in a U.S. Department of Energy (DOE) approved safety basis for an existing nuclear facility. If we understand what MOS looks like regarding Technical Safety Requirements (TSR) parameters, then it helps us compare against other parameters that do notmore » involve a MOS. This paper also documents parameters that are not MOS. These criteria could be used to determine if an MOS exists in safety basis documents. This paper helps DOE, including the National Nuclear Security Administration (NNSA) and its contractors responsible for the safety basis improve safety basis documents and the unreviewed safety question (USQ) process with respect to MOS.« less

A Formal Basis for Safety Case Patterns

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2013-01-01

By capturing common structures of successful arguments, safety case patterns provide an approach for reusing strategies for reasoning about safety. In the current state of the practice, patterns exist as descriptive specifications with informal semantics, which not only offer little opportunity for more sophisticated usage such as automated instantiation, composition and manipulation, but also impede standardization efforts and tool interoperability. To address these concerns, this paper gives (i) a formal definition for safety case patterns, clarifying both restrictions on the usage of multiplicity and well-founded recursion in structural abstraction, (ii) formal semantics to patterns, and (iii) a generic data model and algorithm for pattern instantiation. We illustrate our contributions by application to a new pattern, the requirements breakdown pattern, which builds upon our previous work

Querying Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

2014-01-01

Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

Transcranial Magnetic Stimulation in Child Neurology: Current and Future Directions

PubMed Central

Frye, Richard E.; Rotenberg, Alexander; Ousley, Molliann; Pascual-Leone, Alvaro

2008-01-01

Transcranial magnetic stimulation (TMS) is a method for focal brain stimulation based on the principle of electromagnetic induction, where small intracranial electric currents are generated by a powerful, rapidly changing extracranial magnetic field. Over the past 2 decades TMS has shown promise in the diagnosis, monitoring, and treatment of neurological and psychiatric disease in adults, but has been used on a more limited basis in children. We reviewed the literature to identify potential diagnostic and therapeutic applications of TMS in child neurology and also its safety in pediatrics. Although TMS has not been associated with any serious side effects in children and appears to be well tolerated, general safety guidelines should be established. The potential for applications of TMS in child neurology and psychiatry is significant. Given its excellent safety profile and possible therapeutic effect, this technique should develop as an important tool in pediatric neurology over the next decade. PMID:18056688

Structural Deterministic Safety Factors Selection Criteria and Verification

NASA Technical Reports Server (NTRS)

Verderaime, V.

1992-01-01

Though current deterministic safety factors are arbitrarily and unaccountably specified, its ratio is rooted in resistive and applied stress probability distributions. This study approached the deterministic method from a probabilistic concept leading to a more systematic and coherent philosophy and criterion for designing more uniform and reliable high-performance structures. The deterministic method was noted to consist of three safety factors: a standard deviation multiplier of the applied stress distribution; a K-factor for the A- or B-basis material ultimate stress; and the conventional safety factor to ensure that the applied stress does not operate in the inelastic zone of metallic materials. The conventional safety factor is specifically defined as the ratio of ultimate-to-yield stresses. A deterministic safety index of the combined safety factors was derived from which the corresponding reliability proved the deterministic method is not reliability sensitive. The bases for selecting safety factors are presented and verification requirements are discussed. The suggested deterministic approach is applicable to all NASA, DOD, and commercial high-performance structures under static stresses.

Systematic Evaluation Program (SEP) at Rocky Flats Plant: An overview of practical management issues for evaluation of natural phenomena hazards

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

Badwan, F.M.; Herring, K.S.

1993-08-01

Many of the buildings at the Rocky Flats Plant were designed and built before modern standards were developed, including standards for protection against extreme natural phenomenon such as tornadoes, earthquakes, and floods. The purpose of the SEP is to establish an integrated approach to assessing the design adequacy of specific high and moderate hazard Rocky Flats facilities from a safety perspective and to establish a basis for defining any needed facility improvements. The SEP is to be carried out in three Phases. In Phase 1, topics to be evaluated and an evaluation plan for each topic were developed. Any differencesmore » between Current Design Requirements (CDR) or acceptance criteria and the design of existing facilities, will be identified during Phase 2 and assessed using an integrated systematic approach during Phase 3. The integrated assessment performed during Phase 3 provides a process for evaluating the differences between existing facility design and CDRs so that decisions on corrective actions can be made on the basis of relative risk reduction and cost effectiveness. These efforts will ensure that a balanced and integrated level of safety is achieved for long-term operation of these buildings. Through appropriate selection of topics and identification of the structures, systems, and components to be evaluated, the SEP will address outstanding design issues related to the prevention and mitigation of design basis accidents, including those arising from natural phenomena. The objective of the SEP is not to bring these buildings into strict compliance with current requirements, but rather to ensure that an adequate level of safety is achieved in an economical fashion.« less

To make or buy patient safety solutions: a resource dependence and transaction cost economics perspective.

PubMed

Fareed, Naleef; Mick, Stephen S

2011-01-01

For almost a decade, public and private organizations have pressured hospitals to improve their patient safety records. Since 2008, the Centers for Medicare & Medicaid Services has no longer been reimbursing hospitals for secondary diagnoses not reported during the point of admission. This ruling has motivated some hospitals to engage in safety-oriented programs to decrease adverse events. This study examined which hospitals may engage in patient safety solutions and whether they create these patient safety solutions within their structures or use suppliers in the market. We used a theoretical model that incorporates the key constructs of resource dependence theory and transaction cost economics theory to predict a hospital's reaction to Centers for Medicare & Medicaid Services "never event" regulations. We present propositions that speculate on how forces conceptualized from the resource dependence theory may affect adoption of patient safety innovations and, when they do, whether the adopting hospitals will do so internally or externally according to the transaction cost economics theory. On the basis of forces identified by the resource dependence theory, we predict that larger, teaching, safety net, horizontally integrated, highly interdependent, and public hospitals in concentrated, high public payer presence, competitive, and resource-rich environments will be more likely to engage in patient safety innovations. Following the logic of the transaction cost economics theory, we predict that of the hospitals that react positively to the never event regulation, most will internalize their innovations in patient safety solutions rather than approach the market, a choice that helps hospitals economize on transaction costs. This study helps hospital managers in their strategic thinking and planning in relation to current and future regulations related to patient safety. For researchers and policy analysts, our propositions provide the basis for empirical testing.

Nursing workload, patient safety incidents and mortality: an observational study from Finland

PubMed Central

Kinnunen, Marina; Saarela, Jan

2018-01-01

Objective To investigate whether the daily workload per nurse (Oulu Patient Classification (OPCq)/nurse) as measured by the RAFAELA system correlates with different types of patient safety incidents and with patient mortality, and to compare the results with regressions based on the standard patients/nurse measure. Setting We obtained data from 36 units from four Finnish hospitals. One was a tertiary acute care hospital, and the three others were secondary acute care hospitals. Participants Patients’ nursing intensity (249 123 classifications), nursing resources, patient safety incidents and patient mortality were collected on a daily basis during 1 year, corresponding to 12 475 data points. Associations between OPC/nurse and patient safety incidents or mortality were estimated using unadjusted logistic regression models, and models that adjusted for ward-specific effects, and effects of day of the week, holiday and season. Primary and secondary outcome measures Main outcome measures were patient safety incidents and death of a patient. Results When OPC/nurse was above the assumed optimal level, the adjusted odds for a patient safety incident were 1.24 (95% CI 1.08 to 1.42) that of the assumed optimal level, and 0.79 (95% CI 0.67 to 0.93) if it was below the assumed optimal level. Corresponding estimates for patient mortality were 1.43 (95% CI 1.18 to 1.73) and 0.78 (95% CI 0.60 to 1.00), respectively. As compared with the patients/nurse classification, models estimated on basis of the RAFAELA classification system generally provided larger effect sizes, greater statistical power and better model fit, although the difference was not very large. Net benefits as calculated on the basis of decision analysis did not provide any clear evidence on which measure to prefer. Conclusions We have demonstrated an association between daily workload per nurse and patient safety incidents and mortality. Current findings need to be replicated by future studies. PMID:29691240

Photobiomodulation therapy in the management of oral mucositis: search for the optimal clinical treatment parameters.

PubMed

Elad, Sharon; Arany, Praveen; Bensadoun, Rene-Jean; Epstein, Joel B; Barasch, Andrei; Raber-Durlacher, Judith

2018-05-22

This commentary attempts to clarify the setting of photobiomodulation (BPM) therapy in the management of oral mucositis. The suggested dose range balances efficacy data with our current understanding about PBM safety. The literature about the molecular basis of photobiomodulation and its controversial relationship to malignant transformation is briefly presented.

77 FR 22637 - Federal Motor Vehicle Safety Standards; Accelerator Control Systems

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-16

... severing a conductor at one location. The current language of the test procedure in FMVSS No. 124 is... routinely have variable valve lift and/or timing control. In at least one recent engine design, the level of.... Under the 2002 NPRM, a manufacturer could choose any one of the proposed test procedures as a basis for...

Scientific approach and practical experience for reconstruction of waste water treatment plants in Russia

NASA Astrophysics Data System (ADS)

Makisha, Nikolay; Gogina, Elena

2017-11-01

Protection of water bodies has a strict dependence on reliable operation of engineering systems and facilities for water supply and sewage. The majority of these plants and stations has been constructed in 1970-1980's in accordance with rules and regulations of that time. So now most of them require reconstruction due to serious physical or/and technological wear. The current condition of water supply and sewage systems and facilities frequently means a hidden source of serious danger for normal life support and ecological safety of cities and towns. The article reveals an obtained experience and modern approaches for reconstruction of waste water and sludge treatment plants that proved their efficiency even if applied in limited conditions such as area limits, investments limits. The main directions of reconstruction: overhaul repair and partial modernization of existing facilities on the basis of initial project; - restoration and modernization of existing systems on the basis on the current documents and their current condition; upgrade of waste water treatment plants (WWTPs) performance on the basis of modern technologies and methods; reconstruction of sewage systems and facilities and treatment quality improvement.

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

PubMed

Furlan, Giovanni

2012-08-01

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically required by other documents. The author has identified signal detection (intended not only as adverse event disproportionate reporting, but including non-clinical, laboratory, clinical analysis data and literature screening) and characterization as the basis for the preparation of all drug safety documents, which can be viewed as different ways of presenting the results of this activity. Therefore, the author proposes to merge all the aggregate reports required by current regulations into a single document - the Drug Safety Master File. This report should contain all the available information, from any source, regarding the potential and identified risks of a drug. It should be a living document updated and submitted to regulatory authorities on an ongoing basis.

The emotional reasoning heuristic in children.

PubMed

Muris, P; Merckelbach, H; van Spauwen, I

2003-03-01

A previous study by Arntz, Rauner, and Van den Hout (1995; Behaviour Research and Therapy, 33, 917-925) has shown that adult anxiety patients tend to infer danger not only on the basis of objective danger information, but also on the basis of anxiety response information. The current study examined whether this so-called emotional reasoning phenomenon also occurs in children. Normal primary school children (N = 101) first completed scales tapping anxiety disorders symptoms, anxiety sensitivity, and trait anxiety. Next, they were asked to rate danger levels of scripts in which objective danger versus objective safety and anxiety response versus no anxiety response were systematically varied. Evidence was found for a general emotional reasoning effect. That is, children's danger ratings were not only a function of objective danger information, but also, in the case of objective safety scripts, by anxiety response information. This emotional reasoning effect was predicted by levels of anxiety sensitivity and trait anxiety. More specifically, high levels of anxiety sensitivity and trait anxiety were accompanied by a greater tendency to use anxiety-response information as an heuristic for assessing dangerousness of safety scripts. Implications of these findings are briefly discussed.

Cyber-Informed Engineering: The Need for a New Risk Informed and Design Methodology

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

Price, Joseph Daniel; Anderson, Robert Stephen

Current engineering and risk management methodologies do not contain the foundational assumptions required to address the intelligent adversary’s capabilities in malevolent cyber attacks. Current methodologies focus on equipment failures or human error as initiating events for a hazard, while cyber attacks use the functionality of a trusted system to perform operations outside of the intended design and without the operator’s knowledge. These threats can by-pass or manipulate traditionally engineered safety barriers and present false information, invalidating the fundamental basis of a safety analysis. Cyber threats must be fundamentally analyzed from a completely new perspective where neither equipment nor human operationmore » can be fully trusted. A new risk analysis and design methodology needs to be developed to address this rapidly evolving threatscape.« less

Protection Method of Biological Lightning Safety around Power Grid Based on Grounding Electrode Structure

NASA Astrophysics Data System (ADS)

Sixiang, Chen; Daopin, Chen; Ming, Zhang; Xiao, Huang; Jian, He; Zhijie, He

2017-05-01

Aimed at the actual situation of fish death in fish ponds near the power transmission line towers after the thunderstorm happened in Guangdong Province in China, this paper studied the influence of the ground current on fish in the pond. Firstly, This paper studied the current density of the fish without protection. On this basis, paper studied the horizontal pole with full-shielded, the vertical pole with half-shielded, the horizontal pole with extension three kinds of protective measures and effects. Finally an effective protection scheme was put forward according to the engineering practice. The results can provide some engineering guidance and quantitative basis for the design and modification of grounding devices when the tower is adjacent to the fish ponds in southern China.

THE PHYSIOLOGIC BASIS OF SYMPTOMS IN ECLAMPSIA

PubMed Central

Page, Ernest W.

1949-01-01

The philosophy of treatment in eclampsia cannot rest upon the principle of combatting every symptom with many therapeutic weapons until the symptom, and occasionally the patient, fades away. It should rest rather upon assisting the maternal organism to keep its own compensatory efforts within the bounds of safety, preventing damage to vital organs where possible, and removing the cause of the disease by termination of the pregnancy whenever that may be done with safety to both mother and child. Such assistance must necessarily be based upon current understanding of the disturbances which underlie each symptom. PMID:18104713

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.

PubMed

Ponce, Rafael; Abad, Leslie; Amaravadi, Lakshmi; Gelzleichter, Thomas; Gore, Elizabeth; Green, James; Gupta, Shalini; Herzyk, Danuta; Hurst, Christopher; Ivens, Inge A; Kawabata, Thomas; Maier, Curtis; Mounho, Barbara; Rup, Bonita; Shankar, Gopi; Smith, Holly; Thomas, Peter; Wierda, Dan

2009-07-01

An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. However, approaches for incorporating this information in the interpretation of nonclinical safety studies are not clearly established. Described here are the immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation. We subscribe that immunogenicity testing strategies should be adapted to the specific needs of each therapeutic development program, and data generated from such analyses should be integrated with available clinical and anatomic pathology, pharmacokinetic, and pharmacodynamic data to properly interpret nonclinical studies.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-22

... in OTC drug monographs based on time and extent applications (TEAs). We are currently evaluating the... effectiveness of 13 active ingredients found eligible for possible addition to an OTC drug monograph via the TEA... ingredients found eligible for inclusion in an OTC drug monograph under the TEA process on the basis of...

Inter-Vehicular Ad Hoc Networks: From the Ground Truth to Algorithm Design and Testbed Architecture

ERIC Educational Resources Information Center

Giordano, Eugenio

2011-01-01

Many of the devices we interact with on a daily basis are currently equipped with wireless connectivity. Soon this will be extended to the vehicles we drive/ride every day. Wirelessly connected vehicles will form a new kind of network that will enable a wide set of innovative applications ranging from enhanced safety to entertainment. To…

[Significance of re-evaluation and development of Chinese herbal drugs].

PubMed

Gao, Yue; Ma, Zengchun; Zhang, Boli

2012-01-01

The research of new herbal drugs involves in new herbal drugs development and renew the old drugs. It is necessary to research new herbal drugs based on the theory of traditional Chinese medicine (TCM). The current development of famous TCM focuses on the manufacture process, quality control standards, material basis and clinical research. But system management of security evaluation is deficient, the relevant system for the safety assessment TCM has not been established. The causes of security problems, security risks, target organ of toxicity, weak link of safety evaluation, and ideas of safety evaluation are discussed in this paper. The toxicology research of chinese herbal drugs is necessary based on standard of good laboratory practices (GLP), the characteristic of Chinese herbal drugs is necessary to be fully integrated into safety evaluation. The safety of new drug research is necessary to be integrated throughout the entire process. Famous Chinese medicine safety research must be paid more attention in the future.

A Safety Case Approach for Deep Geologic Disposal of DOE HLW and DOE SNF in Bedded Salt - 13350

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

Sevougian, S. David; MacKinnon, Robert J.; Leigh, Christi D.

2013-07-01

The primary objective of this study is to investigate the feasibility and utility of developing a defensible safety case for disposal of United States Department of Energy (U.S. DOE) high-level waste (HLW) and DOE spent nuclear fuel (SNF) in a conceptual deep geologic repository that is assumed to be located in a bedded salt formation of the Delaware Basin [1]. A safety case is a formal compilation of evidence, analyses, and arguments that substantiate and demonstrate the safety of a proposed or conceptual repository. We conclude that a strong initial safety case for potential licensing can be readily compiled bymore » capitalizing on the extensive technical basis that exists from prior work on the Waste Isolation Pilot Plant (WIPP), other U.S. repository development programs, and the work published through international efforts in salt repository programs such as in Germany. The potential benefits of developing a safety case include leveraging previous investments in WIPP to reduce future new repository costs, enhancing the ability to effectively plan for a repository and its licensing, and possibly expediting a schedule for a repository. A safety case will provide the necessary structure for organizing and synthesizing existing salt repository science and identifying any issues and gaps pertaining to safe disposal of DOE HLW and DOE SNF in bedded salt. The safety case synthesis will help DOE to plan its future R and D activities for investigating salt disposal using a risk-informed approach that prioritizes test activities that include laboratory, field, and underground investigations. It should be emphasized that the DOE has not made any decisions regarding the disposition of DOE HLW and DOE SNF. Furthermore, the safety case discussed herein is not intended to either site a repository in the Delaware Basin or preclude siting in other media at other locations. Rather, this study simply presents an approach for accelerated development of a safety case for a potential DOE HLW and DOE SNF repository using the currently available technical basis for bedded salt. This approach includes a summary of the regulatory environment relevant to disposal of DOE HLW and DOE SNF in a deep geologic repository, the key elements of a safety case, the evolution of the safety case through the successive phases of repository development and licensing, and the existing technical basis that could be used to substantiate the safety of a geologic repository if it were to be sited in the Delaware Basin. We also discuss the potential role of an underground research laboratory (URL). (authors)« less

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

29 CFR 1975.2 - Basis of authority.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) COVERAGE OF EMPLOYERS UNDER THE WILLIAMS-STEIGER OCCUPATIONAL SAFETY AND HEALTH ACT OF 1970 § 1975.2 Basis... Occupational Safety and Health Act of 1970, is derived mainly from the Commerce Clause of the Constitution...

Authorization basis requirements comparison report

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

Brantley, W.M.

The TWRS Authorization Basis (AB) consists of a set of documents identified by TWRS management with the concurrence of DOE-RL. Upon implementation of the TWRS Basis for Interim Operation (BIO) and Technical Safety Requirements (TSRs), the AB list will be revised to include the BIO and TSRs. Some documents that currently form part of the AB will be removed from the list. This SD identifies each - requirement from those documents, and recommends a disposition for each to ensure that necessary requirements are retained when the AB is revised to incorporate the BIO and TSRs. This SD also identifies documentsmore » that will remain part of the AB after the BIO and TSRs are implemented. This document does not change the AB, but provides guidance for the preparation of change documentation.« less

Application of Framework for Integrating Safety, Security and Safeguards (3Ss) into the Design Of Used Nuclear Fuel Storage Facility

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

Badwan, Faris M.; Demuth, Scott F

Department of Energy’s Office of Nuclear Energy, Fuel Cycle Research and Development develops options to the current commercial fuel cycle management strategy to enable the safe, secure, economic, and sustainable expansion of nuclear energy while minimizing proliferation risks by conducting research and development focused on used nuclear fuel recycling and waste management to meet U.S. needs. Used nuclear fuel is currently stored onsite in either wet pools or in dry storage systems, with disposal envisioned in interim storage facility and, ultimately, in a deep-mined geologic repository. The safe management and disposition of used nuclear fuel and/or nuclear waste is amore » fundamental aspect of any nuclear fuel cycle. Integrating safety, security, and safeguards (3Ss) fully in the early stages of the design process for a new nuclear facility has the potential to effectively minimize safety, proliferation, and security risks. The 3Ss integration framework could become the new national and international norm and the standard process for designing future nuclear facilities. The purpose of this report is to develop a framework for integrating the safety, security and safeguards concept into the design of Used Nuclear Fuel Storage Facility (UNFSF). The primary focus is on integration of safeguards and security into the UNFSF based on the existing Nuclear Regulatory Commission (NRC) approach to addressing the safety/security interface (10 CFR 73.58 and Regulatory Guide 5.73) for nuclear power plants. The methodology used for adaptation of the NRC safety/security interface will be used as the basis for development of the safeguards /security interface and later will be used as the basis for development of safety and safeguards interface. Then this will complete the integration cycle of safety, security, and safeguards. The overall methodology for integration of 3Ss will be proposed, but only the integration of safeguards and security will be applied to the design of the UNFSF. The framework for integration of safeguards and security into the UNFSF will include 1) identification of applicable regulatory requirements, 2) selection of a common system that share dual safeguard and security functions, 3) development of functional design criteria and design requirements for the selected system, 4) identification and integration of the dual safeguards and security design requirements, and 5) assessment of the integration and potential benefit.« less

Flood hazard assessment for french NPPs

NASA Astrophysics Data System (ADS)

Rebour, Vincent; Duluc, Claire-Marie; Guimier, Laurent

2015-04-01

This paper presents the approach for flood hazard assessment for NPP which is on-going in France in the framework of post-Fukushima activities. These activities were initially defined considering both European "stress tests" of NPPs pursuant to the request of the European Council, and the French safety audit of civilian nuclear facilities in the light of the Fukushima Daiichi accident. The main actors in that process are the utility (EDF is, up to date, the unique NPP's operator in France), the regulatory authority (ASN) and its technical support organization (IRSN). This paper was prepared by IRSN, considering official positions of the other main actors in the current review process, it was not officially endorsed by them. In France, flood hazard to be considered for design basis definition (for new NPPs and for existing NPPs in periodic safety reviews conducted every 10 years) was revised before Fukushima-Daichi accident, due to le Blayais NPP December 1999 experience (partial site flooding and loss of some safety classified systems). The paper presents in the first part an overview of the revised guidance for design basis flood. In order to address design extension conditions (conditions that could result from natural events exceeding the design basis events), a set of flooding scenarios have been defined by adding margins on the scenarios that are considered for the design. Due to the diversity of phenomena to be considered for flooding hazard, the margin assessment is specific to each flooding scenario in terms of parameter to be penalized and of degree of variation of this parameter. The general approach to address design extension conditions is presented in the second part of the paper. The next parts present the approach for five flooding scenarios including design basis scenario and additional margin to define design extension scenarios.

The Official Control beyond the Official Control. How To Plan And Schedule Controls Starting From Risk Assessment Along The Agro-Food Supply Chain.

PubMed

Panunzio, M F; Caporizzi, R; Lagravinese, D; Conversano, M

2015-01-01

Every year the Italian Ministry of Health, on the basis of regional data, draws up the "Report on Official Controls" to be submitted to the Parliament. The report contains abundant data, diagrams and charts and illustrates the number and type of official controls (OC) performed by the pertinent Bodies (Ministry of Health, Regional and Local Health Authorities) over the previous year on Food Business Operators (FBO), in accordance with the EC Regulation 882/2004. The trend - which has consolidated over the years - relates to the multiplicity of OC and shows a decrease of such controls compared to an increase in "non-conformities". OC frequency is established by the Regional Authorities on the basis of the categorisation of both a "generic risk" for companies calculated taking into account the probability of occurrence of a "non-conformity", and a "specific" risk, assessed on the basis of the results of the OC actually performed on a given "Operatore del Settore Alimentare" (Food Sector Operator, in Italian: OSA). Thus, categorisation (i.e. the probability of occurrence of non-conformities) is the main driver of the OC scheduling and planning process. We have been asking ourselves whether the current OC planning/scheduling method is still suitable for ensuring food safety in the face of internalisation of the food supply chain. As a matter of fact, food safety is now becoming increasingly variable due to the globalization of consumption where "farm to fork", rather than "border to fork", food safety must be ensured. On the basis of these considerations, a different OC planning /scheduling method is being proposed based on the assessment of risks and the estimation of the occurrence of the same along the agro-food chain.

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.

Inside the black box: current policies and concerns with the United States Food and Drug Administration's highest drug safety warning system.

PubMed

Halloran, Kylene; Barash, Paul G

2010-06-01

To evaluate the United States Food and Drug Administration use of the black-box warning system to promote drug safety and to examine the droperidol black-box warning as a case study. Scientific studies report that there is no basis to issue a black-box warning for perioperative administration of droperidol for postoperative nausea and vomiting on the basis of the potential of adverse cardiac events (prolongation of the QT interval and/or development of torsades de pointes). Rather than relying on well conducted clinical investigations, the Food and Drug Administration subjectively issued a black-box warning to droperidol, which effectively removed droperidol from clinical practice for the indication of postoperative nausea and vomiting. Newer data suggest that the incidence of prolongation of the QT interval and the occurrence of torsades de pointes is similar to more expensive alternative medications used to treat postoperative nausea and vomiting.

How can we improve our understanding of cardiovascular safety liabilities to develop safer medicines?

PubMed Central

Laverty, HG; Benson, C; Cartwright, EJ; Cross, MJ; Garland, C; Hammond, T; Holloway, C; McMahon, N; Milligan, J; Park, BK; Pirmohamed, M; Pollard, C; Radford, J; Roome, N; Sager, P; Singh, S; Suter, T; Suter, W; Trafford, A; Volders, PGA; Wallis, R; Weaver, R; York, M; Valentin, JP

2011-01-01

Given that cardiovascular safety liabilities remain a major cause of drug attrition during preclinical and clinical development, adverse drug reactions, and post-approval withdrawal of medicines, the Medical Research Council Centre for Drug Safety Science hosted a workshop to discuss current challenges in determining, understanding and addressing ‘Cardiovascular Toxicity of Medicines’. This article summarizes the key discussions from the workshop that aimed to address three major questions: (i) what are the key cardiovascular safety liabilities in drug discovery, drug development and clinical practice? (ii) how good are preclinical and clinical strategies for detecting cardiovascular liabilities? and (iii) do we have a mechanistic understanding of these liabilities? It was concluded that in order to understand, address and ultimately reduce cardiovascular safety liabilities of new therapeutic agents there is an urgent need to: Fully characterize the incidence, prevalence and impact of drug-induced cardiovascular issues at all stages of the drug development process. Ascertain the predictive value of existing non-clinical models and assays towards the clinical outcome. Understand the mechanistic basis of cardiovascular liabilities; by addressing areas where it is currently not possible to predict clinical outcome based on preclinical safety data. Provide scientists in all disciplines with additional skills to enable them to better integrate preclinical and clinical data and to better understand the biological and clinical significance of observed changes. Develop more appropriate, highly relevant and predictive tools and assays to identify and wherever feasible to eliminate cardiovascular safety liabilities from molecules and wherever appropriate to develop clinically relevant and reliable safety biomarkers. PMID:21306581

10 CFR 830.201 - Performance of work.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Performance of work. 830.201 Section 830.201 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.201 Performance of work. A contractor must perform work in accordance with the safety basis for a hazard category 1, 2, or 3 DOE nuclear...

Insights on in vitro models for safety and toxicity assessment of cosmetic ingredients.

PubMed

Almeida, Andreia; Sarmento, Bruno; Rodrigues, Francisca

2017-03-15

According to the current European legislation, the safety assessment of each individual cosmetic ingredient of any formulation is the basis for the safety evaluation of a cosmetic product. Also, animal testing in the European Union is prohibited for cosmetic ingredients and products since 2004 and 2009, respectively. Additionally, the commercialization of any cosmetic products containing ingredients tested on animal models was forbidden in 2009. In consequence of these boundaries, the European Centre for the Validation of Alternative Methods (ECVAM) proposes a list of validated cell-based in vitro models for predicting the safety and toxicity of cosmetic ingredients. These models have been demonstrated as valuable and effective tools to overcome the limitations of animal in vivo studies. Although the use of in vitro cell-based models for the evaluation of absorption and permeability of cosmetic ingredients is widespread, a detailed study on the properties of these platforms and the in vitro-in vivo correlation compared with human data are required. Moreover, additional efforts must be taken to develop in vitro models to predict carcinogenicity, repeat dose toxicity and reproductive toxicity, for which no alternative in vitro methods are currently available. This review paper summarizes and characterizes the most relevant in vitro models validated by ECVAM employed to predict the safety and toxicology of cosmetic ingredients. Copyright © 2017 Elsevier B.V. All rights reserved.

Canister Storage Building (CSB) Design Basis Accident Analysis Documentation

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

CROWE, R.D.; PIEPHO, M.G.

2000-03-23

This document provided the detailed accident analysis to support HNF-3553, Spent Nuclear Fuel Project Final Safety Analysis Report, Annex A, ''Canister Storage Building Final Safety Analysis Report''. All assumptions, parameters, and models used to provide the analysis of the design basis accidents are documented to support the conclusions in the Canister Storage Building Final Safety Analysis Report.

NASA safety program activities in support of the Space Exploration Initiatives Nuclear Propulsion program

NASA Technical Reports Server (NTRS)

Sawyer, J. C., Jr.

1993-01-01

The activities of the joint NASA/DOE/DOD Nuclear Propulsion Program Technical Panels have been used as the basis for the current development of safety policies and requirements for the Space Exploration Initiatives (SEI) Nuclear Propulsion Technology development program. The Safety Division of the NASA Office of Safety and Mission Quality has initiated efforts to develop policies for the safe use of nuclear propulsion in space through involvement in the joint agency Nuclear Safety Policy Working Group (NSPWG), encouraged expansion of the initial policy development into proposed programmatic requirements, and suggested further expansion into the overall risk assessment and risk management process for the NASA Exploration Program. Similar efforts are underway within the Department of Energy to ensure the safe development and testing of nuclear propulsion systems on Earth. This paper describes the NASA safety policy related to requirements for the design of systems that may operate where Earth re-entry is a possibility. The expected plan of action is to support and oversee activities related to the technology development of nuclear propulsion in space, and support the overall safety and risk management program being developed for the NASA Exploration Program.

[Establishment and application of "multi-dimensional structure and process dynamic quality control technology system" in preparation products of traditional Chinese medicine (I)].

PubMed

Gu, Jun-Fei; Feng, Liang; Zhang, Ming-Hua; Wu, Chan; Jia, Xiao-Bin

2013-11-01

Safety is an important component of the quality control of traditional Chinese medicine (TCM) preparation products, as well as an important guarantee for clinical application. Currently, the quality control of TCMs in Chinese Pharmacopoeia mostly focuses on indicative compounds for TCM efficacy. TCM preparations are associated with multiple links, from raw materials to products, and each procedure may have impacts on the safety of preparation. We make a summary and analysis on the factors impacting safety during the preparation of TCM products, and then expound the important role of the "multi-dimensional structure and process dynamic quality control technology system" in the quality safety of TCM preparations. Because the product quality of TCM preparation is closely related to the safety, the control over safety-related material basis is an important component of the product quality control of TCM preparations. The implementation of the quality control over the dynamic process of TCM preparations from raw materials to products, and the improvement of the TCM quality safety control at the microcosmic level help lay a firm foundation for the development of the modernization process of TCM preparations.

Management of hidradenitis suppurativa in pregnancy.

PubMed

Perng, Powell; Zampella, John G; Okoye, Ginette A

2017-05-01

Hidradenitis suppurativa is a debilitating inflammatory skin disease with a chronic course and often disappointing response to treatment. Though a minority of persons (20%) reports symptom remission during pregnancy, the vast majority experiences no relief (72%), and few experience clinical deterioration (8%). Disease flares are also observed post-partum. The pathophysiological basis for pregnancy-associated fluctuations in clinical status is currently unknown. Because most women with HS require ongoing management throughout pregnancy, it is important to evaluate the suitability and safety of current treatment options for pregnant women. The following review will outline current management strategies for HS and their compatibility with pregnancy and lactation. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Final report on the safety assessment of sodium cetearyl sulfate and related alkyl sulfates as used in cosmetics.

PubMed

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

2010-05-01

Sodium cetearyl sulfate is the sodium salt of a mixture of cetyl and stearyl sulfate. The other ingredients in this safety assessment are also alkyl salts, including ammonium coco-sulfate, ammonium myristyl sulfate, magnesium coco-sulfate, sodium cetyl sulfate, sodium coco/hydrogenated tallow sulfate, sodium coco-sulfate, sodium decyl sulfate, sodium ethylhexyl sulfate, sodium myristyl sulfate, sodium oleyl sulfate, sodium stearyl sulfate, sodium tallow sulfate, sodium tridecyl sulfate, and zinc coco-sulfate. These ingredients are surfactants used at concentrations from 0.1% to 29%, primarily in soaps and shampoos. Many of these ingredients are not in current use. The Cosmetic Ingredient Review (CIR) Expert Panel previously completed a safety assessment of sodium and ammonium lauryl sulfate. The data available for sodium lauryl sulfate and ammonium lauryl sulfate provide sufficient basis for concluding that sodium cetearyl sulfate and related alkyl sulfates are safe in the practices of use and concentration described in the safety assessment.

Nighttime approaches to offshore installations in Brazil: Safety shortcomings experienced by helicopter pilots.

PubMed

Nascimento, Felipe A C; Majumdar, Arnab; Jarvis, Steve

2012-07-01

Accident rates for night sorties by helicopters traveling to offshore oil and gas platforms are at least five times higher than those during the daytime. Because pilots need to transition from automated flight to a manually flown night visual segment during arrival, the approach and landing phases cause great concern. Despite this, in Brazil, regulatory changes have been sought to allow for the execution of offshore night flights because of the rapid expansion of the petroleum industry. This study explores the factors that affect safety during night visual segments in Brazil using 28 semi-structured interviews with offshore helicopter pilots, followed by a template analysis of the narratives. The relationships among the factors suggest that flawed safety oversights, caused by a combination of lack of infrastructure for night flights offshore and declining training, currently favor spatial disorientation on the approach and near misses when close to the destination. Safety initiatives can be derived on the basis of these results. Copyright © 2012 Elsevier Ltd. All rights reserved.

Relative effectiveness of worker safety and health training methods.

PubMed

Burke, Michael J; Sarpy, Sue Ann; Smith-Crowe, Kristin; Chan-Serafin, Suzanne; Salvador, Rommel O; Islam, Gazi

2006-02-01

We sought to determine the relative effectiveness of different methods of worker safety and health training aimed at improving safety knowledge and performance and reducing negative outcomes (accidents, illnesses, and injuries). Ninety-five quasi-experimental studies (n=20991) were included in the analysis. Three types of intervention methods were distinguished on the basis of learners' participation in the training process: least engaging (lecture, pamphlets, videos), moderately engaging (programmed instruction, feedback interventions), and most engaging (training in behavioral modeling, hands-on training). As training methods became more engaging (i.e., requiring trainees' active participation), workers demonstrated greater knowledge acquisition, and reductions were seen in accidents, illnesses, and injuries. All methods of training produced meaningful behavioral performance improvements. Training involving behavioral modeling, a substantial amount of practice, and dialogue is generally more effective than other methods of safety and health training. The present findings challenge the current emphasis on more passive computer-based and distance training methods within the public health workforce.

Relative Effectiveness of Worker Safety and Health Training Methods

PubMed Central

Burke, Michael J.; Sarpy, Sue Ann; Smith-Crowe, Kristin; Chan-Serafin, Suzanne; Salvador, Rommel O.; Islam, Gazi

2006-01-01

Objectives. We sought to determine the relative effectiveness of different methods of worker safety and health training aimed at improving safety knowledge and performance and reducing negative outcomes (accidents, illnesses, and injuries). Methods. Ninety-five quasi-experimental studies (n=20991) were included in the analysis. Three types of intervention methods were distinguished on the basis of learners’ participation in the training process: least engaging (lecture, pamphlets, videos), moderately engaging (programmed instruction, feedback interventions), and most engaging (training in behavioral modeling, hands-on training). Results. As training methods became more engaging (i.e., requiring trainees’ active participation), workers demonstrated greater knowledge acquisition, and reductions were seen in accidents, illnesses, and injuries. All methods of training produced meaningful behavioral performance improvements. Conclusions. Training involving behavioral modeling, a substantial amount of practice, and dialogue is generally more effective than other methods of safety and health training. The present findings challenge the current emphasis on more passive computer-based and distance training methods within the public health workforce. PMID:16380566

Safety aspects of nuclear waste disposal in space

NASA Technical Reports Server (NTRS)

Rice, E. E.; Edgecombe, D. S.; Compton, P. R.

1981-01-01

Safety issues involved in the disposal of nuclear wastes in space as a complement to mined geologic repositories are examined as part of an assessment of the feasibility of nuclear waste disposal in space. General safety guidelines for space disposal developed in the areas of radiation exposure and shielding, containment, accident environments, criticality, post-accident recovery, monitoring systems and isolation are presented for a nuclear waste disposal in space mission employing conventional space technology such as the Space Shuttle. The current reference concept under consideration by NASA and DOE is then examined in detail, with attention given to the waste source and mix, the waste form, waste processing and payload fabrication, shipping casks and ground transport vehicles, launch site operations and facilities, Shuttle-derived launch vehicle, orbit transfer vehicle, orbital operations and space destination, and the system safety aspects of the concept are discussed for each component. It is pointed out that future work remains in the development of an improved basis for the safety guidelines and the determination of the possible benefits and costs of the space disposal option for nuclear wastes.

Criticality Safety Evaluations on the Use of 200-gram Pu Mass Limit for RHWM Waste Storage Operations

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

Chou, P

This work establishes the criticality safety technical basis to increase the fissile mass limit from 120 grams to 200 grams for Type A 55-gallon drums and their equivalents. Current RHWM fissile mass limit is 120 grams Pu for Type A 55-gallon containers and their equivalent. In order to increase the Type A 55-gallon drum limit to 200 grams, a few additional criticality safety control requirements are needed on moderators, reflectors, and array controls to ensure that the 200-gram Pu drums remain criticality safe with inadvertent criticality remains incredible. The purpose of this work is to analyze the use of 200-grammore » Pu drum mass limit for waste storage operations in Radioactive and Hazardous Waste Management (RHWM) Facilities. In this evaluation, the criticality safety controls associated with the 200-gram Pu drums are established for the RHWM waste storage operations. With the implementation of these criticality safety controls, the 200-gram Pu waste drum storage operations are demonstrated to be criticality safe and meet the double-contingency-principle requirement per DOE O 420.1.« less

Safety analysis report for the Waste Storage Facility. Revision 2

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

Bengston, S.J.

1994-05-01

This safety analysis report outlines the safety concerns associated with the Waste Storage Facility located in the Radioactive Waste Management Complex at the Idaho National Engineering Laboratory. The three main objectives of the report are: define and document a safety basis for the Waste Storage Facility activities; demonstrate how the activities will be carried out to adequately protect the workers, public, and environment; and provide a basis for review and acceptance of the identified risk that the managers, operators, and owners will assume.

Vaccine safety monitoring systems in developing countries: an example of the Vietnam model.

PubMed

Ali, Mohammad; Rath, Barbara; Thiem, Vu Dinh

2015-01-01

Only few health intervention programs have been as successful as vaccination programs with respect to preventing morbidity and mortality in developing countries. However, the success of a vaccination program is threatened by rumors and misunderstanding about the risks of vaccines. It is short-sighted to plan the introduction of vaccines into developing countries unless effective vaccine safety monitoring systems are in place. Such systems that track adverse events following immunization (AEFI) is currently lacking in most developing countries. Therefore, any rumor may affect the entire vaccination program. Public health authorities should implement the safety monitoring system of vaccines, and disseminate safety issues in a proactive mode. Effective safety surveillance systems should allow for the conduct of both traditional and alternative epidemiologic studies through the use of prospective data sets. The vaccine safety data link implemented in Vietnam in mid-2002 indicates that it is feasible to establish a vaccine safety monitoring system for the communication of vaccine safety in developing countries. The data link provided the investigators an opportunity to evaluate AEFI related to measles vaccine. Implementing such vaccine safety monitoring system is useful in all developing countries. The system should be able to make objective and clear communication regarding safety issues of vaccines, and the data should be reported to the public on a regular basis for maintaining their confidence in vaccination programs.

Minutes of the Explosives Safety Seminar (25). Volume 4. Held in Anaheim, California on 18-20 Aug 1992

DTIC Science & Technology

1992-08-01

reaction process ; - sensitivity versus damage (vivacity, specific surface, porosity, density variation). So, most of the experimental tests need to...the later mapping process would form a better basis for compliance with published requirementsi I than the current approach. Seytion Summary It takes... Processing of Explosives, Propellants and Ingredients, AIIPA, San Diego, (’alif. April 1991. 49. W.11I. Andersen and N.A. Louie, " Projectile Impact Ignition

Nuclear criticality safety calculational analysis for small-diameter containers

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

LeTellier, M.S.; Smallwood, D.J.; Henkel, J.A.

This report documents calculations performed to establish a technical basis for the nuclear criticality safety of favorable geometry containers, sometimes referred to as 5-inch containers, in use at the Portsmouth Gaseous Diffusion Plant. A list of containers currently used in the plant is shown in Table 1.0-1. These containers are currently used throughout the plant with no mass limits. The use of containers with geometries or material types other than those addressed in this evaluation must be bounded by this analysis or have an additional analysis performed. The following five basic container geometries were modeled and bound all container geometriesmore » in Table 1.0-1: (1) 4.32-inch-diameter by 50-inch-high polyethylene bottle; (2) 5.0-inch-diameter by 24-inch-high polyethylene bottle; (3) 5.25-inch-diameter by 24-inch-high steel can ({open_quotes}F-can{close_quotes}); (4) 5.25-inch-diameter by 15-inch-high steel can ({open_quotes}Z-can{close_quotes}); and (5) 5.0-inch-diameter by 9-inch-high polybottle ({open_quotes}CO-4{close_quotes}). Each container type is evaluated using five basic reflection and interaction models that include single containers and multiple containers in normal and in credible abnormal conditions. The uranium materials evaluated are UO{sub 2}F{sub 2}+H{sub 2}O and UF{sub 4}+oil materials at 100% and 10% enrichments and U{sub 3}O{sub 8}, and H{sub 2}O at 100% enrichment. The design basis safe criticality limit for the Portsmouth facility is k{sub eff} + 2{sigma} < 0.95. The KENO study results may be used as the basis for evaluating general use of these containers in the plant.« less

Thermal-hydraulic analysis capabilities and methods development at NYPA

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

Feltus, M.A.

1987-01-01

The operation of a nuclear power plant must be regularly supported by various thermal-hydraulic (T/H) analyses that may include final safety analysis report (FSAR) design basis calculations and licensing evaluations and conservative and best-estimate analyses. The development of in-house T/H capabilities provides the following advantages: (a) it leads to a better understanding of the plant design basis and operating characteristics; (b) methods developed can be used to optimize plant operations and enhance plant safety; (c) such a capability can be used for design reviews, checking vendor calculations, and evaluating proposed plant modifications; and (d) in-house capability reduces the cost ofmore » analysis. This paper gives an overview of the T/H capabilities and current methods development activity within the engineering department of the New York Power Authority (NYPA) and will focus specifically on reactor coolant system (RCS) transients and plant dynamic response for non-loss-of-coolant accident events. This paper describes NYPA experience in performing T/H analyses in support of pressurized water reactor plant operation.« less

A Qualitative Assessment of Current CCF Guidance Based on a Review of Safety System Digital Implementation Changes with Evolving Technology

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

Korsah, Kofi; Muhlheim, Michael David; Wood, Richard

The US Nuclear Regulatory Commission (NRC) is initiating a new rulemaking project to develop a digital system common-cause failure (CCF) rule. This rulemaking will review and modify or affirm the NRC's current digital system CCF policy as discussed in the Staff Requirements Memorandum to the Secretary of the Commission, Office of the NRC (SECY) 93-087, Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light Water Reactor (ALWR) Designs, and Branch Technical Position (BTP) 7-19, Guidance on Evaluation of Defense-in-Depth and Diversity in Digital Computer-Based Instrumentation and Control Systems, as well as Chapter 7, Instrumentation and Controls, in NRCmore » Regulatory Guide (NUREG)-0800, Standard Review Plan for Review of Safety Analysis Reports for Nuclear Power Plants (ML033580677). The Oak Ridge National Laboratory (ORNL) is providing technical support to the NRC staff on the CCF rulemaking, and this report is one of several providing the technical basis to inform NRC staff members. For the task described in this report, ORNL examined instrumentation and controls (I&C) technology implementations in nuclear power plants in the light of current CCF guidance. The intent was to assess whether the current position on CCF is adequate given the evolutions in digital safety system implementations and, if gaps in the guidance were found, to provide recommendations as to how these gaps could be closed.« less

Development a Comprehensive Food Safety System in Serbia- A Narrative Review Article

PubMed Central

RADOVIĆ, Vesela; KEKOVIĆ, Zoran; AGIĆ, Samir

2014-01-01

Abstract Background Food safety issues are not a new issue in science, but due to the dynamic changes in the modern world it is as equally important as decades ago. The aim of the study was to address the efforts in the development of a comprehensive food safety system in Serbia, and make specific recommendations regarding the improvement of epidemiological investigation capacity as a useful tool which contributes to improving the public health by joint efforts of epidemiologists and law enforcement. Methods We used the methodology appropriate for social sciences. Results The findings show the current state-of-affairs in the area of food safety and health care system and present some most important weaknesses which have to be overcome. Policy makers need timely and reliable information so that they can make informed decisions to improve the population health in an ongoing process of seeking full membership in the European Union. Conclusion Serbia has to apply significant changes in practice because the current state-of-affairs in the area of food safety and health care system is not so favourable due to numerous both objective and subjective factors. Hence, the policy-makers must work on the development of epidemiological investigation capacities as a firm basis for greater efficiency and effectiveness. Epidemiologists would not stay alone in their work. Law enforcement as well as many other stakeholders should recognize their new role in the process of the development of epidemiological investigation capacity as a tool for the development of a comprehensive food safety system in Serbia. PMID:25909057

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2011 CFR

2011-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2011-10-01 2011-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2014 CFR

2014-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2014-10-01 2014-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2013 CFR

2013-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2013-10-01 2013-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2012 CFR

2012-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2012-10-01 2012-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

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

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

Curtis Smith; Diego Mandelli

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

Application of elements of microbiological risk assessment in the food industry via a tiered approach.

PubMed

van Gerwen, Suzanne J C; Gorris, Leon G M

2004-09-01

Food safety control is a matter for concern for all parts of the food supply chain, including governments that develop food safety policy, food industries that must control potential hazards, and consumers who need to keep to the intended use of the food. In the future, food safety policy may be set using the framework of risk analysis, part of which is the development of (inter)national microbiological risk assessment (MRA) studies. MRA studies increase our understanding of the impact of risk management interventions and of the relationships among subsequent parts of food supply chains with regard to the safety of the food when it reaches the consumer. Application of aspects of MRA in the development of new food concepts has potential benefits for the food industry. A tiered approach to applying MRA can best realize these benefits. The tiered MRA approach involves calculation of microbial fate for a product and process design on the basis of experimental data (e.g., monitoring data on prevalence) and predictive microbiological models. Calculations on new product formulations and novel processing technologies provide improved understanding of microbial fate beyond currently known boundaries, which enables identification of new opportunities in process design. The outcome of the tiered approach focuses on developing benchmarks of potential consumer exposure to hazards associated with new products by comparison with exposure associated with products that are already on the market and have a safe history of use. The tiered prototype is a tool to be used by experienced microbiologists as a basis for advice to product developers and can help to make safety assurance for new food concepts transparent to food inspection services.

[Current status of cadmium exposure among Japanese, especially regarding the safety standard for cadmium concentration in rice and adverse effects on proximal renal tubular function observed in farmers exposed to cadmium through consumption of self-grown rice].

PubMed

Horiguchi, Hyogo

2012-01-01

Because the staple food in Japan is rice, which absorbs cadmium (Cd) from the soil efficiently, rice is the main source of exposure to Cd in the Japanese population. In addition, there have been many Cd-contaminated farming areas in Japan. Therefore, a safety standard for the Cd concentration in rice was set as 0.4 ppm by the Japanese government. This safety standard has been followed for decades without any appropriate scientific or legal basis. However, recent epidemiological studies of female Japanese farmers exposed to Cd through self-grown rice, that is, a series of Japanese Multi-centered Environmental Toxicant Study (JMETS), showed evidence that the safety standard is appropriate. Therefore, general Japanese consumers are unlikely exposed to Cd excessively with the application of this safety standard, considering the trend of decreasing amount of rice consumed among the Japanese population. On the other hand, Japanese farmers were found to be at risk of Cd exposure through the consumption of self-grown rice with a high Cd concentration. Actually, the JMETS showed that female farmers at 70 years of age or older had a decreased proximal renal tubular function due to the high renal accumulation of Cd. On the basis of these findings, "medical examinations for Cd exposure" have recently been implemented for farmers residing in Cd-polluted areas in northern Japan. Because it has been estimated that such Cd-polluted areas are actually larger, it is necessary to implement medical examinations of more farmers there, particularly the elderly.

Development of an effective risk management system in a teaching hospital.

PubMed

Adibi, Hossein; Khalesi, Nader; Ravaghi, Hamid; Jafari, Mahdi; Jeddian, Ali Reza

2012-09-21

Unsafe health care provision is a main cause of increased mortality rate amongst hospitalized patients all over the world. A system approach to medical error and its reduction is crucial that is defined by clinical and administrative activities undertaken to identify, evaluate, and reduce the risk of injury. The aim of this study was to develop and implement a risk management system in a large teaching hospital in Iran, especially of the basis of WHO guidelines and patient safety context. WHO draft guideline and patient safety reports from different countries were reviewed for defining acceptable framework of risk management system. Also current situation of mentioned hospital in safety matter and dimensions of patient safety culture was evaluated using HSOPSC questionnaire of AHRQ. With adjustment of guidelines and hospital status, the conceptual framework was developed and next it was validated in expert panel. The members of expert panel were selected according to their role and functions and also their experiences in risk management and patient safety issues. The validated framework consisted of designating a leader and coordinator core, defining communications, and preparing the infrastructure for patient safety education and culture-building. That was developed on the basis of some values and commitments and included reactive and proactive approaches. The findings of reporting activities demonstrated that at least 3.6 percent of hospitalized patients have experienced adverse events and 5.3 percent of all deaths in the hospital related with patient safety problems. Beside the average score of 12 dimensions of patient safety culture was 46.2 percent that was considerably low. The "non-punitive responses to error" had lowest positive score with 21.2 percent. It is of paramount importance for all health organizations to lay necessary foundations in order to identify safety risks and improve the quality of care. Inadequate participation of staff in education, reporting and analyzing, underreporting and uselessness of aggregated data, limitation of human and financial resources, punitive directions and management challenges for solutions were the main executive problems which could affect the effectiveness of system.

Implementation of Recommendations from the One System Comparative Evaluation of the Hanford Tank Farms and Waste Treatment Plant Safety Bases

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

Garrett, Richard L.; Niemi, Belinda J.; Paik, Ingle K.

2013-11-07

A Comparative Evaluation was conducted for One System Integrated Project Team to compare the safety bases for the Hanford Waste Treatment and Immobilization Plant Project (WTP) and Tank Operations Contract (TOC) (i.e., Tank Farms) by an Expert Review Team. The evaluation had an overarching purpose to facilitate effective integration between WTP and TOC safety bases. It was to provide One System management with an objective evaluation of identified differences in safety basis process requirements, guidance, direction, procedures, and products (including safety controls, key safety basis inputs and assumptions, and consequence calculation methodologies) between WTP and TOC. The evaluation identified 25more » recommendations (Opportunities for Integration). The resolution of these recommendations resulted in 16 implementation plans. The completion of these implementation plans will help ensure consistent safety bases for WTP and TOC along with consistent safety basis processes. procedures, and analyses. and should increase the likelihood of a successful startup of the WTP. This early integration will result in long-term cost savings and significant operational improvements. In addition, the implementation plans lead to the development of eight new safety analysis methodologies that can be used at other U.S. Department of Energy (US DOE) complex sites where URS Corporation is involved.« less

Variable dynamic testbed vehicle : safety plan

DOT National Transportation Integrated Search

1997-02-01

This safety document covers the entire safety process from inception to delivery of the Variable Dynamic Testbed Vehicle. In addition to addressing the process of safety on the vehicle , it should provide a basis on which to build future safety proce...

A qualitative exploration of the perceptions and information needs of public health inspectors responsible for food safety

PubMed Central

2010-01-01

Background In Ontario, local public health inspectors play an important frontline role in protecting the public from foodborne illness. This study was an in-depth exploration of public health inspectors' perceptions of the key food safety issues in public health, and their opinions and needs with regards to food safety information resources. Methods Four focus group discussions were conducted with public health inspectors from the Central West region of Ontario, Canada during June and July, 2008. A questioning route was used to standardize qualitative data collection. Audio recordings of sessions were transcribed verbatim and data-driven content analysis was performed. Results A total of 23 public health inspectors participated in four focus group discussions. Five themes emerged as key food safety issues: time-temperature abuse, inadequate handwashing, cross-contamination, the lack of food safety knowledge by food handlers and food premise operators, and the lack of food safety information and knowledge about specialty foods (i.e., foods from different cultures). In general, participants reported confidence with their current knowledge of food safety issues and foodborne pathogens. Participants highlighted the need for a central source for food safety information, access to up-to-date food safety information, resources in different languages, and additional food safety information on specialty foods. Conclusions The information gathered from these focus groups can provide a basis for the development of resources that will meet the specific needs of public health inspectors involved in protecting and promoting food safety. PMID:20553592

Fundamentals of health risk assessment. Use, derivation, validity and limitations of safety indices.

PubMed

Putzrath, R M; Wilson, J D

1999-04-01

We investigated the way results of human health risk assessments are used, and the theory used to describe those methods, sometimes called the "NAS paradigm." Contrary to a key tenet of that theory, current methods have strictly limited utility. The characterizations now considered standard, Safety Indices such as "Acceptable Daily Intake," "Reference Dose," and so on, usefully inform only decisions that require a choice between two policy alternatives (e.g., approve a food additive or not), decided solely on the basis of a finding of safety. Risk is characterized as the quotient of one of these Safety Indices divided by an estimate of exposure: a quotient greater than one implies that the situation may be considered safe. Such decisions are very widespread, both in the U.S. federal government and elsewhere. No current method is universal; different policies lead to different practices, for example, in California's "Proposition 65," where statutory provisions specify some practices. Further, an important kind of human health risk assessment is not recognized by this theory: this kind characterizes risk as likelihood of harm, given estimates of exposure consequent to various decision choices. Likelihood estimates are necessary whenever decision makers have many possible decision choices and must weigh more than two societal values, such as in EPA's implementation of "conventional air pollutants." These estimates can not be derived using current methods; different methods are needed. Our analysis suggests changes needed in both the theory and practice of human health risk assessment, and how what is done is depicted.

10 CFR 830.205 - Technical safety requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... must: (1) Develop technical safety requirements that are derived from the documented safety analysis... 10 Energy 4 2010-01-01 2010-01-01 false Technical safety requirements. 830.205 Section 830.205 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.205 Technical...

10 CFR 830.205 - Technical safety requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... must: (1) Develop technical safety requirements that are derived from the documented safety analysis... 10 Energy 4 2011-01-01 2011-01-01 false Technical safety requirements. 830.205 Section 830.205 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.205 Technical...

Predicting Time Series Outputs and Time-to-Failure for an Aircraft Controller Using Bayesian Modeling

NASA Technical Reports Server (NTRS)

He, Yuning

2015-01-01

Safety of unmanned aerial systems (UAS) is paramount, but the large number of dynamically changing controller parameters makes it hard to determine if the system is currently stable, and the time before loss of control if not. We propose a hierarchical statistical model using Treed Gaussian Processes to predict (i) whether a flight will be stable (success) or become unstable (failure), (ii) the time-to-failure if unstable, and (iii) time series outputs for flight variables. We first classify the current flight input into success or failure types, and then use separate models for each class to predict the time-to-failure and time series outputs. As different inputs may cause failures at different times, we have to model variable length output curves. We use a basis representation for curves and learn the mappings from input to basis coefficients. We demonstrate the effectiveness of our prediction methods on a NASA neuro-adaptive flight control system.

System theory and safety models in Swedish, UK, Dutch and Australian road safety strategies.

PubMed

Hughes, B P; Anund, A; Falkmer, T

2015-01-01

Road safety strategies represent interventions on a complex social technical system level. An understanding of a theoretical basis and description is required for strategies to be structured and developed. Road safety strategies are described as systems, but have not been related to the theory, principles and basis by which systems have been developed and analysed. Recently, road safety strategies, which have been employed for many years in different countries, have moved to a 'vision zero', or 'safe system' style. The aim of this study was to analyse the successful Swedish, United Kingdom and Dutch road safety strategies against the older, and newer, Australian road safety strategies, with respect to their foundations in system theory and safety models. Analysis of the strategies against these foundations could indicate potential improvements. The content of four modern cases of road safety strategy was compared against each other, reviewed against scientific systems theory and reviewed against types of safety model. The strategies contained substantial similarities, but were different in terms of fundamental constructs and principles, with limited theoretical basis. The results indicate that the modern strategies do not include essential aspects of systems theory that describe relationships and interdependencies between key components. The description of these strategies as systems is therefore not well founded and deserves further development. Copyright © 2014 Elsevier Ltd. All rights reserved.

Discussion on the Criterion for the Safety Certification Basis Compilation - Brazilian Space Program Case

NASA Astrophysics Data System (ADS)

Niwa, M.; Alves, N. C.; Caetano, A. O.; Andrade, N. S. O.

2012-01-01

The recent advent of the commercial launch and re- entry activities, for promoting the expansion of human access to space for tourism and hypersonic travel, in the already complex ambience of the global space activities, brought additional difficulties over the development of a harmonized framework of international safety rules. In the present work, with the purpose of providing some complementary elements for global safety rule development, the certification-related activities conducted in the Brazilian space program are depicted and discussed, focusing mainly on the criterion for certification basis compilation. The results suggest that the composition of a certification basis with the preferential use of internationally-recognized standards, as is the case of ISO standards, can be a first step toward the development of an international safety regulation for commercial space activities.

10 CFR 830.204 - Documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Documented safety analysis. 830.204 Section 830.204 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.204 Documented safety analysis... approval from DOE for the methodology used to prepare the documented safety analysis for the facility...

Impact of IgG Fc-Oligosaccharides on Recombinant Monoclonal Antibody Structure, Stability, Safety, and Efficacy.

PubMed

Liu, Hongcheng; Nowak, Christine; Andrien, Bruce; Shao, Mei; Ponniah, Gomathinayagam; Neill, Alyssa

2017-09-01

Glycosylation of the conserved asparagine residue in the CH2 domain is the most common posttranslational modification of recombinant monoclonal antibodies. Ideally, a consistent oligosaccharide profile should be maintained from early clinical material to commercial material for the development of recombinant monoclonal therapeutics, though variation in the profile is a typical result of process changes. The risk of oligosaccharide variation posed to further development is required to be thoroughly evaluated based on its impact on antibody structure, stability, efficacy and safety. The variation should be controlled within a range so that there is no detrimental impact on safety and efficacy and thus allowing the use of early phase safety and efficacy data to support project advancement to later phase. This review article focuses on the current scientific understanding of the commonly observed oligosaccharides found in recombinant monoclonal antibodies and their impact on structure, stability and biological functions, which are the basis to evaluate safety and efficacy. It also provides a brief discussion on critical quality attribute (CQA) assessment with regard to oligosaccharides based on the mechanism of action (MOA). © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 33:1173-1181, 2017. © 2017 American Institute of Chemical Engineers.

10 CFR 830.206 - Preliminary documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Preliminary documented safety analysis. 830.206 Section 830.206 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.206 Preliminary documented safety analysis. If construction begins after December 11, 2000, the contractor...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

Evaluating performance of a Lead Road Safety Agency (LRSA) in a low-income country: a case study from Pakistan.

PubMed

Bhatti, Junaid A; Ahmed, Aizaz

2014-01-01

The World Health Organization recommends identifying a Lead Road Safety Agency (LRSA) within the government to coordinate preventive interventions. As LRSAs in developing countries have rarely been evaluated, this case study describes the performance of the LRSA of Pakistan with respect to the World Bank criteria. The designated LRSA, the National Road Safety Secretariat, was put into operation in 2006 and worked for about two years with World Bank funding. The agency had a stand-alone structure headed by an experienced road safety specialist during the first year only and faced difficulty in recruiting other required experts. The LRSA drafted the first National Road Safety Plan, including strategic review of road safety and existing legislation, articulated multisectorial collaboration nationally and provincially, and collected traffic injury data in some districts. Its progress was halted by its dissolution because of funding problems. Currently, two agencies specialising in traffic enforcement and transport research respectively are fulfilling LRSA functions on an ad-hoc basis. Results suggest that sustainability and consistency of LRSAs in developing countries like Pakistan may only be ensured if they are legally protected, inter-ministerial, have permanent funding and are provided with the required expertise through international cooperation, so they can perform their required functions effectively.

Novel Medications to Treat Addictive Disorders

PubMed Central

Montoya, Iván D.; Vocci, Frank

2008-01-01

Recent discoveries about the effects of drugs of abuse on the brain and the mechanisms of their addictions; new chemical compounds, including immunotherapies; and new actions of available medications are offering many opportunities for the discovery and development of novel medications to treat addictive disorders. Furthermore, advancements in the understanding of the genetic and epigenetic basis of drug addiction and the pharmacogenetics of the safety and/or efficacy of the medications are providing opportunities for more individualized pharmacotherapy approaches. Although multiple medications have been investigated for treating addictions, only a handful have shown acceptable safety and efficacy and are approved by the US Food and Drug Administration. This article reviews the current medications that are medically safe and have shown promising results for treating opioid, cocaine, methamphetamine, and cannabis addictions. PMID:18803912

An early assessment of silicone hydrogel safety: pearls and pitfalls, and current status.

PubMed

Keay, Lisa; Edwards, Katie; Stapleton, Fiona

2007-11-01

The contact lens industry has evolved and now provides many choices, including continuous wear, overnight orthokeratology, frequent-replacement lenses, daily-disposable lenses, and many alternatives in systems of care and maintenance. Epidemiologic studies to date have shown that how a lens is worn, particularly if worn overnight, can increase the risk of microbial keratitis. However, the risk of silicone hydrogel contact lenses worn on a continuous-wear basis has been evaluated only recently. This article summarizes the recent research data on extended-wear silicone hydrogel lenses and discusses the challenges of early evaluations of silicone hydrogel lens safety. Finally, the relevance of this information is discussed to practitioners and contact lens wearers making choices about the risks and benefits of different products and how they are used.

Health and environmental effects of refuse derived fuel (RDF) production and RDF/coal co-firing technologies

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

O'Toole, J.J.; Wessels, T.E.; Lynch, J.F.

1981-10-01

Six facilities, representing the scope of different co-firing techniques with their associated RDF production systems were reviewed in detail for combustion equipment, firing modes, emission control systems, residue handling/disposal, and effluent wastewater treatment. These facilities encompass all currently operational or soon to be operational co-firing plants and associated RDF production systems. Occupational health and safety risks for these plants were evaluated on the basis of fatal and nonfatal accidents and disease arising from the respective fuel cycles, coal and RDF. Occupational risks include exposure to pathogenic organisms in the workplace. Unusual events that are life threatening in the RDF processingmore » industry (e.g., explosions) are also discussed and remedial and safety measures reviewed. 80 refs., 4 figs., 30 tabs.« less

LANL Skid Testing Summary

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

Dickson, Peter

2014-04-09

Our improved understanding of the processes occurring during complex drop / skid events has explained the previously observed scatter in skid and drop test data, and provided new insights into effective mitigation strategies. However, it has been perceived to undermine our current safety assumptions, which is inaccurate. We have no reason to believe that our safety margin from HEVR (the event of concern) is any different to that previously assumed – we just have a much better experimental and theoretical basis by which to measure it more accurately. Until this work is complete or, at least, more mature, we cannotmore » draw any conclusions on whether we are more or less safe than we thought, but we know that use of cushioned surfaces, along with sensible housekeeping, mitigates the potential activation of the skid-grit mechanism.« less

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

Roussel, G.

Leak-Before-Break (LBB) technology has not been applied in the first design of the seven Pressurized Water Reactors the Belgian utility is currently operating. The design basis of these plants required to consider the dynamic effects associated with the ruptures to be postulated in the high energy piping. The application of the LBB technology to the existing plants has been recently approved by the Belgian Safety Authorities but with a limitation to the primary coolant loop. LBB analysis has been initiated for the Doel 3 and Tihange 2 plants to allow the withdrawal of some of the reactor coolant pump snubbersmore » at both plants and not reinstall some of the restraints after steam generator replacement at Doel 3. LBB analysis was also found beneficial to demonstrate the acceptability of the primary components and piping to the new conditions resulting from power uprating and stretch-out operation. LBB analysis has been subsequently performed on the primary coolant loop of the Tihange I plant and is currently being performed for the Doel 4 plant. Application of the LBB to the primary coolant loop is based in Belgium on the U.S. Nuclear Regulatory Commission requirements. However the Belgian Safety Authorities required some additional analyses and put some restrictions on the benefits of the LBB analysis to maintain the global safety of the plant at a sufficient level. This paper develops the main steps of the safety evaluation performed by the Belgian Safety Authorities for accepting the application of the LBB technology to existing plants and summarizes the requirements asked for in addition to the U.S. Nuclear Regulatory Commission rules.« less

Regulating danger on the highways: hours of service regulations.

PubMed

Mansfield, Daniel; Kryger, Meir

2015-12-01

Current hours of service regulations governing commercial truck drivers in place in the United States, Canada, Australia, and the European Union are summarized and compared to facilitate the assessment of the effectiveness of such provisions in preventing fatigue and drowsiness among truck drivers. Current hours of service provisions governing commercial truck drivers were derived from governmental sources. The commercial truck driver hours of service provisions in the United States, Canada, and the European Union permit drivers to work 14 hours and those of Australia permit drivers to work 12 hours a day on a regular basis. The regulations do not state what a driver may do with time off. They are consistent with a driver being able to drive after 24 hours without sleep. They do not take into account circadian rhythm by linking driving or rest to time of day. Current hours of service regulations governing commercial truck drivers leave gaps--permitting drivers to work long hours on a regular basis, permitting driving after no sleep for 24 hours, and failing to take into account the importance of circadian rhythm, endangering the public safety and the truck drivers themselves. Copyright © 2015 National Sleep Foundation. Published by Elsevier Inc. All rights reserved.

10 CFR 830.203 - Unreviewed safety question process.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Unreviewed safety question process. 830.203 Section 830.203 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.203 Unreviewed safety question process. (a) The contractor responsible for a hazard category 1, 2, or 3 DOE...

Exercise in pregnancy. Part 1: Update on pathophysiology.

PubMed Central

Stevenson, L.

1997-01-01

OBJECTIVE: To review the current data regarding the safety of exercise in pregnancy. QUALITY OF EVIDENCE: MEDLINE search was limited to English literature between 1987 and 1995 with the key MeSH words exercise and pregnancy. Other sources included the Sports and Fitness Database between 1991 and 1995 and a manual search for relevant articles. Previous studies on the safety of exercise in pregnancy are limited in many ways and exhibit difficulties in controlling for confounding factors and in establishing associations while maintaining maternal and fetal safety. MAIN FINDINGS: Concerns about the effect of exercise on pregnancy include exercise-induced hyperthermia, birth weight changes, fetal heart rate responses, miscarriage, labour patterns, maternal injury, and maternal weight gain. Exercise during pregnancy also has many potential benefits. CONCLUSIONS: Important gaps in our knowledge of exercise and pregnancy remain. Available data suggest, however, that moderate exercise on a regular basis during a healthy pregnancy has minimal risk for women and their fetuses. PMID:9626428

49 CFR 385.333 - What happens at the end of the 18-month safety monitoring period?

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.333 What happens at the end of the 18-month safety monitoring period? (a) If a safety audit has been performed within... the same basis as any other carrier. (d) If a safety audit or compliance review has not been performed...

Assessing emergency planning zone for new nuclear power plant considering risk of extreme external events

NASA Astrophysics Data System (ADS)

Alzbutas, Robertas

2015-04-01

In general, the Emergency Planning Zones (EPZ) are defined as well as plant site and arrangement structures are designed to minimize the potential for natural and manmade hazards external to the plant from affecting the plant safety related functions, which can affect nearby population and environment. This may include consideration of extreme winds, fires, flooding, aircraft crash, seismic activity, etc. Thus the design basis for plant and site is deeply related to the effects of any postulated external events and the limitation of the plant capability to cope with accidents i.e. perform safety functions. It has been observed that the Probabilistic Safety Assessment (PSA) methodologies to deal with EPZ and extreme external events have not reached the same level of maturity as for severe internal events. The design basis for any plant and site is deeply related to the effects of any postulated external events and the limitation of the plant capability to cope with accidents i.e. perform safety functions. As a prime example of an advanced reactor and new Nuclear Power Plant (NPP) with enhanced safety, the International Reactor Innovative and Secure (IRIS) and Site selection for New NPP in Lithuania had been considered in this work. In the used Safety-by-Design™ approach, the PSA played obviously a key role; therefore a Preliminary IRIS PSA had been developed along with the design. For the design and pre-licensing process of IRIS the external events analysis included both qualitative evaluation and quantitative assessment. As a result of preliminary qualitative analyses, the external events that were chosen for more detailed quantitative scoping evaluation were high winds and tornadoes, aircraft crash, and seismic events. For the site selection in Lithuania a detail site evaluation process was performed and related to the EPZ and risk zoning considerations. In general, applying the quantitative assessment, bounding site characteristics could be used in order to optimize potential redefinition or future restrictions on plant siting and risk zoning. It must be noticed that the use of existing regulations and installations as the basis for this redefinition will not in any way impact the high degree of conservatism inherent in current regulations. Moreover, the remapping process makes this methodology partially independent from the uncertainties still affecting probabilistic techniques. Notwithstanding these considerations, it is still expected that applying this methodology to advanced plant designs with improved safety features will allow significant changes in the emergency planning requirements, and specifically the size of the EPZ. In particular, in the case of IRIS it is expected that taking full credit of the Safety-by-Design™ approach of the IRIS reactor will allow a dramatic changes in the EPZ, while still maintaining a level of protection to the public fully consistent with existing regulations.

The current status of NORM/TENORM industries and establishment of regulatory framework in Korea.

PubMed

Chang, Byung-Uck; Kim, Yongjae; Oh, Jang-Jin

2011-07-01

During the last several years, a nationwide survey on naturally occurring radioactive material (NORM)/technologically enhanced naturally occurring radioactive materials (TENORM) industries has been conducted. Because of the rapid economic growth in Korea, the huge amount of raw materials, including NORM have been consumed in various industrial areas, and some representative TENORM industries exist in Korea. Recently, the Korean government decided to establish a regulatory framework for natural radiation, including NORM/TENORM and is making efforts to introduce relevant publically consent regulations on the basis of international safety standards.

The Dread Factor: How Hazards and Safety Training Influence Learning and Performance

ERIC Educational Resources Information Center

Burke, Michael J.; Salvador, Rommel O.; Smith-Crowe, Kristin; Chan-Serafin, Suzanne; Smith, Alexis; Sonesh, Shirley

2011-01-01

On the basis of hypotheses derived from social and experiential learning theories, we meta-analytically investigated how safety training and workplace hazards impact the development of safety knowledge and safety performance. The results were consistent with an expected interaction between the level of engagement of safety training and hazardous…

Transportation Safety Information Report : Second Quarter 1984

DOT National Transportation Integrated Search

1984-01-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

Transportation Safety Information Report : Second Quarter 1985

DOT National Transportation Integrated Search

1985-10-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

RELEASE OF DRIED RADIOACTIVE WASTE MATERIALS TECHNICAL BASIS DOCUMENT

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

KOZLOWSKI, S.D.

2007-05-30

This technical basis document was developed to support RPP-23429, Preliminary Documented Safety Analysis for the Demonstration Bulk Vitrification System (PDSA) and RPP-23479, Preliminary Documented Safety Analysis for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Facility. The main document describes the risk binning process and the technical basis for assigning risk bins to the representative accidents involving the release of dried radioactive waste materials from the Demonstration Bulk Vitrification System (DBVS) and to the associated represented hazardous conditions. Appendices D through F provide the technical basis for assigning risk bins to the representative dried waste release accident and associated represented hazardous conditionsmore » for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Packaging Unit (WPU). The risk binning process uses an evaluation of the frequency and consequence of a given representative accident or represented hazardous condition to determine the need for safety structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls. A representative accident or a represented hazardous condition is assigned to a risk bin based on the potential radiological and toxicological consequences to the public and the collocated worker. Note that the risk binning process is not applied to facility workers because credible hazardous conditions with the potential for significant facility worker consequences are considered for safety-significant SSCs and/or TSR-level controls regardless of their estimated frequency. The controls for protection of the facility workers are described in RPP-23429 and RPP-23479. Determination of the need for safety-class SSCs was performed in accordance with DOE-STD-3009-94, Preparation Guide for US. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses, as described below.« less

A feasibility assessment of installation, operation and disposal options for nuclear reactor power system concepts for a NASA growth space station

NASA Technical Reports Server (NTRS)

Bloomfield, Harvey S.; Heller, Jack A.

1987-01-01

A preliminary feasibility assessment of the integration of reactor power system concepts with a projected growth space station architecture was conducted to address a variety of installation, operational disposition, and safety issues. A previous NASA sponsored study, which showed the advantages of space station - attached concepts, served as the basis for this study. A study methodology was defined and implemented to assess compatible combinations of reactor power installation concepts, disposal destinations, and propulsion methods. Three installation concepts that met a set of integration criteria were characterized from a configuration and operational viewpoint, with end-of-life disposal mass identified. Disposal destinations that met current aerospace nuclear safety criteria were identified and characterized from an operational and energy requirements viewpoint, with delta-V energy requirement as a key parameter. Chemical propulsion methods that met current and near-term application criteria were identified and payload mass and delta-V capabilities were characterized. These capabilities were matched against concept disposal mass and destination delta-V requirements to provide the feasibility of each combination.

A feasibility assessment of nuclear reactor power system concepts for the NASA Growth Space Station

NASA Technical Reports Server (NTRS)

Bloomfield, H. S.; Heller, J. A.

1986-01-01

A preliminary feasibility assessment of the integration of reactor power system concepts with a projected growth Space Station architecture was conducted to address a variety of installation, operational, disposition and safety issues. A previous NASA sponsored study, which showed the advantages of Space Station - attached concepts, served as the basis for this study. A study methodology was defined and implemented to assess compatible combinations of reactor power installation concepts, disposal destinations, and propulsion methods. Three installation concepts that met a set of integration criteria were characterized from a configuration and operational viewpoint, with end-of-life disposal mass identified. Disposal destinations that met current aerospace nuclear safety criteria were identified and characterized from an operational and energy requirements viewpoint, with delta-V energy requirement as a key parameter. Chemical propulsion methods that met current and near-term application criteria were identified and payload mass and delta-V capabilities were characterized. These capabilities were matched against concept disposal mass and destination delta-V requirements to provide a feasibility of each combination.

Treatment options for nonalcoholic steatohepatitis - a safety evaluation.

PubMed

Issa, Danny; Wattacheril, Julia; Sanyal, Arun J

2017-08-01

There is an urgent as yet unmet need to develop highly effective and safe therapeutics for nonalcoholic fatty liver disease (NAFLD). The remarkable progress in understanding NAFLD pathogenesis allowed the identification of injury pathways which may be recruited as therapy targets. Areas covered: This article reviews the safety and tolerability data of the NAFLD therapies and explains the mechanistic basis for each of the established and investigational drugs. Treatment targets include: weight loss, anti-metabolic agents such as lipid lowering and anti-diabetic drugs, inflammation, fibrosis and others such as targeting gut microbiota, immune modulation and apoptosis. Expert opinion: Current therapies continue to remain suboptimal. Weight loss is effective but hard to achieve. Traditional and endoscopic bariatric procedures are promising although more randomized trials are needed and the long-term safety remains to be established. Clinical trials have demonstrated the efficacy of several drugs for the treatment of NASH. Of these, there remains some uncertainty about the long-term safety of vitamin E. Pioglitazone is associated with osteopenia, fluid retention and weight gain. Obeticholic acid causes pruritus in a substantial proportion of subjects and elafibranor has been associated with transient rises in creatinine. Several exciting therapies are under development and results of clinical and post-marketing trials will help elucidate their safety.

VRLane: a desktop virtual safety management program for underground coal mine

NASA Astrophysics Data System (ADS)

Li, Mei; Chen, Jingzhu; Xiong, Wei; Zhang, Pengpeng; Wu, Daozheng

2008-10-01

VR technologies, which generate immersive, interactive, and three-dimensional (3D) environments, are seldom applied to coal mine safety work management. In this paper, a new method that combined the VR technologies with underground mine safety management system was explored. A desktop virtual safety management program for underground coal mine, called VRLane, was developed. The paper mainly concerned about the current research advance in VR, system design, key techniques and system application. Two important techniques were introduced in the paper. Firstly, an algorithm was designed and implemented, with which the 3D laneway models and equipment models can be built on the basis of the latest mine 2D drawings automatically, whereas common VR programs established 3D environment by using 3DS Max or the other 3D modeling software packages with which laneway models were built manually and laboriously. Secondly, VRLane realized system integration with underground industrial automation. VRLane not only described a realistic 3D laneway environment, but also described the status of the coal mining, with functions of displaying the run states and related parameters of equipment, per-alarming the abnormal mining events, and animating mine cars, mine workers, or long-wall shearers. The system, with advantages of cheap, dynamic, easy to maintenance, provided a useful tool for safety production management in coal mine.

Recent findings relating to firefighter safety zones

Treesearch

Bret Butler; Russ Parsons; William Mell

2015-01-01

Designation of safety zones is a primary duty of all wildland firefighters. Unfortunately, information regarding what constitutes an adequate safety zone is inadequately defined. Measurements of energy release from wildland fires have been used to develop an empirically based safety zone guideline. The basis for this work is described here.

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2011 CFR

2011-01-01

... occurrences, design basis accidents, external events, and natural phenomena for which the plant must be... important to safety, (2) protection of electric equipment important to safety against other natural phenomena and external events, and (3) environmental qualification of electric equipment important to safety...

Application of Microprocessor-Based Equipment in Nuclear Power Plants - Technical Basis for a Qualification Methodology

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

Korsah, K.

This document (1) summarizes the most significant findings of the ''Qualification of Advanced Instrumentation and Control (I&C) Systems'' program initiated by the Nuclear Regulatory Commission (NRC); (2) documents a comparative analysis of U.S. and European qualification standards; and (3) provides recommendations for enhancing regulatory guidance for environmental qualification of microprocessor-based safety-related systems. Safety-related I&C system upgrades of present-day nuclear power plants, as well as I&C systems of Advanced Light-Water Reactors (ALWRs), are expected to make increasing use of microprocessor-based technology. The Nuclear Regulatory Commission (NRC) recognized that the use of such technology may pose environmental qualification challenges different from current,more » analog-based I&C systems. Hence, it initiated the ''Qualification of Advanced Instrumentation and Control Systems'' program. The objectives of this confirmatory research project are to (1) identify any unique environmental-stress-related failure modes posed by digital technologies and their potential impact on the safety systems and (2) develop the technical basis for regulatory guidance using these findings. Previous findings from this study have been documented in several technical reports. This final report in the series documents a comparative analysis of two environmental qualification standards--Institute of Electrical and Electronics Engineers (IEEE) Std 323-1983 and International Electrotechnical Commission (IEC) 60780 (1998)--and provides recommendations for environmental qualification of microprocessor-based systems based on this analysis as well as on the findings documented in the previous reports. The two standards were chosen for this analysis because IEEE 323 is the standard used in the U.S. for the qualification of safety-related equipment in nuclear power plants, and IEC 60780 is its European counterpart. In addition, the IEC document was published in 1998, and should reflect any new qualification concerns, from the European perspective, with regard to the use of microprocessor-based safety systems in power plants.« less

PRELIMINARY NUCLEAR CRITICALITY NUCLEAR SAFETY EVLAUATION FOR THE CONTAINER SURVEILLANCE AND STORAGE CAPABILITY PROJECT

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

Low, M; Matthew02 Miller, M; Thomas Reilly, T

2007-04-30

Washington Safety Management Solutions (WSMS) provides criticality safety services to Washington Savannah River Company (WSRC) at the Savannah River Site. One activity at SRS is the Container Surveillance and Storage Capability (CSSC) Project, which will perform surveillances on 3013 containers (hereafter referred to as 3013s) to verify that they meet the Department of Energy (DOE) Standard (STD) 3013 for plutonium storage. The project will handle quantities of material that are greater than ANS/ANSI-8.1 single parameter mass limits, and thus required a Nuclear Criticality Safety Evaluation (NCSE). The WSMS methodology for conducting an NCSE is outlined in the WSMS methods manual.more » The WSMS methods manual currently follows the requirements of DOE-O-420.1B, DOE-STD-3007-2007, and the Washington Savannah River Company (WSRC) SCD-3 manual. DOE-STD-3007-2007 describes how a NCSE should be performed, while DOE-O-420.1B outlines the requirements for a Criticality Safety Program (CSP). The WSRC SCD-3 manual implements DOE requirements and ANS standards. NCSEs do not address the Nuclear Criticality Safety (NCS) of non-reactor nuclear facilities that may be affected by overt or covert activities of sabotage, espionage, terrorism or other security malevolence. Events which are beyond the Design Basis Accidents (DBAs) are outside the scope of a double contingency analysis.« less

Generic Safety Requirements for Developing Safe Insulin Pump Software

PubMed Central

Zhang, Yi; Jetley, Raoul; Jones, Paul L; Ray, Arnab

2011-01-01

Background The authors previously introduced a highly abstract generic insulin infusion pump (GIIP) model that identified common features and hazards shared by most insulin pumps on the market. The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for insulin pump software. Together, these two publications can serve as a basis for discussing insulin pump safety in the diabetes community. Methods In our previous work, we established a generic insulin pump architecture that abstracts functions common to many insulin pumps currently on the market and near-future pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work presented in this article. Results Generic safety requirements for the GIIP model are presented, as appropriate, in parameterized format to accommodate clinical practices or specific insulin pump criteria important to safe device performance. Conclusions We believe that there is considerable value in having the diabetes, academic, and manufacturing communities consider and discuss these generic safety requirements. We hope that the communities will extend and revise them, make them more representative and comprehensive, experiment with them, and use them as a means for assessing the safety of insulin pump software designs. One potential use of these requirements is to integrate them into model-based engineering (MBE) software development methods. We believe, based on our experiences, that implementing safety requirements using MBE methods holds promise in reducing design/implementation flaws in insulin pump development and evolutionary processes, therefore improving overall safety of insulin pump software. PMID:22226258

Evidence-based safety (EBS) management: A new approach to teaching the practice of safety management (SM).

PubMed

Wang, Bing; Wu, Chao; Shi, Bo; Huang, Lang

2017-12-01

In safety management (SM), it is important to make an effective safety decision based on the reliable and sufficient safety-related information. However, many SM failures in organizations occur for a lack of the necessary safety-related information for safety decision-making. Since facts are the important basis and foundation for decision-making, more efforts to seek the best evidence relevant to a particular SM problem would lead to a more effective SM solution. Therefore, the new paradigm for decision-making named "evidence-based practice (EBP)" can hold important implications for SM, because it uses the current best evidence for effective decision-making. Based on a systematic review of existing SM approaches and an analysis of reasons why we need new SM approaches, we created a new SM approach called evidence-based safety (EBS) management by introducing evidence-based practice into SM. It was necessary to create new SM approaches. A new SM approach called EBS was put forward, and the basic questions of EBS such as its definition and core were analyzed in detail. Moreover, the determinants of EBS included manager's attitudes towards EBS; evidence-based consciousness in SM; evidence sources; technical support; EBS human resources; organizational culture; and individual attributes. EBS is a new and effective approach to teaching the practice of SM. Of course, further research on EBS should be carried out to make EBS a reality. Practical applications: Our work can provide a new and effective idea and method to teach the practice of SM. Specifically, EBS proposed in our study can help safety professionals make an effective safety decision based on a firm foundation of high-grade evidence. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Deriving exposure limits

NASA Astrophysics Data System (ADS)

Sliney, David H.

1990-07-01

Historically many different agencies and standards organizations have proposed laser occupational exposure limits (EL1s) or maximum permissible exposure (MPE) levels. Although some safety standards have been limited in scope to manufacturer system safety performance standards or to codes of practice most have included occupational EL''s. Initially in the 1960''s attention was drawn to setting EL''s however as greater experience accumulated in the use of lasers and some accident experience had been gained safety procedures were developed. It became clear by 1971 after the first decade of laser use that detailed hazard evaluation of each laser environment was too complex for most users and a scheme of hazard classification evolved. Today most countries follow a scheme of four major hazard classifications as defined in Document WS 825 of the International Electrotechnical Commission (IEC). The classifications and the associated accessible emission limits (AEL''s) were based upon the EL''s. The EL and AEL values today are in surprisingly good agreement worldwide. There exists a greater range of safety requirements for the user for each class of laser. The current MPE''s (i. e. EL''s) and their basis are highlighted in this presentation. 2. 0

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2012 CFR

2012-01-01

... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., safety, and health into work planning and execution (48 CFR 970.5223-1, Integration of Environment...) Using the method in DOE-STD-1120-98, Integration of Environment, Safety, and Health into Facility...

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2014 CFR

2014-01-01

... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., safety, and health into work planning and execution (48 CFR 970.5223-1, Integration of Environment...) Using the method in DOE-STD-1120-98, Integration of Environment, Safety, and Health into Facility...

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2013 CFR

2013-01-01

... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., safety, and health into work planning and execution (48 CFR 970.5223-1, Integration of Environment...) Using the method in DOE-STD-1120-98, Integration of Environment, Safety, and Health into Facility...

Evaluation of Canisterized Foams and Evaluation of Radiation Hardened Foams for D&D Activities

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

Nicholson, J. C.

The introduction of polyurethane foams has previously been examined elsewhere within the DOE complex with regards to decontamination and decommissioning (D&D) activities, though its use has been prohibited as a result of excessive heat generation and flammability concerns per the safety basis. Should these foams be found compatible with respect to the facility safety basis requirements, D&D work involving large void containing structures such as gloveboxes could be eased through the fixation of residual contamination after decontamination efforts have concluded. To this end, SRNL embarked on a characterization of commercial epoxy foams to identify the characteristics that would be mostmore » important to safety basis requirements. Through SRNL’s efforts, the performance of commercial two-part epoxy foams was evaluated for their foaming characteristics, temperature profiles, loading capability with high-Z (high density) additives, and applicability for shielding gamma emission from isotopes including; Am-241, Cs-137, and Co-60. It was found that these foams are capable of encapsulation of a desired volume, though the ideal and experimental expansion coefficients were found to differ. While heat is generated during the reaction, no samples generated heat above 70 °C. Of the down–selected materials, heating was on the order of 40 °C for the flexible foam and 60 °C for the rigid foam. Both were found to return to room temperature after 20 minutes regardless of the volume of foam cast. It was also found that the direct introduction of high-Z additives were capable of attenuating 98% of Am-241 gamma signal, 16% of Cs-137 signal, and 9.5% of Co-60 signal at 1:1 loading capacities of total liquid constituent weight to additive weight. These efforts are currently being reviewed for the ASTM January 2017 subcommittee discussions to address the lack of test methods and standards regarding these materials with respect to D&D environments.« less

Lubiprostone: pharmacokinetic, pharmacodynamic, safety and regulatory aspects in the treatment of constipation-predominant irritable bowel syndrome.

PubMed

Raschi, Emanuel; De Ponti, Fabrizio

2014-02-01

Lubiprostone acts locally (apical membrane of human intestinal epithelial cells) as a highly selective type-2 chloride channel activator. It was approved in the USA for chronic idiopathic constipation (January 2006) and in women aged ≥ 18 years suffering from irritable bowel syndrome with constipation (IBS-C) (April 2008). So far, the only other pro-secretory medication approved in IBS-C and currently available in USA and Europe (since August and November 2012, respectively) is linaclotide. This review outlines the regulatory history, pharmacokinetic, pharmacodynamic and safety data in the treatment of IBS-C with a European perspective. It is based on publicly available data, namely, published literature, drug labels and the FDA's spontaneous reporting system. Although interesting pharmacodynamic data suggest that lubiprostone may have additional mechanisms of action, its beneficial effects in IBS-C must be confirmed in the actual clinical scenario taking into account the new version of European Medicines Agency's guideline. This is especially important with regard to duration of studies (recommended to be at least 6 months) to adequately assess long-term sustained efficacy, withdrawal, rebound and safety. Further research is warranted in uncertain areas (i.e., males, pediatric and elderly patients). On the basis of current data, it is still too early to draw definite conclusions on the overall risk-benefit balance for IBS-C.

Vehicle fires and fire safety in tunnels

DOT National Transportation Integrated Search

2002-09-20

Tunnels present what is arguably the most hazardous environment, from the point of view of fire safety, that members of the public ever experience. The fire safety design of tunnels is carried out by tunnel engineers on the basis of a potential fire ...

WHO informal consultation on quality, safety and efficacy specifications for live attenuated rotavirus vaccines Mexico City, Mexico, 8-9 February 2005.

PubMed

Wood, David

2005-12-01

Rotavirus vaccines are at an advanced stage of development but there are as yet no WHO recommendations on production and quality control to provide regulatory guidance. A meeting of experts was convened by WHO and PAHO/AMRO to review the scientific basis for production and quality control of rotavirus vaccines, and to discuss specific measures to assure the safety and efficacy of rotavirus vaccines. The meeting was attended by 25 experts from 14 countries, drawn from academia, public health, national regulatory authorities and vaccine producers. It was agreed that existing guidance for other live virus vaccines provides a very good basis for product characterization, especially for source materials and control of production. The basis for attenuation of current vaccines or vaccine candidates is not known but, at least for the vaccines based on the Jennerian approach of using animal (bovine) rotaviruses, is likely to be multigenic. The risk of intussusception in humans is influenced by genetic background and age. Recent analyzes of large vaccine safety trials found that certain strains of vaccine virus were not associated with intussusception, although in these trials the first dose of vaccine was not administered to children over 3 months of age. Since age is a risk factor for intussusception, this may suggest that early delivery of the first dose of vaccine is desirable. However, maternal antibodies may mitigate against early delivery of the first vaccine dose. Factors which could affect vaccine efficacy or safety include strain diversity, malnutrition, other enteric infections, parasitic infection or immune suppression. It was concluded that data from clinical trials conducted in one part of the world would not necessarily be predictive of vaccine efficacy in other places. It was agreed that in nonclinical evaluations there was a need to use oral dosing for toxicity studies and, because rotavirus is non-neurovirulent, that there was no need for an animal neurovirulence test. For clinical evaluations there was a need for a standard definition of severe disease as the clinical endpoint, a need for studies in diverse geographical regions, and the need to control for possible interference by factors such as other oral vaccinations, intercurrent infections and breast feeding. There is no accepted correlate of protection. Secretory IgA is the most satisfactory laboratory parameter currently available and for a period after vaccination much of the specific serum IgA is of this type, so that serum IgA levels can act as measure of seroconversion. The need for standardization of the potency assay for release of vaccine was identified, as was a need to develop guidance on standardized approaches to post-marketing surveillance for rotavirus vaccines.

An Investigation of Proposed Techniques for Quantifying Confidence in Assurance Arguments

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.; Holloway, C. Michael

2016-01-01

The use of safety cases in certification raises the question of assurance argument sufficiency and the issue of confidence (or uncertainty) in the argument's claims. Some researchers propose to model confidence quantitatively and to calculate confidence in argument conclusions. We know of little evidence to suggest that any proposed technique would deliver trustworthy results when implemented by system safety practitioners. Proponents do not usually assess the efficacy of their techniques through controlled experiment or historical study. Instead, they present an illustrative example where the calculation delivers a plausible result. In this paper, we review current proposals, claims made about them, and evidence advanced in favor of them. We then show that proposed techniques can deliver implausible results in some cases. We conclude that quantitative confidence techniques require further validation before they should be recommended as part of the basis for deciding whether an assurance argument justifies fielding a critical system.

SafeConnect Solar - Final Scientific/Technical Report (Updated)

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

McNish, Zachary

2016-02-03

Final Scientific/Technical Report from Tier 0 SunShot Incubator award for hardware-based solution to reducing soft costs of installed solar. The primary objective of this project was for SafeConnect Solar (“SafeConnect”) to create working proof-of-concept hardware prototypes from its proprietary intellectual property and business concepts for a plug-and-play, safety-oriented hardware solution for photovoltaic solar systems. Specifically, SafeConnect sought to build prototypes of its “SmartBox” and related cabling and connectors, as well as the firmware needed to run the hardware. This hardware is designed to ensure a residential PV system installed with it can address all safety concerns that currently form themore » basis of AHJ electrical permitting and licensing requirements, thereby reducing the amount of permitting and specialized labor required on a residential PV system, and also opening up new sales channels and customer acquisition opportunities.« less

Management of the aging of critical safety-related concrete structures in light-water reactor plants

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

Naus, D.J.; Oland, C.B.; Arndt, E.G.

1990-01-01

The Structural Aging Program has the overall objective of providing the USNRC with an improved basis for evaluating nuclear power plant safety-related structures for continued service. The program consists of a management task and three technical tasks: materials property data base, structural component assessment/repair technology, and quantitative methodology for continued-service determinations. Objectives, accomplishments, and planned activities under each of these tasks are presented. Major program accomplishments include development of a materials property data base for structural materials as well as an aging assessment methodology for concrete structures in nuclear power plants. Furthermore, a review and assessment of inservice inspection techniquesmore » for concrete materials and structures has been complete, and work on development of a methodology which can be used for performing current as well as reliability-based future condition assessment of concrete structures is well under way. 43 refs., 3 tabs.« less

[Safety evaluation of niuhuang jiedu tablet].

PubMed

Feng, Yu-Ling; Miao, Jia-wei; Li, Jing; Sung, An-Sheng; Liu, Jie

2014-09-01

Realgar-containing Niuhuang Jiedu tablet (NHJD) has been applied in clinic for more than 800 years. However, because realgar contains arsenic (As), it has aroused wide concerns and controversies both at home and abroad. Currently, there are two misunderstandings about realgar-containing Chinese patent medicines. First, some people exaggerated realgar's toxicity as that of arsenic. Second, they recommended to remove realgar from traditional Chinese medicine compounds. In this paper, the authors summarized the advance in studies on NHJD, and proposed different opinions: (1) It is inappropriate to take total As as the index in safety evaluation of NHJD. (2) The toxicity of NHJD is dependent on the dose and duration of administration. (3) Realgar is an active ingredient of NHJD, and shall be deeply studied. Classic realgar-containing traditional Chinese medicine prescriptions, such as Niuhuang Jiedu tablet, shall be evaluated with rigorous modern scientific basis, with the aim to guide rational and safe application.

The Evolution of System Safety at NASA

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Everett, Chris; Groen, Frank

2014-01-01

The NASA system safety framework is in the process of change, motivated by the desire to promote an objectives-driven approach to system safety that explicitly focuses system safety efforts on system-level safety performance, and serves to unify, in a purposeful manner, safety-related activities that otherwise might be done in a way that results in gaps, redundancies, or unnecessary work. An objectives-driven approach to system safety affords more flexibility to determine, on a system-specific basis, the means by which adequate safety is achieved and verified. Such flexibility and efficiency is becoming increasingly important in the face of evolving engineering modalities and acquisition models, where, for example, NASA will increasingly rely on commercial providers for transportation services to low-earth orbit. A key element of this objectives-driven approach is the use of the risk-informed safety case (RISC): a structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is or will be adequately safe for a given application in a given environment. The RISC addresses each of the objectives defined for the system, providing a rational basis for making informed risk acceptance decisions at relevant decision points in the system life cycle.

Good practices on cost - effective road infrastructure safety investments.

PubMed

Yannis, George; Papadimitriou, Eleonora; Evgenikos, Petros; Dragomanovits, Anastasios

2016-12-01

The paper presents the findings of a research project aiming to quantify and subsequently classify several infrastructure-related road safety measures, based on the international experience attained through extensive and selected literature review and additionally on a full consultation process including questionnaire surveys addressed to experts and relevant workshops. Initially, a review of selected research reports was carried out and an exhaustive list of road safety infrastructure investments covering all types of infrastructure was compiled. Individual investments were classified according to the infrastructure investment area and the type of investment and were thereafter analysed on the basis of key safety components. These investments were subsequently ranked in relation to their safety effects and implementation costs and on the basis of this ranking, a set of five most promising investments was selected for an in-depth analysis. The results suggest that the overall cost effectiveness of a road safety infrastructure investment is not always in direct correlation with the safety effect and is recommended that cost-benefit ratios and safety effects are always examined in conjunction with each other in order to identify the optimum solution for a specific road safety problem in specific conditions and with specific objectives.

The Toxic Truth About Carbon Nanotubes in Water Purification: a Perspective View.

PubMed

Das, Rasel; Leo, Bey Fen; Murphy, Finbarr

2018-06-18

Without nanosafety guidelines, the long-term sustainability of carbon nanotubes (CNTs) for water purifications is questionable. Current risk measurements of CNTs are overshadowed by uncertainties. New risks associated with CNTs are evolving through different waste water purification routes, and there are knowledge gaps in the risk assessment of CNTs based on their physical properties. Although scientific efforts to design risk estimates are evolving, there remains a paucity of knowledge on the unknown health risks of CNTs. The absence of universal CNT safety guidelines is a specific hindrance. In this paper, we close these gaps and suggested several new risk analysis roots and framework extrapolations from CNT-based water purification technologies. We propose a CNT safety clock that will help assess risk appraisal and management. We suggest that this could form the basis of an acceptable CNT safety guideline. We pay particular emphasis on measuring risks based on CNT physico-chemical properties such as diameter, length, aspect ratio, type, charge, hydrophobicity, functionalities and so on which determine CNT behaviour in waste water treatment plants and subsequent release into the environment.

Bioluminescence lights the way to food safety

NASA Astrophysics Data System (ADS)

Brovko, Lubov Y.; Griffiths, Mansel W.

2003-07-01

The food industry is increasingly adopting food safety and quality management systems that are more proactive and preventive than those used in the past which have tended to rely on end product testing and visual inspection. The regulatory agencies in many countries are promoting one such management tool, Hazard Analysis Critical Control Point (HACCP), as a way to achieve a safer food supply and as a basis for harmonization of trading standards. Verification that the process is safe must involve microbiological testing but the results need not be generated in real-time. Of all the rapid microbiological tests currently available, the only ones that come close to offering real-time results are bioluminescence-based methods. Recent developments in application of bioluminescence for food safety issues are presented in the paper. These include the use of genetically engineered microorganisms with bioluminescent and fluorescent phenotypes as a real time indicator of physiological state and survival of food-borne pathogens in food and food processing environments as well as novel bioluminescent-based methods for rapid detection of pathogens in food and environmental samples. Advantages and pitfalls of the methods are discussed.

Non-animal approaches for consumer safety risk assessments: Unilever's scientific research programme.

PubMed

Carmichael, Paul; Davies, Michael; Dent, Matt; Fentem, Julia; Fletcher, Samantha; Gilmour, Nicola; MacKay, Cameron; Maxwell, Gavin; Merolla, Leona; Pease, Camilla; Reynolds, Fiona; Westmoreland, Carl

2009-12-01

Non-animal based approaches to risk assessment are now routinely used for assuring consumer safety for some endpoints (such as skin irritation) following considerable investment in developing and applying new methods over the past 20 years. Unilever's research programme into non-animal approaches for safety assessment is currently focused on the application of new technologies to risk assessments in the areas of skin allergy, cancer and general toxicity (including inhalation toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biological and chemical processes that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement with EU-funded projects (e.g. Sens-it-iv, carcinoGENOMICS), participation in cross-industry collaborative research (e.g. COLIPA, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US 'Human Toxicology Project' consortium). 2009 FRAME.

Novel approaches to the pharmacotherapy of obesity.

PubMed

Gouni-Berthold, Ioanna; Brüning, Jens C; Berthold, Heiner K

2013-01-01

Although the obesity epidemic is constantly expanding at very high costs for health care systems, the currently available options for the pharmacotherapy of obesity are very limited. This is not due to lack of interest or research on the subject but rather to the poor efficacy and/or safety profile of the majority of the antiobesity drugs developed up to now. Since the late fifties, various medications were brought to advanced states of clinical development but either never made it to the market or were initially approved only to be withdrawn some years later because of safety issues. However, our understanding of the pathophysiology of obesity has been steadily increasing and new, promising drugs targeting various selected obesity-associated and energy-homeostasis-related pathways are now under development. Nonetheless, obesity remains a disease mainly caused by an excess of caloric intake in relation to energy expenditure and on that basis, its treatment should be a healthy diet and physical activity. When these options alone are not sufficient, then additional pharmacotherapy with an acceptable efficacy and safety profile could provide a useful option.

LWRS ATR Irradiation Testing Readiness Status

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

Kristine Barrett

2012-09-01

The Light Water Reactor Sustainability (LWRS) Program was established by the U.S. Department of Energy Office of Nuclear Energy (DOE-NE) to develop technologies and other solutions that can improve the reliability, sustain the safety, and extend the life of the current reactors. The LWRS Program is divided into four R&D Pathways: (1) Materials Aging and Degradation; (2) Advanced Light Water Reactor Nuclear Fuels; (3) Advanced Instrumentation, Information and Control Systems; and (4) Risk-Informed Safety Margin Characterization. This report describes an irradiation testing readiness analysis in preparation of LWRS experiments for irradiation testing at the Idaho National Laboratory (INL) Advanced Testmore » Reactor (ATR) under Pathway (2). The focus of the Advanced LWR Nuclear Fuels Pathway is to improve the scientific knowledge basis for understanding and predicting fundamental performance of advanced nuclear fuel and cladding in nuclear power plants during both nominal and off-nominal conditions. This information will be applied in the design and development of high-performance, high burn-up fuels with improved safety, cladding integrity, and improved nuclear fuel cycle economics« less

26 CFR 1.187-1 - Amortization of certain coal mine safety equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 3 2010-04-01 2010-04-01 false Amortization of certain coal mine safety... (continued) § 1.187-1 Amortization of certain coal mine safety equipment. (a) Allowance of deduction—(1) In... respect to the amortization of the adjusted basis (for determining gain) of any certified coal mine safety...

76 FR 22812 - Safety Zone; Sea World Fireworks; Mission Bay, San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-25

...-AA00 Safety Zone; Sea World Fireworks; Mission Bay, San Diego, CA AGENCY: Coast Guard, DHS. ACTION... navigable waters of Mission Bay in support of the Sea World Fireworks. This safety zone is necessary to... impracticable, because immediate action is needed to ensure the public's safety. Basis and Purpose Sea World is...

Rational and irrational clinical strategies for collaborative medicine.

PubMed

Hammerly, Milt

2002-01-01

Individual practitioners and health care systems/organizations increasingly understand the rationale for collaborative medicine. An absence of collaboration can compromise the quality and safety of patient care. But having a rationale to provide collaborative medicine without also having a rational clinical strategy can be equally compromising to the quality and safety of patient care. Reasonable evidentiary criteria must be used to determine whether specific therapies merit inclusion or exclusion in a collaborative medicine model. Ranking therapies hierarchically on the basis of their risk-benefit ratio simplifies matching of therapies with the needs of the patient. A unifying taxonomy that categorizes all therapies (complementary/alternative and conventional) on the basis of how we think they work (presumed mechanisms of action) facilitates development of a clinical strategy for collaborative medicine. On the basis of these principles, a rational clinical strategy for collaborative medicine is described to help optimize the quality and safety of patient care.

Performance Analysis of a Ring Current Model Driven by Global MHD

NASA Astrophysics Data System (ADS)

Falasca, A.; Keller, K. A.; Fok, M.; Hesse, M.; Gombosi, T.

2003-12-01

Effectively modeling the high-energy particles in Earth's inner magnetosphere has the potential to improve safety in both manned and unmanned spacecraft. One model of this environment is the Fok Ring Current Model. This model can utilize as inputs both solar wind data, and empirical ionospheric electric field and magnetic field models. Alternatively, we have a procedure which allows the model to be driven by outputs from the BATS-R-US global MHD model. By using in-situ satellite data we will compare the predictive capability of this model in its original stand-alone form, to that of the model when driven by the BATS-R-US Global Magnetosphere Model. As a basis for comparison we use the April 2002 and May 2003 storms where suitable LANL geosynchronous data are available.

Occurrence detection and selection procedures in healthcare facilities: a comparison across Canada and Brazil.

PubMed

Morita, Plinio P; Burns, Catherine M

2011-01-01

Healthcare institutions face high levels of risk on a daily basis. Efforts have been made to address these risks and turn this complex environment into a safer environment for patients, staff, and visitors. However, healthcare institutions need more advanced risk management tools to achieve the safety levels currently seen in other industries. One of these potential tools is occurrence investigation systems. In order to be investigated, occurrences must be detected and selected for investigation, since not all institutions have enough resources to investigate all occurrences. A survey was conducted in healthcare institutions in Canada and Brazil to evaluate currently used risk management tools, the difficulties faced, and the possibilities for improvement. The findings include detectability difficulties, lack of resources, lack of support, and insufficient staff involvement.

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

2002-01-01

This Annual Report of the Aerospace Safety Advisory Panel (ASAP) presents results of activities during calendar year 2001. The year was marked by significant achievements in the Space Shuttle and International Space Station (ISS) programs and encouraging accomplishments by the Aerospace Technology Enterprise. Unfortunately, there were also disquieting mishaps with the X-43, a LearJet, and a wind tunnel. Each mishap was analyzed in an orderly process to ascertain causes and derive lessons learned. Both these accomplishments and the responses to the mishaps led the Panel to conclude that safety and risk management is currently being well served within NASA. NASA's operations evidence high levels of safety consciousness and sincere efforts to place safety foremost. Nevertheless, the Panel's safety concerns have never been greater. This dichotomy has arisen because the focus of most NASA programs has been directed toward program survival rather than effective life cycle planning. Last year's Annual Report focused on the need for NASA to adopt a realistically long planning horizon for the aging Space Shuttle so that safety would not erode. NASA's response to the report concurred with this finding. Nevertheless, there has been a greater emphasis on current operations to the apparent detriment of long-term planning. Budget cutbacks and shifts in priorities have severely limited the resources available to the Space Shuttle and ISS for application to risk-reduction and life-extension efforts. As a result, funds originally intended for long-term safety-related activities have been used for operations. Thus, while safety continues to be well served at present, the basis for future safety has eroded. Section II of this report develops this theme in more detail and presents several important, overarching findings and recommendations that apply to many if not all of NASA's programs. Section III of the report presents other significant findings, recommendations and supporting material applicable to specific program areas. Appendix A presents a list of Panel members. Appendix B contains the reaction of the ASAP to NASA's response to the calendar year 2000 findings and recommendations. In accordance with a practice started last year, this Appendix includes brief narratives as well as classifications of the responses as 'open,' 'closed,' or 'continuing.' Appendix C details the Panel's activities during the reporting period.

Aviation and healthcare: a comparative review with implications for patient safety.

PubMed

Kapur, Narinder; Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2016-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing.

Aviation and healthcare: a comparative review with implications for patient safety

PubMed Central

Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2015-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing. PMID:26770817

Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity.

PubMed

Reisinger, Keith S; Block, Stanley L; Izu, Allen; Groth, Nicola; Holmes, Sandra J

2009-09-15

This study assessed the safety, reactogenicity, and immunogenicity of an injectable cell culture-derived influenza vaccine (CCIV), compared with those of an injectable egg-based trivalent inactivated influenza vaccine (TIV). Adult subjects (n = 613; 18 to <50 years of age) were randomized (1:1) to receive either CCIV or TIV. The safety and reactogenicity of the 2 vaccines were assessed on the basis of solicited indicators and other adverse events (AEs) within 7 days of vaccination. All serious AEs and those AEs resulting in withdrawal were recorded throughout the study. Antibody titers were determined by the hemagglutination inhibition assay, using egg- and cell-derived antigens. Immunogenicity was assessed on the basis of the ratio of postvaccination (day 22) geometric mean titers (GMTs) between the 2 vaccines, seroprotection rates, and seroconversion rates. There was no clinically relevant difference between the safety and reactogenicity profiles of the 2 vaccines. The immunogenicity of CCIV was demonstrated to be noninferior to that of TIV on the basis of the ratio of postvaccination GMTs between the 2 vaccines. GMTs, seroprotection rates, and seroconversion rates were comparable between the 2 vaccines. The safety, reactogenicity, and immunogenicity of the CCIV and the egg-based TIV are comparable.

47 CFR 95.1400 - Basis and purpose.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Basis and purpose. 95.1400 Section 95.1400 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Personal Locator Beacons (PLB). § 95.1400 Basis and purpose. The rules in this subpart are...

77 FR 42638 - Safety Zone: Sea World San Diego Fireworks, Mission Bay; San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... 1625-AA00 Safety Zone: Sea World San Diego Fireworks, Mission Bay; San Diego, CA AGENCY: Coast Guard... navigable waters of Mission Bay in support of the Sea World San Diego Fireworks. This safety zone is..., since immediate action is needed to ensure the public's safety. B. Basis and Purpose Sea World is...

Battery collection in municipal waste management in Japan: challenges for hazardous substance control and safety.

PubMed

Terazono, Atsushi; Oguchi, Masahiro; Iino, Shigenori; Mogi, Satoshi

2015-05-01

To clarify current collection rules of waste batteries in municipal waste management in Japan and to examine future challenges for hazardous substance control and safety, we reviewed collection rules of waste batteries in the Tokyo Metropolitan Area. We also conducted a field survey of waste batteries collected at various battery and small waste electric and electronic equipment (WEEE) collection sites in Tokyo. The different types of batteries are not collected in a uniform way in the Tokyo area, so consumers need to pay attention to the specific collection rules for each type of battery in each municipality. In areas where small WEEE recycling schemes are being operated after the enforcement of the Act on Promotion of Recycling of Small Waste Electrical and Electronic Equipment in Japan in 2013, consumers may be confused about the need for separating batteries from small WEEE (especially mobile phones). Our field survey of collected waste batteries indicated that 6-10% of zinc carbon and alkaline batteries discarded in Japan currently could be regarded as containing mercury. More than 26% of zinc carbon dry batteries currently being discarded may have a lead content above the labelling threshold of the EU Batteries Directive (2006/66/EC). In terms of safety, despite announcements by producers and municipalities about using insulation (tape) on waste batteries to prevent fires, only 2.0% of discarded cylindrical dry batteries were insulated. Our field study of small WEEE showed that batteries made up an average of 4.6% of the total collected small WEEE on a weight basis. Exchangeable batteries were used in almost all of mobile phones, digital cameras, radios, and remote controls, but the removal rate was as low as 22% for mobile phones. Given the safety issues and the rapid changes occurring with mobile phones or other types of small WEEE, discussion is needed among stakeholders to determine how to safely collect and recycle WEEE and waste batteries. Copyright © 2015 Elsevier Ltd. All rights reserved.

The clinical benefit and safety of current and future assisted reproductive technology.

PubMed

Brown, Rachel; Harper, Joyce

2012-08-01

Since the first birth by IVF was achieved in 1978, the techniques involved in assisted reproductive technology have grown at an enormous rate. However, new technology has rarely been robustly validated before clinical use and developing scientific understanding of the available techniques has done little to alter their use. Furthermore, there are inconsistencies in the available clinical studies and endpoints. The benefits of some technologies already established for routine use are currently dubious and there are clear ethical concerns with providing them to patients when their scientific basis is not clear. As the uptake of assisted reproductive technology increases and newer technologies continue to push the boundaries of science, it is important to consider the clinical benefits and safety of all assisted reproductive technologies. This review will discuss aspects of some of the more recent techniques, including sperm DNA-damage tests, intracytoplasmic morphologically selected sperm injection, amino acid and metabolomics profiling, preimplantation genetic screening and time-lapse imaging, and those that may have substantial impacts on the field of reproductive medicine in the future including artificial gametes, ovarian transplantation and gene therapy. Copyright © 2012 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Drug error in paediatric anaesthesia: current status and where to go now.

PubMed

Anderson, Brian J

2018-06-01

Medication errors in paediatric anaesthesia and the perioperative setting continue to occur despite widespread recognition of the problem and published advice for reduction of this predicament at international, national, local and individual levels. Current literature was reviewed to ascertain drug error rates and to appraise causes and proposed solutions to reduce these errors. The medication error incidence remains high. There is documentation of reduction through identification of causes with consequent education and application of safety analytics and quality improvement programs in anaesthesia departments. Children remain at higher risk than adults because of additional complexities such as drug dose calculations, increased susceptibility to some adverse effects and changes associated with growth and maturation. Major improvements are best made through institutional system changes rather than a commitment to do better on the part of each practitioner. Medication errors in paediatric anaesthesia represent an important risk to children and most are avoidable. There is now an understanding of the genesis of adverse drug events and this understanding should facilitate the implementation of known effective countermeasures. An institution-wide commitment and strategy are the basis for a worthwhile and sustained improvement in medication safety.

Engineered nanomaterials in food: implications for food safety and consumer health.

PubMed

Martirosyan, Alina; Schneider, Yves-Jacques

2014-05-28

From the current state-of-the-art, it is clear that nanotechnology applications are expected to bring a range of benefits to the food sector aiming at providing better quality and conservation. In the meantime, a growing number of studies indicate that the exposure to certain engineered nanomaterials (ENMs) has a potential to lead to health complications and that there is a need for further investigations in order to unravel the biological outcomes of nanofood consumption. In the current review, we summarize the existing data on the (potential) use of ENMs in the food industry, information on the toxicity profiles of the commonly applied ENMs, such as metal (oxide) nanoparticles (NPs), address the potential food safety implications and health hazards connected with the consumption of nanofood. A number of health complications connected with the human exposure to ENMs are discussed, demonstrating that there is a real basis for the arisen concern not only connected with the gut health, but also with the potency to lead to systemic toxicity. The toxicological nature of hazard, exposure levels and risk to consumers from nanotechnology-derived food are on the earliest stage of investigation and this review also highlights the major gaps that need further research and regulation.

78 FR 54280 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-03

... safety-related batteries would remain operable if all the inter-cell and terminal connections were at the... new acceptance criteria for total battery connection resistance to ensure that the safety-related batteries can perform their specified safety function. Basis for proposed no significant hazards...

29 CFR 1952.160 - Description of the plan as initially approved.

Code of Federal Regulations, 2010 CFR

2010-07-01

... include both occupational safety and occupational health, the latter on a developmental basis. The plan defines the covered occupational safety and health issues as defined by the Secretary of Labor in 29 CFR... Section 1952.160 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

29 CFR 1952.160 - Description of the plan as initially approved.

Code of Federal Regulations, 2011 CFR

2011-07-01

... include both occupational safety and occupational health, the latter on a developmental basis. The plan defines the covered occupational safety and health issues as defined by the Secretary of Labor in 29 CFR... Section 1952.160 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

29 CFR 1952.210 - Description of the plan as initially approved.

Code of Federal Regulations, 2011 CFR

2011-07-01

... throughout the State. The plan defines the covered occupational safety and health issues on the basis of... Section 1952.210 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... standards will be considered by the State Occupational Safety and Health Advisory Board which will make...

The Development and Deployment of a Maintenance Operations Safety Survey.

PubMed

Langer, Marie; Braithwaite, Graham R

2016-11-01

Based on the line operations safety audit (LOSA), two studies were conducted to develop and deploy an equivalent tool for aircraft maintenance: the maintenance operations safety survey (MOSS). Safety in aircraft maintenance is currently measured reactively, based on the number of audit findings, reportable events, incidents, or accidents. Proactive safety tools designed for monitoring routine operations, such as flight data monitoring and LOSA, have been developed predominantly for flight operations. In Study 1, development of MOSS, 12 test peer-to-peer observations were collected to investigate the practicalities of this approach. In Study 2, deployment of MOSS, seven expert observers collected 56 peer-to-peer observations of line maintenance checks at four stations. Narrative data were coded and analyzed according to the threat and error management (TEM) framework. In Study 1, a line check was identified as a suitable unit of observation. Communication and third-party data management were the key factors in gaining maintainer trust. Study 2 identified that on average, maintainers experienced 7.8 threats (operational complexities) and committed 2.5 errors per observation. The majority of threats and errors were inconsequential. Links between specific threats and errors leading to 36 undesired states were established. This research demonstrates that observations of routine maintenance operations are feasible. TEM-based results highlight successful management strategies that maintainers employ on a day-to-day basis. MOSS is a novel approach for safety data collection and analysis. It helps practitioners understand the nature of maintenance errors, promote an informed culture, and support safety management systems in the maintenance domain. © 2016, Human Factors and Ergonomics Society.

The Development and Deployment of a Maintenance Operations Safety Survey

PubMed Central

Langer, Marie; Braithwaite, Graham R.

2016-01-01

Objective: Based on the line operations safety audit (LOSA), two studies were conducted to develop and deploy an equivalent tool for aircraft maintenance: the maintenance operations safety survey (MOSS). Background: Safety in aircraft maintenance is currently measured reactively, based on the number of audit findings, reportable events, incidents, or accidents. Proactive safety tools designed for monitoring routine operations, such as flight data monitoring and LOSA, have been developed predominantly for flight operations. Method: In Study 1, development of MOSS, 12 test peer-to-peer observations were collected to investigate the practicalities of this approach. In Study 2, deployment of MOSS, seven expert observers collected 56 peer-to-peer observations of line maintenance checks at four stations. Narrative data were coded and analyzed according to the threat and error management (TEM) framework. Results: In Study 1, a line check was identified as a suitable unit of observation. Communication and third-party data management were the key factors in gaining maintainer trust. Study 2 identified that on average, maintainers experienced 7.8 threats (operational complexities) and committed 2.5 errors per observation. The majority of threats and errors were inconsequential. Links between specific threats and errors leading to 36 undesired states were established. Conclusion: This research demonstrates that observations of routine maintenance operations are feasible. TEM-based results highlight successful management strategies that maintainers employ on a day-to-day basis. Application: MOSS is a novel approach for safety data collection and analysis. It helps practitioners understand the nature of maintenance errors, promote an informed culture, and support safety management systems in the maintenance domain. PMID:27411354

The Gift Relationship Revisited.

PubMed

Shearmur, Jeremy Frank

2015-12-01

If unremunerated blood donors are willing to participate, and if the use of them is economical from the perspective of those collecting blood, I can see no objection to their use. But there seems to me no good reason, moral or practical, why they should be used. The system of paid plasmapheresis as it currently operates in the United States and in Canada would seem perfectly adequate, and while there may always be ways in which the safety and efficiency of supply could be increased, there seems no reason whatever to think that there would be an improvement if the current system changed so as to rely entirely on unpaid donors. Further, given the adequacy of paid plasmapheresis, I could see no problem if the collection of whole blood were to take place on a similar, fully-commercial, basis. Such a view is controversial. To argue for it, this paper offers just one strand in a complex argument: a critique of Richard Titmuss's Gift Relationship, which holds an iconic position in the critical literature on the paid provision of blood. As I conclude: all told, there seems no good basis for rejecting supply of whole blood for money--let alone the supply of blood plasma.

Aspirin in polycythemia vera and essential thrombocythemia: current facts and perspectives.

PubMed

Landolfi, R; Patrono, C

1996-09-01

The role of aspirin in the antithrombotic strategy of patients with polycythemia vera (PV) and essential thrombocythemia (ET) is highly controversial. Long considered unsafe on the basis of a single clinical trial testing very high doses in PV patients, aspirin is being increasingly used at lower dosage. The rationale for the use of aspirin in patients with PV and ET is provided by the efficacy of this agent in the treatment of microcirculatory disturbances of thrombocythemic states associated with myeloproliferative disorders and by recent evidence that asymptomatic PV and ET patients have persistently increased thromboxane (TX) A2-biosynthesis. This increase, which most likely reflects enhanced platelet activation in vivo, is independent of the platelet mass and blood viscosity and largely supressed by a short term low-dose aspirin regimen (50 mg/day for 7 days). Since enhanced TXA2 biosynthesis may play a role in transducing the increased thrombotic risk associated with PV and ET, long-term low-dose aspirin administration has been proposed as a possible antithombotic strategy in these subjects. The safety of this treatment in PV patients has been recently reassessed by the Gruppo Italiano per lo Studio della Policitemia Vera (GISP) which has followed for over one year 112 patients randomized to receive 40 mg/day aspirin or placebo. In the same study, serum TXB2 measurements provided evidence that the low-dose aspirin regimen tested was fully effective in inhibiting platelet cyclooxygenase activity. On this basis, a large scale trial aimed at assessing the antithrombotic efficacy of this approach is currently being organized. In patients with ET both the minimal aspirin dose required for complete inhibition of platelet cyclooxygenase and the safety of long-term aspirin administration need to be established prior to extensive clinical evaluation of this strategy.

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products...

[State of supply services for industrial hygiene and safety in Colombia].

PubMed

Varona, Marcela E; Torres, Carlos Humberto; Díaz, Sonia M; Palma, Ruth Marién; Checa, Diana Milena; Conde, Juan Vicente

2012-01-01

Institutions that supply occupational health services must offer services that are reliable and of high quality across the spectrum of industrial hygiene and safety needs. Services for occupational health were identified at several institutions, and the technical quality and reliability of these services were compared in different regions of Colombia. This descriptive study identified the services available for industrial hygiene and safety in 15 cities of Colombia. A survey was conducted in 192 institutions offering such services and a statistical analysis of these results was undertaken. This sample was taken from a nationwide list of institutions purportedly licensed for this activity. Thirty-two percent (61) of the evaluated institutions provided hygiene services, and 48% (93) provided safety services. The range of health services was provided on a subcontract basis both for professional personnel and the equipment. Six institutions in the area of industrial hygiene and 1 in the area of industrial security were supplying services with pending or suspended institutional licenses. Deficiencies in the quality, infrastructure and levels of automation were identified at institutions that supply services of hygiene and industrial security. The resulting recommendatios are that the Ministry of the Social Protection fortifies mechanisms for (1) the evaluation and control of the supplied services, and (2) verify that the institutional activity is in accordance with current and valid licensing.

A system safety model for developmental aircraft programs

NASA Technical Reports Server (NTRS)

Amberboy, E. J.; Stokeld, R. L.

1982-01-01

Basic tenets of safety as applied to developmental aircraft programs are presented. The integration of safety into the project management aspects of planning, organizing, directing and controlling is illustrated by examples. The basis for project management use of safety and the relationship of these management functions to 'real-world' situations is presented. The rationale which led to the safety-related project decision and the lessons learned as they may apply to future projects are presented.

FLAMMABLE GAS TECHNICAL BASIS DOCUMENT

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

KRIPPS, L.J.

2005-02-18

This document describes the qualitative evaluation of frequency and consequences for double shell tank (DST) and single shell tank (SST) representative flammable gas accidents and associated hazardous conditions without controls. The evaluation indicated that safety-significant SSCs and/or TSRS were required to prevent or mitigate flammable gas accidents. Discussion on the resulting control decisions is included. This technical basis document was developed to support of the Tank Farms Documented Safety Analysis (DSA) and describes the risk binning process for the flammable gas representative accidents and associated represented hazardous conditions. The purpose of the risk binning process is to determine the needmore » for safety-significant structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls for a given representative accident or represented hazardous condition based on an evaluation of the event frequency and consequence.« less

AP1000{sup R} nuclear power plant safety overview for spent fuel cooling

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

Gorgemans, J.; Mulhollem, L.; Glavin, J.

2012-07-01

The AP1000{sup R} plant is an 1100-MWe class pressurized water reactor with passive safety features and extensive plant simplifications that enhance construction, operation, maintenance, safety and costs. The AP1000 design uses passive features to mitigate design basis accidents. The passive safety systems are designed to function without safety-grade support systems such as AC power, component cooling water, service water or HVAC. Furthermore, these passive features 'fail safe' during a non-LOCA event such that DC power and instrumentation are not required. The AP1000 also has simple, active, defense-in-depth systems to support normal plant operations. These active systems provide the first levelmore » of defense against more probable events and they provide investment protection, reduce the demands on the passive features and support the probabilistic risk assessment. The AP1000 passive safety approach allows the plant to achieve and maintain safe shutdown in case of an accident for 72 hours without operator action, meeting the expectations provided in the U.S. Utility Requirement Document and the European Utility Requirements for passive plants. Limited operator actions are required to maintain safe conditions in the spent fuel pool via passive means. In line with the AP1000 approach to safety described above, the AP1000 plant design features multiple, diverse lines of defense to ensure spent fuel cooling can be maintained for design-basis events and beyond design-basis accidents. During normal and abnormal conditions, defense-in-depth and other systems provide highly reliable spent fuel pool cooling. They rely on off-site AC power or the on-site standby diesel generators. For unlikely design basis events with an extended loss of AC power (i.e., station blackout) or loss of heat sink or both, spent fuel cooling can still be provided indefinitely: - Passive systems, requiring minimal or no operator actions, are sufficient for at least 72 hours under all possible pool heat load conditions. - After 3 days, several different means are provided to continue spent fuel cooling using installed plant equipment as well as off-site equipment with built-in connections. Even for beyond design basis accidents with postulated pool damage and multiple failures in the passive safety-related systems and in the defense-in-depth active systems, the AP1000 multiple spent fuel pool spray and fill systems provide additional lines of defense to prevent spent fuel damage. (authors)« less

Psychosocial influences on safety climate: evidence from community pharmacies.

PubMed

Phipps, Denham L; Ashcroft, Darren M

2011-12-01

To examine the relationship between psychosocial job characteristics and safety climate. Cross-sectional survey. Community pharmacies in Great Britain. Participants A random sample of community pharmacists registered in Great Britain (n = 860). Survey instruments Effort-reward imbalance (ERI) indicator and Job Content Questionnaire (JCQ). Main outcome measures Pharmacy Safety Climate Questionnaire (PSCQ). The profile of scores from the ERI indicated a relatively high risk of adverse psychological effects. The profile of scores from the JCQ indicated both high demand on pharmacists and a high level of psychological and social resources to meet these demands. Path analysis confirmed a model in which the ERI and JCQ measures, as well as the type of pharmacy and pharmacist role, predicted responses to the PSCQ (χ(2)(36) = 111.38, p < 0.001; Tucker-Lewis index = 0.96; comparative fit index = 0.98; root mean square error of approximation=0.05). Two general factors (effort vs reward and control vs demand) accounted for the effect of job characteristics on safety climate ratings; each had differential effects on the PSCQ scales. The safety climate in community pharmacies is influenced by perceptions of job characteristics, such as the level of job demands and the resources available to meet these demands. Hence, any efforts to improve safety should take into consideration the effect of the psychosocial work environment on safety climate. In addition, there is a need to address the presence of work-related stressors, which have the potential to cause direct or indirect harm to staff and service users. The findings of the current study provide a basis for future research to improve the safety climate and well-being, both in the pharmacy profession and in other healthcare settings.

Five year follow-up after a first booster vaccination against tick-borne encephalitis following different primary vaccination schedules demonstrates long-term antibody persistence and safety.

PubMed

Beran, Jiří; Xie, Fang; Zent, Olaf

2014-07-23

Long-term vaccination programs are recommended for individuals living in regions endemic for tick-borne encephalitis (TBE). Current recommendations suggest a first booster vaccine be administered 3 years after a conventional regimen or 12-18 months after a rapid regimen. However, the research supporting subsequent booster intervals is limited. The aim of this study was thus to evaluate the long-term persistence of TBE antibodies in adults and adolescents after a first booster dose with Encepur(®). A total of 323 subjects aged 15 years and over, who had received one of four different primary TBE vaccination series in a parent study, participated in this follow-up Phase IV trial. Immunogenicity and safety were assessed for up to five years after a first booster dose, which was administered three years after completion of the primary series. One subset of subjects was excluded from the booster vaccination since they had already received their booster prior to enrollment. For comparison, immune responses were still recorded for these subjects on Day 0 and on an annual basis until Year 5, but safety information was not collected. Following a booster vaccination, high antibody titers were recorded in all groups throughout the study. Neutralization test (NT) titers of ≥ 10 were noted in at least 94% of subjects at every time point post-booster (on Day 21 and through Years 1-5). These results demonstrated that a first booster vaccination following any primary immunization schedule results in high and long-lasting (>5 years) immune responses. These data lend support to the current belief that subsequent TBE booster intervals could be extended from the current recommendation. NCT00387634. Copyright © 2014 Elsevier Ltd. All rights reserved.

Crash risk factors for interstate large trucks in North Carolina.

PubMed

Teoh, Eric R; Carter, Daniel L; Smith, Sarah; McCartt, Anne T

2017-09-01

Provide an updated examination of risk factors for large truck involvements in crashes resulting in injury or death. A matched case-control study was conducted in North Carolina of large trucks operated by interstate carriers. Cases were defined as trucks involved in crashes resulting in fatal or non-fatal injury, and one control truck was matched on the basis of location, weekday, time of day, and truck type. The matched-pair odds ratio provided an estimate of the effect of various driver, vehicle, or carrier factors. Out-of-service (OOS) brake violations tripled the risk of crashing; any OOS vehicle defect increased crash risk by 362%. Higher historical crash rates (fatal, injury, or all crashes) of the carrier were associated with increased risk of crashing. Operating on a short-haul exemption increased crash risk by 383%. Antilock braking systems reduced crash risk by 65%. All of these results were statistically significant at the 95% confidence level. Other safety technologies also showed estimated benefits, although not statistically significant. With the exception of the finding that short-haul exemption is associated with increased crash risk, results largely bolster what is currently known about large truck crash risk and reinforce current enforcement practices. Results also suggest vehicle safety technologies can be important in lowering crash risk. This means that as safety technology continues to penetrate the fleet, whether from voluntary usage or government mandates, reductions in large truck crashes may be achieved. Practical application: Results imply that increased enforcement and use of crash avoidance technologies can improve the large truck crash problem. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

What do you feel if I apply transcranial electric stimulation? Safety, sensations and secondary induced effects.

PubMed

Fertonani, Anna; Ferrari, Clarissa; Miniussi, Carlo

2015-11-01

The goals of this work are to report data regarding a large number of stimulation sessions and to use model analyses to explain the similarities or differences in the sensations induced by different parameters of tES application. We analysed sensation data relative to 693 different tES sessions. In particular, we studied the effects on sensations induced by different types of current, categories of polarity and frequency, different timing, levels of current density and intensity, different electrode sizes and different electrode locations (areas). The application of random or fixed alternating current stimulation (i.e., tRNS and tACS) over the scalp induced less sensation compared with transcranial direct current stimulation (tDCS), regardless of the application parameters. Moreover, anodal tDCS induced more annoyance in comparison to other tES. Additionally, larger electrodes induced stronger sensations compared with smaller electrodes, and higher intensities were more strongly perceived. Timing of stimulation, montage and current density did not influence sensations perception. The analyses demonstrated that the induced sensations could be clustered on the basis of the type of somatosensory system activated. Finally and most important no adverse events were reported. Induced sensations are modulated by electrode size and intensity and mainly pertain to the cutaneous receptor activity of the somatosensory system. Moreover, the procedure currently used to perform placebo stimulation may not be totally effective when compared with anodal tDCS. The reported observations enrich the literature regarding the safety aspects of tES, confirming that it is a painless and safe technique. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2011 CFR

2011-01-01

... for the design and construction of a new DOE nuclear facility or a major modification to an existing... acceptable nuclear safety design criteria for use in preparing a preliminary documented safety analysis. As a... mitigate hazards to workers, the public, or the environment. They include (1) physical, design, structural...

49 CFR Appendix A to Part 385 - Explanation of Safety Audit Evaluation Criteria

Code of Federal Regulations, 2010 CFR

2010-10-01

... safety management controls in place, is included in Appendix B, VII. List of Acute and Critical... having similar characteristics are combined together into six regulatory areas called “factors.” The regulatory factors, evaluated on the basis of the adequacy of the carrier's safety management controls, are...

76 FR 4420 - OSRAM SYLVANIA Products, Inc., Receipt of Petition for Decision of Inconsequential Noncompliance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

... basis that this noncompliance is inconsequential to motor vehicle safety. This notice of receipt of... petition OSRAM SYLVANIA argues that the noncompliance is inconsequential to motor vehicle safety for the... conforming to all applicable Federal motor vehicle safety standards. Subject ``H11 C'' light sources are...

Safe Schools Report 2004-2005

ERIC Educational Resources Information Center

New Mexico Public Education Department, 2006

2006-01-01

Safety in New Mexico's schools is one of the most important issues facing our communities. Every school and school district in the state make it a priority to identify and implement ways to increase the safety, security and integrity of students, teachers, staff, parents and visitors at our schools on a daily basis. Safety is critical for…

76 FR 23708 - Safety Zone; Pierce County Department of Emergency Management Regional Water Exercise, East...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-28

...-AA00 Safety Zone; Pierce County Department of Emergency Management Regional Water Exercise, East... the Regional Water Rescue Exercise. Basis and Purpose The Pierce County, Washington, Department of... to read as follows: Sec. 165.T13-0251 Safety Zone; Pierce County Department of Emergency Management...

ITS logical architecture : volume 3, data dictionary.

DOT National Transportation Integrated Search

1981-01-01

The objective of the research effort was to develop an empirically and experiencially based model pedestrian safety program which cities can use as guidelines for pedestrian safety program planning, implementation, and evaluation. The basis of these ...

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2014 CFR

2014-01-01

... following design basis events to ensure— (A) The integrity of the reactor coolant pressure boundary; (B) The...) Design basis events are defined as conditions of normal operation, including anticipated operational occurrences, design basis accidents, external events, and natural phenomena for which the plant must be...

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2013 CFR

2013-01-01

... following design basis events to ensure— (A) The integrity of the reactor coolant pressure boundary; (B) The...) Design basis events are defined as conditions of normal operation, including anticipated operational occurrences, design basis accidents, external events, and natural phenomena for which the plant must be...

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2010 CFR

2010-01-01

... following design basis events to ensure— (A) The integrity of the reactor coolant pressure boundary; (B) The...) Design basis events are defined as conditions of normal operation, including anticipated operational occurrences, design basis accidents, external events, and natural phenomena for which the plant must be...

28 CFR 32.16 - Payment.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) more than one individual, on the basis of being a public safety officer's parent as his mother, or on that basis as his father. If more than one parent qualifies as the officer's mother, or as his father...

Replacement Condition Detection of Railway Point Machines Using an Electric Current Sensor.

PubMed

Sa, Jaewon; Choi, Younchang; Chung, Yongwha; Kim, Hee-Young; Park, Daihee; Yoon, Sukhan

2017-01-29

Detecting replacement conditions of railway point machines is important to simultaneously satisfy the budget-limit and train-safety requirements. In this study, we consider classification of the subtle differences in the aging effect-using electric current shape analysis-for the purpose of replacement condition detection of railway point machines. After analyzing the shapes of after-replacement data and then labeling the shapes of each before-replacement data, we can derive the criteria that can handle the subtle differences between "does-not-need-to-be-replaced" and "needs-to-be-replaced" shapes. On the basis of the experimental results with in-field replacement data, we confirmed that the proposed method could detect the replacement conditions with acceptable accuracy, as well as provide visual interpretability of the criteria used for the time-series classification.

Replacement Condition Detection of Railway Point Machines Using an Electric Current Sensor

PubMed Central

Sa, Jaewon; Choi, Younchang; Chung, Yongwha; Kim, Hee-Young; Park, Daihee; Yoon, Sukhan

2017-01-01

Detecting replacement conditions of railway point machines is important to simultaneously satisfy the budget-limit and train-safety requirements. In this study, we consider classification of the subtle differences in the aging effect—using electric current shape analysis—for the purpose of replacement condition detection of railway point machines. After analyzing the shapes of after-replacement data and then labeling the shapes of each before-replacement data, we can derive the criteria that can handle the subtle differences between “does-not-need-to-be-replaced” and “needs-to-be-replaced” shapes. On the basis of the experimental results with in-field replacement data, we confirmed that the proposed method could detect the replacement conditions with acceptable accuracy, as well as provide visual interpretability of the criteria used for the time-series classification. PMID:28146057

Safety and Security Interface Technology Initiative

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

Dr. Michael A. Lehto; Kevin J. Carroll; Dr. Robert Lowrie

Safety and Security Interface Technology Initiative Mr. Kevin J. Carroll Dr. Robert Lowrie, Dr. Micheal Lehto BWXT Y12 NSC Oak Ridge, TN 37831 865-576-2289/865-241-2772 carrollkj@y12.doe.gov Work Objective. Earlier this year, the Energy Facility Contractors Group (EFCOG) was asked to assist in developing options related to acceleration deployment of new security-related technologies to assist meeting design base threat (DBT) needs while also addressing the requirements of 10 CFR 830. NNSA NA-70, one of the working group participants, designated this effort the Safety and Security Interface Technology Initiative (SSIT). Relationship to Workshop Theme. “Supporting Excellence in Operations Through Safety Analysis,” (workshop theme)more » includes security and safety personnel working together to ensure effective and efficient operations. One of the specific workshop elements listed in the call for papers is “Safeguards/Security Integration with Safety.” This paper speaks directly to this theme. Description of Work. The EFCOG Safety Analysis Working Group (SAWG) and the EFCOG Security Working Group formed a core team to develop an integrated process involving both safety basis and security needs allowing achievement of the DBT objectives while ensuring safety is appropriately considered. This effort garnered significant interest, starting with a two day breakout session of 30 experts at the 2006 Safety Basis Workshop. A core team was formed, and a series of meetings were held to develop that process, including safety and security professionals, both contractor and federal personnel. A pilot exercise held at Idaho National Laboratory (INL) in mid-July 2006 was conducted as a feasibility of concept review. Work Results. The SSIT efforts resulted in a topical report transmitted from EFCOG to DOE/NNSA in August 2006. Elements of the report included: Drivers and Endstate, Control Selections Alternative Analysis Process, Terminology Crosswalk, Safety Basis/Security Documentation Integration, Configuration Control, and development of a shared ‘tool box’ of information/successes. Specific Benefits. The expectation or end state resulting from the topical report and associated implementation plan includes: (1) A recommended process for handling the documentation of the security and safety disciplines, including an appropriate change control process and participation by all stakeholders. (2) A means to package security systems with sufficient information to help expedite the flow of that system through the process. In addition, a means to share successes among sites, to include information and safety basis to the extent such information is transportable. (3) Identification of key security systems and associated essential security elements being installed and an arrangement for the sites installing these systems to host an appropriate team to review a specific system and determine what information is exportable. (4) Identification of the security systems’ essential elements and appropriate controls required for testing of these essential elements in the facility. (5) The ability to help refine and improve an agreed to control set at the manufacture stage.« less

National Environmental Policy Act Hazards Assessment for the TREAT Alternative

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

Boyd D. Christensen; Annette L. Schafer

2013-11-01

This document provides an assessment of hazards as required by the National Environmental Policy Act for the alternative of restarting the reactor at the Transient Reactor Test (TREAT) facility by the Resumption of Transient Testing Program. Potential hazards have been identified and screening level calculations have been conducted to provide estimates of unmitigated dose consequences that could be incurred through this alternative. Consequences considered include those related to use of the TREAT Reactor, experiment assembly handling, and combined events involving both the reactor and experiments. In addition, potential safety structures, systems, and components for processes associated with operating TREAT andmore » onsite handling of nuclear fuels and experiments are listed. If this alternative is selected, a safety basis will be prepared in accordance with 10 CFR 830, “Nuclear Safety Management,” Subpart B, “Safety Basis Requirements.”« less

National Environmental Policy Act Hazards Assessment for the TREAT Alternative

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

Christensen, Boyd D.; Schafer, Annette L.

2014-02-01

This document provides an assessment of hazards as required by the National Environmental Policy Act for the alternative of restarting the reactor at the Transient Reactor Test (TREAT) facility by the Resumption of Transient Testing Program. Potential hazards have been identified and screening level calculations have been conducted to provide estimates of unmitigated dose consequences that could be incurred through this alternative. Consequences considered include those related to use of the TREAT Reactor, experiment assembly handling, and combined events involving both the reactor and experiments. In addition, potential safety structures, systems, and components for processes associated with operating TREAT andmore » onsite handling of nuclear fuels and experiments are listed. If this alternative is selected, a safety basis will be prepared in accordance with 10 CFR 830, “Nuclear Safety Management,” Subpart B, “Safety Basis Requirements.”« less

The Development of Project Orion Ground Safety Requirements

NASA Technical Reports Server (NTRS)

Kirkpatrick, Paul; Condzella, Bill; Williams, Jeff

2011-01-01

In spite of a very compressed schedule, Project Orion's AFT safety team was able to pull together a comprehensive set of ground safety requirements using existing requirements and subject matter experts. These requirements will serve as the basis for the design of GSE and ground operations. Using the above lessons as a roadmap, new Projects can produce the same results. A rigorous set of ground safety requirements is required to assure ground support equipment (GSE) and associated flight hardware ground operations are conducted safety

Medication safety.

PubMed

Keohane, Carol A; Bates, David W

2008-03-01

Patient safety is a state of mind, not a technology. The technologies used in the medical setting represent tools that must be properly designed, used well, and assessed on an on-going basis. Moreover, in all settings, building a culture of safety is pivotal for improving safety, and many nontechnologic approaches, such as medication reconciliation and teaching patients about their medications, are also essential. This article addresses the topic of medication safety and examines specific strategies being used to decrease the incidence of medication errors across various clinical settings.

77 FR 64411 - Safety Zone; Cooper T. Smith Fireworks Event; Mobile River; Mobile, AL

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... 1625-AA00 Safety Zone; Cooper T. Smith Fireworks Event; Mobile River; Mobile, AL AGENCY: Coast Guard.... Smith Fireworks Event. Entry into, transiting or anchoring in this zone is prohibited to all vessels... safety hazards associated with a fireworks display. B. Basis and Purpose Cooper T. Smith Corp. has hired...

Quantifying Pilot Contribution to Flight Safety During Dual Generator Failure

NASA Technical Reports Server (NTRS)

Etherington, Timothy J.; Kramer, Lynda J.; Kennedy, Kellie D.; Bailey, Randall E.; Last, Mary Carolyn

2017-01-01

Accident statistics cite flight crew error in over 60% of accidents involving transport category aircraft. Yet, a well-trained and well-qualified pilot is acknowledged as the critical center point of aircraft systems safety and an integral safety component of the entire commercial aviation system. No data currently exists that quantifies the contribution of the flight crew in this role. Neither does data exist for how often the flight crew handles non-normal procedures or system failures on a daily basis in the National Airspace System. A pilot-in-the-loop high fidelity motion simulation study was conducted by the NASA Langley Research Center in partnership with the Federal Aviation Administration (FAA) to evaluate the pilot's contribution to flight safety during normal flight and in response to aircraft system failures. Eighteen crews flew various normal and non-normal procedures over a two-day period and their actions were recorded in response to failures. To quantify the human's contribution, crew complement was used as the experiment independent variable in a between-subjects design. Pilot actions and performance when one of the flight crew was unavailable were also recorded for comparison against the nominal two-crew operations. This paper details diversion decisions, perceived safety of flight, workload, time to complete pertinent checklists, and approach and landing results while dealing with a complete loss of electrical generators. Loss of electrical power requires pilots to complete the flight without automation support of autopilots, flight directors, or auto throttles. For reduced crew complements, the additional workload and perceived safety of flight was considered unacceptable.

Assessing patient safety in Canadian ambulatory surgery facilities: A national survey

PubMed Central

Ahmad, Jamil; Ho, Olivia A; Carman, Wayne W; Thoma, Achilles; Lalonde, Donald H; Lista, Frank

2014-01-01

BACKGROUND: There has been increased interest regarding patient safety and standards of care in Canadian ambulatory surgery facilities where surgical procedures are performed. The Canadian Association for Accreditation of Ambulatory Surgical Facilities (CAAASF) is a national organization formed to establish and maintain standards to ensure that surgical procedures conducted outside of public hospitals are performed safely. OBJECTIVE: To determine how many procedures are performed annually at CAAASF member sites, and to examine complication rates and several key patient safety practices. METHODS: All 69 facilities accredited by the CAAASF were surveyed. The survey focused on procedural data, complication rates and patient safety interventions. RESULTS: In 2010, 40,240 estimated procedures were performed. A total of 263 (0.007%) complications were reported. Sixteen (0.0004%) patients required reoperations in hospital and 19 (0.0004%) patients required transfer to hospital on the day of surgery. There were only two mortalities within 30 days of surgery reported in the past five years. With regard to patient safety practices, 93% used antimicrobial prophylaxis, 100% used strategies to maintain normothermia and 82% used measures for venous thromboembolism prevention. CONCLUSION: The present study is the first to report on the Canadian experience in ambulatory surgery facilities and provides insight into current practices at these facilities. Appropriate accreditation of ambulatory surgery facilities, well-established patient safety-related standards of care, careful patient selection and procedures performed by qualified health care professionals with appropriate certification practicing within the scope of their practice form the basis for safe and effective ambulatory surgery. PMID:25152645

Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases.

PubMed

Novák, Zoltán; Yáñez, Anahí; Kiss, Ildikó; Kuna, Piotr; Tortajada-Girbés, Miguel; Valiente, Román

2016-08-01

Regulations on medicinal products for paediatric use require that pharmacokinetics and safety be characterized specifically in the paediatric population. A previous study established that a 10-mg dose of bilastine in children aged 2 to <12 years provided an equivalent systemic exposure as 20 mg in adults. The current study assessed the safety and tolerability of bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria. In this phase III, multicentre, double-blind study, children were randomized to once-daily treatment with bilastine 10-mg oral dispersible table (n = 260) or placebo (n = 249) for 12 weeks. Safety evaluations included treatment-emergent adverse events (TEAEs), laboratory tests, cardiac safety (ECG recordings) and somnolence/sedation using the Pediatric Sleep Questionnaire (PSQ). The primary hypothesis of non-inferiority between bilastine 10 mg and placebo was demonstrated on the basis of a near-equivalent proportion of children in each treatment arm without TEAEs during 12 weeks' treatment (31.5 vs. 32.5%). No clinically relevant differences between bilastine 10 mg and placebo were observed from baseline to study end for TEAEs or related TEAEs, ECG parameters and PSQ scores. The majority of TEAEs were mild or moderate in intensity. TEAEs led to discontinuation of two patients treated with bilastine 10 mg and one patient treated with placebo. Bilastine 10 mg had a safety and tolerability profile similar to that of placebo in children aged 2 to <12 years with allergic rhinoconjunctivitis or chronic urticaria. © 2016 The Authors. Pediatric Allergy and Immunology Published by John Wiley & Sons Ltd.

Using the Human Systems Simulation Laboratory at Idaho National Laboratory for Safety Focused Research

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

Joe, Jeffrey .C; Boring, Ronald L.

Under the United States (U.S.) Department of Energy (DOE) Light Water Reactor Sustainability (LWRS) program, researchers at Idaho National Laboratory (INL) have been using the Human Systems Simulation Laboratory (HSSL) to conduct critical safety focused Human Factors research and development (R&D) for the nuclear industry. The LWRS program has the overall objective to develop the scientific basis to extend existing nuclear power plant (NPP) operating life beyond the current 60-year licensing period and to ensure their long-term reliability, productivity, safety, and security. One focus area for LWRS is the NPP main control room (MCR), because many of the instrumentation andmore » control (I&C) system technologies installed in the MCR, while highly reliable and safe, are now difficult to replace and are therefore limiting the operating life of the NPP. This paper describes how INL researchers use the HSSL to conduct Human Factors R&D on modernizing or upgrading these I&C systems in a step-wise manner, and how the HSSL has addressed a significant gap in how to upgrade systems and technologies that are built to last, and therefore require careful integration of analog and new advanced digital technologies.« less

Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices.

PubMed

Kraft, Marc

2008-09-03

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority.

Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices

PubMed Central

Kraft, Marc

2008-01-01

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority. PMID:20204095

Using Risk Assessment Methodologies to Meet Management Objectives

NASA Technical Reports Server (NTRS)

DeMott, D. L.

2015-01-01

Current decision making involves numerous possible combinations of technology elements, safety and health issues, operational aspects and process considerations to satisfy program goals. Identifying potential risk considerations as part of the management decision making process provides additional tools to make more informed management decision. Adapting and using risk assessment methodologies can generate new perspectives on various risk and safety concerns that are not immediately apparent. Safety and operational risks can be identified and final decisions can balance these considerations with cost and schedule risks. Additional assessments can also show likelihood of event occurrence and event consequence to provide a more informed basis for decision making, as well as cost effective mitigation strategies. Methodologies available to perform Risk Assessments range from qualitative identification of risk potential, to detailed assessments where quantitative probabilities are calculated. Methodology used should be based on factors that include: 1) type of industry and industry standards, 2) tasks, tools, and environment 3) type and availability of data and 4) industry views and requirements regarding risk & reliability. Risk Assessments are a tool for decision makers to understand potential consequences and be in a position to reduce, mitigate or eliminate costly mistakes or catastrophic failures.

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

Hurt, Christopher J.; Freels, James D.; Hobbs, Randy W.

There has been a considerable effort over the previous few years to demonstrate and optimize the production of plutonium-238 ( 238Pu) at the High Flux Isotope Reactor (HFIR). This effort has involved resources from multiple divisions and facilities at the Oak Ridge National Laboratory (ORNL) to demonstrate the fabrication, irradiation, and chemical processing of targets containing neptunium-237 ( 237Np) dioxide (NpO 2)/aluminum (Al) cermet pellets. A critical preliminary step to irradiation at the HFIR is to demonstrate the safety of the target under irradiation via documented experiment safety analyses. The steady-state thermal safety analyses of the target are simulated inmore » a finite element model with the COMSOL Multiphysics code that determines, among other crucial parameters, the limiting maximum temperature in the target. Safety analysis efforts for this model discussed in the present report include: (1) initial modeling of single and reduced-length pellet capsules in order to generate an experimental knowledge base that incorporate initial non-linear contact heat transfer and fission gas equations, (2) modeling efforts for prototypical designs of partially loaded and fully loaded targets using limited available knowledge of fabrication and irradiation characteristics, and (3) the most recent and comprehensive modeling effort of a fully coupled thermo-mechanical approach over the entire fully loaded target domain incorporating burn-up dependent irradiation behavior and measured target and pellet properties, hereafter referred to as the production model. These models are used to conservatively determine several important steady-state parameters including target stresses and temperatures, the limiting condition of which is the maximum temperature with respect to the melting point. The single pellet model results provide a basis for the safety of the irradiations, followed by parametric analyses in the initial prototypical designs that were necessary due to the limiting fabrication and irradiation data available. The calculated parameters in the final production target model are the most accurate and comprehensive, while still conservative. Over 210 permutations in irradiation time and position were evaluated, and are supported by the most recent inputs and highest fidelity methodology. The results of these analyses show that the models presented in this report provide a robust and reliable basis for previous, current and future experiment safety analyses. In addition, they reveal an evolving knowledge of the steady-state behavior of the NpO 2/Al pellets under irradiation for a variety of target encapsulations and potential conditions.« less

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

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

PubMed

Leszczynski, Dariusz; Xu, Zhengping

2010-01-27

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

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

PubMed Central

2010-01-01

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

ASME Nuclear Crane Standards for Enhanced Crane Safety and Increased Profit

NASA Astrophysics Data System (ADS)

Parkhurst, Stephen N.

2000-01-01

The ASME NOG-1 standard, 'Rules for Construction of Overhead and Gantry Cranes', covers top running cranes for nuclear facilities; with the ASME NUM-1 standard, 'Rules for Construction of Cranes, Monorails, and Hoists', covering the single girder, underhung, wall and jib cranes, as well as the monorails and hoists. These two ASME nuclear crane standards provide criteria for designing, inspecting and testing overhead handling equipment with enhanced safety to meet the 'defense-in-depth' approach of the United States Nuclear Regulatory Commission (USNRC) documents NUREG 0554 and NUREG 0612. In addition to providing designs for enhanced safety, the ASME nuclear crane standards provide a basis for purchasing overhead handling equipment with standard safety features, based upon accepted engineering principles, and including performance and environmental parameters specific to nuclear facilities. The ASME NOG-1 and ASME NUM-1 standards not only provide enhanced safety for handling a critical load, but also increase profit by minimizing the possibility of load drops, by reducing cumbersome operating restrictions, and by providing the foundation for a sound licensing position. The ASME nuclear crane standards can also increase profit by providing the designs and information to help ensure that the right standard equipment is purchased. Additionally, the ASME nuclear crane standards can increase profit by providing designs and information to help address current issues, such as the qualification of nuclear plant cranes for making 'planned engineered lifts' for steam generator replacement and decommissioning.

Fire safety in transit systems fault tree analysis

DOT National Transportation Integrated Search

1981-09-01

Fire safety countermeasures applicable to transit vehicles are identified and evaluated. This document contains fault trees which illustrate the sequences of events which may lead to a transit-fire related casualty. A description of the basis for the...

Pilot Construction Project for Granular Shoulder Stabilization

DOT National Transportation Integrated Search

2013-09-30

Granular shoulders need to be maintained on a regular basis because edge ruts and potholes develop, posing a safety hazard to motorists. The successful mitigation of edge-rut issues for granular shoulders would increase safety and reduce the number o...

Perspectives on setting limits for RF contact currents: a commentary.

PubMed

Tell, Richard A; Tell, Christopher A

2018-01-15

Limits for exposure to radiofrequency (RF) contact currents are specified in the two dominant RF safety standards and guidelines developed by the Institute of Electrical and Electronics Engineers (IEEE) and the International Commission on Non-Ionizing Radiation Protection (ICNIRP). These limits are intended to prevent RF burns when contacting RF energized objects caused by high local tissue current densities. We explain what contact currents are and review some history of the relevant limits with an emphasis on so-called "touch" contacts, i.e., contact between a person and a contact current source during touch via a very small contact area. Contact current limits were originally set on the basis of controlling the specific absorption rate resulting from the current flowing through regions of small conductive cross section within the body, such as the wrist or ankle. More recently, contact currents have been based on thresholds of perceived heating. In the latest standard from the IEEE developed for NATO, contact currents have been based on two research studies in which thresholds for perception of thermal warmth or thermal pain have been measured. Importantly, these studies maximized conductive contact between the subject and the contact current source. This factor was found to dominate the response to heating wherein high resistance contact, such as from dry skin, can result in local heating many times that from a highly conductive contact. Other factors such as electrode size and shape, frequency of the current and the physical force associated with contact are found to introduce uncertainty in threshold values when comparing data across multiple studies. Relying on studies in which the contact current is minimized for a given threshold does not result in conservative protection limits. Future efforts to develop limits on contact currents should include consideration of (1) the basis for the limits (perception, pain, tissue damage); (2) understanding of the practical conditions of real world exposure for contact currents such as contact resistance, size and shape of the contact electrode and applied force at the point of contact; (3) consistency of how contact currents are applied in research studies across different researchers; (4) effects of frequency.

Scientific evaluation of the safety factor for the acceptable daily intake (ADI). Case study: butylated hydroxyanisole (BHA).

PubMed

Würtzen, G

1993-01-01

The principles of 'data-derived safety factors' are applied to toxicological and biochemical information on butylated hydroxyanisole (BHA). The calculated safety factor for an ADI is, by this method, comparable to the existing internationally recognized safety evaluations. Relevance for humans of forestomach tumours in rodents is discussed. The method provides a basis for organizing data in a way that permits an explicit assessment of its relevance.

Simulation of data safety components for corporative systems

NASA Astrophysics Data System (ADS)

Yaremko, Svetlana A.; Kuzmina, Elena M.; Savchuk, Tamara O.; Krivonosov, Valeriy E.; Smolarz, Andrzej; Arman, Abenov; Smailova, Saule; Kalizhanova, Aliya

2017-08-01

The article deals with research of designing data safety components for corporations by means of mathematical simulations and modern information technologies. Simulation of threats ranks has been done which is based on definite values of data components. The rules of safety policy for corporative information systems have been presented. The ways of realization of safety policy rules have been proposed on the basis of taken conditions and appropriate class of valuable data protection.

DWPF Melter Off-Gas Flammability Assessment for Sludge Batch 9

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

Choi, A. S.

2016-07-11

The slurry feed to the Defense Waste Processing Facility (DWPF) melter contains several organic carbon species that decompose in the cold cap and produce flammable gases that could accumulate in the off-gas system and create potential flammability hazard. To mitigate such a hazard, DWPF has implemented a strategy to impose the Technical Safety Requirement (TSR) limits on all key operating variables affecting off-gas flammability and operate the melter within those limits using both hardwired/software interlocks and administrative controls. The operating variables that are currently being controlled include; (1) total organic carbon (TOC), (2) air purges for combustion and dilution, (3)more » melter vapor space temperature, and (4) feed rate. The safety basis limits for these operating variables are determined using two computer models, 4-stage cold cap and Melter Off-Gas (MOG) dynamics models, under the baseline upset scenario - a surge in off-gas flow due to the inherent cold cap instabilities in the slurry-fed melter.« less

Review of the OSHA framework for oversight of occupational environments.

PubMed

Choi, Jae-Young; Ramachandran, Gurumurthy

2009-01-01

The OSHA system for oversight of chemicals in the workplace was evaluated to derive lessons for oversight of nanotechnology. Criteria relating to the development, attributes, evolution, and outcomes of the system were used for evaluation that was based upon quantitative expert elicitation and historical literature analysis. The oversight system had inadequate resources in terms of finances, expertise, and personnel, and insufficient incentive for compliance. The system showed a lack of flexibility in novel situations. There were minimal requirements on companies for data on health and safety of their products. These factors have a strong influence on public confidence and health and safety. The oversight system also scored low on attributes such as public input, transparency, empirical basis, conflict of interest, and informed consent. The experts in our sample tend to believe that the current oversight system for chemicals in the workplace is neither adequate nor effective. It is very likely that the performance of the OSHA oversight system for nanomaterials will be equally inadequate.

High Content Analysis technology for evaluating the joint toxicity of sunset yellow and sodium sulfite in vitro.

PubMed

Qu, Daofeng; Gu, Yanpei; Feng, Lifang; Han, Jianzhong

2017-10-15

Foods contain various additives that affect our daily lives. At present, food additive safety evaluation standards are based on the toxicity of single additives, but food additives are often used in combination and may have additive, synergistic or antagonistic actions. The current study investigated the toxicity of food additives and mechanisms of damage in HepG2 cells using High Content Analysis (HCA). We used the CCK-8 assay to determine cell viability, providing an experimental basis for determining the safety of food additives. All of the food additives tested were observed to decrease the growth of HepG2 cells in a dose-dependent manner. Sunset yellow and sodium sulfite had IC50 values of 1.06, and 0.30g/L at 24h, respectively. HCA showed that both sunset yellow and sodium sulfite had synergistic effects on cell number, membrane permeability, mitochondrial membrane potential, intracellular calcium level, oxidative stress, and high dose group DNA damage. Copyright © 2017 Elsevier Ltd. All rights reserved.

Routine pharmacogenetic testing in clinical practice: dream or reality?

PubMed

Grossman, Iris

2007-10-01

Pharmacogenetics (PGx) has become progressively popular in recent years, thanks to growing anticipation among scientists, healthcare providers and the general public for the incorporation of genetic tests into the diagnostic arsenal at the physician's disposal. Indeed, much research has been dedicated to elucidation of genetic determinants underlying interindividual variability in pharmacokinetic parameters, as well as drug safety and efficacy. However, few PGx applications have thus far been realized in healthcare management. This review uses examples from PGx research of psychiatric drugs to illustrate why the current published findings are inadequate and insufficient for utilization as routine clinical predictors of treatment safety, efficacy or dosing. I therefore suggest the necessary steps to demonstrate the validity, utility and cost-effectiveness of PGx. These recommendations include a whole range of aspects, starting from standardization of criteria and assessment of the technical quality of genotyping assays, up to design of prospective PGx studies, providing the basis for reimbursement programs to be recognized in routine clinical practice.

Impact of Passive Safety on FHR Instrumentation Systems Design and Classification

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

Holcomb, David Eugene

2015-01-01

Fluoride salt-cooled high-temperature reactors (FHRs) will rely more extensively on passive safety than earlier reactor classes. 10CFR50 Appendix A, General Design Criteria for Nuclear Power Plants, establishes minimum design requirements to provide reasonable assurance of adequate safety. 10CFR50.69, Risk-Informed Categorization and Treatment of Structures, Systems and Components for Nuclear Power Reactors, provides guidance on how the safety significance of systems, structures, and components (SSCs) should be reflected in their regulatory treatment. The Nuclear Energy Institute (NEI) has provided 10 CFR 50.69 SSC Categorization Guideline (NEI-00-04) that factors in probabilistic risk assessment (PRA) model insights, as well as deterministic insights, throughmore » an integrated decision-making panel. Employing the PRA to inform deterministic requirements enables an appropriately balanced, technically sound categorization to be established. No FHR currently has an adequate PRA or set of design basis accidents to enable establishing the safety classification of its SSCs. While all SSCs used to comply with the general design criteria (GDCs) will be safety related, the intent is to limit the instrumentation risk significance through effective design and reliance on inherent passive safety characteristics. For example, FHRs have no safety-significant temperature threshold phenomena, thus enabling the primary and reserve reactivity control systems required by GDC 26 to be passively, thermally triggered at temperatures well below those for which core or primary coolant boundary damage would occur. Moreover, the passive thermal triggering of the primary and reserve shutdown systems may relegate the control rod drive motors to the control system, substantially decreasing the amount of safety-significant wiring needed. Similarly, FHR decay heat removal systems are intended to be running continuously to minimize the amount of safety-significant instrumentation needed to initiate operation of systems and components important to safety as required in GDC 20. This paper provides an overview of the design process employed to develop a pre-conceptual FHR instrumentation architecture intended to lower plant capital and operational costs by minimizing reliance on expensive, safety related, safety-significant instrumentation through the use of inherent passive features of FHRs.« less

Assessment of Integrated Pedestrian Protection Systems with Autonomous Emergency Braking (AEB) and Passive Safety Components.

PubMed

Edwards, Mervyn; Nathanson, Andrew; Carroll, Jolyon; Wisch, Marcus; Zander, Oliver; Lubbe, Nils

2015-01-01

Autonomous emergency braking (AEB) systems fitted to cars for pedestrians have been predicted to offer substantial benefit. On this basis, consumer rating programs-for example, the European New Car Assessment Programme (Euro NCAP)-are developing rating schemes to encourage fitment of these systems. One of the questions that needs to be answered to do this fully is how the assessment of the speed reduction offered by the AEB is integrated with the current assessment of the passive safety for mitigation of pedestrian injury. Ideally, this should be done on a benefit-related basis. The objective of this research was to develop a benefit-based methodology for assessment of integrated pedestrian protection systems with AEB and passive safety components. The method should include weighting procedures to ensure that it represents injury patterns from accident data and replicates an independently estimated benefit of AEB. A methodology has been developed to calculate the expected societal cost of pedestrian injuries, assuming that all pedestrians in the target population (i.e., pedestrians impacted by the front of a passenger car) are impacted by the car being assessed, taking into account the impact speed reduction offered by the car's AEB (if fitted) and the passive safety protection offered by the car's frontal structure. For rating purposes, the cost for the assessed car is normalized by comparing it to the cost calculated for a reference car. The speed reductions measured in AEB tests are used to determine the speed at which each pedestrian in the target population will be impacted. Injury probabilities for each impact are then calculated using the results from Euro NCAP pedestrian impactor tests and injury risk curves. These injury probabilities are converted into cost using "harm"-type costs for the body regions tested. These costs are weighted and summed. Weighting factors were determined using accident data from Germany and Great Britain and an independently estimated AEB benefit. German and Great Britain versions of the methodology are available. The methodology was used to assess cars with good, average, and poor Euro NCAP pedestrian ratings, in combination with a current AEB system. The fitment of a hypothetical A-pillar airbag was also investigated. It was found that the decrease in casualty injury cost achieved by fitting an AEB system was approximately equivalent to that achieved by increasing the passive safety rating from poor to average. Because the assessment was influenced strongly by the level of head protection offered in the scuttle and windscreen area, a hypothetical A-pillar airbag showed high potential to reduce overall casualty cost. A benefit-based methodology for assessment of integrated pedestrian protection systems with AEB has been developed and tested. It uses input from AEB tests and Euro NCAP passive safety tests to give an integrated assessment of the system performance, which includes consideration of effects such as the change in head impact location caused by the impact speed reduction given by the AEB.

Rail Safety/Equipment Crashworthiness : Volume 1. A Systems Analysis of Injury Minimization in Rail Systems

DOT National Transportation Integrated Search

1978-07-01

The Department of Transportation, Transportation Systems Center (TSC), is providing technical assistance to the Federal Railroad Administration (FRA) in a program to improve railroad safety and efficiency by providing a technological basis for improv...

76 FR 55796 - Safety Zone; TriRock Triathlon, San Diego Bay, San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

...-AA00 Safety Zone; TriRock Triathlon, San Diego Bay, San Diego, CA AGENCY: Coast Guard, DHS. ACTION.... Basis and Purpose Competitor Group is sponsoring the TriRock Triathlon, consisting of 2000 swimmers.... 165.T11-431 to read as follows: Sec. 165.T11-431 Safety Zone; TriRock Triathlon, San Diego Bay, San...

[International trend of guidance for nanomaterial risk assessment].

PubMed

Hirose, Akihiko

2013-01-01

In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.

Current global and Korean issues in radiation safety of nuclear medicine procedures.

PubMed

Song, H C

2016-06-01

In recent years, the management of patient doses in medical imaging has evolved as concern about radiation exposure has increased. Efforts and techniques to reduce radiation doses are focussed not only on the basis of patient safety, but also on the fundamentals of justification and optimisation in cooperation with international organisations such as the International Commission on Radiological Protection, the International Atomic Energy Agency, and the World Health Organization. The Image Gently campaign in children and Image Wisely campaign in adults to lower radiation doses have been initiated in the USA. The European Association of Nuclear Medicine paediatric dosage card, North American consensus guidelines, and Nuclear Medicine Global Initiative have recommended the activities of radiopharmaceuticals that should be administered in children. Diagnostic reference levels (DRLs), developed predominantly in Europe, may be an important tool to manage patient doses. In Korea, overexposure to radiation, even from the use of medical imaging, has become a public issue, particularly since the accident at the Fukushima nuclear power plant. As a result, the Korean Nuclear Safety and Security Commission revised the technical standards for radiation safety management in medical fields. In parallel, DRLs for nuclear medicine procedures have been collected on a nationwide scale. Notice of total effective dose from positron emission tomography-computed tomography for cancer screening has been mandatory since mid-November 2014. © The International Society for Prosthetics and Orthotics.

Why patients need leaders: introducing a ward safety checklist

PubMed Central

Amin, Yogen; Grewcock, Dave; Andrews, Steve; Halligan, Aidan

2012-01-01

The safety and consistency of the care given to hospital inpatients has recently become a particular political and public concern. The traditional ‘ward round’ presents an obvious opportunity for systematically and collectively ensuring that proper standards of care are being achieved for individual patients. This paper describes the design and implementation of a ‘ward safety checklist’ that defines a set of potential risk factors that should be checked on a daily basis, and offers multidisciplinary teams a number of prompts for sharing and clarifying information between themselves, and with the patient, during a round. The concept of the checklist and the desire to improve ward rounds were well received in many teams, but the barriers to adoption were informative about the current culture on many inpatient wards. Although the ‘multidisciplinary ward round’ is widely accepted as good practice, the medical and nursing staff in many teams are failing to coordinate their workloads well enough to make multidisciplinary rounds a working reality. ‘Nursing’ and ‘medical’ care on the ward have become ‘de-coupled’ and the potential consequences for patient safety and good communication are largely self-evident. This problem is further complicated by a medical culture which values the primacy of clinical autonomy and as a result can be resistant to perceived attempts to ‘systematize’ medical care through instruments such as checklists. PMID:22977047

SLUDGE TREATMENT PROJECT KOP DISPOSITION - THERMAL AND GAS ANALYSIS FOR THE COLD VACUUM DRYING FACILITY

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

SWENSON JA; CROWE RD; APTHORPE R

2010-03-09

The purpose of this document is to present conceptual design phase thermal process calculations that support the process design and process safety basis for the cold vacuum drying of K Basin KOP material. This document is intended to demonstrate that the conceptual approach: (1) Represents a workable process design that is suitable for development in preliminary design; and (2) Will support formal safety documentation to be prepared during the definitive design phase to establish an acceptable safety basis. The Sludge Treatment Project (STP) is responsible for the disposition of Knock Out Pot (KOP) sludge within the 105-K West (KW) Basin.more » KOP sludge consists of size segregated material (primarily canister particulate) from the fuel and scrap cleaning process used in the Spent Nuclear Fuel process at K Basin. The KOP sludge will be pre-treated to remove fines and some of the constituents containing chemically bound water, after which it is referred to as KOP material. The KOP material will then be loaded into a Multi-Canister Overpack (MCO), dried at the Cold Vacuum Drying Facility (CVDF) and stored in the Canister Storage Building (CSB). This process is patterned after the successful drying of 2100 metric tons of spent fuel, and uses the same facilities and much of the same equipment that was used for drying fuel and scrap. Table ES-l present similarities and differences between KOP material and fuel and between MCOs loaded with these materials. The potential content of bound water bearing constituents limits the mass ofKOP material in an MCO load to a fraction of that in an MCO containing fuel and scrap; however, the small particle size of the KOP material causes the surface area to be significantly higher. This relatively large reactive surface area represents an input to the KOP thermal calculations that is significantly different from the calculations for fuel MCOs. The conceptual design provides for a copper insert block that limits the volume available to receive KOP material, enhances heat conduction, and functions as a heat source and sink during drying operations. This use of the copper insert represents a significant change to the thermal model compared to that used for the fuel calculations. A number of cases were run representing a spectrum of normal and upset conditions for the drying process. Dozens of cases have been run on cold vacuum drying of fuel MCOs. Analysis of these previous calculations identified four cases that provide a solid basis for judgments on the behavior of MCO in drying operations. These four cases are: (1) Normal Process; (2) Degraded vacuum pumping; (3) Open MCO with loss of annulus water; and (4) Cool down after vacuum drying. The four cases were run for two sets of input parameters for KOP MCOs: (1) a set of parameters drawn from safety basis values from the technical data book and (2) a sensitivity set using parameters selected to evaluate the impact of lower void volume and smaller particle size on MCO behavior. Results of the calculations for the drying phase cases are shown in Table ES-2. Cases using data book safety basis values showed dry out in 9.7 hours and heat rejection sufficient to hold temperature rise to less than 25 C. Sensitivity cases which included unrealistically small particle sizes and corresponding high reactive surface area showed higher temperature increases that were limited by water consumption. In this document and in the attachment (Apthorpe, R. and M.G. Plys, 2010) cases using Technical Databook safety basis values are referred to as nominal cases. In future calculations such cases will be called safety basis cases. Also in these documents cases using parameters that are less favorable to acceptable performance than databook safety values are referred to as safety cases. In future calculations such cases will be called sensitivity cases or sensitivity evaluations Calculations to be performed in support of the detailed design and formal safety basis documentation will expand the calculations presented in this document to include: additional features of the drying cycle, more realistic treatment of uranium metal consumption during oxidation, larger water inventory, longer time scales, and graphing of results of hydrogen gas concentration.« less

Shielding Strategies for Human Space Exploration

NASA Technical Reports Server (NTRS)

Wilson J. W. (Editor); Miller, J. (Editor); Konradi, A. (Editor); Cucinotta, F. A. (Editor)

1997-01-01

A group of twenty-nine scientists and engineers convened a 'Workshop on Shielding Strategies for Human Space Exploration' at the Lyndon B. Johnson Space Center in Houston, Texas. The provision of shielding for a Mars mission or a Lunar base from the hazards of space radiations is a critical technology since astronaut radiation safety depends on it and shielding safety factors to control risk uncertainty appear to be great. The purpose of the workshop was to define requirements for the development and evaluation of high performance shield materials and designs and to develop ideas regarding approaches to radiation shielding. The workshop was organized to review the recent experience on shielding strategies gained in studies of the 'Space Exploration Initiative (SEI),' to review the current knowledge base for making shield assessment, to examine a basis for new shielding strategies, and to recommend a strategy for developing the required technologies for a return to the moon or for Mars exploration. The uniqueness of the current workshop arises from the expected long duration of the missions without the protective cover of the geomagnetic field in which the usually small and even neglected effects of the galactic cosmic rays (GCR) can no longer be ignored. It is the peculiarity of these radiations for which the inter-action physics and biological action are yet to be fully understood.

Safety margins in zircaloy oxidation and embrittlement criteria for emergency core cooling system acceptance

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

Williford, R.E.

1986-09-01

Current emergency core cooling system acceptance criteria for light water reactors specify that, under loss-of-coolant accident (LOCA) conditions, the Baker-Just (BJ) correlation must be used to calculate Zircaloy-steam oxidation, calculated peak cladding temperatures (PCT) must not exceed 1204/sup 0/C, and calculated oxidation must not exceed 17% equivalent cladding reacted (ECR). An appropriately defined minimum margin of safety was estimated for each of these criteria. The currently required BJ oxidation correlation provides margins only over the 1100 to 1500/sup 0/C temperature range at the 95% confidence level. The PCT margins for thermal shock and handling failures are adequate at oxidation temperaturesmore » above 1204/sup 0/C for up to 210 and 160 s, respectively, at the 95% confidence level. The ECR thermal shock and handling margins at the 50 and 95% confidence levels, respectively, range between 2 and 7% ECR for the BJ correlation, but vanish at temperatures above 1100 to 1160/sup 0/C for the best-estimate Cathcart-Pawel correlation. However, use of the Cathcart Pawel correlation for ''design basis'' LOCA calculations can be justified at the 85 to 88% confidence level if cooling rate effects can be neglected.« less

Engineered Nanomaterials in Food: Implications for Food Safety and Consumer Health

PubMed Central

Martirosyan, Alina; Schneider, Yves-Jacques

2014-01-01

From the current state-of-the-art, it is clear that nanotechnology applications are expected to bring a range of benefits to the food sector aiming at providing better quality and conservation. In the meantime, a growing number of studies indicate that the exposure to certain engineered nanomaterials (ENMs) has a potential to lead to health complications and that there is a need for further investigations in order to unravel the biological outcomes of nanofood consumption. In the current review, we summarize the existing data on the (potential) use of ENMs in the food industry, information on the toxicity profiles of the commonly applied ENMs, such as metal (oxide) nanoparticles (NPs), address the potential food safety implications and health hazards connected with the consumption of nanofood. A number of health complications connected with the human exposure to ENMs are discussed, demonstrating that there is a real basis for the arisen concern not only connected with the gut health, but also with the potency to lead to systemic toxicity. The toxicological nature of hazard, exposure levels and risk to consumers from nanotechnology-derived food are on the earliest stage of investigation and this review also highlights the major gaps that need further research and regulation. PMID:24879486

Rationales for home safety promotion in the Iranian primary healthcare system: results from a pilot study.

PubMed

Mohammadi, R; Ekman, R; Svanström, L; Gooya, M M

2006-01-01

To analyse the prerequisites for a nationwide primary healthcare (PHC) home safety promotion programme in Iran. Injury is a major public health problem throughout the world, currently accounting for one-seventh of all premature deaths and disabilities. Within 20 years, it is estimated that the proportion will increase to one-fifth. The present healthcare system in Iran was started in 1979, with a major focus on easy access to services and prevention. The system is based on the 'health house', which is run by community health workers. A survey shows that 36% of injuries occur in the home environment. A pilot phase of the Home Safety Promotion Programme was initiated in 1994, and included safety checking at home for fences, kitchens, drugs and poisons, heaters, electricity, and stairs and ladders. The pilot study covered 478,551 households out of the 12 million (approximately) in Iran. Sixty-nine supervisors were involved individually, assembled into eight focus groups. Household safety increased by 10-20% over the 4 years of the study. The frequency of home visits changed from annual to seasonal, since all participants agreed that there were seasonal differences in safety problems. The supervisors showed a high level of knowledge of injury as a public health problem, and also positive attitudes towards doing something about safety on the basis of a PHC scheme. The role of a surveillance system was highlighted, and it was suggested that such a system should be added to the programme. Based on our preliminary findings, there were reasons to obtain a policy decision concerning a national programme for safety promotion before extending the pilot scheme to the whole country. A national safety programme was decided upon following completion of the pilot study. It includes a home-related-injury surveillance system that is mandatory in rural areas and voluntary in some cities.

Occupational Safety Review of High Technology Facilities

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

Lee Cadwallader

2005-01-31

This report contains reviews of operating experiences, selected accident events, and industrial safety performance indicators that document the performance of the major US DOE magnetic fusion experiments and particle accelerators. These data are useful to form a basis for the occupational safety level at matured research facilities with known sets of safety rules and regulations. Some of the issues discussed are radiation safety, electromagnetic energy exposure events, and some of the more widespread issues of working at height, equipment fires, confined space work, electrical work, and other industrial hazards. Nuclear power plant industrial safety data are also included for comparison.

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

Ensuring safety of implanted devices under MRI using reversed RF polarization.

PubMed

Overall, William R; Pauly, John M; Stang, Pascal P; Scott, Greig C

2010-09-01

Patients with long-wire medical implants are currently prevented from undergoing magnetic resonance imaging (MRI) scans due to the risk of radio frequency (RF) heating. We have developed a simple technique for determining the heating potential for these implants using reversed radio frequency (RF) polarization. This technique could be used on a patient-to-patient basis as a part of the standard prescan procedure to ensure that the subject's device does not pose a heating risk. By using reversed quadrature polarization, the MR scan can be sensitized exclusively to the potentially dangerous currents in the device. Here, we derive the physical principles governing the technique and explore the primary sources of inaccuracy. These principles are verified through finite-difference simulations and through phantom scans of implant leads. These studies demonstrate the potential of the technique for sensitively detecting potentially dangerous coupling conditions before they can do any harm. 2010 Wiley-Liss, Inc.

Study on the Rule of Super Strata Movement and Subsidence

NASA Astrophysics Data System (ADS)

Yao, Shunli; Yuan, Hongyong; Jiang, Fuxing; Chen, Tao; Wu, Peng

2018-01-01

The movement of key strata is related to the safety of the whole earth’s surface for coal mining under super strata. Based on the key strata theory, the paper comprehensively analyzes the characteristics of the subsidence before and after the instability of the super strata by studing through FLAC3D and microseismic dynamic monitoring of the surface rock movement observation. The stability of the super strata movement is analyzed according to the characteristic value of the subsidence. The subsidence law and quantitative indexes under the control of the super rock strata that provides basis for the prevention and control of surface risk, optimize mining area and face layout and reasonably set mining boundary around mining area. It provides basis for the even growth of mine safety production and regional public safety.

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

Egg processing plant sanitation, SSOPs, and GMPs.

USDA-ARS?s Scientific Manuscript database

The basis of food safety programs in processing facilities is prerequisite programs such as sanitation and good manufacturing practices. Thoughtful, thorough, and complete sanitation programs are necessary to enhance the food safety of products and reduce the likelihood of foodborne illness. Egg p...

Large trucks involved in fatal crashes : the North Carolina data 1993-1997

DOT National Transportation Integrated Search

1999-03-01

An analysis of large, truck-involved crash outcomes in North Carolina for the period 1993-1997 was conducted by the UNC Highway Safety Research Center (HSRC) for the purpose of establishing an empirical basis for subsequent Governor's Highway Safety ...

Further Analysis of Motorcycle Helmet Effectiveness Using CODES Linked Data

DOT National Transportation Integrated Search

1998-01-01

Linked data from the Crash Outcome Data Evaluation System (CODES) in seven : states was used by the National Highway Traffic Safety Administration as the : basis of a 1996 Report to Congress on the Benefits of Safety Belts and : Motorcycle Helmets (D...

1998 motor vehicle occupant safety survey. Volume 1, methodology report

DOT National Transportation Integrated Search

2000-03-01

This is the Methodology Report for the 1998 Motor Vehicle Occupant Safety Survey. The survey is conducted on a biennial basis (initiated in 1994), and is administered by telephone to a randomly selected national sample. Two questionnaires are used, e...

47 CFR 101.1305 - Private internal service.

Code of Federal Regulations, 2010 CFR

2010-10-01

... business purposes or public safety communications and not on a for-hire or for-profit basis. ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Private internal service. 101.1305 Section 101.1305 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES...

Materials Safety Data Sheets: the basis for control of toxic chemicals

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

Ketchen, E.E.; Porter, W.E.

1979-09-01

The Material Safety Data Sheets contained in this volume are the basis for the Toxic Chemical Control Program developed by the Industrial Hygiene Department, Health Division, ORNL. The three volumes are the update and expansion of ORNL/TM-5721 and ORNL/TM-5722 Material Safety Data Sheets: The Basis for Control of Toxic Chemicals, Volume I and Volume II. As such, they are a valuable adjunct to the data cards issued with specific chemicals. The chemicals are identified by name, stores catalog number where appropriate, and sequence numbers from the NIOSH Registry of Toxic Effects of Chemical Substances, 1977 Edition, if available. The datamore » sheets were developed and compiled to aid in apprising the employees of hazards peculiar to the handling and/or use of specific toxic chemicals. Space limitation necessitate the use of descriptive medical terms and toxicological abbreviations. A glossary and an abbreviation list were developed to define some of those sometimes unfamiliar terms and abbreviations. The page numbers are keyed to the catalog number in the chemical stores at ORNL.« less

Materials Safety Data Sheets: the basis for control of toxic chemicals

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

Ketchen, E.E.; Porter, W.E.

The Material Safety Data Sheets contained in this volume are the basis for the Toxic Chemical Control Program developed by the Industrial Hygiene Department, Health Division, ORNL. The three volumes are the update and expansion of ORNL/TM-5721 and ORNL/TM-5722 Material Safety Data Sheets: The Basis for Control of Toxic Chemicals, Volume I and Volume II. As such, they are a valuable adjunct to the data cards issued with specific chemicals. The chemicals are identified by name, stores catalog number where appropriate, and sequence numbers from the NIOSH Registry of Toxic Effects of Chemical Substances, 1977 Edition, if available. The datamore » sheets were developed and compiled to aid in apprising the employees of hazards peculiar to the handling and/or use of specific toxic chemicals. Space limitation necessitate the use of descriptive medical terms and toxicological abbreviations. A glossary and an abbreviation list were developed to define some of those sometimes unfamiliar terms and abbreviations. The page numbers are keyed to the catalog number in the chemical stores at ORNL.« less

The carcinogenic effects of aspartame: The urgent need for regulatory re-evaluation.

PubMed

Soffritti, Morando; Padovani, Michela; Tibaldi, Eva; Falcioni, Laura; Manservisi, Fabiana; Belpoggi, Fiorella

2014-04-01

Aspartame (APM) is an artificial sweetener used since the 1980s, now present in >6,000 products, including over 500 pharmaceuticals. Since its discovery in 1965, and its first approval by the US Food and Drugs Administration (FDA) in 1981, the safety of APM, and in particular its carcinogenicity potential, has been controversial. The present commentary reviews the adequacy of the design and conduct of carcinogenicity bioassays on rodents submitted by G.D. Searle, in the 1970s, to the FDA for market approval. We also review how experimental and epidemiological data on the carcinogenic risks of APM, that became available in 2005 motivated the European Commission (EC) to call the European Food and Safety Authority (EFSA) for urgent re-examination of the available scientific documentation (including the Searle studies). The EC has further requested that, if the results of the evaluation should suggest carcinogenicity, major changes must be made to the current APM specific regulations. Taken together, the studies performed by G.D. Searle in the 1970s and other chronic bioassays do not provide adequate scientific support for APM safety. In contrast, recent results of life-span carcinogenicity bioassays on rats and mice published in peer-reviewed journals, and a prospective epidemiological study, provide consistent evidence of APM's carcinogenic potential. On the basis of the evidence of the potential carcinogenic effects of APM herein reported, a re-evaluation of the current position of international regulatory agencies must be considered an urgent matter of public health. © 2014 Wiley Periodicals, Inc.

Engineering test facility design definition

NASA Technical Reports Server (NTRS)

Bercaw, R. W.; Seikel, G. R.

1980-01-01

The Engineering Test Facility (ETF) is the major focus of the Department of Energy (DOE) Magnetohydrodynamics (MHD) Program to facilitate commercialization and to demonstrate the commercial operability of MHD/steam electric power. The ETF will be a fully integrated commercial prototype MHD power plant with a nominal output of 200 MW sub e. Performance of this plant is expected to meet or surpass existing utility standards for fuel, maintenance, and operating costs; plant availability; load following; safety; and durability. It is expected to meet all applicable environmental regulations. The current design concept conforming to the general definition, the basis for its selection, and the process which will be followed in further defining and updating the conceptual design.

Machine-Checkable Timed CSP

NASA Technical Reports Server (NTRS)

Goethel, Thomas; Glesner, Sabine

2009-01-01

The correctness of safety-critical embedded software is crucial, whereas non-functional properties like deadlock-freedom and real-time constraints are particularly important. The real-time calculus Timed Communicating Sequential Processes (CSP) is capable of expressing such properties and can therefore be used to verify embedded software. In this paper, we present our formalization of Timed CSP in the Isabelle/HOL theorem prover, which we have formulated as an operational coalgebraic semantics together with bisimulation equivalences and coalgebraic invariants. Furthermore, we apply these techniques in an abstract specification with real-time constraints, which is the basis for current work in which we verify the components of a simple real-time operating system deployed on a satellite.

The unpaved journey of vitamin C in cancer treatment.

PubMed

Chen, Qi; Polireddy, Kishore; Chen, Ping; Dong, Ruochen

2015-12-01

Effectiveness and low-toxicity to normal tissues are ideal properties for a cancer treatment, and one that numerous research programs are aiming for. Vitamin C has long been used in the field of Complementary and Alternative Medicine as a cancer treatment, with profound safety and anecdotal efficacy. Recent studies revealed the scientific basis for this use, and indicated that vitamin C, at supra-nutritional doses, holds considerable promise as an effective and low-toxic therapeutic strategy to treat cancer. Reviewed here are the early controversies surrounding vitamin C and cancer treatment, the breakthrough discoveries that led to the current advancement, and recent clinical studies, as well as research into its mechanisms of action.

Orbital transfer vehicle concept definition and systems analysis study. Volume 11: Study extension 2 results

NASA Technical Reports Server (NTRS)

Willcockson, W. H.

1988-01-01

Work conducted in the second extension of the Phase A Orbit Transfer Vehicle Concept Definition and Systems Analysis Study is summarized. Four major tasks were identified: (1) define an initial OTV program consistent with near term Civil Space Leadership Initiative missions; (2) develop program evolution to long term advanced missions; (3) investigate the implications of current STS safety policy on an Aft Cargo Carrier based OTV; and (4) expand the analysis of high entry velocity aeroassist. An increased emphasis on the breath of OTV applications was undertaken to show the need for the program on the basis of the expansion of the nation's capabilities in space.

Integrated deterministic and probabilistic safety analysis for safety assessment of nuclear power plants

DOE PAGES

Di Maio, Francesco; Zio, Enrico; Smith, Curtis; ...

2015-07-06

The present special issue contains an overview of the research in the field of Integrated Deterministic and Probabilistic Safety Assessment (IDPSA) of Nuclear Power Plants (NPPs). Traditionally, safety regulation for NPPs design and operation has been based on Deterministic Safety Assessment (DSA) methods to verify criteria that assure plant safety in a number of postulated Design Basis Accident (DBA) scenarios. Referring to such criteria, it is also possible to identify those plant Structures, Systems, and Components (SSCs) and activities that are most important for safety within those postulated scenarios. Then, the design, operation, and maintenance of these “safety-related” SSCs andmore » activities are controlled through regulatory requirements and supported by Probabilistic Safety Assessment (PSA).« less

The dread factor: how hazards and safety training influence learning and performance.

PubMed

Burke, Michael J; Salvador, Rommel O; Smith-Crowe, Kristin; Chan-Serafin, Suzanne; Smith, Alexis; Sonesh, Shirley

2011-01-01

On the basis of hypotheses derived from social and experiential learning theories, we meta-analytically investigated how safety training and workplace hazards impact the development of safety knowledge and safety performance. The results were consistent with an expected interaction between the level of engagement of safety training and hazardous event/exposure severity in the promotion of safety knowledge and performance. For safety knowledge and safety performance, highly engaging training was considerably more effective than less engaging training when hazardous event/exposure severity was high, whereas highly and less engaging training had comparable levels of effectiveness when hazardous event/exposure severity was low. Implications of these findings for theory testing and incorporating information on objective risk into workplace safety research and practice are discussed.

77 FR 29929 - Safety Zone; Town of Cape Charles Fireworks, Cape Charles Harbor, Cape Charles, VA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... section of this notice. Basis and Purpose On July 4, 2012 the Town of Cape Charles will sponsor a...-AA00 Safety Zone; Town of Cape Charles Fireworks, Cape Charles Harbor, Cape Charles, VA AGENCY: Coast... temporary safety zone on the waters of Cape Charles City Harbor in Cape Charles, VA in support of the Fourth...

76 FR 18672 - Safety Zone; Big Rock Blue Marlin Air Show; Bogue Sound, Morehead City, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-05

...-AA00 Safety Zone; Big Rock Blue Marlin Air Show; Bogue Sound, Morehead City, NC AGENCY: Coast Guard... Safety Zone for the ``Big Rock Blue Marlin Air Show'', an aerial demonstration to be held over the waters... Register. Basis and Purpose On June 11, 2011 from 7 p.m. to 8 p.m., the Big Rock Blue Marlin Tournament...

77 FR 35850 - Safety Zone; F/V Deep Sea, Penn Cove, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... 1625-AA00 Safety Zone; F/V Deep Sea, Penn Cove, WA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a safety zone around the Fishing Vessel (F/V) Deep Sea... with the sunken F/V Deep Sea. B. Basis and Purpose On the evening of May 13, 2012, the F/V Deep Sea...

School Safety, Severe Disciplinary Actions, and School Characteristics: A Secondary Analysis of the School Survey on Crime and Safety

ERIC Educational Resources Information Center

Han, Seunghee; Akiba, Motoko

2011-01-01

On the basis of a secondary analysis of survey data collected from 1,872 secondary school principals in the 2005-2006 School Survey on Crime and Safety, we examined the frequency of and reasons for severe disciplinary actions and the relationship between school characteristics and severe disciplinary actions. We found that severe disciplinary…

National survey on dose data analysis in computed tomography.

PubMed

Heilmaier, Christina; Treier, Reto; Merkle, Elmar Max; Alkhadi, Hatem; Weishaupt, Dominik; Schindera, Sebastian

2018-05-28

A nationwide survey was performed assessing current practice of dose data analysis in computed tomography (CT). All radiological departments in Switzerland were asked to participate in the on-line survey composed of 19 questions (16 multiple choice, 3 free text). It consisted of four sections: (1) general information on the department, (2) dose data analysis, (3) use of a dose management software (DMS) and (4) radiation protection activities. In total, 152 out of 241 Swiss radiological departments filled in the whole questionnaire (return rate, 63%). Seventy-nine per cent of the departments (n = 120/152) analyse dose data on a regular basis with considerable heterogeneity in the frequency (1-2 times per year, 45%, n = 54/120; every month, 35%, n = 42/120) and method of analysis. Manual analysis is carried out by 58% (n = 70/120) compared with 42% (n = 50/120) of departments using a DMS. Purchase of a DMS is planned by 43% (n = 30/70) of the departments with manual analysis. Real-time analysis of dose data is performed by 42% (n = 21/50) of the departments with a DMS; however, residents can access the DMS in clinical routine only in 20% (n = 10/50) of the departments. An interdisciplinary dose team, which among other things communicates dose data internally (63%, n = 76/120) and externally, is already implemented in 57% (n = 68/120) departments. Swiss radiological departments are committed to radiation safety. However, there is high heterogeneity among them regarding the frequency and method of dose data analysis as well as the use of DMS and radiation protection activities. • Swiss radiological departments are committed to and interest in radiation safety as proven by a 63% return rate of the survey. • Seventy-nine per cent of departments analyse dose data on a regular basis with differences in the frequency and method of analysis: 42% use a dose management software, while 58% currently perform manual dose data analysis. Of the latter, 43% plan to buy a dose management software. • Currently, only 25% of the departments add radiation exposure data to the final CT report.

Novel in vitro and mathematical models for the prediction of chemical toxicity.

PubMed

Williams, Dominic P; Shipley, Rebecca; Ellis, Marianne J; Webb, Steve; Ward, John; Gardner, Iain; Creton, Stuart

2013-01-01

The focus of much scientific and medical research is directed towards understanding the disease process and defining therapeutic intervention strategies. The scientific basis of drug safety is very complex and currently remains poorly understood, despite the fact that adverse drug reactions (ADRs) are a major health concern and a serious impediment to development of new medicines. Toxicity issues account for ∼21% drug attrition during drug development and safety testing strategies require considerable animal use. Mechanistic relationships between drug plasma levels and molecular/cellular events that culminate in whole organ toxicity underpins development of novel safety assessment strategies. Current in vitro test systems are poorly predictive of toxicity of chemicals entering the systemic circulation, particularly to the liver. Such systems fall short because of (1) the physiological gap between cells currently used and human hepatocytes existing in their native state, (2) the lack of physiological integration with other cells/systems within organs, required to amplify the initial toxicological lesion into overt toxicity, (3) the inability to assess how low level cell damage induced by chemicals may develop into overt organ toxicity in a minority of patients, (4) lack of consideration of systemic effects. Reproduction of centrilobular and periportal hepatocyte phenotypes in in vitro culture is crucial for sensitive detection of cellular stress. Hepatocyte metabolism/phenotype is dependent on cell position along the liver lobule, with corresponding differences in exposure to substrate, oxygen and hormone gradients. Application of bioartificial liver (BAL) technology can encompass in vitro predictive toxicity testing with enhanced sensitivity and improved mechanistic understanding. Combining this technology with mechanistic mathematical models describing intracellular metabolism, fluid-flow, substrate, hormone and nutrient distribution provides the opportunity to design the BAL specifically to mimic the in vivo scenario. Such mathematical models enable theoretical hypothesis testing, will inform the design of in vitro experiments, and will enable both refinement and reduction of in vivo animal trials. In this way, development of novel mathematical modelling tools will help to focus and direct in vitro and in vivo research, and can be used as a framework for other areas of drug safety science.

Novel in vitro and mathematical models for the prediction of chemical toxicity

PubMed Central

Shipley, Rebecca; Ellis, Marianne J.; Webb, Steve; Ward, John; Gardner, Iain; Creton, Stuart

2013-01-01

The focus of much scientific and medical research is directed towards understanding the disease process and defining therapeutic intervention strategies. The scientific basis of drug safety is very complex and currently remains poorly understood, despite the fact that adverse drug reactions (ADRs) are a major health concern and a serious impediment to development of new medicines. Toxicity issues account for ∼21% drug attrition during drug development and safety testing strategies require considerable animal use. Mechanistic relationships between drug plasma levels and molecular/cellular events that culminate in whole organ toxicity underpins development of novel safety assessment strategies. Current in vitro test systems are poorly predictive of toxicity of chemicals entering the systemic circulation, particularly to the liver. Such systems fall short because of (1) the physiological gap between cells currently used and human hepatocytes existing in their native state, (2) the lack of physiological integration with other cells/systems within organs, required to amplify the initial toxicological lesion into overt toxicity, (3) the inability to assess how low level cell damage induced by chemicals may develop into overt organ toxicity in a minority of patients, (4) lack of consideration of systemic effects. Reproduction of centrilobular and periportal hepatocyte phenotypes in in vitro culture is crucial for sensitive detection of cellular stress. Hepatocyte metabolism/phenotype is dependent on cell position along the liver lobule, with corresponding differences in exposure to substrate, oxygen and hormone gradients. Application of bioartificial liver (BAL) technology can encompass in vitro predictive toxicity testing with enhanced sensitivity and improved mechanistic understanding. Combining this technology with mechanistic mathematical models describing intracellular metabolism, fluid-flow, substrate, hormone and nutrient distribution provides the opportunity to design the BAL specifically to mimic the in vivo scenario. Such mathematical models enable theoretical hypothesis testing, will inform the design of in vitro experiments, and will enable both refinement and reduction of in vivo animal trials. In this way, development of novel mathematical modelling tools will help to focus and direct in vitro and in vivo research, and can be used as a framework for other areas of drug safety science. PMID:26966512

16 CFR 1034.110 - Self-evaluation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Self-evaluation. 1034.110 Section 1034.110 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE CONSUMER PRODUCT SAFETY COMMISSION § 1034.110...

Prediction of main factors’ values of air transportation system safety based on system dynamics

NASA Astrophysics Data System (ADS)

Spiridonov, A. Yu; Rezchikov, A. F.; Kushnikov, V. A.; Ivashchenko, V. A.; Bogomolov, A. S.; Filimonyuk, L. Yu; Dolinina, O. N.; Kushnikova, E. V.; Shulga, T. E.; Tverdokhlebov, V. A.; Kushnikov, O. V.; Fominykh, D. S.

2018-05-01

On the basis of the system-dynamic approach [1-8], a set of models has been developed that makes it possible to analyse and predict the values of the main safety indicators for the operation of aviation transport systems.

76 FR 53072 - Certification; Importation of Vehicles and Equipment Subject to Federal Safety, Bumper, and Theft...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-25

... used as a basis for the non-automatic suspension of an RI registration, deletes redundant text from... Part 592 as a Basis for the Non-Automatic Suspension or Revocation of an RI Registration B. Deletion of... violations of the regulations in part 592 as a basis for the non-automatic suspension or revocation of an RI...

75 FR 11574 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-11

... agency's ``Regulatory Guide'' series. This series was developed to describe and make available to the... protection during plant operation and maintenance activities. For plants that have a design basis that... coatings be qualified and capable of surviving a design-basis accident without adversely affecting safety...

16 CFR 1034.130 - General prohibitions against discrimination.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... 1034.130 Section 1034.130 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE CONSUMER... handicapped person shall, on the basis of handicap, be excluded from participation in, be denied the benefits...

47 CFR 87.1 - Basis and purpose.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES... purpose for which this part is issued. (a) Basis. The rules for the aviation services in this part are... Regulations). (3) The Convention on International Civil Aviation—(ICAO Convention). (b) Purpose. This part...

Assuring safety without animal testing: Unilever's ongoing research programme to deliver novel ways to assure consumer safety.

PubMed

Westmoreland, Carl; Carmichael, Paul; Dent, Matt; Fentem, Julia; MacKay, Cameron; Maxwell, Gavin; Pease, Camilla; Reynolds, Fiona

2010-01-01

Assuring consumer safety without the generation of new animal data is currently a considerable challenge. However, through the application of new technologies and the further development of risk-based approaches for safety assessment, we remain confident it is ultimately achievable. For many complex, multi-organ consumer safety endpoints, the development, evaluation and application of new, non-animal approaches is hampered by a lack of biological understanding of the underlying mechanistic processes involved. The enormity of this scientific challenge should not be underestimated. To tackle this challenge a substantial research programme was initiated by Unilever in 2004 to critically evaluate the feasibility of a new conceptual approach based upon the following key components: 1.Developing new, exposure-driven risk assessment approaches. 2.Developing new biological (in vitro) and computer-based (in silico) predictive models. 3.Evaluating the applicability of new technologies for generating data (e.g. "omics", informatics) and for integrating new types of data (e.g. systems approaches) for risk-based safety assessment. Our research efforts are focussed in the priority areas of skin allergy, cancer and general toxicity (including inhaled toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biology and molecular mechanisms that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement in EU-funded projects (e.g. Sens-it-iv, Carcinogenomics), participation in cross-industry collaborative research (e.g. Colipa, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US "Human Toxicology Project" consortium).

77 FR 48856 - Safety Zone; Superior Bay, Duluth, MN

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-15

... participants, event safety personnel, boaters and spectators during the Superior Man Triathlon. DATES: This..., spectators, and vessels from the hazards associated with the Superior Man Triathlon, which are discussed... interest. B. Basis and Purpose On August 26, 2012, the inaugural Superior Man Triathlon will occur along...

2007 motor vehicle occupant safety survey : use of and support for emergency medical services systems.

DOT National Transportation Integrated Search

2009-09-01

The Motor Vehicle Occupant Safety Survey (MVOSS) is a national telephone survey administered by NHTSA on a periodic basis to obtain data on attitudes, knowledge, and self-reported behavior primarily in areas of occupant protection. The sample is comp...

Equivalent Safety Basis for Evaluation of On-Site Packages for US DOE Facilities

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

Smith, A.C.

Packages for transport of radioactive material within the boundaries of a Department of Energy facility (on-site) must conform to the requirements for packages shipped in normal commerce, or must provide equivalent safety. Equivalence is achieved if the frequency of severe on-site accidents, which could result in a release of radioactive material, is less than or equal to the frequency of Beyond-HAC accidents for packages in commerce. This is shown to be achieved it the rate of on-site accident is 22 per 100 MVM or lower. For equivalence to Normal Conditions of Transport, for on-site packages, appropriate, defensible Design Basis Conditionsmore » can be established and the ability of the package to meet the reduced requirements shown in the On-site Safety Assessment.« less

42 CFR 485.701 - Basis and scope.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Therapy and Speech-Language Pathology Services § 485.701 Basis and scope. This subpart implements section 1861(p)(4) of the Act, which— (a) Defines outpatient physical therapy and speech pathology services; (b... records; and (c) Authorizes the Secretary to establish by regulation other health and safety requirements...

Criticality Safety Evaluation of the LLNL Inherently Safe Subcritical Assembly (ISSA)

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

Percher, Catherine

2012-06-19

The LLNL Nuclear Criticality Safety Division has developed a training center to illustrate criticality safety and reactor physics concepts through hands-on experimental training. The experimental assembly, the Inherently Safe Subcritical Assembly (ISSA), uses surplus highly enriched research reactor fuel configured in a water tank. The training activities will be conducted by LLNL following the requirements of an Integration Work Sheet (IWS) and associated Safety Plan. Students will be allowed to handle the fissile material under the supervision of LLNL instructors. This report provides the technical criticality safety basis for instructional operations with the ISSA experimental assembly.

Class act: safety comparison of approved tyrosine kinase inhibitors for non-small-cell lung carcinoma.

PubMed

Burotto, Mauricio; Ali, Syed Abbas; O'Sullivan Coyne, Geraldine

2015-01-01

The past decade has seen the development and widespread use of tyrosine kinase inhibitors (TKIs) targeting a mutated EGFR (mEGFR) for the treatment of metastatic NSCLC. We discuss the main properties of the TKIs currently recommended for the treatment of mEGFR NSCLC: gefitinib, erlotinib and afatinib. The mechanism of action, pharmacodynamics and pharmacokinetics of these drugs, with emphasis on the historical context of their preclinical and clinical development, will be covered, including potential resistance mechanisms to these first-generation TKIs that has driven the trial design for second and third generations of EGFR inhibitors. Six Phase III clinical trials comparing these three TKIs with cisplatin-based chemotherapy upfront for mEGFR NSCLC provide the basis for the comparative safety and toxicity analysis between these agents. Class-related toxicity of these EGFR inhibitors, including life-threatening effects, will be discussed. Toxicity and safety analysis from the Phase III trials of these agents in mEGFR populations suggests that afatinib has more frequent and severe side effects. Given that an efficacy advantage has not yet been demonstrated for afatinib over erlotinib and gefitinib, the consistent class toxicity profile of these agents means that gefitinib and erlotinib are a safer first-line treatment recommendation.

Critical features of an auditable management system for an ISO 9000-compatible occupational health and safety standard.

PubMed

Levine, S; Dyjack, D T

1997-04-01

An International Organization for Standardization (ISO) 9001: 1994-harmonized occupational health and safety (OHS) management system has been written at the University of Michigan, and reviewed, revised, and accepted under the direction of the American Industrial Hygiene Association (AIHA) Occupational Health and Safety Management Systems (OHSMS) Task Force and the Board of Directors. This system is easily adaptable to the ISO 14001 format and to both OHS and environmental management system applications. As was the case with ISO 9001: 1994, this system is expected to be compatible with current production quality and OHS quality systems and standards, have forward compatibility for new applications, and forward flexibility, with new features added as needed. Since ISO 9001: 1987 and 9001: 1994 have been applied worldwide, the incorporation of harmonized OHS and environmental management system components should be acceptable to business units already performing first-party (self-) auditing, and second-party (contract qualification) auditing. This article explains the basis of this OHS management system, its relationship to ISO 9001 and 14001 standards, the philosophy and methodology of an ISO-harmonized system audit, the relationship of these systems to traditional OHS audit systems, and the authors' vision of the future for application of such systems.

Occupational safety and health in Japan: current situations and the future.

PubMed

Sakurai, Haruhiko

2012-01-01

The Industrial Safety and Health Law enacted in 1972 has contributed much to the progress of occupational safety and health (OSH) activities. Many indicators including death and illness statistics show continued improvement up to date. The establishment of OSH organization within enterprises and 5-yr administrative programs formulated by the Ministry of Health, Labour, and Welfare (MHLW) were important factors for satisfactory management. The past programs indicate that the weight of self regulation in comparison to legal control gradually increased since late 1990s. In spite of the past achievement, many hazards such as overwork, mental stress, chemical agents and others still remain to be prevented. The systematic risk assessment of unregulated chemicals by the MHLW proved to be an effective scheme for risk-based management and to deserve continued implementation. The size of human resources for OSH was estimated at 1.5 million. In view of the adverse effect on OSH by economic, social and political environment in the future, the importance of the efficiency of OSH management was indicated. Since the efficiency depends on the competence of OSH personnel and the level of scientific basis, it was concluded that the fundamental policy for the future should give high priority to education and research.

Assessing safety climate in acute hospital settings: a systematic review of the adequacy of the psychometric properties of survey measurement tools.

PubMed

Alsalem, Gheed; Bowie, Paul; Morrison, Jillian

2018-05-10

The perceived importance of safety culture in improving patient safety and its impact on patient outcomes has led to a growing interest in the assessment of safety climate in healthcare organizations; however, the rigour with which safety climate tools were developed and psychometrically tested was shown to be variable. This paper aims to identify and review questionnaire studies designed to measure safety climate in acute hospital settings, in order to assess the adequacy of reported psychometric properties of identified tools. A systematic review of published empirical literature was undertaken to examine sample characteristics and instrument details including safety climate dimensions, origin and theoretical basis, and extent of psychometric evaluation (content validity, criterion validity, construct validity and internal reliability). Five questionnaire tools, designed for general evaluation of safety climate in acute hospital settings, were included. Detailed inspection revealed ambiguity around concepts of safety culture and climate, safety climate dimensions and the methodological rigour associated with the design of these measures. Standard reporting of the psychometric properties of developed questionnaires was variable, although evidence of an improving trend in the quality of the reported psychometric properties of studies was noted. Evidence of the theoretical underpinnings of climate tools was limited, while a lack of clarity in the relationship between safety culture and patient outcome measures still exists. Evidence of the adequacy of the psychometric development of safety climate questionnaire tools is still limited. Research is necessary to resolve the controversies in the definitions and dimensions of safety culture and climate in healthcare and identify related inconsistencies. More importance should be given to the appropriate validation of safety climate questionnaires before extending their usage in healthcare contexts different from those in which they were originally developed. Mixed methods research to understand why psychometric assessment and measurement reporting practices can be inadequate and lacking in a theoretical basis is also necessary.

49 CFR 807.151 - Program accessibility: New construction and alterations.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) NATIONAL TRANSPORTATION SAFETY BOARD ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE NATIONAL TRANSPORTATION SAFETY BOARD § 807.151 Program accessibility... the Architectural Barriers Act (42 U.S.C. 4151-4157), as established in 41 CFR 101-19.600 to 101-19...

47 CFR 90.528 - Public safety broadband license.

Code of Federal Regulations, 2010 CFR

2010-10-01

... financial and operational information. The Public Safety Broadband Licensee shall submit, on a quarterly basis, a full financial accounting to the Commission, in a format to be set forth in the Network Sharing Agreement, and as approved by the Commission. Such quarterly financial reports shall be filed with the...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

75 FR 39197 - Safety Zone; Fireworks Display, Portland, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

...-AA00 Safety Zone; Fireworks Display, Portland, OR AGENCY: Coast Guard, DHS. ACTION: Notice of proposed..., and the shoreline to the east and west in support of the Oregon Symphony Celebration Fireworks Display... Register. Basis and Purpose The Oregon Symphony Celebration Fireworks display is an annual event. The...

School Safety Project: Product Evaluation, 1990-1991.

ERIC Educational Resources Information Center

Saginaw Public Schools, MI. Dept. of Evaluation Services.

A districtwide school safety project implemented in Saginaw, Michigan, in 1990-91, the third year of its operation, is evaluated in this report. The project is evaluated on the basis of the following objectives: employment and training of home-school liaison officers; establishment of an advisory council; development and implementation of…

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2010 CFR

2010-01-01

... Analysis Reports for Nuclear Power Plants, or successor document. (2) A DOE nonreactor nuclear facility... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., the public and the environment from adverse consequences. These analyses and hazard controls...

A Daily Diary Approach to the Examination of Chronic Stress, Daily Hassles and Safety Perceptions in Hospital Nursing.

PubMed

Louch, Gemma; O'Hara, Jane; Gardner, Peter; O'Connor, Daryl B

2017-12-01

Stress is a significant concern for individuals and organisations. Few studies have explored stress, burnout and patient safety in hospital nursing on a daily basis at the individual level. This study aimed to examine the effects of chronic stress and daily hassles on safety perceptions, the effect of chronic stress on daily hassles experienced and chronic stress as a potential moderator. Utilising a daily diary design, 83 UK hospital nurses completed three end-of-shift diaries, yielding 324 person days. Hassles, safety perceptions and workplace cognitive failure were measured daily, and a baseline questionnaire included a measure of chronic stress. Hierarchical multivariate linear modelling was used to analyse the data. Higher chronic stress was associated with more daily hassles, poorer perceptions of safety and being less able to practise safely, but not more workplace cognitive failure. Reporting more daily hassles was associated with poorer perceptions of safety, being less able to practise safely and more workplace cognitive failure. Chronic stress did not moderate daily associations. The hassles reported illustrate the wide-ranging hassles nurses experienced. The findings demonstrate, in addition to chronic stress, the importance of daily hassles for nurses' perceptions of safety and the hassles experienced by hospital nurses on a daily basis. Nurses perceive chronic stress and daily hassles to contribute to their perceptions of safety. Measuring the number of daily hassles experienced could proactively highlight when patient safety threats may arise, and as a result, interventions could usefully focus on the management of daily hassles.

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

PubMed Central

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

2015-01-01

Background Current approaches to chemical screening, prioritization, and assessment are being reenvisioned, driven by innovations in chemical safety testing, new chemical regulations, and demand for information on human and environmental impacts of chemicals. To conceptualize these changes through the lens of a prevalent disease, the Breast Cancer and Chemicals Policy project convened an interdisciplinary expert panel to investigate methods for identifying chemicals that may increase breast cancer risk. Methods Based on a review of current evidence, the panel identified key biological processes whose perturbation may alter breast cancer risk. We identified corresponding assays to develop the Hazard Identification Approach for Breast Carcinogens (HIA-BC), a method for detecting chemicals that may raise breast cancer risk. Finally, we conducted a literature-based pilot test of the HIA-BC. Results The HIA-BC identifies assays capable of detecting alterations to biological processes relevant to breast cancer, including cellular and molecular events, tissue changes, and factors that alter susceptibility. In the pilot test of the HIA-BC, chemicals associated with breast cancer all demonstrated genotoxic or endocrine activity, but not necessarily both. Significant data gaps persist. Conclusions This approach could inform the development of toxicity testing that targets mechanisms relevant to breast cancer, providing a basis for identifying safer chemicals. The study identified important end points not currently evaluated by federal testing programs, including altered mammary gland development, Her2 activation, progesterone receptor activity, prolactin effects, and aspects of estrogen receptor β activity. This approach could be extended to identify the biological processes and screening methods relevant for other common diseases. Citation Schwarzman MR, Ackerman JM, Dairkee SH, Fenton SE, Johnson D, Navarro KM, Osborne G, Rudel RA, Solomon GM, Zeise L, Janssen S. 2015. Screening for chemical contributions to breast cancer risk: a case study for chemical safety evaluation. Environ Health Perspect 123:1255–1264; http://dx.doi.org/10.1289/ehp.1408337 PMID:26032647

49 CFR 195.452 - Pipeline integrity management in high consequence areas.

Code of Federal Regulations, 2011 CFR

2011-10-01

... engineering evaluation and provides an equivalent level of public safety and environmental protection. (c... situations—(i) Engineering basis. An operator may be able to justify an engineering basis for a longer assessment interval on a segment of line pipe. The justification must be supported by a reliable engineering...

Reduced nicotine product standards for combustible tobacco: Building an empirical basis for effective regulation

PubMed Central

Donny, Eric C.; Hatsukami, Dorothy K.; Benowitz, Neal L.; Sved, Alan F.; Tidey, Jennifer W.; Cassidy, Rachel N.

2014-01-01

Introduction Both the Tobacco Control Act in the U.S. and Article 9 of the Framework Convention on Tobacco Control enable governments to directly address the addictiveness of combustible tobacco by reducing nicotine through product standards. Although nicotine may have some harmful effects, the detrimental health effects of smoked tobacco are primarily due to non-nicotine constituents. Hence, the health effects of nicotine reduction would likely be determined by changes in behavior that result in changes in smoke exposure. Methods Herein, we review the current evidence on nicotine reduction and discuss some of the challenges in establishing the empirical basis for regulatory decisions. Results To date, research suggests that very low nicotine content cigarettes produce a desirable set of outcomes, including reduced exposure to nicotine, reduced smoking, and reduced dependence, without significant safety concerns. However, much is still unknown, including the effects of gradual versus abrupt changes in nicotine content, effects in vulnerable populations, and impact on youth. Discussion A coordinated effort must be made to provide the best possible scientific basis for regulatory decisions. The outcome of this effort may provide the foundation for a novel approach to tobacco control that dramatically reduces the devastating health consequences of smoked tobacco. PMID:24967958

Reduced nicotine product standards for combustible tobacco: building an empirical basis for effective regulation.

PubMed

Donny, Eric C; Hatsukami, Dorothy K; Benowitz, Neal L; Sved, Alan F; Tidey, Jennifer W; Cassidy, Rachel N

2014-11-01

Both the Tobacco Control Act in the U.S. and Article 9 of the Framework Convention on Tobacco Control enable governments to directly address the addictiveness of combustible tobacco by reducing nicotine through product standards. Although nicotine may have some harmful effects, the detrimental health effects of smoked tobacco are primarily due to non-nicotine constituents. Hence, the health effects of nicotine reduction would likely be determined by changes in behavior that result in changes in smoke exposure. Herein, we review the current evidence on nicotine reduction and discuss some of the challenges in establishing the empirical basis for regulatory decisions. To date, research suggests that very low nicotine content cigarettes produce a desirable set of outcomes, including reduced exposure to nicotine, reduced smoking, and reduced dependence, without significant safety concerns. However, much is still unknown, including the effects of gradual versus abrupt changes in nicotine content, effects in vulnerable populations, and impact on youth. A coordinated effort must be made to provide the best possible scientific basis for regulatory decisions. The outcome of this effort may provide the foundation for a novel approach to tobacco control that dramatically reduces the devastating health consequences of smoked tobacco. Copyright © 2014 Elsevier Inc. All rights reserved.

Critical appraisal of 3-monthly paliperidone depot injections in the treatment of schizophrenia.

PubMed

Carpiniello, Bernardo; Pinna, Federica

2016-01-01

Three-monthly injections of paliperidone palmitate (PP-3M) represent a new and recently introduced long-acting antipsychotic therapeutic option. This review focuses on available data relating to the efficacy and safety of PP-3M and its position in the current therapeutic scenario. An analysis of PubMed, Scopus, and ISI Web of Knowledge databases was conducted, and all available papers on PP-3M, including poster presentations, were selected and considered for the purpose of the present review. to date, three full papers have been published, the first, a Phase 1 randomized, open label study investigating the pharmacokinetics, safety, and tolerability of the drug; the second, a Phase 3 double blind study vs placebo focusing on efficacy and tolerability; and the last relating to the practical use of PP-3M. The five posters identified describe data reported in the above-cited papers. Overall, the pharmacokinetic findings obtained in these studies highlight the feasibility of administering PP-3M on a 3-monthly basis, subsequent to the administration of four 1-monthly injections of PP at doses 3.5 times higher than the stabilized dose of 1-monthly injections of PP (ie, 175, 300, 450, and 525 mgs). The published studies highlight a significantly longer time to relapse compared to placebo, and significantly better results compared to placebo for all secondary end-points (Positive and Negative Syndrome Scale, Clinical Global Impression-Severity Scale, Personal and Social Performance Scale scores), in addition to reasonably good safety and tolerability profiles. PP-3M emerges as a potential candidate for use as a first-line long-acting agent in the maintenance treatment of patients with schizophrenia. Further studies should however be conducted to confirm this expectation. In view of its efficacy, tolerability, and safety, together with the longer timespan between injections, PP-3M currently represents one of the best available options, and may contribute towards addressing the issue of poor adherence, even in early psychosis.

Enhancement of NRC station blackout requirements for nuclear power plants

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

McConnell, M. W.

2012-07-01

The U.S. Nuclear Regulatory Commission (NRC) established a Near-Term Task Force (NTTF) in response to Commission direction to conduct a systematic and methodical review of NRC processes and regulations to determine whether the agency should make additional improvements to its regulatory system and to make recommendations to the Commission for its policy direction, in light of the accident at the Fukushima Dai-ichi Nuclear Power Plant. The NTTF's review resulted in a set of recommendations that took a balanced approach to defense-in-depth as applied to low-likelihood, high-consequence events such as prolonged station blackout (SBO) resulting from severe natural phenomena. Part 50,more » Section 63, of Title 10 of the Code of Federal Regulations (CFR), 'Loss of All Alternating Current Power,' currently requires that each nuclear power plant must be able to cool the reactor core and maintain containment integrity for a specified duration of an SBO. The SBO duration and mitigation strategy for each nuclear power plant is site specific and is based on the robustness of the local transmission system and the transmission system operator's capability to restore offsite power to the nuclear power plant. With regard to SBO, the NTTF recommended that the NRC strengthen SBO mitigation capability at all operating and new reactors for design-basis and beyond-design-basis external events. The NTTF also recommended strengthening emergency preparedness for prolonged SBO and multi-unit events. These recommendations, taken together, are intended to clarify and strengthen US nuclear reactor safety regarding protection against and mitigation of the consequences of natural disasters and emergency preparedness during SBO. The focus of this paper is on the existing SBO requirements and NRC initiatives to strengthen SBO capability at all operating and new reactors to address prolonged SBO stemming from design-basis and beyond-design-basis external events. The NRC initiatives are intended to enhance core and spent fuel pool cooling, reactor coolant system integrity, and containment integrity. (authors)« less

Findings From the National Machine Guarding Program

PubMed Central

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

2017-01-01

Objectives: This manuscript assesses safety climate data from the National Machine Guarding Program (NMGP)—a nationwide intervention to improve machine safety. Methods: Baseline safety climate surveys were completed by 2161 employees and 341 owners or managers at 115 businesses. A separate onsite audit of safety management practices and machine guarding equipment was conducted at each business. Results: Safety climate measures were not correlated with machine guarding or safety management practices. The presence of a safety committee was correlated with higher scores on the safety management audit when contrasted with those without one. Conclusions: The presence of a safety committee is easily assessed and provides a basis on which to make recommendations with regard to how it functions. Measures of safety climate fail to provide actionable information. Future research on small manufacturing firms should emphasize the presence of an employee-management safety committee. PMID:28930801

[Study on "multi-dimensional structure and process dynamics quality control system" of Danshen infusion solution based on component structure theory].

PubMed

Feng, Liang; Zhang, Ming-Hua; Gu, Jun-Fei; Wang, Gui-You; Zhao, Zi-Yu; Jia, Xiao-Bin

2013-11-01

As traditional Chinese medicine (TCM) preparation products feature complex compounds and multiple preparation processes, the implementation of quality control in line with the characteristics of TCM preparation products provides a firm guarantee for the clinical efficacy and safety of TCM preparation products. Danshen infusion solution is a preparation commonly used in clinic, but its quality control is restricted to indexes of finished products, which can not guarantee its inherent quality. Our study group has proposed "multi-dimensional structure and process dynamics quality control system" on the basis of "component structure theory", for the purpose of controlling the quality of Danshen infusion solution at multiple levels and in multiple links from the efficacy-related material basis, the safety-related material basis, the characteristics of dosage form to the preparation process. This article, we bring forth new ideas and models to the quality control of TCM preparation products.

A FRAME response to the Draft Report on Alternative (Non-animal) Methods for Cosmetics Testing: Current Status and Future Prospects--2010.

PubMed

Balls, Michael; Clothier, Richard

2010-10-01

This response on behalf of FRAME to the European Commission's consultation on the five chapters of the Draft Report on Alternative (Non-animal) Methods for Cosmetics Testing: Current Status and Future Prospects--2010, is via a Comment in ATLA, rather than via the template supplied by the Commission. This is principally so that a number of general points about cosmetic ingredient testing can be made. It is concluded that the five draft chapters do not provide a credible basis for the Commission's forthcoming report to the European Parliament and the European Council on the five cosmetic ingredient safety issues for which the 7th Amendment to the Cosmetic Directive's ban on animal testing was postponed until 2013. This is mainly because there is insufficient focus in the draft chapters on the specific nature of cosmetic ingredients, their uses, their local effects and metabolism at their sites of application, and, in particular, on whether their possible absorption into the body would be likely to lead to their accumulation in target sites at levels approaching Thresholds of Toxicological Concern. Meanwhile, there continues to be uncertainty about how the provisions of the Cosmetics Directive should be applied, given the requirements of the REACH system and directives concerned with the safety of other chemicals and products. © 2010 FRAME.

Current practice and recommendations in UK epilepsy monitoring units. Report of a national survey and workshop.

PubMed

Hamandi, Khalid; Beniczky, Sandor; Diehl, Beate; Kandler, Rosalind H; Pressler, Ronit M; Sen, Arjune; Solomon, Juliet; Walker, Matthew C; Bagary, Manny

2017-08-01

Inpatient video-EEG monitoring (VEM) is an important investigation in patients with seizures or blackouts, and in the pre-surgical workup of patients with epilepsy. There has been an expansion in the number of Epilepsy Monitoring Units (EMU) in the UK offering VEM with a necessary increase in attention on quality and safety. Previous surveys have shown variation across centres on issues including consent and patient monitoring. In an effort to bring together healthcare professionals in the UK managing patients on EMU, we conducted an online survey of current VEM practice and held a one-day workshop convened under the auspices of the British Chapter of the ILAE. The survey and workshop aimed to cover all aspects of VEM, including pre-admission, consent procedures, patient safety, drug reduction and reinstatement, seizure management, staffing levels, ictal testing and good data recording practice. This paper reports on the findings of the survey, the workshop presentations and workshop discussions. 32 centres took part in the survey and there were representatives from 22 centres at the workshop. There was variation in protocols, procedures and consent processes between units, and levels of observation of monitored patients. Nevertheless, the workshop discussion found broad areas of agreement on points. A survey and workshop of UK epilepsy monitoring units found that some variability in practice is inevitable due to different local arrangements and patient groups under investigation. However, there were areas of clear consensus particularly in relation to consent and patient safety that can be applied to most units and form a basis for setting minimum standards. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Safety evaluation and lipid-lowering effects of food-grade biopolymer complexes (ε-polylysine-pectin) in mice fed a high-fat diet.

PubMed

Song, Mingyue; Lopez-Pena, Cynthia Lyliam; McClements, David Julian; Decker, Eric Andrew; Xiao, Hang

2017-05-24

ε-Polylysine (ε-PL) is a potent cationic antimicrobial, but its application as a food additive is currently limited because it tends to precipitate with anionic species in food matrices. Previous research has shown that the formation of an electrostatic complex between cationic ε-PL and anionic pectin (P) improved the physical stability of ε-PL while maintaining its antimicrobial activity. However, the impact of complexation on the effects of ε-PL on health is currently unknown. A subchronic toxicity study was therefore carried out to determine the safety of ingested ε-PL-P complexes using high-fat diet-fed male and female mice. After a 13-week dietary treatment with P, ε-PL, or ε-PL-P complexes, no significant toxicological effects were observed on the survival, mean body weight, food consumption, and organ weights of the animals, suggesting that the complexes were safe for oral consumption. Interestingly, the ε-PL-P complexes were found to have several beneficial health effects: suppression of high-fat diet-induced elevation of serum aspartate aminotransferase and alanine aminotransferase activities, reduction in serum total triglyceride and cholesterol levels, and an increase in fecal excretion of triglycerides. These effects were much stronger in female mice than in male mice. Moreover, the lipid-lowering effects were observed only for the ε-PL-P complexes but not for ε-PL or P alone at the same doses. Overall, our results demonstrate the oral safety of ε-PL-P complexes and their gender-specific lipid-lowering effects in high-fat diet-fed mice, which provide an important basis for the utilization of ε-PL-P complexes in food systems as functional ingredients.

Increasing patient safety and efficiency in transfusion therapy using formal process definitions.

PubMed

Henneman, Elizabeth A; Avrunin, George S; Clarke, Lori A; Osterweil, Leon J; Andrzejewski, Chester; Merrigan, Karen; Cobleigh, Rachel; Frederick, Kimberly; Katz-Bassett, Ethan; Henneman, Philip L

2007-01-01

The administration of blood products is a common, resource-intensive, and potentially problem-prone area that may place patients at elevated risk in the clinical setting. Much of the emphasis in transfusion safety has been targeted toward quality control measures in laboratory settings where blood products are prepared for administration as well as in automation of certain laboratory processes. In contrast, the process of transfusing blood in the clinical setting (ie, at the point of care) has essentially remained unchanged over the past several decades. Many of the currently available methods for improving the quality and safety of blood transfusions in the clinical setting rely on informal process descriptions, such as flow charts and medical algorithms, to describe medical processes. These informal descriptions, although useful in presenting an overview of standard processes, can be ambiguous or incomplete. For example, they often describe only the standard process and leave out how to handle possible failures or exceptions. One alternative to these informal descriptions is to use formal process definitions, which can serve as the basis for a variety of analyses because these formal definitions offer precision in the representation of all possible ways that a process can be carried out in both standard and exceptional situations. Formal process definitions have not previously been used to describe and improve medical processes. The use of such formal definitions to prospectively identify potential error and improve the transfusion process has not previously been reported. The purpose of this article is to introduce the concept of formally defining processes and to describe how formal definitions of blood transfusion processes can be used to detect and correct transfusion process errors in ways not currently possible using existing quality improvement methods.

Antimicrobial peptides and plant disease control.

PubMed

Montesinos, Emilio

2007-05-01

Several diseases caused by viruses, bacteria and fungi affect plant crops, resulting in losses and decreasing the quality and safety of agricultural products. Plant disease control relies mainly on chemical pesticides that are currently subject to strong restrictions and regulatory requirements. Antimicrobial peptides are interesting compounds in plant health because there is a need for new products in plant protection that fit into the new regulations. Living organisms secrete a wide range of antimicrobial peptides produced through ribosomal (defensins and small bacteriocins) or non-ribosomal synthesis (peptaibols, cyclopeptides and pseudopeptides). Several antimicrobial peptides are the basis for the design of new synthetic analogues, have been expressed in transgenic plants to confer disease protection or are secreted by microorganisms that are active ingredients of commercial biopesticides.

Overview of Icing Research at NASA Glenn

NASA Technical Reports Server (NTRS)

Kreeger, Richard E.

2013-01-01

The aviation industry continues to deal with icing-related incidents and accidents on a regular basis. Air traffic continues to increase, placing more aircraft in adverse icing conditions more frequently and for longer periods. Icing conditions once considered rare or of little consequence, such as super-cooled large droplet icing or high altitude ice crystals, have emerged as major concerns for modern aviation. Because of this, there is a need to better understand the atmospheric environment, the fundamental mechanisms and characteristics of ice growth, and the aerodynamic effects due to icing, as well as how best to protect these aircraft. The icing branch at NASA Glenn continues to develop icing simulation methods and engineering tools to address current aviation safety issues in airframe, engine and rotorcraft icing.

Metocean Data Needs Assessment for U.S. Offshore Wind Energy

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

Bailey, Bruce H.; Filippelli, Matthew; Baker, Matthew

2015-01-01

A potential barrier to developing offshore wind energy in the United States is the general lack of accurate information in most offshore areas about the wind resource characteristics and external metocean design conditions at the heights and depths relevant to wind turbines and their associated structures and components. Knowledge of these conditions enables specification of the appropriate design basis for wind turbine structures and components so they can withstand the loads expected over a project’s lifetime. Human safety, vessel navigation, and project construction and maintenance activities are equally tied to the metocean environment. Currently, metocean data is sparse in potentialmore » development areas and even when available, does not include the detail or quality required to make informed decisions.« less

The use of interactive computer vision and robot hand controllers for enhancing manufacturing safety

NASA Technical Reports Server (NTRS)

Marzwell, Neville I.; Jacobus, Charles J.; Peurach, Thomas M.; Mitchell, Brian T.

1994-01-01

Current available robotic systems provide limited support for CAD-based model-driven visualization, sensing algorithm development and integration, and automated graphical planning systems. This paper describes ongoing work which provides the functionality necessary to apply advanced robotics to automated manufacturing and assembly operations. An interface has been built which incorporates 6-DOF tactile manipulation, displays for three dimensional graphical models, and automated tracking functions which depend on automated machine vision. A set of tools for single and multiple focal plane sensor image processing and understanding has been demonstrated which utilizes object recognition models. The resulting tool will enable sensing and planning from computationally simple graphical objects. A synergistic interplay between human and operator vision is created from programmable feedback received from the controller. This approach can be used as the basis for implementing enhanced safety in automated robotics manufacturing, assembly, repair and inspection tasks in both ground and space applications. Thus, an interactive capability has been developed to match the modeled environment to the real task environment for safe and predictable task execution.

The use of interactive computer vision and robot hand controllers for enhancing manufacturing safety

NASA Astrophysics Data System (ADS)

Marzwell, Neville I.; Jacobus, Charles J.; Peurach, Thomas M.; Mitchell, Brian T.

1994-02-01

Current available robotic systems provide limited support for CAD-based model-driven visualization, sensing algorithm development and integration, and automated graphical planning systems. This paper describes ongoing work which provides the functionality necessary to apply advanced robotics to automated manufacturing and assembly operations. An interface has been built which incorporates 6-DOF tactile manipulation, displays for three dimensional graphical models, and automated tracking functions which depend on automated machine vision. A set of tools for single and multiple focal plane sensor image processing and understanding has been demonstrated which utilizes object recognition models. The resulting tool will enable sensing and planning from computationally simple graphical objects. A synergistic interplay between human and operator vision is created from programmable feedback received from the controller. This approach can be used as the basis for implementing enhanced safety in automated robotics manufacturing, assembly, repair and inspection tasks in both ground and space applications. Thus, an interactive capability has been developed to match the modeled environment to the real task environment for safe and predictable task execution.

Regulatory Agencies and Food Safety

PubMed Central

Chapman, R. A.; Morrison, A. B.

1966-01-01

Prior to Confederation, food control legislation in Canada consisted of only a few simple laws governing the quality, grading, packing and inspection of certain staple foods. The Inland Revenue Act of 1875 provided the first real control in Canada over adulteration of liquor, foods and drugs. Since then, food legislation has evolved in scope and complexity as the industries involved have developed, as consumers have become better informed, and as scientific advances have provided a sound basis for regulations. Present regulations under the Food and Drugs Act are intended to give consumers broad protection against health hazards and fraud in the production, manufacture, labelling, packaging, advertising, and sale of foods. This principle is well illustrated by present requirements for the control of pesticide residues, chemical additives, and the addition of vitamins to foods. In today's era of rapid technological change, application of current scientific knowledge to the food industry obviously involves the possibility of hazards to health. Regulatory agencies with responsibility for food safety must, therefore, fully utilize scientific knowledge in order to reduce the risks involved to a minimum. PMID:5905951

Bio-markers: traceability in food safety issues.

PubMed

Raspor, Peter

2005-01-01

Research and practice are focusing on development, validation and harmonization of technologies and methodologies to ensure complete traceability process throughout the food chain. The main goals are: scale-up, implementation and validation of methods in whole food chains, assurance of authenticity, validity of labelling and application of HACCP (hazard analysis and critical control point) to the entire food chain. The current review is to sum the scientific and technological basis for ensuring complete traceability. Tracing and tracking (traceability) of foods are complex processes due to the (bio)markers, technical solutions and different circumstances in different technologies which produces various foods (processed, semi-processed, or raw). Since the food is produced for human or animal consumption we need suitable markers to be stable and traceable all along the production chain. Specific biomarkers can have a function in technology and in nutrition. Such approach would make this development faster and more comprehensive and would make possible that food effect could be monitored with same set of biomarkers in consumer. This would help to develop and implement food safety standards that would be based on real physiological function of particular food component.

75 FR 38716 - Safety Zone; Vietnam Veterans of America Fireworks Display, Brookings, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-06

...-AA00 Safety Zone; Vietnam Veterans of America Fireworks Display, Brookings, OR AGENCY: Coast Guard, DHS... waters of Pelican Bay and the Pacific Ocean for the Vietnam Veterans of America Fireworks Display near... period will have passed. Basis and Purpose The Vietnam Veterans of America are holding a fireworks...

Developing a Model on Improving Maritime English Training for Maritime Transportation Safety

ERIC Educational Resources Information Center

Yercan, Funda; Fricke, Donna; Stone, Laurie

2005-01-01

Maritime services form an integral part of what regulatory agencies requires for the safe navigation and operation of vessels. Therefore, the maritime industry's compliance with governmental regulations and international protocols has been essential for maritime safety management. As a basis to this aspect, the preparation of maritime students as…

75 FR 37720 - Safety Zone; New Bern Air Show, Neuse River, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... would be contrary to public interest, since immediate action is needed to ensure the safety of human life and property from the hazards associated with air show operations. Basis and Purpose Coast Guard... effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g...

76 FR 38568 - Safety Zone; Bullhead City Regatta, Bullhead City, AZ

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

...-AA00 Safety Zone; Bullhead City Regatta, Bullhead City, AZ AGENCY: Coast Guard, DHS. ACTION: Temporary... the Colorado River in Bullhead City, Arizona for the Bullhead City Regatta on August 13, 2011. This... the waterway during the Regatta event. Basis and Purpose The City of Bullhead is sponsoring the...

Safety recommendation component of mobile information assistant of the tourist

NASA Astrophysics Data System (ADS)

Savchuk, Valeriya V.; Kunanec, Natalia E.; Pasichnyk, Volodymyr V.; Popiel, Piotr; Weryńska-Bieniasz, RóŻa; Kashaganova, Gulzhamal; Kalizhanova, Aliya

2017-08-01

The goal of article is to introduce and justify the need for the safety system components of Mobile Information of the tourist (MIAT). One of the objectives of the system is to determine the level of risk in a particular tourist destination on the basis of available information in the knowledge base.

Safety in the Air: A Curriculum About Flight and Air Traffic Control Designed for Middle School Students

DOT National Transportation Integrated Search

1983-01-01

Safety in the Air is designed to be taught as a six-lesson unit to middle school : students, preferably sixth, seventh, or eighth grade level. : This curriculum is designed first of all to familiarize both the teacher and the : student with some basi...

47 CFR 90.528 - Public safety broadband license.

Code of Federal Regulations, 2012 CFR

2012-10-01

... basis, a full financial accounting to the Commission, in a format to be set forth in the Network Sharing... Commission, with a copy to the Chiefs of the Wireless Telecommunications and the Public Safety and Homeland Security Bureaus. [72 FR 48860, Aug. 24, 2007, as amended at 74 FR 8879, Feb. 27, 2009] ...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

9 CFR 307.6 - Basis of billing for overtime and holiday services.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Basis of billing for overtime and holiday services. 307.6 Section 307.6 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION...

New risk metrics and mathematical tools for risk analysis: Current and future challenges

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

Skandamis, Panagiotis N., E-mail: pskan@aua.gr; Andritsos, Nikolaos, E-mail: pskan@aua.gr; Psomas, Antonios, E-mail: pskan@aua.gr

The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) themore » Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total ‘failure’ that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user-friendly softwares, (e.g., Seafood Spoilage Predictor) have evolved the use of information systems in the food safety management. Such tools are updateable with new food-pathogen specific models containing cardinal parameters and multiple dependent variables, including plate counts, concentration of metabolic products, or even expression levels of certain genes. Then, these tools may further serve as decision-support tools which may assist in product logistics, based on their scientifically-based and “momentary” expressed spoilage and safety level.« less

New risk metrics and mathematical tools for risk analysis: Current and future challenges

NASA Astrophysics Data System (ADS)

Skandamis, Panagiotis N.; Andritsos, Nikolaos; Psomas, Antonios; Paramythiotis, Spyridon

2015-01-01

The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) the Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total `failure' that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user-friendly softwares, (e.g., Seafood Spoilage Predictor) have evolved the use of information systems in the food safety management. Such tools are updateable with new food-pathogen specific models containing cardinal parameters and multiple dependent variables, including plate counts, concentration of metabolic products, or even expression levels of certain genes. Then, these tools may further serve as decision-support tools which may assist in product logistics, based on their scientifically-based and "momentary" expressed spoilage and safety level.

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

Nicholson, J. C.

Performance metrics for evaluating commercial fixatives are often not readily available for important parameters that must be considered per the facility safety basis and the facility Basis for Interim Operations (BIO). One such parameter is the behavior of such materials in varied, “non-ideal” conditions where ideal is defined as 75 °F, 40% RH. Coupled with the inherent flammable nature of the fixative materials that can act to propagate flame along surfaces that are otherwise fireproof (concrete, sheet metal), much is left unknown when considering the safety basis implications for introducing these materials into nuclear facilities. Through SRNL’s efforts, three (3)more » fixatives, one (1) decontamination gel, and six (6) intumescent coatings were examined for their responses to environmental conditions to determine whether these materials were impervious to non-nominal temperatures and humidities that may be found in nuclear facilities. Characteristics that were examined included set-to-touch time, dust free time, and adhesion testing of the fully cured compounds. Of these ten materials, three were two-part epoxy materials while the other seven consisted of only one constituent. The results show that the epoxies tested are unable to cure in sub-freezing temperatures, with the low temperatures inhibiting crosslinking to a very significant degree. These efforts show significant inhibiting of performance for non-nominal environmental conditions, something that must be addressed both in the decision process for a fixative material to apply and per the safety basis to ensure the accurate flammability and material at risk is calculated.« less

Registered dietitian's personal beliefs and characteristics predict their teaching or intention to teach fresh vegetable food safety.

PubMed

Casagrande, Gina; LeJeune, Jeffery; Belury, Martha A; Medeiros, Lydia C

2011-04-01

The Theory of Planned Behavior was used to determine if dietitians personal characteristics and beliefs about fresh vegetable food safety predict whether they currently teach, intend to teach, or neither currently teach nor intend to teach food safety information to their clients. Dietitians who participated in direct client education responded to this web-based survey (n=327). The survey evaluated three independent belief variables: Subjective Norm, Attitudes, and Perceived Behavioral Control. Spearman rho correlations were completed to determine variables that correlated best with current teaching behavior. Multinomial logistical regression was conducted to determine if the belief variables significantly predicted dietitians teaching behavior. Binary logistic regression was used to determine which independent variable was the better predictor of whether dietitians currently taught. Controlling for age, income, education, and gender, the multinomial logistical regression was significant. Perceived behavioral control was the best predictor of whether a dietitian currently taught fresh vegetable food safety. Factors affecting whether dietitians currently taught were confidence in fresh vegetable food safety knowledge, being socially influenced, and a positive attitude toward the teaching behavior. These results validate the importance of teaching food safety effectively and may be used to create more informed food safety curriculum for dietitians. Copyright © 2011 Elsevier Ltd. All rights reserved.

Mock Certification Basis for an Unmanned Rotorcraft for Precision Agricultural Spraying

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J.; Maddalon, Jeffrey M.; Neogi, Natasha A.; Verstynen, Harry A.; Buelow, Barry; McCormick, G. Frank

2015-01-01

This technical report presents the results of a case study using a hazard-based approach to develop preliminary design and performance criteria for an unmanned agricultural rotorcraft requiring airworthiness certification. This case study is one of the first in the public domain to examine design and performance criteria for an unmanned aircraft system (UAS) in tandem with its concept of operations. The case study results are intended to support development of airworthiness standards that could form a minimum safety baseline for midsize unmanned rotorcraft performing precision agricultural spraying operations under beyond visual line-of-sight conditions in a rural environment. This study investigates the applicability of current methods, processes, and standards for assuring airworthiness of conventionally piloted (manned) aircraft to assuring the airworthiness of UAS. The study started with the development of a detailed concept of operations for precision agricultural spraying with an unmanned rotorcraft (pp. 5-18). The concept of operations in conjunction with a specimen unmanned rotorcraft were used to develop an operational context and a list of relevant hazards (p. 22). Minimum design and performance requirements necessary to mitigate the hazards provide the foundation of a proposed (or mock) type certification basis. A type certification basis specifies the applicable standards an applicant must show compliance with to receive regulatory approval. A detailed analysis of the current airworthiness regulations for normal-category rotorcraft (14 Code of Federal Regulations, Part 27) was performed. Each Part 27 regulation was evaluated to determine whether it mitigated one of the relevant hazards for the specimen UAS. Those regulations that did were included in the initial core of the type certification basis (pp. 26-31) as written or with some simple modifications. Those regulations that did not mitigate a recognized hazard were excluded from the certification basis. The remaining regulations were applicable in intent, but the text could not be easily tailored. Those regulations were addressed in separate issue papers. Exploiting established regulations avoids the difficult task of generating and interpreting novel requirements, through the use of acceptable, standardized language. The rationale for the disposition of the regulations was assessed and captured (pp. 58-115). The core basis was then augmented by generating additional requirements (pp. 38-47) to mitigate hazards for an unmanned sprayer that are not covered in Part 27.

A probabilistic technique for the assessment of complex dynamic system resilience

NASA Astrophysics Data System (ADS)

Balchanos, Michael Gregory

In the presence of operational uncertainty, one of the greatest challenges in systems engineering is to ensure system effectiveness, mission capability and survivability for large scale, complex system architectures. Historic events such as the 2003 Northeastern Blackout, and the 2005 Hurricane Katrina, have underlined the great importance of system safety, and survivability. With safety management currently applied on a reactive basis to emerging incidents and risk challenges, there is a paradigm shift from passive, reactive and diagnosis-based approaches to the development of architectures that will autonomously manage safety and survivability through active, proactive and prognosis-based engineering solutions. The shift aims to bring safety considerations early in the engineering design process, in order to reduce retrofitting and additional safety certification costs, increase flexibility in risk management, and essentially make safety be "built-in" the design. As a possible enabling research direction, resilience engineering is an emerging discipline, pertinent to safety management, which offers alternative insights on the design of more safe and survivable system architectures. Conceptually, resilience engineering brings new perspectives on the understanding of system safety, accidents, failures, performance degradations and risk. A resilient system can "absorb" the impact of change due to unexpected disturbances, while it "adapts" to change, in order to maintain the system's physical integrity and capability to carry on with its mission. The leading hypothesis advocates that if a complex dynamic system is more resilient, then it would be more survivable, thus more effective, despite the unexpected disturbances that could affect its normal operating conditions. For investigating the impact of more resilient systems on survivability and safety, a framework for theoretical resilience estimations has been formulated. It constitutes the basis for quantitative techniques for total system resilience evaluation, based on scenario-based, dynamic system simulations. Physics-based Modeling and Simulation (M&S) is applied for dynamical system behavior analysis, which includes system performance, health monitoring, damage propagation and overall mission capability. For the development of the assessment framework and testing of a resilience assessment technique, a small-scale canonical problem has been formulated, involving a computational model of a degradable and reconfigurable spring-mass-damper SDOF system, in a multiple main and redundant spring configuration. A rule-based feedback controller is responsible for system performance recovery, through the application of different reconfiguration strategies and strategic activation of the necessary main or redundant springs. Uncertainty effects on system operation are introduced through disturbance factors, such as external forces with varying magnitude, input frequency, event duration and occurrence time. Such factors are the basis for scenario formulation, in support of a Monte Carlo simulation analysis. Case studies with varying levels of damping and different reconfiguration strategies, involve the investigation of operational uncertainty effects on system performance, mission capability, and system survivability. These studies furthermore explore uncertainty effects on resilience functions that describe the system's capacities on "restoring" mission capability, on "absorbing" the effects of changing conditions, and on "adapting" to the occurring change. The proposed resilience assessment technique or the Topological Investigation for Resilient and Effective Systems, through Increased Architecture Survivability (TIRESIAS) is then applied and demonstrated for a naval system application, in the form of a reduced scale, reconfigurable cooling network of a naval combatant. Uncertainty effects are modeled through combinations of different number of network fluid leaks. The TIRESIAS approach on the system baseline (32-control valve configuration) has allowed for the investigation of leak effects on survival times, mission capability degradations, as well as the resilience function capacities. As part of the technique demonstration, case studies were conducted for different architecture configurations, which have been generated for different total number of control valves and valve locations on the topology.

A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

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

None

1995-11-01

The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors.more » To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.« less

Landslide and Land Subsidence Hazards to Pipelines

USGS Publications Warehouse

Baum, Rex L.; Galloway, Devin L.; Harp, Edwin L.

2008-01-01

Landslides and land subsidence pose serious hazards to pipelines throughout the world. Many existing pipeline corridors and more and more new pipelines cross terrain that is affected by either landslides, land subsidence, or both. Consequently the pipeline industry recognizes a need for increased awareness of methods for identifying and evaluating landslide and subsidence hazard for pipeline corridors. This report was prepared in cooperation with the U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration, and Pipeline Research Council International through a cooperative research and development agreement (CRADA) with DGH Consulting, Inc., to address the need for up-to-date information about current methods to identify and assess these hazards. Chapters in this report (1) describe methods for evaluating landslide hazard on a regional basis, (2) describe the various types of land subsidence hazard in the United States and available methods for identifying and quantifying subsidence, and (3) summarize current methods for investigating individual landslides. In addition to the descriptions, this report provides information about the relative costs, limitations and reliability of various methods.

New generation lidar systems for eye safe full time observations

NASA Technical Reports Server (NTRS)

Spinhirne, James D.

1995-01-01

The traditional lidar over the last thirty years has typically been a big pulse low repetition rate system. Pulse energies are in the 0.1 to 1.0 J range and repetition rates from 0.1 to 10 Hz. While such systems have proven to be good research tools, they have a number of limitations that prevent them from moving beyond lidar research to operational, application oriented instruments. These problems include a lack of eye safety, very low efficiency, poor reliability, lack of ruggedness and high development and operating costs. Recent advances in solid state laser, detectors and data systems have enabled the development of a new generation of lidar technology that meets the need for routine, application oriented instruments. In this paper the new approaches to operational lidar systems will be discussed. Micro pulse lidar (MPL) systems are currently in use, and their technology is highlighted. The basis and current development of continuous wave (CW) lidar and potential of other technical approaches is presented.

Genetically Modified Foods: A Brief Overview of the Risk Assessment Process.

PubMed

Finkelstein, Paige E

2016-02-18

Billions of people worldwide are unable to meet their daily micro nutritional needs. Genetically modified (GM) foods, while initially developed to tolerate herbicides and resist disease and insects, have the potential to help alleviate this issue that is currently posing a serious public health concern. However, there is a negative public perception surrounding GM foods, calling for more research regarding the risks that GM foods could pose to the public, specifically on the topics of allergenicity and gene transfer. The risk assessments of GM foods should be performed on a case-by-case basis, by a process outlined by the WHO. The goal of determining food safety is to obtain reasonable certainty that under normal levels of consumption, there will be no harm to people. Current research has shown that GM foods do not cause increased allergenicity or have a meaningful risk of gene transfer to people. GM foods should become publicly accepted products that can bring significant benefit to people at risk of under nutrition.

Biological effects and physical safety aspects of NMR imaging and in vivo spectroscopy

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

Tenforde, T.S.; Budinger, T.F.

1985-08-01

An assessment is made of the biological effects and physical hazards of static and time-varying fields associated with the NMR devices that are being used for clinical imaging and in vivo spectroscopy. A summary is given of the current state of knowledge concerning the mechanisms of interaction and the bioeffects of these fields. Additional topics that are discussed include: (1) physical effects on pacemakers and metallic implants such as aneurysm clips, (2) human health studies related to the effects of exposure to nonionizing electromagnetic radiation, and (3) extant guidelines for limiting exposure of patients and medical personnel to the fieldsmore » produced by NMR devices. On the basis of information available at the present time, it is concluded that the fields associated with the current generation of NMR devices do not pose a significant health risk in themselves. However, rigorous guidelines must be followed to avoid the physical interaction of these fields with metallic implants and medical electronic devices. 476 refs., 5 figs., 2 tabs.« less

California Guide for Pedestrian Safety Education. Volumes I-III.

ERIC Educational Resources Information Center

California State Dept. of Education, Sacramento.

This guide is designed to serve as the basis for a pedestrian safety education program for pupils in kindergarten through grade two. The basic printed materials for use in the program are provided in three volumes, each of which is intended for a different audience. Volume I, directed to school administrators and teachers, contains information for…

Study on Safety Monitoring System for Submarine Power Cable on the Basis of AIS and Radar Technology

NASA Astrophysics Data System (ADS)

Jie, Wang; Yao-Tian, Fan

Through analyzing the risks of submarine power cable, the highest risk to damage the cable identified is from ship. Based on concept of Vessel Traffic Management Information Systems, the three core sub-systems of safety monitoring system for submarine power cable were studied and described, also some suggestions were given.

78 FR 78362 - National Institute for Occupational Safety and Health Personal; Notice of public meeting in...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-26

... public commenter has spoken, whichever occurs first. ADDRESSES: First United Methodist Church, 53..., first served basis. The meeting will end at 8:30PM EST or after the last public commenter has spoken... Institute for Occupational Safety and Health Personal; Notice of public meeting in Endicott, New York AGENCY...

Safety profile: fifteen years of clinical experience with ibuprofen.

PubMed

Royer, G L; Seckman, C E; Welshman, I R

1984-07-13

Since its introduction in the United States in 1974, ibuprofen (Motrin, Upjohn) has been shown to be safe and effective for the treatment of pain, dysmenorrhea, inflammation, and fever. A careful review of pre-registration and postmarketing data from both patients and normal subjects clearly indicates ibuprofen's remarkable safety profile compared with that of aspirin and other commonly prescribed nonsteroidal anti-inflammatory agents. Continued safety can be anticipated on the basis of the past 15 years of review experience.

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.

Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study.

PubMed

Chhatbar, Pratik Y; Chen, Rong; Deardorff, Rachael; Dellenbach, Blair; Kautz, Steven A; George, Mark S; Feng, Wuwei

A prior meta-analysis revealed that higher doses of transcranial direct current stimulation (tDCS) have a better post-stroke upper-extremity motor recovery. While this finding suggests that currents greater than the typically used 2 mA may be more efficacious, the safety and tolerability of higher currents have not been assessed in stroke patients. We aim to assess the safety and tolerability of single session of up to 4 mA in stroke patients. We adapted a traditional 3 + 3 study design with a current escalation schedule of 1»2»2.5»3»3.5»4 mA for this tDCS safety study. We administered one 30-min session of bihemispheric montage tDCS and simultaneous customary occupational therapy to patients with first-ever ischemic stroke. We assessed safety with pre-defined stopping rules and investigated tolerability through a questionnaire. Additionally, we monitored body resistance and skin temperature in real-time at the electrode contact site. Eighteen patients completed the study. The current was escalated to 4 mA without meeting the pre-defined stopping rules or causing any major safety concern. 50% of patients experienced transient skin redness without injury. No rise in temperature (range 26°C-35 °C) was noted and skin barrier function remained intact (i.e. body resistance >1 kΩ). Our phase I safety study supports that single session of bihemispheric tDCS with current up to 4 mA is safe and tolerable in stroke patients. A phase II study to further test the safety and preliminary efficacy with multi-session tDCS at 4 mA (as compared with lower current and sham stimulation) is a logical next step. ClinicalTrials.gov Identifier: NCT02763826. Copyright © 2017 Elsevier Inc. All rights reserved.

Regulatory considerations on new adjuvants and delivery systems.

PubMed

Sesardic, D

2006-04-12

New and improved vaccines and delivery systems are increasingly being developed for prevention, treatment and diagnosis of human diseases. Prior to their use in humans, all new biological products must undergo pre-clinical evaluation. These pre-clinical studies are important not only to establish the biological properties of the material and to evaluate its possible risk to the public, but also to plan protocols for subsequent clinical trials from which safety and efficacy can be evaluated. For vaccines, evaluation in pre-clinical studies is particularly important as information gained may also contribute to identifying the optimum composition and formulation process and provide an opportunity to develop suitable indicator tests for quality control. Data from pre-clinical and laboratory evaluation studies, which continue during clinical studies, is used to support an application for marketing authorisation. Addition of a new adjuvant and exploration of new delivery systems for vaccines presents challenges to both manufacturers and regulatory authorities. Because no adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine, pre-clinical and appropriate toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/vaccine combination. Current regulatory requirements for the pharmaceutical and pre-clinical safety assessment of vaccines are insufficient and initiatives are in place to develop more specific guidelines for evaluation of adjuvants in vaccines.

[CIRRNET® - learning from errors, a success story].

PubMed

Frank, O; Hochreutener, M; Wiederkehr, P; Staender, S

2012-06-01

CIRRNET® is the network of local error-reporting systems of the Swiss Patient Safety Foundation. The network has been running since 2006 together with the Swiss Society for Anaesthesiology and Resuscitation (SGAR), and network participants currently include 39 healthcare institutions from all four different language regions of Switzerland. Further institutions can join at any time. Local error reports in CIRRNET® are bundled at a supraregional level, categorised in accordance with the WHO classification, and analysed by medical experts. The CIRRNET® database offers a solid pool of data with error reports from a wide range of medical specialist's areas and provides the basis for identifying relevant problem areas in patient safety. These problem areas are then processed in cooperation with specialists with extremely varied areas of expertise, and recommendations for avoiding these errors are developed by changing care processes (Quick-Alerts®). Having been approved by medical associations and professional medical societies, Quick-Alerts® are widely supported and well accepted in professional circles. The CIRRNET® database also enables any affiliated CIRRNET® participant to access all error reports in the 'closed user area' of the CIRRNET® homepage and to use these error reports for in-house training. A healthcare institution does not have to make every mistake itself - it can learn from the errors of others, compare notes with other healthcare institutions, and use existing knowledge to advance its own patient safety.

Clinical risk management in mental health: a qualitative study of main risks and related organizational management practices.

PubMed

Briner, Matthias; Manser, Tanja

2013-02-04

A scientific understanding of clinical risk management (CRM) in mental health care is essential for building safer health systems and for improving patient safety. While evidence on patient safety and CRM in physical health care has increased, there is limited research on these issues in mental health care. This qualitative study provides an overview of the most important clinical risks in mental health and related organizational management practices. We conducted in-depth expert interviews with professionals responsible for CRM in psychiatric hospitals. Interviews were transcribed and analyzed applying qualitative content analysis to thematically sort the identified risks. The main concerns for CRM in mental health are a) violence and self-destructive behavior (i.e. protecting patients and staff from other patients, and patients from themselves), b) treatment errors, especially in the process of therapy, and c) risks associated with mental illnesses (e.g. psychosis or depression). This study identified critical differences to CRM in hospitals for physical disorder and challenges specific to CRM in mental health. Firstly, many psychiatric patients do not believe that they are ill and are therefore in hospital against their will. Secondly, staff safety is a much more prominent theme for CRM in mental health care as it is directly related to the specifics of mental illnesses. The current study contributes to the understanding of patient safety and raises awareness for CRM in mental health. The mental health specific overview of central risks and related organizational management practices offers a valuable basis for CRM development in mental health and an addition to CRM in general.

The AP1000{sup R} nuclear power plant innovative features for extended station blackout mitigation

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

Vereb, F.; Winters, J.; Schulz, T.

2012-07-01

Station Blackout (SBO) is defined as 'a condition wherein a nuclear power plant sustains a loss of all offsite electric power system concurrent with turbine trip and unavailability of all onsite emergency alternating current (AC) power system. Station blackout does not include the loss of available AC power to buses fed by station batteries through inverters or by alternate AC sources as defined in this section, nor does it assume a concurrent single failure or design basis accident...' in accordance with Reference 1. In this paper, the innovative features of the AP1000 plant design are described with their operation inmore » the scenario of an extended station blackout event. General operation of the passive safety systems are described as well as the unique features which allow the AP1000 plant to cope for at least 7 days during station blackout. Points of emphasis will include: - Passive safety system operation during SBO - 'Fail-safe' nature of key passive safety system valves; automatically places the valve in a conservatively safe alignment even in case of multiple failures in all power supply systems, including normal AC and battery backup - Passive Spent Fuel Pool cooling and makeup water supply during SBO - Robustness of AP1000 plant due to the location of key systems, structures and components required for Safe Shutdown - Diverse means of supplying makeup water to the Passive Containment Cooling System (PCS) and the Spent Fuel Pool (SFP) through use of an engineered, safety-related piping interface and portable equipment, as well as with permanently installed onsite ancillary equipment. (authors)« less

The Rated Voltage Determination of DC Building Power Supply System Considering Human Beings Safety

NASA Astrophysics Data System (ADS)

Wang, Zhicheng; Yu, Kansheng; Xie, Guoqiang; Zou, Jin

2018-01-01

Generally two-level voltages are adopted for DC building power supply system. From the point of view of human beings safety, only the lower level voltage which may be contacted barehanded is discussed in this paper based on the related safety thresholds of human beings current effect. For several voltage levels below 100V recommended by IEC, the body current and current density of human electric shock under device normal work condition, as well as effect of unidirectional single impulse currents of short durations are calculated and analyzed respectively. Finally, DC 60V is recommended as the lower level rating voltage through the comprehensive consideration of technical condition and cost of safety criteria.

Non-Use of Motor Vehicle Safety Belts as an Issue in Civil Litigation

DOT National Transportation Integrated Search

1983-08-01

The current and potential role of the "safety belt defense" in civil litigation is studied. The paper presents an overview of the safety belt defense, including an evaluation of current precedent. Based on interviews with leading motor vehicle civil ...

Evaluation of Environmental Conditions on the Curing Of Commercial Fixative and Intumescent Coatings

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

Nicholson, J. C.

2016-09-26

Performance metrics for evaluating commercial fixatives are often not readily available for important parameters that must be considered per the facility safety basis and the facility Basis for Interim Operations (BIO). One such parameter is the behavior of such materials in varied, “non-ideal” conditions where ideal is defined as 75 °F, 40% RH. Coupled with the inherent flammable nature of the fixative materials that can act to propagate flame along surfaces that are otherwise fireproof (concrete, sheet metal), much is left unknown when considering the safety basis implications for introducing these materials into nuclear facilities. Through SRNL’s efforts, three (3)more » fixatives, one (1) decontamination gel, and six (6) intumescent coatings were examined for their responses to environmental conditions to determine whether these materials were impervious to non-nominal temperatures and humidities that may be found in nuclear facilities. Characteristics that were examined included set-to-touch time, dust free time, and adhesion testing of the fully cured compounds. Of these ten materials, three were two-part epoxy materials while the other seven consisted of only one constituent. The results show that the epoxies tested are unable to cure in sub-freezing temperatures, with the low temperatures inhibiting crosslinking to a very significant degree. These efforts show significant inhibiting of performance for non-nominal environmental conditions, something that must be addressed both in the decision process for a fixative material to apply and per the safety basis to ensure the accurate flammability and material at risk is calculated.« less

Overview of Energy Systems` safety analysis report programs. Safety Analysis Report Update Program

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

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility`s safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This ``Overview of Energy Systems Safety Analysis Report Programs`` Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

National Highway Safety Administration. Automatic collision notice field test summary.

PubMed

2001-10-01

From 1995 to 2000, the National Highway Traffic Safety Administration (NHTSA) sponsored an initiative to create and operate an Automatic Collision Notification (ACN) system on a demonstration basis in a rural area to provide faster and smarter emergency medical responses and in an attempt to save lives and reduce disabilities from injuries. This article is a brief summary of that demonstration.

14 CFR 382.29 - May a carrier require a passenger with a disability to travel with a safety assistant?

Code of Federal Regulations, 2013 CFR

2013-01-01

...) Concern that a passenger with a disability may need personal care services (e.g., assistance in using... disability to travel with a safety assistant? 382.29 Section 382.29 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Nondiscrimination and Access to Services and Information § 382.29 May...

14 CFR 382.29 - May a carrier require a passenger with a disability to travel with a safety assistant?

Code of Federal Regulations, 2014 CFR

2014-01-01

...) Concern that a passenger with a disability may need personal care services (e.g., assistance in using... disability to travel with a safety assistant? 382.29 Section 382.29 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Nondiscrimination and Access to Services and Information § 382.29 May...

14 CFR 382.29 - May a carrier require a passenger with a disability to travel with a safety assistant?

Code of Federal Regulations, 2012 CFR

2012-01-01

...) Concern that a passenger with a disability may need personal care services (e.g., assistance in using... disability to travel with a safety assistant? 382.29 Section 382.29 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Nondiscrimination and Access to Services and Information § 382.29 May...

Reaping the Benefits of Task Conflict in Teams: The Critical Role of Team Psychological Safety Climate

ERIC Educational Resources Information Center

Bradley, Bret H.; Postlethwaite, Bennett E.; Klotz, Anthony C.; Hamdani, Maria R.; Brown, Kenneth G.

2012-01-01

Past research suggests that task conflict may improve team performance under certain conditions; however, we know little about these specific conditions. On the basis of prior theory and research on conflict in teams, we argue that a climate of psychological safety is one specific context under which task conflict will improve team performance.…

NASA's Spaceliner 100 Investment Area Technology Activities

NASA Technical Reports Server (NTRS)

Hueter, Uwe; Lyles, Garry M. (Technical Monitor)

2001-01-01

NASA's has established long term goals for access-to-space. The third generation launch systems are to be fully reusable and operational around 2025. The goals for the third generation launch system are to reduce cost by a factor of 100 and improve safety by a factor of 10,000 over current conditions. The Advanced Space Transportation Program Office (ASTP) at the NASA's Marshall Space Flight Center in Huntsville, AL has the agency lead to develop space transportation technologies. Within ASTP, under the Spaceliner100 Investment Area, third generation technologies are being pursued in the areas of propulsion, airframes, integrated vehicle health management (IVHM), launch systems, and operations and range. The ASTP program will mature these technologies through ground system testing. Flight testing where required, will be advocated on a case by case basis.

Defining quality in radiology.

PubMed

Blackmore, C Craig

2007-04-01

The introduction of pay for performance in medicine represents an opportunity for radiologists to define quality in radiology. Radiology quality can be defined on the basis of the production model that currently drives reimbursement, codifying the role of radiologists as being limited to the production of timely and accurate radiology reports produced in conditions of maximum patient safety and communicated in a timely manner. Alternately, quality in radiology can also encompass the professional role of radiologists as diagnostic imaging specialists responsible for the appropriate use, selection, interpretation, and application of imaging. Although potentially challenging to implement, the professional model for radiology quality is a comprehensive assessment of the ways in which radiologists add value to patient care. This essay is a discussion of the definition of radiology quality and the implications of that definition.

Nutrigenomics and Personalized Diets: What Will They Mean for Food?

PubMed Central

German, J. Bruce; Zivkovic, Angela M.; Dallas, David C.; Smilowitz, Jennifer T.

2015-01-01

The modern food system feeds six billion people with safety, and nutrition. Yet, the current rise in diet-related mising health and devaluing many aspects of modern increase the nutritional quality of individual foods will health and in guiding individuals to achieve superior is the scientific field of the genetic basis for varying and the diverse responses to foods. Although some of nants will be simple and amenable to personal predict health, in practice most will not. As a result, the secret to personalizing diet and health. Human from imaging to proteomics and metabolomics are understand and accurately assess the nutritional The business models are also emerging to bring these ties to industrial practice, in which consumers will personal health and seek personal solutions. PMID:22129377

Thermal properties and effects for Li/BCX (thionyl chloride) cells

NASA Technical Reports Server (NTRS)

Takeuchi, E. S.; Holmes, C. F.; Clark, W. D. K.

1987-01-01

New NASA requirements for the screening of lithium cells for space applications involve thermal soaks at elevated temperatures (149 C). The currently qualified Li/BCX cells and three design modifications have been evaluated showing that a design incorporating a shortened electrode stack met this test condition while continuing to satisfy the performance and safety requirements for cells used on NASA manned space vehicles. Information was also developed to show that measured heat capacities for the BCX D size cells correlated well with the heat generated from cells discharged in an insulated environment. Calculated heat capacities based on the amounts and types of materials in a cell were low compared to these values. This information provides the basis for the design of battery packs in the highly insulating environment of outer space.

Total Diet Study: For a Closer-to-real Estimate of Dietary Exposure to Chemical Substances

PubMed Central

Lee, Jeeyeon; Kwon, Sungok; Yoon, Hae-Jung

2015-01-01

Recent amendment on the Food Sanitation Act in Korea mandated the Minister of Food & Drug Safety to secure the scientific basis for management and reevaluation of standards and specifications of foods. Especially because the current food safety control is limited within the scope of ‘Farm to Market’ covering from production to retail in Korea, safety control at the plane of true ‘Farm to Fork’ scope is urgently needed and should include ‘total diet’ of population instead of individual food items. Therefore, ‘Total Diet Study (TDS)’ which provides ‘closer-to-real’ estimates of exposure to hazardous materials through analysis on table-ready (cooked) samples of foods would be the solution to more comprehensive food safety management, as suggested by World Health Organization and Food and Agriculture Organization of the United Nations. Although the protection of diets from hazards must be considered as one of the most essential public health functions of any country, we may need to revisit the value of foods which has been too much underrated by the meaningless amount of some hazardous materials in Korea. Considering the primary value of foods lies on sustaining life, growth, development, and health promotion of human being, food safety control should be handled not only by the presence or absence of hazardous materials but also by maximizing the value of foods via balancing with the preservation of beneficial components in foods embracing total diet. In this regard, this article aims to provide an overview on TDS by describing procedures involved except chemical analysis which is beyond our scope. Also, details on the ongoing TDS in Korea are provided as an example. Although TDS itself might not be of keen interest for most readers, it is the main user of the safety reference values resulted from toxicological research in the public health perspective. PMID:26483882

[Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

PubMed

Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

2011-10-01

The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

Impact of economic incentives on costs and benefits of occupational health and safety.

PubMed

Pawłowska, Z; Rzepecki, J

2000-01-01

The most common type of economic incentive used in the field of health and safety is experience rating of insurance premiums. The impact of this incentive on occupational health and safety (OHS) costs in the company was analysed by comparing insurance costs with other OHS costs associated with inadequate working conditions, such as accident costs borne by a company. Accident costs were estimated on the basis of research carried out in 10 companies. Insurance costs and their adjustments according to the health and safety level in a company were calculated according to an experience rating model developed in the Central Institute for Labour Protection.

[Chemical safety, health, and environment: prospects for governance in the Brazilian context].

PubMed

Freitas, Carlos Machado de; Porto, Marcelo Firpo S; Moreira, Josino Costa; Pivetta, Fatima; Machado, Jorge M Huet; Freitas, Nilton B B de; Arcuri, Arline S

2002-01-01

Chemical safety is acknowledged by Agenda 21 as one of the most serious problems worldwide, involving governance at the national and international levels. In Brazil, chemical safety problems have increased in intensity and extent, far beyond the capacity to deal with them. The problems are all the more serious in Brazil because issues of democracy, security, sustainability, and equity, all fundamental to governance, are still incipient and still far from being solved. New societal arrangements and a new, contextualized and more participatory science form the basis for developing and expanding strategies for governance to deal with the problem of chemical safety.

Research on station management in subway operation safety

NASA Astrophysics Data System (ADS)

Li, Yiman

2017-10-01

The management of subway station is an important part of the safe operation of urban subway. In order to ensure the safety of subway operation, it is necessary to study the relevant factors that affect station management. In the protection of subway safety operations on the basis of improving the quality of service, to promote the sustained and healthy development of subway stations. This paper discusses the influencing factors of subway operation accident and station management, and analyzes the specific contents of station management security for subway operation, and develops effective suppression measures. It is desirable to improve the operational quality and safety factor for subway operations.

From Vineyard Soil to Wine Fermentation: Microbiome Approximations to Explain the “terroir” Concept

PubMed Central

Belda, Ignacio; Zarraonaindia, Iratxe; Perisin, Matthew; Palacios, Antonio; Acedo, Alberto

2017-01-01

Wine originally emerged as a serendipitous mix of chemistry and biology, where microorganisms played a decisive role. From these ancient fermentations to the current monitored industrial processes, winegrowers and winemakers have been continuously changing their practices according to scientific knowledge and advances. A new enology direction is emerging and aiming to blend the complexity of spontaneous fermentations with industrial safety of monitored fermentations. In this context, wines with distinctive autochthonous peculiarities have a great acceptance among consumers, causing important economic returns. The concept of terroir, far from being a rural term, conceals a wide range of analytical parameters that are the basis of the knowledge-based enology trend. In this sense, the biological aspect of soils has been underestimated for years, when actually it contains a great microbial diversity. This soil-associated microbiota has been described as determinant, not only for the chemistry and nutritional properties of soils, but also for health, yield, and quality of the grapevine. Additionally, recent works describe the soil microbiome as the reservoir of the grapevine associated microbiota, and as a contributor to the final sensory properties of wines. To understand the crucial roles of microorganisms on the entire wine making process, we must understand their ecological niches, population dynamics, and relationships between ‘microbiome- vine health’ and ‘microbiome-wine metabolome.’ These are critical steps for designing precision enology practices. For that purpose, current metagenomic techniques are expanding from laboratories, to the food industry. This review focuses on the current knowledge about vine and wine microbiomes, with emphasis on their biological roles and the technical basis of next-generation sequencing pipelines. An overview of molecular and informatics tools is included and new directions are proposed, highlighting the importance of –omics technologies in wine research and industry. PMID:28533770

Auditory midbrain implant: a review.

PubMed

Lim, Hubert H; Lenarz, Minoo; Lenarz, Thomas

2009-09-01

The auditory midbrain implant (AMI) is a new hearing prosthesis designed for stimulation of the inferior colliculus in deaf patients who cannot sufficiently benefit from cochlear implants. The authors have begun clinical trials in which five patients have been implanted with a single shank AMI array (20 electrodes). The goal of this review is to summarize the development and research that has led to the translation of the AMI from a concept into the first patients. This study presents the rationale and design concept for the AMI as well a summary of the animal safety and feasibility studies that were required for clinical approval. The authors also present the initial surgical, psychophysical, and speech results from the first three implanted patients. Overall, the results have been encouraging in terms of the safety and functionality of the implant. All patients obtain improvements in hearing capabilities on a daily basis. However, performance varies dramatically across patients depending on the implant location within the midbrain with the best performer still not able to achieve open set speech perception without lip-reading cues. Stimulation of the auditory midbrain provides a wide range of level, spectral, and temporal cues, all of which are important for speech understanding, but they do not appear to sufficiently fuse together to enable open set speech perception with the currently used stimulation strategies. Finally, several issues and hypotheses for why current patients obtain limited speech perception along with several feasible solutions for improving AMI implementation are presented.

Reaping the benefits of task conflict in teams: the critical role of team psychological safety climate.

PubMed

Bradley, Bret H; Postlethwaite, Bennett E; Klotz, Anthony C; Hamdani, Maria R; Brown, Kenneth G

2012-01-01

Past research suggests that task conflict may improve team performance under certain conditions; however, we know little about these specific conditions. On the basis of prior theory and research on conflict in teams, we argue that a climate of psychological safety is one specific context under which task conflict will improve team performance. Using evidence from 117 project teams, the present research found that psychological safety climate moderates the relationship between task conflict and performance. Specifically, task conflict and team performance were positively associated under conditions of high psychological safety. The results support the conclusion that psychological safety facilitates the performance benefits of task conflict in teams. Theoretical implications and suggestions for future research are discussed.

The effect of terrain slope on firefighter safety zone effectiveness

Treesearch

Bret Butler; J. Forthofer; K. Shannon; D. Jimenez; D. Frankman

2010-01-01

The current safety zone guidelines used in the US were developed based on the assumption that the fire and safety zone were located on flat terrain. The minimum safe distance for a firefighter to be from a flame was calculated as that corresponding to a radiant incident energy flux level of 7.0kW-m-2. Current firefighter safety guidelines are based on the assumption...

Current trends and progress in clinical applications of oocyte cryopreservation.

PubMed

Cil, Aylin P; Seli, Emre

2013-06-01

To delineate the current trends in the clinical application of oocyte cryopreservation. Although the first live birth from oocyte cryopreservation was reported approximately three decades ago, significant improvement in the clinical application of oocyte cryopreservation took place only over the past decade. On the basis of the available evidence suggesting that success rates with donor oocyte vitrification are similar to that of IVF with fresh donor oocytes, the American Society of Reproductive Medicine has recently stated that oocyte cryopreservation should no longer be considered experimental for medical indications, outlying elective oocyte cryopreservation. Meanwhile, a few surveys on the attitudes toward oocyte cryopreservation revealed that elective use for the postponement of fertility is currently the most common indication for oocyte cryopreservation. Most recently, a randomized controlled trial revealed important evidence on the safety of nondonor oocyte cryopreservation, and confirmed that the clinical success of vitrification is comparable to that of IVF with fresh oocytes. The evidence suggesting similar IVF success rates with both donor and nondonor cryopreserved oocytes compared with fresh oocytes will increase the utilization of elective oocyte cryopreservation. Appropriate counseling of women for oocyte cryopreservation requires the establishment of age-based clinical success rates with cryopreserved oocytes for various indications.

Steam Generator tube integrity -- US Nuclear Regulatory Commission perspective

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

Murphy, E.L.; Sullivan, E.J.

1997-02-01

In the US, the current regulatory framework was developed in the 1970s when general wall thinning was the dominant degradation mechanism; and, as a result of changes in the forms of degradation being observed and improvements in inspection and tube repair technology, the regulatory framework needs to be updated. Operating experience indicates that the current U.S. requirements should be more stringent in some areas, while in other areas they are overly conservative. To date, this situation has been dealt with on a plant-specific basis in the US. However, the NRC staff is now developing a proposed steam generator rule asmore » a generic framework for ensuring that the steam generator tubes are capable of performing their intended safety functions. This paper discusses the current U.S. regulatory framework for assuring steam generator (SG) tube integrity, the need to update this regulatory framework, the objectives of the new proposed rule, the US Nuclear Regulatory Commission (NRC) regulatory guide (RG) that will accompany the rule, how risk considerations affect the development of the new rule, and some outstanding issues relating to the rule that the NRC is still dealing with.« less

Overview of Energy Systems' safety analysis report programs

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

Not Available

1992-03-01

The primary purpose of an Safety Analysis Report (SAR) is to provide a basis for judging the adequacy of a facility's safety. The SAR documents the safety analyses that systematically identify the hazards posed by the facility, analyze the consequences and risk of potential accidents, and describe hazard control measures that protect the health and safety of the public and employees. In addition, some SARs document, as Technical Safety Requirements (TSRs, which include Technical Specifications and Operational Safety Requirements), technical and administrative requirements that ensure the facility is operated within prescribed safety limits. SARs also provide conveniently summarized information thatmore » may be used to support procedure development, training, inspections, and other activities necessary to facility operation. This Overview of Energy Systems Safety Analysis Report Programs'' Provides an introduction to the programs and processes used in the development and maintenance of the SARs. It also summarizes some of the uses of the SARs within Energy Systems and DOE.« less

Safety Needs Mediate Stressful Events Induced Mental Disorders.

PubMed

Zheng, Zheng; Gu, Simeng; Lei, Yu; Lu, Shanshan; Wang, Wei; Li, Yang; Wang, Fushun

2016-01-01

"Safety first," we say these words almost every day, but we all take this for granted for what Maslow proposed in his famous theory of Hierarchy of Needs : safety needs come second to physiological needs. Here we propose that safety needs come before physiological needs. Safety needs are personal security, financial security, and health and well-being, which are more fundamental than physiological needs. Safety worrying is the major reason for mental disorders, such as anxiety, phobia, depression, and PTSD. The neural basis for safety is amygdala, LC/NE system, and corticotrophin-releasing hormone system, which can be regarded as a "safety circuitry," whose major behavior function is "fight or flight" and "fear and anger" emotions. This is similar to the Appraisal theory for emotions: fear is due to the primary appraisal, which is related to safety of individual, while anger is due to secondary appraisal, which is related to coping with the unsafe situations. If coping is good, the individual will be happy; if coping failed, the individual will be sad or depressed.

Validation of the group nuclear safety climate questionnaire.

PubMed

Navarro, M Felisa Latorre; Gracia Lerín, Francisco J; Tomás, Inés; Peiró Silla, José María

2013-09-01

Group safety climate is a leading indicator of safety performance in high reliability organizations. Zohar and Luria (2005) developed a Group Safety Climate scale (ZGSC) and found it to have a single factor. The ZGSC scale was used as a basis in this study with the researchers rewording almost half of the items on this scale, changing the referents from the leader to the group, and trying to validate a two-factor scale. The sample was composed of 566 employees in 50 groups from a Spanish nuclear power plant. Item analysis, reliability, correlations, aggregation indexes and CFA were performed. Results revealed that the construct was shared by each unit, and our reworded Group Safety Climate (GSC) scale showed a one-factor structure and correlated to organizational safety climate, formalized procedures, safety behavior, and time pressure. This validation of the one-factor structure of the Zohar and Luria (2005) scale could strengthen and spread this scale and measure group safety climate more effectively. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

[Patient safety in education and training of healthcare professionals in Germany].

PubMed

Hoffmann, Barbara; Siebert, H; Euteneier, A

2015-01-01

In order to improve patient safety, healthcare professionals who care for patients directly or indirectly are required to possess specific knowledge and skills. Patient safety education is not or only poorly represented in education and examination regulations of healthcare professionals in Germany; therefore, it is only practiced rarely and on a voluntary basis. Meanwhile, several training curricula and concepts have been developed in the past 10 years internationally and recently in Germany, too. Based on these concepts the German Coalition for Patient Safety developed a catalogue of core competencies required for safety in patient care. This catalogue will serve as an important orientation when patient safety is to be implemented as a subject of professional education in Germany in the future. Moreover, teaching staff has to be trained and educational and training activities have to be evaluated. Patient safety education and training for (undergraduate) healthcare professional will require capital investment.

78 FR 32412 - Navigation Safety Advisory Council; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-30

...) does not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and generic...

Challenges Ahead for Nuclear Facility Site-Specific Seismic Hazard Assessment in France: The Alternative Energies and the Atomic Energy Commission (CEA) Vision

NASA Astrophysics Data System (ADS)

Berge-Thierry, C.; Hollender, F.; Guyonnet-Benaize, C.; Baumont, D.; Ameri, G.; Bollinger, L.

2017-09-01

Seismic analysis in the context of nuclear safety in France is currently guided by a pure deterministic approach based on Basic Safety Rule ( Règle Fondamentale de Sûreté) RFS 2001-01 for seismic hazard assessment, and on the ASN/2/01 Guide that provides design rules for nuclear civil engineering structures. After the 2011 Tohohu earthquake, nuclear operators worldwide were asked to estimate the ability of their facilities to sustain extreme seismic loads. The French licensees then defined the `hard core seismic levels', which are higher than those considered for design or re-assessment of the safety of a facility. These were initially established on a deterministic basis, and they have been finally justified through state-of-the-art probabilistic seismic hazard assessments. The appreciation and propagation of uncertainties when assessing seismic hazard in France have changed considerably over the past 15 years. This evolution provided the motivation for the present article, the objectives of which are threefold: (1) to provide a description of the current practices in France to assess seismic hazard in terms of nuclear safety; (2) to discuss and highlight the sources of uncertainties and their treatment; and (3) to use a specific case study to illustrate how extended source modeling can help to constrain the key assumptions or parameters that impact upon seismic hazard assessment. This article discusses in particular seismic source characterization, strong ground motion prediction, and maximal magnitude constraints, according to the practice of the French Atomic Energy Commission. Due to increases in strong motion databases in terms of the number and quality of the records in their metadata and the uncertainty characterization, several recently published empirical ground motion prediction models are eligible for seismic hazard assessment in France. We show that propagation of epistemic and aleatory uncertainties is feasible in a deterministic approach, as in a probabilistic way. Assessment of seismic hazard in France in the framework of the safety of nuclear facilities should consider these recent advances. In this sense, the opening of discussions with all of the stakeholders in France to update the reference documents (i.e., RFS 2001-01; ASN/2/01 Guide) appears appropriate in the short term.

45 CFR 2543.84 - Contract Work Hours and Safety Standards Act.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Contract Work Hours and Safety Standards Act. 2543... laborer on the basis of a standard work week of 40 hours. Work in excess of the standard work week is... pay for all hours worked in excess of 40 hours in the work week. Section 107 of the Act is applicable...

14 CFR 382.29 - May a carrier require a passenger with a disability to travel with a safety assistant?

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false May a carrier require a passenger with a disability to travel with a safety assistant? 382.29 Section 382.29 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Nondiscrimination and Access to Services and Information § 382.29 May...

14 CFR 382.29 - May a carrier require a passenger with a disability to travel with a safety assistant?

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false May a carrier require a passenger with a disability to travel with a safety assistant? 382.29 Section 382.29 Aeronautics and Space OFFICE OF THE... BASIS OF DISABILITY IN AIR TRAVEL Nondiscrimination and Access to Services and Information § 382.29 May...

Factors influencing the retention of registered nurses in the Gauteng Province of South Africa.

PubMed

Mokoka, Kgaogelo E; Ehlers, Valerie J; Oosthuizen, Martha J

2011-12-14

South Africa is a source country for many destination countries that recruit registered nurses who emigrate for personal and/or professional reasons. A large number of South African nurses belong to the baby boomer generation (born between 1943 and 1964) who will retire within the foreseeable future. Statistics from the South African Nursing Council show a decline of 42.0% in the number of nurses who completed their training in South Africa from 1996 to 2005. These aspects combine to predict a potential dire shortage of nurses in South Africa within the foreseeable future. Retention of registered nurses should be the focus of health-care planners to avoid crises in South Africa's health-care services. This study attempted to identify factors that would influence registered nurses' decisions to stay with their current employers in the Gauteng Province of South Africa. An exploratory descriptive quantitative design was adopted and questionnaires were sent to a sample of nurses, registered with the South African Nursing Council (SANC), with addresses in the Gauteng Province. A total of 108 nurses completed and returned questionnaires, of whom 77 (73.1%) had considered leaving their current employers. The most important factors that would influence more than 90.0% of these nurses' decisions to stay with their current employers related to finances, safety and security, equipment and/or supplies, management, staff and patients. In terms of Maslow's Hierarchy of Needs Theory, deficiency needs (physiological, safety and social needs) should be met by improved salaries revised on an annual basis, paying long-service and outstanding-service bonuses, and improving the safety and security, as well the available equipment and supplies, at institutions. Sufficient numbers of nurses should be employed and vacancies should be filled rapidly. However, not all changes required to enhance nurses' retention rates involve increased costs. Managers should lead by example and respect nurses, and encourage doctors as well as patients to do so, to meet nurses' self-esteem needs. Recognising and rewarding outstanding service would meet nurses' self-actualisation needs, as well as opportunities to further their education.

Investigational hormone receptor agonists as ongoing female contraception: a focus on selective progesterone receptor modulators in early clinical development.

PubMed

Nelson, Anita L

2015-01-01

As efforts are made to continue to increase the safety of contraceptive methods, those without estrogen have attracted new attention. Progestin-only options are available in many delivery systems, but most cause disturbed bleeding patterns. For gynecologic patients, selective progesterone receptor modulators (SPRMs) have been approved for medical abortion, for ovulation suppression in emergency contraception, and for the treatment of heavy menstrual bleeding due to leiomyoma. This article discusses the role of SPRMs in controlling fertility on an ongoing basis with particular emphasis on mifepristone and ulipristal acetate (UPA), since none of the other compounds has progressed out of early Phase I - II testing. It also discusses important information about the mechanisms of action and safety of these two SPRMs. Of all the investigational hormone agonist/antagonists, SPRMs have demonstrated the greatest potential as ongoing female contraceptives. They have the ability to suppress ovulation after initiation of the luteinizing hormone (LH) surge without affecting ovarian production of estrogen or inducing any significant metabolic changes. SPRMs may well be able to provide longer term contraception as oral agents, vaginal rings, and perhaps even intrauterine devices. UPA has the greatest promise. Current research needs to be expanded.

Food consumption data needs for food and agricultural policy.

PubMed

Myers, L H

1994-09-01

Food and agricultural policy strives to provide stable, safe, nutritional, and affordable food supplies with policies on farm income, low-income food security, food safety (including nutritional risk), and nutrition education. For each policy area, comparisons are made between food consumption data needs and information currently collected with four human nutrition monitoring system components administered by the U.S. Department of Agriculture. Identified data gaps become the basis for recommendations for future data needs. Food consumption data are essential to management of programs. However, many food safety and nutritional well-being issues require specific food product consumption data for high risk groups. Sampling procedures are often too aggregate to meet these needs. Food consumed away-from-home is not well measured, yet this market segment now accounts for about half of all consumer food expenditures. Surveys should be designed to provide complementary and additive data. A premium should be placed on standardizing household description variables to enable "splicing" together data from different surveys. Survey continuity across time is essential. Data collection should be planned with funding limitations and respondent burden in mind so that a balance is achieved between survey objectives and the practical constraints of obtaining accurate data.

Essential oils, their therapeutic properties, and implication in dentistry: A review.

PubMed

Dagli, Namrata; Dagli, Rushabh; Mahmoud, Rasha Said; Baroudi, Kusai

2015-01-01

Antibacterial treatments currently used for treatment cause several side effects, and bacterial resistance to the antibiotics is also increasing. Therefore, there is need to find better alternatives. Essential oils (EOs) have been used for treatment of various ailments since ancient times and have gained popularity over the years. Safety and efficacy of EOs have been proved by several clinical trials. This review gives an overview on the EOs, their uses, and adverse effects. A literature search was performed in the PubMed for clinical trial studies and review articles on EOs published up to February 2015. The search was performed during March 2015. The following keywords were used: "Lavender essential oil," "cinnamon oil," "clove oil," "eucalyptus oil," "peppermint oil," "lemon EOs," and "tea tree oil." Total 70 relevant articles were found in PubMed database. After screening of abstracts, 52 articles were selected to be included in the present review. On the basis of the available information, it can be concluded that EOs have the potential to be developed as preventive or therapeutic agents for various oral diseases, but further clinical trials are required to establish their safety and efficacy.

Robot-Assisted Versus Open Liver Resection in the Right Posterior Section

PubMed Central

Cipriani, Federica; Ratti, Francesca; Bartoli, Alberto; Ceccarelli, Graziano; Casciola, Luciano; Aldrighetti, Luca

2014-01-01

Background: Open liver resection is the current standard of care for lesions in the right posterior liver section. The objective of this study was to determine the safety of robot-assisted liver resection for lesions located in segments 6 and 7 in comparison with open surgery. Methods: Demographics, comorbidities, clinicopathologic characteristics, surgical treatments, and outcomes from patients who underwent open and robot-assisted liver resection at 2 centers for lesions in the right posterior section between January 2007 and June 2012 were reviewed. A 1:3 matched analysis was performed by individually matching patients in the robotic cohort to patients in the open cohort on the basis of demographics, comorbidities, performance status, tumor stage, and location. Results: Matched patients undergoing robotic and open liver resections displayed no significant differences in postoperative outcomes as measured by blood loss, transfusion rate, hospital stay, overall complication rate (15.8% vs 13%), R0 negative margin rate, and mortality. Patients undergoing robotic liver surgery had significantly longer operative time (mean, 303 vs 233 minutes) and inflow occlusion time (mean, 75 vs 29 minutes) compared with their open counterparts. Conclusions: Robotic and open liver resections in the right posterior section display similar safety and feasibility. PMID:25516700

Experimental study and finite element analysis of wind-induced vibration of modal car based on fluid-structure interaction

NASA Astrophysics Data System (ADS)

Tao, Li-li; Du, Guang-sheng; Liu, Li-ping; Liu, Yong-hui; Shao, Zhu-feng

2013-02-01

The wind-induced vibration of the front windshield concerns the traffic safety and the aerodynamic characteristics of cars. In this paper, the numerical simulation and the experiment are combined to study the wind-induced vibrations of the front windshield at different speeds of a van-body model bus. The Fluid-Structure Interaction (FSI) model is used for the finite element analysis of the vibration characteristics of the front windshield glass in the travelling process, and the wind-induced vibration response characteristics of the glass is obtained. A wind-tunnel experiment with an eddy current displacement sensor is carried out to study the deformation of the windshield at different wind speeds, and to verify the numerical simulation results. It is shown that the windshield of the model bus windshield undergoes a noticeable deformation as the speed changes, and from the deformation curve obtained, it is seen that in the accelerating process, the deformation of the glass increases as the speed increases, and with the speed being stablized, it also tends to a certain value. The results of this study can provide a scientific basis for the safety design of the windshield and the body.

How a Stressed Local Public System Copes With People in Psychiatric Crisis

PubMed Central

Wells, Rebecca; La, Elizabeth Holdsworth; Morrissey, Joseph; Hall, Marissa; Lich, Kristen Hassmiller; Blouin, Rachel

2012-01-01

In order to bolster the public mental health safety net, we must first understand how these systems function on a day-to-day basis. This study explored how individual attributes and organizational interdependencies within one predominantly urban US county affected responses to individuals’ needs during psychiatric crises. We interviewed clinicians and managers within the crisis response network about people at immediate risk of psychiatric hospitalization, what had happened to them during their crises, and factors affecting services provided (N = 94 individuals and 9 agencies). Social network diagrams depicted patterns of referrals between agencies. Iterative coding of interview transcripts was used to contextualize the social network findings. Often, agencies saw crises through to resolution. However, providers also limited the types of people they served, leaving many people in crisis in limbo. This study illustrates how attributes of individuals with mental illness, service providers and their interactions, and state and federal policies intersect to shape the trajectories of individuals during psychiatric crises. Understanding both the structures of current local systems and their contexts may support continued evolution toward a more humane and robust safety net for some of our society’s most vulnerable members. PMID:23065371

Factors influencing patient safety in Sweden: perceptions of patient safety officers in the county councils

PubMed Central

2013-01-01

Background National, regional and local activities to improve patient safety in Sweden have increased over the last decade. There are high ambitions for improved patient safety in Sweden. This study surveyed health care professionals who held key positions in their county council’s patient safety work to investigate their perceptions of the conditions for this work, factors they believe have been most important in reaching the current level of patient safety and factors they believe would be most important for achieving improved patient safety in the future. Methods The study population consisted of 218 health care professionals holding strategic positions in patient safety work in Swedish county councils. Using a questionnaire, the following topics were analysed in this study: profession/occupation; number of years involved in a designated task on patient safety issues; knowledge/overview of the county council’s patient safety work; ability to influence this work; conditions for this work; and the importance of various factors for current and future levels of patient safety. Results The response rate to the questionnaire was 79%. The conditions that had the highest number of responses in complete agreement were “patients’ involvement is important for patient safety” and “patient safety work has good support from the county council’s management”. Factors that were considered most important for achieving the current level of patient safety were root cause and risk analyses, incident reporting and the Swedish Patient Safety Law. An organizational culture that encourages reporting and avoids blame was considered most important for improved patient safety in the future, closely followed by improved communication between health care practitioners and patients. Conclusion Health care professionals with important positions in the Swedish county councils’ patient safety work believe that conditions for this work are somewhat constrained. They attribute the current levels of patient safety to a broad range of factors and believe that many different solutions can contribute to enhanced patient safety in the future, suggesting that this work must be multifactorial. PMID:23391301

Safety Surveillance of Traditional Chinese Medicine: Current and Future

PubMed Central

Liu, Shwu-Huey; Chuang, Wu-Chang; Lam, Wing; Jiang, Zaoli

2015-01-01

Herbal medicine, including traditional Chinese medicine, has been used for the prevention, treatment, and cure of disorders or diseases for centuries. In addition to being used directly as therapeutic agents, medicinal plants are also important sources for pharmacological drug research and development. With the increasing consumption of herbal products intended to promote better health, it is extremely important to assure the safety and quality of herbal preparations. However, under current regulation surveillance, herbal preparations may not meet expectations in safety, quality, and efficacy. The challenge is how to assure the safety and quality of herbal products for consumers. It is the responsibility of producers to minimize hazardous contamination and additives during cultivation, harvesting, handling, processing, storage, and distribution. This article reviews the current safety obstacles that have been involved in traditional Chinese herbal medicine preparations with examples of popular herbs. Approaches to improve the safety of traditional Chinese medicine are proposed. PMID:25647717

Facts and Fallacies in the Debate on Glyphosate Toxicity.

PubMed

Mesnage, Robin; Antoniou, Michael N

2017-01-01

The safety profile of the herbicide glyphosate and its commercial formulations is controversial. Reviews have been published by individuals who are consultants and employees of companies commercializing glyphosate-based herbicides in support of glyphosate's reapproval by regulatory agencies. These authors conclude that glyphosate is safe at levels below regulatory permissible limits. In contrast, reviews conducted by academic scientists independent of industry report toxic effects below regulatory limits, as well as shortcomings of the current regulatory evaluation of risks associated with glyphosate exposures. Two authors in particular (Samsel and Seneff) have published a series of commentaries proposing that long-term exposure to glyphosate is responsible for many chronic diseases (including cancers, diabetes, neuropathies, obesity, asthma, infections, osteoporosis, infertility, and birth defects). The aim of this review is to examine the evidential basis for these claimed negative health effects and the mechanisms that are alleged to be at their basis. We found that these authors inappropriately employ a deductive reasoning approach based on syllogism. We found that their conclusions are not supported by the available scientific evidence. Thus, the mechanisms and vast range of conditions proposed to result from glyphosate toxicity presented by Samsel and Seneff in their commentaries are at best unsubstantiated theories, speculations, or simply incorrect. This misrepresentation of glyphosate's toxicity misleads the public, the scientific community, and regulators. Although evidence exists that glyphosate-based herbicides are toxic below regulatory set safety limits, the arguments of Samsel and Seneff largely serve to distract rather than to give a rational direction to much needed future research investigating the toxicity of these pesticides, especially at levels of ingestion that are typical for human populations.

Facts and Fallacies in the Debate on Glyphosate Toxicity

PubMed Central

Mesnage, Robin; Antoniou, Michael N.

2017-01-01

The safety profile of the herbicide glyphosate and its commercial formulations is controversial. Reviews have been published by individuals who are consultants and employees of companies commercializing glyphosate-based herbicides in support of glyphosate’s reapproval by regulatory agencies. These authors conclude that glyphosate is safe at levels below regulatory permissible limits. In contrast, reviews conducted by academic scientists independent of industry report toxic effects below regulatory limits, as well as shortcomings of the current regulatory evaluation of risks associated with glyphosate exposures. Two authors in particular (Samsel and Seneff) have published a series of commentaries proposing that long-term exposure to glyphosate is responsible for many chronic diseases (including cancers, diabetes, neuropathies, obesity, asthma, infections, osteoporosis, infertility, and birth defects). The aim of this review is to examine the evidential basis for these claimed negative health effects and the mechanisms that are alleged to be at their basis. We found that these authors inappropriately employ a deductive reasoning approach based on syllogism. We found that their conclusions are not supported by the available scientific evidence. Thus, the mechanisms and vast range of conditions proposed to result from glyphosate toxicity presented by Samsel and Seneff in their commentaries are at best unsubstantiated theories, speculations, or simply incorrect. This misrepresentation of glyphosate’s toxicity misleads the public, the scientific community, and regulators. Although evidence exists that glyphosate-based herbicides are toxic below regulatory set safety limits, the arguments of Samsel and Seneff largely serve to distract rather than to give a rational direction to much needed future research investigating the toxicity of these pesticides, especially at levels of ingestion that are typical for human populations. PMID:29226121

77 FR 15784 - Navigation Safety Advisory Council; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-16

... discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and generic information, age, membership...

78 FR 20684 - Towing Safety Advisory Committee; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... Government. DHS does not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disabilities and...

The power of simplification: Operator interface with the AP1000{sup R} during design-basis and beyond design-basis events

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

Williams, M. G.; Mouser, M. R.; Simon, J. B.

2012-07-01

The AP1000{sup R} plant is an 1100-MWe pressurized water reactor with passive safety features and extensive plant simplifications that enhance construction, operation, maintenance, safety and cost. The passive safety features are designed to function without safety-grade support systems such as component cooling water, service water, compressed air or HVAC. The AP1000 passive safety features achieve and maintain safe shutdown in case of a design-basis accident for 72 hours without need for operator action, meeting the expectations provided in the European Utility Requirements and the Utility Requirement Document for passive plants. Limited operator actions may be required to maintain safe conditionsmore » in the spent fuel pool (SFP) via passive means. This safety approach therefore minimizes the reliance on operator action for accident mitigation, and this paper examines the operator interaction with the Human-System Interface (HSI) as the severity of an accident increases from an anticipated transient to a design basis accident and finally, to a beyond-design-basis event. The AP1000 Control Room design provides an extremely effective environment for addressing the first 72 hours of design-basis events and transients, providing ease of information dissemination and minimal reliance upon operator actions. Symptom-based procedures including Emergency Operating Procedures (EOPs), Abnormal Operating Procedures (AOPs) and Alarm Response Procedures (ARPs) are used to mitigate design basis transients and accidents. Use of the Computerized Procedure System (CPS) aids the operators during mitigation of the event. The CPS provides cues and direction to the operators as the event progresses. If the event becomes progressively worse or lasts longer than 72 hours, and depending upon the nature of failures that may have occurred, minimal operator actions may be required outside of the control room in areas that have been designed to be accessible using components that have been designed to be reliable in these conditions. The primary goal of any such actions is to maintain or refill the passive inventory available to cool the core, containment and spent fuel pool in the safety-related and seismically qualified Passive Containment Cooling Water Storage Tank (PCCWST). The seismically-qualified, ground-mounted Passive Containment Cooling Ancillary Water Storage Tank (PCCAWST) is also available for this function as appropriate. The primary effect of these actions would be to increase the coping time for the AP1000 during design basis events, as well as events such as those described above, from 72 hours without operator intervention to 7 days with minimal operator actions. These Operator actions necessary to protect the health and safety of the public are addressed in the Post-72 Hour procedures, as well as some EOPs, AOPs, ARPs and the Severe Accident Management Guidelines (SAMGs). Should the event continue to become more severe and plant conditions degrade further with indications of inadequate core cooling, the SAMGs provide guidance for strategies to address these hypothetical severe accident conditions. The AP1000 SAMG diagnoses and actions are prioritized to first utilize the AP1000 features that are expected to retain a damaged core inside the reactor vessel. Only one strategy is undertaken at any time. This strategy will be followed and its effectiveness evaluated before other strategies are undertaken. This is a key feature of both the symptom-oriented AP1000 EOPs and the AP1000 SAMGs which maximizes the probability of retaining a damaged core inside the reactor vessel and containment while minimizing the chances for confusion and human errors during implementation. The AP1000 SAMGs are simple and straight-forward and have been developed with considerable input from human factors and plant operations experts. Most importantly, and different from severe accident management strategies for other plants, the AP1000 SAMGs do not require diagnosis of the location of the core (i.e., whether reactor vessel failure has occurred). This is a fundamental consequence of the AP1000 In-Vessel Retention approach, which allows severe accident management to be based on fundamental principles (e.g. provide coolant as close as possible to the core) that do not change during a specific event. This eliminates the need for one of the more difficult diagnostic requirements, since reactor vessel failure does not directly relate to any measurable plant parameter, and differs from other designs in that an engineered failure of the pressure vessel' (e.g. core catcher) is never required. (authors)« less

Efficacy of Web-Based Instruction to Provide Training on Federal Motor Carrier Safety Regulations

DOT National Transportation Integrated Search

2011-05-01

This report presents an evaluation of the current state-of-the-art Web-based instruction (WBI), reviews the current computer platforms of potential users of WBI, reviews the current status of WBI applications for Federal Motor Carrier Safety Administ...

Corporate Functional Management Evaluation of the LLNL Radiation Safety Organization

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

Sygitowicz, L S

2008-03-20

A Corporate Assess, Improve, and Modernize review was conducted at Lawrence Livermore National Laboratory (LLNL) to evaluate the LLNL Radiation Safety Program and recommend actions to address the conditions identified in the Internal Assessment conducted July 23-25, 2007. This review confirms the findings of the Internal Assessment of the Institutional Radiation Safety Program (RSP) including the noted deficiencies and vulnerabilities to be valid. The actions recommended are a result of interviews with about 35 individuals representing senior management through the technician level. The deficiencies identified in the LLNL Internal Assessment of the Institutional Radiation Safety Program were discussed with Radiationmore » Safety personnel team leads, customers of Radiation Safety Program, DOE Livermore site office, and senior ES&H management. There are significant issues with the RSP. LLNL RSP is not an integrated, cohesive, consistently implemented program with a single authority that has the clear roll and responsibility and authority to assure radiological operations at LLNL are conducted in a safe and compliant manner. There is no institutional commitment to address the deficiencies that are identified in the internal assessment. Some of these deficiencies have been previously identified and corrective actions have not been taken or are ineffective in addressing the issues. Serious funding and staffing issues have prevented addressing previously identified issues in the Radiation Calibration Laboratory, Internal Dosimetry, Bioassay Laboratory, and the Whole Body Counter. There is a lack of technical basis documentation for the Radiation Calibration Laboratory and an inadequate QA plan that does not specify standards of work. The Radiation Safety Program lack rigor and consistency across all supported programs. The implementation of DOE Standard 1098-99 Radiological Control can be used as a tool to establish this consistency across LLNL. The establishment of a site wide ALARA Committee and administrative control levels would focus attention on improved processes. Currently LLNL issues dosimeters to a large number of employees and visitors that do not enter areas requiring dosimetry. This includes 25,000 visitor TLDs per year. Dosimeters should be issued to only those personnel who enter areas where dosimetry is required.« less

78 FR 18618 - National Offshore Safety Advisory Committee; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-27

... employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disabilities and genetic information, age, membership in an...

"Evidence" Under a Magnifying Glass: Thoughts on Safety Argument Epistemology

NASA Technical Reports Server (NTRS)

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

2015-01-01

Common definitions of "safety case" emphasize that evidence is the basis of a safety argument, yet few widely referenced works explicitly define "evidence". Their examples suggest that similar things can be regarded as evidence. But the category evidence seems to contain (1) processes for finding things out, (2) information resulting from such processes, and (3) relevant documents. Moreover, any item of evidence could be replaced by further argument. Normative models of informal argumentation do not offer clear guidance on when a safety argument should cite evidence rather than appeal to a more detailed argument. Disciplines such as the law address the problem with a practical, domain-specific epistemology. In this paper, we explore these problems associated with evidence citations in safety arguments, identify goals for a theory of safety argument evidence and a practical safety argument epistemology, propose a model of safety evidence citation that advances the identified goals, and present a related extension to the Goal Structuring Notation (GSN).

Development and initial validation of an Aviation Safety Climate Scale.

PubMed

Evans, Bronwyn; Glendon, A Ian; Creed, Peter A

2007-01-01

A need was identified for a consistent set of safety climate factors to provide a basis for aviation industry benchmarking. Six broad safety climate themes were identified from the literature and consultations with industry safety experts. Items representing each of the themes were prepared and administered to 940 Australian commercial pilots. Data from half of the sample (N=468) were used in an exploratory factor analysis that produced a 3-factor model of Management commitment and communication, Safety training and equipment, and Maintenance. A confirmatory factor analysis on the remaining half of the sample showed the 3-factor model to be an adequate fit to the data. The results of this study have produced a scale of safety climate for aviation that is both reliable and valid. This study developed a tool to assess the level of perceived safety climate, specifically of pilots, but may also, with minor modifications, be used to assess other groups' perceptions of safety climate.

Safety planning in focus groups of Malawian women living with HIV: helping each other deal with violence and abuse.

PubMed

Mkandawire-Valhmu, Lucy; Stevens, Patricia E; Kako, Peninnah M; Dressel, Anne

2013-11-01

In this critical ethnography, 72 HIV-infected women in Southern Malawi participated in 12 focus groups discussing the impact of HIV and violence. Our analysis, informed by a postcolonial feminist perspective, revealed women's capacity to collectively engage in safety planning. We present our findings about women's experiences based on narratives detailing how women collectively strategized safety planning efforts to mitigate the impact of violence. This study helps to fill a gap in the literature on the intersection between HIV and violence in women's lives. Strategies discussed by the women could form a basis for safety planning interventions for women in similar circumstances.

Transactions of the Twenty-First Water Reactor Safety Information Meeting

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

Monteleone, S.

1993-10-01

This report contains summaries of papers on reactor safety research to be presented at the 21st Water Reactor Safety Information Meeting at the Bethesda Marriott Hotel, Bethesda, Maryland, October 25--27, 1993. The summaries briefly describe the programs and results of nuclear safety research sponsored by the Office of Nuclear Regulatory Research, US NRC. Summaries of invited papers concerning nuclear safety issues from US government laboratories, the electric utilities, the Electric Power Research Institute (EPRI), the nuclear industry, and from foreign governments and industry are also included. The summaries have been compiled in one report to provide a basis for meaningfulmore » discussion and information exchange during the course of the meeting and are given in the order of their presentation in each session.« less

Waterborne GI Illness

Science.gov Websites

Outbreaks in North Dakota Handwashing Education Materials Contact Us Current Issues Healthy Swimming Food Safety Current Recalls Food Safety and Raw Milk Norovirus Copyright © 2014 North Dakota Department of

78 FR 36790 - Commercial Fishing Safety Advisory Committee; Vacancies

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

... Homeland Security (DHS) does not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability and...

Water Ingress Testing of the Turbula Jar and U-233 Lead Pig Containers

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

Reeves, Kirk Patrick; Karns, Tristan; Smith, Paul Herrick

Understanding the water ingress behavior of containers used at the TA-55 Plutonium Facility has significant implications for criticality safety. The purpose of this report is to document the water ingress behavior of the Turbula Jar with Bakelite lid and Viton gaskets (Turbula Jar) used in oxide blending operations and the U-233 lead pig container used to store and transport U-233 material. The technical basis for water resistant containers at TA-55 is described in LA-UR-15-22781, “Water Resistant Container Technical Basis Document for the TA-55 Criticality Safety Program.” Testing of the water ingress behavior of various containers is described in LA-CP-13-00695, “Watermore » Penetration Tests on the Filters of Hagan and SAVY Containers,” LA-UR-15-23121, “Water Ingress into Crimped Convenience Containers under Flooding Conditions,” and in LA-UR- 16-2411, “Water Ingress Testing for TA-55 Containers.” Water ingress criteria are defined in TA55-AP-522 “TA-55 Criticality Safety Program”, and in PA-RD-01009 “TA55 Criticality Safety Requirements.” The water ingress criteria for submersion is no more than 50 ml of water ingress at a 6” water column height for a period of 2 hours.« less

Constructing a safety and security system by medical applications of a fast face recognition optical parallel correlator

NASA Astrophysics Data System (ADS)

Watanabe, Eriko; Ishikawa, Mami; Ohta, Maiko; Murakami, Yasuo; Kodate, Kashiko

2006-01-01

Medical errors and patient safety have always received a great deal of attention, as they can be critically life-threatening and significant matters. Hospitals and medical personnel are trying their utmost to avoid these errors. Currently in the medical field, patients' record is identified through their PIN numbers and ID cards. However, for patients who cannot speak or move, or who suffer from memory disturbances, alternative methods would be more desirable, and necessary in some cases. The authors previously proposed and fabricated a specially-designed correlator called FARCO (Fast Face Recognition Optical Correlator) based on the Vanderlugt Correlator1, which operates at the speed of 1000 faces/s 2,3,4. Combined with high-speed display devices, the four-channel processing could achieve such high operational speed as 4000 faces/s. Running trial experiments on a 1-to-N identification basis using the optical parallel correlator, we succeeded in acquiring low error rates of 1 % FMR and 2.3 % FNMR. In this paper, we propose a robust face recognition system using the FARCO for focusing on the safety and security of the medical field. We apply our face recognition system to registration of inpatients, in particular children and infants, before and after medical treatments or operations. The proposed system has recorded a higher recognition rate by multiplexing both input and database facial images from moving images. The system was also tested and evaluated for further practical use, leaving excellent results. Hence, our face recognition system could function effectively as an integral part of medical system, meeting these essential requirements of safety, security and privacy.

Clinical risk management in mental health: a qualitative study of main risks and related organizational management practices

PubMed Central

2013-01-01

Background A scientific understanding of clinical risk management (CRM) in mental health care is essential for building safer health systems and for improving patient safety. While evidence on patient safety and CRM in physical health care has increased, there is limited research on these issues in mental health care. This qualitative study provides an overview of the most important clinical risks in mental health and related organizational management practices. Methods We conducted in-depth expert interviews with professionals responsible for CRM in psychiatric hospitals. Interviews were transcribed and analyzed applying qualitative content analysis to thematically sort the identified risks. Results The main concerns for CRM in mental health are a) violence and self-destructive behavior (i.e. protecting patients and staff from other patients, and patients from themselves), b) treatment errors, especially in the process of therapy, and c) risks associated with mental illnesses (e.g. psychosis or depression). This study identified critical differences to CRM in hospitals for physical disorder and challenges specific to CRM in mental health. Firstly, many psychiatric patients do not believe that they are ill and are therefore in hospital against their will. Secondly, staff safety is a much more prominent theme for CRM in mental health care as it is directly related to the specifics of mental illnesses. Conclusions The current study contributes to the understanding of patient safety and raises awareness for CRM in mental health. The mental health specific overview of central risks and related organizational management practices offers a valuable basis for CRM development in mental health and an addition to CRM in general. PMID:23379842

Beyond metrics? Utilizing ‘soft intelligence’ for healthcare quality and safety

PubMed Central

Martin, Graham P.; McKee, Lorna; Dixon-Woods, Mary

2015-01-01

Formal metrics for monitoring the quality and safety of healthcare have a valuable role, but may not, by themselves, yield full insight into the range of fallibilities in organizations. ‘Soft intelligence’ is usefully understood as the processes and behaviours associated with seeking and interpreting soft data—of the kind that evade easy capture, straightforward classification and simple quantification—to produce forms of knowledge that can provide the basis for intervention. With the aim of examining current and potential practice in relation to soft intelligence, we conducted and analysed 107 in-depth qualitative interviews with senior leaders, including managers and clinicians, involved in healthcare quality and safety in the English National Health Service. We found that participants were in little doubt about the value of softer forms of data, especially for their role in revealing troubling issues that might be obscured by conventional metrics. Their struggles lay in how to access softer data and turn them into a useful form of knowing. Some of the dominant approaches they used risked replicating the limitations of hard, quantitative data. They relied on processes of aggregation and triangulation that prioritised reliability, or on instrumental use of soft data to animate the metrics. The unpredictable, untameable, spontaneous quality of soft data could be lost in efforts to systematize their collection and interpretation to render them more tractable. A more challenging but potentially rewarding approach involved processes and behaviours aimed at disrupting taken-for-granted assumptions about quality, safety, and organizational performance. This approach, which explicitly values the seeking out and the hearing of multiple voices, is consistent with conceptual frameworks of organizational sensemaking and dialogical understandings of knowledge. Using soft intelligence this way can be challenging and discomfiting, but may offer a critical defence against the complacency that can precede crisis. PMID:26282705

Advancing Usability Evaluation through Human Reliability Analysis

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

Ronald L. Boring; David I. Gertman

2005-07-01

This paper introduces a novel augmentation to the current heuristic usability evaluation methodology. The SPAR-H human reliability analysis method was developed for categorizing human performance in nuclear power plants. Despite the specialized use of SPAR-H for safety critical scenarios, the method also holds promise for use in commercial off-the-shelf software usability evaluations. The SPAR-H method shares task analysis underpinnings with human-computer interaction, and it can be easily adapted to incorporate usability heuristics as performance shaping factors. By assigning probabilistic modifiers to heuristics, it is possible to arrive at the usability error probability (UEP). This UEP is not a literal probabilitymore » of error but nonetheless provides a quantitative basis to heuristic evaluation. When combined with a consequence matrix for usability errors, this method affords ready prioritization of usability issues.« less

Radiological control manual. Revision 1

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

Kloepping, R.

1996-05-01

This Lawrence Berkeley National Laboratory Radiological Control Manual (LBNL RCM) has been prepared to provide guidance for site-specific additions, supplements and interpretation of the DOE Radiological Control Manual. The guidance provided in this manual is one methodology to implement the requirements given in Title 10 Code of Federal Regulations Part 835 (10 CFR 835) and the DOE Radiological Control Manual. Information given in this manual is also intended to provide demonstration of compliance to specific requirements in 10 CFR 835. The LBNL RCM (Publication 3113) and LBNL Health and Safety Manual Publication-3000 form the technical basis for the LBNL RPPmore » and will be revised as necessary to ensure that current requirements from Rules and Orders are represented. The LBNL RCM will form the standard for excellence in the implementation of the LBNL RPP.« less

Bases of the scientific conception of the “green frame” designing in urban areas for providing ecological safety of the urban environment

NASA Astrophysics Data System (ADS)

Bespalov, V.; Kotlyarova, E.

2017-10-01

In modern conditions of a stable urban areas development special place is occupied by the problem of ecological security of built-up areas, including residential, recreational, industrial areas and objects of transport and engineering infrastructure. The main results of the study are to establish the basis of formation of the concept of choice of energy-efficient technologies and tools of forming an ecologically efficient “green frame” of urban areas on the basis of a single integrated scientific concept. Analysis allowed us to divide the measures for improvement into the following main groups: organizational and planning, engineering and technical and special engineering and environmental. The significance of these results for the construction industry, including transport infrastructure, is to increase the level of environmental safety in the construction and reconstruction of urban areas due to the organization of their improvement on the basis suggested by the authors scientific approach. Its basis is integrated accounting of the natural and climatic features of the landscaping territory, the types and level of environmental impact of negative anthropogenic factors, the features of architectural and planning solutions of the existing or projected on the studied area, the structure and types of green spaces and their functional ecological properties.

Comparative efficacy and safety of antibiotics used to treat acute bacterial skin and skin structure infections: Results of a network meta-analysis.

PubMed

Guest, Julian F; Esteban, Jaime; Manganelli, Anton G; Novelli, Andrea; Rizzardini, Giuliano; Serra, Miquel

2017-01-01

This NMA compared the efficacy and safety between IV antibiotics that are used in the current standard of care for managing adult patients (≥18 years of age) with ABSSSI. Comparators were chosen on the basis that both direct and indirect comparisons between the interventions of interest could be performed. Outcomes of the analysis were selected on the basis that they are frequently measured and reported in trials involving ABSSSI patients, and only published randomised control trials of any size and duration and with any blinding status were eligible for inclusion in the analysis. The NMA was performed using both a fixed-effect and random-effect model. Efficacy-related endpoints were (1) clinical treatment success and (2) microbiological success at TOC visit. Safety-related endpoints were (1) number of discontinuations due to AEs/SAEs, (2) patients experiencing AEs, (3) patients experiencing SAEs and (4) all-cause mortality. Study interventions included daptomycin, dalbavancin, linezolid and tigecycline. Vancomycin was the comparator in all studies, except in two where it was linezolid and teicoplanin. The NMA showed that irrespective of patient subgroup, the likelihood of clinical and microbiological success with dalbavancin was statistically similar to the comparators studied. No statistically significant differences were observed between dalbavancin and any of the comparators in the discontinuation rate due to AEs/SAEs. In contrast, dalbavancin was associated with a significantly lower likelihood of experiencing an AE than linezolid, a significantly lower likelihood of experiencing a SAE than vancomycin and daptomycin, and a significantly lower risk of all-cause mortality than vancomycin, linezolid and tigecycline. Dalbavancin affords a promising, new alternative IV antimicrobial agent which is as effective as traditional therapies, but with the added benefit of enabling clinicians to treat patients with ABSSSI in different organisational settings. Notwithstanding, any introduction of an effective treatment with a differential mode of administration into healthcare systems must be followed by a change in clinical practice and patient management in order to fully achieve desirable economic outcomes.

Effectiveness of mandatory license testing for older drivers in reducing crash risk among urban older Australian drivers.

PubMed

Langford, Jim; Fitzharris, Michael; Koppel, Sjaanie; Newstead, Stuart

2004-12-01

Most licensing jurisdictions in Australia maintain mandatory assessment programs targeting older drivers, whereby a driver reaching a specified age is required to prove his or her fitness to drive through medical assessment and/or on-road testing. Previous studies both in Australia and elsewhere have consistently failed to demonstrate that age-based mandatory assessment results in reduced crash involvement for older drivers. However studies that have based their results upon either per-population or per-driver crash rates fail to take into account possible differences in driving activity. Because some older people maintain their driving licenses but rarely if ever drive, the proportion of inactive license-holders might be higher in jurisdictions without mandatory assessment relative to jurisdictions with periodic license assessment, where inactive drivers may more readily either surrender or lose their licenses. The failure to control for possible differences in driving activity across jurisdictions may be disguising possible safety benefits associated with mandatory assessment. The current study compared the crash rates of drivers in Melbourne, Australia, where there is no mandatory assessment and Sydney, Australia, where there is regular mandatory assessment from 80 years of age onward. The crash rate comparisons were based on four exposure measures: per population, per licensed driver, per distance driven, and per time spent driving. Poisson regression analysis incorporating an offset to control for inter-jurisdictional road safety differences indicated that there was no difference in crash risk for older drivers based on population. However drivers aged 80 years and older in the Sydney region had statistically higher rates of casualty crash involvement than their Melbourne counterparts on a per license issued basis (RR: 1.15, 1.02-1.29, p=0.02) and time spent driving basis (RR: 1.19, 1.06-1.34, p=0.03). A similar trend was apparent based on distance travelled but was of borderline statistical significance (RR: 1.11, 0.99-1.25, p=0.07). Collectively, it can be inferred from these findings that mandatory license re-testing schemes of the type evaluated have no demonstrable road safety benefits overall. Further research to resolve this on-going policy debate is discussed and recommended.

Comparative efficacy and safety of antibiotics used to treat acute bacterial skin and skin structure infections: Results of a network meta-analysis

PubMed Central

Esteban, Jaime; Manganelli, Anton G.; Novelli, Andrea; Rizzardini, Giuliano; Serra, Miquel

2017-01-01

Objective This NMA compared the efficacy and safety between IV antibiotics that are used in the current standard of care for managing adult patients (≥18 years of age) with ABSSSI. Methods Comparators were chosen on the basis that both direct and indirect comparisons between the interventions of interest could be performed. Outcomes of the analysis were selected on the basis that they are frequently measured and reported in trials involving ABSSSI patients, and only published randomised control trials of any size and duration and with any blinding status were eligible for inclusion in the analysis. The NMA was performed using both a fixed-effect and random-effect model. Efficacy-related endpoints were (1) clinical treatment success and (2) microbiological success at TOC visit. Safety-related endpoints were (1) number of discontinuations due to AEs/SAEs, (2) patients experiencing AEs, (3) patients experiencing SAEs and (4) all-cause mortality. Results Study interventions included daptomycin, dalbavancin, linezolid and tigecycline. Vancomycin was the comparator in all studies, except in two where it was linezolid and teicoplanin. The NMA showed that irrespective of patient subgroup, the likelihood of clinical and microbiological success with dalbavancin was statistically similar to the comparators studied. No statistically significant differences were observed between dalbavancin and any of the comparators in the discontinuation rate due to AEs/SAEs. In contrast, dalbavancin was associated with a significantly lower likelihood of experiencing an AE than linezolid, a significantly lower likelihood of experiencing a SAE than vancomycin and daptomycin, and a significantly lower risk of all-cause mortality than vancomycin, linezolid and tigecycline. Conclusion Dalbavancin affords a promising, new alternative IV antimicrobial agent which is as effective as traditional therapies, but with the added benefit of enabling clinicians to treat patients with ABSSSI in different organisational settings. Notwithstanding, any introduction of an effective treatment with a differential mode of administration into healthcare systems must be followed by a change in clinical practice and patient management in order to fully achieve desirable economic outcomes. PMID:29136035

The breakdown of coordinated decision making in distributed systems.

PubMed

Bearman, Christopher; Paletz, Susannah B F; Orasanu, Judith; Thomas, Matthew J W

2010-04-01

This article aims to explore the nature and resolution of breakdowns in coordinated decision making in distributed safety-critical systems. In safety-critical domains, people with different roles and responsibilities often must work together to make coordinated decisions while geographically distributed. Although there is likely to be a large degree of overlap in the shared mental models of these people on the basis of procedures and experience, subtle differences may exist. Study 1 involves using Aviation Safety Reporting System reports to explore the ways in which coordinated decision making breaks down between pilots and air traffic controllers and the way in which the breakdowns are resolved. Study 2 replicates and extends those findings with the use of transcripts from the Apollo 13 National Aeronautics and Space Administration space mission. Across both studies, breakdowns were caused in part by different types of lower-level breakdowns (or disconnects), which are labeled as operational, informational, or evaluative. Evaluative disconnects were found to be significantly harder to resolve than other types of disconnects. Considering breakdowns according to the type of disconnect involved appears to capture useful information that should assist accident and incident investigators. The current trend in aviation of shifting responsibilities and providing increasingly more information to pilots may have a hidden cost of increasing evaluative disconnects. The proposed taxonomy facilitates the investigation of breakdowns in coordinated decision making and draws attention to the importance of considering subtle differences between participants' mental models when considering complex distributed systems.

Reduction in pediatric identification band errors: a quality collaborative.

PubMed

Phillips, Shannon Connor; Saysana, Michele; Worley, Sarah; Hain, Paul D

2012-06-01

Accurate and consistent placement of a patient identification (ID) band is used in health care to reduce errors associated with patient misidentification. Multiple safety organizations have devoted time and energy to improving patient ID, but no multicenter improvement collaboratives have shown scalability of previously successful interventions. We hoped to reduce by half the pediatric patient ID band error rate, defined as absent, illegible, or inaccurate ID band, across a quality improvement learning collaborative of hospitals in 1 year. On the basis of a previously successful single-site intervention, we conducted a self-selected 6-site collaborative to reduce ID band errors in heterogeneous pediatric hospital settings. The collaborative had 3 phases: preparatory work and employee survey of current practice and barriers, data collection (ID band failure rate), and intervention driven by data and collaborative learning to accelerate change. The collaborative audited 11377 patients for ID band errors between September 2009 and September 2010. The ID band failure rate decreased from 17% to 4.1% (77% relative reduction). Interventions including education of frontline staff regarding correct ID bands as a safety strategy; a change to softer ID bands, including "luggage tag" type ID bands for some patients; and partnering with families and patients through education were applied at all institutions. Over 13 months, a collaborative of pediatric institutions significantly reduced the ID band failure rate. This quality improvement learning collaborative demonstrates that safety improvements tested in a single institution can be disseminated to improve quality of care across large populations of children.

Quality requirements for cross-border care in Europe: a qualitative study of patients’, professionals’ and healthcare financiers’ views

PubMed Central

Groene, O; Poletti, P; Vallejo, P; Cucic, C; Klazinga, N; Suñol, R

2009-01-01

Background: In the past decade the issue of patient mobility has emerged on the European health policy agenda. Although the volume of patients crossing borders to obtain healthcare is low, it is increasing continuously and, due to its legal, financial and medical implications, has generated considerable interest among health policy and other decision makers. However, there is little information available on the safety and patient-centredness of cross-border care and neither governments nor citizens have an explicit basis for comparing healthcare delivery in Europe. Methods: This study investigated the viewpoints of patients, professionals and healthcare financiers on the safety and patient-centredness of cross-border care. Qualitative interviews were carried out during 2005 and early 2006 with 40 patients, 30 professionals (doctors, nurses and managers) and 3 healthcare-financing bodies. Results: Although cross-border care has become a common issue in many European countries, there remain uncertainties on the side of each of the parties addressed—patients, professionals and financiers—with regard to the provision of cross-border care. One of the most striking results of this project is the current lack of research on systematic knowledge on the quality of cross-border care. Conclusion: Many of the issues identified through this research may have a potential impact on the quality and safety of cross-border care and will support further investigation and help shape the health policy agenda on patients crossing borders in European Union countries. PMID:19188456

Inland Waterway Environmental Safety

NASA Astrophysics Data System (ADS)

Reshnyak, Valery; Sokolov, Sergey; Nyrkov, Anatoliy; Budnik, Vlad

2018-05-01

The article presents the results of development of the main components of the environmental safety when operating vessels on inland waterways, which include strategy selection ensuring the environmental safety of vessels, the selection and justification of a complex of environmental technical means, activities to ensure operation of vessels taking into account the environmental technical means. Measures to ensure environmental safety are developed on the basis of the principles aimed at ensuring environmental safety of vessels. They include the development of strategies for the use of environmental protection equipment, which are determined by the conditions for wastewater treatment of purified sewage and oily bilge water as well as technical characteristics of the vessels, the introduction of the process of the out-of-the-vessel processing of ship pollution as a technology for their movement. This must take into account the operating conditions of vessels on different sections of waterways. An algorithm of actions aimed at ensuring ecological safety of operated vessels is proposed.

The case for regulatory reform in the business and healthcare environments.

PubMed

Younis, Mustafa Z; Barhem, Belal; Hamidi, Samir; Inungu, Joseph; Prater, Gwendolyn S; O'Keefe, Arthur

2009-01-01

Government regulations affect corporations and consumers on a daily basis. For example, environmental and safety regulations in the workplace are administrated by the Occupational Safety and Health Administration (OSHA) under the Department of Labor. OSHA sets and enforces standards in work environment to ensure the safety and health of workers. Other regulatory agencies, such as the National Highway and Transportation Agency (NHTSA), oversee the transportation and the safety of the automobile and truck industry. The U.S. Food and Drug Administration (FDA) plays a major role in approving new drugs on the market and in monitoring drug safety, and it has the power to remove drugs from the market if they are proved to be safety and health problems to the public. However, the mere existence of these regulations often causes impediments to businesses, and the extent of their ultimate usefulness is examined and analyzed in this paper

Towards a Formal Basis for Modular Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh

2015-01-01

Safety assurance using argument-based safety cases is an accepted best-practice in many safety-critical sectors. Goal Structuring Notation (GSN), which is widely used for presenting safety arguments graphically, provides a notion of modular arguments to support the goal of incremental certification. Despite the efforts at standardization, GSN remains an informal notation whereas the GSN standard contains appreciable ambiguity especially concerning modular extensions. This, in turn, presents challenges when developing tools and methods to intelligently manipulate modular GSN arguments. This paper develops the elements of a theory of modular safety cases, leveraging our previous work on formalizing GSN arguments. Using example argument structures we highlight some ambiguities arising through the existing guidance, present the intuition underlying the theory, clarify syntax, and address modular arguments, contracts, well-formedness and well-scopedness of modules. Based on this theory, we have a preliminary implementation of modular arguments in our toolset, AdvoCATE.

Employee Safety Motivation: perspectives and measures on the basis of the Self-Determination theory.

PubMed

Mariani, M G; Soldà, Bianca Lara; Curcuruto, M

2015-09-09

There is a growing body of literature demonstrating that employee's safety behaviour is largely influenced by their motivation to work safely. The Self-Determination Theory, which proposes a multidimensional conceptualization of motivation, is now established in various domains of the academic field (Healthcare, Education, Psychopathology, Organizations, Sport etc.). However, there are few publications concerning its use in the analysis of motivation in a safety context, where it constitutes a new topic of study. The aim of this study was to develop and validate the Italian version of the Self-Determined Safety Motivation Scale and analyze the psychometric properties of the scale in terms of construct validity. The research involved 387 Italian employees from three companies, who occupied medium-low levels in the organizational hierarchy. A good level of psychometric properties was shown. The Italian version of the Self-Determined Safety Motivation Scale is a reliable and valid instrument to assess safety motivation.

Battery collection in municipal waste management in Japan: Challenges for hazardous substance control and safety

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

Terazono, Atsushi, E-mail: terazono@nies.go.jp; Oguchi, Masahiro; Iino, Shigenori

Highlights: • Consumers need to pay attention to the specific collection rules for each type of battery in each municipality in Japan. • 6–10% of zinc carbon and alkaline batteries discarded in Japan currently could be regarded as containing mercury. • Despite announcements by producers and municipalities, only 2.0% of discarded cylindrical dry batteries were insulated. • Batteries made up an average of 4.6% of the total collected small WEEE under the small WEEE recycling scheme in Japan. • Exchangeable batteries were used in almost all of mobile phones, but the removal rate was as low as 22% for mobilemore » phones. - Abstract: To clarify current collection rules of waste batteries in municipal waste management in Japan and to examine future challenges for hazardous substance control and safety, we reviewed collection rules of waste batteries in the Tokyo Metropolitan Area. We also conducted a field survey of waste batteries collected at various battery and small waste electric and electronic equipment (WEEE) collection sites in Tokyo. The different types of batteries are not collected in a uniform way in the Tokyo area, so consumers need to pay attention to the specific collection rules for each type of battery in each municipality. In areas where small WEEE recycling schemes are being operated after the enforcement of the Act on Promotion of Recycling of Small Waste Electrical and Electronic Equipment in Japan in 2013, consumers may be confused about the need for separating batteries from small WEEE (especially mobile phones). Our field survey of collected waste batteries indicated that 6–10% of zinc carbon and alkaline batteries discarded in Japan currently could be regarded as containing mercury. More than 26% of zinc carbon dry batteries currently being discarded may have a lead content above the labelling threshold of the EU Batteries Directive (2006/66/EC). In terms of safety, despite announcements by producers and municipalities about using insulation (tape) on waste batteries to prevent fires, only 2.0% of discarded cylindrical dry batteries were insulated. Our field study of small WEEE showed that batteries made up an average of 4.6% of the total collected small WEEE on a weight basis. Exchangeable batteries were used in almost all of mobile phones, digital cameras, radios, and remote controls, but the removal rate was as low as 22% for mobile phones. Given the safety issues and the rapid changes occurring with mobile phones or other types of small WEEE, discussion is needed among stakeholders to determine how to safely collect and recycle WEEE and waste batteries.« less

Posttraumatic stress disorder, depression, and perceived safety 13 months after September 11.

PubMed

Grieger, Thomas A; Fullerton, Carol S; Ursano, Robert J

2004-09-01

This study assessed relationships between exposure to the September 11, 2001, terrorist attack, current posttraumatic stress disorder (PTSD), current major depression, and current safety perceptions in a sample of 212 Pentagon staff members 13 months after the attack. Forty-eight respondents (23 percent) had possible PTSD; eight (4 percent) had probable major depression. Respondents who were directly exposed to the attack were more likely to have PTSD and major depression and were less likely to have a perception of safety at work and in usual activities and travel only. In contrast, respondents with PTSD reported a lower perception of safety at home, at work, and in usual activities and travel.

Probing safety of nanoparticles by outlining sea urchin sensing and signaling cascades.

PubMed

Alijagic, Andi; Pinsino, Annalisa

2017-10-01

Among currently identified issues presenting risks and benefits to human and ocean health, engineered nanoparticles (ENP) represent a priority. Predictions of their economic and social impact appear extraordinary, but their release in the environment at an uncontrollable rate is in striking contrast with the extremely limited number of studies on environmental impact, especially on the marine environment. The sea urchin has a remarkable sensing environmental system whose function and diversity came into focus during the recent years, after sea urchin genome sequencing. The complex immune system may be the basis wherefore sea urchins can adapt to a dynamic environment and survive even in hazardous conditions both in the adult and in the embryonic life. This review is aimed at discussing the literature in nanotoxicological/ecotoxicological studies with a focus on stress and innate immune signaling in sea urchins. In addition, here we introduce our current development of in vitro-driven probes that could be used to dissect ENP aftermaths, suggesting their future use in immune-nanotoxicology. Copyright © 2017 Elsevier Inc. All rights reserved.

[Current position on Vedolizumab for ulcerative colitis and Crohn's disease].

PubMed

Schreiber, S; Dignass, A U; Hartmann, H; Kruis, W; Rogler, G; Siegmund, B; Stallmach, A; Witte, C; Bokemeyer, B

2015-06-01

Vedolizumab, the first drug in the class of anti-integrin molecules, is newly approved for ulcerative colitis and Crohn's disease and can be prescribed in Germany since mid-2014. By a specific receptor binding a relatively gut-selective mode of action was achieved without the known side effects of the systemic immunosuppression of the anti-TNF-alpha antibodies. According to the present data the safety profile of Vedolizumab appears to be more favorable than that of the anti-TNF- alpha therapy. Vedolizumab is suitable for induction therapy in patients with ulcerative colitis and Crohn's disease, however the kinetic of response compared with the anti-TNF-alpha antibodies seems to be slower. For maintenance therapy the Vedolizumab data show a deep and sustained remission in patients initially responding to induction therapy with a lower loss of efficacy in the long-term treatment known from the anti-TNF-alpha therapy. On the basis of currently available data the efficacy of Vedolizumab in ulcerative colitis appears to be slightly better than in Crohn's disease. © Georg Thieme Verlag KG Stuttgart · New York.

Live attenuated vaccines: Historical successes and current challenges

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

Minor, Philip D., E-mail: Philip.Minor@nibsc.org

Live attenuated vaccines against human viral diseases have been amongst the most successful cost effective interventions in medical history. Smallpox was declared eradicated in 1980; poliomyelitis is nearing global eradication and measles has been controlled in most parts of the world. Vaccines function well for acute diseases such as these but chronic infections such as HIV are more challenging for reasons of both likely safety and probable efficacy. The derivation of the vaccines used has in general not been purely rational except in the sense that it has involved careful clinical trials of candidates and subsequent careful follow up inmore » clinical use; the identification of the candidates is reviewed. - Highlights: • Live vaccines against human diseases caused by viruses have been very successful. • They have been developed by empirical clinical studies and problems identified in later use. • It can be difficult to balance ability to cause disease and ability to immunise for a strain. • There is currently no reliable basis for predicting success from pure virological studies. • Vaccinia, which eradicated smallpox, is the paradigm for all successes and issues.« less

Chromosomal disorders and male infertility

PubMed Central

Harton, Gary L; Tempest, Helen G

2012-01-01

Infertility in humans is surprisingly common occurring in approximately 15% of the population wishing to start a family. Despite this, the molecular and genetic factors underlying the cause of infertility remain largely undiscovered. Nevertheless, more and more genetic factors associated with infertility are being identified. This review will focus on our current understanding of the chromosomal basis of male infertility specifically: chromosomal aneuploidy, structural and numerical karyotype abnormalities and Y chromosomal microdeletions. Chromosomal aneuploidy is the leading cause of pregnancy loss and developmental disabilities in humans. Aneuploidy is predominantly maternal in origin, but concerns have been raised regarding the safety of intracytoplasmic sperm injection as infertile men have significantly higher levels of sperm aneuploidy compared to their fertile counterparts. Males with numerical or structural karyotype abnormalities are also at an increased risk of producing aneuploid sperm. Our current understanding of how sperm aneuploidy translates to embryo aneuploidy will be reviewed, as well as the application of preimplantation genetic diagnosis (PGD) in such cases. Clinical recommendations where possible will be made, as well as discussion of the use of emerging array technology in PGD and its potential applications in male infertility. PMID:22120929

Chromosomal disorders and male infertility.

PubMed

Harton, Gary L; Tempest, Helen G

2012-01-01

Infertility in humans is surprisingly common occurring in approximately 15% of the population wishing to start a family. Despite this, the molecular and genetic factors underlying the cause of infertility remain largely undiscovered. Nevertheless, more and more genetic factors associated with infertility are being identified. This review will focus on our current understanding of the chromosomal basis of male infertility specifically: chromosomal aneuploidy, structural and numerical karyotype abnormalities and Y chromosomal microdeletions. Chromosomal aneuploidy is the leading cause of pregnancy loss and developmental disabilities in humans. Aneuploidy is predominantly maternal in origin, but concerns have been raised regarding the safety of intracytoplasmic sperm injection as infertile men have significantly higher levels of sperm aneuploidy compared to their fertile counterparts. Males with numerical or structural karyotype abnormalities are also at an increased risk of producing aneuploid sperm. Our current understanding of how sperm aneuploidy translates to embryo aneuploidy will be reviewed, as well as the application of preimplantation genetic diagnosis (PGD) in such cases. Clinical recommendations where possible will be made, as well as discussion of the use of emerging array technology in PGD and its potential applications in male infertility.

Active surveillance of postmarket medical product safety in the Federal Partners' Collaboration.

PubMed

Robb, Melissa A; Racoosin, Judith A; Worrall, Chris; Chapman, Summer; Coster, Trinka; Cunningham, Francesca E

2012-11-01

After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they are marketed. On the basis of experience gathered through a number of collaborative efforts, the Federal Partners' Collaboration pilot project, involving FDA, the Centers for Medicare & Medicaid Services, the Department of Veteran Affairs, and the Department of Defense, is already enabling FDA to leverage the power of large public health care databases to assess, in near real time, the utility of analytical tools and methodologies that are being developed for use in the Sentinel System. Active medical product safety surveillance is enhanced by use of these large public health databases because specific populations of exposed patients can be identified and analyzed, and can be further stratified by key variables such as age, sex, race, socioeconomic status, and basis for eligibility to examine important subgroups.

Neurovirulence safety testing of mumps vaccines--historical perspective and current status.

PubMed

Rubin, S A; Afzal, M A

2011-04-05

Many live, attenuated viral vaccines are derived from wild type viruses with known neurovirulent properties. To assure the absence of residual neurotoxicity, pre-clinical neurovirulence safety testing of candidate vaccines is performed. For mumps virus, a highly neurotropic virus, neurovirulence safety testing is performed in monkeys. However, laboratory studies suggest an inability of this test to correctly discern among virus strains of varying neurovirulence potential in man, and, further, some vaccines found to be neuroattenuated in monkeys were later found to be neurovirulent in humans when administered in large numbers. Over the past decade, concerted efforts have been made to replace monkey-based neurovirulence safety testing with more informative, alternative methods. This review summarizes the current status of mumps vaccine neurovirulence safety testing and insights into models currently approved and those under development. Published by Elsevier Ltd.

Task 2 - Limits for High-Frequency Conducted Susceptibility Testing - CS114 (NRC-HQ-60-14-D-0015)

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

Wood, Richard Thomas; Ewing, Paul D.; Moses, Rebecca J.

2015-09-01

A principal focus of Task 2 under this project was for ORNL to evaluate the basis for susceptibility testing against high-frequency conducted interference and to establish recommendations to resolve concerns about the severity of test limits for the conducted susceptibility (CS) test, CS114, from MIL-STD-461. The primary concern about the test limit has been characterized by the EPRI EMI Working Group in the following terms: Demonstrating compliance with the CS114 test limits recommended in TR-102323 has proven to be problematic, even for components that have been tested to commercial standards and demonstrated proper operation in industrial applications [6]. Specifically, EPRImore » notes that the CS114 limits approved in regulatory documents are significantly higher than those invoked by the US military and similar commercial standards in the frequency range below 200 kHz. For this task, ORNL evaluated the original approach to establishing the test limit, EPRI technical findings from a review of the limit, and the regulatory basis through which the currently approved limits were accepted. Based on this analysis, strategies have been developed regarding changes to the CS114 limit that can resolve the technical concerns raised by the industry. Guided by the principles that reasonable assurance of safety must not be compromised but excessive conservatism should be reduced, recommendations on a suitable basis for a revised limit have been developed and can be incorporated into the planned Revision 2 of RG 1.180.« less

[Medicinal cannabis for diseases of the nervous system: no convincing evidence of effectiveness].

PubMed

Killestein, J; Bet, P M; van Loenen, A C; Polman, C H

2004-11-27

--In 1996, the Netherlands Health Council issued a negative recommendation regarding the use of medication on the basis of cannabis (marihuana). However, interest in medicinal cannabis has certainly not waned since. --The neurological diseases for which cannabis could presently be used therapeutically are: multiple sclerosis, chronic (neuropathic) pain and the syndrome of Gilles de la Tourette. --Since September 2003, the Dutch Ministry of Health, Welfare and Sport delivers medicinal cannabis to Dutch pharmacies, so that now for the first time, medicinal cannabis can be given to patients on a prescription basis within the framework of the Opium Law. The result of this is that doctors and patients now assume that this is a medication for which the efficacy and safety have been established. --The question arises whether new scientific data have become available since 1996 that provide scientific support for the current Governmental policy. --In a recent clinical trial that has aroused much discussion, patients with multiple sclerosis and problematic spasticity were treated with oral cannabis or a placebo. There was no significant effect of treatment on the primary outcome measure, i.e. objectively determined spasticity. Nevertheless, it was concluded that the mobility was improved and that the pain was subjectively decreased. --Until now, convincing scientific evidence that cannabinoids are effective in neurological conditions is still lacking. --However, it is also not possible to conclude definitely that cannabinoids are ineffective; still, this is no basis for official stimulation of their use.

[On improvement of the mechanism for establishing and changing indicators of quality and food safety in the regulatory and legal acts of the Eurasian Economical Union].

PubMed

Arnautov, O V

2016-01-01

In accordance with the Treaty on the Eurasian Economic Union (EAEU) to ensure the sanitary and epidemiological welfare of the population within the Union, a coordinated policy in agreed policy in the sphere of application of sanitary measures is carried out. Sanitary measures are the obligatory requirements and procedures, including requirements for the final product, processing methods, production, transportation, storage and disposal, sampling procedures, methods of research (tests), risk assessment, the state registration, requirements for packaging directly aimed at ensuring the safety of products (goods) in order to protect human welfare, and they should be applied on the basis having a scientific explanation, and only to the extent that is necessary to protect human welfare. Sanitary measures applied within the Union should be based on international and regional standards, guidelines and (or) the recommendations, except when they based on appropriate scientific studies and explanations. In this case sanitary measures which could provide a higher level of sanitary protection are introduced. At present, the mechanism of the development, justification and approval of common sanitary and epidemiological requirements (ESR) and procedures of the Eurasian Economic Commission (the Commission) is not installed. The absence of a clear mechanism for the development, approval and implementation of the ESR to the products (goods) on the basis having a scientific explanation on the one hand could lead to the creation of unjustified barriers to foreign and mutual trade, on the other--to weaken the level of safety for human life and health of products (goods) placed on markets of the Union. In order to bring the regulatory legal acts of the Customs Union in accordance with the Treaty on the Eurasian Economic Union the Commission in cooperation with the competent authorities of the Member States in the field of sanitary and epidemiological welfare developed the project of Guidelines for development, approval, modification and application of common sanitary epidemiological and hygienic requirements and procedures (hereinafter--Guidelines) which is currently undergoing approval procedures. The project envisages that the Uniform sanitary requirements are established on the basis of scientific research, including the evaluation of the risk of harmful effects of the environment on the human factors, taking into consideration the analysis of international experience in order to harmonize common sanitary requirements with international standards, guidelines and (or) recommendations. Adoption of the draft Guidelines, as well as the application of common methodologies of risk assessment and the hygienic standardization in establishing and justifying safety performance of products (goods) in the Eurasian Economic Union allow quickly and transparently develop, validate, coordinate and approve the Uniform sanitary and epidemiological and hygienic requirements and procedures for sanitary inspection (control) of products (goods) and include them into technical regulations Union.

Current collectors for improved safety

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

Abdelmalak, Michael Naguib; Allu, Srikanth; Dudney, Nancy J.

A battery electrode assembly includes a current collector with conduction barrier regions having a conductive state in which electrical conductivity through the conduction barrier region is permitted, and a safety state in which electrical conductivity through the conduction barrier regions is reduced. The conduction barrier regions change from the conductive state to the safety state when the current collector receives a short-threatening event. An electrode material can be connected to the current collector. The conduction barrier regions can define electrical isolation subregions. A battery is also disclosed, and methods for making the electrode assembly, methods for making a battery, andmore » methods for operating a battery.« less

Safety Needs Mediate Stressful Events Induced Mental Disorders

PubMed Central

Gu, Simeng; Lei, Yu; Lu, Shanshan

2016-01-01

“Safety first,” we say these words almost every day, but we all take this for granted for what Maslow proposed in his famous theory of Hierarchy of Needs: safety needs come second to physiological needs. Here we propose that safety needs come before physiological needs. Safety needs are personal security, financial security, and health and well-being, which are more fundamental than physiological needs. Safety worrying is the major reason for mental disorders, such as anxiety, phobia, depression, and PTSD. The neural basis for safety is amygdala, LC/NE system, and corticotrophin-releasing hormone system, which can be regarded as a “safety circuitry,” whose major behavior function is “fight or flight” and “fear and anger” emotions. This is similar to the Appraisal theory for emotions: fear is due to the primary appraisal, which is related to safety of individual, while anger is due to secondary appraisal, which is related to coping with the unsafe situations. If coping is good, the individual will be happy; if coping failed, the individual will be sad or depressed. PMID:27738527

Impact of Resident Duty Hour Limits on Safety in the ICU: A National Survey of Pediatric and Neonatal Intensivists

PubMed Central

Typpo, Katri V.; Tcharmtchi, M. Hossein; Thomas, Eric J.; Kelly, P. Adam; Castillo, Leticia D.; Singh, Hardeep

2011-01-01

Objective Resident duty-hour regulations potentially shift workload from resident to attending physicians. We sought to understand how current or future regulatory changes might impact safety in academic pediatric and neonatal intensive care units (ICUs). Design Web-based survey Setting US academic pediatric and neonatal ICUs Subjects Attending pediatric and neonatal intensivists Interventions We evaluated perceptions on four ICU safety-related risk measures potentially affected by current duty-hour regulations: 1) Attending physician and resident fatigue, 2) Attending physician work-load, 3) Errors (self-reported rates by attending physicians or perceived resident error rates), and 4) Safety culture. We also evaluated perceptions of how these risks would change with further duty hour restrictions. Measurements and Main Results We administered our survey between February and April 2010 to 688 eligible physicians, of which 360 (52.3%) responded. Most believed that resident error rates were unchanged or worse (91.9%) and safety culture was unchanged or worse (84.4%) with current duty-hour regulations. Of respondents, 61.9% believed their own work-hours providing direct patient care increased and 55.8% believed they were more fatigued while providing direct patient care. Most (85.3%) perceived no increase in their own error rates currently, but in the scenario of further reduction in resident duty-hours, over half (53.3%) believed that safety culture would worsen and a significant proportion (40.3%) believed that their own error rates would increase. Conclusions Pediatric intensivists do not perceive improved patient safety from current resident duty hour restrictions. Policies to further restrict resident duty hours should consider unintended consequences of worsening certain aspects of ICU safety. PMID:22614570

Impact of resident duty hour limits on safety in the intensive care unit: a national survey of pediatric and neonatal intensivists.

PubMed

Typpo, Katri V; Tcharmtchi, M Hossein; Thomas, Eric J; Kelly, P Adam; Castillo, Leticia D; Singh, Hardeep

2012-09-01

Resident duty-hour regulations potentially shift the workload from resident to attending physicians. We sought to understand how current or future regulatory changes might impact safety in academic pediatric and neonatal intensive care units. Web-based survey. U.S. academic pediatric and neonatal intensive care units. Attending pediatric and neonatal intensivists. We evaluated perceptions on four intensive care unit safety-related risk measures potentially affected by current duty-hour regulations: 1) attending physician and resident fatigue; 2) attending physician workload; 3) errors (self-reported rates by attending physicians or perceived resident error rates); and 4) safety culture. We also evaluated perceptions of how these risks would change with further duty-hour restrictions. We administered our survey between February and April 2010 to 688 eligible physicians, of whom 360 (52.3%) responded. Most believed that resident error rates were unchanged or worse (91.9%) and safety culture was unchanged or worse (84.4%) with current duty-hour regulations. Of respondents, 61.9% believed their own work-hours providing direct patient care increased and 55.8% believed they were more fatigued while providing direct patient care. Most (85.3%) perceived no increase in their own error rates currently, but in the scenario of further reduction in resident duty-hours, over half (53.3%) believed that safety culture would worsen and a significant proportion (40.3%) believed that their own error rates would increase. Pediatric intensivists do not perceive improved patient safety from current resident duty-hour restrictions. Policies to further restrict resident duty-hours should consider unintended consequences of worsening certain aspects of intensive care unit safety.

2008 traffic safety culture index

DOT National Transportation Integrated Search

2008-04-01

This report provides an overview of the attitudes, opinions, behaviors, and experiences of the American : public, and contains insights that will serve as the basis for research, educational outreachand perhaps : most importantly, dialoguein th...

14 CFR 91.521 - Shoulder harness.

Code of Federal Regulations, 2010 CFR

2010-01-01

... inertia load factors established under the certification basis of the airplane. (b) No person may operate... used; and (2) Safety belt and shoulder harness restraint systems may be designed to the inertia load...

14 CFR 91.521 - Shoulder harness.

Code of Federal Regulations, 2013 CFR

2013-01-01

... inertia load factors established under the certification basis of the airplane. (b) No person may operate... used; and (2) Safety belt and shoulder harness restraint systems may be designed to the inertia load...

14 CFR 91.521 - Shoulder harness.

Code of Federal Regulations, 2014 CFR

2014-01-01

... inertia load factors established under the certification basis of the airplane. (b) No person may operate... used; and (2) Safety belt and shoulder harness restraint systems may be designed to the inertia load...

14 CFR 91.521 - Shoulder harness.

Code of Federal Regulations, 2011 CFR

2011-01-01

... inertia load factors established under the certification basis of the airplane. (b) No person may operate... used; and (2) Safety belt and shoulder harness restraint systems may be designed to the inertia load...

14 CFR 91.521 - Shoulder harness.

Code of Federal Regulations, 2012 CFR

2012-01-01

... inertia load factors established under the certification basis of the airplane. (b) No person may operate... used; and (2) Safety belt and shoulder harness restraint systems may be designed to the inertia load...

Safety and fitness electronic records system (SAFER) : user and system requirements document

DOT National Transportation Integrated Search

1996-10-28

The Federal Highway Administration (FHWA) is currently testing and evaluating Intelligent : Transportation Systems (ITS) technologies to enhance the safety and efficiency of interstate and : intrastate commercial vehicle operations. The current focus...

1995 Bicycle and Pedestrian Safety Report

DOT National Transportation Integrated Search

1995-03-01

This report provides a review of the current data on bicycle and pedestrian : safety across the United States, finding that safety and education : programs could significantly improve bicycle and pedestrian safety in the : Dallas-Fort Worth Metropoli...

Degrees of connectivity: Systems model for upstream risk assessment and mitigation.

PubMed

Gambatese, John; AlOmari, Kasim

2016-08-01

There is growing recognition that in order to further improve safety performance, attention needs to be given beyond the immediate working conditions and worker actions. A systems approach to construction safety enables considering: multiple project elements simultaneously; connections between different elements; and all system elements affected by safety risk. This paper describes recent and current research to conceptualize a typical building project in terms of connections between workers, activities, and design elements, and to verify and analyze impacts of the design and worker interactions on worker safety. Prior research provides the basis for a network tying the design elements, construction activities, and work crews on a typical building project together along with the extent of interaction between each of the system elements in terms of safety. In conjunction with this systems approach, the researchers propose a concept for viewing and managing construction safety through four different types of connections, or "degrees of connectivity," between the different workers, activities, and design elements in the system. The degrees of connectivity are defined as: interacting with the design element during its construction (DoC #1); interacting with the design element in its final form to attach another component to it (DoC #2) or by working in the vicinity of it (DoC #3); and indirectly interacting with the design element through another worker (DoC #4). To support and verify the presence of the concept in practice, the researchers conducted a survey of construction personnel. The survey results confirm that the four different degrees of connectivity are present and felt during construction operations, and indicate that attention should be given to all design elements, activities, and workers to which a worker is "connected". According to the survey respondents, DoC's #1 and #2 are recognized as the most widely present on construction sites. Eighty percent of the respondents believe that the design element has a moderate or greater impact on worker safety while it is being constructed. These initial research steps provide the starting point for continuing study that aims to develop and demonstrate the degrees of connectivity concept linking workers and design elements, with the goal of understanding how to design a project and work operations in order to improve safety during construction. Copyright © 2015 Elsevier Ltd. All rights reserved.

Space safety and rescue 1979-1981: Worldwide disaster response, rescue and safety employing space-borne systems

NASA Technical Reports Server (NTRS)

Brown, J. W. (Editor)

1983-01-01

Selected papers from the 1979, 1980, and 1981 IAA symposia on space safety and rescue and on worldwide disaster response, safety, and rescue employing spaceborne systems are presented. Available papers published elsewhere and those presented at the 1976, 1977, and 1978 symposia are presented in abstract form. Subjects discussed include man-made space debris, nuclear-waste disposal in space, space-station safety design, psychological training, the introduction of female crewmembers, analysis of the November 23, 1980 earthquake as a design basis for satellite emergency communication, disaster warning using the GOES satellite, and satellite communications for disaster relief operations. Three reviews of the application of space technology to emergency and disaster relief and prevention, given at other symposia in 1981, are presented in an appendix. No individual items are abstracted in this volume

Little shop of errors: an innovative simulation patient safety workshop for community health care professionals.

PubMed

Tupper, Judith B; Pearson, Karen B; Meinersmann, Krista M; Dvorak, Jean

2013-06-01

Continuing education for health care workers is an important mechanism for maintaining patient safety and high-quality health care. Interdisciplinary continuing education that incorporates simulation can be an effective teaching strategy for improving patient safety. Health care professionals who attended a recent Patient Safety Academy had the opportunity to experience firsthand a simulated situation that included many potential patient safety errors. This high-fidelity activity combined the best practice components of a simulation and a collaborative experience that promoted interdisciplinary communication and learning. Participants were challenged to see, learn, and experience "ah-ha" moments of insight as a basis for error reduction and quality improvement. This innovative interdisciplinary educational training method can be offered in place of traditional lecture or online instruction in any facility, hospital, nursing home, or community care setting. Copyright 2013, SLACK Incorporated.

Understanding the molecular mechanism of pulse current charging for stable lithium-metal batteries

PubMed Central

Li, Qi; Tan, Shen; Li, Linlin; Lu, Yingying; He, Yi

2017-01-01

High energy and safe electrochemical storage are critical components in multiple emerging fields of technologies. Rechargeable lithium-metal batteries are considered to be promising alternatives for current lithium-ion batteries, leading to as much as a 10-fold improvement in anode storage capacity (from 372 to 3860 mAh g−1). One of the major challenges for commercializing lithium-metal batteries is the reliability and safety issue, which is often associated with uneven lithium electrodeposition (lithium dendrites) during the charging stage of the battery cycling process. We report that stable lithium-metal batteries can be achieved by simply charging cells with square-wave pulse current. We investigated the effects of charging period and frequency as well as the mechanisms that govern this process at the molecular level. Molecular simulations were performed to study the diffusion and the solvation structure of lithium cations (Li+) in bulk electrolyte. The model predicts that loose association between cations and anions can enhance the transport of Li+ and eventually stabilize the lithium electrodeposition. We also performed galvanostatic measurements to evaluate the cycling behavior and cell lifetime under pulsed electric field and found that the cell lifetime can be more than doubled using certain pulse current waveforms. Both experimental and simulation results demonstrate that the effectiveness of pulse current charging on dendrite suppression can be optimized by choosing proper time- and frequency-dependent pulses. This work provides a molecular basis for understanding the mechanisms of pulse current charging to mitigating lithium dendrites and designing pulse current waveforms for stable lithium-metal batteries. PMID:28776039

Radiation safety standards and their application: international policies and current issues.

PubMed

González, Abel J

2004-09-01

This paper briefly describes the current policies of the United Nations Scientific Committee on the Effects of Atomic Radiation and the International Commission on Radiological Protection and how these policies are converted into international radiation safety standards by the International Atomic Energy Agency, which is the only global organization-within the United Nations family of international agencies-with a statutory mandate not only to establish such standards but also to provide for their application. It also summarizes the current status of the established corpus of such international standards, and of it foreseeable evolution, as well as of legally binding undertakings by countries around the world that are linked to these standards. Moreover, this paper also reviews some major current global issues related to the application of international standards, including the following: strengthening of national infrastructures for radiation safety, including technical cooperation programs for assisting developing countries; occupational radiation safety challenges, including the protection of pregnant workers and their unborn children, dealing with working environments with high natural radiation levels, and occupational attributability of health effects (probability of occupational causation); restricting discharges of radioactive substances into the environment: reviewing current international policies vis-a-vis the growing concern on the radiation protection of the "environment;" radiological protection of patients undergoing radiodiagnostic and radiotherapeutic procedures: the current International Action Plan; safety and security of radiation sources: post-11 September developments; preparedness and response to radiation emergencies: enhancing the international network; safe transport of radioactive materials: new apprehensions; safety of radioactive waste management: concerns and connections with radiation protection; and radioactive residues remaining after the termination of activities: radiation protection response to the forthcoming wave of decommissioning of installations with radioactive materials. The ultimate aim of this paper is to encourage information exchange, cooperation, and collaboration within the radiation protection professional community. In particular, the paper tries to facilitate consolidation of the growing international regime on radiation safety, including the expansion of legally binding undertakings by countries, the strengthening of the current corpus of international radiation safety standards, and the development of international provisions for ensuring the proper worldwide application of these standards, such as a system of international appraisals by peer review.

Polish Experience of Implementing Vision Zero.

PubMed

Jamroz, Kazimierz; Michalski, Lech; Żukowska, Joanna

2017-01-01

The aim of this study is to present an outline and the principles of Poland's road safety strategic programming as it has developed over the last 25 years since the first Integrated Road Safety System with a strong focus on Sweden's "Vision Zero". Countries that have successfully improved road safety have done so by following strategies centred around the idea that people are not infallible and will make mistakes. The human body can only take a limited amount of energy upon impact, so roads, vehicles and road safety programmes must be designed to address this. The article gives a summary of Poland's experience of programming preventative measures that have "Vision Zero" as their basis. It evaluates the effectiveness of relevant programmes.

The comfort and satisfaction of air travelers - Basis for a descriptive model

NASA Technical Reports Server (NTRS)

Jacobson, I. D.; Martinez, J.

1974-01-01

The results of a questionnaire and interview survey are used as a basis for proposing a descriptive model of the comfort and satisfaction of the commercial air traveler. Passenger attitudes toward the present commercial air travel system are examined. Comfort is interpreted as being represented by a four-dimensional composite of commonly encountered environmental variables. Satisfaction is represented as a composite of safety, cost-benefit, luxury, and in-flight activity dimensions.

Developing integrated benchmarks for DOE performance measurement

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

Barancik, J.I.; Kramer, C.F.; Thode, Jr. H.C.

1992-09-30

The objectives of this task were to describe and evaluate selected existing sources of information on occupational safety and health with emphasis on hazard and exposure assessment, abatement, training, reporting, and control identifying for exposure and outcome in preparation for developing DOE performance benchmarks. Existing resources and methodologies were assessed for their potential use as practical performance benchmarks. Strengths and limitations of current data resources were identified. Guidelines were outlined for developing new or improved performance factors, which then could become the basis for selecting performance benchmarks. Data bases for non-DOE comparison populations were identified so that DOE performance couldmore » be assessed relative to non-DOE occupational and industrial groups. Systems approaches were described which can be used to link hazards and exposure, event occurrence, and adverse outcome factors, as needed to generate valid, reliable, and predictive performance benchmarks. Data bases were identified which contain information relevant to one or more performance assessment categories . A list of 72 potential performance benchmarks was prepared to illustrate the kinds of information that can be produced through a benchmark development program. Current information resources which may be used to develop potential performance benchmarks are limited. There is need to develop an occupational safety and health information and data system in DOE, which is capable of incorporating demonstrated and documented performance benchmarks prior to, or concurrent with the development of hardware and software. A key to the success of this systems approach is rigorous development and demonstration of performance benchmark equivalents to users of such data before system hardware and software commitments are institutionalized.« less

Feasibility Study of a Rotorcraft Health and Usage Monitoring System (HUMS): Results of Operator's Evaluation

NASA Technical Reports Server (NTRS)

Romero, Raylund; Summers, Harold; Cronkhite, James

1996-01-01

The objective was to evaluate the feasibility of a state-of-the-art health and usage monitoring system (HUMS) to provide monitoring of critical mechanical systems on the helicopter, including motors, drive train, engines, and life-limited components. The implementation of HUMS and cost integration with current maintenance procedures was assessed from the operator's viewpoint in order to achieve expected benefits from these systems, such as enhanced safety, reduced maintenance cost, and increased availability. An operational HUMS that was installed and operated under an independent flight trial program was used as a basis for this study. The HUMS equipment and software were commercially available. Based on the results of the feasibility study, the HUMS used in the flight trial program generally demonstrated a high level of reliability in monitoring the rotor system, engines, drive train, and life-limited components. The system acted as a sentinel to warn of impending failures. A worn tail rotor pitch bearing was detected by HUMS, which had the capability for self testing to diagnose system and sensor faults. Examples of potential payback to the operator with HUMS were identified, including reduced insurance cost through enhanced safety, lower operating costs derived from maintenance credits, increased aircraft availability, and improved operating efficiency. The interfacing of HUMS with current operational procedures was assessed to require only minimal revisions to the operator's maintenance manuals. Finally the success in realizing the potential benefits from HUMS technology was found to depend on the operator, helicopter manufacturer, regulator (FAA), and HUMS supplier working together.

Nurses' Perceptions of Patient Safety Culture in Three Hospitals in Saudi Arabia.

PubMed

Alquwez, Nahed; Cruz, Jonas Preposi; Almoghairi, Ahmed Mohammed; Al-Otaibi, Raid Salman; Almutairi, Khalid Obaid; Alicante, Jerico G; Colet, Paolo C

2018-05-14

To assess the present patient safety culture of three general hospitals in Saudi Arabia, as perceived by nurses. This study utilized a descriptive, cross-sectional design. A convenience sample of 351 nurses working in three general hospitals in the central region of Saudi Arabia was surveyed in this study using the Hospital Survey of Patients' Safety Culture (HSOPSC) from October 2016 to April 2017. From the 12 composites of the HSOPSC, the nurses perceived only the following two patient safety areas as strengths: teamwork within units and organizational learning-continuous improvement. Six areas of patient safety were identified as weaknesses, namely overall perception of patient safety, handoffs and transitions, communication openness, staffing, frequency of events reported, and nonpunitive response to errors. Nationality, educational attainment, hospital, length of service in the hospital, work area or unit, length of service in the current work area or unit, current position, and direct patient contact or interaction were significant predictors of the nurses' perceived patient safety culture. The findings in this study clarify the current status of patient safety culture in three hospitals in the Kingdom of Saudi Arabia. The present findings should be considered by policymakers, hospital leaders, and nurse executives in creating interventions aimed at improving the patient safety culture in hospitals. A multidimensional network intervention targeting the different dimensions of patient safety culture and involving different organizational levels should be implemented to improve patient safety. © 2018 Sigma Theta Tau International.

Review article: practical current issues in perioperative patient safety.

PubMed

Eichhorn, John H

2013-02-01

This brief review provides an overview and, importantly, a context perspective of relevant current practical issues in perioperative patient safety. The dramatic improvement in anesthesia patient safety over the last 30 years was not initiated by electronic monitors but, rather, largely by a set of behaviours known as "safety monitoring" that were then made decidedly more effective by extending the human senses through electronic monitoring, for example, capnography and pulse oximetry. In the highly developed world, this current success is threatened by complacency and production pressure. In some areas of the developing/underdeveloped world, the challenge is implementing the components of anesthesia practice that will bring safety improvements to parallel the overall current success, for instance, applying the World Federation of Societies of Anaesthesiologists (WFSA) "International Standards for A Safe Practice of Anaesthesia". Generally, expanding the current success in safety involves many practical issues. System issues involve research, effective reporting mechanisms and analysis/broadcasting of results, perioperative communication (including "speaking up to power"), and checklists. Monitoring issues involve enforcing existing published monitoring standards and also recognizing the risk of danger to the patient from hypoventilation during procedural sedation and from postoperative intravenous pain medications. Issues of clinical care include medication errors in the operating room, cerebral hypoperfusion (especially in the head-up position), dangers of airway management, postoperative residual weakness from muscle relaxants, operating room fires, and risks specific in obstetric anesthesia. Recognition of the issues outlined here and empowerment of all anesthesia professionals, from the most senior professors and administrators to the newest practitioners, should help maintain, solidify, and expand the improvements in anesthesia and perioperative patient safety.

Safety assessment of personal care products/cosmetics and their ingredients.

PubMed

Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

2010-03-01

We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However, current evidence suggests that these particles are non-toxic, do not penetrate into or through normal or compromised human skin and, therefore, pose no risk to human health. The increasing use of natural plant ingredients in personal care products raised new safety issues that require novel approaches to their safety evaluation similar to those of plant-derived food ingredients. For example, the Threshold of Toxicological Concern (TTC) is a promising tool to assess the safety of substances present at trace levels as well as minor ingredients of plant-derived substances. The potential human systemic exposure to PCP ingredients is increasingly estimated on the basis of in vitro skin penetration data. However, new evidence suggests that the in vitro test may overestimate human systemic exposure to PCP ingredients due to the absence of metabolism in cadaver skin or misclassification of skin residues that, in vivo, remain in the stratum corneum or hair follicle openings, i.e. outside the living skin. Overall, today's safety assessment of PCP and their ingredients is not only based on science, but also on their respective regulatory status as well as other issues, such as the ethics of animal testing. Nevertheless, the record shows that today's PCP are safe and offer multiple benefits to quality of life and health of the consumer. In the interest of all stakeholders, consumers, regulatory bodies and producers, there is an urgent need for an international harmonization on the status and safety requirements of these products and their ingredients.

Safety assessment of personal care products/cosmetics and their ingredients

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

Nohynek, Gerhard J., E-mail: gnohynec@rd.loreal.co; Antignac, Eric; Re, Thomas

2010-03-01

We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed,more » the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO{sub 2} and ZnO in sunscreens. However, current evidence suggests that these particles are non-toxic, do not penetrate into or through normal or compromised human skin and, therefore, pose no risk to human health. The increasing use of natural plant ingredients in personal care products raised new safety issues that require novel approaches to their safety evaluation similar to those of plant-derived food ingredients. For example, the Threshold of Toxicological Concern (TTC) is a promising tool to assess the safety of substances present at trace levels as well as minor ingredients of plant-derived substances. The potential human systemic exposure to PCP ingredients is increasingly estimated on the basis of in vitro skin penetration data. However, new evidence suggests that the in vitro test may overestimate human systemic exposure to PCP ingredients due to the absence of metabolism in cadaver skin or misclassification of skin residues that, in vivo, remain in the stratum corneum or hair follicle openings, i.e. outside the living skin. Overall, today's safety assessment of PCP and their ingredients is not only based on science, but also on their respective regulatory status as well as other issues, such as the ethics of animal testing. Nevertheless, the record shows that today's PCP are safe and offer multiple benefits to quality of life and health of the consumer. In the interest of all stakeholders, consumers, regulatory bodies and producers, there is an urgent need for an international harmonization on the status and safety requirements of these products and their ingredients.« less

Putting Safety in the Frame: Nurses' Sensemaking at Work.

PubMed

O'Keeffe, Valerie Jean; Thompson, Kirrilly Rebecca; Tuckey, Michelle Rae; Blewett, Verna Lesley

2015-01-01

Current patient safety policy focuses nursing on patient care goals, often overriding nurses' safety. Without understanding how nurses construct work health and safety (WHS), patient and nurse safety cannot be reconciled. Using ethnography, we examine social contexts of safety, studying 72 nurses across five Australian hospitals making decisions during patient encounters. In enacting safe practice, nurses used "frames" built from their contextual experiences to guide their behavior. Frames are produced by nurses, and they structure how nurses make sense of their work. Using thematic analysis, we identify four frames that inform nurses' decisions about WHS: (a) communicating builds knowledge, (b) experiencing situations guides decisions, (c) adapting procedures streamlines work, and (d) team working promotes safe working. Nurses' frames question current policy and practice by challenging how nurses' safety is positioned relative to patient safety. Recognizing these frames can assist the design and implementation of effective WHS management.

Putting Safety in the Frame

PubMed Central

O’Keeffe, Valerie Jean; Thompson, Kirrilly Rebecca; Tuckey, Michelle Rae; Blewett, Verna Lesley

2015-01-01

Current patient safety policy focuses nursing on patient care goals, often overriding nurses’ safety. Without understanding how nurses construct work health and safety (WHS), patient and nurse safety cannot be reconciled. Using ethnography, we examine social contexts of safety, studying 72 nurses across five Australian hospitals making decisions during patient encounters. In enacting safe practice, nurses used “frames” built from their contextual experiences to guide their behavior. Frames are produced by nurses, and they structure how nurses make sense of their work. Using thematic analysis, we identify four frames that inform nurses’ decisions about WHS: (a) communicating builds knowledge, (b) experiencing situations guides decisions, (c) adapting procedures streamlines work, and (d) team working promotes safe working. Nurses’ frames question current policy and practice by challenging how nurses’ safety is positioned relative to patient safety. Recognizing these frames can assist the design and implementation of effective WHS management. PMID:28462311

Structural basis for the binding of the neutralizing antibody, 7D11, to the poxvirus L1 protein

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

Su, Hua-Poo; Golden, Joseph W.; Gittis, Apostolos G.

2007-11-25

Medical countermeasures to prevent or treat smallpox are needed due to the potential use of poxviruses as biological weapons. Safety concerns with the currently available smallpox vaccine indicate a need for research on alternative poxvirus vaccine strategies. Molecular vaccines involving the use of proteins and/or genes and recombinant antibodies are among the strategies under current investigation. The poxvirus L1 protein, encoded by the L1R open reading frame, is the target of neutralizing antibodies and has been successfully used as a component of both protein subunit and DNA vaccines. L1-specific monoclonal antibodies (e.g., mouse monoclonal antibody mAb-7D11, mAb-10F5) with potent neutralizingmore » activity bind L1 in a conformation-specific manner. This suggests that proper folding of the L1 protein used in molecular vaccines will affect the production of neutralizing antibodies and protection. Here, we co-crystallized the Fab fragment of mAb-7D11 with the L1 protein. The crystal structure of the complex between Fab-7D11 and L1 reveals the basis for the conformation-specific binding as recognition of a discontinuous epitope containing two loops that are held together by a disulfide bond. The structure of this important conformational epitope of L1 will contribute to the development of molecular poxvirus vaccines and also provides a novel target for anti-poxvirus drugs. In addition, the sequence and structure of Fab-7D11 will contribute to the development of L1-targeted immunotherapeutics.« less

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016.

PubMed

Bikson, Marom; Grossman, Pnina; Thomas, Chris; Zannou, Adantchede Louis; Jiang, Jimmy; Adnan, Tatheer; Mourdoukoutas, Antonios P; Kronberg, Greg; Truong, Dennis; Boggio, Paulo; Brunoni, André R; Charvet, Leigh; Fregni, Felipe; Fritsch, Brita; Gillick, Bernadette; Hamilton, Roy H; Hampstead, Benjamin M; Jankord, Ryan; Kirton, Adam; Knotkova, Helena; Liebetanz, David; Liu, Anli; Loo, Colleen; Nitsche, Michael A; Reis, Janine; Richardson, Jessica D; Rotenberg, Alexander; Turkeltaub, Peter E; Woods, Adam J

2016-01-01

This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations. Copyright © 2016 Elsevier Inc. All rights reserved.

Safety of transcranial Direct Current Stimulation: Evidence Based Update 2016

PubMed Central

Bikson, Marom; Grossman, Pnina; Thomas, Chris; Zannou, Adantchede Louis; Jiang, Jimmy; Adnan, Tatheer; Mourdoukoutas, Antonios P; Kronberg, Greg; Truong, Dennis; Boggio, Paulo; Brunoni, André R.; Charvet, Leigh; Fregni, Felipe; Fritsch, Brita; Gillick, Bernadette; Hamilton, Roy H.; Hampstead, Benjamin M.; Jankord, Ryan; Kirton, Adam; Knotkova, Helena; Liebetanz, David; Liu, Anli; Loo, Colleen; Nitsche, Michael A.; Reis, Janine; Richardson, Jessica D.; Rotenberg, Alexander; Turkeltaub, Peter E.; Woods, Adam J.

2016-01-01

This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3–13 A/m2) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1,000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations. PMID:27372845

Saudi Arabian ICU safety culture and nurses' attitudes.

PubMed

Alayed, Abdulrahman S; Lööf, Helena; Johansson, Unn-Britt

2014-01-01

The purpose of this paper is to examine nurses' attitudes towards safety culture in six Saudi Arabian intensive care units (ICUs). The study is descriptive with a cross-sectional design. The Safety Attitude Questionnaire (SAQ)-ICU version was distributed and 216 completed questionnaires were returned. The findings provide a basis for further research on Saudi Arabian ICU safety culture. This study showed that the SAQ-ICU can be used to measure safety climate to identify areas for improvement according to nurse attitudes and perceptions. Findings indicate that ICU safety culture is an important issue that hospital managers should prioritise. The SAQ-ICU questionnaire, used to measure safety climate in Saudi Arabian ICUs, identifies service strengths and improvement areas according to attitudes and perceptions. To the knowledge, this is the first study to use SAQ to examine nurses' safety culture attitudes in Saudi Arabian ICUs. The present findings provide a baseline and further details about Saudi Arabian ICU safety. Study participants represented nine nationalities, indicating the nursing workforce's diversity, which is expected to continue in the future. Such a nursing cultural heterogeneity calls for further studies to examine and evaluate attitudes and values to improve ICU safety culture.

49 CFR 193.2633 - Interference currents.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 3 2010-10-01 2010-10-01 false Interference currents. 193.2633 Section 193.2633 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS FACILITIES...

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

DOT National Transportation Integrated Search

1981-01-01

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

AP1000{sup R} design robustness against extreme external events - Seismic, flooding, and aircraft crash

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

Pfister, A.; Goossen, C.; Coogler, K.

2012-07-01

Both the International Atomic Energy Agency (IAEA) and the U.S. Nuclear Regulatory Commission (NRC) require existing and new nuclear power plants to conduct plant assessments to demonstrate the unit's ability to withstand external hazards. The events that occurred at the Fukushima-Dai-ichi nuclear power station demonstrated the importance of designing a nuclear power plant with the ability to protect the plant against extreme external hazards. The innovative design of the AP1000{sup R} nuclear power plant provides unparalleled protection against catastrophic external events which can lead to extensive infrastructure damage and place the plant in an extended abnormal situation. The AP1000 plantmore » is an 1100-MWe pressurized water reactor with passive safety features and extensive plant simplifications that enhance construction, operation, maintenance and safety. The plant's compact safety related footprint and protection provided by its robust nuclear island structures prevent significant damage to systems, structures, and components required to safely shutdown the plant and maintain core and spent fuel pool cooling and containment integrity following extreme external events. The AP1000 nuclear power plant has been extensively analyzed and reviewed to demonstrate that it's nuclear island design and plant layout provide protection against both design basis and extreme beyond design basis external hazards such as extreme seismic events, external flooding that exceeds the maximum probable flood limit, and malicious aircraft impact. The AP1000 nuclear power plant uses fail safe passive features to mitigate design basis accidents. The passive safety systems are designed to function without safety-grade support systems (such as AC power, component cooling water, service water, compressed air or HVAC). The plant has been designed to protect systems, structures, and components critical to placing the reactor in a safe shutdown condition within the steel containment vessel which is further surrounded by a substantial 'steel concrete' composite shield building. The containment vessel is not affected by external flooding, and the shield building design provides hazard protection beyond that provided by a comparable reinforced concrete structure. The intent of this paper is to demonstrate the robustness of the AP1000 design against extreme events. The paper will focus on the plants ability to withstand extreme external events such as beyond design basis flooding, seismic events, and malicious aircraft impact. The paper will highlight the robustness of the AP1000 nuclear island design including the protection provided by the unique AP1000 composite shield building. (authors)« less

Current trends and progress in clinical applications of oocyte cryopreservation

PubMed Central

Cil, Aylin P.; Seli, Emre

2013-01-01

Purpose of review To delineate the current trends in the clinical application of oocyte cryopreservation. Recent findings Although the first live birth from oocyte cryopreservation was reported approximately three decades ago, significant improvement in the clinical application of oocyte cryopreservation took place only over the past decade. On the basis of the available evidence suggesting that success rates with donor oocyte vitrification are similar to that of IVF with fresh donor oocytes, the American Society of Reproductive Medicine has recently stated that oocyte cryopreservation should no longer be considered experimental for medical indications, outlying elective oocyte cryopreservation. Meanwhile, a few surveys on the attitudes toward oocyte cryopreservation revealed that elective use for the postponement of fertility is currently the most common indication for oocyte cryopreservation. Most recently, a randomized controlled trial revealed important evidence on the safety of nondonor oocyte cryopreservation, and confirmed that the clinical success of vitrification is comparable to that of IVF with fresh oocytes. Summary The evidence suggesting similar IVF success rates with both donor and nondonor cryopreserved oocytes compared with fresh oocytes will increase the utilization of elective oocyte cryopreservation. Appropriate counseling of women for oocyte cryopreservation requires the establishment of age-based clinical success rates with cryopreserved oocytes for various indications. PMID:23562954

Vulnerability, safety and response of nuclear power plants to the hydroclimatic hazards

NASA Astrophysics Data System (ADS)

János Katona, Tamás; Vilimi, András

2016-04-01

The Great Tohoku Earthquake and Tsunami, and the severe accident at Fukushima Dai-ichi nuclear power plant 2011 alerted the nuclear industry to danger of extreme rare natural hazards. The subsequent "stress tests" performed by the nuclear industry in Europe and all over the world identifies the nuclear power plant (NPP) vulnerabilities and define the measures for increasing the plant safety. According to the international practice of nuclear safety regulations, the cumulative core damage frequency for NPPs has to be 10-5/a, and the cumulative frequency of early large release has to be 10-6/a. In case of operating plants these annual probabilities can be little higher, but the licensees are obliged to implement all reasonable practicable measures for increasing the plant safety. For achieving the required level of safety, design basis of NPPs for natural hazards has to be defined at the 10-4/a ⎯10-5/a levels of annual exceedance probability. Tornado hazard is some kind of exception, e.g., the design basis annual probability for tornado in the US is equal to 10-7/a. Design of the NPPs shall provide for an adequate margin to protect items ultimately necessary to prevent large or early radioactive releases in the event of levels of natural hazards exceeding those to be considered for design. The plant safety has to be reviewed for accounting the changes of the environmental conditions and natural hazards in case of necessity, but as minimum every ten years in the frame of periodic safety reviews. Long-term forecast of environmental conditions and hazards has to be accounted for in the design basis of the new plants. Changes in hydroclimatic variables, e.g., storms, tornadoes, river floods, flash floods, extreme temperatures, droughts affect the operability and efficiency as well as the safety the NPPs. Low flow rates and high water temperature in the rivers may force to operate at reduced power level or shutdown the plant (Cernavoda NPP, Romania, August 2009). The practice demonstrated that the NPPs could safely withstand the meteorological extremes (Katrina hurricane, 2005). However the floods at some sites cause significant safety issues. Design of NPPs and their response to extreme hydroclimatic events depends on the features of particular hazards, e.g., predictability, possibility and time available for the protective actions, potential for causing cliff-edge effects and the possible combinations of events. The uncertainty of the prediction of extreme values for the design and safety assessment is a fundamental issue. In the paper the consequences of hydroclimatic extremes are analysed for nuclear power plants. The possibility of operational response to extremes is presented. The safety margins are assessed with respect to the effects caused by hydroclimatic extremes. The direct actions (e.g. wind) and the indirect consequences (e.g. changing of ground water level) are also considered. Methods for accounting the uncertainties of the characterisation of low probability hazards are also considered. The preparedness to severe hydroclimatic conditions / events and actions for mitigation and management are presented and discussed. The considerations in the paper are illustrated by the case of the Paks Nuclear Power Plant, Hungary.

Measurement tools and outcome measures used in transitional patient safety; a systematic review.

PubMed

van Melle, Marije A; van Stel, Henk F; Poldervaart, Judith M; de Wit, Niek J; Zwart, Dorien L M

2018-01-01

Patients are at risk for harm when treated simultaneously by healthcare providers from different healthcare organisations. To assess current practice and improvements of transitional patient safety, valid measurement tools are needed. To identify and appraise all measurement tools and outcomes that measure aspects of transitional patient safety, PubMed, Cinahl, Embase and Psychinfo were systematically searched. Two researchers performed the title and abstract and full-text selection. First, publications about validation of measurement tools were appraised for quality following COSMIN criteria. Second, we inventoried all measurement tools and outcome measures found in our search that assessed current transitional patient safety or the effect of interventions targeting transitional patient safety. The initial search yielded 8288 studies, of which 18 assessed validity of measurement tools of different aspects of transitional safety, and 191 assessed current transitional patient safety or effect of interventions. In the validated measurement tools, the overall quality of content and structural validity was acceptable; other COSMIN criteria, such as reliability, measurement error and responsiveness, were mostly poor or not reported. In our outcome inventory, the most frequently used validated outcome measure was the Care Transition Measure (n = 9). The most frequently used non-validated outcome measures were: medication discrepancies (n = 98), hospital readmissions (n = 55), adverse events (n = 34), emergency department visits (n = 33), (mental or physical) health status (n = 28), quality and timeliness of discharge summary, and patient satisfaction (n = 23). Although no validated measures exist that assess all aspects of transitional patient safety, we found validated measurement tools on specific aspects. Reporting of validity of transitional measurement tools was incomplete. Numerous outcome measures with unknown measurement properties are used in current studies on safety of care transitions, which makes interpretation or comparison of their results uncertain.

78 FR 42457 - Hazardous Materials: Revision to Fireworks Regulations (RRR)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

... the current level of transportation safety of Division 1.4G consumer fireworks. A. Notice of Proposed... and whether the FCA certification process provides an equivalent level of oversight as the current... level of safety while allowing [[Page 42459

Retrofit of existing statewide Louisiana safety walk bridge barrier railing systems : research project capsule.

DOT National Transportation Integrated Search

2016-07-01

Currently, the Louisiana Department of Transportation and Development (DOTD) : maintains approximately 200 miles of concrete safety walk barrier railing systems on : its bridges. Some of these vintage systems do not meet the current crash performance...

For all the right reasons. Approaching CPOE from a patient safety and care quality perspective is the first critical step toward success.

PubMed

Hagland, Mark

2009-09-01

True CPOE success is about facilitating improved patient safety, care quality, and efficiency in a multidisciplinar environment, and on an ongoing basis. CPOE implementation forces clinician leaders to examine and rework long-ingrained care delivery processes, especially as they build or adapt order sets. The likelihood that CPOE will be a requirement of meaningful use could compel a rapid acceleration in implementation.

Integrated therapy safety management system

PubMed Central

Podtschaske, Beatrice; Fuchs, Daniela; Friesdorf, Wolfgang

2013-01-01

Aims The aim is to demonstrate the benefit of the medico-ergonomic approach for the redesign of clinical work systems. Based on the six layer model, a concept for an ‘integrated therapy safety management’ is drafted. This concept could serve as a basis to improve resilience. Methods The concept is developed through a concept-based approach. The state of the art of safety and complexity research in human factors and ergonomics forms the basis. The findings are synthesized to a concept for ‘integrated therapy safety management’. The concept is applied by way of example for the ‘medication process’ to demonstrate its practical implementation. Results The ‘integrated therapy safety management’ is drafted in accordance with the six layer model. This model supports a detailed description of specific work tasks, the corresponding responsibilities and related workflows at different layers by using the concept of ‘bridge managers’. ‘Bridge managers’ anticipate potential errors and monitor the controlled system continuously. If disruptions or disturbances occur, they respond with corrective actions which ensure that no harm results and they initiate preventive measures for future procedures. The concept demonstrates that in a complex work system, the human factor is the key element and final authority to cope with the residual complexity. The expertise of the ‘bridge managers’ and the recursive hierarchical structure results in highly adaptive clinical work systems and increases their resilience. Conclusions The medico-ergonomic approach is a highly promising way of coping with two complexities. It offers a systematic framework for comprehensive analyses of clinical work systems and promotes interdisciplinary collaboration. PMID:24007448

A Review of Research on Driving Styles and Road Safety.

PubMed

Sagberg, Fridulv; Selpi; Piccinini, Giulio Francesco Bianchi; Engström, Johan

2015-11-01

The aim of this study was to outline a conceptual framework for understanding driving style and, on this basis, review the state-of-the-art research on driving styles in relation to road safety. Previous research has indicated a relationship between the driving styles adopted by drivers and their crash involvement. However, a comprehensive literature review of driving style research is lacking. A systematic literature search was conducted, including empirical, theoretical, and methodological research, on driving styles related to road safety. A conceptual framework was proposed whereby driving styles are viewed in terms of driving habits established as a result of individual dispositions as well as social norms and cultural values. Moreover, a general scheme for categorizing and operationalizing driving styles was suggested. On this basis, existing literature on driving styles and indicators was reviewed. Links between driving styles and road safety were identified and individual and sociocultural factors influencing driving style were reviewed. Existing studies have addressed a wide variety of driving styles, and there is an acute need for a unifying conceptual framework in order to synthesize these results and make useful generalizations. There is a considerable potential for increasing road safety by means of behavior modification. Naturalistic driving observations represent particularly promising approaches to future research on driving styles. Knowledge about driving styles can be applied in programs for modifying driver behavior and in the context of usage-based insurance. It may also be used as a means for driver identification and for the development of driver assistance systems. © 2015, Human Factors and Ergonomics Society.

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.

Neonicotinoid insecticides: highlights of a symposium on strategic molecular designs.

PubMed

Tomizawa, Motohiro; Casida, John E

2011-04-13

Neonicotinoids are the newest of the five major classes of insecticides (the others are chlorinated hydrocarbons, organophosphorus compounds, methylcarbamates, and pyrethroids), and they make up approximately one-fourth of the world insecticide market. Nithiazine was the lead compound from Shell Development Co. in California later optimized by Shinzo Kagabu of Nihon Tokushu Noyaku Seizo to increase the potency and photostability, resulting in imidacloprid and thiacloprid. These discoveries are the basis for the International Award for Research in Agrochemicals of the American Chemical Society presented in 2010 to Professor Shinzo Kagabu. Five other neonicotinoids were added by others for the current set of seven commercial compounds. This symposium considers the progress in discovery and development of novel chemotype nicotinic insecticides with enhanced effectiveness, unique biological properties, and maximal safety. Chemorational approaches considered include physicochemical properties, metabolic activation and detoxification, and chemical and structural biology aspects potentially facilitating receptor structure-guided insecticide design.

Vacuum cooling of meat products: current state-of-the-art research advances.

PubMed

Feng, Chaohui; Drummond, Liana; Zhang, Zhihang; Sun, Da-Wen; Wang, Qijun

2012-01-01

Vacuum cooling (VC) is commonly applied for cooling of several foodstuffs, to provide exceptionally rapid cooling rates with low energy consumption and resulting in high-quality food products. However, for products such as meat and cooked meat products, the higher cooling loss of vacuum cooling compared with established methods still means lower yields, and important meat quality parameters can be negatively affected. Substantial efforts during the past ten years have aimed to improve the technology in order to offer the meat industry, especially the cooked meat industry, optimized production in terms of safety regulations and guidelines, as well as meat quality. This review presents and discusses recent VC developments directed to the cooked meat industry. The principles of VC, and the basis for improvements of this technology, are firstly discussed; future prospects for research and development in this area are later explored, particularly in relation to cooling of cooked meat and meat products.

NIOSH testimony to DOL on the Occupational Safety and Health Administration's notice of proposed rulemaking on occupational exposure to asbestos, tremolite, anthophyllite, and actinolite by R. A. Lemen, May 9, 1990

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

Not Available

1990-05-09

The testimony summarized information pertinent to the proposed rulemaking to remove nonasbestiform tremolite, anthophyllite, and actinolite from the asbestos standard. NIOSH concludes that on the basis of current data that cleavage fragments of the appropriate aspect ratio and length from the nonasbestiform minerals should be considered as hazardous as fibers from the asbestiform minerals. No scientifically valid health evidence was found for removing from the asbestos standard cleavage fragments that become airborne when nonasbestiform tremolite, anthophyllite and actinolite are mined, milled and used, and that meet the microscopic definition of a fiber. The risk of cancer from such exposures warrantsmore » limiting exposures to these minerals to the lowest feasible concentration. A glossary of terms is provided in an appendix.« less

Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative.

PubMed

Lansky, Alexandra J; Messé, Steven R; Brickman, Adam M; Dwyer, Michael; Bart van der Worp, H; Lazar, Ronald M; Pietras, Cody G; Abrams, Kevin J; McFadden, Eugene; Petersen, Nils H; Browndyke, Jeffrey; Prendergast, Bernard; Ng, Vivian G; Cutlip, Donald E; Kapadia, Samir; Krucoff, Mitchell W; Linke, Axel; Scala Moy, Claudia; Schofer, Joachim; van Es, Gerrit-Anne; Virmani, Renu; Popma, Jeffrey; Parides, Michael K; Kodali, Susheel; Bilello, Michel; Zivadinov, Robert; Akar, Joseph; Furie, Karen L; Gress, Daryl; Voros, Szilard; Moses, Jeffrey; Greer, David; Forrest, John K; Holmes, David; Kappetein, Arie P; Mack, Michael; Baumbach, Andreas

2018-05-14

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.

Dysphagia in Stroke: A New Solution

PubMed Central

Langdon, Claire; Blacker, David

2010-01-01

Dysphagia is extremely common following stroke, affecting 13%–94% of acute stroke sufferers. It is associated with respiratory complications, increased risk of aspiration pneumonia, nutritional compromise and dehydration, and detracts from quality of life. While many stroke survivors experience a rapid return to normal swallowing function, this does not always happen. Current dysphagia treatment in Australia focuses upon prevention of aspiration via diet and fluid modifications, compensatory manoeuvres and positional changes, and exercises to rehabilitate paretic muscles. This article discusses a newer adjunctive treatment modality, neuromuscular electrical stimulation (NMES), and reviews the available literature on its efficacy as a therapy for dysphagia with particular emphasis on its use as a treatment for dysphagia in stroke. There is a good theoretical basis to support the use of NMES as an adjunctive therapy in dysphagia and there would appear to be a great need for further well-designed studies to accurately determine the safety and efficacy of this technique. PMID:20721336

The European hospital exemption clause-new option for gene therapy?

PubMed

Buchholz, Christian J; Sanzenbacher, Ralf; Schüle, Silke

2012-01-01

Gene-therapy medicinal products are currently applied to patients enrolled in authorized clinical trials to demonstrate safety and efficacy. Given a positive outcome, marketing authorization can subsequently be achieved via the centralized procedure coordinated by the European Medicines Agency. With Regulation (EC) No. 1394/2007 in force, advanced therapy medicinal products, including gene- and cell-therapy products, can be excepted from the obligation of obtaining a marketing authorization via the centralized procedure under specific conditions (so-called "hospital exemption"). This hospital exemption allows the application of gene-therapy medicinal products prepared on a non-routine basis for an individual patient and used under the exclusive professional responsibility of a medical practitioner. Here, we explain the requirements to be fulfilled in order to fall under this exemption, the implementation of this regulation into the German national legislation, and its impact on gene-therapy product development in the future.

Current concepts and prospects of herbal nutraceutical: A review

PubMed Central

Chauhan, Baby; Kumar, Gopal; Kalam, Nazia; Ansari, Shahid H.

2013-01-01

Nutraceuticals are food or part of food that provides medical or health benefits including the prevention and/or treatment of a disease. Nutraceutical has advantage over the medicine because they avoid side effect, have naturally dietary supplement, etc. Nutraceutical; on the basis of their natural source, chemical grouping, categories into three key terms -nutrients, herbals, dietary supplements, dietary fiber, etc. The most rapidly growing segments of the industry were dietary supplements (19.5 percent per year) and natural/herbal products (11.6 percent per year). Global nutraceutical market is estimated as USD 117 billion. FDA regulated dietary supplements as foods to ensure that they were safe. In 2006, the Indian government passed Food Safety and Standard Act to regulate the nutraceutical industry. Herbal nutraceutical is used as a powerful instrument in maintaining health and to act against nutritionally induced acute and chronic diseases, thereby promoting optimal health, longevity, and quality of life. PMID:23662276

Photodynamic therapy in dermatology: past, present, and future

NASA Astrophysics Data System (ADS)

Darlenski, Razvigor; Fluhr, Joachim W.

2013-06-01

Photodynamic therapy (PDT) is a noninvasive therapeutic method first introduced in the field of dermatology. It is mainly used for the treatment of precancerous and superficial malignant skin tumors. Today PDT finds new applications not only for nononcologic dermatoses but also in the field of other medical specialties such as otorhinolaryngology, ophthalmology, neurology, gastroenterology, and urology. We are witnessing a broadening of the spectrum of skin diseases that are treated by PDT. Since its introduction, PDT protocol has evolved significantly in terms of increasing method efficacy and patient safety. In this era of evidence-based medicine, it is expected that much effort will be put into creating a worldwide accepted consensus on PDT. A review on the current knowledge of PDT is given, and the historical basis of the method's evolution since its introduction in the 1900s is presented. At the end, future challenges of PDT are focused on discussing gaps that exist for research in the field.

Day labor and occupational health: time to take a closer look.

PubMed

Buchanan, Susan

2004-01-01

The term "day labor" refers to work performed by individuals who are hired on a temporary basis, often for one day at a time. This type of employment has increased in North America as informal work arrangements and immigration have increased. Research on the occupational health of day laborers is minimal. The objectives of this article are to review the current literature pertaining to occupational health in day laborers, and to characterize the issues that affect this population's access to occupational health services. Surveys of day laborers and other immigrant, low-wage workers show that they are at elevated risk for occupational injury and are often unable to access medical care when injured on the job. Reasons include workers' reluctance to complain about unsafe work conditions, inadequate safety training, and lack of incentive for employers to reduce workplace injuries. More research is needed to better characterize the occupational health of this population.

The ethics and economics of consuming Canadian drugs.

PubMed

Seaman, Rachel M H

2005-01-01

Many U.S. citizens are unable to afford prescription medication in their own country, so they purchase them from Canadian pharmacies. This paper examines the ethics of importing drugs from Canada, including economic implications and how physicians should respond to this dilemma. The four basic principles of ethics are balanced by examining financial incentives, current Canadian and U.S. law, safety issues, the burden of research and development, the impact on Canadian physicians, and issues of liability. The paper concludes that the principle of autonomy permits individuals to cross the border and purchase drugs for personal use; however, nonmaleficence prohibits the purchase of these drugs through third parties. In addition, the U.S. government has special obligations to justice and beneficence and may not ethically sponsor the importation of Canadian drugs. Finally, the paper shows that U.S. doctors must not recommend importation on the basis of beneficence and autonomy.

Selective androgen receptor modulators for the treatment of late onset male hypogonadism.

PubMed

Coss, Christopher C; Jones, Amanda; Hancock, Michael L; Steiner, Mitchell S; Dalton, James T

2014-01-01

Several testosterone preparations are used in the treatment of hypogonadism in the ageing male. These therapies differ in their convenience, flexibility, regional availability and expense but share their pharmacokinetic basis of approval and dearth of long-term safety data. The brevity and relatively reduced cost of pharmacokinetic based registration trials provides little commercial incentive to develop improved novel therapies for the treatment of late onset male hypogonadism. Selective androgen receptor modulators (SARMs) have been shown to provide anabolic benefit in the absence of androgenic effects on prostate, hair and skin. Current clinical development for SARMs is focused on acute muscle wasting conditions with defi ned clinical endpoints of physical function and lean body mass. Similar regulatory clarity concerning clinical deficits in men with hypogonadism is required before the beneficial pharmacology and desirable pharmacokinetics of SARMs can be employed in the treatment of late onset male hypogonadism.

Hospital ventilation standards and energy conservation: a summary of the literature with conclusions and recommendations. Final report, FY 78

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

Hollowell, C.; Rosenfeld, A.

1978-09-01

This research examines the basis of current hospital HVAC standards and determines if they can be relaxed on criteria that do not compromise the health, safety, and comfort of patients and staff and has acceptance of the health care community. Chapter 2 summarizes existing standards in use throughout the United States governing hospital ventilation systems and the thermal environment. Chapter 3 explores the role of air in hospital-acquired infections. Chapter 4 explores the realm of indoor air quality within the hospital. Chapter 5 contains a discussion concerning the influence of thermal factors on patient comfort. Chapter 6 discusses the hospitalmore » odor problem with regards to ventilation rates. The final chapter includes conclusions and recommendations developed from the literature review and from a small working conference sponsored by the University of Minnesota School of Public Health.« less

Selective androgen receptor modulators for the treatment of late onset male hypogonadism

PubMed Central

Coss, Christopher C; Jones, Amanda; Hancock, Michael L; Steiner, Mitchell S; Dalton, James T

2014-01-01

Several testosterone preparations are used in the treatment of hypogonadism in the ageing male. These therapies differ in their convenience, flexibility, regional availability and expense but share their pharmacokinetic basis of approval and dearth of long-term safety data. The brevity and relatively reduced cost of pharmacokinetic based registration trials provides little commercial incentive to develop improved novel therapies for the treatment of late onset male hypogonadism. Selective androgen receptor modulators (SARMs) have been shown to provide anabolic benefit in the absence of androgenic effects on prostate, hair and skin. Current clinical development for SARMs is focused on acute muscle wasting conditions with defined clinical endpoints of physical function and lean body mass. Similar regulatory clarity concerning clinical deficits in men with hypogonadism is required before the beneficial pharmacology and desirable pharmacokinetics of SARMs can be employed in the treatment of late onset male hypogonadism. PMID:24407183

Assessment of Literature Related to Combustion Appliance Venting Systems

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

Rapp, V. H.; Less, B. D.; Singer, B. C.

In many residential building retrofit programs, air tightening to increase energy efficiency is often constrained by safety concerns with naturally vented combustion appliances. Tighter residential buildings more readily depressurize when exhaust equipment is operated, making combustion appliances more prone to backdraft or spill combustion exhaust into the living space. Several measures, such as installation guidelines, vent sizing codes, and combustion safety diagnostics, are in place with the intent to prevent backdrafting and combustion spillage, but the diagnostics conflict and the risk mitigation objective is inconsistent. This literature review summarizes the metrics and diagnostics used to assess combustion safety, documents theirmore » technical basis, and investigates their risk mitigations. It compiles information from the following: codes for combustion appliance venting and installation; standards and guidelines for combustion safety diagnostics; research evaluating combustion safety diagnostics; research investigating wind effects on building depressurization and venting; and software for simulating vent system performance.« less

An epistemology of patient safety research: a framework for study design and interpretation. Part 1. Conceptualising and developing interventions.

PubMed

Brown, C; Hofer, T; Johal, A; Thomson, R; Nicholl, J; Franklin, B D; Lilford, R J

2008-06-01

This is the first of a four-part series of articles examining the epistemology of patient safety research. Parts 2 and 3 will describe different study designs and methods of measuring outcomes in the evaluation of patient safety interventions, before Part 4 suggests that "one size does not fit all". Part 1 sets the scene by defining patient safety research as a challenging form of service delivery and organisational research that has to deal (although not exclusively) with some very rare events. It then considers two inter-related ideas: a causal chain that can be used to identify where in an organisation's structure and/or processes an intervention may impact; and the need for preimplementation evaluation of proposed interventions. Finally, the paper outlines the authors' pragmatist ontological stance to patient safety research, which sets the philosophical basis for the remaining three articles.

Safety policy and requirements for payloads using the Space Transportation System (STS)

NASA Technical Reports Server (NTRS)

1982-01-01

The Space Transportation Operations (STO) safety policy is to minimize STO involvement in the payload and its GSE (ground support equipment) design process while maintaining the assurance of a safe operation. Requirements for assuring payload mission success are the responsibility of the payload organization and are beyond the scope of this document. The intent is to provide the overall safety policies and requirements while allowing for negotiation between the payload organization and the STO operator in the method of implementation of payload safety. This revision provides for a relaxation in the monitoring requirements for inhibits, allows the payload organization to pursue design options and reflects, additionally, some new requirements. As of the issue date of this NHB, payloads which have completed the formal safety assessment reviews of their preliminary design on the basis of the May 1979 issue will be reassessed for compliance with the above changes.

SCAP: a new methodology for safety management based on feedback from credible accident-probabilistic fault tree analysis system.

PubMed

Khan, F I; Iqbal, A; Ramesh, N; Abbasi, S A

2001-10-12

As it is conventionally done, strategies for incorporating accident--prevention measures in any hazardous chemical process industry are developed on the basis of input from risk assessment. However, the two steps-- risk assessment and hazard reduction (or safety) measures--are not linked interactively in the existing methodologies. This prevents a quantitative assessment of the impacts of safety measures on risk control. We have made an attempt to develop a methodology in which risk assessment steps are interactively linked with implementation of safety measures. The resultant system tells us the extent of reduction of risk by each successive safety measure. It also tells based on sophisticated maximum credible accident analysis (MCAA) and probabilistic fault tree analysis (PFTA) whether a given unit can ever be made 'safe'. The application of the methodology has been illustrated with a case study.

Modeling patient safety incidents knowledge with the Categorial Structure method.

PubMed

Souvignet, Julien; Bousquet, Cédric; Lewalle, Pierre; Trombert-Paviot, Béatrice; Rodrigues, Jean Marie

2011-01-01

Following the WHO initiative named World Alliance for Patient Safety (PS) launched in 2004 a conceptual framework developed by PS national reporting experts has summarized the knowledge available. As a second step, the Department of Public Health of the University of Saint Etienne team elaborated a Categorial Structure (a semi formal structure not related to an upper level ontology) identifying the elements of the semantic structure underpinning the broad concepts contained in the framework for patient safety. This knowledge engineering method has been developed to enable modeling patient safety information as a prerequisite for subsequent full ontology development. The present article describes the semantic dissection of the concepts, the elicitation of the ontology requirements and the domain constraints of the conceptual framework. This ontology includes 134 concepts and 25 distinct relations and will serve as basis for an Information Model for Patient Safety.

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

Pind, C.

The SECURE heating reactor was designed by ASEA-ATOM as a realistic alternative for district heating in urban areas and for supplying heat to process industries. SECURE has unique safety characteristics, that are based on fundamental laws of physics. The safety does not depend on active components or operator intervention for shutdown and cooling of the reactor. The inherent safety characteristics of the plant cannot be affected by operator errors. Due to its very low environment impact, it can be sited close to heat consumers. The SECURE heating reactor has been shown to be competitive in comparison with other alternatives formore » heating Helsinki and Seoul. The SECURE heating reactor forms a basis for the power-producing SECURE-P reactor known as PIUS (Process Inherent Ultimate Safety), which is based on the same inherent safety principles. The thermohydraulic function and transient response have been demonstrated in a large electrically heated loop at the ASEA-ATOM laboratories.« less

Implications of human tissue studies for radiation protection.

PubMed

Kathren, R L

1988-08-01

Through radiochemical analysis of voluntary tissue donations, the U.S. Transuranium and Uranium Registries (USTR) are gaining improved understanding of the distribution and biokinetics of actinide elements in occupationally exposed persons. Evaluation of the first two whole-body contributions to the USTR revealed an inverse proportionality between actinide concentration and bone ash. The analysis of a whole body with significant 241Am deposition indicated a significantly shorter half-time in liver and a greater fraction resident in the skeleton than predicted by existing models. Other studies with tissues obtained at autopsy suggest that existing biokinetic models for 238Pu and 241Am and the currently accepted models and limits on intake, which use these models as their basis, may be inaccurately implying that revisions of existing safety standards may be necessary. Other studies of the registries are designed to evaluate in-vivo estimates of actinide deposition with those derived from postmortem tissue analysis, to compare results of animal experiments with human data, and to review histopathologic slides for tissue changes that might be attributable to exposure to transuranic elements. The implications of these recent findings and other work of the registries is discussed from the standpoint of this potential effect on biokinetic modeling, internal dose assessment, and safety standards and operational health physics practices.

Haematopoietic SCT in severe autoimmune diseases: updated guidelines of the European Group for Blood and Marrow Transplantation

PubMed Central

Snowden, J A; Saccardi, R; Allez, M; Ardizzone, S; Arnold, R; Cervera, R; Denton, C; Hawkey, C; Labopin, M; Mancardi, G; Martin, R; Moore, J J; Passweg, J; Peters, C; Rabusin, M; Rovira, M; van Laar, J M; Farge, D

2012-01-01

In 1997, the first consensus guidelines for haematopoietic SCT (HSCT) in autoimmune diseases (ADs) were published, while an international coordinated clinical programme was launched. These guidelines provided broad principles for the field over the following decade and were accompanied by comprehensive data collection in the European Group for Blood and Marrow Transplantation (EBMT) AD Registry. Subsequently, retrospective analyses and prospective phase I/II studies generated evidence to support the feasibility, safety and efficacy of HSCT in several types of severe, treatment-resistant ADs, which became the basis for larger-scale phase II and III studies. In parallel, there has also been an era of immense progress in biological therapy in ADs. The aim of this document is to provide revised and updated guidelines for both the current application and future development of HSCT in ADs in relation to the benefits, risks and health economic considerations of other modern treatments. Patient safety considerations are central to guidance on patient selection and HSCT procedural aspects within appropriately experienced and Joint Accreditation Committee of International Society for Cellular Therapy and EBMT accredited centres. A need for prospective interventional and non-interventional studies, where feasible, along with systematic data reporting, in accordance with EBMT policies and procedures, is emphasized. PMID:22002489

Implications of human tissue studies for radiation protection

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

Kathren, R.L.

1988-08-01

Through radiochemical analysis of voluntary tissue donations, the U.S. Transuranium and Uranium Registries (USTR) are gaining improved understanding of the distribution and biokinetics of actinide elements in occupationally exposed persons. Evaluation of the first two whole-body contributions to the USTR revealed an inverse proportionality between actinide concentration and bone ash. The analysis of a whole body with significant /sup 241/Am deposition indicated a significantly shorter half-time in liver and a greater fraction resident in the skeleton than predicted by existing models. Other studies with tissues obtained at autopsy suggest that existing biokinetic models for /sup 238/Pu and /sup 241/Am andmore » the currently accepted models and limits on intake, which use these models as their basis, may be inaccurately implying that revisions of existing safety standards may be necessary. Other studies of the registries are designed to evaluate in-vivo estimates of actinide deposition with those derived from postmortem tissue analysis, to compare results of animal experiments with human data, and to review histopathologic slides for tissue changes that might be attributable to exposure to transuranic elements. The implications of these recent findings and other work of the registries is discussed from the standpoint of this potential effect on biokinetic modeling, internal dose assessment, and safety standards and operational health physics practices.« less

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

Weber, Nicholas D., E-mail: nweber@fhcrc.org; Department of Laboratory Medicine, University of Washington, Seattle, WA 98195; Aubert, Martine, E-mail: maubert@fhcrc.org

Treatment for most persistent viral infections consists of palliative drug options rather than curative approaches. This is often because long-lasting viral DNA in infected cells is not affected by current antivirals, providing a source for viral persistence and reactivation. Targeting latent viral DNA itself could therefore provide a basis for novel curative strategies. DNA cleavage enzymes can be used to induce targeted mutagenesis of specific genes, including those of exogenous viruses. Although initial in vitro and even in vivo studies have been carried out using DNA cleavage enzymes targeting various viruses, many questions still remain concerning the feasibility of thesemore » strategies as they transition into preclinical research. Here, we review the most recent findings on DNA cleavage enzymes for human viral infections, consider the most relevant animal models for several human viral infections, and address issues regarding safety and enzyme delivery. Results from well-designed in vivo studies will ideally provide answers to the most urgent remaining questions, and allow continued progress toward clinical application. - Highlights: • Recent in vitro and in vivo results for DNA cleavage enzymes targeting persistent viral infections. • Analysis of the best animal models for testing enzymes for HBV, HSV, HIV and HPV. • Challenges facing in vivo delivery of therapeutic enzymes for persistent viral infections. • Safety issues to be addressed with proper animal studies.« less

Reflectance calibration of focal plane array hyperspectral imaging system for agricultural and food safety applications

NASA Astrophysics Data System (ADS)

Lawrence, Kurt C.; Park, Bosoon; Windham, William R.; Mao, Chengye; Poole, Gavin H.

2003-03-01

A method to calibrate a pushbroom hyperspectral imaging system for "near-field" applications in agricultural and food safety has been demonstrated. The method consists of a modified geometric control point correction applied to a focal plane array to remove smile and keystone distortion from the system. Once a FPA correction was applied, single wavelength and distance calibrations were used to describe all points on the FPA. Finally, a percent reflectance calibration, applied on a pixel-by-pixel basis, was used for accurate measurements for the hyperspectral imaging system. The method was demonstrated with a stationary prism-grating-prism, pushbroom hyperspectral imaging system. For the system described, wavelength and distance calibrations were used to reduce the wavelength errors to <0.5 nm and distance errors to <0.01mm (across the entrance slit width). The pixel-by-pixel percent reflectance calibration, which was performed at all wavelengths with dark current and 99% reflectance calibration-panel measurements, was verified with measurements on a certified gradient Spectralon panel with values ranging from about 14% reflectance to 99% reflectance with errors generally less than 5% at the mid-wavelength measurements. Results from the calibration method, indicate the hyperspectral imaging system has a usable range between 420 nm and 840 nm. Outside this range, errors increase significantly.

Randomized phase II study of cilengitide, an integrin-targeting arginine-glycine-aspartic acid peptide, in recurrent glioblastoma multiforme.

PubMed

Reardon, David A; Fink, Karen L; Mikkelsen, Tom; Cloughesy, Timothy F; O'Neill, Alison; Plotkin, Scott; Glantz, Michael; Ravin, Paula; Raizer, Jeffrey J; Rich, Keith M; Schiff, David; Shapiro, William R; Burdette-Radoux, Susan; Dropcho, Edward J; Wittemer, Sabine M; Nippgen, Johannes; Picard, Martin; Nabors, L Burt

2008-12-01

Cilengitide, an inhibitor of alphavbeta3 and alphavbeta5 integrin receptors, demonstrated minimal toxicity and durable activity across a wide range of doses administered to adults with recurrent glioblastoma multiforme (GBM) in a prior phase I study. The current multicenter phase II study was conducted to evaluate the activity and safety of cilengitide in GBM patients at first recurrence. Eligible patients were randomly assigned to receive either 500 or 2,000 mg of cilengitide twice weekly on a continuous basis. Patients were assessed every 4 weeks. The primary end point was 6-month progression-free survival (PFS) rate. Secondary end points included PFS, overall survival (OS), and radiographic response, as well as quality-of-life and pharmacokinetic assessments. Eighty-one patients were enrolled, including 41 on the 500-mg arm and 40 on the 2,000-mg arm. The safety profile of cilengitide was excellent, with no significant reproducible toxicities observed on either arm. Antitumor activity was observed in both treatment cohorts but trended more favorably among patients treated with 2,000 mg, including a 6-month PFS of 15% and a median OS of 9.9 months. Cilengitide monotherapy is well tolerated and exhibits modest antitumor activity among recurrent GBM patients. Additional studies integrating cilengitide into combinatorial regimens for GBM are warranted.