36 CFR 4.11 - Load, weight and size limits.

Code of Federal Regulations, 2011 CFR

2011-07-01

... limits established by State law apply to a vehicle operated on a park road. However, the superintendent may designate more restrictive limits when appropriate for traffic safety or protection of the road... 36 Parks, Forests, and Public Property 1 2011-07-01 2011-07-01 false Load, weight and size limits...

36 CFR 4.11 - Load, weight and size limits.

Code of Federal Regulations, 2013 CFR

2013-07-01

... limits established by State law apply to a vehicle operated on a park road. However, the superintendent may designate more restrictive limits when appropriate for traffic safety or protection of the road... 36 Parks, Forests, and Public Property 1 2013-07-01 2013-07-01 false Load, weight and size limits...

Workplace training for senior trainees: a systematic review and narrative synthesis of current approaches to promote patient safety.

PubMed

Walton, Merrilyn; Harrison, Reema; Burgess, Annette; Foster, Kirsty

2015-10-01

Preventable harm is one of the top six health problems in the developed world. Developing patient safety skills and knowledge among advanced trainee doctors is critical. Clinical supervision is the main form of training for advanced trainees. The use of supervision to develop patient safety competence has not been established. To establish the use of clinical supervision and other workplace training to develop non-technical patient safety competency in advanced trainee doctors. Keywords, synonyms and subject headings were used to search eight electronic databases in addition to hand-searching of relevant journals up to 1 March 2014. Titles and abstracts of retrieved publications were screened by two reviewers and checked by a third. Full-text articles were screened against the eligibility criteria. Data on design, methods and key findings were extracted. Clinical supervision documents were assessed against components common to established patient safety frameworks. Findings from the reviewed articles and document analysis were collated in a narrative synthesis. Clinical supervision is not identified as an avenue for embedding patient safety skills in the workplace and is consequently not evaluated as a method to teach trainees these skills. Workplace training in non-technical patient safety skills is limited, but one-off training courses are sometimes used. Clinical supervision is the primary avenue for learning in postgraduate medical education but the most overlooked in the context of patient safety learning. The widespread implementation of short courses is not matched by evidence of rigorous evaluation. Supporting supervisors to identify teaching moments during supervision and to give weight to non-technical skills and technical skills equally is critical. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The limits of thresholds: silica and the politics of science, 1935 to 1990.

PubMed Central

Markowitz, G; Rosner, D

1995-01-01

Since the 1930s threshold limit values have been presented as an objectively established measure of US industrial safety. However, there have been important questions raised regarding the adequacy of these thresholds for protecting workers from silicosis. This paper explores the historical debates over silica threshold limit values and the intense political negotiation that accompanied their establishment. In the 1930s and early 1940s, a coalition of business, public health, insurance, and political interests formed in response to a widely perceived "silicosis crisis." Part of the resulting program aimed at containing the crisis was the establishment of threshold limit values. Yet silicosis cases continued to be documented. By the 1960s these cases had become the basis for a number of revisions to the thresholds. In the 1970s, following a National Institute for Occupational Safety and Health recommendation to lower the threshold limit value for silica and to eliminate sand as an abrasive in blasting, industry fought attempts to make the existing values more stringent. This paper traces the process by which threshold limit values became part of a compromise between the health of workers and the economic interests of industry. Images p254-a p256-a p257-a p259-a PMID:7856788

Safety practices in Jordanian manufacturing enterprises within industrial estates.

PubMed

Khrais, Samir; Al-Araidah, Omar; Aweisi, Assaf Mohammad; Elias, Fadia; Al-Ayyoub, Enas

2013-01-01

This paper investigates occupational health and safety practices in manufacturing enterprises within Jordanian industrial estates. Response rates were 21.9%, 58.6% and 70.8% for small, medium and large sized enterprises, respectively. Survey results show that most companies comply with state regulations, provide necessary facilities to enhance safety and provide several measures to limit and control hazards. On the negative side, little attention is given to safety training that might be due to the lack of related regulations and follow-up, financial limitations or lack of awareness on the importance of safety training. In addition, results show that ergonomic hazards, noise and hazardous chemicals are largely present. Accident statistics show that medium enterprises have the highest accident cases per enterprise, and chemical industries reported highest total number of accidents per enterprise. The outcomes of this study establish a base for appropriate safety recommendations to enhance the awareness and commitment of companies to appropriate safety rules.

Overcoming Language and Literacy Barriers in Safety and Health Training of Agricultural Workers

PubMed Central

Arcury, Thomas A.; Estrada, Jorge M.; Quandt, Sara A.

2010-01-01

The workforce in all areas of United States agriculture and forestry is becoming increasingly diverse in language, culture, and education. Many agricultural workers are immigrants who have limited English language skills and limited educational attainment. Providing safety and health training to this large, diverse, dispersed, and often transient population of workers is challenging. This review, prepared for the 2010 Agricultural Safety and Health Council of America/National Institute for Occupational Safety and Health conference, “Be Safe, Be Profitable: Protecting Workers in Agriculture,” is divided into five sections. First, we describe the occupational and demographic characteristics of agricultural workers in the US to highlight their safety and health training needs. Second, we summarize current research on the social and cultural attributes of agricultural workers and agricultural employers that affect the provision of safety and health training. Worker and employer attributes include language, literacy, financial limitations, work beliefs, and health beliefs. Third, we review current initiatives addressing safety and health training for agricultural workers that consider worker language and literacy. These initiatives are limited to a few specific topics (e.g., pesticides, heat stress); they do not provide general programs of safety training that would help establish a culture of workplace safety. However, several innovative approaches to health and safety training are being implemented, including the use of community-based participatory approaches and lay health promoter programs. Fourth, the limited industry response for safety training with this linguistically diverse and educationally limited workforce is summarized. Finally, gaps in knowledge and practice are summarized and recommendations to develop educationally, culturally, and linguistically appropriate safety and health training are presented. PMID:20665309

Establishing powder-handling workflow practices and standard operating procedures: compounding pharmacy and safety.

PubMed

Prince, Bryan; Lundevall, Jeremy

2014-01-01

This is an ongoing discussion and analysis of powder-handling safety in the compounding pharmacy laboratory that started in the November/December 2013 issue of the International Journal of Pharmaceutical Compounding. In the previous technical article, we established that most chemical powders handled during compounding procedures have an established occupational exposure limits and that powders are micronized during manipulation. All micronized powders handled on an open bench create health hazards to the technicians and create a potential for cross-contamination to the lab environment. Proper identification of the chemical hazard and established standard operating procedures in direct correlation to Good Lab Practices when working inside a powder hood will positively improve the compounding pharmacy's work environment.

Ensuring the validity of calculated subcritical limits

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

Clark, H.K.

1977-01-01

The care taken at the Savannah River Laboratory and Plant to ensure the validity of calculated subcritical limits is described. Close attention is given to ANSI N16.1-1975, ''Validation of Calculational Methods for Nuclear Criticality Safety.'' The computer codes used for criticality safety computations, which are listed and are briefly described, have been placed in the SRL JOSHUA system to facilitate calculation and to reduce input errors. A driver module, KOKO, simplifies and standardizes input and links the codes together in various ways. For any criticality safety evaluation, correlations of the calculational methods are made with experiment to establish bias. Occasionallymore » subcritical experiments are performed expressly to provide benchmarks. Calculated subcritical limits contain an adequate but not excessive margin to allow for uncertainty in the bias. The final step in any criticality safety evaluation is the writing of a report describing the calculations and justifying the margin.« less

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2013 CFR

2013-07-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2012 CFR

2012-01-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2014 CFR

2014-01-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2011 CFR

2011-01-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

Bioactive nutrients - Time for tolerable upper intake levels to address safety.

PubMed

Yates, Allison A; Erdman, John W; Shao, Andrew; Dolan, Laurie C; Griffiths, James C

2017-03-01

There is increasing interest by consumers, researchers, and regulators into the roles that certain bioactive compounds, derived from plants and other natural sources, can play in health maintenance and promotion, and even prolonging a productive quality of life. Research has rapidly emerged suggesting that a wide range of compounds and mixtures in and from plants (such as fruits and vegetables, tea and cocoa) and animals (such as fish and probiotics) may exert substantial health benefits. There is interest in exploring the possibility of establishing recommended intakes or dietary guidance for certain bioactive substances to help educate consumers. A key aspect of establishing dietary guidance is the assessment of safety/toxicity of these substances. Toxicologists need to be involved in both the development of the safety framework and in the evaluation of the science to establish maximum intake/upper limits. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

International Harmonization of Food Safety Assessment of Pesticide Residues.

PubMed

Ambrus, Árpád

2016-01-13

This paper summarizes the development of principles and methods applied within the program of the FAO/WHO Codex Alimentarius during the past 50 years for the safety assessment of pesticide residues in food and feed and establishing maximum residue limits (MRLs) to promote free international trade and assure the safety of consumers. The role of major international organizations in this process, the FAO capacity building activities, and some problematic areas that require special attention are briefly described.

Asymptotic Safety Guaranteed in Supersymmetry

NASA Astrophysics Data System (ADS)

Bond, Andrew D.; Litim, Daniel F.

2017-11-01

We explain how asymptotic safety arises in four-dimensional supersymmetric gauge theories. We provide asymptotically safe supersymmetric gauge theories together with their superconformal fixed points, R charges, phase diagrams, and UV-IR connecting trajectories. Strict perturbative control is achieved in a Veneziano limit. Consistency with unitarity and the a theorem is established. We find that supersymmetry enhances the predictivity of asymptotically safe theories.

77 FR 21868 - Safety Zone; Marina Salvage, Bellingham Bay, Bellingham, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-12

.... This rule is not a significant regulatory action due to being limited in size and duration. Small... entities'' comprises small businesses, not-for-profit organizations that are independently owned and... substantial number of small entities because the zone established in this rule is limited in size and short in...

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

PubMed

Leu, Sou-Sen; Chang, Ching-Miao

2013-05-01

There are four primary accident types at steel building construction (SC) projects: falls (tumbles), object falls, object collapse, and electrocution. Several systematic safety risk assessment approaches, such as fault tree analysis (FTA) and failure mode and effect criticality analysis (FMECA), have been used to evaluate safety risks at SC projects. However, these traditional methods ineffectively address dependencies among safety factors at various levels that fail to provide early warnings to prevent occupational accidents. To overcome the limitations of traditional approaches, this study addresses the development of a safety risk-assessment model for SC projects by establishing the Bayesian networks (BN) based on fault tree (FT) transformation. The BN-based safety risk-assessment model was validated against the safety inspection records of six SC building projects and nine projects in which site accidents occurred. The ranks of posterior probabilities from the BN model were highly consistent with the accidents that occurred at each project site. The model accurately provides site safety-management abilities by calculating the probabilities of safety risks and further analyzing the causes of accidents based on their relationships in BNs. In practice, based on the analysis of accident risks and significant safety factors, proper preventive safety management strategies can be established to reduce the occurrence of accidents on SC sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

Electrical safety Q&A. A reference guide for the clinical engineer.

PubMed

2005-02-01

This guide, which ECRI developed to answer the electrical safety questions most frequently asked by member hospitals, features practical advice for addressing electrical safety concerns in the healthcare environment. Questions addressed include: STANDARDS AND APPROVALS: What electrical safety standards apply? How do NFPA 99 and IEC 60601-1 differ? What organizations approve medical devices? LEAKAGE CURRENT LIMITS AND TESTING: How are leakage current limits established? What limits apply to equipment used in the hospital? And how should the limits be applied in special cases, such as the use of PCs in the patient care area or equipment used in the clinical laboratory? ISOLATED POWER: What are its advantages and disadvantages, and is isolated power needed in the operating room? Other topics addressed include double insulation, ground-fault circuit interrupters (GFCIs), and requirements for medical devices used in the home. Supplementary articles discuss acceptable alternatives to UL listing, the use of Hospital Grade plugs, the limitations of leakage current testing of devices connected to isolated power systems, and the debate about whether to designate ORs as wet locations. Experienced clinical engineers should find this guide to be a handy reference, while those new to the field should find it to be a helpful educational resource.

Workplace hazards and prevention options from a nonrandom sample of retail trade businesses.

PubMed

Anderson, Vern Putz; Chun, Heekyoung

2014-01-01

Employer commitment is a key factor in an effective safety program, yet limited research has focused on the safety priorities of retail store managers. To address this, the U.S. National Institute for Occupational Safety and Health recruited 4 experienced ergonomists, who met and interviewed 9 retailers in different parts of the eastern USA. The reports from the 9 interviews were used to document the hazards facing retailers and the interventions they attempted. Those interviewed were managers/owners of establishments that ranged from a small bakery with 11 employees to a supermarket with 85 or more employees. The main hazards across all establishments included overexertion, contact-with-objects, and falls-to-the-same-level. We also compared the retailers' perceptions of safety hazards with injuries from actual hazards as supplied by the U.S. Bureau of Labor Statistics. This report provides insight into the retailers' perceptions of safety hazards as well as their commitment to the prevention of workplace injuries.

Workplace Hazards and Prevention Options From a Nonrandom Sample of Retail Trade Businesses

PubMed Central

Anderson, Vern Putz; Chun, Heekyoung

2015-01-01

Employer commitment is a key factor in an effective safety program, yet limited research has focused on the safety priorities of retail store managers. To address this, the U.S. National Institute for Occupational Safety and Health recruited 4 experienced ergonomists, who met and interviewed 9 retailers in different parts of the eastern USA. The reports from the 9 interviews were used to document the hazards facing retailers and the interventions they attempted. Those interviewed were managers/owners of establishments that ranged from a small bakery with 11 employees to a supermarket with 85 or more employees. The main hazards across all establishments included overexertion, contact-with-objects, and falls-to-the-same-level. We also compared the retailers’ perceptions of safety hazards with injuries from actual hazards as supplied by the U.S. Bureau of Labor Statistics. This report provides insight into the retailers’ perceptions of safety hazards as well as their commitment to the prevention of workplace injuries. PMID:24629880

Mine Improvement and New Emergency Response Act of 2006. Public Law 109-236, S2803

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

NONE

2006-06-15

This Act may be cited as the 'Mine Improvement and New Emergency Response Act of 2006' or the 'MINER Act'. It amends the Federal Mine Safety and Health Act of 1977 to improve the safety of mines and mining. The Act requires operators of underground coal mines to improve accident preparedness. The legislation requires mining companies to develop an emergency response plan specific to each mine they operate, and requires that every mine has at least two rescue teams located within one hour. S. 2803 also limits the legal liability of rescue team members and the companies that employ them.more » The act increases both civil and criminal penalties for violations of federal mining safety standards and gives the Mine Safety and Health Administration (MSHA) the ability to temporarily close a mine that fails to pay the penalties or fines. In addition, the act calls for several studies into ways to enhance mine safety, as well as the establishment of a new office within the National Institute for Occupational Safety and Health devoted to improving mine safety. Finally, the legislation establishes new scholarship and grant programs devoted to training individuals with respect to mine safety.« less

Hydrogen flammability limits and implications on fire safety of transportation vehicles

DOT National Transportation Integrated Search

2008-01-01

The recent establishment of the National University Transportation Center at MST under the "Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users," expands the research and education activities to include alternative tr...

High-level waste tank farm set point document

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

Anthony, J.A. III

1995-01-15

Setpoints for nuclear safety-related instrumentation are required for actions determined by the design authorization basis. Minimum requirements need to be established for assuring that setpoints are established and held within specified limits. This document establishes the controlling methodology for changing setpoints of all classifications. The instrumentation under consideration involve the transfer, storage, and volume reduction of radioactive liquid waste in the F- and H-Area High-Level Radioactive Waste Tank Farms. The setpoint document will encompass the PROCESS AREA listed in the Safety Analysis Report (SAR) (DPSTSA-200-10 Sup 18) which includes the diversion box HDB-8 facility. In addition to the PROCESS AREASmore » listed in the SAR, Building 299-H and the Effluent Transfer Facility (ETF) are also included in the scope.« less

Exposure-related health effects of silver and silver compounds: a review.

PubMed

Drake, Pamela L; Hazelwood, Kyle J

2005-10-01

A critical review of studies examining exposures to the various forms of silver was conducted to determine if some silver species are more toxic than others. The impetus behind conducting this review is that several occupational exposure limits and guidelines exist for silver, but the values for each depend on the form of silver as well as the individual agency making the recommendations. For instance, the American Conference of Governmental Industrial Hygienists has established separate threshold limit values for metallic silver (0.1 mg/m3) and soluble compounds of silver (0.01 mg/m3). On the other hand, the permissible exposure limit (PEL) recommended by the Occupational Safety and Health Administration and the Mine Safety and Health Administration and the recommended exposure limit set by the National Institute for Occupational Safety and Health is 0.01 mg/m3 for all forms of silver. The adverse effects of chronic exposure to silver are a permanent bluish-gray discoloration of the skin (argyria) or eyes (argyrosis). Most studies discuss cases of argyria and argyrosis that have resulted primarily from exposure to the soluble forms of silver. Besides argyria and argyrosis, exposure to soluble silver compounds may produce other toxic effects, including liver and kidney damage, irritation of the eyes, skin, respiratory, and intestinal tract, and changes in blood cells. Metallic silver appears to pose minimal risk to health. The current occupational exposure limits do not reflect the apparent difference in toxicities between soluble and metallic silver; thus, many researchers have recommended that separate PELs be established.

Potential health and environmental issues of mercury-contaminated amalgamators.

PubMed

Roberts, H W; Leonard, D; Osborne, J

2001-01-01

Dental amalgamators may become contaminated internally with metallic mercury. This contamination may result from mercury leakage from capsules during trituration or from the long-term accrual from microscopic exterior contaminants that result from the industrial assembly process. The potential health risk to dental personnel from this contamination is unknown. The authors assessed used amalgamators from the federal service inventory for the amounts of mercury vapor levels, as well as the visual presence of mercury contamination. They evaluated these amalgamators for potential mercury vapor health risk, using established National Institute for Occupational Safety and Health methods and American Conference of Governmental Industrial Hygienists standards. Ten of the 11 amalgamators assessed had measurable mercury vapor levels. Four amalgamators were found to have internal static mercury vapor levels above Occupational Safety and Health Administration ceiling limit thresholds. During a simulated worst-case clinical use protocol, the authors found that no amalgamators produced mercury vapor in the breathing space of dental personnel that exceeded established time-weighted federal mercury vapor limits. Amalgamators may be contaminated internally with metallic mercury. Although the authors detected mercury vapor from these units during aggressive, simulated clinical use, dilution factors combined with room air exchange were found to keep health risks below established federal safety thresholds. Dental personnel should be aware that amalgamators may be contaminated with mercury and produce minute amounts of mercury vapor. These contaminated amalgamators may require disposal as environmentally hazardous waste.

Effect of 90-day continuous exposure to methylisobutylketone on dogs, monkeys and rats

NASA Technical Reports Server (NTRS)

Macewen, J. D.; Vernot, E. H.; Haun, C. C.

1971-01-01

Continuous exposure of rats, dogs and monkeys to 410 mg/cu M methylisobutylketone vapor (MIBK) was conducted to evaluate the provisional spacecraft exposure limit of 20 ppm established by the Space Science Board in 1968. The exposure, conducted in a simulated space cabin environment, did not produce any measurable changes in dogs or monkeys. Rats developed hyaline droplet nephrosis within 2 weeks of exposure which was reversible upon removal from the MIBK even after 90 days. The data obtained indicated that the 60-minute emergency exposure limit of 100 ppm and the 90- and 1000-day provisional limits as established by the Space Science Board contain a wide margin of safety.

[SUBSTANTIATION OF DOSE LIMITS FOR A NEW NORMATIVE DOCUMENT ON RADIATION SAFETY OF LONG-DURATION SPACE MISSIONS AT ORBIT ALTITUDES OF UP TO 500 KM].

PubMed

Ushakov, I B; Grigoriev, Yu G; Shafirkin, A V; Shurshakov, V A

2016-01-01

Review of the data of experimental radiobiology and epidemiological follow-up of large groups of people subjected to radiation exposures on Earth has been undertaken to substantiate dose limits for critical organs of cosmonauts in order to ensure good performance and vitality while on long-duration orbital missions. The career dose limits for cosmonauts and astronauts established earlier in the USSR and USA amounted to nothing more but banning the risk of cancer death increase to 3%. To apply more rigorous criteria of delayed radiation risks, the Russian limits for cosmonauts were revised to substantiate a 4-fold reduction of the average tissue equivalent dose maximum to 1 Sv. The total of cancer and non-cancer radiation risks over lifetime and probable reduction of mean life expectancy (MLE) were calculated using the model of radiation-induced mortality for mammals and taken as the main damage to health. The established dose limit is equal to the career dose for nuclear industry personnel set forth by Russian standard document NRB 99/2009. For better agreement of admissible threshold doses to critical human organs (bone marrow, lens and skin) in the revised radiation limits for long-duration space missions and radiation safety limits on Earth, reduction of dose limits for the critical organs were substantiated additionally; these limits comply with those for planned over-exposure on Earth in document NRB 99/2009.

The Informatics Opportunities at the Intersection of Patient Safety and Clinical Informatics

PubMed Central

Kilbridge, Peter M.; Classen, David C.

2008-01-01

Health care providers have a basic responsibility to protect patients from accidental harm. At the institutional level, creating safe health care organizations necessitates a systematic approach. Effective use of informatics to enhance safety requires the establishment and use of standards for concept definitions and for data exchange, development of acceptable models for knowledge representation, incentives for adoption of electronic health records, support for adverse event detection and reporting, and greater investment in research at the intersection of informatics and patient safety. Leading organizations have demonstrated that health care informatics approaches can improve safety. Nevertheless, significant obstacles today limit optimal application of health informatics to safety within most provider environments. The authors offer a series of recommendations for addressing these challenges. PMID:18436896

Integrated Response Time Evaluation Methodology for the Nuclear Safety Instrumentation System

NASA Astrophysics Data System (ADS)

Lee, Chang Jae; Yun, Jae Hee

2017-06-01

Safety analysis for a nuclear power plant establishes not only an analytical limit (AL) in terms of a measured or calculated variable but also an analytical response time (ART) required to complete protective action after the AL is reached. If the two constraints are met, the safety limit selected to maintain the integrity of physical barriers used for preventing uncontrolled radioactivity release will not be exceeded during anticipated operational occurrences and postulated accidents. Setpoint determination methodologies have actively been developed to ensure that the protective action is initiated before the process conditions reach the AL. However, regarding the ART for a nuclear safety instrumentation system, an integrated evaluation methodology considering the whole design process has not been systematically studied. In order to assure the safety of nuclear power plants, this paper proposes a systematic and integrated response time evaluation methodology that covers safety analyses, system designs, response time analyses, and response time tests. This methodology is applied to safety instrumentation systems for the advanced power reactor 1400 and the optimized power reactor 1000 nuclear power plants in South Korea. The quantitative evaluation results are provided herein. The evaluation results using the proposed methodology demonstrate that the nuclear safety instrumentation systems fully satisfy corresponding requirements of the ART.

BSE situation and establishment of Food Safety Commission in Japan

PubMed Central

Kim, Chi-Kyeong

2006-01-01

Eight major policies were implemented by Japanese Government since Oct. 2001, to deal with bovine spongiform encephalopathy (BSE). These are; 1) Surveillance in farm by veterinarian, 2) Prion test at healthy 1.3mi cows/yr, by veterinarian, 3) Elimination of specified risk material (SRM), 4) Ban of MBM for production, sale use, 5) Prion test for fallen stocks, 6) Transparent information and traceability, 7) New Measures such as Food Safety Basic Law, and 8) Establish of Food Safety Commission in the Cabinet Office. At this moment, the extent of SRM risk has only been indicated by several reports employing tests with a limited sensitivity. There is still a possibility that the items in the SRM list will increase in the future, and this indiscriminately applies to Japanese cattle as well. Although current practices of SRM elimination partially guarantee total food safety, additional latent problems and imminent issues remain as potential headaches to be addressed. If the index of SRM elimination cannot guarantee reliable food safety, we have but to resort to total elimination of tissues from high risk-bearing and BSE-infected animals. However, current BSE tests have their limitations and can not yet completely detect high-risk and/or infected animals. Under such circumstances, tissues/wastes and remains of diseased, affected fallen stocks and cohort animals have to be eliminated to prevent BSE invading the human food chain systems. The failure to detect any cohort should never be allowed to occur, and with regular and persistent updating of available stringent records, we are at least adopting the correct and useful approach as a reawakening strategy to securing food safety. In this perspective, traceability based on a National Identification System is required. PMID:16434842

49 CFR 214.325 - Train coordination.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Train coordination. 214.325 Section 214.325..., DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection § 214.325 Train coordination. Working limits established by a roadway worker through the use of train coordination shall comply with the...

49 CFR 214.325 - Train coordination.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Train coordination. 214.325 Section 214.325..., DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection § 214.325 Train coordination. Working limits established by a roadway worker through the use of train coordination shall comply with the...

29 CFR 1926.706 - Requirements for masonry construction.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 8 2014-07-01 2014-07-01 false Requirements for masonry construction. 1926.706 Section..., DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Concrete and Masonry Construction § 1926.706 Requirements for masonry construction. (a) A limited access zone shall be established...

29 CFR 1926.706 - Requirements for masonry construction.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 8 2011-07-01 2011-07-01 false Requirements for masonry construction. 1926.706 Section..., DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Concrete and Masonry Construction § 1926.706 Requirements for masonry construction. (a) A limited access zone shall be established...

29 CFR 1926.706 - Requirements for masonry construction.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 8 2012-07-01 2012-07-01 false Requirements for masonry construction. 1926.706 Section..., DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Concrete and Masonry Construction § 1926.706 Requirements for masonry construction. (a) A limited access zone shall be established...

29 CFR 1926.706 - Requirements for masonry construction.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 8 2013-07-01 2013-07-01 false Requirements for masonry construction. 1926.706 Section..., DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Concrete and Masonry Construction § 1926.706 Requirements for masonry construction. (a) A limited access zone shall be established...

49 CFR 214.323 - Foul time.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Foul time. 214.323 Section 214.323 Transportation... TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection § 214.323 Foul time. Working limits established on controlled track through the use of foul time procedures shall comply with the following...

49 CFR 214.323 - Foul time.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 4 2013-10-01 2013-10-01 false Foul time. 214.323 Section 214.323 Transportation... TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection § 214.323 Foul time. Working limits established on controlled track through the use of foul time procedures shall comply with the following...

49 CFR 214.323 - Foul time.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 4 2014-10-01 2014-10-01 false Foul time. 214.323 Section 214.323 Transportation... TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection § 214.323 Foul time. Working limits established on controlled track through the use of foul time procedures shall comply with the following...

Environmental exposure scenarios: development, challenges and possible solutions.

PubMed

Ahrens, Andreas; Traas, Theo P

2007-12-01

Under the new REACH system, companies importing, producing and marketing chemical substances will be obliged to register the single substances and to carry out a safety assessment for all identified uses during the life cycle of the substance. This duty will apply to about 10,000 existing substances in the EU market exceeding an annual production or import volume of 10 t per company. If the substance is already known to be dangerous or turns out to be dangerous(1) during the hazard assessment, the registrant is obliged to carry out an exposure assessment and a risk characterisation for all identified uses. The goal of the safety assessment is to define the conditions of use that allow for adequate control of risk with regard to health and safety at the work place, consumer safety and protection of the environment. Once the registrant has established and documented these conditions in the Chemicals Safety Report (CSR), that information is to be communicated down the supply chain by means of the Extended Safety Data Sheet (eSDS). The ultimate aim of the new legislation is to establish duties and mechanisms that systematically prevent or limit exposure to dangerous industrial chemicals. The current paper explains this concept with regard to environmental exposure and highlights the challenges and possible solutions.

18 CFR 1304.410 - Navigation restrictions.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., structures, land based or water use, shall not be located within the limits of safety harbors and landings established for commercial navigation. (b) Structures shall not be located in such a way as to block the... OF CONSTRUCTION IN THE TENNESSEE RIVER SYSTEM AND REGULATION OF STRUCTURES AND OTHER ALTERATIONS...

18 CFR 1304.410 - Navigation restrictions.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., structures, land based or water use, shall not be located within the limits of safety harbors and landings established for commercial navigation. (b) Structures shall not be located in such a way as to block the... OF CONSTRUCTION IN THE TENNESSEE RIVER SYSTEM AND REGULATION OF STRUCTURES AND OTHER ALTERATIONS...

36 CFR 1001.5 - Closures and public use limits.

Code of Federal Regulations, 2011 CFR

2011-07-01

... the Presidio Trust, adversely affect the natural, aesthetic, scenic or cultural values of the area... public health and safety, protection of environmental or scenic values, protection of natural or cultural...) Establish, for all or a portion of the area administered by the Presidio Trust, a reasonable schedule of...

76 FR 22620 - Triflusulfuron-Methyl; Pesticide Tolerances

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-22

... under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective April 22... Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit... determination on aggregate exposure for triflusulfuron-methyl, including exposure resulting from the tolerances...

Randomized trial to compare the safety and immunogenicity of CSL Limited's 2009 trivalent inactivated influenza vaccine to an established vaccine in United States children.

PubMed

Brady, Rebecca C; Hu, Wilson; Houchin, Vonda G; Eder, Frank S; Jackson, Kenneth C; Hartel, Gunter F; Sawlwin, Daphne C; Albano, Frank R; Greenberg, Michael

2014-12-12

A trivalent inactivated influenza vaccine (CSL's TIV, CSL Limited) was licensed under USA accelerated approval regulations for use in persons≥18 years. We performed a randomized, observer-blind study to assess the safety and immunogenicity of CSL's TIV versus an established US-licensed vaccine in a population≥6 months to <18 years of age. Subjects were stratified as follows: Cohort A (≥6 months to <3 years); Cohort B (≥3 years to <9 years); and Cohort C (≥9 years to <18 years). The subject's age and influenza vaccination history determined the dosing regimen (one or two vaccinations). Subjects received CSL's TIV (n=739) or the established vaccine (n=735) in the autumn of 2009. Serum hemagglutination-inhibition titers were determined pre-vaccination and 30 days after the last vaccination. No febrile seizures or other vaccine-related SAEs were reported. After the first vaccination for Cohorts A and B, respectively, the relative risks of fever were 2.73 and 2.32 times higher for CSL's TIV compared to the established vaccine. Irritability and loss of appetite (for Cohort A) and malaise (for Cohort B) were also significantly higher for CSL's TIV compared to the established vaccine. Post-vaccination geometric mean titers (GMTs) for CSL's TIV versus the established vaccine were 385.49 vs. 382.45 for H1N1; 669.13 vs. 705.61 for H3N2; and 100.65 vs. 93.72 for B. CSL's TIV demonstrated immunological non-inferiority to the established vaccine in all cohorts. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

Occupational exposure limits for carcinogens--variant approaches by different countries

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

Cook, W.A.

1989-09-01

The differences in treatment of occupational exposure limits for carcinogens by 24 countries is described along with a discussion of the American Conference of Governmental Industrial Hygienists (ACGIH) threshold limit values (TLV) treatment, the similar treatment of the new Occupational Safety and Health Administration (OSHA) standard, and the treatment by provinces of Canada. The unique listing by the Federal Republic of Germany of so-called technical guiding concentrations of a group of carcinogens is discussed with the note that Austria used this same system. Publications on justification for establishing occupational exposure limits for certain carcinogens are discussed also.

Working Safely at Some Times and Unsafely at Others: A Typology and Within-Person Process Model of Safety-Related Work Behaviors.

PubMed

Beus, Jeremy M; Taylor, William D

2017-06-22

Why do individuals choose to work safely in some instances and unsafely in others? Though this inherently within-person question is straightforward, the preponderance of between-person theory and research in the workplace safety literature is not equipped to answer it. Additionally, the limited way in which safety-related behaviors tend to be conceptualized further restricts understanding of why individuals vary in their safety-related actions. We use a goal-focused approach to conceptually address this question of behavioral variability and contribute to workplace safety research in 2 key ways. First, we establish an updated typology of safety-related behaviors that differentiates behaviors based on goal choice (i.e., safe vs. unsafe behaviors), goal-directedness (i.e., intentional vs. unintentional behaviors), and the means of goal pursuit (i.e., commission vs. omission and promotion vs. prevention-focused behaviors). Second, using an expectancy-value theoretical framework to explain variance in goal choice, we establish within-person propositions stating that safety-related goal choice and subsequent behaviors are a function of the target of safety-related behaviors, the instrumentality and resource requirement of behaviors, and the perceived severity, likelihood, and immediacy of the threats associated with behaviors. Taken together, we define what safety-related behaviors are, explain how they differ, and offer propositions concerning when and why they may vary within-persons. We explore potential between-person moderators of our theoretical propositions and discuss the practical implications of our typology and process model of safety-related behavior. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Medical and non-medical protection standards for ultrasound and infrasound.

PubMed

Duck, Francis A

2007-01-01

Protection from inappropriate or hazardous exposure to ultrasound is controlled through international standards and national regulations. IEC standard 60601 part 1 establishes requirements for the mechanical, electrical, chemical and thermal safety for all electro-medical equipment. The associated part 2 standard for diagnostic medical ultrasonic equipment sets no upper limits on ultrasonic exposure. Instead, safety indices are defined that are intended to advise users on the degree of thermal and mechanical hazard. At present the display of these safety indices satisfies regulatory requirements in both the USA and Europe. Nevertheless there are reservations about the effectiveness of this approach to protection management. In the USA, there are national regulatory limits on diagnostic exposure, based on acoustic output from clinical equipment in use over 20 years ago. The IEC 60601 part 2 standard for therapeutic equipment sets 3 W cm(-2) as the limit on acoustic intensity. Transducer surface temperature is controlled for both diagnostic and therapy devices. For airborne ultrasound, interim guidelines on limits of human exposure published by the IRPA are now 2 decades old. A limit on sound pressure level of 100 dB for the general population is recommended. The absence of protection standards for infrasound relates to difficulties in measurement at these low frequencies.

A bio-inspired memory model for structural health monitoring

NASA Astrophysics Data System (ADS)

Zheng, Wei; Zhu, Yong

2009-04-01

Long-term structural health monitoring (SHM) systems need intelligent management of the monitoring data. By analogy with the way the human brain processes memories, we present a bio-inspired memory model (BIMM) that does not require prior knowledge of the structure parameters. The model contains three time-domain areas: a sensory memory area, a short-term memory area and a long-term memory area. First, the initial parameters of the structural state are specified to establish safety criteria. Then the large amount of monitoring data that falls within the safety limits is filtered while the data outside the safety limits are captured instantly in the sensory memory area. Second, disturbance signals are distinguished from danger signals in the short-term memory area. Finally, the stable data of the structural balance state are preserved in the long-term memory area. A strategy for priority scheduling via fuzzy c-means for the proposed model is then introduced. An experiment on bridge tower deformation demonstrates that the proposed model can be applied for real-time acquisition, limited-space storage and intelligent mining of the monitoring data in a long-term SHM system.

Military Dependents: Services Provide Limited Confidentiality in Family Abuse Cases

DTIC Science & Technology

2000-04-01

regarding family abuse. To respond to this mandate, we determined (1) the extent of reported spousal and child abuse within the military, (2) the degree...violence and as emotional and financial maltreatment, including any actions that harm or limit the spouse’s freedom of choice. Child abuse includes...military services has established a Family Advocacy Program to provide family counseling and to help ensure the safety of alleged spousal and child abuse victims.

75 FR 18907 - Notice of Opportunity for Public Comment on the Proposed Model Safety Evaluation for Plant...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-13

... Specifications (STS) to define a new time limit for restoring inoperable RCS leakage detection instrumentation to... contents of the facility design bases related to the operability of the RCS leakage detection... leakage detection instrumentation to operable status and establish alternate methods of monitoring RCS...

NDE: A key to engine rotor life prediction

NASA Technical Reports Server (NTRS)

Doherty, J. E.

1977-01-01

A key ingredient in the establishment of safe life times for critical components is the means of reliably detecting flaws which may potentially exist. Currently used nondestructive evaluation procedures are successful in detecting life limiting defects; however, the development of automated and computer aided NDE technology permits even greater assurance of flight safety.

Safety and efficacy of targeted hyperthermia treatment utilizing gold nanorod therapy in spontaneous canine neoplasia.

PubMed

Schuh, Elizabeth M; Portela, Roberta; Gardner, Heather L; Schoen, Christian; London, Cheryl A

2017-10-02

Hyperthermia is an established anti-cancer treatment but is limited by tolerance of adjacent normal tissues. Parenteral administration of gold nanorods (NRs) as a photosensitizer amplifies the effects of hyperthermia treatment while sparing normal tissues. This therapy is well tolerated and has demonstrated anti-tumor effects in mouse models. The purpose of this phase 1 study was to establish the safety and observe the anti-tumor impact of gold NR enhanced (plasmonic) photothermal therapy (PPTT) in client owned canine patients diagnosed with spontaneous neoplasia. Seven dogs underwent gold NR administration and subsequent NIR PPTT. Side effects were mild and limited to local reactions to NIR laser. All of the dogs enrolled in the study experienced stable disease, partial remission or complete remission. The overall response rate (ORR) was 28.6% with partial or complete remission of tumors at study end. PPTT utilizing gold nanorod therapy can be safely administered to canine patients. Further studies are needed to determine the true efficacy in a larger population of canine cancer patients and to and identify those patients most likely to benefit from this therapy.

Relationship between preventable hospital deaths and other measures of safety: an exploratory study.

PubMed

Hogan, Helen; Healey, Frances; Neale, Graham; Thomson, Richard; Vincent, Charles; Black, Nick

2014-06-01

To explore associations between the proportion of hospital deaths that are preventable and other measures of safety. Retrospective case record review to provide estimates of preventable death proportions. Simple monotonic correlations using Spearman's rank correlation coefficient to establish the relationship with eight other measures of patient safety. Ten English acute hospital trusts. One thousand patients who died during 2009. The proportion of preventable deaths varied between hospitals (3-8%) but was not statistically significant (P = 0.94). Only one of the eight measures of safety (Methicillin-resistant Staphylococcus aureus bacteraemia rate) was clinically and statistically significantly associated with preventable death proportion (r = 0.73; P < 0.02). There were no significant associations with the other measures including hospital standardized mortality ratios (r = -0.01). There was a suggestion that preventable deaths may be more strongly associated with some other measures of outcome than with process or with structure measures. The exploratory nature of this study inevitably limited its power to provide definitive results. The observed relationships between safety measures suggest that a larger more powerful study is needed to establish the inter-relationship of different measures of safety (structure, process and outcome), in particular the widely used standardized mortality ratios. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Enzymes in cleaning products: an overview of toxicological properties and risk assessment/management.

PubMed

Basketter, David; Berg, Ninna; Broekhuizen, Cees; Fieldsend, Mark; Kirkwood, Sheila; Kluin, Cornelia; Mathieu, Sophie; Rodriguez, Carlos

2012-10-01

Enzymes used in cleaning products have an excellent safety profile, with little ability to cause adverse responses in humans. For acute toxicity, genotoxicity, sub-acute and repeated dose toxicity, enzymes are unremarkable. Reproductive toxicity and carcinogenicity are also not endpoints of concern. Exceptions are the ability of some proteases to produce irritating effects at high concentrations and more importantly, the intrinsic potential of these bacterial/fungal proteins to act as respiratory sensitizers. It is a reasonable assumption that the majority of enzyme proteins possess this hazard. However, methods for characterising the respiratory sensitisation hazard of enzymes are lacking and the information required for risk assessment and risk management, although sufficient, remains limited. Previously, most data was generated in animal models and in in vitro immunoassays that assess immunological cross-reactivity. Nevertheless, by the establishment of strict limits on airborne exposure (based on a defined minimal effect limit of 60ng active enzyme protein/m(3)) and air and health monitoring, occupational safety can be assured. Similarly, by ensuring that airborne exposure is kept similarly low, coupled with knowledge of the fate of these enzymes on skin and fabrics, it has proven possible to establish a long history of safe consumer use of enzyme containing products. Copyright © 2012 Elsevier Inc. All rights reserved.

Defining a reference set to support methodological research in drug safety.

PubMed

Ryan, Patrick B; Schuemie, Martijn J; Welebob, Emily; Duke, Jon; Valentine, Sarah; Hartzema, Abraham G

2013-10-01

Methodological research to evaluate the performance of methods requires a benchmark to serve as a referent comparison. In drug safety, the performance of analyses of spontaneous adverse event reporting databases and observational healthcare data, such as administrative claims and electronic health records, has been limited by the lack of such standards. To establish a reference set of test cases that contain both positive and negative controls, which can serve the basis for methodological research in evaluating methods performance in identifying drug safety issues. Systematic literature review and natural language processing of structured product labeling was performed to identify evidence to support the classification of drugs as either positive controls or negative controls for four outcomes: acute liver injury, acute kidney injury, acute myocardial infarction, and upper gastrointestinal bleeding. Three-hundred and ninety-nine test cases comprised of 165 positive controls and 234 negative controls were identified across the four outcomes. The majority of positive controls for acute kidney injury and upper gastrointestinal bleeding were supported by randomized clinical trial evidence, while the majority of positive controls for acute liver injury and acute myocardial infarction were only supported based on published case reports. Literature estimates for the positive controls shows substantial variability that limits the ability to establish a reference set with known effect sizes. A reference set of test cases can be established to facilitate methodological research in drug safety. Creating a sufficient sample of drug-outcome pairs with binary classification of having no effect (negative controls) or having an increased effect (positive controls) is possible and can enable estimation of predictive accuracy through discrimination. Since the magnitude of the positive effects cannot be reliably obtained and the quality of evidence may vary across outcomes, assumptions are required to use the test cases in real data for purposes of measuring bias, mean squared error, or coverage probability.

The human, primate and rabbit ultraviolet action spectra

NASA Technical Reports Server (NTRS)

Pitts, D. G.; Gibbons, W. D.

1972-01-01

A 5000 watt xenon-mercury high pressure lamp was used to produce a continuous ultraviolet spectrum. Human and animal exposures were made to establish the photokeratitis threshold and abiotic action spectrum. The lower limit of the abiotic action spectrum was 220 nm while the upper limit was 310 nm. The radiant exposure threshold at 270 nm was 0.005 watts/sq cm for the rabbit, 0.004 watts/sq cm for the primate, and 0.004 watts/ sq cm for the human. The rabbit curve was bi-peaked with minimums at 220 nm, 240 nm and 270 nm. The primate curve was tri-peaked with minimums at 220 nm, 240 nm and 270 nm. The human data showed a rather shallow curve with a minimum at 270 nm. Formulas and calculations are given to predict minimum exposure times for ocular damage to man in outer space, to establish valid safety criteria, and to establish protective design criteria.

Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD.

PubMed

Kardos, Peter; Worsley, Sally; Singh, Dave; Román-Rodríguez, Miguel; Newby, David E; Müllerová, Hana

2016-01-01

Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this. Evaluation of CV safety for COPD treatments is important because many patients with COPD have underlying CV comorbidities. However, severe CV and other comorbidities are often exclusion criteria for RCTs, contributing to a lack in external validity and generalizability. Real-world observational studies are another important tool to evaluate the effectiveness and safety of COPD therapies in a broader population of patients and can improve upon the external validity limitations of RCTs. We examine what is already known regarding the CV and cerebrovascular safety of LAMA/LABA combination therapy from RCTs and real-world observational studies, and explore the advantages and limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol) and LAMA monotherapy (umeclidinium) versus tiotropium, with a focus on the relative merits of the study design.

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

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

Poet, Torka S.; Timchalk, Chuck

A large number of volatile chemicals have been identified in the headspaces of tanks used to store mixed chemical and radioactive waste at the U.S. Department of Energy (DOE) Hanford Site, and there is concern that vapor releases from the tanks may be hazardous to workers. Contractually established occupational exposure limits (OELs) established by the Occupational Safety and Health Administration (OSHA) and American Conference of Governmental Industrial Hygienists (ACGIH) do not exist for all chemicals of interest. To address the need for worker exposure guidelines for those chemicals that lack OSHA or ACGIH OELs, a procedure for assigning Acceptable Occupationalmore » Exposure Limits (AOELs) for Hanford Site tank farm workers has been developed and applied to a selected group of 57 headspace chemicals.« less

21 CFR 520.804 - Enalapril tablets.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is...) Sponsor. See 050604 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. 0.5 to 1.0... dogs. (iii) Limitations. Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical...

21 CFR 520.804 - Enalapril tablets.

Code of Federal Regulations, 2013 CFR

2013-04-01

.... The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is...) Sponsor. See 050604 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. 0.5 to 1.0... dogs. (iii) Limitations. Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical...

75 FR 20010 - Pacific Gas & Electric Company; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-16

...] Pacific Gas & Electric Company; Establishment of Atomic Safety and Licensing Board Pursuant to delegation....321, notice is hereby given that an Atomic Safety and Licensing Board (Board) is being established to... of the following administrative judges: Alex S. Karlin, Chair, Atomic Safety and Licensing Board...

77 FR 26792 - Union Electric Company; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... Company; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission dated... Atomic Safety and Licensing Board (Board) is being established to preside over the following proceeding... Board is comprised of the following administrative judges: G. Paul Bollwerk, III, Chair, Atomic Safety...

78 FR 78402 - Exelon Generation Company, LLC; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-26

...] Exelon Generation Company, LLC; Establishment of Atomic Safety and Licensing Board Pursuant to delegation... Atomic Safety and Licensing Board (Board) is being established to preside over the following proceeding... Board is comprised of the following administrative judges: Paul S. Ryerson, Chairman, Atomic Safety and...

77 FR 30559 - Entergy Nuclear Operations, Inc.; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-23

... Operations, Inc.; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission... Atomic Safety and Licensing Board (Board) is being established to preside over the following proceeding... is comprised of the following administrative judges: Ann Marshall Young, Chair, Atomic Safety and...

77 FR 20853 - Entergy Nuclear Operations, Inc.; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

... Operations, Inc.; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission... Atomic Safety and Licensing Board (Board) is being established to preside over the following proceeding... administrative judges: Ann Marshall Young, Chair, Atomic Safety and Licensing Board Panel, U.S. Nuclear...

76 FR 41312 - Honeywell International Inc.; Establishment of Atomic Safety And Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-13

...] Honeywell International Inc.; Establishment of Atomic Safety And Licensing Board Pursuant to delegation by..., notice is hereby given that an Atomic Safety and Licensing Board (Board) is being established to preside... comprised of the following administrative judges: Paul S. Ryerson, Chair, Atomic Safety and Licensing Board...

77 FR 30029 - Entergy Nuclear Operations, Inc.; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... Operations, Inc.; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission... Atomic Safety and Licensing Board (Board) is being established to preside over the following proceeding... of the following administrative judges: Ann Marshall Young, Chair, Atomic Safety and Licensing Board...

Integrated optimisation technique based on computer-aided capacity and safety evaluation for managing downstream lane-drop merging area of signalised junctions

NASA Astrophysics Data System (ADS)

Chen, CHAI; Yiik Diew, WONG

2017-02-01

This study provides an integrated strategy, encompassing microscopic simulation, safety assessment, and multi-attribute decision-making, to optimize traffic performance at downstream merging area of signalized intersections. A Fuzzy Cellular Automata (FCA) model is developed to replicate microscopic movement and merging behavior. Based on simulation experiment, the proposed FCA approach is able to provide capacity and safety evaluation of different traffic scenarios. The results are then evaluated through data envelopment analysis (DEA) and analytic hierarchy process (AHP). Optimized geometric layout and control strategies are then suggested for various traffic conditions. An optimal lane-drop distance that is dependent on traffic volume and speed limit can thus be established at the downstream merging area.

Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety.

PubMed

Shimazawa, Rumiko; Ikeda, Masayuki

2016-03-01

Concurrent development and co-approval of a companion diagnostic (CDx) with a corresponding drug is ideal, but often unfeasible. Because of limited exposure to a drug in clinical trials, crucial information on safety is sometimes revealed only after approval. Therefore, a CDx for monitoring/safety is often developed after approval of a corresponding drug. However, regulatory guidance is insufficient if contemporaneous development is not possible, thereby leaving plenty of opportunities for improvement with respect to pharmacovigilance and retrospective validation of the CDx. Furthermore, global harmonization of guidance on how to incorporate new scientific information from retrospective analyses of biomarkers should lead to the establishment of more evidence for the development of CDx for approved drugs.

Assessment of softball bat safety performance using mid-compression polyurethane softballs.

PubMed

McDowell, Mark

2004-07-01

There is currently much debate about the safety of the sport of softball. Batted-ball speed and average pitcher reaction time are factors often used to determine safe performance. Batted-ball speed is shown to be the most important factor to consider when determining safe play. Average pitcher reaction time is explained and directly correlated to batted-ball speed. Eleven aluminum multi-wall, three aluminum single-wall and two composite softball bats were tested with mid-compression polyurethane softballs averaging 1721+/-62 N/6.4 mm to represent the relative bat-ball performance for the sport of slowpitch softball. Nine men and six women were chosen for this study out of a test group of over three hundred slowpitch softball players. On average, aluminum bat performance results were within the recommended safety limits established by the national softball associations. However, when composite bats were used, their performance results exceeded the recommended safety limits which can pose a significant safety risk. Using aluminum softball bats, batted-ball speeds ranged from 80 to 145km x h(-1) Using composite softball bats, batted-ball speeds ranged from 146 to 161 km x h(-1). The scientific relevance of this study is to provide performance information that can lead to injury prevention in the sport of softball.

Anthropology in Agricultural Health and Safety Research and Intervention.

PubMed

Arcury, Thomas

2017-01-01

Agriculture remains a dangerous industry, even as agricultural science and technology continue to advance. Research that goes beyond technological changes to address safety culture and policy are needed to improve health and safety in agriculture. In this commentary, I consider the potential for anthropology to contribute to agricultural health and safety research by addressing three aims: (1) I briefly consider what the articles in this issue of the Journal of Agromedicine say about anthropologists in agricultural health and safety; (2) I discuss what anthropologists can add to agricultural health and safety research; and (3) I examine ways in which anthropologists can participate in agricultural health and safety research. In using their traditions of rigorous field research to understand how those working in agriculture perceive and interpret factors affecting occupational health and safety (their "emic" perspective), and translating this perspective to improve the understanding of occupational health professionals and policy makers (an "etic" perspective), anthropologists can expose myths that limit improvements in agricultural health and safety. Addressing significant questions, working with the most vulnerable agricultural communities, and being outside establishment agriculture provide anthropologists with the opportunity to improve health and safety policy and regulation in agriculture.

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

PubMed

Roberts, I; Wentz, R; Edwards, P

2006-10-01

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

Assessment of Tribal Bison Worker Hazards Using Trusted Research Facilitators.

PubMed

Duysen, Ellen; Irvine, Kelsey; Yoder, Aaron; Topliff, Christina; Kelling, Clayton; Rajaram, Shireen

2017-01-01

Agriculture is one of the most hazardous industries in the United States. Within agriculture, livestock handling is particularly dangerous. While injury and fatality rates for bison handlers have not been reported, workers in many of the newly established tribal bison herds have limited safety training and animal handling experience, making this a vulnerable workforce. Veterinarians and herd managers, working with tribal bison herds, recognized the need for improvement in the working environment and for worker safety training. In response, partnerships were established and a pilot project was developed in order to characterize risks and hazards associated with bison handling under contemporary reservation field conditions. Individuals and organizations working as change agents included veterinarians at the University of Nebraska - Lincoln School of Veterinary Medicine, a tribal advocacy organization, the Intertribal Buffalo Council and researchers at the Central States Center for Agricultural Safety and Health at the University of Nebraska Medical Center. This is a mixed-methods study and data were gathered through closed and open-ended questions pertaining to bison worker safety hazards. A veterinarian gathered data through observational safety audits at bison herding locations. American Indian bison herd managers completed surveys using a convenience sampling method. Findings indicate that the most common worker safety risks are associated with the use of high-stress handling methods and substandard facilities and equipment. Adverse environmental conditions also contribute to worker health risks. Most common causes of injuries included those caused by equipment and tools, adverse weather, and direct contact with animals. This collaborative research study contributes to a better understanding of hazards faced by tribal bison workers. Findings from this research influenced the ITBC in their decision to add worker safety and health training to the agenda of their yearly conference and promote tailgate trainings for their workers. UNL veterinarians have taken the lessons learned from this research and provided safety and health information to mangers of other non-tribal bison herds. This research partnership will continue with a 5-year research study focusing on best management practices and establishing training to improve the health and safety bison workers.

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

Lee Cadwallader

The safety of personnel at existing fusion experiments is an important concern that requires diligence. Looking to the future, fusion experiments will continue to increase in power and operating time until steady state power plants are achieved; this causes increased concern for personnel safety. This paper addresses four important aspects of personnel safety in the present and extrapolates these aspects to future power plants. The four aspects are personnel exposure to ionizing radiation, chemicals, magnetic fields, and radiofrequency (RF) energy. Ionizing radiation safety is treated well for present and near-term experiments by the use of proven techniques from other nuclearmore » endeavors. There is documentation that suggests decreasing the annual ionizing radiation exposure limits that have remained constant for several decades. Many chemicals are used in fusion research, for parts cleaning, as use as coolants, cooling water cleanliness control, lubrication, and other needs. In present fusion experiments, a typical chemical laboratory safety program, such as those instituted in most industrialized countries, is effective in protecting personnel from chemical exposures. As fusion facilities grow in complexity, the chemical safety program must transition from a laboratory scale to an industrial scale program that addresses chemical use in larger quantity. It is also noted that allowable chemical exposure concentrations for workers have decreased over time and, in some cases, now pose more stringent exposure limits than those for ionizing radiation. Allowable chemical exposure concentrations have been the fastest changing occupational exposure values in the last thirty years. The trend of more restrictive chemical exposure regulations is expected to continue into the future. Other issues of safety importance are magnetic field exposure and RF energy exposure. Magnetic field exposure limits are consensus values adopted as best practices for worker safety; a typical exposure value is ~1000 times the Earth’s magnetic field, but the Earth’s field is a very low value. Allowable static magnetic field exposure limits have remained constant over the recent past and would appear to remain constant for the foreseeable future. Some existing fusion experiments have suffered from RF energy leakage from waveguides, the typical practice to protect personnel is establishing personnel exclusion areas when systems are operating. RF exposure limits have remained fairly constant for overall body exposures, but have become more specific in the exposure frequency values. This paper describes the occupational limits for those types of exposure, how these exposures are managed, and also discusses the likelihood of more restrictive regulations being promulgated that will affect the design of future fusion power plants and safety of their personnel.« less

75 FR 67145 - Nextera Energy Seabrook, LLC; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-01

... Seabrook, LLC; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission... that an Atomic Safety and Licensing Board (Board) is being established to preside over the following... Board is comprised of the following administrative judges: Paul S. Ryerson, Chair, Atomic Safety and...

76 FR 6837 - Exelon Nuclear Texas Holdings, LLC; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-08

... Texas Holdings, LLC; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the... given that an Atomic Safety and Licensing Board (Board) is being established to preside over the... Board is comprised of the following administrative judges: Michael M. Gibson, Chair, Atomic Safety and...

76 FR 3678 - FirstEnergy Nuclear Operating Company; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

... Nuclear Operating Company; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by... hereby given that an Atomic Safety and Licensing Board (Board) is being established to preside over the... administrative judges: William J. Froehlich, Chair, Atomic Safety and Licensing Board Panel, U.S. Nuclear...

75 FR 16869 - Areva Enrichment Services, LLC; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-02

... Enrichment Services, LLC; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the... given that an Atomic Safety and Licensing Board (Board) is being established to preside over the... administrative judges: Alex S. Karlin, Chair, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory...

76 FR 79229 - Exelon Generation Company, LLC; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

...] Exelon Generation Company, LLC; Establishment of Atomic Safety and Licensing Board Pursuant to delegation....321, notice is hereby given that an Atomic Safety and Licensing Board (Board) is being established to... judges: William J. Froehlich, Chair, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory...

78 FR 64255 - Exelon Generation Company, LLC; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-28

.... 13- 929-02-LR-BD01] Exelon Generation Company, LLC; Establishment of Atomic Safety and Licensing... hereby given that an Atomic Safety and Licensing Board (Board) is being established to preside over the... is comprised of the following administrative judges: Paul S. Ryerson, Chairman, Atomic Safety and...

45 CFR 156.1110 - Establishment of patient safety standards for QHP issuers.

Code of Federal Regulations, 2014 CFR

2014-10-01

... STANDARDS RELATED TO EXCHANGES Quality Standards § 156.1110 Establishment of patient safety standards for QHP issuers. (a) Patient safety standards. A QHP issuer that contracts with a hospital with greater... 45 Public Welfare 1 2014-10-01 2014-10-01 false Establishment of patient safety standards for QHP...

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

Ronold, K.O.; Nielsen, N.J.R.; Tura, F.

This paper demonstrates how a structural reliability method can be applied as a rational means to analyze free spans of submarine pipelines with respect to failure in ultimate loading, and to establish partial safety factors for design of such free spans against this failure mode. It is important to note that the described procedure shall be considered as an illustration of a structural reliability methodology, and that the results do not represent a set of final design recommendations. A scope of design cases, consisting of a number of available site-specific pipeline spans, is established and is assumed representative for themore » future occurrence of submarine pipeline spans. Probabilistic models for the wave and current loading and its transfer to stresses in the pipe wall of a pipeline span is established together with a stochastic representation of the material resistance. The event of failure in ultimate loading is considered as based on a limit state which is reached when the maximum stress over the design life of the pipeline exceeds the yield strength of the pipe material. The yielding limit state is considered an ultimate limit state (ULS).« less

Do safety checklists improve teamwork and communication in the operating room? A systematic review.

PubMed

Russ, Stephanie; Rout, Shantanu; Sevdalis, Nick; Moorthy, Krishna; Darzi, Ara; Vincent, Charles

2013-12-01

The aim of this systematic review was to assess the impact of surgical safety checklists on the quality of teamwork and communication in the operating room (OR). Safety checklists have been shown to impact positively on patient morbidity and mortality following surgery, but it is unclear whether this clinical improvement is related to an improvement in OR teamwork and communication. A systematic search strategy of MEDLINE, EMBASE, PsycINFO, Google Scholar, and the Cochrane Database for Systematic Reviews was undertaken to obtain relevant articles. After de-duplication and the addition of limits, 315 articles were screened for inclusion by 2 researchers and all articles meeting a set of prespecified inclusion criteria were retained. Information regarding the type of checklist, study design, assessment tools used, outcomes, and study limitations was extracted. Twenty articles formed the basis of this systematic review. All articles described an empirical study relating to a case-specific safety checklist for surgery as the primary intervention, with some measure of change/improvement in teamwork and/or communication relating to its use. The methods for assessing teamwork and communication varied greatly, including surveys, observations, interviews, and 360° assessments. The evidence suggests that safety checklists improve the perceived quality of OR teamwork and communication and reduce observable errors relating to poor team skills. This is likely to function through establishing an open platform for communication at the start of a procedure: encouraging the sharing of critical case-related information, promoting team coordination and decision making, flagging knowledge gaps, and enhancing team cohesion. However, the evidence would also suggest that when used suboptimally or when individuals have not bought in to the process, checklists may conversely have a negative impact on the function of the team. Safety checklists are beneficial for OR teamwork and communication and this may be one mechanism through which patient outcomes are improved. Future research should aim to further elucidate the relationship between how safety checklists are used and team skills in the OR using more consistent methodological approaches and utilizing validated measures of teamwork such that best practice guidelines can be established.

Mitigation of Patulin in Fresh and Processed Foods and Beverages

PubMed Central

Ioi, J. David; Zhou, Ting; Tsao, Rong; F. Marcone, Massimo

2017-01-01

Patulin is a mycotoxin of food safety concern. It is produced by numerous species of fungi growing on fruits and vegetables. Exposure to the toxin is connected to issues neurological, immunological, and gastrointestinal in nature. Regulatory agencies worldwide have established maximum allowable levels of 50 µg/kg in foods. Despite regulations, surveys continue to find patulin in commercial food and beverage products, in some cases, to exceed the maximum limits. Patulin content in food can be mitigated throughout the food processing chain. Proper handling, storage, and transportation of food can limit fungal growth and patulin production. Common processing techniques including pasteurisation, filtration, and fermentation all have an effect on patulin content in food but individually are not sufficient safety measures. Novel methods to remove or detoxify patulin have been reviewed. Non-thermal processing techniques such as high hydrostatic pressure, UV radiation, enzymatic degradation, binding to microorganisms, and chemical degradation all have potential but have not been optimised. Until further refinement of these methods, the hurdle approach to processing should be used where food safety is concerned. Future development should focus on determining the nature and safety of chemicals produced from the breakdown of patulin in treatment techniques. PMID:28492465

Promoting parental management of teen driving

PubMed Central

Simons-Morton, B; Hartos, J; Leaf, W; Beck, K

2002-01-01

Methods: Parent-teen dyads (n = 452) were recruited when teens received learner's permits and interviewed over the telephone at baseline, licensure, and three months post-licensure. After baseline, families were randomized to either the intervention group that received persuasive communications or to the comparison group that received general information about driving safety. Results: Both parents and teens in the intervention group reported significantly greater limits on teen driving at licensure and three months post-licensure. In multivariate analyses, intervention and baseline driving expectations had significant effects on driving limits at licensure. Intervention and driving limits established at licensure were associated with three month driving limits. Conclusion: The findings indicate that exposure to the Checkpoints Program increased parental limits on teen driving. PMID:12221027

Using driving simulators to assess driving safety.

PubMed

Boyle, Linda Ng; Lee, John D

2010-05-01

Changes in drivers, vehicles, and roadways pose substantial challenges to the transportation safety community. Crash records and naturalistic driving data are useful for examining the influence of past or existing technology on drivers, and the associations between risk factors and crashes. However, they are limited because causation cannot be established and technology not yet installed in production vehicles cannot be assessed. Driving simulators have become an increasingly widespread tool to understand evolving and novel technologies. The ability to manipulate independent variables in a randomized, controlled setting also provides the added benefit of identifying causal links. This paper introduces a special issue on simulator-based safety studies. The special issue comprises 25 papers that demonstrate the use of driving simulators to address pressing transportation safety problems and includes topics as diverse as neurological dysfunction, work zone design, and driver distraction. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Radiation exposure control from the application of nuclear gauges in the mining industry in Ghana.

PubMed

Faanu, A; Darko, E O; Awudu, A R; Schandorf, C; Emi-Reynolds, G; Yeboah, J; Glover, E T; Kattah, V K

2010-05-01

The use of nuclear gauges for process control and elemental analysis in the mining industry in Ghana, West Africa, is wide spread and on the increase in recent times. The Ghana Radiation Protection Board regulates nuclear gauges through a system of notification and authorization by registration or licensing, inspection, and enforcement. Safety assessments for authorization and enforcement have been established to ensure the safety and security of radiation sources as well as protection of workers and the general public. Appropriate training of mine staff is part of the efforts to develop the necessary awareness about the safety and security of radiation sources. The knowledge and skills acquired will ensure the required protection and safety at the workplaces. Doses received by workers monitored over a period between 1998 and 2007 are well below the annual dose limit of 20 mSv recommended by the International Commission on Radiological Protection.

Pre- and postharvest preventive measures and intervention strategies to control microbial food safety hazards of fresh leafy vegetables.

PubMed

Gil, Maria I; Selma, Maria V; Suslow, Trevor; Jacxsens, Liesbeth; Uyttendaele, Mieke; Allende, Ana

2015-01-01

This review includes an overview of the most important preventive measures along the farm to fork chain to prevent microbial contamination of leafy greens. It also includes the technological and managerial interventions related to primary production, postharvest handling, processing practices, distribution, and consumer handling to eliminate pathogens in leafy greens. When the microbiological risk is already present, preventive measures to limit actual contamination events or pathogen survival are considered intervention strategies. In codes of practice the focus is mainly put on explaining preventive measures. However, it is also important to establish more focused intervention strategies. This review is centered mainly on leafy vegetables as the commodity identified as the highest priority in terms of fresh produce microbial safety from a global perspective. There is no unique preventive measure or intervention strategy that could be applied at one point of the food chain. We should encourage growers of leafy greens to establish procedures based on the HACCP principles at the level of primary production. The traceability of leafy vegetables along the chain is an essential element in ensuring food safety. Thus, in dealing with the food safety issues associated with fresh produce it is clear that a multidisciplinary farm to fork strategy is required.

Considerations on long-term immuno-intervention in the treatment of multiple sclerosis: an expert opinion.

PubMed

Grigoriadis, Nikolaos; Linnebank, Michael; Alexandri, Nektaria; Muehl, Sarah; Hofbauer, Günther F L

2016-10-01

As management of multiple sclerosis (MS) requires life-long treatment with disease-modifying agents, any risks associated with long-term use should be considered when evaluating therapeutic options. Immune cells of the innate and adaptive immune systems play various roles in the pathogenesis of MS. MS therapies affect the immune system, each with a unique mode of action, and consequently possess different long-term safety profiles. Rare, but serious safety concerns, including an increased risk of infection and cancer, have been associated with immunosuppressant use. The risks associated with newer immunosuppressive agents, which target specific elements of MS disease pathophysiology, are not yet fully established as the duration of clinical trials is relatively short and post-marketing experience is limited. Non-immunosuppressants used to treat MS have well-defined safety profiles established over a large number of patient-years demonstrating them to be well-tolerated long-term treatment options. When considering the long-term use of disease-modifying agents for treating MS, classification as immunosuppressants or non-immunosuppressants can be useful when evaluating potential risks associated with chronic use. A successful therapeutic strategy for any serious, chronic disease such as MS should weigh effectiveness versus long-term safety of available treatments.

Key Performance Indicators in the Evaluation of the Quality of Radiation Safety Programs.

PubMed

Schultz, Cheryl Culver; Shaffer, Sheila; Fink-Bennett, Darlene; Winokur, Kay

2016-08-01

Beaumont is a multiple hospital health care system with a centralized radiation safety department. The health system operates under a broad scope Nuclear Regulatory Commission license but also maintains several other limited use NRC licenses in off-site facilities and clinics. The hospital-based program is expansive including diagnostic radiology and nuclear medicine (molecular imaging), interventional radiology, a comprehensive cardiovascular program, multiple forms of radiation therapy (low dose rate brachytherapy, high dose rate brachytherapy, external beam radiotherapy, and gamma knife), and the Research Institute (including basic bench top, human and animal). Each year, in the annual report, data is analyzed and then tracked and trended. While any summary report will, by nature, include items such as the number of pieces of equipment, inspections performed, staff monitored and educated and other similar parameters, not all include an objective review of the quality and effectiveness of the program. Through objective numerical data Beaumont adopted seven key performance indicators. The assertion made is that key performance indicators can be used to establish benchmarks for evaluation and comparison of the effectiveness and quality of radiation safety programs. Based on over a decade of data collection, and adoption of key performance indicators, this paper demonstrates one way to establish objective benchmarking for radiation safety programs in the health care environment.

A successful model of Road Traffic Injury surveillance in a developing country: process and lessons learnt.

PubMed

Razzak, Junaid Abdul; Shamim, Muhammad Shahzad; Mehmood, Amber; Hussain, Syed Ameer; Ali, Mir Shabbar; Jooma, Rashid

2012-05-16

Road Traffic Injuries (RTIs) are one of the leading causes of death and disability worldwide with 90% of global mortality concentrated in the low and middle income countries. RTI surveillance is recommended to define the burden, identify high risk groups, plan intervention and monitor their impact. Despite its stated importance in the literature, very few examples of sustained surveillance systems are reported from low income countries. This paper shares the experience of setting up an urban RTI surveillance program in the emergency departments of five major hospitals in Karachi, Pakistan. We describe the process of establishing a surveillance system including assembling a multi-institution research group, developing a data collection methodology, carrying out data collection and analysis and dissemination of information to the relevant stakeholders. In the absence of a road safety agency, the surveillance system required developing individual partnerships with industry, police, city government, media and many other stakeholders. Impact of the surveillance is demonstrated by some initiatives in the local trauma system and improvements in road design to effect hazard reduction. We demonstrated that a functional RTI surveillance program can be established, and effectively managed in a developing country, despite lack of infrastructure and limitation of resources. Data utilization in the absence of well defined road safety infrastructure within the government is a challenge. More effective actions are hampered by the limited capacity in the transport and health sectors to do in-depth analysis through road safety audits and trauma registries.

75 FR 16010 - Safety Zone; Red River, MN

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-31

...-AAOO Safety Zone; Red River, MN AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard Captain of the Port (COTP), Marine Safety Unit Duluth, MN is establishing a temporary safety zone on the waters of the Red River, MN. This safety zone is being established to ensure the safety of...

29 CFR 1910.18 - Changes in established Federal standards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 1910.18 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.18 Changes in established Federal standards. Whenever an occupational safety and health...

29 CFR 1910.18 - Changes in established Federal standards.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 1910.18 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.18 Changes in established Federal standards. Whenever an occupational safety and health...

Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance.

PubMed

Lupattelli, Angela; Spigset, Olav; Nordeng, Hedvig

2018-06-15

The growing evidence on psychotropic drug safety in pregnancy has been possible thanks to the increasing availability of real-world data, i.e. data not collected in conventional randomised controlled trials. Use of these data is a key to establish psychotropic drug effects on foetal, child, and maternal health. Despite the inherent limitations and pitfalls of observational data, these can still be informative after a critical appraisal of the collective body of evidence has been done. By valuing real-world safety data, and making these a larger part of the regulatory decision-making process, we move toward a modern pregnancy pharmacovigilance. The recent uptake of real-world safety data by health authorities has set the basis for an important paradigm shift, which is integrating such data into drug labelling. The recent safety assessment of sodium valproate in pregnant and childbearing women is probably one of the first examples of modern pregnancy pharmacovigilance.

Evaluation of the AHRQ Patient Safety Initiative: Synthesis of Findings

PubMed Central

Farley, Donna O; Damberg, Cheryl L

2009-01-01

Objective To present overall findings from the 4-year evaluation of the national patient safety initiative operated by the Agency for Healthcare Research and Quality (AHRQ). Data Sources Interviews with AHRQ staff, grantees, and other patient safety stakeholders; published materials; and internal AHRQ documents. Study Design The evaluation was structured to address a system framework of five components involved in improving safety. The initiative's contributions to improving each system component were assessed qualitatively, comparing results from three separate analyses—AHRQ's achievement of its patient safety goals, our own assessment of the initiative's activities, and independent stakeholder ratings of AHRQ's contributions. Findings and Conclusions AHRQ has faced a daunting challenge for improving patient safety, given the complex problems of the U.S. health care system and the limited resources AHRQ has had to address them. The patient safety initiative achieved strongest progress for its contributions to knowledge of patient safety epidemiology and effective practices, where AHRQ has considerable experience, and to strengthening infrastructure to support adoption of safe practices. Progress was slower in establishing a national monitoring capability and dissemination of safe practices for adoption. AHRQ needs to expand efforts to apply new knowledge for stimulating use of safe practices in the field. PMID:21456115

78 FR 5717 - Safety Zone; Military Ocean Terminal Concord Safety Zone, Suisun Bay, Military Ocean Terminal...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

...-AA00 Safety Zone; Military Ocean Terminal Concord Safety Zone, Suisun Bay, Military Ocean Terminal... Guard is establishing a safety zone in the navigable waters of Suisun Bay near Military Ocean Terminal Concord, CA in support of military onload and offload operations. This safety zone is established to...

Evaluation of Agency Non-Code Layered Pressure Vessels (LPVs) . Volume 2; Appendices

NASA Technical Reports Server (NTRS)

Prosser, William H.

2014-01-01

In coordination with the Office of Safety and Mission Assurance and the respective Center Pressure System Managers (PSMs), the NASA Engineering and Safety Center (NESC) was requested to formulate a consensus draft proposal for the development of additional testing and analysis methods to establish the technical validity, and any limitation thereof, for the continued safe operation of facility non-code layered pressure vessels. The PSMs from each NASA Center were asked to participate as part of the assessment team by providing, collecting, and reviewing data regarding current operations of these vessels. This document contains the appendices to the main report.

A Systematic Review of the Use of Social Media for Food Safety Risk Communication.

PubMed

Overbey, Katie N; Jaykus, Lee-Ann; Chapman, Benjamin J

2017-09-01

This article covers the current published literature related to the use of social media in food safety and infectious disease communication. The aim was to analyze literature recommendations and draw conclusions about how best to utilize social media for food safety risk communication going forward. A systematic literature review was conducted, and 24 articles were included for analysis. The inclusion criteria were (i) original peer-reviewed articles and (ii) primary focus on communication through social media about food safety and/or infectious diseases. Studies were coded for themes about social media applications, benefits, limitations, and best practices. Trust and personal beliefs were important drivers of social media use. The wide reach, immediacy, and information gathering capacities of social media were frequently cited benefits. Suggestions for social media best practices were inconsistent among studies, and study designs were highly variable. More evidence-based suggestions are needed to better establish guidelines for social media use in food safety and infectious disease risk communication. The information gleaned from this review can be used to create effective messages for shaping food safety behaviors.

Time series modeling in traffic safety research.

PubMed

Lavrenz, Steven M; Vlahogianni, Eleni I; Gkritza, Konstantina; Ke, Yue

2018-08-01

The use of statistical models for analyzing traffic safety (crash) data has been well-established. However, time series techniques have traditionally been underrepresented in the corresponding literature, due to challenges in data collection, along with a limited knowledge of proper methodology. In recent years, new types of high-resolution traffic safety data, especially in measuring driver behavior, have made time series modeling techniques an increasingly salient topic of study. Yet there remains a dearth of information to guide analysts in their use. This paper provides an overview of the state of the art in using time series models in traffic safety research, and discusses some of the fundamental techniques and considerations in classic time series modeling. It also presents ongoing and future opportunities for expanding the use of time series models, and explores newer modeling techniques, including computational intelligence models, which hold promise in effectively handling ever-larger data sets. The information contained herein is meant to guide safety researchers in understanding this broad area of transportation data analysis, and provide a framework for understanding safety trends that can influence policy-making. Copyright © 2017 Elsevier Ltd. All rights reserved.

Food Supply and Food Safety Issues in China

PubMed Central

Lam, Hon-Ming; Remais, Justin; Fung, Ming-Chiu; Xu, Liqing; Sun, Samuel Sai-Ming

2013-01-01

Food supply and food safety are major global public health issues, and are particularly important in heavily populated countries such as China. Rapid industrialisation and modernisation in China are having profound effects on food supply and food safety. In this Review, we identified important factors limiting agricultural production in China, including conversion of agricultural land to other uses, freshwater deficits, and soil quality issues. Additionally, increased demand for some agricultural products is examined, particularly those needed to satisfy the increased consumption of animal products in the Chinese diet, which threatens to drive production towards crops used as animal feed. Major sources of food poisoning in China include pathogenic microorganisms, toxic animals and plants entering the food supply, and chemical contamination. Meanwhile, two growing food safety issues are illegal additives and contamination of the food supply by toxic industrial waste. China’s connections to global agricultural markets are also having important effects on food supply and food safety within the country. Although the Chinese Government has shown determination to reform laws, establish monitoring systems, and strengthen food safety regulation, weak links in implementation remain. PMID:23746904

75 FR 53985 - Southern Nuclear Operating Company Establishment of Atomic Safety And Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-02

...] Southern Nuclear Operating Company Establishment of Atomic Safety And Licensing Board Pursuant to..., notice is hereby given that an Atomic Safety and Licensing Board (Board) is being established to preside...). The Board is comprised of the following administrative judges: G. Paul Bollwerk, III, Chairman, Atomic...

The Holy Grail of Polymer Therapeutics for Cancer Therapy: An Overview on the Pharmacokinetics and Bio Distribution.

PubMed

Dyawanapelly, Sathish; Junnuthula, Vijayabhaskar Reddy; Singh, AkhileshVikram

2015-01-01

In recent years, multifaceted clinical benefits of polymeric therapeutics have been reported. Over the past decades, cancer has been one of the leading causes of mortality in the world. Many clinically approved chemotherapeutics encounter potential challenges against deadly cancer. Moreover, safety and efficacy of anticancer agents have been limited by undesirable pharmacokinetics and biodistribution. To address these limitations, various polymer drug conjugates are being studied and developed to improve the antitumor efficacy. Among other therapeutics, polymer therapeutics are well established platforms that circumvent anticancer therapeutics from enzymatic metabolism via direct conjugation to therapeutic molecules. Interestingly, polymer therapeutics meets an unmet need of small molecules. Further clinical study showed that polymer-drug conjugation can achieve desired pharmacokinetics and biodistribution properties of several anticancer drugs. The present retrospective review mainly enlightens the most recent preclinical and clinical studies include safety, stability, pharmacokinetic behavior and distribution of polymer therapeutics.

77 FR 39415 - Safety Zone: Independence Day Fireworks Celebration for the City of Richmond, Richmond Inner...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

...-AA00 Safety Zone: Independence Day Fireworks Celebration for the City of Richmond, Richmond Inner... establishing a temporary safety zone in the navigable waters of Richmond Inner Harbor near Richmond, CA in... safety zone is established to ensure the safety of participants and spectators from the dangers...

Criticality Safety Analysis on the Mixed Be, Nat-U, and C (Graphite) Reflectors in 55-Gallon Waste Drums and Their Equivalents for HWM Applications

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

Chou, P

The objective of this analysis is to develop and establish the technical basis on the criticality safety controls for the storage of mixed beryllium (Be), natural uranium (Nat-U), and carbon (C)/graphite reflectors in 55-gallon waste containers and/or their equivalents in Hazardous Waste Management (HWM) facilities. Based on the criticality safety limits and controls outlined in Section 3.0, the operations involving the use of mixed-reflector drums satisfy the double-contingency principle as required by DOE Order 420.1 and are therefore criticality safe. The mixed-reflector mass limit is 120 grams for each 55-gallon drum or its equivalent. a reflector waiver of 50 gramsmore » is allowed for Be, Nat-U, or C/graphite combined. The waived reflectors may be excluded from the reflector mass calculations when determining if a drum is compliant. The mixed-reflector drums are allowed to mix with the typical 55-gallon one-reflector drums with a Pu mass limit of 120 grams. The fissile mass limit for the mixed-reflector container is 65 grams of Pu equivalent each. The corresponding reflector mass limits are 300 grams of Be, and/or 100 kilograms of Nat-U, and/or 110 kilograms of C/graphite for each container. All other unaffected control parameters for the one-reflector containers remain in effect for the mixed-reflector drums. For instance, Superior moderators, such as TrimSol, Superla white mineral oil No. 9, paraffin, and polyethylene, are allowed in unlimited quantities. Hydrogenous materials with a hydrogen density greater than 0.133 gram/cc are not allowed. Also, an isolation separation of no less than 76.2 cm (30-inch) is required between a mixed array and any other array. Waste containers in the action of being transported are exempted from this 76.2-cm (30-inch) separation requirement. All deviations from the CS controls and mass limits listed in Section 3.0 will require individual criticality safety analyses on a case-by-case basis for each of them to confirm their criticality safety prior to their deployment and implementation.« less

[Using fractional polynomials to estimate the safety threshold of fluoride in drinking water].

PubMed

Pan, Shenling; An, Wei; Li, Hongyan; Yang, Min

2014-01-01

To study the dose-response relationship between fluoride content in drinking water and prevalence of dental fluorosis on the national scale, then to determine the safety threshold of fluoride in drinking water. Meta-regression analysis was applied to the 2001-2002 national endemic fluorosis survey data of key wards. First, fractional polynomial (FP) was adopted to establish fixed effect model, determining the best FP structure, after that restricted maximum likelihood (REML) was adopted to estimate between-study variance, then the best random effect model was established. The best FP structure was first-order logarithmic transformation. Based on the best random effect model, the benchmark dose (BMD) of fluoride in drinking water and its lower limit (BMDL) was calculated as 0.98 mg/L and 0.78 mg/L. Fluoride in drinking water can only explain 35.8% of the variability of the prevalence, among other influencing factors, ward type was a significant factor, while temperature condition and altitude were not. Fractional polynomial-based meta-regression method is simple, practical and can provide good fitting effect, based on it, the safety threshold of fluoride in drinking water of our country is determined as 0.8 mg/L.

Establishing Medical Students' Cultural and Linguistic Competence for the Care of Spanish-Speaking Limited English Proficient Patients.

PubMed

Vela, Monica; Fritz, Cassandra; Jacobs, Elizabeth A

2016-09-01

Limited English proficient (LEP) patients are at risk of disparities in health and health care quality. These disparities can be mitigated by providing care in a language they understand. Undergraduate medical education provides an opportunity to stress that language barriers negatively impact the quality and safety of health care for LEP patients and to teach students how to overcome them. Because the preponderance of LEP patients in the USA is Spanish speaking, the majority of US medical schools have established medical Spanish coursework for interested students. However, 70 % of medical schools note significant obstacles to delivering this curriculum. The most commonly cited obstacles include a lack of time to deliver it, heterogeneous student skill levels, and insufficient faculty support. We also note that educators need to make sure not to propagate disparities and medical errors for LEP patients. We provide recommendations for establishing medical students' linguistic and cultural competence for the care Spanish-speaking limited English proficiency patients, with the caution that this instruction must be coupled with education as to when to call on an interpreter if participants are not fluent in Spanish at the end of the course.

Aviation Safety Reporting System: Process and Procedures

NASA Technical Reports Server (NTRS)

Connell, Linda J.

1997-01-01

The Aviation Safety Reporting System (ASRS) was established in 1976 under an agreement between the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration (NASA). This cooperative safety program invites pilots, air traffic controllers, flight attendants, maintenance personnel, and others to voluntarily report to NASA any aviation incident or safety hazard. The FAA provides most of the program funding. NASA administers the program, sets its policies in consultation with the FAA and aviation community, and receives the reports submitted to the program. The FAA offers those who use the ASRS program two important reporting guarantees: confidentiality and limited immunity. Reports sent to ASRS are held in strict confidence. More than 350,000 reports have been submitted since the program's beginning without a single reporter's identity being revealed. ASRS removes all personal names and other potentially identifying information before entering reports into its database. This system is a very successful, proof-of-concept for gathering safety data in order to provide timely information about safety issues. The ASRS information is crucial to aviation safety efforts both nationally and internationally. It can be utilized as the first step in safety by providing the direction and content to informed policies, procedures, and research, especially human factors. The ASRS process and procedures will be presented as one model of safety reporting feedback systems.

DOE explosives safety manual

NASA Astrophysics Data System (ADS)

1990-05-01

The Department of Energy (DOE) policy requires that all activities be conducted in a manner that protects the safety of the public and provides a safe and healthful workplace for employees. DOE has also prescribed that all personnel be protected in any explosives operation undertaken. The level of safety provided shall be at least equivalent to that of the best industrial practice. The risk of death or serious injury shall be limited to the lowest practicable minimum. DOE and contractors shall continually review their explosives operations with the aim of achieving further refinements and improvements in safety practices and protective features. This manual describes the Department's explosive safety requirements applicable to operations involving the development, testing, handling, and processing of explosives or assemblies containing explosives. It is intended to reflect the state-of-the-art in explosives safety. In addition, it is essential that applicable criteria and requirements for implementing this policy be readily available and known to those responsible for conducting DOE programs. This document shall be periodically reviewed and updated to establish new requirements as appropriate. Users are requested to submit suggestions for improving the DOE Explosives Safety Manual through their appropriate Operations Office to the Office of Quality Programs.

Patient-specific Distraction Regimen to Avoid Growth-rod Failure.

PubMed

Agarwal, Aakash; Jayaswal, Arvind; Goel, Vijay K; Agarwal, Anand K

2018-02-15

A finite element study to establish the relationship between patient's curve flexibility (determined using curve correction under gravity) in juvenile idiopathic scoliosis and the required distraction frequency to avoid growth rod fracture, as a function of time. To perform a parametric analysis using a juvenile scoliotic spine model (single mid-thoracic curve with the apex at the eighth thoracic vertebra) and establish the relationship between curve flexibility (determined using curve correction under gravity) and the distraction interval that allows a higher factor of safety for the growth rods. Previous studies have shown that frequent distraction with smaller magnitude of distractions are less likely to result in rod failure. However there has not been any methodology or a chart provided to apply this knowledge on to the individual patients that undergo the treatment. This study aims to fill in that gap. The parametric study was performed by varying the material properties of the disc, hence altering the axial stiffness of the scoliotic spine model. The stresses on the rod were found to increase with increased axial stiffness of the spine, and this resulted in the increase of required optimal frequency to achieve a factor of safety of two for growth rods. A relationship between the percentage correction in Cobb's angle due to gravity alone, and the required distraction interval for limiting the maximum von Mises stress to 255 MPa on the growth rods was established. The distraction interval required to limit the stresses to the selected nominal value reduces with increase in stiffness of the spine. Furthermore, the appropriate distraction interval reduces for each model as the spine becomes stiffer with time (autofusion). This points to the fact the optimal distraction frequency is a time-dependent variable that must be achieved to keep the maximum von Mises stress under the specified factor of safety. The current study demonstrates the possibility of translating fundamental information from finite element modeling to the clinical arena, for mitigating the occurrence of growth rod fracture, that is, establishing a relationship between optimal distraction interval and curve flexibility (determined using curve correction under gravity). N/A.

The Feasibility of Establishing Highway Safety Manpower Development and Research Centers at University-Level Institutions. Final Report, Volume I: Study Report.

ERIC Educational Resources Information Center

Chorness, Maury H.; And Others

To examine the feasibility of establishing Highway Safety Manpower Development and Research (HSMDR) Centers at university-level institutions which would produce three types of manpower--safety specialists, safety professionals, and research manpower, previous National Highway Safety Bureau research studies and approximately 50 federally funded…

76 FR 34862 - Safety Zone; M/V DAVY CROCKETT, Columbia River

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-15

...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending the enforcement of a safety zone established on the... original safety zone was established on January 28, 2011. The safety zone is necessary to help ensure the...

Technical Study on Improvement of Endurance Capability of Limit Short-circuit Current of Charge Control SMART Meter

NASA Astrophysics Data System (ADS)

Li, W. W.; Du, Z. Z.; Yuan, R. m.; Xiong, D. Z.; Shi, E. W.; Lu, G. N.; Dai, Z. Y.; Chen, X. Q.; Jiang, Z. Y.; Lv, Y. G.

2017-10-01

Smart meter represents the development direction of energy-saving smart grid in the future. The load switch, one of the core parts of smart meter, should be of high reliability, safety and endurance capability of limit short-circuit current. For this reason, this paper discusses the quick simulation of relationship between attraction and counterforce of load switch without iteration, establishes dual response surface model of attraction and counterforce and optimizes the design scheme of load switch for charge control smart meter, thus increasing electromagnetic attraction and spring counterforce. In this way, this paper puts forward a method to improve the withstand capacity of limit short-circuit current.

Guidelines for noise and vibration levels for the space station

NASA Technical Reports Server (NTRS)

1987-01-01

Human habitability noise and vibration guidelines for the Space Station are presented. These were developed by a working group of experts established by the Committee on Hearing, Bioacoustics, and Biomechanics (CHABA) of the National Research Council's Commission on Behavioral and Social Science and Education. Noise exposure limits are suggested that will permit adequate speech communication, sleep, and hearing safety. Vibration exposure limits are suggested which will provide adequate comfort and permit adequate task performance. These are provided for guidance only for setting criteria. The exact criteria will depend on Space Station design and duty cycles.

Guidelines for noise and vibration levels for the space station

NASA Astrophysics Data System (ADS)

1987-06-01

Human habitability noise and vibration guidelines for the Space Station are presented. These were developed by a working group of experts established by the Committee on Hearing, Bioacoustics, and Biomechanics (CHABA) of the National Research Council's Commission on Behavioral and Social Science and Education. Noise exposure limits are suggested that will permit adequate speech communication, sleep, and hearing safety. Vibration exposure limits are suggested which will provide adequate comfort and permit adequate task performance. These are provided for guidance only for setting criteria. The exact criteria will depend on Space Station design and duty cycles.

Response Time Analysis and Test of Protection System Instrument Channels for APR1400 and OPR1000

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

Lee, Chang Jae; Han, Seung; Yun, Jae Hee

2015-07-01

Safety limits are required to maintain the integrity of physical barriers designed to prevent the uncontrolled release of radioactive materials in nuclear power plants. The safety analysis establishes two critical constraints that include an analytical limit in terms of a measured or calculated variable, and a specific time after the analytical limit is reached to begin protective action. Keeping with the nuclear regulations and industry standards, satisfying these two requirements will ensure that the safety limit will not be exceeded during the design basis event, either an anticipated operational occurrence or a postulated accident. Various studies on the setpoint determinationmore » methodology for the safety-related instrumentation have been actively performed to ensure that the requirement of the analytical limit is satisfied. In particular, the protection setpoint methodology for the advanced power reactor 1400 (APP1400) and the optimized power reactor 1000 (OPR1000) has been recently developed to cover both the design basis event and the beyond design basis event. The developed setpoint methodology has also been quantitatively validated using specific computer programs and setpoint calculations. However, the safety of nuclear power plants cannot be fully guaranteed by satisfying the requirement of the analytical limit. In spite of the response time verification requirements of nuclear regulations and industry standards, it is hard to find the studies on the systematically integrated methodology regarding the response time evaluation. In cases of APR1400 and OPR1000, the response time analysis for the plant protection system is partially included in the setpoint calculation and the response time test is separately performed via the specific plant procedure. The test technique has a drawback which is the difficulty to demonstrate completeness of timing test. The analysis technique has also a demerit of resulting in extreme times that not actually possible. Thus, the establishment of the systematic response time evaluation methodology is needed to justify the conformance to the response time requirement used in the safety analysis. This paper proposes the response time evaluation methodology for APR1400 and OPR1000 using the combined analysis and test technique to confirm that the plant protection system can meet the analytical response time assumed in the safety analysis. In addition, the results of the quantitative evaluation performed for APR1400 and OPR1000 are presented in this paper. The proposed response time analysis technique consists of defining the response time requirement, determining the critical signal path for the trip parameter, allocating individual response time to each component on the signal path, and analyzing the total response time for the trip parameter, and demonstrates that the total analyzed response time does not exceed the response time requirement. The proposed response time test technique is composed of defining the response time requirement, determining the critical signal path for the trip parameter, determining the test method for each component on the signal path, performing the response time test, and demonstrates that the total test result does not exceed the response time requirement. The total response time should be tested in a single test that covers from the sensor to the final actuation device on the instrument channel. When the total channel is not tested in a single test, separate tests on groups of components or single components including the total instrument channel shall be combined to verify the total channel response. For APR1400 and OPR1000, the ramp test technique is used for the pressure and differential pressure transmitters and the step function testing technique is applied to the signal processing equipment and final actuation device. As a result, it can be demonstrated that the response time requirement is satisfied by the combined analysis and test technique. Therefore, the proposed methodology in this paper plays a crucial role in guaranteeing the safety of the nuclear power plants systematically satisfying one of two critical requirements from the safety analysis. (authors)« less

Lessons learned from the Galileo and Ulysses flight safety review experience

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

Bennett, Gary L.

In preparation for the launches of the Galileo and Ulysses spacecraft, a very comprehensive aerospace nuclear safety program and flight safety review were conducted. A review of this work has highlighted a number of important lessons which should be considered in the safety analysis and review of future space nuclear systems. These lessons have been grouped into six general categories: (1) establishment of the purpose, objectives and scope of the safety process; (2) establishment of charters defining the roles of the various participants; (3) provision of adequate resources; (4) provision of timely peer-reviewed information to support the safety program; (5)more » establishment of general ground rules for the safety review; and (6) agreement on the kinds of information to be provided from the safety review process.« less

21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

Code of Federal Regulations, 2010 CFR

2010-04-01

... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

Code of Federal Regulations, 2011 CFR

2011-04-01

... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

Code of Federal Regulations, 2012 CFR

2012-04-01

... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

Code of Federal Regulations, 2014 CFR

2014-04-01

... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

Code of Federal Regulations, 2013 CFR

2013-04-01

... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation...

33 CFR 150.905 - Why are safety zones, no anchoring areas, and areas to be avoided established?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Why are safety zones, no...: OPERATIONS Safety Zones, No Anchoring Areas, and Areas To Be Avoided § 150.905 Why are safety zones, no anchoring areas, and areas to be avoided established? (a) Safety zones, no anchoring areas (NAAs) and areas...

Polymer therapeutics in surgery: the next frontier

PubMed Central

Conlan, R. Steven; Whitaker, Iain S.

2016-01-01

Abstract Polymer therapeutics is a successful branch of nanomedicine, which is now established in several facets of everyday practice. However, to our knowledge, no literature regarding the application of the underpinning principles, general safety, and potential of this versatile class to the perioperative patient has been published. This study provides an overview of polymer therapeutics applied to clinical surgery, including the evolution of this demand‐oriented scientific field, cutting‐edge concepts, its implications, and limitations, illustrated by products already in clinical use and promising ones in development. In particular, the effect of design of polymer therapeutics on biophysical and biochemical properties, the potential for targeted delivery, smart release, and safety are addressed. Emphasis is made on principles, giving examples in salient areas of demand in current surgical practice. Exposure of the practising surgeon to this versatile class is crucial to evaluate and maximise the benefits that this established field presents and to attract a new generation of clinician–scientists with the necessary knowledge mix to drive highly successful innovation. PMID:27588210

A probabilistic safety analysis of incidents in nuclear research reactors.

PubMed

Lopes, Valdir Maciel; Agostinho Angelo Sordi, Gian Maria; Moralles, Mauricio; Filho, Tufic Madi

2012-06-01

This work aims to evaluate the potential risks of incidents in nuclear research reactors. For its development, two databases of the International Atomic Energy Agency (IAEA) were used: the Research Reactor Data Base (RRDB) and the Incident Report System for Research Reactor (IRSRR). For this study, the probabilistic safety analysis (PSA) was used. To obtain the result of the probability calculations for PSA, the theory and equations in the paper IAEA TECDOC-636 were used. A specific program to analyse the probabilities was developed within the main program, Scilab 5.1.1. for two distributions, Fischer and chi-square, both with the confidence level of 90 %. Using Sordi equations, the maximum admissible doses to compare with the risk limits established by the International Commission on Radiological Protection (ICRP) were obtained. All results achieved with this probability analysis led to the conclusion that the incidents which occurred had radiation doses within the stochastic effects reference interval established by the ICRP-64.

Evaluation of Agency Non-Code Layered Pressure Vessels (LPVs)

NASA Technical Reports Server (NTRS)

Prosser, William H.

2014-01-01

In coordination with the Office of Safety and Mission Assurance and the respective Center Pressure System Managers (PSMs), the NASA Engineering and Safety Center (NESC) was requested to formulate a consensus draft proposal for the development of additional testing and analysis methods to establish the technical validity, and any limitation thereof, for the continued safe operation of facility non-code layered pressure vessels. The PSMs from each NASA Center were asked to participate as part of the assessment team by providing, collecting, and reviewing data regarding current operations of these vessels. This report contains the outcome of the assessment and the findings, observations, and NESC recommendations to the Agency and individual NASA Centers.

Evaluation of Agency Non-Code Layered Pressure Vessels (LPVs). Corrected Copy, Aug. 25, 2014

NASA Technical Reports Server (NTRS)

Prosser, William H.

2014-01-01

In coordination with the Office of Safety and Mission Assurance and the respective Center Pressure System Managers (PSMs), the NASA Engineering and Safety Center (NESC) was requested to formulate a consensus draft proposal for the development of additional testing and analysis methods to establish the technical validity, and any limitation thereof, for the continued safe operation of facility non-code layered pressure vessels. The PSMs from each NASA Center were asked to participate as part of the assessment team by providing, collecting, and reviewing data regarding current operations of these vessels. This report contains the outcome of the assessment and the findings, observations, and NESC recommendations to the Agency and individual NASA Centers.

76 FR 17460 - South Texas Project Nuclear Operating Company; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-29

...] South Texas Project Nuclear Operating Company; Establishment of Atomic Safety and Licensing Board..., 2.318, and 2.321, notice is hereby given that an Atomic Safety and Licensing Board (Board) is being...: Ronald M. Spritzer, Chair, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory Commission...

76 FR 73511 - Safety Zone; M/V DAVY CROCKETT, Columbia River

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-29

...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending the enforcement period of a safety zone established on... sight at approximate river mile 117. The original safety zone was established on January 28, 2011. The...

Noise Control in Space Shuttle Orbiter

NASA Technical Reports Server (NTRS)

Goodman, Jerry R.

2009-01-01

Acoustic limits in habitable space enclosures are required to ensure crew safety, comfort, and habitability. Noise control is implemented to ensure compliance with the acoustic requirements. The purpose of this paper is to describe problems with establishing acoustic requirements and noise control efforts, and present examples of noise control treatments and design applications used in the Space Shuttle Orbiter. Included is the need to implement the design discipline of acoustics early in the design process, and noise control throughout a program to ensure that limits are met. The use of dedicated personnel to provide expertise and oversight of acoustic requirements and noise control implementation has shown to be of value in the Space Shuttle Orbiter program. It is concluded that to achieve acceptable and safe noise levels in the crew habitable space, early resolution of acoustic requirements and implementation of effective noise control efforts are needed. Management support of established acoustic requirements and noise control efforts is essential.

23 CFR 1205.2 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HIGHWAY SAFETY PROGRAMS; DETERMINATIONS OF EFFECTIVENESS § 1205.2 Purpose. The purpose of this part is to establish national highway safety priorities and establish program areas within which highway safety programs developed by the states would be eligible to receive Federal funding. ...

23 CFR 1205.2 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HIGHWAY SAFETY PROGRAMS; DETERMINATIONS OF EFFECTIVENESS § 1205.2 Purpose. The purpose of this part is to establish national highway safety priorities and establish program areas within which highway safety programs developed by the states would be eligible to receive Federal funding. ...

29 CFR 1960.40 - Establishment committee duties.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Occupational Safety and Health Committees § 1960.40 Establishment committee...

29 CFR 1960.40 - Establishment committee duties.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Occupational Safety and Health Committees § 1960.40 Establishment committee...

29 CFR 1960.40 - Establishment committee duties.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Occupational Safety and Health Committees § 1960.40 Establishment committee...

At the Crossroads of Nanotoxicology: Past Achievements and Current Challenges

DTIC Science & Technology

2015-01-01

rates of ionic dissolution, improving in vitro to in vivo predictive efficiencies, and establishing safety exposure limits. This Review will discuss...Oberdörster et al., 2005a), which drove the focus of in vitro and in vivo model selection to accommodate these areas of higher NM exposure. Most...Accordingly, a current challenge is the design of simple, in vitro models that reliably predict in vivo effects following a NM challenge. In order

Current safety practices in nano-research laboratories in China.

PubMed

Zhang, Can; Zhang, Jing; Wang, Guoyu

2014-06-01

China has become a key player in the global nanotechnology field, however, no surveys have specifically examined safety practices in the Chinese nano-laboratories in depth. This study reports results of a survey of 300 professionals who work in research laboratories that handle nanomaterials in China. We recruited participants at three major nano-research laboratories (which carry out research in diverse fields such as chemistry, material science, and biology) and the nano-chemistry session of the national meeting of the Chinese Chemical Society. Results show that almost all nano-research laboratories surveyed had general safety regulations, whereas less than one third of respondents reported having nanospecific safety rules. General safety measures were in place in most surveyed nano-research laboratories, while nanospecific protective measures existed or were implemented less frequently. Several factors reported from the scientific literature including nanotoxicology knowledge gaps, technical limitations on estimating nano-exposure, and the lack of nano-occupational safety legislation may contribute to the current state of affairs. With these factors in mind and embracing the precautionary principle, we suggest strengthening or providing nanosafety training (including raising risk awareness) and establishing nanosafety guidelines in China, to better protect personnel in the nano-workplace.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

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

77 FR 58591 - Northern States Power Company; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-21

...] Northern States Power Company; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by....300, 2.313, 2.318, and 2.321, notice is hereby given that an Atomic Safety and Licensing Board (Board... Commission to E. Roy Hawkens, Chief Administrative Judge, Atomic Safety and Licensing Board Panel (Sept. 13...

78 FR 33449 - FirstEnergy Nuclear Operating Company; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-04

... Nuclear Operating Company; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by... 2.104, 2.105, 2.300, 2.309, 2.313, 2.318, and 2.321, notice is hereby given that an Atomic Safety... administrative judges: Paul S. Ryerson, Chairman, Atomic Safety and Licensing Board Panel, U.S. Nuclear...

77 FR 65909 - Southern California Edison Company; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-31

...] Southern California Edison Company; Establishment of Atomic Safety and Licensing Board Pursuant to... 2.104, 2.105, 2.300, 2.309, 2.313, 2.318, and 2.321, notice is hereby given that an Atomic Safety... following administrative judges: Alex S. Karlin, Chair, Atomic Safety and Licensing Board Panel, U.S...

77 FR 39418 - Safety Zone: Independence Day Fireworks Celebration for the City of Vallejo, Mare Island Strait...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

...-AA00 Safety Zone: Independence Day Fireworks Celebration for the City of Vallejo, Mare Island Strait... establishing a temporary safety zone in the navigable waters of Mare Island Strait near Vallejo, CA in support... zone is established to ensure the safety of participants and spectators from the dangers associated...

A qualitative evaluation of fire safety education programs for older adults.

PubMed

Diekman, Shane T; Stewart, Tamara A; Teh, S Leesia; Ballesteros, Michael F

2010-03-01

This article presents a qualitative evaluation of six fire safety education programs for older adults delivered by public fire educators. Our main aims were to explore how these programs are implemented and to determine important factors that may lead to program success, from the perspectives of the public fire educators and the older adults. For each program, we interviewed the public fire educator(s), observed the program in action, and conducted focus groups with older adults attending the program. Analysis revealed three factors that were believed to facilitate program success (established relationships with the older adult community, rapport with older adult audiences, and presentation relevance) as well as three challenges (lack of a standardized curriculum and program implementation strategies, attendance difficulties, and physical limitations due to age). More fire safety education should be developed for older adult populations. For successful programs, public fire educators should address the specific needs of their local older adult community.

Closed-loop control of anesthesia: a primer for anesthesiologists.

PubMed

Dumont, Guy A; Ansermino, J Mark

2013-11-01

Feedback control is ubiquitous in nature and engineering and has revolutionized safety in fields from space travel to the automobile. In anesthesia, automated feedback control holds the promise of limiting the effects on performance of individual patient variability, optimizing the workload of the anesthesiologist, increasing the time spent in a more desirable clinical state, and ultimately improving the safety and quality of anesthesia care. The benefits of control systems will not be realized without widespread support from the health care team in close collaboration with industrial partners. In this review, we provide an introduction to the established field of control systems research for the everyday anesthesiologist. We introduce important concepts such as feedback and modeling specific to control problems and provide insight into design requirements for guaranteeing the safety and performance of feedback control systems. We focus our discussion on the optimization of anesthetic drug administration.

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

Economic Techniques of Occupational Health and Safety Management

NASA Astrophysics Data System (ADS)

Sidorov, Aleksandr I.; Beregovaya, Irina B.; Khanzhina, Olga A.

2016-10-01

The article deals with the issues on economic techniques of occupational health and safety management. Authors’ definition of safety management is given. It is represented as a task-oriented process to identify, establish and maintain such a state of work environment in which there are no possible effects of hazardous and harmful factors, or their influence does not go beyond certain limits. It was noted that management techniques that are the part of the control mechanism, are divided into administrative, organizational and administrative, social and psychological and economic. The economic management techniques are proposed to be classified depending on the management subject, management object, in relation to an enterprise environment, depending on a control action. Technoeconomic study, feasibility study, planning, financial incentives, preferential crediting of enterprises, pricing, profit sharing and equity, preferential tax treatment for enterprises, economic regulations and standards setting have been distinguished as economic techniques.

Fatal accidents in nighttime vs. daytime highway construction work zones.

PubMed

Arditi, David; Lee, Dong-Eun; Polat, Gul

2007-01-01

Awareness about worker safety in nighttime construction has been a major concern because it is believed that nighttime construction creates hazardous work conditions. However, only a few studies provide valuable comparative information about accident characteristics of nighttime and daytime highway construction activities. This study investigates fatal accidents that occurred in Illinois highway work zones in the period 1996-2001 in order to determine the safety differences between nighttime and daytime highway construction. The lighting and weather conditions were included into the study as control parameters to see their effects on the frequency of fatal accidents occurring in work zones. According to this study, there is evidence that nighttime construction is more hazardous than daytime construction. The inclusion of a weather parameter into the analysis has limited effect on this finding. The study justifies establishing an efficient work zone accident reporting system and taking all necessary measures to enhance safety in nighttime work zones.

Assessing Risk-Based Upper Limits of Melamine Migration from Food Containers.

PubMed

Ling, Min-Pei; Lien, Keng-Wen; Hsieh, Dennis P H

2016-12-01

Melamine contamination of food has become a major food safety issue because of incidents of infant disease caused by exposure to this chemical. This study was aimed at establishing a safety limit in Taiwan for the degree of melamine migration from food containers. Health risk assessment was performed for three exposure groups (preschool children, individuals who dine out, and elderly residents of nursing homes). Selected values of tolerable daily intake (TDI) for melamine were used to calculate the reference migration concentration limit (RMCL) or reference specific migration limit (RSML) for melamine food containers. The only existing values of these limits for international standards today are 1.2 mg/L (0.2 mg/dm 2 ) in China and 30 mg/L (5 mg/dm 2 ) in the European Union. The factors used in the calculations included the specific surface area of food containers, daily food consumption rate, body weight, TDI, and the percentile of the population protected at a given migration concentration limit (MCL). The results indicate that children are indeed at higher risk of melamine exposure at toxic levels than are other groups and that the 95th percentile of MCL (specific surface area = 5) for children aged 1-6 years should be the RMCL (0.07 mg/dm 2 ) for protecting the sensitive and general population. © 2016 Society for Risk Analysis.

UV protection for sunglasses: revisiting the standards

NASA Astrophysics Data System (ADS)

Masili, Mauro; Schiabel, Homero; Ventura, Liliane

2014-02-01

In a continuing work of establishing safe limits for UV protection on sunglasses, we have estimated the incident UV radiation for the 280 nm - 400 nm range for 5500 locations in Brazil. Current literature establishes safe limits regarding ultraviolet radiation exposure in the spectral region 180nm-400nm for weighted and unweighted UV radiant exposure. British Standard BSEN1836(2005) and American Standard ANZI Z80.3(2009) require the UV protection in the spectral range 280nm-380nm, and The Brazilian Standard for sunglasses protection, NBR15111(20013), currently requires protection for the 280nm - 400nm range as established by literature. However, none of them take into account the total (unweighted) UVA radiant exposure.Calculations of these limits have been made for 5500 Brazilian locations which included the geographic position of the city; altitude, inclination angle of the Earth; typical atmospheric data (ozone column; water vapor and others) as well as scattering from concrete, grass, sand, water, etc.. Furthermore, regarding UV safety for the ocular media, the resistance to irradiance test required on this standard of irradiating the lenses for 25 continuous hours with a 450W sunlight simulator leads to a correspondence of 26 hours and 10 minutes of continuous exposure to the Sun. Moreover, since the sun irradiance in Brazil is quite large, integrations made for the 280-400 nm range shows an average of 45% of greater ultraviolet radiant exposure than for the 280-380 nm range. Suggestions on the parameters of these tests are made in order to establish safe limits according to the UV irradiance in Brazil.

15 CFR 270.102 - Conditions for establishment and deployment of a Team.

Code of Federal Regulations, 2010 CFR

2010-01-01

... deployment of a Team. 270.102 Section 270.102 Commerce and Foreign Trade Regulations Relating to Commerce and... SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.102 Conditions for establishment and deployment of a Team. (a) The Director may establish a Team for deployment...

15 CFR 270.102 - Conditions for establishment and deployment of a Team.

Code of Federal Regulations, 2014 CFR

2014-01-01

... deployment of a Team. 270.102 Section 270.102 Commerce and Foreign Trade Regulations Relating to Commerce and... SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.102 Conditions for establishment and deployment of a Team. (a) The Director may establish a Team for deployment...

15 CFR 270.102 - Conditions for establishment and deployment of a Team.

Code of Federal Regulations, 2013 CFR

2013-01-01

... deployment of a Team. 270.102 Section 270.102 Commerce and Foreign Trade Regulations Relating to Commerce and... SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.102 Conditions for establishment and deployment of a Team. (a) The Director may establish a Team for deployment...

15 CFR 270.102 - Conditions for establishment and deployment of a Team.

Code of Federal Regulations, 2012 CFR

2012-01-01

... deployment of a Team. 270.102 Section 270.102 Commerce and Foreign Trade Regulations Relating to Commerce and... SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.102 Conditions for establishment and deployment of a Team. (a) The Director may establish a Team for deployment...

15 CFR 270.102 - Conditions for establishment and deployment of a Team.

Code of Federal Regulations, 2011 CFR

2011-01-01

... deployment of a Team. 270.102 Section 270.102 Commerce and Foreign Trade Regulations Relating to Commerce and... SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.102 Conditions for establishment and deployment of a Team. (a) The Director may establish a Team for deployment...

77 FR 70487 - Southern California Edison Company; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

...] Southern California Edison Company; Establishment of Atomic Safety and Licensing Board Pursuant to... 2.104, 2.105, 2.300, 2.309, 2.313, 2.318, and 2.321, notice is hereby given that an Atomic Safety...), and the NRC Commission's November 8, 2012 decision in CLI-12-20 referring to the Atomic Safety and...

Pre-surgery briefings and safety climate in the operating theatre.

PubMed

Allard, Jon; Bleakley, Alan; Hobbs, Adrian; Coombes, Lee

2011-08-01

In 2008, the WHO produced a surgical safety checklist against a background of a poor patient safety record in operating theatres. Formal team briefings are now standard practice in high-risk settings such as the aviation industry and improve safety, but are resisted in surgery. Research evidence is needed to persuade the surgical workforce to adopt safety procedures such as briefings. To investigate whether exposure to pre-surgery briefings is related to perception of safety climate. Three Safety Attitude Questionnaires, completed by operating theatre staff in 2003, 2004 and 2006, were used to evaluate the effects of an educational intervention introducing pre-surgery briefings. Individual practitioners who agree with the statement 'briefings are common in the operating theatre' also report a better 'safety climate' in operating theatres. The study reports a powerful link between briefing practices and attitudes towards safety. Findings build on previous work by reporting on the relationship between briefings and safety climate within a 4-year period. Briefings, however, remain difficult to establish in local contexts without appropriate team-based patient safety education. Success in establishing a safety culture, with associated practices, may depend on first establishing unidirectional, positive change in attitudes to create a safety climate.

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

78 FR 48029 - Improving Chemical Facility Safety and Security

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-07

... responding to risks in chemical facilities (including during pre-inspection, inspection execution, post.... Sec. 2. Establishment of the Chemical Facility Safety and Security Working Group. (a) There is established a Chemical Facility Safety and Security Working Group (Working Group) co-chaired by the Secretary...

75 FR 29155 - Publicly Available Consumer Product Safety Information Database

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-24

...The Consumer Product Safety Commission (``Commission,'' ``CPSC,'' or ``we'') is issuing a notice of proposed rulemaking that would establish a publicly available consumer product safety information database (``database''). Section 212 of the Consumer Product Safety Improvement Act of 2008 (``CPSIA'') amended the Consumer Product Safety Act (``CPSA'') to require the Commission to establish and maintain a publicly available, searchable database on the safety of consumer products, and other products or substances regulated by the Commission. The proposed rule would interpret various statutory requirements pertaining to the information to be included in the database and also would establish provisions regarding submitting reports of harm; providing notice of reports of harm to manufacturers; publishing reports of harm and manufacturer comments in the database; and dealing with confidential and materially inaccurate information.

Step voltage analysis for the catenoid lightning protection system

NASA Technical Reports Server (NTRS)

Chai, J. C.; Briet, R.; Barker, D. L.; Eley, H. E.

1991-01-01

The main objective of the proposed overhead Catenoid Lightning Protection System (CLPS) is personnel safety. To ensure working personnel's safety in lightning situations, it is necessary that the potential difference developed across a distance equal to a person's pace (step voltage) does not exceed a separately established safe voltage in order to avoid electrocution (ventricular fibrillation) of humans. Therefore, the first stage of the analytical effort is to calculate the open circuit step voltage. An impedance model is developed for this purpose. It takes into consideration the earth's complex impedance behavior and the transient nature of the lightning phenomenon. In the low frequency limit, this impedance model is shown to reduce to results similar to those predicted by the conventional resistor model in a DC analysis.

75 FR 21680 - GE-Hitachi Global Laser Enrichment LLC;

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... Global Laser Enrichment LLC; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by... is hereby given that an Atomic Safety and Licensing Board (Board) is being established to preside... comprised of the following administrative judges: Paul S. Ryerson, Chair, Atomic Safety and Licensing Board...

Evaluation of a Broad-Spectrum Partially Automated Adverse Event Surveillance System: A Potential Tool for Patient Safety Improvement in Hospitals With Limited Resources.

PubMed

Saikali, Melody; Tanios, Alain; Saab, Antoine

2017-11-21

The aim of the study was to evaluate the sensitivity and resource efficiency of a partially automated adverse event (AE) surveillance system for routine patient safety efforts in hospitals with limited resources. Twenty-eight automated triggers from the hospital information system's clinical and administrative databases identified cases that were then filtered by exclusion criteria per trigger and then reviewed by an interdisciplinary team. The system, developed and implemented using in-house resources, was applied for 45 days of surveillance, for all hospital inpatient admissions (N = 1107). Each trigger was evaluated for its positive predictive value (PPV). Furthermore, the sensitivity of the surveillance system (overall and by AE category) was estimated relative to incidence ranges in the literature. The surveillance system identified a total of 123 AEs among 283 reviewed medical records, yielding an overall PPV of 52%. The tool showed variable levels of sensitivity across and within AE categories when compared with the literature, with a relatively low overall sensitivity estimated between 21% and 44%. Adverse events were detected in 23 of the 36 AE categories defined by an established harm classification system. Furthermore, none of the detected AEs were voluntarily reported. The surveillance system showed variable sensitivity levels across a broad range of AE categories with an acceptable PPV, overcoming certain limitations associated with other harm detection methods. The number of cases captured was substantial, and none had been previously detected or voluntarily reported. For hospitals with limited resources, this methodology provides valuable safety information from which interventions for quality improvement can be formulated.

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2010 CFR

2010-07-01

... equivalent level of safety. (c) As a third option, other technical analysis procedures, as approved by the... Equivalent Level of Safety Analysis § 102-80.115 Is there more than one option for establishing that an... areas of safety. Available safe egress times would be developed based on analysis of a number of assumed...

Educating future leaders in patient safety

PubMed Central

Leotsakos, Agnès; Ardolino, Antonella; Cheung, Ronny; Zheng, Hao; Barraclough, Bruce; Walton, Merrilyn

2014-01-01

Education of health care professionals has given little attention to patient safety, resulting in limited understanding of the nature of risk in health care and the importance of strengthening systems. The World Health Organization developed the Patient Safety Curriculum Guide: Multiprofessional Edition to accelerate the incorporation of patient safety teaching into higher educational curricula. The World Health Organization Curriculum Guide uses a health system-focused, team-dependent approach, which impacts all health care professionals and students learning in an integrated way about how to operate within a culture of safety. The guide is pertinent in the context of global educational reforms and growing recognition of the need to introduce patient safety into health care professionals’ curricula. The guide helps to advance patient safety education worldwide in five ways. First, it addresses the variety of opportunities and contexts in which health care educators teach, and provides practical recommendations to learning. Second, it recommends shared learning by students of different professions, thus enhancing student capacity to work together effectively in multidisciplinary teams. Third, it provides guidance on a range of teaching methods and pedagogical activities to ensure that students understand that patient safety is a practical science teaching them to act in evidence-based ways to reduce patient risk. Fourth, it encourages supportive teaching and learning, emphasizing the need to establishing teaching environments in which students feel comfortable to learn and practice patient safety. Finally, it helps educators incorporate patient safety topics across all areas of clinical practice. PMID:25285012

Feedback from incident reporting: information and action to improve patient safety.

PubMed

Benn, J; Koutantji, M; Wallace, L; Spurgeon, P; Rejman, M; Healey, A; Vincent, C

2009-02-01

Effective feedback from incident reporting systems in healthcare is essential if organisations are to learn from failures in the delivery of care. Despite the wide-scale development and implementation of incident reporting in healthcare, studies in the UK suggest that information concerning system vulnerabilities could be better applied to improve operational safety within organisations. In this article, the findings and implications of research to identify forms of effective feedback from incident reporting are discussed, to promote best practices in this area. The research comprised a mixed methods review to investigate mechanisms of effective feedback for healthcare, drawing upon experience within established reporting programmes in high-risk industry and transport domains. Systematic searches of published literature were undertaken, and 23 case studies describing incident reporting programmes with feedback were identified for analysis from the international healthcare literature. Semistructured interviews were undertaken with 19 subject matter experts across a range of domains, including: civil aviation, maritime, energy, rail, offshore production and healthcare. In analysis, qualitative information from several sources was synthesised into practical requirements for developing effective feedback in healthcare. Both action and information feedback mechanisms were identified, serving safety awareness, improvement and motivational functions. The provision of actionable feedback that visibly improved systems was highlighted as important in promoting future reporting. Fifteen requirements for the design of effective feedback systems were identified, concerning: the role of leadership, the credibility and content of information, effective dissemination channels, the capacity for rapid action and the need for feedback at all levels of the organisation, among others. Above all, the safety-feedback cycle must be closed by ensuring that reporting, analysis and investigation result in timely corrective actions that effectively address vulnerabilities in existing work systems. Limited research evidence exists concerning the issue of effective forms of safety feedback within healthcare. Much valuable operational knowledge resides in safety management communities within high-risk industries. Multiple means of feeding back recommended actions and safety information may be usefully employed to promote safety awareness, improve clinical processes and promote future reporting. Further work is needed to establish best practices for feedback systems in healthcare that effectively close the safety loop.

NIOSH comments to DOL on the Mine Safety and Health Administration's proposed rule on air quality, chemical substances, and respiratory protection standards by J. D. Millar, March 1, 1990

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

Not Available

The testimony concerns the views of NIOSH regarding the Mine Safety and Health Administration (MSHA) proposed rule on permissible exposure limits; exposure monitoring, abrasive blasting; drill dust control; dangerous atmospheres; and prohibited areas for food and beverages. NIOSH continues to endorse the recommended exposure limit of 1 part per million (ppm) as a 15 minute short term exposure limit for nitrogen-dioxide (10102440). NIOSH supports MSHA in proposing an 8 hour time weighted average of 25ppm for nitric-oxide (10102439). NIOSH supports MSHA in proposing a limit of 35ppm as an 8 hour time weighted average (TWA) for carbon-monoxide (630080) and recommendsmore » that sulfur-dioxide (7446095) exposure be limited to 0.5ppm as an 8 hour TWA. NIOSH recommends that routine air monitoring be required on a periodic basis. NIOSH recommends that mine operators be required to establish a written exposure monitoring plan for each facility that outlines where area and personal samples should be taken, how many samples should be taken, and the implementation of the remaining portions of the proposed rule change. NIOSH supports the rules for abrasive blasting for both coal and metal/nonmetal mines and has identified several substitutive materials for silica sand that could be used in abrasive blasting.« less

Critical roles of orthopaedic surgeon leadership in healthcare systems to improve orthopaedic surgical patient safety.

PubMed

Kuo, Calvin C; Robb, William J

2013-06-01

The prevention of medical and surgical harm remains an important public health problem despite increased awareness and implementation of safety programs. Successful introduction and maintenance of surgical safety programs require both surgeon leadership and collaborative surgeon-hospital alignment. Documentation of success of such surgical safety programs in orthopaedic practice is limited. We describe the scope of orthopaedic surgical patient safety issues, define critical elements of orthopaedic surgical safety, and outline leadership roles for orthopaedic surgeons needed to establish and sustain a culture of safety in contemporary healthcare systems. We identified the most common causes of preventable surgical harm based on adverse and sentinel surgical events reported to The Joint Commission. A comprehensive literature review through a MEDLINE(®) database search (January 1982 through April 2012) to identify pertinent orthopaedic surgical safety articles found 14 articles. Where gaps in orthopaedic literature were identified, the review was supplemented by 22 nonorthopaedic surgical references. Our final review included 36 articles. Six important surgical safety program elements needed to eliminate preventable surgical harm were identified: (1) effective surgical team communication, (2) proper informed consent, (3) implementation and regular use of surgical checklists, (4) proper surgical site/procedure identification, (5) reduction of surgical team distractions, and (6) routine surgical data collection and analysis to improve the safety and quality of surgical patient care. Successful surgical safety programs require a culture of safety supported by all six key surgical safety program elements, active surgeon champions, and collaborative hospital and/or administrative support designed to enhance surgical safety and improve surgical patient outcomes. Further research measuring improvements from such surgical safety systems in orthopaedic care is needed.

Assessment of Risk Communication about Undercooked Hamburgers by Restaurant Servers.

PubMed

Thomas, Ellen M; Binder, Andrew R; McLAUGHLIN, Anne; Jaykus, Lee-Ann; Hanson, Dana; Powell, Douglas; Chapman, Benjamin

2016-12-01

According to the U.S. Food and Drug Administration 2013 Model Food Code, it is the duty of a food establishment to disclose and remind consumers of risk when ordering undercooked food such as ground beef. The purpose of this study was to explore actual risk communication behaviors of food establishment servers. Secret shoppers visited 265 restaurants in seven geographic locations across the United States, ordered medium rare burgers, and collected and coded risk information from chain and independent restaurant menus and from server responses. The majority of servers reported an unreliable method of doneness (77%) or other incorrect information (66%) related to burger doneness and safety. These results indicate major gaps in server knowledge and risk communication, and the current risk communication language in the Model Food Code does not sufficiently fill these gaps. The question is "should servers even be acting as risk communicators?" There are numerous challenges associated with this practice, including high turnover rates, limited education, and the high stress environment based on pleasing a customer. If servers are designated as risk communicators, food establishment staff should be adequately trained and provided with consumer advisory messages that are accurate, audience appropriate, and delivered in a professional manner so that customers can make informed food safety decisions.

Implementation of a Data-Based Medical Event Reporting System in the U.S. Department of Defense

DTIC Science & Technology

2005-05-01

where patient safety events warrant further investigation. Introduction Department of Defense Instruction 6025.17 established the Military Health ...Administration (VHA) Patient Safety Reporting Program for error tracking and reporting within all military health care facilities. 5 On August 16, 2001...DoD Instruction number 6025.17 “established a Military Health System Patient Safety Center (MHSPSC), including a MHS Patient Safety Registry (MHSPSR

A no-fault compensation system for medical injury is long overdue.

PubMed

Weisbrot, David; Breen, Kerry J

2012-09-03

The 2011 report of the Productivity Commission (PC) recommended the establishment of a no-fault national injury insurance scheme limited to "catastrophic" injury, including medical injury. The report is welcome, but represents a missed opportunity to establish simultaneously a much-needed no-fault scheme for all medical injuries. The existing indemnity scheme based on negligence remains a slow, costly, inefficient, ill targeted and stress-creating system. A fault-based negligence scheme cannot deter non-intentional errors and does little to identify or prevent systems failures. In addition, it discourages reporting, and thus is antithetical to the modern focus on universal patient safety. A no-fault scheme has the potential to be fairer, quicker and no more costly, and to contribute to patient safety. No-fault schemes have been in place in at least six developed countries for many years. This extensive experience in comparable countries should be examined to assist Australia to design an effective, comprehensive system. Before implementing the recommendations of the PC, the federal government should ask the Commission to study and promptly report on an ancillary no-fault scheme that covers all medical injury.

Reducing oral and maxillofacial surgery resident risk exposure: lessons from graduate medical education reform.

PubMed

Buhrow, Suzanne Morse; Buhrow, Jack A

2013-12-01

It is estimated that, in the United States, more than 40,000 patients are injured each day because of preventable medical errors. Although numerous studies examine the causes of medical trainee errors and efforts to mitigate patient injuries in this population, little research exists on adverse events experienced by oral and maxillofacial surgery (OMFS) residents or strategies to improve patient safety awareness in OMFS residency programs. The authors conducted a retrospective literature review of contemporary studies on medical trainees' reported risk exposure and the impact of integrating evidence-based patient safety training into residency curricula. A review of the literature suggests that OMFS residents face similar risks as medical trainees in medical, surgical, and anesthesia residency programs and may benefit from integrating competency-based safety training in the OMFS residency curriculum. OMFS trainees face particular challenges when transitioning from dental student to surgical resident, particularly related to their limited clinical exposure to high-reliability organizations, which may place them at higher risk than other medical trainees. OMFS educators should establish resident competence in patient safety principles and system improvement strategies throughout the training period.

GAO’s Views on DOE’s 1991 Budget for Addressing Problems at the Nuclear Weapons Complex

DTIC Science & Technology

1990-03-02

management, and efforts by DOE to make its contractors more accountable. Also, the Defense Nuclear Facilities Safety Board mandated by the Congress became...and safety matters. 6 Finally, the Defense Nuclear Facilities Safety Board was established. Although not a DOE action, its establishment, nevertheless

[Comprehensive drug safety plan in a health department].

PubMed

Bujaldón-Querejeta, N; Aznar-Saliente, T; Esplá-González, S; Ruíz-Darbonnéns, S; Pons-Martínez, L; Talens-Bolos, A; Martínez-Ramírez, M; Camacho-Romera, D; Aranaz-Andrés, J M

2014-01-01

To develop and implement a comprehensive drug safety plan in a hospital for the years 2009-2011. Applying the Strengths Weaknesses/Limitations Opportunities Threats (SWOT) methodology, the baseline situation was analyzed and a broad strategy or plan was subsequently developed, defining the scope, responsibilities, objectives and strategic actions and indicators in order to measure the achievement of the results. A comprehensive drug safety plan with the main objective of identifying and reducing the medication-related problems in patients treated in the Hospital de San Juan in Alicante has been developed. The plan contains five strategic objectives, twenty strategic actions and the indicators to assess its outcomes. It also contains a timetable for its establishment and evaluation. Developing a comprehensive strategic plan allows the current situation relating to drug safety to be determined. The results obtained after its introduction will define its applicability. Due to the lack of publications of similar plans and results, the evaluation of this plan will be useful whether it is favorable or not. As a side benefit of the development, the multidisciplinary team continues to work on improving patient safety in the care process, and the safety culture continues to grow among the professionals. Copyright © 2013 SECA. Published by Elsevier Espana. All rights reserved.

The Emerging Role for rTMS in Optimizing the Treatment of Adolescent Depression

PubMed Central

Croarkin, Paul E.; Wall, Christopher A.; McClintock, Shawn M.; Kozel, F. Andrew; Husain, Mustafa M.; Sampson, Shirlene M.

2010-01-01

Major depressive disorder (MDD) in adolescents is a common illness and significant public health problem. Treatment is challenging due to recurrences and limited modalities. Selective serotonin reuptake inhibitors (SSRIs) and Cognitive Behavioral Therapy (CBT) are considered the standard of care in severe or treatment resistant MDD in this age group. However, responses to these interventions are often suboptimal. A growing body of research supports the efficacy of repetitive transcranial magnetic stimulation for the treatment of MDD in adults. Induced seizures are a primary safety concern, although this is rare with appropriate precautions. There is, however, limited experience with rTMS as a therapeutic intervention for adolescent psychiatric disturbances. This review will summarize the rTMS efficacy and safety data in adults and describe all published experience with adolescent MDD. Applications in other adolescent psychiatric illnesses such as schizophrenia and attention-deficit/hyperactivity disorder (ADHD) are reviewed. Safety and ethical issues are paramount with investigational treatments in adolescent psychiatric illnesses. However, further research with rTMS in adolescent MDD is imperative to establish standards for optimal stimulation site, treatment parameters, and its role in treatment algorithms. These may diverge from adult data. Early intervention with neuromodulation could also hold the promise of addressing the developmental course of dysfunctional neurocircuitry. PMID:20418774

A quantitative comparison of the safety margins in the european indicative occupational exposure limits and the derived no-effect levels for workers under REACH.

PubMed

Schenk, Linda; Johanson, Gunnar

2011-06-01

The new European Union (EU) REACH legislation requires derived no-effect levels (DNELs) to be calculated for substances produced in quantities above 10 tonnes/year. Meanwhile, the setting of occupational exposure limits (OELs) continues both at the member state and the EU levels. According to REACH, indicative OEL values (IOELVs) from the Commission may under some circumstances be used as worker-DNELs. On the other hand, worker-DNELs will be derived for several thousand substances, far more than the approximately 100 substances for which IOELVs have been established. Thus, the procedure to set health-based OELs may become influential on that of DNELs and vice versa. In this study, we compare the safety margins of 88 Scientific Committee on OELs (SCOEL) recommendations with those of the corresponding worker-DNELs, derived according to the default approach as described in the REACH guidance document. Overall, the REACH safety margins were approximately six times higher than those derived from the SCOEL documentation but varied widely with REACH/SCOEL safety margin ratios ranging by two orders of magnitude, from 0.3 to 58 (n = 88). The discrepancies may create confusion in terms of legal compliance, risk management, and risk communication. We also found that the REACH guidance document, although encompassing detailed advice on many issues, including default assessment factors for species and route extrapolation, gives little quantitative guidance on when and how to depart from defaults.

75 FR 43092 - Airworthiness Directives; Viking Air Limited (Type Certificate Previously Held by Bombardier, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-23

... completed a system safety review of the aircraft fuel system against fuel tank safety standards introduced... Limited has completed a system safety review of the aircraft fuel system against fuel tank safety... describes the unsafe condition as: Viking Air Limited has completed a system safety review of the aircraft...

76 FR 56243 - Southern Nuclear Operating Co., PPL Bell Bend, L.L.C., Luminant Generation Company LLC...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-12

... Generation Company LLC; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the... hereby given that an Atomic Safety and Licensing Board (Board) is being established to preside over this.... The contested proceedings in these cases had been terminated at the Atomic Safety and Licensing Board...

75 FR 50009 - Babcock & Wilcox Nuclear Operations Group, Inc.; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... Nuclear Operations Group, Inc.; Establishment of Atomic Safety and Licensing Board Pursuant to delegation... 2.106, 2.300, 2.313(a), and 2.318, notice is hereby given that an Atomic Safety and Licensing Board..., 2010. The Board is comprised of the following administrative judges: Alan S. Rosenthal, Chair, Atomic...

75 FR 48992 - Baseline Safety and Health Practices; Office of Management and Budget's (OMB) Approval of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-12

... health practices of private sector establishments in agriculture (with 10 or more workers) and non-agriculture industries, as well as public sector establishments in those states with OSHA-approved safety and... agriculture sector to assess the prevalence of safety and health practices among farms with more than 10...

[Design of a Hazard Analysis and Critical Control Points (HACCP) plan to assure the safety of a bologna product produced by a meat processing plant].

PubMed

Bou Rached, Lizet; Ascanio, Norelis; Hernández, Pilar

2004-03-01

The Hazard Analysis and Critical Control Point (HACCP) is a systematic integral program used to identify and estimate the hazards (microbiological, chemical and physical) and the risks generated during the primary production, processing, storage, distribution, expense and consumption of foods. To establish a program of HACCP has advantages, being some of them: to emphasize more in the prevention than in the detection, to diminish the costs, to minimize the risk of manufacturing faulty products, to allow bigger trust to the management, to strengthen the national and international competitiveness, among others. The present work is a proposal based on the design of an HACCP program to guarantee the safety of the Bologna Special Type elaborated by a meat products industry, through the determination of hazards (microbiological, chemical or physical), the identification of critical control points (CCP), the establishment of critical limits, plan corrective actions and the establishment of documentation and verification procedures. The used methodology was based in the application of the seven basic principles settled down by the Codex Alimentarius, obtaining the design of this program. In view of the fact that recently the meat products are linked with pathogens like E. coli O157:H7 and Listeria monocytogenes, these were contemplated as microbiological hazard for the establishment of the HACCP plan whose application will guarantee the obtaining of a safe product.

21 CFR 310.533 - Drug products containing active ingredients offered over-the-counter (OTC) for human use as an...

Code of Federal Regulations, 2010 CFR

2010-04-01

...); however, there are inadequate data to establish general recognition of the effectiveness of this... milligram) but there are inadequate data to establish general recognition of the effectiveness of these... are inadequate safety and effectiveness data to establish general recognition of the safety and/or...

An assessment of food safety information provision for UK chemotherapy patients to reduce the risk of foodborne infection.

PubMed

Evans, E W; Redmond, E C

2017-12-01

Given the increased risk of foodborne infection to cancer patients receiving chemotherapy treatment, and the risk of listeriosis reportedly five-times greater to this immunocompromised patient group, there is a need to ensure the implementation of domestic food safety practices among chemotherapy patients and their family caregivers. However, information regarding the adequacy of resources to inform and enable patients to implement domestic food safety practices to reduce the risk of foodborne infection is limited. Consequently, this study aimed to evaluate the provision of food safety information available to UK chemotherapy patients. In-depth semi-structured interviews and content analysis of online patient information resources. Interviews with patients and family caregivers (n = 15) were conducted to explore food-related experiences during chemotherapy treatment. Online food-related information resources for chemotherapy patients (n = 45) were obtained from 35 of 154 National Health Service chemotherapy providers in England, Scotland, and Wales, the Department of Health (DoH) and three of 184 identified UK cancer charities. Identified food-related information resources were reviewed using a content-analysis approach to assess the inclusion of food safety information for chemotherapy patients. In-depth interviews established that many patients indicated awareness of immunosuppression during treatment. Although patients reported practicing caution to reduce the risk of communicable diseases by avoiding crowded spaces/public transport, food safety was reported to be of minimal concern during treatment and the risk of foodborne infection was often underestimated. The review of online food-related patient information resources established that many resources failed to highlight the increased risk of foodborne infection and emphasize the importance of food safety for patients during chemotherapy treatment. Considerable information gaps exist, particularly in relation to listeriosis prevention practices. Cumulatively, information was inconsistent, insufficient, and varied between resources. The study has identified the need for an effective, standardized food safety resource specifically targeting chemotherapy patients and family caregivers. Such intervention is essential to assist efforts in reducing the risks associated with foodborne infection among chemotherapy patients. Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Do aluminium-based phosphate binders continue to have a role in contemporary nephrology practice?

PubMed

Mudge, David W; Johnson, David W; Hawley, Carmel M; Campbell, Scott B; Isbel, Nicole M; van Eps, Carolyn L; Petrie, James J B

2011-05-13

Aluminium-containing phosphate binders have long been used for treatment of hyperphosphatemia in dialysis patients. Their safety became controversial in the early 1980's after reports of aluminium related neurological and bone disease began to appear. Available historical evidence however, suggests that neurological toxicity may have primarily been caused by excessive exposure to aluminium in dialysis fluid, rather than aluminium-containing oral phosphate binders. Limited evidence suggests that aluminium bone disease may also be on the decline in the era of aluminium removal from dialysis fluid, even with continued use of aluminium binders. The K/DOQI and KDIGO guidelines both suggest avoiding aluminium-containing binders. These guidelines will tend to promote the use of the newer, more expensive binders (lanthanum, sevelamer), which have limited evidence for benefit and, like aluminium, limited long-term safety data. Treating hyperphosphatemia in dialysis patients continues to represent a major challenge, and there is a large body of evidence linking serum phosphate concentrations with mortality. Most nephrologists agree that phosphate binders have the potential to meaningfully reduce mortality in dialysis patients. Aluminium is one of the cheapest, most effective and well tolerated of the class, however there are no prospective or randomised trials examining the efficacy and safety of aluminium as a binder. Aluminium continues to be used as a binder in Australia as well as some other countries, despite concern about the potential for toxicity. There are some data from selected case series that aluminium bone disease may be declining in the era of reduced aluminium content in dialysis fluid, due to rigorous water testing. This paper seeks to revisit the contemporary evidence for the safety record of aluminium-containing binders in dialysis patients. It puts their use into the context of the newer, more expensive binders and increasing concerns about the risks of calcium binders, which continue to be widely used. The paper seeks to answer whether the continued use of aluminium is justifiable in the absence of prospective data establishing its safety, and we call for prospective trials to be conducted comparing the available binders both in terms of efficacy and safety. © 2011 Mudge et al; licensee BioMed Central Ltd.

Do aluminium-based phosphate binders continue to have a role in contemporary nephrology practice?

PubMed Central

2011-01-01

Background Aluminium-containing phosphate binders have long been used for treatment of hyperphosphatemia in dialysis patients. Their safety became controversial in the early 1980's after reports of aluminium related neurological and bone disease began to appear. Available historical evidence however, suggests that neurological toxicity may have primarily been caused by excessive exposure to aluminium in dialysis fluid, rather than aluminium-containing oral phosphate binders. Limited evidence suggests that aluminium bone disease may also be on the decline in the era of aluminium removal from dialysis fluid, even with continued use of aluminium binders. Discussion The K/DOQI and KDIGO guidelines both suggest avoiding aluminium-containing binders. These guidelines will tend to promote the use of the newer, more expensive binders (lanthanum, sevelamer), which have limited evidence for benefit and, like aluminium, limited long-term safety data. Treating hyperphosphatemia in dialysis patients continues to represent a major challenge, and there is a large body of evidence linking serum phosphate concentrations with mortality. Most nephrologists agree that phosphate binders have the potential to meaningfully reduce mortality in dialysis patients. Aluminium is one of the cheapest, most effective and well tolerated of the class, however there are no prospective or randomised trials examining the efficacy and safety of aluminium as a binder. Aluminium continues to be used as a binder in Australia as well as some other countries, despite concern about the potential for toxicity. There are some data from selected case series that aluminium bone disease may be declining in the era of reduced aluminium content in dialysis fluid, due to rigorous water testing. Summary This paper seeks to revisit the contemporary evidence for the safety record of aluminium-containing binders in dialysis patients. It puts their use into the context of the newer, more expensive binders and increasing concerns about the risks of calcium binders, which continue to be widely used. The paper seeks to answer whether the continued use of aluminium is justifiable in the absence of prospective data establishing its safety, and we call for prospective trials to be conducted comparing the available binders both in terms of efficacy and safety. PMID:21569446

Safety in the Workplace.

ERIC Educational Resources Information Center

Shaw, Richard

1999-01-01

Addresses workplace safety needs and tips for helping an organization achieve a high level of safety. Tips include showing administration commitment, establishing retribution-free reporting of safety problems and violations, rewarding excellent safety effort, and allowing no compromises in following safety procedures. (GR)

The Importance of Quality Specifications in Safety Assessments of Amino Acids: The Cases of l-Tryptophan and l-Citrulline.

PubMed

Oketch-Rabah, Hellen A; Roe, Amy L; Gurley, Bill J; Griffiths, James C; Giancaspro, Gabriel I

2016-12-01

The increasing consumption of amino acids from a wide variety of sources, including dietary supplements, natural health products, medical foods, infant formulas, athletic and work-out products, herbal medicines, and other national and international categories of nutritional and functional food products, increases the exposure to amino acids to amounts far beyond those normally obtained from the diet, thereby necessitating appropriate and robust safety assessments of these ingredients. Safety assessments of amino acids, similar to all food constituents, largely rely on the establishment of an upper limit [Tolerable Upper Intake Level (UL)] considered to be a guide for avoiding high intake, above which adverse or toxic effects might occur. However, reliable ULs have been difficult or impossible to define for amino acids because of inadequate toxicity studies in animals and scarce or missing clinical data, as well as a paucity or absence of adverse event reporting data. This review examines 2 amino acids that have been associated with in-market adverse events to show how quality specifications might have helped prevent the adverse clinical outcomes. We further highlight the importance of various factors that should be incorporated into an overall safety assessment of these and other amino acids. In addition to the traditional reliance on the established UL, well-defined quality specifications, review of synthesis and production strategies, potential interactions with drugs, contraindications with certain disease states, and cautionary use within certain age groups should all be taken into consideration. © 2016 American Society for Nutrition.

International recommendations for national patient safety incident reporting systems: an expert Delphi consensus-building process.

PubMed

Howell, Ann-Marie; Burns, Elaine M; Hull, Louise; Mayer, Erik; Sevdalis, Nick; Darzi, Ara

2017-02-01

Patient safety incident reporting systems (PSRS) have been established for over a decade, but uncertainty remains regarding the role that they can and ought to play in quantifying healthcare-related harm and improving care. To establish international, expert consensus on the purpose of PSRS regarding monitoring and learning from incidents and developing recommendations for their future role. After a scoping review of the literature, semi-structured interviews with experts in PSRS were conducted. Based on these findings, a survey-based questionnaire was developed and subsequently completed by a larger expert panel. Using a Delphi approach, consensus was reached regarding the ideal role of PSRSs. Recommendations for best practice were devised. Forty recommendations emerged from the Delphi procedure on the role and use of PSRS. Experts agreed reporting system should not be used as an epidemiological tool to monitor the rate of harm over time or to appraise the relative safety of hospitals. They agreed reporting is a valuable mechanism for identifying organisational safety needs. The benefit of a national system was clear with respect to medication error, device failures, hospital-acquired infections and never events as these problems often require solutions at a national level. Experts recommended training for senior healthcare professionals in incident investigation. Consensus recommendation was for hospitals to take responsibility for creating safety solutions locally that could be shared nationally. We obtained reasonable consensus among experts on aims and specifications of PSRS. This information can be used to reflect on existing and future PSRS, and their role within the wider patient safety landscape. The role of PSRS as instruments for learning needs to be elaborated and developed further internationally. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Risk Management Plans: are they a tool for improving drug safety?

PubMed

Frau, Serena; Font Pous, Maria; Luppino, Maria Rosa; Conforti, Anita

2010-08-01

In 2005, new European legislation authorised Regulatory Agencies to require drug companies to submit a risk management plan (RMP) comprising detailed commitments for post-marketing pharmacovigilance. The aim of the study is to describe the characteristics of RMP for 15 drugs approved by the European Medicines Agency (EMA) and their impact on post-marketing safety issues. Of the 90 new Chemical Entities approved through a centralised procedure by the EMA during 2006 and 2007, 15 of them were selected and their safety aspects and relative RMPs analysed. All post-marketing communications released for safety reasons related to these drugs were also considered. A total of 157 safety specifications were established for the drugs assessed. Risk minimisation activities were foreseen for 5 drugs as training activities. Post-marketing safety issues emerged for 12 of them, leading to 39 type II variations in Summary of Product Characteristics (SPC). Nearly half of such variations, 19 (49%), concerned safety aspects not envisaged by the RMPs. Besides this, 9 Safety Communications were published for 6 out of 15 drugs assessed. The present study reveals several critical points on the way RMPs have been implemented. Several activities proposed by the RMPs do not appear to be adequate in dealing with the potential risks of drugs. Poor communication of risk to practitioners and to the public, and above all limited transparency for the total assessment of risk, seem to transform RMPs into a tool to reassure the public when inadequately evaluated drugs are granted premature marketing authorisation.

12 CFR Appendix A to Part 30 - Interagency Guidelines Establishing Standards for Safety and Soundness

Code of Federal Regulations, 2013 CFR

2013-01-01

... establish certain safety and soundness standards by regulation or by guideline for all insured depository... rules and regulations to establish deadlines for submission and review of compliance plans. 2 2 For the Office of the Comptroller of the Currency, these regulations appear at 12 CFR part 30; for the Board of...

12 CFR Appendix A to Part 170 - Interagency Guidelines Establishing Standards for Safety and Soundness

Code of Federal Regulations, 2013 CFR

2013-01-01

... agencies) to establish certain safety and soundness standards by regulation or by guideline for all insured... adopted amendments to their rules and regulations to establish deadlines for submission and review of compliance plans.2 2 For the Office of the Comptroller of the Currency, these regulations appear at 12 CFR...

New technology for food safety: role of the new technology staff in FSIS

NASA Astrophysics Data System (ADS)

Early, Howard

2004-03-01

The Food Safety and Inspection Service (FSIS) has implemented new procedures for meat and poultry establishments, egg products plants, and companies that manufacture and sell technology to official establishments to notify the Agency of new technology that they propose to use in meat and poultry establishments or egg products plants. If the new technology could affect FSIS regulations, product safety, inspection procedures, or the safety of Federal inspection program personnel, then the establishment or plant would need to submit a written protocol to the Agency. As part of this process, the submitter will be expected to conduct in-plant trials of the new technology. The submitter will need to provide data to FSIS throughout the duration of the in-plant trial for the Agency to examine. Data may take several forms: laboratory results, weekly or monthly summary production reports, and evaluations from inspection program personnel.

Basis for Interim Operation for Fuel Supply Shutdown Facility

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

BENECKE, M.W.

2003-02-03

This document establishes the Basis for Interim Operation (BIO) for the Fuel Supply Shutdown Facility (FSS) as managed by the 300 Area Deactivation Project (300 ADP) organization in accordance with the requirements of the Project Hanford Management Contract procedure (PHMC) HNF-PRO-700, ''Safety Analysis and Technical Safety Requirements''. A hazard classification (Benecke 2003a) has been prepared for the facility in accordance with DOE-STD-1027-92 resulting in the assignment of Hazard Category 3 for FSS Facility buildings that store N Reactor fuel materials (303-B, 3712, and 3716). All others are designated Industrial buildings. It is concluded that the risks associated with the currentmore » and planned operational mode of the FSS Facility (uranium storage, uranium repackaging and shipment, cleanup, and transition activities, etc.) are acceptable. The potential radiological dose and toxicological consequences for a range of credible uranium storage building have been analyzed using Hanford accepted methods. Risk Class designations are summarized for representative events in Table 1.6-1. Mitigation was not considered for any event except the random fire event that exceeds predicted consequences based on existing source and combustible loading because of an inadvertent increase in combustible loading. For that event, a housekeeping program to manage transient combustibles is credited to reduce the probability. An additional administrative control is established to protect assumptions regarding source term by limiting inventories of fuel and combustible materials. Another is established to maintain the criticality safety program. Additional defense-in-depth controls are established to perform fire protection system testing, inspection, and maintenance to ensure predicted availability of those systems, and to maintain the radiological control program. It is also concluded that because an accidental nuclear criticality is not credible based on the low uranium enrichment, the form of the uranium, and the required controls, a Criticality Alarm System (CAS) is not required as allowed by DOE Order 420.1 (DOE 2000).« less

Semiquantitative analysis of gaps in microbiological performance of fish processing sector implementing current food safety management systems: a case study.

PubMed

Onjong, Hillary Adawo; Wangoh, John; Njage, Patrick Murigu Kamau

2014-08-01

Fish processing plants still face microbial food safety-related product rejections and the associated economic losses, although they implement legislation, with well-established quality assurance guidelines and standards. We assessed the microbial performance of core control and assurance activities of fish exporting processors to offer suggestions for improvement using a case study. A microbiological assessment scheme was used to systematically analyze microbial counts in six selected critical sampling locations (CSLs). Nine small-, medium- and large-sized companies implementing current food safety management systems (FSMS) were studied. Samples were collected three times on each occasion (n = 324). Microbial indicators representing food safety, plant and personnel hygiene, and overall microbiological performance were analyzed. Microbiological distribution and safety profile levels for the CSLs were calculated. Performance of core control and assurance activities of the FSMS was also diagnosed using an FSMS diagnostic instrument. Final fish products from 67% of the companies were within the legally accepted microbiological limits. Salmonella was absent in all CSLs. Hands or gloves of workers from the majority of companies were highly contaminated with Staphylococcus aureus at levels above the recommended limits. Large-sized companies performed better in Enterobacteriaceae, Escherichia coli, and S. aureus than medium- and small-sized ones in a majority of the CSLs, including receipt of raw fish material, heading and gutting, and the condition of the fish processing tables and facilities before cleaning and sanitation. Fish products of 33% (3 of 9) of the companies and handling surfaces of 22% (2 of 9) of the companies showed high variability in Enterobacteriaceae counts. High variability in total viable counts and Enterobacteriaceae was noted on fish products and handling surfaces. Specific recommendations were made in core control and assurance activities associated with sampling locations showing poor performance.

Quinolones and tetracyclines in aquaculture fish by a simple and rapid LC-MS/MS method.

PubMed

Guidi, Letícia Rocha; Santos, Flávio Alves; Ribeiro, Ana Cláudia S R; Fernandes, Christian; Silva, Luiza H M; Gloria, Maria Beatriz A

2018-04-15

The determination of antimicrobials in aquaculture fish is important to ensure food safety. Therefore, simple and fast multiresidue methods are needed. A liquid chromatography tandem mass spectrometry method was developed and validated for the quantification of 14 antimicrobials (quinolones and tetracyclines) in fish. Antimicrobials were extracted with trichloroacetic acid and chromatographic separation was achieved with a C18 column and gradient elution (water and acetonitrile). The method was validated (Decision 2002/657/EC) and it was fit for the purpose. Linearities were established in the matrix and the coefficients of determination were ≥0.98. The method was applied to Nile tilapia and rainbow trout (n = 29) and 14% of them contained enrofloxacin at levels above the limit of quantification (12.53-19.01 µg.kg -1 ) but below the maximum residue limit (100 µg.kg -1 ). Even though prohibited in Brazil and other countries, this antimicrobial reached fish. Measures are needed to ascertain the source of this compound to warrant human safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Patient exposure to electromagnetic fields in magnetic resonance scanners: a review].

PubMed

Guibelalde del Castillo, E

2013-12-01

The use of non-ionizing electromagnetic fields in the low frequency end of the electromagnetic spectrum and static fields, radiofrequencies (RF), and microwaves is fundamental both in modern communication systems and in diagnostic medical imaging techniques like magnetic resonance imaging (MRI). The proliferation of these applications in recent decades has led to intense activity in developing regulations to guarantee their safety and to the establishment of guidelines and legal recommendations for the public, workers, and patients. In April 2012 it was foreseen that the European Parliament and Council would approve and publish a directive on the minimum health and safety requirements regarding the exposure of workers to the risks arising from electromagnetic fields, which would modify Directive 2004/40/EC. New studies related to the exposure to electromagnetic radiation and its impact on health published in recent years have led to a new postponement, and it is now foreseen that the directive will come into effect in October 2013. One of the most noteworthy aspects of the new version of the directive is the exclusion of the limits of occupational exposure to electromagnetic fields in the clinical use of MRI. In exchange for this exception, physicians and experts in protection against non-ionizing radiation are asked to make additional efforts to train workers exposed to non-ionizing radiation and to establish mechanisms to guarantee the correct application of non-ionizing electromagnetic fields in patients, along similar lines to the principles of justification and optimization established for ionizing radiation. On the basis of the most recently published studies, this article reviews some safety-related aspects to take into account when examining patients with MRI with high magnetic fields. Copyright © 2013 SERAM. Published by Elsevier Espana. All rights reserved.

Evaluation of ultrasound based sterilization approaches in terms of shelf life and quality parameters of fruit and vegetable juices.

PubMed

Khandpur, Paramjeet; Gogate, Parag R

2016-03-01

The present work evaluates the performance of ultrasound based sterilization approaches for processing of different fruit and vegetable juices in terms of microbial growth and changes in the quality parameters during the storage. Comparison with the conventional thermal processing has also been presented. A novel approach based on combination of ultrasound with ultraviolet irradiation and crude extract of essential oil from orange peels has been used for the first time. Identification of the microbial growth (total bacteria and yeast content) in the juices during the subsequent storage and assessing the safety for human consumption along with the changes in the quality parameters (Brix, titratable acidity, pH, ORP, salt, conductivity, TSS and TDS) has been investigated in details. The optimized ultrasound parameters for juice sterilization were established as ultrasound power of 100 W and treatment time of 15 min for the constant frequency operation (20 kHz). It has been established that more than 5 log reduction was achieved using the novel combined approaches based on ultrasound. The treated juices using different approaches based on ultrasound also showed lower microbial growth and improved quality characteristics as compared to the thermally processed juice. Scale up studies were also performed using spinach juice as the test sample with processing at 5 L volume for the first time. The ultrasound treated juice satisfied the microbiological and physiochemical safety limits in refrigerated storage conditions for 20 days for the large scale processing. Overall the present work conclusively established the usefulness of combined treatment approaches based on ultrasound for maintaining the microbiological safety of beverages with enhanced shelf life and excellent quality parameters as compared to the untreated and thermally processed juices. Copyright © 2015 Elsevier B.V. All rights reserved.

Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances ('legal highs') in New Zealand.

PubMed

Rychert, Marta; Wilkins, Chris; Witten, Karen

2017-09-01

New Zealand's Psychoactive Substances Act (2013) established the world's first regulated market for 'low risk' psychoactive products ('legal highs'). Under an interim PSA regime, 47 existing products were permitted to be continued to be sold. To explore issues with the implementation of regulatory systems to monitor the safety of products on the legal market under the interim Psychoactive Substances Act regime. Semi-structured interviews with 30 key stakeholders, including industry, government agency, health and drug service professionals were conducted, transcribed and analysed thematically. In retrospect stakeholders questioned the decision to approve strong synthetic cannabinoid smoking products, noting their health risks because of product formulation, inconsistent manufacturing practices and smoking as the means of administration. Industry actors claimed the decision to approve synthetic cannabinoid smokeable products prevented potentially safer products from gaining market share. The system for withdrawing approved products which were subsequently found to be harmful was criticised for the poor quality of data available, limited engagement with health professionals and the slowness of product withdrawal. Many of the problems with the regime were attributed to the urgency under which the legal market under the interim Psychoactive Substances Act was established and implemented. The selection of 'safer' products, implementation of the product monitoring system, and engagement with health professionals may have benefited from more time and resources. An incremental approach to establishing the new market may have made the regulatory management of the new regime more workable. [Rychert M, Wilkins C, Witten K. Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances ('legal highs') in New Zealand. Drug Alcohol Rev 2017;00:000-000]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

A critical care network pressure ulcer prevention quality improvement project.

PubMed

McBride, Joanna; Richardson, Annette

2015-03-30

Pressure ulcer prevention is an important safety issue, often underrated and an extremely painful event harming patients. Critically ill patients are one of the highest risk groups in hospital. The impact of pressure ulcers are wide ranging, and they can result in increased critical care and the hospital length of stay, significant interference with functional recovery and rehabilitation and increase cost. This quality improvement project had four aims: (1) to establish a critical care network pressure ulcer prevention group; (2) to establish baseline pressure ulcer prevention practices; (3) to measure, compare and monitor pressure ulcers prevalence; (4) to develop network pressure ulcer prevention standards. The approach used to improve quality included strong critical care nursing leadership to develop a cross-organisational pressure ulcer prevention group and a benchmarking exercise of current practices across a well-established critical care Network in the North of England. The National Safety Thermometer tool was used to measure pressure ulcer prevalence in 23 critical care units, and best available evidence, local consensus and another Critical Care Networks' bundle of interventions were used to develop a local pressure ulcer prevention standards document. The aims of the quality improvement project were achieved. This project was driven by successful leadership and had an agreed common goal. The National Safety Thermometer tool was an innovative approach to measure and compare pressure ulcer prevalence rates at a regional level. A limitation was the exclusion of moisture lesions. The project showed excellent engagement and collaborate working in the quest to prevent pressure ulcers from many critical care nurses with the North of England Critical Care Network. A concise set of Network standards was developed for use in conjunction with local guidelines to enhance pressure ulcer prevention. © 2015 British Association of Critical Care Nurses.

78 FR 10099 - Implementation of the Middle Class Tax Relief and Job Creation Act of 2012; Establishment of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-13

... of the Middle Class Tax Relief and Job Creation Act of 2012; Establishment of a Public Safety... establish a do-not-call registry for public safety answering points (PSAP) and prohibit the use of automatic... amended rules are necessary to implement the enforcement provisions of the Middle Class Tax Relief and Job...

Unions, Health and Safety Committees, and Workplace Accidents in the Korean Manufacturing Sector.

PubMed

Kim, Woo-Yung; Cho, Hm-Hak

2016-06-01

Despite the declining trend of workplace accidents in Republic of Korea, its level is still quite high compared with that in other developed countries. Factors that are responsible for high workplace accidents have not been well documented in Republic of Korea. The main purpose of this paper is to estimate the effects of unions and health and safety committees on workplace accidents in Korean manufacturing firms. We also allow for the interactions between unions and health and safety committees in the analysis. The results obtained in this paper will not only contribute to the literature in this field, but might also be useful for employers and worker representatives who are trying to find an effective way to reduce workplace accidents. This paper utilizes the 2012 Occupational Safety and Health Trend Survey data, which is a unique data set providing information on workplace injuries and illness as well as other characteristics of participatory firms, representative of the manufacturing industry in Republic of Korea. In estimating the effects of unions and health and safety committees, we build a negative binomial regression model in which the interactions between unions and health and safety committees are permissible in reducing workplace accidents. Health and safety committees were found to reduce the incidence of accidents whereas unionized establishments have higher incidence of accidents than nonunionized establishments. We also found that health and safety committees can more effectively reduce accidents in nonunionized establishments. By contrast, nonexclusive joint committees can more effectively reduce accidents in unionized establishments.

Collaboration and patient safety at an emergency department - a qualitative case study.

PubMed

Pedersen, Anna Helene Meldgaard; Rasmussen, Kurt; Grytnes, Regine; Nielsen, Kent Jacob

2018-03-19

Purpose The purpose of this paper is to examine how conflicts about collaboration between staff at different departments arose during the establishment of a new emergency department and how these conflicts affected the daily work and ultimately patient safety at the emergency department. Design/methodology/approach This qualitative single case study draws on qualitative semi-structured interviews and participant observation. The theoretical concepts "availability" and "receptiveness" as antecedents for collaboration will be applied in the analysis. Findings Close collaboration between departments was an essential precondition for the functioning of the new emergency department. The study shows how a lack of antecedents for collaboration affected the working relation and communication between employees and departments, which spurred negative feelings and reproduced conflicts. This situation was seen as a potential threat for the safety of the emergency patients. Research limitations/implications This study presents a single case study, at a specific point in time, and should be used as an illustrative example of how contextual and situational factors affect the working environment and through that patient safety. Originality/value Few studies provide an in-depth investigation of what actually takes place when collaboration between professional groups goes wrong and escalates, and how problems in collaboration may affect patient safety.

The effects of temperature and pressure on airborne exposure concentrations when performing compliance evaluations using ACGIH TLVs and OSHA PELs.

PubMed

Stephenson, D J; Lillquist, D R

2001-04-01

Occupational hygienists perform air sampling to characterize airborne contaminant emissions, assess occupational exposures, and establish allowable workplace airborne exposure concentrations. To perform these air sampling applications, occupational hygienists often compare an airborne exposure concentration to a corresponding American Conference of Governmental Industrial Hygienists (ACGIH) threshold limit value (TLV) or an Occupational Safety and Health Administration (OSHA) permissible exposure limit (PEL). To perform such comparisons, one must understand the physiological assumptions used to establish these occupational exposure limits, the relationship between a workplace airborne exposure concentration and its associated TLV or PEL, and the effect of temperature and pressure on the performance of an accurate compliance evaluation. This article illustrates the correct procedure for performing compliance evaluations using airborne exposure concentrations expressed in both parts per million and milligrams per cubic meter. In so doing, a brief discussion is given on the physiological assumptions used to establish TLVs and PELs. It is further shown how an accurate compliance evaluation is fundamentally based on comparison of a measured work site exposure dose (derived from the sampling site exposure concentration estimate) to an estimated acceptable exposure dose (derived from the occupational exposure limit concentration). In addition, this article correctly illustrates the effect that atmospheric temperature and pressure have on airborne exposure concentrations and the eventual performance of a compliance evaluation. This article also reveals that under fairly moderate conditions of temperature and pressure, 30 degrees C and 670 torr, a misunderstanding of how varying atmospheric conditions affect concentration values can lead to a 15 percent error in assessing compliance.

75 FR 70106 - Airworthiness Directives; Viking Air Limited (Type Certificate Previously Held by Bombardier, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

... states: Viking Air Limited has completed a system safety review of the aircraft fuel system against fuel... safety review of the aircraft fuel system against fuel tank safety standards introduced in Chapter 525 of... describes the unsafe condition as: Viking Air Limited has completed a system safety review of the aircraft...

The Demands of Nuclear Safety: Mishaps and USSTRATCOM

DTIC Science & Technology

2011-06-01

maintenance operation—the unexpected will occur. Scott D. Sagan On 30 August 2007 the unexpected occurred. Ironically, the safety problem did... Sagan , The Limits of Safety: Organizations, Accidents, and Nuclear Weapons (Princeton, NJ: Princeton University Press, 1993), 14, 48. 39 Sagan , Limits...1 Scott D. Sagan , The Limits of Safety: Organizations, Accidents, and Nuclear Weapons (Princeton, NJ: Princeton

16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 101 of the Consumer Product Safety Improvement Act for certain electronic devices. 1500.88 Section... from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain electronic devices. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits...

2003 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2003-08-01

The objective of this study was to establish 2003 safety belt and child safety seat usage rates in Kentucky. The 2003 survey continues to document the results after enactment of a statewide mandatory safety belt law in 1994 and safety belt enforcemen...

2004 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2004-08-01

The objective of this study was to establish 2004 safety belt and child safety seat usage rates in Kentucky. The 2004 survey continues to document the results after enactment of a statewide mandatory safety belt law in 1994 and safety belt enforcemen...

Fundamental ignition study for material fire safety improvement, part 1

NASA Technical Reports Server (NTRS)

Paciorek, K. L.; Zung, L. B.

1970-01-01

The investigation of preignition, ignition, and combustion characteristics of Delrin (acetate terminated polyformaldehyde) and Teflon (polytetrafluoroethylene) resins in air and oxygen are presented. The determination of ignition limits and their dependence on temperature and the oxidizing media, as well as the analyses of the volatiles produced, were studied. Tests were conducted in argon, an inert medium in which only purely pyrolytic reactions can take place, using the stagnation burner arrangement designed and constructed for this purpose. A theoretical treatment of the ignition and combination phenomena was devised. In the case of Delrin the ignition and ignition delays are apparently independent of the gas (air, oxygen) temperatures. The results indicate that hydrogen is the ignition triggering agent. Teflon ignition limits were established in oxygen only.

Robotics in invasive cardiac electrophysiology.

PubMed

Shurrab, Mohammed; Schilling, Richard; Gang, Eli; Khan, Ejaz M; Crystal, Eugene

2014-07-01

Robotic systems allow for mapping and ablation of different arrhythmia substrates replacing hand maneuvering of intracardiac catheters with machine steering. Currently there are four commercially available robotic systems. Niobe magnetic navigation system (Stereotaxis Inc., St Louis, MO) and Sensei robotic navigation system (Hansen Medical Inc., Mountain View, CA) have an established platform with at least 10 years of clinical studies looking at their efficacy and safety. AMIGO Remote Catheter System (Catheter Robotics, Inc., Mount Olive, NJ) and Catheter Guidance Control and Imaging (Magnetecs, Inglewood, CA) are in the earlier phases of implementations with ongoing feasibility and some limited clinical studies. This review discusses the advantages and limitations related to each existing system and highlights the ideal futuristic robotic system that may include the most promising features of the current ones.

A RE-LOOK AT THE US NRC SAFETY GOALS

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

mubayi v.

2013-09-22

Since they were adopted in 1986, the US NRC’s Safety Goals have played a valuable role as a de facto risk acceptance criterion against which the predicted performance of a commercial nuclear power reactor can be evaluated and assessed. The current safety goals are cast in terms of risk metrics called quantitative health objectives (QHOs), limiting numerical values of the risks of the early and latent health effects of accidental releases of radioactivity to the offsite population. However, while demonstrating compliance with current safety goals has been an important step in assessing the acceptance of the risk posed by LWRs,more » new or somewhat different goals may be needed that go beyond the current early fatality and latent cancer fatality QHOs in assessing reactor risk. Natural phenomena such as hurricanes seem to be suitable candidates for establishing a background rate to derive a risk goal as their order of magnitude cost of damages is similar to those estimated in severe accident Level 3 PRAs done for nuclear power plants. This paper obtains a risk goal that could have a wider applicability, compared to the current QHOs, as a technology-neutral goal applicable to future reactors and multi-unit sites.« less

Safety and pharmacokinetics of paclitaxel and the oral mTOR inhibitor everolimus in advanced solid tumours

PubMed Central

Campone, M; Levy, V; Bourbouloux, E; Berton Rigaud, D; Bootle, D; Dutreix, C; Zoellner, U; Shand, N; Calvo, F; Raymond, E

2009-01-01

Everolimus displays antiproliferative effects on cancer cells, yields antiangiogenic activity in established tumours, and shows synergistic activity with paclitaxel in preclinical models. This study assessed the safety and the pharmacokinetic interactions of everolimus and paclitaxel in patients with advanced malignancies. Everolimus was dose escalated from 15 to 30 mg and administered with paclitaxel 80 mg m−2 on days 1, 8, and 15 every 28 days. Safety was assessed weekly, and dose-limiting toxicity (DLT) was evaluated in cycle 1. A total of 16 patients (median age 54.5 years, range 33–69) were entered; 11 had prior taxane therapy for breast (n=5), ovarian (n=3), and vaginal cancer (n=1) or angiosarcoma (n=2). Grade 3 neutropenia in six patients met the criteria for DLT in two patients receiving everolimus 30 mg weekly. Other drug-related grade 3 toxicities were leucopenia, anaemia, thrombocytopenia, stomatitis, asthenia, and increased liver enzymes. Tumour stabilisation reported in 11 patients exceeded 6 months in 2 patients with breast cancer. Everolimus showed an acceptable safety profile at the dose of 30 mg when combined with weekly paclitaxel 80 mg m−2, warranting further clinical investigation. PMID:19127256

Herbal Medicine in the United States: Review of Efficacy, Safety, and Regulation

PubMed Central

2008-01-01

Introduction Herbal products have gained increasing popularity in the last decade, and are now used by approximately 20% of the population. Herbal products are complex mixtures of organic chemicals that may come from any raw or processed part of a plant, including leaves, stems, flowers, roots, and seeds. Under the current law, herbs are defined as dietary supplements, and manufacturers can therefore produce, sell, and market herbs without first demonstrating safety and efficacy, as is required for pharmaceutical drugs. Although herbs are often perceived as “natural” and therefore safe, many different side effects have been reported owing to active ingredients, contaminants, or interactions with drugs. Results Unfortunately, there is limited scientific evidence to establish the safety and efficacy of most herbal products. Of the top 10 herbs, 5 (ginkgo, garlic, St. John’s wort, soy, and kava) have scientific evidence suggesting efficacy, but concerns over safety and a consideration of other medical therapies may temper the decision to use these products. Conclusions Herbal products are not likely to become an important alternative to standard medical therapies unless there are changes to the regulation, standardization, and funding for research of these products. PMID:18415652

[Aripiprazole in pregnancy: a review of literature].

PubMed

Bellantuono, Cesario; Di Massimo, Giorgia; Mauro, Antonella; Martellini, Mariasole; Nardi, Bernardo

2015-01-01

Data on tolerability and safety of aripiprazolo during pregnancy and in childbirth are so far limited. Aim of the present study is to provide a review of the literature on the safety profile of aripiprazole during pregnancy and on maternal and neonatal outcomes, including two cases coming from our database (www.degradatabase.it). Medline database was searched for English language articles by using the following keywords: "aripiprazole", "atypical antipsychotic", "major malformations", "perinatal complications", "pregnancy". We reported 2 cases of women treated with aripiprazole during their pregnancy at the Clinic of Affective Disorders in Pregnancy and Postpartum of the United Hospital of Ancona (DEGRA Center - www.depressionegravidanza.it). The data available in the literature did not provide clear evidence about the safety and potential risks related to this drug during pregnancy. Data coming from our database did not detected any malformations and perinatal complications after exposure to aripiprazole in 2 newborns beyond the first trimester of pregnancy. From the evidence available, aripiprazole seems to be an antipsychotic effective and well tolerated in the treatment of women with psychotic disorders in pregnancy. However, further studies are needed to better establish the safety of aripiprazole during pregnancy, particularly as the risk of major malformtions and perinatal complications is concerned.

Applications and safety considerations of Lactobacillus salivarius as a probiotic in animal and human health.

PubMed

Chaves, B D; Brashears, M M; Nightingale, K K

2017-03-03

The goals of this review are to summarize the current knowledge on the application of Lactobacillus salivarius as a probiotic in animals and humans, and to address safety concerns with its use on live hosts. Overall, several strains of L. salivarius are well established probiotics with multiple applications in animal health, particularly to reduce colonization by gastrointestinal pathogens, and to a lesser extent, as a production and quality aid. In humans, L. salivarius has been used to prevent and treat a variety of chronic diseases, including asthma, cancer, atopic dermatitis and halitosis, and to a much limited extent, to prevent or treat infections. Based on the results from primary research evidence, it seems that L. salivarius does not pose a health risk to animals or humans in the doses currently used for a variety of applications; however, there is a systematic lack of studies assuring the safety of many of the strains intended for clinical use. This review provides researchers in the field with up-to-date information regarding applications and safety of L. salivarius. Furthermore, it helps researchers identify knowledge gaps and potential opportunities for microbiological and clinical research. © 2017 The Society for Applied Microbiology.

A Global Perspective on Vaccine Safety and Public Health: The Global Advisory Committee on Vaccine Safety

PubMed Central

Folb, Peter I.; Bernatowska, Ewa; Chen, Robert; Clemens, John; Dodoo, Alex N. O.; Ellenberg, Susan S.; Farrington, C. Patrick; John, T. Jacob; Lambert, Paul-Henri; MacDonald, Noni E.; Miller, Elizabeth; Salisbury, David; Schmitt, Heinz-J.; Siegrist, Claire-Anne; Wimalaratne, Omala

2004-01-01

Established in 1999, the Global Advisory Committee on Vaccine Safety advises the World Health Organization (WHO) on vaccine-related safety issues and enables WHO to respond promptly, efficiently, and with scientific rigor to issues of vaccine safety with potential global importance. The committee also assesses the implications of vaccine safety for practice worldwide and for WHO policies. We describe the principles on which the committee was established, its modus operandi, and the scope of the work undertaken, both present and future. We highlight its recent recommendations on major issues, including the purported link between the measles–mumps–rubella vaccine and autism and the safety of the mumps, influenza, yellow fever, BCG, and smallpox vaccines as well as that of thiomersal-containing vaccines. PMID:15514229

29 CFR 1910.11 - Scope and purpose.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.11..., established Federal standards in effect on April 28, 1971, with respect to every employer, employee, and...

Evaluation of the effectiveness of child safety restraints

DOT National Transportation Integrated Search

1987-03-01

The goals of the study were to better establish the relationsips between proper and improper usage of safety seats in crashes and the resulting injury levels and mechanisms and to establish measures of the distance from home that the children were wh...

15 CFR 270.100 - General.

Code of Federal Regulations, 2012 CFR

2012-01-01

... STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.100 General. (a) Based on prior NIST experience, NIST expects that the Director will establish and deploy a Team to conduct an investigation at a...

15 CFR 270.101 - Preliminary reconnaissance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.101 Preliminary reconnaissance. (a) To... the site of a building failure. The Director may establish and deploy a Team to conduct the...

15 CFR 270.100 - General.

Code of Federal Regulations, 2010 CFR

2010-01-01

... STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.100 General. (a) Based on prior NIST experience, NIST expects that the Director will establish and deploy a Team to conduct an investigation at a...

15 CFR 270.101 - Preliminary reconnaissance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.101 Preliminary reconnaissance. (a) To... the site of a building failure. The Director may establish and deploy a Team to conduct the...

15 CFR 270.101 - Preliminary reconnaissance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.101 Preliminary reconnaissance. (a) To... the site of a building failure. The Director may establish and deploy a Team to conduct the...

15 CFR 270.100 - General.

Code of Federal Regulations, 2013 CFR

2013-01-01

... STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.100 General. (a) Based on prior NIST experience, NIST expects that the Director will establish and deploy a Team to conduct an investigation at a...

15 CFR 270.100 - General.

Code of Federal Regulations, 2014 CFR

2014-01-01

... STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.100 General. (a) Based on prior NIST experience, NIST expects that the Director will establish and deploy a Team to conduct an investigation at a...

15 CFR 270.101 - Preliminary reconnaissance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.101 Preliminary reconnaissance. (a) To... the site of a building failure. The Director may establish and deploy a Team to conduct the...

15 CFR 270.101 - Preliminary reconnaissance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.101 Preliminary reconnaissance. (a) To... the site of a building failure. The Director may establish and deploy a Team to conduct the...

15 CFR 270.100 - General.

Code of Federal Regulations, 2011 CFR

2011-01-01

... STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE NATIONAL CONSTRUCTION SAFETY TEAMS NATIONAL CONSTRUCTION SAFETY TEAMS Establishment and Deployment of Teams § 270.100 General. (a) Based on prior NIST experience, NIST expects that the Director will establish and deploy a Team to conduct an investigation at a...

Participatory design of a preliminary safety checklist for general practice

PubMed Central

Bowie, Paul; Ferguson, Julie; MacLeod, Marion; Kennedy, Susan; de Wet, Carl; McNab, Duncan; Kelly, Moya; McKay, John; Atkinson, Sarah

2015-01-01

Background The use of checklists to minimise errors is well established in high reliability, safety-critical industries. In health care there is growing interest in checklists to standardise checking processes and ensure task completion, and so provide further systemic defences against error and patient harm. However, in UK general practice there is limited experience of safety checklist use. Aim To identify workplace hazards that impact on safety, health and wellbeing, and performance, and codesign a standardised checklist process. Design and setting Application of mixed methods to identify system hazards in Scottish general practices and develop a safety checklist based on human factors design principles. Method A multiprofessional ‘expert’ group (n = 7) and experienced front-line GPs, nurses, and practice managers (n = 18) identified system hazards and developed and validated a preliminary checklist using a combination of literature review, documentation review, consensus building workshops using a mini-Delphi process, and completion of content validity index exercise. Results A prototype safety checklist was developed and validated consisting of six safety domains (for example, medicines management), 22 sub-categories (for example, emergency drug supplies) and 78 related items (for example, stock balancing, secure drug storage, and cold chain temperature recording). Conclusion Hazards in the general practice work system were prioritised that can potentially impact on the safety, health and wellbeing of patients, GP team members, and practice performance, and a necessary safety checklist prototype was designed. However, checklist efficacy in improving safety processes and outcomes is dependent on user commitment, and support from leaders and promotional champions. Although further usability development and testing is necessary, the concept should be of interest in the UK and internationally. PMID:25918338

[What Surgeons Should Know about Risk Management].

PubMed

Strametz, R; Tannheimer, M; Rall, M

2017-02-01

Background: The fact that medical treatment is associated with errors has long been recognized. Based on the principle of "first do no harm", numerous efforts have since been made to prevent such errors or limit their impact. However, recent statistics show that these measures do not sufficiently prevent grave mistakes with serious consequences. Preventable mistakes such as wrong patient or wrong site surgery still frequently occur in error statistics. Methods: Based on insight from research on human error, in due consideration of recent legislative regulations in Germany, the authors give an overview of the clinical risk management tools needed to identify risks in surgery, analyse their causes, and determine adequate measures to manage those risks depending on their relevance. The use and limitations of critical incident reporting systems (CIRS), safety checklists and crisis resource management (CRM) are highlighted. Also the rationale for IT systems to support the risk management process is addressed. Results/Conclusion: No single tool of risk management can be effective as a standalone instrument, but unfolds its effect only when embedded in a superordinate risk management system, which integrates tailor-made elements to increase patient safety into the workflows of each organisation. Competence in choosing adequate tools, effective IT systems to support the risk management process as well as leadership and commitment to constructive handling of human error are crucial components to establish a safety culture in surgery. Georg Thieme Verlag KG Stuttgart · New York.

Risk management systems for health care and safety development on transplantation: a review and a proposal.

PubMed

Pretagostini, R; Gabbrielli, F; Fiaschetti, P; Oliveti, A; Cenci, S; Peritore, D; Stabile, D

2010-05-01

Starting from the report on medical errors published in 1999 by the US Institute of Medicine, a number of different approaches to risk management have been developed for maximum risk reduction in health care activities. The health care authorities in many countries have focused attention on patient safety, employing action research programs that are based on quite different principles. We performed a systematic Medline research of the literature since 1999. The following key words were used, also combining boolean operators and medical subheading terms: "adverse event," "risk management," "error," and "governance." Studies published in the last 5 years were particularly classified in various groups: risk management in health care systems; safety in specific hospital activities; and health care institutions' official documents. Methods of action researches have been analysed and their characteristics compared. Their suitability for safety development in donation, retrieval, and transplantation processes were discussed in the reality of the Italian transplant network. Some action researches and studies were dedicated to entire national healthcare systems, whereas others focused on specific risks. Many research programs have undergone critical review in the literature. Retrospective analysis has centered on so-called sentinel events to particularly analyze only a minor portion of the organizational phenomena, which can be the origin of an adverse event, an incident, or an error. Sentinel events give useful information if they are studied in highly engineered and standardized organizations like laboratories or tissue establishments, but they show several limits in the analysis of organ donation, retrieval, and transplantation processes, which are characterized by prevailing human factors, with high intrinsic risk and variability. Thus, they are poorly effective to deliver sure elements to base safety management improvement programs, especially regarding multidisciplinary systems with high complexity. In organ transplantation, the possibility to increase safety seems greater using proactive research, mainly centred on organizational processes together with retrospective analyses but not limited to sentinel event reports. Copyright (c) 2010. Published by Elsevier Inc.

10 CFR 76.87 - Technical safety requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 2 2010-01-01 2010-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

10 CFR 76.87 - Technical safety requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 2 2012-01-01 2012-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

10 CFR 76.87 - Technical safety requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 2 2011-01-01 2011-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

10 CFR 76.87 - Technical safety requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 2 2013-01-01 2013-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

10 CFR 76.87 - Technical safety requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 2 2014-01-01 2014-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

The daily relationships between staffing, safety perceptions and personality in hospital nursing: A longitudinal on-line diary study.

PubMed

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

2016-07-01

The association between poor staffing conditions and negative patient safety consequences is well established within hospital nursing. However, many studies have been limited to nurse population level associations, and have used routine data to examine relationships. As a result, it is less clear how these relationships might be manifested at the individual nurse level on a day-to-day basis. Furthermore, personality may have direct and moderating roles in terms of work environment and patient safety associations, but limited research has explored personality in this context. To further our understanding of these associations, this paper takes a within-person approach to examine nurses' daily perceptions of staffing and patient safety. In addition, we explore the potential role of personality factors as moderators of daily level associations. We recruited eighty-three hospital nurses from three acute NHS Trusts in the UK between March and July 2013. Nurses completed online end-of-shift diaries over three-five shifts which collected information on perceptions of staffing, patient-nurse ratio and patient safety (perceptions of patient safety, ability to act as a safe practitioner, and workplace cognitive failure). Personality was also assessed within a baseline questionnaire. Data were analysed using hierarchical linear modelling, and moderation effects of personality factors were examined using simple slopes analyses, which decomposed relationships at high and low levels of the moderator. On days when lower patient-nurse ratios were indicated, nurses reported being more able to act as a safe practitioner (p=.011) and more favourable perceptions of patient safety (p=<.001). Additionally, when staffing was perceived more favourably, nurses reported being more able to act as a safe practitioner (p=<.001), more favourable perceptions of patient safety (p=<.001) and experienced less workplace cognitive failure (p=<.001). Conscientiousness and emotional stability emerged as key moderators of daily level associations between staffing and patient safety variables, with many relationships differing at high and low levels of these personality factors. The findings elucidate the potential mechanisms by which patient safety risks arise within hospital nursing, and suggest that nurses may not respond to staffing conditions in the same way, dependent upon personality. Further understanding of these relationships will enable staff to be supported in terms of work environment conditions on an individual basis. Copyright © 2016 Elsevier Ltd. All rights reserved.

Establishing research priorities for patient safety in emergency medicine: a multidisciplinary consensus panel.

PubMed

Plint, Amy C; Stang, Antonia S; Calder, Lisa A

2015-01-01

Patient safety in the context of emergency medicine is a relatively new field of study. To date, no broad research agenda for patient safety in emergency medicine has been established. The objective of this study was to establish patient safety-related research priorities for emergency medicine. These priorities would provide a foundation for high-quality research, important direction to both researchers and health-care funders, and an essential step in improving health-care safety and patient outcomes in the high-risk emergency department (ED) setting. A four-phase consensus procedure with a multidisciplinary expert panel was organized to identify, assess, and agree on research priorities for patient safety in emergency medicine. The 19-member panel consisted of clinicians, administrators, and researchers from adult and pediatric emergency medicine, patient safety, pharmacy, and mental health; as well as representatives from patient safety organizations. In phase 1, we developed an initial list of potential research priorities by electronically surveying a purposeful and convenience sample of patient safety experts, ED clinicians, administrators, and researchers from across North America using contact lists from multiple organizations. We used simple content analysis to remove duplication and categorize the research priorities identified by survey respondents. Our expert panel reached consensus on a final list of research priorities through an in-person meeting (phase 3) and two rounds of a modified Delphi process (phases 2 and 4). After phases 1 and 2, 66 unique research priorities were identified for expert panel review. At the end of phase 4, consensus was reached for 15 research priorities. These priorities represent four themes: (1) methods to identify patient safety issues (five priorities), (2) understanding human and environmental factors related to patient safety (four priorities), (3) the patient perspective (one priority), and (4) interventions for improving patient safety (five priorities). This study established expert, consensus-based research priorities for patient safety in emergency medicine. This framework could be used by researchers and health-care funders and represents an essential guiding step towards enhancing quality of care and patient safety in the ED.

Development of a software safety process and a case study of its use

NASA Technical Reports Server (NTRS)

Knight, John C.

1993-01-01

The goal of this research is to continue the development of a comprehensive approach to software safety and to evaluate the approach with a case study. The case study is a major part of the project, and it involves the analysis of a specific safety-critical system from the medical equipment domain. The particular application being used was selected because of the availability of a suitable candidate system. We consider the results to be generally applicable and in no way particularly limited by the domain. The research is concentrating on issues raised by the specification and verification phases of the software lifecycle since they are central to our previously-developed rigorous definitions of software safety. The theoretical research is based on our framework of definitions for software safety. In the area of specification, the main topics being investigated are the development of techniques for building system fault trees that correctly incorporate software issues and the development of rigorous techniques for the preparation of software safety specifications. The research results are documented. Another area of theoretical investigation is the development of verification methods tailored to the characteristics of safety requirements. Verification of the correct implementation of the safety specification is central to the goal of establishing safe software. The empirical component of this research is focusing on a case study in order to provide detailed characterizations of the issues as they appear in practice, and to provide a testbed for the evaluation of various existing and new theoretical results, tools, and techniques. The Magnetic Stereotaxis System is summarized.

14 CFR 91.1021 - Internal safety reporting and incident/accident response.

Code of Federal Regulations, 2011 CFR

2011-01-01

.../accident response. 91.1021 Section 91.1021 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... incident/accident response. (a) Each program manager must establish an internal anonymous safety reporting.... (b) Each program manager must establish procedures to respond to an aviation incident/accident. ...

50 CFR 25.71 - Public safety.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 50 Wildlife and Fisheries 8 2011-10-01 2011-10-01 false Public safety. 25.71 Section 25.71... NATIONAL WILDLIFE REFUGE SYSTEM ADMINISTRATIVE PROVISIONS Safety Regulations § 25.71 Public safety. Persons using national wildlife refuges shall comply with the safety requirements which are established under...

76 FR 54806 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-02

... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2011-0007] Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and... Committee for Occupational Safety and Health (MACOSH) was established under Section 7 of the Occupational...

50 CFR 25.71 - Public safety.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 50 Wildlife and Fisheries 6 2010-10-01 2010-10-01 false Public safety. 25.71 Section 25.71... NATIONAL WILDLIFE REFUGE SYSTEM ADMINISTRATIVE PROVISIONS Safety Regulations § 25.71 Public safety. Persons using national wildlife refuges shall comply with the safety requirements which are established under...

10 CFR 830.202 - Safety basis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Safety basis. 830.202 Section 830.202 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.202 Safety basis. (a) The contractor responsible for a hazard category 1, 2, or 3 DOE nuclear facility must establish and maintain the safety basis...

10 CFR 830.202 - Safety basis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Safety basis. 830.202 Section 830.202 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.202 Safety basis. (a) The contractor responsible for a hazard category 1, 2, or 3 DOE nuclear facility must establish and maintain the safety basis...

Costs of Food Safety Investments in the Meat and Poultry Slaughter Industries.

PubMed

Viator, Catherine L; Muth, Mary K; Brophy, Jenna E; Noyes, Gary

2017-02-01

To develop regulations efficiently, federal agencies need to know the costs of implementing various regulatory alternatives. As the regulatory agency responsible for the safety of meat and poultry products, the U.S. Dept. of Agriculture's Food Safety and Inspection Service is interested in the costs borne by meat and poultry establishments. This study estimated the costs of developing, validating, and reassessing hazard analysis and critical control points (HACCP), sanitary standard operating procedures (SSOP), and sampling plans; food safety training for new employees; antimicrobial equipment and solutions; sanitizing equipment; third-party audits; and microbial tests. Using results from an in-person expert consultation, web searches, and contacts with vendors, we estimated capital equipment, labor, materials, and other costs associated with these investments. Results are presented by establishment size (small and large) and species (beef, pork, chicken, and turkey), when applicable. For example, the cost of developing food safety plans, such as HACCP, SSOP, and sampling plans, can range from approximately $6000 to $87000, depending on the type of plan and establishment size. Food safety training costs from approximately $120 to $2500 per employee, depending on the course and type of employee. The costs of third-party audits range from approximately $13000 to $24000 per audit, and establishments are often subject to multiple audits per year. Knowing the cost of these investments will allow researchers and regulators to better assess the effects of food safety regulations and evaluate cost-effective alternatives. © 2017 Institute of Food Technologists®.

Hypothermia for preventing chemotherapy-induced neuropathy - a pilot study on safety and tolerability in healthy controls.

PubMed

Bandla, Aishwarya; Sundar, Raghav; Liao, Lun-De; Sze Hui Tan, Stacey; Lee, Soo-Chin; Thakor, Nitish V; Wilder-Smith, Einar P V

2016-01-01

Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of several chemotherapeutic agents, often leading to treatment discontinuation. Up to 20% of patients treated with weekly paclitaxel experience severe CIPN and no effective treatment has been established so far. The mechanisms of CIPN damage are unclear, but are directly dose-related. We had earlier demonstrated, in rats, the influence of hypothermia in reducing nerve blood flow. Here, we hypothesize that continuous flow limb hypothermia during chemotherapy reduces the incidence and severity of CIPN, by limiting deliverance of the neurotoxic drug to the peripheral nerves. In this study, prior to assessing the effect of hypothermia in preventing CIPN in cancer subjects undergoing paclitaxel chemotherapy, we assess the safety and tolerable temperatures for limb hypothermia in healthy human subjects. In 15 healthy human subjects, hypothermia was administered as continuous flow cooling, unilaterally, via a thermoregulator setup covering the digits up to the elbow/knee, along with continuous skin temperature monitoring. Thermoregulator coolant temperatures between 25 °C and 20 °C were tested for tolerability, based on a carefully designed temperature regulation protocol, and maintained for three hours mimicking the duration of chemotherapy. Tolerability was evaluated using various safety and tolerability scores to monitor the subjects. At the end of the cooling session the healthy subjects presented without significant adverse effects, the main being brief mild skin erythema and transient numbness. Coolant temperatures as low as 22 °C were well tolerated continuously over three hours. Our results confirm the safety and tolerability of continuous flow limb hypothermia in healthy subjects. Further studies will use 22 °C thermoregulator temperature to investigate hypothermia in preventing CIPN in breast cancer patients receiving adjuvant weekly paclitaxel. This pilot study may contribute to alleviating chemotherapy dose limitation due to CIPN and increase the likelihood of success of chemotherapy.

Heavy metals in aromatic spices by inductively coupled plasma-mass spectrometry.

PubMed

Bua, Daniel Giuseppe; Annuario, Giovanni; Albergamo, Ambrogina; Cicero, Nicola; Dugo, Giacomo

2016-09-01

Objective of this study was to determine the content of Cd, Hg, As and Pb in common spices traded in the Italian market, using inductively coupled plasma-mass spectrometry (ICP-MS). The results were compared with the maximum limits established by the national Legislative Decree (LD) no. 107 implementing the Council Directive 88/388/EEC and by international organisations, such as Food and Agriculture Organization (FAO) and World Health Organization (WHO). Food safety for spices was assessed considering the tolerable weekly intake (TWI) and the provisional tolerable weekly intake (PTWI), respectively, for Cd and Hg and the 95% lower confidence limit of the benchmark dose of 1% extra risk (BMDL01) for As and Pb. Investigated elements in all samples were within the maximum limits as set by the national and international normative institutions. Nevertheless, the heavy metal content of some spices exceeded the PTWI, TWI and BMDL01, which needs attention when considering consumer's health.

75 FR 13783 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-23

... DEPARTMENT OF LABOR Occupational Safety and Health Administration Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and Health Administration (OSHA), Labor... Health (MACOSH) was established under Section 7 of the Occupational Safety and Health (OSH) Act of 1970...

Quo vadis? – Monitoring Campylobacter in Germany

PubMed Central

Stingl, K.; Knüver, M.-T.; Vogt, P.; Buhler, C.; Krüger, N.-J.; Alt, K.; Tenhagen, B.-A.; Hartung, M.; Schroeter, A.; Ellerbroek, L.; Appel, B.; Käsbohrer, A.

2012-01-01

Campylobacter is a poorly recognized foodborne pathogen, leading the statistics of bacterially caused human diarrhoea in Europe during the last years. In this review, we present qualitative and quantitative German data obtained in the framework of specific monitoring programs and from routine surveillance. These also comprise recent data on antimicrobial resistances of food isolates. Due to the considerable reduction of in vitro growth capabilities of stressed bacteria, there is a clear discrepancy between the detection limit of Campylobacter by cultivation and its infection potential. Moreover, antimicrobial resistances of Campylobacter isolates established during fattening of livestock are alarming, since they constitute an additional threat to human health. The European Food Safety Authority (EFSA) discusses the establishment of a quantitative limit for Campylobacter contamination of broiler carcasses in order to achieve an appropriate level of protection for consumers. Currently, a considerable amount of German broiler carcasses would not comply with this future criterion. We recommend Campylobacter reduction strategies to be focussed on the prevention of fecal contamination during slaughter. Decontamination is only a sparse option, since the reduction efficiency is low and its success depends on the initial contamination concentration. PMID:24611125

Aluminium content of foods originating from aluminium-containing food additives.

PubMed

Ogimoto, Mami; Suzuki, Kumi; Haneishi, Nahoko; Kikuchi, Yuu; Takanashi, Mayu; Tomioka, Naoko; Uematsu, Yoko; Monma, Kimio

2016-09-01

Aluminium (Al) levels of 90 food samples were investigated. Nineteen samples contained Al levels exceeding the tolerable weekly intake (TWI) for young children [body weight (bw): 16 kg] when consuming two servings/week. These samples were purchased multiple times at specific intervals and were evaluated for Al levels. Al was detected in 27 of the 90 samples at levels ranging from 0.01 (limit of quantitation) to 1.06 mg/g. Of these, the Al intake levels in two samples (cookie and scone mix, 1.3 and 2 mg/kg bw/week, respectively) exceeded the TWI as established by European Food Safety Authority, although the level in the scone mix was equivalent to the provisional TWI (PTWI) as established by Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Committee on Food Additives. The Al levels markedly decreased in 14 of the 19 samples with initially high Al levels. These results indicated reductions in the Al levels to below the PTWI limits in all but two previously identified food samples.

Safety belt use estimate for Native American tribal reservations

DOT National Transportation Integrated Search

2005-10-01

The National Highway Traffic Safety Administration (NHTSA) and the Bureau of Indian Affairs (BIA), Indian Highway Safety Program, sponsored a project to (a) establish the first baseline tribal reservation safety belt use rate, and (b) develop a metho...

2010 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2010-07-01

The objective of this study was to establish 2010 safety belt and child safety seat usage rates in Kentucky. The 2010 survey continues to document the results after enactment of the original "second enforcement" statewide mandatory safety belt law in...

2009 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2009-07-01

The objective of this study was to establish 2009 safety belt and child safety seat usage rates in Kentucky. The 2009 survey continues to document the results after enactment of original "secondary enforcement" statewide mandatory safety belt law in ...

2002 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2002-07-01

The objective of this study was to establish 2002 safety belt and child safety seat usage rates in Kentucky. The 2002 survey continues to document the results after enactment of original "secondary enforcement" statewide mandatory safety belt law in ...

2007 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2007-08-01

The objective of this study was to establish 2007 safety belt and child safety seat usage rates in Kentucky. The 2007 survey continues to document the results after enactment of the initial "second enforcement" statewide mandatory safety belt law in ...

2001 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2001-08-01

The objective of this study was to establish 2001 safety belt and child safety seat usage rates in Kentucky. The 2001 survey continues to document the results after enactment of original "secondary enforcement" statewide mandatory safety belt law in ...

2006 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2006-08-01

The objective of this study was to establish 2006 safety belt and child safety seat usage rates in Kentucky. The 2006 survey continues to document the results after enactment of the initial "second enforcement" statewide mandatory safety belt law in ...

2008 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2008-08-01

The objective of this study was to establish 2008 safety belt and child safety seat usage rates in Kentucky. The 2008 survey continues to document the results after enactment of the initial "second enforcement" statewide mandatory safety belt law in ...

2005 safety belt usage survey in Kentucky.

DOT National Transportation Integrated Search

2005-08-01

The objective of this study was to establish 2005 safety belt and child safety seat usage rates in Kentucky. The 2005 survey continues to document the results after enactment of the initial "second enforcement" statewide mandatory safety belt law in ...

Use of information on disease diagnoses from databases for animal health economic, welfare and food safety purposes: strengths and limitations of recordings.

PubMed

Houe, Hans; Gardner, Ian Andrew; Nielsen, Liza Rosenbaum

2011-01-01

Many animal health, welfare and food safety databases include data on clinical and test-based disease diagnoses. However, the circumstances and constraints for establishing the diagnoses vary considerably among databases. Therefore results based on different databases are difficult to compare and compilation of data in order to perform meta-analysis is almost impossible. Nevertheless, diagnostic information collected either routinely or in research projects is valuable in cross comparisons between databases, but there is a need for improved transparency and documentation of the data and the performance characteristics of tests used to establish diagnoses. The objective of this paper is to outline the circumstances and constraints for recording of disease diagnoses in different types of databases, and to discuss these in the context of disease diagnoses when using them for additional purposes, including research. Finally some limitations and recommendations for use of data and for recording of diagnostic information in the future are given. It is concluded that many research questions have such a specific objective that investigators need to collect their own data. However, there are also examples, where a minimal amount of extra information or continued validation could make sufficient improvement of secondary data to be used for other purposes. Regardless, researchers should always carefully evaluate the opportunities and constraints when they decide to use secondary data. If the data in the existing databases are not sufficiently valid, researchers may have to collect their own data, but improved recording of diagnostic data may improve the usefulness of secondary diagnostic data in the future.

Highway crash rates and age-related driver limitations: Literature review and evaluation of data bases

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

Hu, P.S.; Young, J.R.; Lu, An

1993-08-01

American society is undergoing a major demographic transformation that is resulting in a larger proportion of older individuals in the population. Moreover, recent travel surveys show that an increasing number of older individuals are licensed to drive and that they drive more than their same age cohort a decade ago. However, they continue to take shorter trips than younger drivers and they avoid driving during congested hours. This recent demographic transformation in our society, the graying of America, coupled with the increasing mobility of the older population impose a serious highway safety issue that cannot be overlooked. Some of themore » major concerns are the identification of ``high-risk`` older drivers and the establishment of licensing guidelines and procedures that are based on conclusive scientific evidence. Oak Ridge National Laboratory`s (ORNL) objectives in this project can be characterized by the following tasks: Review and evaluate the 1980 American Association of Motor Vehicle Administrators (AAMVA) and National Highway Traffic Safety Administration (NHTSA) licensing guidelines. Determine whether the license restriction recommended in the 1980 AAMVA and NHTSA guidelines was based on scientific evidence or on judgement of medical advisors. Identify in the scientific literature any medical conditions which are found to be highly associated with highway crashes, and which are not mentioned in the 1980 guidelines. Summarize States` current licensing practices for drivers with age-related physical and mental limitations. Identify potential data sources to establish conclusive evidence on age-related functional impairments and highway crashes.« less

Establishment and implementation of common product assurance and safety requirements for the contractors of the Columbus programme

NASA Astrophysics Data System (ADS)

Wessels, H.; Stephan, H. J.

1991-08-01

When establishing the Columbus Product Assurance (PA)/safety requirements, the international environment of the Space Station Freedom program has to be taken into account. Considerations given to multiple ways of requirement definition and stages within the European Space Agency (ESA) Procedures, Specifications, and Standards (PSS-01) series of documents and the NASA Space Station requirements are discussed. A series of adaptations introduced by way of tailoring the basic ESA and NASA requirement sets to the Columbus program's needs are described. For the implementation of these tailored requirements, a scheme is developed, which recognizes the PA/safety approach within the European industries by way of various company handbooks and manuals. The changes introduced in the PSS-01 series and the applicable NASA Space Station requirements in recent years, has coincided with the establishment of Columbus PA/safety requirements. To achieve the necessary level of cooperation between ESA and the Columbus industries, a PA Working Group (PAWG) is established. The PAWG supervises the establishement of the Common PA/Safety Plan and the Standards to be used. Due to the high number of European industries participating in the Columbus program, a positive influence on the evolution of the industrial approaches in PA/safety can be expected. Cooperation in the PAWG has brought issues to light which are related to the ESA PSS-01 series and its requirements. Due to the rapid changes of recent years, basic company documentation has not followed the development, specifically as various recent ESA projects use different project specifc issues of the evolving PSS-01 documents.

Evaluation of safety ratings of roads based on frontal crashes with known crash pulse and injury outcome.

PubMed

Stigson, H

2009-06-01

The objective in this study, using data from crashed cars fitted with on-board crash pulse recorders, was to present differences in average crash severity, distribution of crash severity, and injury outcomes, based on an independent safety rating of roads, also taking road type and speed limit into consideration. Furthermore, the objective was to evaluate differences in injury risk, based on the distribution of crash severity. The investigation included both frontal two-vehicle crashes and single-vehicle crashes with known injury outcome. In total, 209 real-world crashes involving cars fitted with crash pulse recorders were included. For all crashes, average mean acceleration and change of velocity of the vehicle acceleration pulse were measured and calculated. All crash spots were classified according to an independent road safety rating program (European Road Assessment Programme Road Protection Score), where the safety quality of roads is rated in relation to posted speed limits. The crash severity and injury outcome in crashes that occurred on roads with good safety ratings were compared with crashes on roads with poor safety ratings. The data were also divided into subcategories according to posted speed limit and road type, to evaluate whether there was a difference in crash severity and injury outcome within the categories. In total, crash severity was statistically significantly lower in crashes occurring on roads with good safety ratings than in crashes occurring on roads with poor safety ratings. It was found that crash severity and injury risk were lower on roads with good safety ratings with a speed limit of above 90 km/h compared with roads with poor safety ratings, irrespective of speed limit. On the other hand, crash severity was higher on roads with good safety ratings with speed limit of 70 km/h than on roads with poor safety ratings with the same speed limit. Though it was found that a higher speed limit resulted in higher crash severity on roads with poor safety ratings, the opposite was found on roads with good safety ratings. The main reason for this was that lanes for traffic traveling in opposite directions were more often separated at higher speeds on roads with good safety ratings. On divided roads with good safety ratings, there were no crashes resulting in crash severity above the level corresponding to a 10 percent risk of sustaining serious or fatal injury. This indicates that one of the most important safety measures is divided roads.

78 FR 67298 - Establishment of Class E Airspace; Ennis, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... instrument approach procedures at Ennis-Big Sky Airport. This improves the safety and management of...) standard instrument approach procedures at the airport. This action is necessary for the safety and management of IFR operations. The FAA has determined this regulation only involves an established body of...

78 FR 21607 - National Institute for Occupational Safety and Health Partnership Opportunity on a Research...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-11

... Performance of Isolation Gowns AGENCY: National Institute for Occupational Safety and Health (NIOSH) of the...) International standards development to establish minimum performance requirements for isolation gowns for health... will be recognized as contributing to the establishment of the performance standard. Manufacturers...

49 CFR 214.331 - Definite train location.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Definite train location. 214.331 Section 214.331... location. A roadway worker may establish on-track safety by using definite train location only where... may only use definite train location to establish on-track safety at points where such procedures were...

75 FR 57081 - Revised Draft Safety Culture Policy Statement: Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-17

... on Safety Culture at the Health Physics Society Annual Meeting, and presentations on the development... holders \\2\\ establish and maintain a positive safety culture that protects public health and safety and... public health and safety, the Commission has required the regulated entity involved to determine the...

Overview of Federal Motor Carrier Safety Administration safety training research for new entrant motor carriers.

DOT National Transportation Integrated Search

2015-07-01

New entrant motor carriers generally are very small and have poorer safety performance than more established carriers. This may be because very small carriers do not have the resources for a safety department or a safety official on staff. To help ad...

78 FR 48046 - Safety Zone; Kuoni Destination Management Fireworks; San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-07

...-AA00 Safety Zone; Kuoni Destination Management Fireworks; San Diego, CA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a safety zone on the navigable..., 2013. This temporary safety zone is necessary to provide for the safety of the participants, crew...

78 FR 54578 - Safety Zone, Tiki Swim; Oceanside Harbor, Oceanside, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-05

...-AA00 Safety Zone, Tiki Swim; Oceanside Harbor, Oceanside, CA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a safety zone on the navigable waters of..., 2013. This temporary safety zone is necessary to provide for the safety of the participants, crew...

21 CFR 315.6 - Evaluation of safety.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Evaluation of safety. 315.6 Section 315.6 Food and... USE DIAGNOSTIC RADIOPHARMACEUTICALS § 315.6 Evaluation of safety. (a) Factors considered in the safety...)(1) To establish the safety of a diagnostic radiopharmaceutical, FDA may require, among other...

10 CFR 835.901 - Radiation safety training.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Radiation safety training. 835.901 Section 835.901 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Radiation Safety Training § 835.901 Radiation safety training. (a) Each individual shall complete radiation safety training on the topics established at § 835...

The application of the psychological contract to workplace safety.

PubMed

Walker, Arlene; Hutton, Dorothy M

2006-01-01

Psychological contracts of safety are conceptualized as the beliefs of individuals about reciprocal safety obligations inferred from implicit or explicit promises. Although the literature on psychological contracts is growing, the existence of psychological contracts in relation to safety has not been established. The research sought to identify psychological contracts in the conversations of employees about safety, by demonstrating reciprocity in relation to employer and employee safety obligations. The identified safety obligations were used to develop a measure of psychological contracts of safety. The participants were 131 employees attending safety training sessions in retail and manufacturing organizations. Non-participant observation was used to collect the data during safety training sessions. Content analysis was used to analyze the data. Categories for coding were established through identification of language markers that demonstrated contingencies or other implied obligations. Direct evidence of reciprocity between employer safety obligations and employee safety obligations was found in statements from the participants demonstrating psychological contracts. A comprehensive list of perceived employer and employee safety obligations was compiled and developed into a measure of psychological contracts of safety. A small sample of 33 safety personnel was used to validate the safety obligations. CONCLUSIONS AND IMPACT ON INDUSTRY: Implications of these findings for safety and psychological contract research are discussed.

Vehicle Safety Communications project task 3 final report : identify intelligent vehicle safety applications enabled by DSRC

DOT National Transportation Integrated Search

2005-03-01

The Crash Avoidance Metrics Partnership (CAMP) Vehicle Safety Communications Consortium (VSCC) comprised of BMW, DaimlerChrysler, Ford, GM, Nissan, Toyota, and Volkswagen, in partnership with USDOT, established the Vehicle Safety Communications (VSC)...

76 FR 22033 - Safety Zone; Red River Safety Zone, Red River, MN

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-20

...-AAOO Safety Zone; Red River Safety Zone, Red River, MN AGENCY: Coast Guard, DHS. ACTION: Temporary... a temporary safety zone on the Red River, MN. This safety zone is being established to ensure the... Red River in the State of Minnesota north of a line drawn across latitude 46[deg]20'00'' N, including...

OSHA Laboratory Standard: Driving Force for Laboratory Safety!

ERIC Educational Resources Information Center

Roy, Kenneth R.

2000-01-01

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

Leadership and management in quality radiology

PubMed Central

2007-01-01

The practice of medical imaging and interventional radiology are undergoing rapid change in recent years due to technological advances, workload escalation, workforce shortage, globalisation, corporatisation, commercialisation and commoditisation of healthcare. These professional and economical changes are challenging the established norm but may bring new opportunities. There is an increasing awareness of and interest in the quality of care and patient safety in medical imaging and interventional radiology. Among the professional organisations, a range of quality systems are available to address individual, facility and system needs. To manage the limited resources successfully, radiologists and professional organisations must be leaders and champion for the cause of quality care and patient safety. Close collaboration with other stakeholders towards the development and management of proactive, long-term, system-based strategies and infrastructures will underpin a sustainable future in quality radiology. The International Radiology Quality Network can play a useful facilitating role in this worthwhile but challenging endeavour. PMID:21614284

INDUSTRIAL/MILITARY ACTIVITY-INITIATED ACCIDENT SCREENING ANALYSIS

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

D.A. Kalinich

1999-09-27

Impacts due to nearby installations and operations were determined in the Preliminary MGDS Hazards Analysis (CRWMS M&O 1996) to be potentially applicable to the proposed repository at Yucca Mountain. This determination was conservatively based on limited knowledge of the potential activities ongoing on or off the Nevada Test Site (NTS). It is intended that the Industrial/Military Activity-Initiated Accident Screening Analysis provided herein will meet the requirements of the ''Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants'' (NRC 1987) in establishing whether this external event can be screened from further consideration or must be includedmore » as a design basis event (DBE) in the development of accident scenarios for the Monitored Geologic Repository (MGR). This analysis only considers issues related to preclosure radiological safety. Issues important to waste isolation as related to impact from nearby installations will be covered in the MGR performance assessment.« less

Controlling hazardous energy sources (lockout/tagout)

NASA Technical Reports Server (NTRS)

Dominguez, Manuel B.

1991-01-01

The minimum requirements as established by the Occupational Safety and Health Administration (OSHA) standard 29 CFR 1910.147 are discussed for preventing the unexpected operation of equipment or release of energy which could cause injury to personnel, damage to equipment, harm to the environment, or loss or compromise of test data. Safety requirements both for government and contractor personnel are explained for potentially hazardous energy sources during work operations at LeRC (Cleveland and Plum Brook Stations). Basic rules are presented to ensure protection against harmful exposures, and baseline implementation requirements are discussed from which detailed lockout/tagout procedures can be developed for individual equipment items. Examples of energy sources covered by this document include electrical, pneumatic, mechanical, chemical, cryogenic, thermal, spring tension/compression suspended or moving loads, and other potentially hazardous sources. Activities covered by this standard include, but are not limited to, construction, maintenance, installation, calibration, inspection, cleaning, or repair.

Controlling hazardous energy sources (lockout/tagout)

NASA Astrophysics Data System (ADS)

Dominguez, Manuel B.

1991-10-01

The minimum requirements as established by the Occupational Safety and Health Administration (OSHA) standard 29 CFR 1910.147 are discussed for preventing the unexpected operation of equipment or release of energy which could cause injury to personnel, damage to equipment, harm to the environment, or loss or compromise of test data. Safety requirements both for government and contractor personnel are explained for potentially hazardous energy sources during work operations at LeRC (Cleveland and Plum Brook Stations). Basic rules are presented to ensure protection against harmful exposures, and baseline implementation requirements are discussed from which detailed lockout/tagout procedures can be developed for individual equipment items. Examples of energy sources covered by this document include electrical, pneumatic, mechanical, chemical, cryogenic, thermal, spring tension/compression suspended or moving loads, and other potentially hazardous sources. Activities covered by this standard include, but are not limited to, construction, maintenance, installation, calibration, inspection, cleaning, or repair.

Safety and effectiveness of stem cell therapies in early-phase clinical trials in stroke: a systematic review and meta-analysis.

PubMed

Nagpal, Anjali; Choy, Fong Chan; Howell, Stuart; Hillier, Susan; Chan, Fiona; Hamilton-Bruce, Monica A; Koblar, Simon A

2017-08-30

Stem cells have demonstrated encouraging potential as reparative therapy for patients suffering from post-stroke disability. Reperfusion interventions in the acute phase of stroke have shown significant benefit but are limited by a narrow window of opportunity in which they are beneficial. Thereafter, rehabilitation is the only intervention available. The current review summarises the current evidence for use of stem cell therapies in stroke from early-phase clinical trials. The safety and feasibility of administering different types of stem cell therapies in stroke seem to be reasonably proven. However, the effectiveness needs still to be established through bigger clinical trials with more pragmatic clinical trial designs that address the challenges raised by the heterogeneous nature of stroke per se, as well those due to unique characteristics of stem cells as therapeutic agents.

Sharpening the focus on occupational safety and health in nanotechnology.

PubMed

Schulte, Paul; Geraci, Charles; Zumwalde, Ralph; Hoover, Mark; Castranova, Vincent; Kuempel, Eileen; Murashov, Vladimir; Vainio, Harri; Savolainen, Kai

2008-12-01

Increasing numbers of workers are involved with the production, use, distribution, and disposal of nanomaterials. At the same time, there is a growing number of reports of adverse biological effects of engineered nanoparticles in test systems. It is useful, at this juncture, to identify critical questions that will help address knowledge gaps concerning the potential occupational hazards of these materials. The questions address (i) hazard classification of engineered nanoparticles, (ii) exposure metrics, (iii) the actual exposures to the different engineered nanoparticles in the workplace, (iv) the limits of engineering controls and personal protective equipment with respect to engineered nanoparticles, (v) the kinds of surveillance programs that may be required at workplaces to protect potentially exposed workers, (vi) whether exposure registers should be established for workers potentially exposed to engineered nanoparticles, and, (vii) whether engineered nanoparticles should be treated as "new" substances and evaluated for safety and hazards?

2001 Safety belt usage survey in Kentucky

DOT National Transportation Integrated Search

2001-08-01

The objective of this study was to establish 2001 safety belt and child safety seat usage rates in Kentucky. The 2001 survey continues to document the results after enactment of a statewide mandatory safety belt law in 1994. It also documented the lo...

2002 safety belt usage survey in Kentucky

DOT National Transportation Integrated Search

2002-07-01

The objective of this study was to establish 2002 safety belt and child safety seat usage rates in Kentucky. The 2002 survey continues to document the results after enactment of a statewide mandatory safety belt law in 1994. Data were collected at 20...

2000 Safety belt usage survey in Kentucky

DOT National Transportation Integrated Search

2000-08-01

The objective of this study was to establish 2000 safety belt and child safety seat usage rates in Kentucky. The 2000 survey continues to document the results after enactment of a statewide mandatory safety belt law in 1994. Data were collected at 20...

[Current status of occupational health activities and the way that occupational health services should be offered to small- and medium-scale enterprises].

PubMed

Kayashima, Kotaro

2013-10-01

Activating occupational safety and health activities among Small- and Medium-scale Enterprises (SMEs) is a major issue because more than 80% of Japanese workers belong to these enterprises, in which the number of workers are less than 300 people. However, as the size of the enterprise decreases, the occurrence of problems of safety and health management systems and safety and health activities increases. Reasons for this include both the limitations of investments shortages of human resources. Occupational health services in SMEs has been provided by the cooperation of the following institutions: public associations (such as Regional Occupational Health Centers, Occupational Health Promotion Centers, Japan Industrial Safety and Health Association (JISHA)), occupational health agencies which provide checkup services, health insurance associations, and regional medical services. In contrast to the low coverage of occupational health services among SMEs in Japan, there are some countries in Europe in which this coverage is almost 100%. This is because of the development of occupational health services outside the company. To show the benefits of the safety and health activities to managers of SMEs, and to motivate them to take advantage of the services, it is important to consider measurements. Also, establishing systems that provide those services, improving the quality of specialists such as occupational physicians, and educating human resources, are all necessary.

Application of the Safety Attitudes Questionnaire (SAQ) in Albanian hospitals: a cross-sectional study.

PubMed

Gabrani, Adriatik; Hoxha, Adrian; Simaku, Artan; Gabrani, Jonila Cyco

2015-04-15

To establish the reliability and validity of the translated version of the Safety Attitudes Questionnaire (SAQ) by evaluating its psychometric properties and to determine possible differences among nurses and physicians regarding safety attitudes. A cross-sectional study utilising the Albanian version of the SAQ and a demographic questionnaire. Four regional hospitals in Albania. 341 healthcare providers, including 132 nurses and 209 doctors. The translation, construct validity and internal validity of the SAQ. The SAQ includes six scales and 30 items. A total of 341 valid questionnaires were returned, for a response rate of 70%. The confirmatory factor analysis and its goodness-of-fit indices (standardised root mean square residual 0.075, root mean square error of approximation 0.044 and comparative fit index 0.97) showed good model fit. The Cronbach's α values for each of the scales of the SAQ ranged from 0.64 to 0.82. The percentage of hospital healthcare workers who had a positive attitude was 60.3% for the teamwork climate, 57.2% for the safety climate, 58.4% for job satisfaction, 37.4% for stress recognition, 59.3% for the perception of management and 49.5% for working conditions. Intercorrelations showed that the subscales had moderate-to-high correlations with one another. Nurses were more hesitant to admit and report errors; only 55% of physicians and 44% of nurses endorsed this statement (χ(2)=4.9, p=0.02). Moreover, nurses received lower scores on team work compared with doctors (N 45.7 vs D 52.3, p=0.01). Doctors denied the effects of stress and fatigue on their performance (N 46.7 vs D 39.5, p<0.01), neglecting the workload. The SAQ is a useful tool for evaluating safety attitudes in Albanian hospitals. In light of the health workforce's poor recognition of stress, establishing patient safety programmes should be a priority among policymakers in Albania. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Predicting clinical biological responses to dental materials.

PubMed

Wataha, John C

2012-01-01

Methods used to measure and predict clinical biological responses to dental materials remain controversial, confusing, and to some extent, unsuccessful. The current paper reviews significant issues surrounding how we assess the biological safety of materials, with a historical summary and critical look at the biocompatibility literature. The review frames these issues from a U.S. perspective to some degree, but emphasizes their global nature and universal importance. The PubMed database and information from the U.S. Food and Drug Administration, International Standards Organization, and American National Standards Institute were searched for prominent literature addressing the definition of biocompatibility, types of biological tests employed, regulatory and standardization issues, and how biological tests are used together to establish the biological safety of materials. The search encompassed articles published in English from approximately 1965-2011. The review does not comprehensively review the literature, but highlights significant issues that confront the field. Years ago, tests for biological safety sought to establish material inertness as the measure of safety, a criterion that is now deemed naive; the definition of biocompatibility has broadened along with the roles for materials in patient oral health care. Controversies persist about how in vitro or animal tests should be used to evaluate the biological safety of materials for clinical use. Controlled clinical trials remain the single best measure of the clinical response to materials, but even these tests have significant limitations and are less useful to identify mechanisms that shape material performance. Practice-based research networks and practitioner databases are emerging as important supplements to controlled clinical trials, but their final utility remains to be determined. Today we ask materials to play increasingly sophisticated structural and therapeutic roles in patient treatment. To accommodate these roles, strategies to assess, predict, and monitor material safety need to evolve. This evolution will be driven not only by researchers and manufacturers, but also by patients and practitioners, who want to use novel materials in new ways to treat oral disease. Copyright © 2011 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Microbial diversity and prevalence of foodborne pathogens in cheap and junk foods consumed by primary schoolchildren.

PubMed

Kim, M J; Kim, S A; Kang, Y S; Hwang, I G; Rhee, M S

2013-07-01

Aerobic plate counts (APC), coliforms, Bacillus cereus, Escherichia coli and eight foodborne pathogens were tested in 1008 cheap and junk foods, including candies, dried cakes, chewing gum, chocolate, dried and seasoned seafood, ice cream, and sugary foods. APCs were positive for 342 samples (33·9%), and the majority of the counts were 2-3 log CFU g(-1) or ml(-1) (average: 1·10 log CFU g(-1) or ml(-1) ). Most samples (97·3%) contained no coliforms (average: 0·07 log CFU g(-1) or ml(-1) ). Bacillus cereus was detected in 68 samples (average: 0·14 log CFU g(-1) or ml(-1) ). Escherichia coli and Listeria monocytogenes were detected in 6 and 1 samples, respectively, whereas other foodborne pathogens were not isolated. The highest bacterial counts were associated with dried and seasoned seafood products and dried cakes, suggesting that appropriate regulations of these food types should be considered. Cheap and junk foods were produced mainly in developing countries, but there were no significant differences in the bacterial counts among different countries of origin. The presence of foodborne pathogens may pose a risk for children. These results suggest that there is cause for deeper concern about the safety of these foods and that effective countermeasures should be established to improve their microbiological safety. Food safety is especially important for children, but only limited information is available about the microbiological quality of cheap and junk foods that are consumed frequently by primary schoolchildren (e.g. dried cakes, candies and chocolates). The present study investigated the microbial quality of cheap and junk foods, and our results indicate that these foods are a potential health risk for children, therefore, deeper concern about the safety of these foods and effective countermeasures should be established to improve their microbiological safety. The present study may contribute to the development of an appropriate child food safety management system. © 2013 The Society for Applied Microbiology.

The Extent of Consumer Product Involvement in Paediatric Injuries

PubMed Central

Catchpoole, Jesani; Walker, Sue; Vallmuur, Kirsten

2016-01-01

A challenge in utilising health sector injury data for Product Safety purposes is that clinically coded data have limited ability to inform regulators about product involvement in injury events, given data entry is bound by a predefined set of codes. Text narratives collected in emergency departments can potentially address this limitation by providing relevant product information with additional accompanying context. This study aims to identify and quantify consumer product involvement in paediatric injuries recorded in emergency department-based injury surveillance data. A total of 7743 paediatric injuries were randomly selected from Queensland Injury Surveillance Unit database and associated text narratives were manually reviewed to determine product involvement in the injury event. A Product Involvement Factor classification system was used to categorise these injury cases. Overall, 44% of all reviewed cases were associated with consumer products, with proximity factor (25%) being identified as the most common involvement of a product in an injury event. Only 6% were established as being directly due to the product. The study highlights the importance of utilising injury data to inform product safety initiatives where text narratives can be used to identify the type and involvement of products in injury cases. PMID:27399744

The Extent of Consumer Product Involvement in Paediatric Injuries.

PubMed

Catchpoole, Jesani; Walker, Sue; Vallmuur, Kirsten

2016-07-07

A challenge in utilising health sector injury data for Product Safety purposes is that clinically coded data have limited ability to inform regulators about product involvement in injury events, given data entry is bound by a predefined set of codes. Text narratives collected in emergency departments can potentially address this limitation by providing relevant product information with additional accompanying context. This study aims to identify and quantify consumer product involvement in paediatric injuries recorded in emergency department-based injury surveillance data. A total of 7743 paediatric injuries were randomly selected from Queensland Injury Surveillance Unit database and associated text narratives were manually reviewed to determine product involvement in the injury event. A Product Involvement Factor classification system was used to categorise these injury cases. Overall, 44% of all reviewed cases were associated with consumer products, with proximity factor (25%) being identified as the most common involvement of a product in an injury event. Only 6% were established as being directly due to the product. The study highlights the importance of utilising injury data to inform product safety initiatives where text narratives can be used to identify the type and involvement of products in injury cases.

76 FR 21253 - Safety Zone; M/V DAVY CROCKETT, Columbia River

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending and expanding the emergency safety zone established on... January 28, 2011. The safety zone is necessary to help ensure the safety of the response workers and...

76 FR 51065 - Florida Power & Light Company; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

... & Light Company; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the... following proceeding: Florida Power & Light Company (St. Lucie Plant, Unit 1) This proceeding involves a license amendment request by Florida Power & Light Company to increase, from 2,700 megawatts thermal to 3...

75 FR 54400 - Florida Power and Light Company; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

...] Florida Power and Light Company; Establishment of Atomic Safety and Licensing Board Pursuant to delegation... over the following proceeding: Florida Power & Light Company (Turkey Point Units 6 and 7) This...). Petitioners challenge the application filed by Florida Power & Light Company pursuant to Subpart C of 10 CFR...

78 FR 21085 - Establishment of a Public Docket for Administrative Detention Under the Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-09

... Administration Safety and Innovation Act AGENCY: Food and Drug Administration, HHS. ACTION: Establishment of... authority with respect to drugs under the Food and Drug Administration Safety and Innovation Act (FDASIA....regulations.gov . Submit written comments to the Division of Dockets Management (HFA- 305), Food and Drug...

75 FR 6069 - Idaho State University; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-05

... University; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission dated... University This proceeding concerns a Petition to Intervene submitted by Dr. Kevan Crawford in response to a... opportunity for hearing with respect to a revised application from Idaho State University requesting renewal...

78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and...: The Food and Drug Administration (FDA) is extending the comment period for the notice entitled...

Allogeneic blood stem cell transplantation: considerations for donors.

PubMed

Anderlini, P; Körbling, M; Dale, D; Gratwohl, A; Schmitz, N; Stroncek, D; Howe, C; Leitman, S; Horowitz, M; Gluckman, E; Rowley, S; Przepiorka, D; Champlin, R

1997-08-01

Allogeneic transplantation of cytokine-mobilized peripheral blood stem cells (PBSCs) is now being increasingly performed, but safety considerations for hematologically normal PBSC donors have not been fully addressed. Progenitors are generally mobilized for collection from normal donors using recombinant human granulocyte colony-stimulating factor (rhG-CSF). Although the short-term safety profile of rhG-CSF seems acceptable, experience remains limited and its optimal dose and schedule have not been defined. Minimal data exist regarding long-term safety of rhG-CSF, primarily derived from experience in patients with chronic neutropenia or cancer. An "ad hoc" workshop was recently convened among a group of investigators actively involved in the field of allogeneic stem cell transplantation to discuss the safety issues pertaining to normal PBSC donors. There was agreement on the following points: (1) On the basis of available data, it appears that rhG-CSF treatment and PBSC collection have an acceptable short-term safety profile in normal donors. However, the need for continued safety monitoring was recognized. (2) rhG-CSF doses up to 10 microg/kg/d show a consistent dose-response relationship with the mobilization (and collection) of CD34+ progenitor cells, and this dose is acceptable for routine clinical use. Whether higher doses are superior (or cost effective) remains to be determined, and they may produce more severe side effects. The potential risks of marked leukocytosis (arbitrarily defined as a leukocyte count of more than 70 x 10(9)/L) have been a concern, and rhG-CSF dose reduction is performed by many centers to maintain leukocyte counts below this level. (3) Transient post donation cytopenias, involving granulocytes, lymphocytes, and platelets, may occur and are at least partly related to the leukapheresis procedure. These are generally asymptomatic and self-limited; follow-up blood counts are not necessarily required. Reinfusion of autologous platelet-rich plasma should be considered for donors with expected postdonation thrombocytopenia (platelet count < 80 to 100 x 10(9)/L). (4) Donors should meet the eligibility criteria which apply to donors of apheresis platelets, with the exception that pediatric donors may also be considered. Any deviation from these criteria should have supporting documentation. There is insufficient information at this time to clearly establish definite contraindications for PBSC collection in a hematologically normal donor. Potential contraindications include the presence of inflammatory, autoimmune, or rheumatologic disorders, as well as atherosclerotic or cerebrovascular disease. (5) The creation of an International PBSC Donor Registry is desirable to facilitate monitoring the long-term effects of the procedure. Individual institutions or donor centers are encouraged to establish their own PBSC donor follow-up system, preferably with a standardized approach to data collection.

75 FR 73158 - Railroad Safety Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... regarding the Development, Use, and Implementation of Rail Safety Technology in Dark Territory. This agenda.... The RSAC was established to provide advice and recommendations to FRA on railroad safety matters. The...

The Research on Safety Management Information System of Railway Passenger Based on Risk Management Theory

NASA Astrophysics Data System (ADS)

Zhu, Wenmin; Jia, Yuanhua

2018-01-01

Based on the risk management theory and the PDCA cycle model, requirements of the railway passenger transport safety production is analyzed, and the establishment of the security risk assessment team is proposed to manage risk by FTA with Delphi from both qualitative and quantitative aspects. The safety production committee is also established to accomplish performance appraisal, which is for further ensuring the correctness of risk management results, optimizing the safety management business processes and improving risk management capabilities. The basic framework and risk information database of risk management information system of railway passenger transport safety are designed by Ajax, Web Services and SQL technologies. The system realizes functions about risk management, performance appraisal and data management, and provides an efficient and convenient information management platform for railway passenger safety manager.

Effect of a Publicly Accessible Disclosure System on Food Safety Inspection Scores in Retail and Food Service Establishments.

PubMed

Choi, Jihee; Scharff, Robert L

2017-07-01

The increased frequency with which people are dining out coupled with an increase in the publicity of foodborne disease outbreaks has led the public to an increased awareness of food safety issues associated with food service establishments. To accommodate consumer needs, local health departments have increasingly publicized food establishments' health inspection scores. The objective of this study was to estimate the effect of the color-coded inspection score disclosure system in place since 2006 in Columbus, OH, by controlling for several confounding factors. This study incorporated cross-sectional time series data from food safety inspections performed from the Columbus Public Health Department. An ordinary least squares regression was used to assess the effect of the new inspection regime. The introduction of the new color-coded food safety inspection disclosure system increased inspection scores for all types of establishments and for most types of inspections, although significant differences were found in the degree of improvement. Overall, scores increased significantly by 1.14 points (of 100 possible). An exception to the positive results was found for inspections in response to foodborne disease complaints. Scores for these inspections declined significantly by 10.2 points. These results should be useful for both food safety researchers and public health decision makers.

75 FR 26094 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-11

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago... establishing a temporary safety zone from Brandon Road Lock and Dam to Lake Michigan. This temporary safety...

76 FR 29333 - Pipeline Safety: Meetings of the Technical Pipeline Safety Standards Committee and the Technical...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-20

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... Technical Hazardous Liquid Pipeline Safety Standards Committee AGENCY: Pipeline and Hazardous Materials... for natural gas pipelines and for hazardous liquid pipelines. Both committees were established under...

The right to know and the duty to disclose hazard information.

PubMed

Baram, M S

1984-04-01

In late 1983, the Occupational Safety and Health Administration (OSHA) promulgated its final rule on "hazard communication," establishing the right of workers in manufacturing industries to information about chemical hazards, and the duty of importers and manufacturers to disclose such information. Baram reviews areas where the new, limited OSHA regulation conflicts with existing local, state, and federal laws, many of which are more stringent and more protective of worker and community health. He suggests steps that could be taken to avoid the extensive litigation that might result from the potential preemptive effect of the new OSHA rule.

Are Limits of Concern a useful concept to improve the environmental risk assessment of GM plants?

PubMed

Dolezel, Marion; Miklau, Marianne; Heissenberger, Andreas; Reichenbecher, Wolfram

2017-01-01

The European Food Safety Authority (EFSA) has introduced a concept for the environmental risk assessment of genetically modified (GM) plants which foresees the definition of ecological threshold values defining acceptable adverse effects of the GM plant on the environment (Limits of Concern, LoC). We analysed the LoC concept by scrutinising its feasibility with regard to important aspects of the environmental risk assessment. We then considered its relationship with protection goals, the comparative safety assessment and the stepwise testing approach. We finally discussed its usefulness for assessing long-term effects, effects on non-target organisms and species of conservation concern. The LoC concept is a possible approach to introduce ecological thresholds into environmental risk assessment in order to evaluate environmental harm. However, the concept leaves many important aspects open. Thresholds for environmental harm for protection goals need spatial and temporal differentiation from LoCs used for ERA indicators. Regionalisation of LoCs must be provided for as biodiversity levels and protection goals vary across the EU. Further guidance is needed with respect to the consequences, in case LoCs are exceeded and a link needs to be established between environmentally relevant results from the comparative safety assessment and the LoC concept. LoCs for long-term effects have to be evaluated by long-term monitoring. LoCs for non-target organisms need to be discriminated according to the species and parameters assessed. The overall LoC concept is considered useful if LoCs are further specified and differentiated. Although LoCs will finally be determined by political decisions, they should be based on scientific grounds in order to increase confidence in the conclusions on the safety of GM plants.

Defining Occupational and Consumer Exposure Limits for Nanomaterials - First Experiences from REACH Registrations

NASA Astrophysics Data System (ADS)

Aschberger, K.; Klöslova, Z.; Falck, G.; Christensen, F. M.

2013-04-01

By 1 December 2010 substances manufactured or imported in the EU >= 1000 t (as well as certain other substances) had to be registered under the REACH Regulation 1907/2006. The Joint Research Centre (JRC) in close cooperation with the European Chemicals Agency (ECHA) carried out an analysis and assessment of what type of information on nanomaterials was provided in the received registrations. The aim of the assessment was to develop options for an adaptation of the REACH regulation to ensure proper information generation and reporting and an appropriate risk/safety assessment of nanomaterials (Nano Support project). It should be noted that this analysis and assessment was not a compliance check of the dossiers. From 26000 submitted registration dossiers covering 4700 substances finally 25 dossiers (19 substances) were identified to cover nanomaterials or nanoforms of a substance. It is possible that other dossiers are considered to cover nanomaterials or nanoforms by the registrants, however such dossiers could not be identified to address nanoforms given the information contained in those dossiers. The identified 25 dossiers were subject to a detailed analysis and assessment of information provided for all endpoints including substance identity, physico-chemical properties, human health, environmental fate & behaviour, ecotoxicity, PBT6 assessment, Classification and Labelling as well as the attached Chemical Safety Report documenting the Chemical Risk/Safety Assessment. In order to evaluate how the safety of workers and consumers was ensured, it was appropriate to check how the "Derived No (Minimum) Effect Levels" (DN(M)ELs) were established for substances, covering nanomaterials or nanoforms. DNELs were established mainly for long term inhalation exposure of workers. Half of the assessed dossiers included an oral long term DNEL for the general population. DNELs were usually not specific for nanosized forms and, in the few cases where they were calculated for nanosized materials, they were not derived from hazard data for the nanoform. Different methods for deriving the DNELs were applied and few dossiers derived DNELs by applying the default assessment factors in the REACH guidance. Several DNELs were based on available Occupational Exposure Limits (OELs) for inhalable and respirable dust or the nuisance dust levels, which have not been established for nanosized materials. In general lower (i.e. less strict) assessment factors were applied with different types of justification. All DNELs were expressed in the mass metrics. It is important to note that submission, identification and selection of the dossiers addressed in this study was done before the adoption of the EC recommendation (2011/696/EU) on a definition of nanomaterial and before the publication of the revised ECHA guidance documents that include recommendations for nanomaterials.

Food hygiene and safety measures among food handlers in street food shops and food establishments of Dessie town, Ethiopia: A community-based cross-sectional study.

PubMed

Adane, Metadel; Teka, Brhanu; Gismu, Yirga; Halefom, Goitom; Ademe, Muluneh

2018-01-01

In sub-Saharan Africa foodborne disease and foodborne disease outbreaks are frequently ascribed to poor personal hygiene of street food vendors and food handlers in food establishments. Evidence on the level of food hygiene practices and food safety measures among food handlers is required for proper planning and implementation of targeted interventions. In this study, we aimed to determine the level of food hygiene and safety measures among street food vendors and food handlers in food establishments of Dessie Town, Ethiopia. A community-based cross-sectional study was performed in Dessie town, Ethiopia from December 2013 to June 2014. Data were collected using a pre-tested structured questionnaire and an observational checklist by a trained data collector among 116 food handlers from 116 food establishments and 19 food handlers from 19 street food vendors. Multivariable logistic regression analysis with 95% confidence interval (CI) was used to identify the factors significantly associated with good level of food hygiene and safety practices. Almost three-quarter (72%; 84/116) of food handlers in food establishments had a good level of food hygiene and safety practices compared to nearly half (53%; 10/19) of street food vendors. However, this difference was not statistically significant. Average monthly income of >$21 US (adjusted odds ratio [AOR] = 3.2; 95%CI: 1.3-7.7), availability of service training (AOR = 6.7; 95%CI: 1.8-25), wearing a gown during food handling (AOR = 19; 95%CI: 6.8-51) and medical checkup (AOR = 5.2; 95%CI: 2.1-13) were significantly associated with good levels of food hygiene and safety measures. Comprehensive health education and promotion programs through continuous training on food hygiene and safety, with promotion of wearing gown during food handling, regular medical checkups of food handlers and programs that enhance the monthly income of food handlers are promising strategies for promoting proper food handling practices in Dessie town, Ethiopia.

FMCSA’s advanced system testing utilizing a data acquisition system on the highways (FAST DASH) safety technology evaluation project #2 : technology brief.

DOT National Transportation Integrated Search

2016-11-01

The Federal Motor Carrier Safety Administration (FMCSA) established the FAST DASH program to perform efficient independent evaluations of promising safety technologies aimed at commercial vehicle operations. In this second FAST DASH safety technology...

78 FR 70858 - Safety Zones; Pacific Northwest Grain Handlers Association Facilities; Columbia and Willamette...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-27

... 1625-AA00 Safety Zones; Pacific Northwest Grain Handlers Association Facilities; Columbia and... establishing temporary safety zones around the following Pacific Northwest Grain Handlers Association... Commodities facility on the Willamette River in Portland, OR. These safety zones extend approximately between...

Alcohol and highway safety : a bibliography

DOT National Transportation Integrated Search

1976-05-15

This bibliography represents literature acquired since the establishment of the National Highway Traffic Safety Administration (NHTSA) in 1967, as related to alcohol and highway safety. It is comprised of NHTSA contract reports, reports of other orga...

State funding of alcohol safety countermeasure programs

DOT National Transportation Integrated Search

1979-09-01

This study was to analyze current State practices in funding State alcohol highway safety programs. The results were intended to provide guidelines for establishing and improving self-sustaining alcohol safety programs. The literature was reviewed an...

Food Safety Practices in the U.S. Meat Slaughter and Processing Industry: Changes from 2005 to 2015.

PubMed

Viator, Catherine L; Cates, Sheryl C; Karns, Shawn A; Muth, Mary K

2017-08-01

Meat slaughter establishments use a multipronged approach to ensure beef and pork products are safe for human consumption. To determine the approaches most commonly used, we conducted a national survey of federally inspected meat slaughter and processing establishments (376 completed surveys, 66% response rate) in 2015. We compared the results with a survey that was conducted in 2005, albeit of potentially different establishments, by using a similar questionnaire and similar data collection methods, thus allowing for an evaluation of trends in food safety practices over time. The use of some food safety practices has increased over the 10-yr time period, whereas others remained the same or decreased. For example, the use of chemical sanitizers or hot water for food contact surfaces and tools increased from 51 to 93%. As another example, microbiological testing of raw meat after fabrication, in addition to that required by regulation, increased from 50 to 72%. However, the use of organic acid rinse on carcasses in the slaughter area remained the same, at 66% of establishments. Written policies and procedures to control the use of hazardous chemicals decreased from 75 to 65% of establishments. The survey findings can be used to characterize food safety practices and technologies in the meat slaughter and processing industry and identify areas for improvement.

School Safety Handbook. A Handbook for School Business Officials and School Safety Supervisors. Research Bulletin No. 23.

ERIC Educational Resources Information Center

Haering, Franklin C.

A wide variety of school safety guidelines are included in this handbook. The introduction provides guidelines for delegating responsibility to school personnel. Procedures for developing safety policies and for establishing school safety councils and committees are outlined. A chapter on traffic control specifies procedures for pavement marking…

33 CFR 165.155 - Northville Industries Offshore Platform, Riverhead, Long Island, New York-safety zone.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Platform, Riverhead, Long Island, New York-safety zone. 165.155 Section 165.155 Navigation and Navigable...—safety zone. (a) The following area is established as a safety zone during the specified condition: (1... (LPG) vessel is moored at the Offshore Platform. The safety zone remains in effect until the LPG vessel...

33 CFR 165.155 - Northville Industries Offshore Platform, Riverhead, Long Island, New York-safety zone.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Platform, Riverhead, Long Island, New York-safety zone. 165.155 Section 165.155 Navigation and Navigable...—safety zone. (a) The following area is established as a safety zone during the specified condition: (1... (LPG) vessel is moored at the Offshore Platform. The safety zone remains in effect until the LPG vessel...

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

PubMed

Wu, Tsung-Chih

2011-10-01

The perspectives of both internal and external members have to be considered when developing safety curricula. This study discusses perceptional differences between safety educators (SEs) and safety professionals (SPs) regarding the function of SPs. The findings will serve as a reference framework for the establishment of core safety competencies and the development of safety curricula for SPs. 248 respondents, including both SEs and SPs, completed self-administered questionnaires, which included the 45-item safety function scale (SFS). Nine factors were extracted from the scale using exploratory factor analysis (EFA), namely inspection and research, regulatory tasks, emergency procedures and settlement of damage, management and financial affairs, culture change, problem identification and analysis, developing and implementing solutions, knowledge management, and training and communications. Descriptive statistical results indicated that SPs and SEs hold differing views on the rank of the frequency of safety functions. MANOVA results indicated that SPs' perceptions of developing and implementing solutions, training and communications, inspection and research, and management and financial affairs were significantly higher than that of SEs. On the other hand, SE's perceptions regarding participation in regulatory tasks were significantly higher than those of SPs. Based on these results, the author suggests that a clear communication channel should be established between universities and industry to reduce the gap between the perceptions of SEs and SPs. The results of the study are statistically and practically significant. In addition to serving as a reference for the development of safety curricula, the results are also conducive to the establishment of SP roles and functions. Ultimately the development of more suitable safety curricula would open up employment competition for students who graduate from safety-related programs. SPs, on the other hand, can correctly recognize their roles and functions so as to realize the safety expectations invested in them by organizations. Copyright © 2011 Elsevier Ltd. All rights reserved.

Prediction of area under the curve for a p-glycoprotein, a CYP3A4 and a CYP2C9 substrate using a single time point strategy: assessment using fexofenadine, itraconazole and losartan and metabolites.

PubMed

Srinivas, Nuggehally R

2016-01-01

In the present age of polypharmacy, limited sampling strategy becomes important to verify if drug levels are within the prescribed threshold limits from efficacy and safety considerations. The need to establish reliable single time concentration dependent models to predict exposure becomes important from cost and time perspectives. A simple unweighted linear regression model was developed to describe the relationship between Cmax versus AUC for fexofenadine, losartan, EXP3174, itraconazole and hydroxyitraconazole. The fold difference, defined as the quotient of the observed and predicted AUC values, were evaluated along with statistical comparison of the predicted versus observed values. The correlation between Cmax versus AUC was well established for all the five drugs with a correlation coefficient (r) ranging from 0.9130 to 0.9997. Majority of the predicted values for all the five drugs (77%) were contained within a narrow boundary of 0.75- to 1.5-fold difference. The r values for observed versus predicted AUC were 0.9653 (n = 145), 0.8342 (n = 76), 0.9524 (n = 88), 0.9339 (n = 89) and 0.9452 (n = 66) for fexofenadine, losartan, EXP3174, itraconazole and hydroxyitraconazole, respectively. Cmax versus AUC relationships were established for all drugs and were amenable for limited sampling strategy for AUC prediction. However, fexofenadine, EXP3174 and hydroxyitraconazole may be most relevant for AUC prediction by a single time concentration as judged by the various criteria applied in this study.

Rapid prototyping of flexible intrafascicular electrode arrays by picosecond laser structuring.

PubMed

Mueller, Matthias; de la Oliva, Natalia; Del Valle, Jaume; Delgado-Martínez, Ignacio; Navarro, Xavier; Stieglitz, Thomas

2017-12-01

Interfacing the peripheral nervous system can be performed with a large variety of electrode arrays. However, stimulating and recording a nerve while having a reasonable amount of channels limits the number of available systems. Translational research towards human clinical trial requires device safety and biocompatibility but would benefit from design flexibility in the development process to individualize probes. We selected established medical grade implant materials like precious metals and Parylene C to develop a rapid prototyping process for novel intrafascicular electrode arrays using a picosecond laser structuring. A design for a rodent animal model was developed in conjunction with an intrafascicular implantation strategy. Electrode characterization and optimization was performed first in saline solution in vitro before performance and biocompatibility were validated in sciatic nerves of rats in chronic implantation. The novel fabrication process proved to be suitable for prototyping and building intrafascicular electrode arrays. Electrochemical properties of the electrode sites were enhanced and tested for long-term stability. Chronic implantation in the sciatic nerve of rats showed good biocompatibility, selectivity and stable stimulation thresholds. Established medical grade materials can be used for intrafascicular nerve electrode arrays when laser structuring defines structure size in the micro-scale. Design flexibility reduces re-design cycle time and material certificates are beneficial support for safety studies on the way to clinical trials.

Care in the community: what would happen if the lights went out?

PubMed

Smallbone, Carolyn; Staniland, Karen

2011-07-01

This article reports on a student nurse project carried out on a community placement in respect to patients dependent on medical devices in the event of power cuts. The project was designed to identify relevant literature to establish what emergency and preparatory procedures and protocols are in place in a primary care trust for this type of emergency and to identify what action a nurse in the community should take to ensure the safety and welfare of their patients if a there was a prolonged power failure. The literature and knowledge of community staff for the correct procedures to follow in the event of a power cut in the community established that there was some cause for concern, and identified that a loss of power to a patient with a medical device poses a serious risk. Recommendations are that an initial risk assessment of power failure needs to be undertaken and included in the appropriate documentation and guidance plans prepared for community staff and should include the listing of the patient as vulnerable. The limited research identified within this project also indicates that contingency plans to ensure the safety and well-being of patients in the community clearly need to be included in disaster and emergency planning.

Physical Properties and Effect in a Battery of Safety Pharmacology Models for Three Structurally Distinct Enteric Polymers Employed as Spray-Dried Dispersion Carriers

PubMed Central

Fryer, Ryan M.; Patel, Mita; Zhang, Xiaomei; Baum-Kroker, Katja S.; Muthukumarana, Akalushi; Linehan, Brian; Tseng, Yin-Chao

2016-01-01

Establishing a wide therapeutic index (TI) for pre-clinical safety is important during lead optimization (LO) in research, prior to clinical development, although is often limited by a molecules physiochemical characteristics. Recent advances in the application of the innovative vibrating mesh spray-drying technology to prepare amorphous solid dispersions may offer an opportunity to achieve high plasma concentrations of poorly soluble NCEs to enable testing and establishment of a wide TI in safety pharmacology studies. While some of the amorphous solid dispersion carriers are generally recognized as safe for clinical use, whether they are sufficiently benign to enable in vivo pharmacology studies has not been sufficiently demonstrated. Thus, the physical properties, and effect in a battery of in vivo safety pharmacology models, were assessed in three classes of polymers employed as spray-dried dispersion carriers. The polymers (HPMC-AS, Eudragit, PVAP) displayed low affinity with acetone/methanol, suitable for solvent-based spray drying. The water sorption of the polymers was moderate, and the degree of hysteresis of HPMC-AS was smaller than Eudragit and PVAP indicating the intermolecular interaction of water-cellulose molecules is weaker than water-acrylate or water-polyvinyl molecules. The polymer particles were well-suspended without aggregation with a mean particle size less than 3 μm in an aqueous vehicle. When tested in conscious Wistar Han rats in safety pharmacology models (n = 6–8/dose/polymer) investigating effects on CNS, gastrointestinal, and cardiovascular function, no liabilities were identified at any dose tested (30–300 mg/kg PO, suspension). In brief, the polymers had no effect in a modified Irwin test that included observational and evoked endpoints related to stereotypies, excitation, sedation, pain/anesthesia, autonomic balance, reflexes, and others. No effect of the polymers on gastric emptying or intestinal transit was observed when measured using a barium sulfate tracer material. Finally, in telemetry-instrumented rats the polymers had no effect on acute or 24-h mean blood pressure and heart rate values at doses up to 300 mg/kg. Thus, the properties of the three enteric polymers are appropriate as spray-dried dispersion carriers and were benign in a battery of safety pharmacology studies, demonstrating their applicability to enable in vivo safety pharmacology profiling of poorly soluble molecules during LO. PMID:27790142

78 FR 41803 - Establishment of a Public Docket for Comment on the Report Prepared Under the Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-11

... Safety and Innovation Act Section 1138 AGENCY: Food and Drug Administration, HHS. ACTION: Establishment... Administration Safety and Innovation Act (FDASIA) Section 1138, enacted July 9, 2012, and posted on the FDA Web... comments to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA...

77 FR 24538 - Fukushima-Related Orders Modifying Licenses; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-24

... NUCLEAR REGULATORY COMMISSION [Docket Nos. EA-12-050, EA-12-051; ASLBP No. 12-918-01-EA-BD01] Fukushima-Related Orders Modifying Licenses; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission dated December 29, 1972, published in the Federal Register, 37 FR 28,710 (1972...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-25

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

78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and... information. SUMMARY: In September 2011, the Food and Drug Administration (FDA or the Agency) asked the...

FMCSA’s advanced system testing utilizing a data acquisition system on the highways (FAST DASH) safety technology evaluation project #3 : novel convex mirrors : technology brief.

DOT National Transportation Integrated Search

2016-11-01

The Federal Motor Carrier Safety Administration (FMCSA) established the FAST DASH program to perform efficient independent evaluations of promising safety technologies aimed at commercial vehicle operations. In this third FAST DASH safety technology ...

33 CFR 165.755 - Safety Zone; Guayanilla, Puerto Rico.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Zone; Guayanilla, Puerto Rico. (a) The following area is established as a safety zone during the... the Eco-Electrica waterfront facility in Guayanilla Bay, Puerto Rico. The safety zone remains in... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Safety Zone; Guayanilla, Puerto...

33 CFR 165.755 - Safety Zone; Guayanilla, Puerto Rico

Code of Federal Regulations, 2012 CFR

2012-07-01

... Zone; Guayanilla, Puerto Rico (a) The following area is established as a safety zone during the... the Eco-Electrica waterfront facility in Guayanilla Bay, Puerto Rico. The safety zone remains in... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Safety Zone; Guayanilla, Puerto...

33 CFR 165.755 - Safety Zone; Guayanilla, Puerto Rico

Code of Federal Regulations, 2010 CFR

2010-07-01

... Zone; Guayanilla, Puerto Rico (a) The following area is established as a safety zone during the... the Eco-Electrica waterfront facility in Guayanilla Bay, Puerto Rico. The safety zone remains in... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety Zone; Guayanilla, Puerto...

33 CFR 165.755 - Safety Zone; Guayanilla, Puerto Rico

Code of Federal Regulations, 2011 CFR

2011-07-01

... Zone; Guayanilla, Puerto Rico (a) The following area is established as a safety zone during the... the Eco-Electrica waterfront facility in Guayanilla Bay, Puerto Rico. The safety zone remains in... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Safety Zone; Guayanilla, Puerto...

33 CFR 165.755 - Safety Zone; Guayanilla, Puerto Rico.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Zone; Guayanilla, Puerto Rico. (a) The following area is established as a safety zone during the... the Eco-Electrica waterfront facility in Guayanilla Bay, Puerto Rico. The safety zone remains in... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false Safety Zone; Guayanilla, Puerto...

78 FR 27033 - Safety Zone; High Water Conditions; Illinois River

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

...-AA00 Safety Zone; High Water Conditions; Illinois River AGENCY: Coast Guard, DHS. ACTION: Temporary... current extreme high-water conditions. This safety zone is necessary to protect the general public, levee... dangerously high water conditions, the Coast Guard established a safety zone on the Illinois River from Mile...

33 CFR 96.250 - What documents and reports must a safety management system have?

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Safety management system document and data maintenance (1) Procedures which establish and maintain control of all documents and data relevant to the safety management system. (2) Documents are available at... safety management system have? 96.250 Section 96.250 Navigation and Navigable Waters COAST GUARD...

76 FR 8699 - Locomotive Safety Standards; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-15

.... FRA-2009-0094 and FRA-2009-0095, Notice No. 2] RIN 2130-AC16 Locomotive Safety Standards; Correction... notifying the public that the correct docket number for the Locomotive Safety Standards notice of proposed... locomotive safety standards. See 76 FR 2200. The NPRM established a public docket to receive comments in...

77 FR 23159 - Locomotive Safety Standards; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-18

.... FRA-2009-0094 and FR-2009-0095, Notice No. 4] RIN 2130-AC16 Locomotive Safety Standards; Correction... notifying the public that the correct docket number for the Locomotive Safety Standards final rule is FRA... rule related to locomotive safety standards. See 77 FR 21312. The final rule established a public...

14 CFR 417.221 - Time delay analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... OF TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.221 Time delay analysis. (a) General. A flight safety analysis must include a time delay analysis that establishes the mean elapsed time between the violation of a flight termination rule and the time when the flight safety system is...

14 CFR 417.221 - Time delay analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... OF TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.221 Time delay analysis. (a) General. A flight safety analysis must include a time delay analysis that establishes the mean elapsed time between the violation of a flight termination rule and the time when the flight safety system is...

49 CFR 222.39 - How is a quiet zone established?

Code of Federal Regulations, 2010 CFR

2010-10-01

...-rail grade crossings within the quiet zone, the State agency responsible for highway and road safety... for highway and road safety; the State agency responsible for grade crossing safety; and the Associate..., and the State agency responsible for highway and road safety stating that the railroad, vehicular...

49 CFR 222.39 - How is a quiet zone established?

Code of Federal Regulations, 2011 CFR

2011-10-01

...-rail grade crossings within the quiet zone, the State agency responsible for highway and road safety... for highway and road safety; the State agency responsible for grade crossing safety; and the Associate..., and the State agency responsible for highway and road safety stating that the railroad, vehicular...

Photovoltaic system criteria documents. Volume 5: Safety criteria for photovoltaic applications

NASA Technical Reports Server (NTRS)

Koenig, John C.; Billitti, Joseph W.; Tallon, John M.

1979-01-01

Methodology is described for determining potential safety hazards involved in the construction and operation of photovoltaic power systems and provides guidelines for the implementation of safety considerations in the specification, design and operation of photovoltaic systems. Safety verification procedures for use in solar photovoltaic systems are established.

U.S. Food safety and Inspection Service testing for Salmonella in selected raw meat and poultry products in the United States, 1998 through 2003: an establishment-level analysis.

PubMed

Eblen, Denise R; Barlow, Kristina E; Naugle, Alecia Larew

2006-11-01

The U.S. Food Safety and Inspection Service (FSIS) pathogen reduction-hazard analysis critical control point systems final rule, published in 1996, established Salmonella performance standards for broiler chicken, cow and bull, market hog, and steer and heifer carcasses and for ground beef, chicken, and turkey meat. In 1998, the FSIS began testing to verify that establishments are meeting performance standards. Samples are collected in sets in which the number of samples is defined but varies according to product class. A sample set fails when the number of positive Salmonella samples exceeds the maximum number of positive samples allowed under the performance standard. Salmonella sample sets collected at 1,584 establishments from 1998 through 2003 were examined to identify factors associated with failure of one or more sets. Overall, 1,282 (80.9%) of establishments never had failed sets. In establishments that did experience set failure(s), generally the failed sets were collected early in the establishment testing history, with the exception of broiler establishments where failure(s) occurred both early and late in the course of testing. Small establishments were more likely to have experienced a set failure than were large or very small establishments, and broiler establishments were more likely to have failed than were ground beef, market hog, or steer-heifer establishments. Agency response to failed Salmonella sample sets in the form of in-depth verification reviews and related establishment-initiated corrective actions have likely contributed to declines in the number of establishments that failed sets. A focus on food safety measures in small establishments and broiler processing establishments should further reduce the number of sample sets that fail to meet the Salmonella performance standard.

Establishment of microbiological safety criteria for foods in international trade. International Commission on Microbiological Specifications for Foods.

PubMed

1997-01-01

Microbiological safety is achieved by applying good hygienic practices throughout the food chain, "from farm to fork". Governmental food control is traditionally based on inspection of the facilities where foods are handled, and on testing food samples. Testing is usually applied to imported foods, when no information concerning the safety of a consignment is available. The microbiological safety is judged by means of microbiological criteria. Such criteria should, in the context of the WTO/SPS measures, be scientifically justified, and established according to the principles described by the Codex Alimentarius. However, microbiological testing is not a very reliable tool for consumer protection; the emphasis is currently shifting to the application of food safety management tools such as the Hazard Analysis Critical Control Point system (HACCP).

16 CFR 1209.38 - Records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION Certification § 1209.38 Records. (a) Establishment and maintenance. Each... product specification containing all information required by § 1209.35. (This includes information...

Environment, Safety, and Health: Status of DOE’s Reorganization of it’s Safety Oversight Function

DTIC Science & Technology

1990-01-01

facilities. After deliberation, the Congress in late 1988 directed that the Defense Nuclear Facilities Safety Board be established to provide...nuclear safety matters will be conducted by either the Advisory Committee on Nuclear Facility Safety or the recently mandated Defense Nuclear Facilities Safety...the facilities under the statutory purview of the Defense Nuclear Facilities Safety Board once the board determines it is ready to assume independent

Dose limits to the lens of the eye: International Basic Safety Standards and related guidance.

PubMed

Boal, T J; Pinak, M

2015-06-01

The International Atomic Energy Agency (IAEA) safety requirements: 'General Safety Requirements Part 3--Radiation protection and safety of radiation sources: International Basic Safety Standards' (BSS) was approved by the IAEA Board of Governors at its meeting in September 2011, and was issued as General Safety Requirements Part 3 in July 2014. The equivalent dose limit for the lens of the eye for occupational exposure in planned exposure situations was reduced from 150 mSv year(-1) to 20 mSv year(-1), averaged over defined periods of 5 years, with no annual dose in a single year exceeding 50 mSv. This reduction in the dose limit for the lens of the eye followed the recommendation of the International Commission on Radiological Protection in its statement on tissue reactions of 21 April 2011. IAEA has developed guidance on the implications of the new dose limit for the lens of the eye. This paper summarises the process that led to the inclusion of the new dose limit for the lens of the eye in the BSS, and the implications of the new dose limit. © The International Society for Prosthetics and Orthotics Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

29 CFR 5.15 - Limitations, variations, tolerances, and exemptions under the Contract Work Hours and Safety...

Code of Federal Regulations, 2010 CFR

2010-07-01

... the Contract Work Hours and Safety Standards Act. 5.15 Section 5.15 Labor Office of the Secretary of... WORK HOURS AND SAFETY STANDARDS ACT) Davis-Bacon and Related Acts Provisions and Procedures § 5.15 Limitations, variations, tolerances, and exemptions under the Contract Work Hours and Safety Standards Act. (a...

Interrelation Between Safety Factors and Reliability

NASA Technical Reports Server (NTRS)

Elishakoff, Isaac; Chamis, Christos C. (Technical Monitor)

2001-01-01

An evaluation was performed to establish relationships between safety factors and reliability relationships. Results obtained show that the use of the safety factor is not contradictory to the employment of the probabilistic methods. In many cases the safety factors can be directly expressed by the required reliability levels. However, there is a major difference that must be emphasized: whereas the safety factors are allocated in an ad hoc manner, the probabilistic approach offers a unified mathematical framework. The establishment of the interrelation between the concepts opens an avenue to specify safety factors based on reliability. In cases where there are several forms of failure, then the allocation of safety factors should he based on having the same reliability associated with each failure mode. This immediately suggests that by the probabilistic methods the existing over-design or under-design can be eliminated. The report includes three parts: Part 1-Random Actual Stress and Deterministic Yield Stress; Part 2-Deterministic Actual Stress and Random Yield Stress; Part 3-Both Actual Stress and Yield Stress Are Random.

Preclinical modeling highlights the therapeutic potential of hematopoietic stem cell gene editing for correction of SCID-X1.

PubMed

Schiroli, Giulia; Ferrari, Samuele; Conway, Anthony; Jacob, Aurelien; Capo, Valentina; Albano, Luisa; Plati, Tiziana; Castiello, Maria C; Sanvito, Francesca; Gennery, Andrew R; Bovolenta, Chiara; Palchaudhuri, Rahul; Scadden, David T; Holmes, Michael C; Villa, Anna; Sitia, Giovanni; Lombardo, Angelo; Genovese, Pietro; Naldini, Luigi

2017-10-11

Targeted genome editing in hematopoietic stem/progenitor cells (HSPCs) is an attractive strategy for treating immunohematological diseases. However, the limited efficiency of homology-directed editing in primitive HSPCs constrains the yield of corrected cells and might affect the feasibility and safety of clinical translation. These concerns need to be addressed in stringent preclinical models and overcome by developing more efficient editing methods. We generated a humanized X-linked severe combined immunodeficiency (SCID-X1) mouse model and evaluated the efficacy and safety of hematopoietic reconstitution from limited input of functional HSPCs, establishing thresholds for full correction upon different types of conditioning. Unexpectedly, conditioning before HSPC infusion was required to protect the mice from lymphoma developing when transplanting small numbers of progenitors. We then designed a one-size-fits-all IL2RG (interleukin-2 receptor common γ-chain) gene correction strategy and, using the same reagents suitable for correction of human HSPC, validated the edited human gene in the disease model in vivo, providing evidence of targeted gene editing in mouse HSPCs and demonstrating the functionality of the IL2RG -edited lymphoid progeny. Finally, we optimized editing reagents and protocol for human HSPCs and attained the threshold of IL2RG editing in long-term repopulating cells predicted to safely rescue the disease, using clinically relevant HSPC sources and highly specific zinc finger nucleases or CRISPR (clustered regularly interspaced short palindromic repeats)/Cas9 (CRISPR-associated protein 9). Overall, our work establishes the rationale and guiding principles for clinical translation of SCID-X1 gene editing and provides a framework for developing gene correction for other diseases. Copyright © 2017 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.

Equivalence between solar irradiance and solar simulators in aging tests of sunglasses.

PubMed

Masili, Mauro; Ventura, Liliane

2016-08-26

This work is part of a broader research that focuses on ocular health. Three outlines are the basis of the pyramid that comprehend the research as a whole: authors' previous work, which has provided the public to self-check their own sunglasses regarding the ultraviolet protection compatible to their category; Brazilian national survey in order to improve nationalization of sunglasses standards; and studies conducted on revisiting requirements of worldwide sunglasses standards, in which this work is inserted. It is still controversial on the literature the ultraviolet (UV) radiation effects on the ocular media, but the World Health Organization has established safe limits on the exposure of eyes to UV radiation based on the studies reported in literature. Sunglasses play an important role in providing safety, and their lenses should provide adequate UV filters. Regarding UV protection for ocular media, the resistance-to-irradiance test for sunglasses under many national standards requires irradiating lenses for 50 uninterrupted hours with a 450 W solar simulator. This artificial aging test may provide a corresponding evaluation of exposure to the sun. Calculating the direct and diffuse solar irradiance at a vertical surface and the corresponding radiant exposure for the entire year, we compare the latter with the 50-h radiant exposure of a 450 W xenon arc lamp from a solar simulator required by national standards. Our calculations indicate that this stress test is ineffective in its present form. We provide evidence of the need to re-evaluate the parameters of the tests to establish appropriate safe limits for UV irradiance. This work is potentially significant for scientists and legislators in the field of sunglasses standards to improve the requirements of sunglasses quality and safety.

Hospital hygiene in an age of Diagnostic Related Groups (DRG), Protection against Infection Act (IfSG), Book V of the German Code of Social Law (SGB V) and administrative reforms - facts and visions from Bavaria.

PubMed

Hingst, Volker

2007-09-13

Since 1 January 2001, German hospitals and establishments engaged in outpatient surgery are obliged to continually record and evaluate nosocomial infections and the emergence of nosocomial pathogens showing special resistance and multi-resistance profiles. A survey conducted among 164 hospitals revealed that 79 % of establishments already carried out separate surveillance and evaluation of postoperative wound infections, while 77 % also recorded nosocomial infections and 91 % recorded pathogens with special resistance and multi-resistance profiles. However, only the larger hospitals had their own in-house infection control physician, while the smaller establishments generally consulted external infection control physicians. When asked how long such experts made their services available to the hospitals, no clear answer was given. Furthermore, only two-thirds of hospitals had their own infection control nurses (most of whom worked part time). These findings have induced the State Office for Health and Food Safety (LGL) in Bavaria to expand its advisory and information services and to formulate standards in consultation with partners at state level. The public health offices are legally obliged to supervise infection control policies in hospitals and medical establishments. These supervisory activities have not always been conducted in a uniform manner, thus engendering anxiety among the institutions to be supervised when it comes to discharging their prescribed duties. A concept devised to improve and standardize the monitoring of hospital hygiene is to be used to standardize supervision of infection control practices (by the statutory authorities). With the incorporation of the, hitherto, State Office for Occupational Safety, Occupational Medicine and Safety Engineering into the LGL, the specialist centers for public health and the Trade Supervisory Office will be united under one umbrella. The idea is to avail of the resulting improved cooperation possibilities, so as to avoid duplication of effort as regards the overlapping areas of medical and trade supervision and limit contradictory commentaries and avoid a situation whereby several public health officials have to pay visits to the various establishments. This will also reinforce partnerships between medical establishments and the public health authorities at local level. Some thirty years ago, while the present author could possibly dream of such an outcome when he took his first steps into the, at times arduous, terrain of hospital hygiene, he probably would not have dared to express it.

77 FR 49401 - Safety Zones; Revolution 3 Triathlon, Lake Erie, Sandusky Bay, Cedar Point, OH

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-16

...-AA00 Safety Zones; Revolution 3 Triathlon, Lake Erie, Sandusky Bay, Cedar Point, OH AGENCY: Coast Guard... permanent safety zones on Lake Erie near Sandusky, OH. This action is necessary to provide for the safety of... injuries or fatalities. The Captain of the Port Detroit proposes to establish this safety zone to protect...

29 CFR Appendix A to Subpart P of... - Model Fire Safety Plan (Non-Mandatory)

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 7 2013-07-01 2013-07-01 false Model Fire Safety Plan (Non-Mandatory) A Appendix A to...—Model Fire Safety Plan (Non-Mandatory) Model Fire Safety Plan Note: This appendix is non-mandatory and provides guidance to assist employers in establishing a Fire Safety Plan as required in § 1915.502. Table...

29 CFR Appendix A to Subpart P to... - Model Fire Safety Plan (Non-Mandatory)

Code of Federal Regulations, 2012 CFR

2012-07-01

... 29 Labor 7 2012-07-01 2012-07-01 false Model Fire Safety Plan (Non-Mandatory) A Appendix A to...—Model Fire Safety Plan (Non-Mandatory) Model Fire Safety Plan Note: This appendix is non-mandatory and provides guidance to assist employers in establishing a Fire Safety Plan as required in § 1915.502. Table...

29 CFR Appendix A to Subpart P of... - Model Fire Safety Plan (Non-Mandatory)

Code of Federal Regulations, 2014 CFR

2014-07-01

... 29 Labor 7 2014-07-01 2014-07-01 false Model Fire Safety Plan (Non-Mandatory) A Appendix A to...—Model Fire Safety Plan (Non-Mandatory) Model Fire Safety Plan Note: This appendix is non-mandatory and provides guidance to assist employers in establishing a Fire Safety Plan as required in § 1915.502. Table...

Adjusting the Passing Scores for Gearing up for Safety: Production Agriculture Safety Training for Youth Curriculum Test Instruments

ERIC Educational Resources Information Center

Hoover, William Brian; French, Brian F.; Field, William E.; Tormoehlen, Roger L.

2012-01-01

Minimum passing scores for the Gearing Up for Safety: Production Agriculture Safety Training for Youth curriculum (Gearing Up for Safety) were set in 2006 with widely used and established procedures by efforts of subject matter experts (French, Breidenbach et al., 2007; French, Field, and Tormoehlen, 2006, 2007). While providing a research-based…

Safety in the Chemical Laboratory: Impressions of Safety in Universities in the United States of America.

ERIC Educational Resources Information Center

Bush, Dick; Renfrew, Malcolm M., Ed.

1979-01-01

This is a report on a study done in 1976 of safety arrangements and procedures in teaching, research, and medical establishments in the United States. The results show that the Occupational Safety & Health Act (OSHA) has not yet had much impact as far as safety in teaching and research is concerned. (BB)

Implications of the implementation of the revised dose limit to the lens of the eye: the view of IRPA professionals.

PubMed

Broughton, J; Cantone, M C; Ginjaume, M; Shah, B; Czarwinski, R

2015-06-01

In April 2011, the International Commission on Radiological Protection issued a statement on reduction of the equivalent dose limits for the lens of the eye, and strongly recommended its consideration in the revision of the International Atomic Energy Agency's International Basic Safety Standards on Radiation Protection. The reduced dose limit was incorporated in the final version of the Basic Safety Standards. As significant concern was expressed by radiation protection professionals worldwide, the International Radiation Protection Association (IRPA) established a task group to assess the impact of implementation of the revised dose limit for the lens of the eye for occupational exposure. IRPA Associate Societies (ASs) were asked for their views using a questionnaire addressing three topics: implications for dosimetry, implications for methods of protection, and wider implications. The responses received indicate various methods of approach and express different points of view, reflecting nuances of particular ASs or specific professional groups. Topic experts nominated by ASs were selected to assist with collation of responses, and a report was produced by the task group. Conclusions were drawn on the three issues, including potential cost implications. A number of recommendations were drawn from the responses received including: the request for more understanding about the relationship between exposure of the lens of the eye and cataract formation, and further guidance to assist implementation; the importance of economic and social considerations when introducing the limits into national regulations; the need to propose or define procedures related to employment of people with existing or pre-cataract conditions; and the practical aspects relating to dosimetry and protective equipment. © The International Society for Prosthetics and Orthotics Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Efficacy and safety of limited endoscopic sphincterotomy before self-expandable metal stent insertion for malignant biliary obstruction

PubMed Central

Nam, Hyeong Seok; Kang, Dae Hwan; Kim, Hyung Wook; Choi, Cheol Woong; Park, Su Bum; Kim, Su Jin; Ryu, Dae Gon

2017-01-01

AIM To evaluate the safety and efficacy of limited endoscopic sphincterotomy (ES) before placement of self-expandable metal stent (SEMS). METHODS This was a retrospective analysis of 244 consecutive patients with unresectable malignant biliary obstruction, who underwent placement of SEMSs following limited ES from December 2008 to February 2015. The diagnosis of malignant biliary obstruction and assessment of patient eligibility for the study was established by a combination of clinical findings, laboratory investigations, imaging and pathological results. All patients were monitored in the hospital for at least 24 h following endoscopic retrograde cholangio pancreatography (ERCP). The incidence of immediate or early post-ERCP complications such as post-ERCP pancreatitis (PEP) and bleeding related to limited ES were considered as primary outcomes. Also, characteristics and complications according to the cancer type were classified. RESULTS Among the 244 patients included, the underlying diagnosis was cholangiocarcinoma in 118 patients, pancreatic cancer in 79, and non-pancreatic or non-biliary malignancies in the remaining 47 patients. Early post-ERCP complications occurred in 9 patients (3.7%), with PEP in 7 patients (2.9%; mild, 6; moderate, 1) and mild bleeding in 2 patients (0.8%). There was no significant association between the incidence of post-ERCP complications and the type of malignancy (cholangiocarcinoma vs pancreatic cancer vs others, P = 0.696) or the type of SEMS used (uncovered vs covered, P = 1.000). Patients who had more than one SEMS placed at the first instance were at a significantly higher risk of post-ERCP complications (one SEMS vs two SEMS, P = 0.031). No other factors were predictive of post-ERCP complications. CONCLUSION Limited ES is feasible and safe, and effectively facilitates the placement of SEMS, without any significant risk of PEP or severe bleeding. PMID:28321164

Efficacy and safety of limited endoscopic sphincterotomy before self-expandable metal stent insertion for malignant biliary obstruction.

PubMed

Nam, Hyeong Seok; Kang, Dae Hwan; Kim, Hyung Wook; Choi, Cheol Woong; Park, Su Bum; Kim, Su Jin; Ryu, Dae Gon

2017-03-07

To evaluate the safety and efficacy of limited endoscopic sphincterotomy (ES) before placement of self-expandable metal stent (SEMS). This was a retrospective analysis of 244 consecutive patients with unresectable malignant biliary obstruction, who underwent placement of SEMSs following limited ES from December 2008 to February 2015. The diagnosis of malignant biliary obstruction and assessment of patient eligibility for the study was established by a combination of clinical findings, laboratory investigations, imaging and pathological results. All patients were monitored in the hospital for at least 24 h following endoscopic retrograde cholangio pancreatography (ERCP). The incidence of immediate or early post-ERCP complications such as post-ERCP pancreatitis (PEP) and bleeding related to limited ES were considered as primary outcomes. Also, characteristics and complications according to the cancer type were classified. Among the 244 patients included, the underlying diagnosis was cholangiocarcinoma in 118 patients, pancreatic cancer in 79, and non-pancreatic or non-biliary malignancies in the remaining 47 patients. Early post-ERCP complications occurred in 9 patients (3.7%), with PEP in 7 patients (2.9%; mild, 6; moderate, 1) and mild bleeding in 2 patients (0.8%). There was no significant association between the incidence of post-ERCP complications and the type of malignancy (cholangiocarcinoma vs pancreatic cancer vs others, P = 0.696) or the type of SEMS used (uncovered vs covered, P = 1.000). Patients who had more than one SEMS placed at the first instance were at a significantly higher risk of post-ERCP complications (one SEMS vs two SEMS, P = 0.031). No other factors were predictive of post-ERCP complications. Limited ES is feasible and safe, and effectively facilitates the placement of SEMS, without any significant risk of PEP or severe bleeding.

Comparisons of Wilks’ and Monte Carlo Methods in Response to the 10CFR50.46(c) Proposed Rulemaking

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

Zhang, Hongbin; Szilard, Ronaldo; Zou, Ling

The Nuclear Regulatory Commission (NRC) is proposing a new rulemaking on emergency core system/loss-of-coolant accident (LOCA) performance analysis. In the proposed rulemaking, designated as 10CFR50.46(c), the US NRC put forward an equivalent cladding oxidation criterion as a function of cladding pre-transient hydrogen content. The proposed rulemaking imposes more restrictive and burnup-dependent cladding embrittlement criteria; consequently nearly all the fuel rods in a reactor core need to be analyzed under LOCA conditions to demonstrate compliance to the safety limits. New analysis methods are required to provide a thorough characterization of the reactor core in order to identify the locations of themore » limiting rods as well as to quantify the safety margins under LOCA conditions. With the new analysis method presented in this work, the limiting transient case and the limiting rods can be easily identified to quantify the safety margins in response to the proposed new rulemaking. In this work, the best-estimate plus uncertainty (BEPU) analysis capability for large break LOCA with the new cladding embrittlement criteria using the RELAP5-3D code is established and demonstrated with a reduced set of uncertainty parameters. Both the direct Monte Carlo method and the Wilks’ nonparametric statistical method can be used to perform uncertainty quantification. Wilks’ method has become the de-facto industry standard to perform uncertainty quantification in BEPU LOCA analyses. Despite its widespread adoption by the industry, the use of small sample sizes to infer statement of compliance to the existing 10CFR50.46 rule, has been a major cause of unrealized operational margin in today’s BEPU methods. Moreover the debate on the proper interpretation of the Wilks’ theorem in the context of safety analyses is not fully resolved yet, even more than two decades after its introduction in the frame of safety analyses in the nuclear industry. This represents both a regulatory and application risk in rolling out new methods. With the 10CFR50.46(c) proposed rulemaking, the deficiencies of the Wilks’ approach are further exacerbated. The direct Monte Carlo approach offers a robust alternative to perform uncertainty quantification within the context of BEPU analyses. In this work, the Monte Carlo method is compared with the Wilks’ method in response to the NRC 10CFR50.46(c) proposed rulemaking.« less

29 CFR 1910.17 - Effective dates.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.17... Harbor Workers' Compensation Act, that occupational safety and health standard as incorporated by...

29 CFR 1910.17 - Effective dates.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.17... Harbor Workers' Compensation Act, that occupational safety and health standard as incorporated by...

Administrative and research policies required to bring cellular therapies from the research laboratory to the patient's bedside.

PubMed

Yim, Robyn

2005-10-01

The research process is a balance between the inherent risks of new discoveries and the risks of research participant safety. Conflicts of interest, inherent to the research process, as well as those introduced by emerging cellular therapies, have the potential to compromise safety. The relationship of trust between the researcher and the clinical trial participant facilitates objective decision making, in the best interest of both parties. In the setup of each clinical trial, investigators incorporate ethical, political, legal, financial, and regulatory considerations as protocols are established. Responsibility to abide by these decisions ensures a systematic process and safeguards participants in this process. The integrity of the research process is strengthened by identifying potential conflicting issues with the guiding principles established in the protocols, which may threaten the objectivity of involved parties and jeopardize safety of the participants. The rapid pace and changing paradigms of new discoveries in cellular therapies exaggerate existing conflicts and introduce new ones. Ethical issues raised by emerging cellular therapies include the division of opinions regarding the use of embryonic and fetal tissue to develop stem cell lines for research, the individual versus professional conscience of a researcher, overselling of outcomes as a result of the researcher's desire to be the first to discover a cellular therapy, and therapeutic misconception resulting from a participant's desire for a miracle cure. The basic ethical issue of whether stem cells should be utilized as a cellular therapy raises heated debates because some believe that it is not acceptable to use fetal material as a source of research material for future cures and others feel equally as strong that inaction is unethical because it results in needless suffering and death owing to the absence of this research. Political issues include the divergent position statements of presidential administrations on cellular therapy, variations in individual state laws, and states becoming involved in research funding, such as California's Proposition 71. Legal concerns include expanding private litigation with diversity of lawsuits, expanding lists of defendants, and the use of class-action lawsuits in research cases. Ownership issues also arise in terms of intellectual property, patents, and ownership of stem cells collected from minors, as in umbilical cord blood donations. Situations that challenge the regulatory processes established to ensure participant safety include differences in reporting requirements for private- and public-funded research and the lack of adequate funding and resources to implement and support the institutional review board (IRB) process. Financial considerations influence the development of clinical protocols, because funding is often limited. Financial incentives, personal investment in companies funding research activities, and fundraising pressures may present potential conflicts. In addition, the increasing role of emerging biotechnology start-up companies and pharmaceutical companies in clinical research introduces additional financial considerations. Administrative policies are needed to address these possible conflicts and ensure research participant safety as cellular therapies progress from the research laboratories to the patient's bedside. Administrative policies to ensure minimum standards of quality for emerging products before human clinical trials, policies to enforce consistent reporting requirements for private and public cellular research, policies to minimize financial conflicts of interest, policies to strengthen implementation of the existing IRB process and to structure into the process a consistent, systematic review of these identified conflicts, and policies to limit private litigation will help to preserve the objectivity of the review process and ultimately increase participant safety.

Large Scale Experiments on Spacecraft Fire Safety

NASA Technical Reports Server (NTRS)

Urban, David L.; Ruff, Gary A.; Minster, Olivier; Toth, Balazs; Fernandez-Pello, A. Carlos; T'ien, James S.; Torero, Jose L.; Cowlard, Adam J.; Legros, Guillaume; Eigenbrod, Christian;

Large Scale Experiments on Spacecraft Fire Safety

NASA Technical Reports Server (NTRS)

Urban, David; Ruff, Gary A.; Minster, Olivier; Fernandez-Pello, A. Carlos; Tien, James S.; Torero, Jose L.; Legros, Guillaume; Eigenbrod, Christian; Smirnov, Nickolay; Fujita, Osamu;

36 CFR § 1004.11 - Load, weight and size limits.

Code of Federal Regulations, 2013 CFR

2013-07-01

... designate more restrictive limits when appropriate for traffic safety or protection of the road surface. The... 36 Parks, Forests, and Public Property 3 2013-07-01 2012-07-01 true Load, weight and size limits... TRAFFIC SAFETY § 1004.11 Load, weight and size limits. (a) Vehicle load, weight and size limits...

Coronary artery disease detection - limitations of stress testing in left ventricular dysfunction

PubMed Central

Bomb, Ritin; Kumar, Senthil; Chockalingam, Anand

2017-01-01

Incidental diagnosis of left ventricular systolic dysfunction (LVD) is common in clinical practice. The prevalence of asymptomatic LVD (Ejection Fraction, EF < 50%) is 6.0% in men and 0.8% in women and is twice as common as symptomatic LVD. The timely and definitive exclusion of an ischemic etiology is central to optimizing care and reducing mortality in LVD. Advances in cardiovascular imaging provide many options for imaging of patients with left ventricular dysfunction. Clinician experience, patient endurance, imaging modality characteristics, cost and safety determine the choice of testing. In this review, we have compared the diagnostic utility of established tests - nuclear and echocardiographic stress testing with newer techniques like coronary computerized tomography and cardiac magnetic resonance imaging and highlight their inherent limitations in patients with underlying left ventricular dysfunction. PMID:28515848

Americans with Disabilities Act considerations for the practice of occupational medicine

NASA Technical Reports Server (NTRS)

St.clair, Steven; Shults, Theodore

1993-01-01

The Americans with Disabilities Act (ADA), although developed in the context of civil rights legislation, is likely to have notable impact on the practice of occupational medicine. The ADA contains provisions limiting the use of preplacement examinations to determinations of the capability to perform the essential functions of the job and of direct threat to the health and safety of the job applicant and others. The Title 1 employment provisions of the ADA established definitions and requirements similar to those found in section 504 of the Rehabilitation Act of 1973, as amended; leading cases that have been litigated under the Rehabilitation Act, as amended, are described. The limitations of available scientific and medical information related to determinations of job capability and direct threat and ramifications of the ADA on the practice of occupational medicine are discussed.

76 FR 42683 - Establishment of a Team Under the National Construction Safety Team Act

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-19

... Safety Team Act. The Team was established to study the effects of the tornado that touched down in Joplin... reconnaissance team to collect information and data related to the tornado that touched down in Joplin, MO, on... the effects of the tornado that touched down in Joplin, MO, on May 22. The NIST Director will appoint...

Saudi Vigilance Program: Challenges and lessons learned.

PubMed

Alharf, Adel; Alqahtani, Nasser; Saeed, Ghazi; Alshahrani, Ali; Alshahrani, Mubarak; Aljasser, Nasser; Alquwaizani, Mohammed; Bawazir, Saleh

2018-03-01

Pharmacovigilance is vital to public health. Adopting a robust spontaneous reporting system for adverse drug events can counteract most hazards that arise from utilizing medicinal products. Prior to the establishment of the Saudi Food and Drug Authority (SFDA), the number of pharmacovigilance-related activities in Saudi Arabia was limited. In 2009, the SFDA established the National Pharmacovigilance and Drug Safety Center (Saudi Vigilance). The pharmacovigilance system has remarkably improved during the past few years. Several initiatives have been taken to improve the program's performance. These initiatives include initiation of pharmacovigilance guidelines, enhancement of communication and reporting tools, training sessions for concerned staff and healthcare providers, and compliance from stakeholders. This review article provides an overview of what the Saudi Vigilance program is, focusing on the scope, mission and vision, hierarchy, operational themes, and overall work processes. Additionally, we will shed light on the challenges we encountered during the early phase and on our future plans.

Development of the Space Station Freedom Environmental Health System

NASA Technical Reports Server (NTRS)

Richard, Elizabeth E.; Russo, Dane

1990-01-01

The Environmental Health System (EHS), a subsystem of the Space Station Freedom (SSF) Crew Health Care System, was established to ensure that crewmembers will have a safe and healthy environment in which to live and work. EHS is comprised of six subsystems: Microbiology, Toxicology, Water Quality, Radiological Health, Vibroacoustics, and Barothermal Physiology. Each subsystem contributes to the overall functions of the EHS including environmental planning, environmental monitoring, environmental monitoring, environmental health assessments, and operations support. The EHS will provide hardware for monitoring the air, water, and internal surfaces of Freedom, including capabilities for inflight sample collection, processing, and analysis. The closed environment of SSF, and its dependence on recycled air and water, will necessitate a reliable monitoring system to alert crewmembers if contamination levels exceed the maximum allowable limits established to ensure crew health and safety. This paper describes the functions and hardware design status of the EHS.

Treatment of Established Status Epilepticus.

PubMed

Falco-Walter, Jessica J; Bleck, Thomas

2016-04-25

Status epilepticus is the most severe form of epilepsy, with a high mortality rate and high health care costs. Status epilepticus is divided into four stages: early, established, refractory, and super-refractory. While initial treatment with benzodiazepines has become standard of care for early status epilepticus, treatment after benzodiazepine failure (established status epilepticus (ESE)) is incompletely studied. Effective treatment of ESE is critical as morbidity and mortality increases dramatically the longer convulsive status epilepticus persists. Phenytoin/fosphenytoin, valproic acid, levetiracetam, phenobarbital, and lacosamide are the most frequently prescribed antiseizure medications for treatment of ESE. To date there are no class 1 data to support pharmacologic recommendations of one agent over another. We review each of these medications, their pharmacology, the scientific evidence in support and against each in the available literature, adverse effects and safety profiles, dosing recommendations, and limitations of the available evidence. We also discuss future directions including the established status epilepticus treatment trial (ESETT). Substantial further research is urgently needed to identify these patients (particularly those with non-convulsive status epilepticus), elucidate the most efficacious antiseizure treatment with head-to-head randomized prospective trials, and determine whether this differs for convulsive vs. non-convulsive ESE.

Treatment of Established Status Epilepticus

PubMed Central

Falco-Walter, Jessica J.; Bleck, Thomas

2016-01-01

Status epilepticus is the most severe form of epilepsy, with a high mortality rate and high health care costs. Status epilepticus is divided into four stages: early, established, refractory, and super-refractory. While initial treatment with benzodiazepines has become standard of care for early status epilepticus, treatment after benzodiazepine failure (established status epilepticus (ESE)) is incompletely studied. Effective treatment of ESE is critical as morbidity and mortality increases dramatically the longer convulsive status epilepticus persists. Phenytoin/fosphenytoin, valproic acid, levetiracetam, phenobarbital, and lacosamide are the most frequently prescribed antiseizure medications for treatment of ESE. To date there are no class 1 data to support pharmacologic recommendations of one agent over another. We review each of these medications, their pharmacology, the scientific evidence in support and against each in the available literature, adverse effects and safety profiles, dosing recommendations, and limitations of the available evidence. We also discuss future directions including the established status epilepticus treatment trial (ESETT). Substantial further research is urgently needed to identify these patients (particularly those with non-convulsive status epilepticus), elucidate the most efficacious antiseizure treatment with head-to-head randomized prospective trials, and determine whether this differs for convulsive vs. non-convulsive ESE. PMID:27120626

Dietary Supplements are Not all Safe and Not all Food: How the Low Cost of Dietary Supplements Preys on the Consumer.

PubMed

Sax, Joanna K

2015-01-01

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural' with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco--a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food. Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful. The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.

Social Media Listening for Routine Post-Marketing Safety Surveillance.

PubMed

Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

2016-05-01

Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

10 CFR 2.321 - Atomic Safety and Licensing Boards.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Atomic Safety and Licensing Boards. 2.321 Section 2.321... Management for NRC Adjudicatory Hearings § 2.321 Atomic Safety and Licensing Boards. (a) The Commission or the Chief Administrative Judge may establish one or more Atomic Safety and Licensing Boards, each...

10 CFR 2.321 - Atomic Safety and Licensing Boards.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Atomic Safety and Licensing Boards. 2.321 Section 2.321... Management for NRC Adjudicatory Hearings § 2.321 Atomic Safety and Licensing Boards. (a) The Commission or the Chief Administrative Judge may establish one or more Atomic Safety and Licensing Boards, each...

10 CFR 2.321 - Atomic Safety and Licensing Boards.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Atomic Safety and Licensing Boards. 2.321 Section 2.321... Management for NRC Adjudicatory Hearings § 2.321 Atomic Safety and Licensing Boards. (a) The Commission or the Chief Administrative Judge may establish one or more Atomic Safety and Licensing Boards, each...

77 FR 42179 - Safety Zone; Fireworks Display, Potomac River, Charles County, Newburg, MD

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-18

...]30[sec] W, located at Newburg in Charles County, Maryland (NAD 1983). The temporary safety zone will... 1625-AA00 Safety Zone; Fireworks Display, Potomac River, Charles County, Newburg, MD AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard will establish a safety zone upon...

77 FR 24838 - Safety Zone; Magothy River, Sillery Bay, MD

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-26

...-AA00 Safety Zone; Magothy River, Sillery Bay, MD AGENCY: Coast Guard, DHS. ACTION: Final rule. SUMMARY: The Coast Guard is establishing a safety zone in certain waters of the Magothy River, in Sillery Bay... a notice of proposed rulemaking (NPRM) entitled ``Safety Zone; Magothy River, Sillery Bay, MD'' in...

Model Policy for Security and Safety Committee.

ERIC Educational Resources Information Center

Perillo, Stephen E.

The starting point of an effective school safety program is the development of a written policy statement that reflects the school board's belief in safety for its students and that is widely publicized to the staff and community. A sample safety/security policy is provided that lists, first, the superintendent's responsibilities in establishing a…

78 FR 43064 - Safety Zone; Maritime Heritage Festival Fireworks, St. Helens, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-19

...-AA00 Safety Zone; Maritime Heritage Festival Fireworks, St. Helens, OR AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a safety zone in St. Helens, OR. This safety... associated with fireworks displays. As part of the Maritime Heritage Festival Fireworks in St. Helens, OR...

29 CFR 1912.5 - National Advisory Committee on Occupational Safety and Health.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Health. 1912.5 Section 1912.5 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND... Matters § 1912.5 National Advisory Committee on Occupational Safety and Health. (a) Section 7(a) of the Act established a National Advisory Committee on Occupational Safety and Health. The Committee is to...

29 CFR 1912.5 - National Advisory Committee on Occupational Safety and Health.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Health. 1912.5 Section 1912.5 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND... Matters § 1912.5 National Advisory Committee on Occupational Safety and Health. (a) Section 7(a) of the Act established a National Advisory Committee on Occupational Safety and Health. The Committee is to...

29 CFR 1912.5 - National Advisory Committee on Occupational Safety and Health.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Health. 1912.5 Section 1912.5 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND... Matters § 1912.5 National Advisory Committee on Occupational Safety and Health. (a) Section 7(a) of the Act established a National Advisory Committee on Occupational Safety and Health. The Committee is to...

77 FR 72998 - Policy Statement on Occupational Safety and Health Standards for Aircraft Cabin Crewmembers

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-07

... aircraft by the Occupational Safety and Health Administration (OSHA). This policy statement will enhance occupational safety and health in the aircraft cabin by establishing the extent to which OSHA requirements may... [Docket No.: FAA-2012-0953] Policy Statement on Occupational Safety and Health Standards for Aircraft...

78 FR 67086 - Safety Zone, Submarine Cable Replacement Operations, Kent Island Narrows; Queen Anne's County, MD

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-08

... 1625-AA00 Safety Zone, Submarine Cable Replacement Operations, Kent Island Narrows; Queen Anne's County... Guard proposes to establish a temporary safety zone encompassing certain waters of Kent Island Narrows... potential safety hazards associated with the bridge project. Entry into this zone would be prohibited unless...

76 FR 23485 - Safety Zone; Red River

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

...-AA00 Safety Zone; Red River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone for all waters of the Red River in the State of North..., extending the entire width of the river. This safety zone is needed to protect persons and vessels from...

78 FR 45059 - Safety Zone; Sherman Private Party Fireworks, Lake Michigan, Winnetka, IL

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

...-AA00 Safety Zone; Sherman Private Party Fireworks, Lake Michigan, Winnetka, IL AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Lake Michigan near Winnetka, IL. This safety zone is intended to restrict vessels from a portion of Lake...

77 FR 41686 - Safety Zone; Sheffield Lake Fireworks, Lake Erie, Sheffield Lake, OH

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-16

...-AA00 Safety Zone; Sheffield Lake Fireworks, Lake Erie, Sheffield Lake, OH AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Lake Erie, Sheffield Lake, OH. This safety zone is intended to restrict vessels from a portion of Lake Erie...

78 FR 21260 - Safety Zone; Lubbers Cup Regatta; Spring Lake, MI

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-10

...-AA00 Safety Zone; Lubbers Cup Regatta; Spring Lake, MI AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Spring Lake in Spring Lake, Michigan. This safety zone is intended to restrict vessels from a portion of Spring Lake due to...

77 FR 25080 - Safety Zones; TriMet Bridge Project, Willamette River, Portland, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-27

...-AA00 Safety Zones; TriMet Bridge Project, Willamette River, Portland, OR AGENCY: Coast Guard, DHS... trestles and construction cranes involved in the construction of the TriMet Bridge on the Willamette River... project. These safety zones replace the prior safety zones established for the TriMet Bridge construction...

Preparing Safety Cases for Operating Outside Prescriptive Fatigue Risk Management Regulations.

PubMed

Gander, Philippa; Mangie, Jim; Wu, Lora; van den Berg, Margo; Signal, Leigh; Phillips, Adrienne

2017-07-01

Transport operators seeking to operate outside prescriptive fatigue management regulations are typically required to present a safety case justifying how they will manage the associated risk. This paper details a method for constructing a successful safety case. The method includes four elements: 1) scope (prescriptive rules and operations affected); 2) risk assessment; 3) risk mitigation strategies; and 4) monitoring ongoing risk. A successful safety case illustrates this method. It enables landing pilots in 3-pilot crews to choose the second or third in-flight rest break, rather than the regulatory requirement to take the third break. Scope was defined using a month of scheduled flights that would be covered (N = 4151). These were analyzed in the risk assessment using existing literature on factors affecting fatigue to estimate the maximum time awake at top of descent and sleep opportunities in each break. Additionally, limited data collected before the new regulations showed that pilots flying at landing chose the third break on only 6% of flights. A prospective survey comparing subjective reports (N = 280) of sleep in the second vs. third break and fatigue and sleepiness ratings at top of descent confirmed that the third break is not consistently superior. The safety case also summarized established systems for fatigue monitoring, risk assessment and hazard identification, and multiple fatigue mitigation strategies that are in place. Other successful safety cases have used this method. The evidence required depends on the expected level of risk and should evolve as experience with fatigue risk management systems builds.Gander P, Mangie J, Wu L, van den Berg M, Signal L, Phillips A. Preparing safety cases for operating outside prescriptive fatigue risk management regulations. Aerosp Med Hum Perform. 2017; 88(7):688-696.

[Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring].

PubMed

Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe

2013-09-01

To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.

49 CFR 1106.1 - Purpose.

Code of Federal Regulations, 2012 CFR

2012-10-01

... TRANSPORTATION RULES OF PRACTICE PROCEDURES FOR SURFACE TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION.... This part is designed to ensure adequate and coordinated consideration of safety integration issues, by... subject to the Board's jurisdiction. It establishes the procedures by which the Board will consider safety...

49 CFR 1106.1 - Purpose.

Code of Federal Regulations, 2013 CFR

2013-10-01

... TRANSPORTATION RULES OF PRACTICE PROCEDURES FOR SURFACE TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION.... This part is designed to ensure adequate and coordinated consideration of safety integration issues, by... subject to the Board's jurisdiction. It establishes the procedures by which the Board will consider safety...

49 CFR 1106.1 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-10-01

... TRANSPORTATION RULES OF PRACTICE PROCEDURES FOR SURFACE TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION.... This part is designed to ensure adequate and coordinated consideration of safety integration issues, by... subject to the Board's jurisdiction. It establishes the procedures by which the Board will consider safety...

49 CFR 1106.1 - Purpose.

Code of Federal Regulations, 2014 CFR

2014-10-01

... TRANSPORTATION RULES OF PRACTICE PROCEDURES FOR SURFACE TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION.... This part is designed to ensure adequate and coordinated consideration of safety integration issues, by... subject to the Board's jurisdiction. It establishes the procedures by which the Board will consider safety...

Hydrogen Fuel Cell Vehicle Fuel System Integrity Research : Electrical Isolation Test Procedure Development and Verification

DOT National Transportation Integrated Search

2012-03-01

The Federal Motor Vehicle Safety Standards (FMVSS) establish minimum levels for vehicle safety, and manufacturers of motor vehicle and equipment items must comply with these standards. The National Highway Traffic Safety Administration (NHTSA) contra...

29 CFR 1910.16 - Longshoring and marine terminals.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.16 Longshoring and marine terminals. (a) Safety and health standards for longshoring. (1...

29 CFR 1910.16 - Longshoring and marine terminals.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.16 Longshoring and marine terminals. (a) Safety and health standards for longshoring. (1...

33 CFR 96.200 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Company and Vessel Safety Management Systems § 96.200 Purpose. This subpart establishes the minimum standards that the safety...

29 CFR 1960.34 - General provisions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED... affecting Federal employee safety and health. Both agencies shall establish and publish a joint procedure...

75 FR 62008 - Safety Management System for Certificated Airports

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-07

.... The majority of pilot study airports indicated an existing organizational structure to manage safety... organizational structure; Identifies the lines of safety responsibility and accountability; Establishes and... understands that airport operations and organizational structures vary widely. Accordingly, the FAA would not...

Safety Action Plan 2000-2003

DOT National Transportation Integrated Search

2002-02-01

The Federal Motor Carrier Safety Administration (FMCSA) is a new agency established on January 1, 2000, within the U.S. Department of Transportation (DOT). The FMCSA mission is to improve truck and bus safety on our Nation's highway. In 1998, 5,374 p...

Development and evaluation of Virginia's highway safety corridor program.

DOT National Transportation Integrated Search

2006-01-01

On July 1, 2003, legislation went into effect that established a highway safety corridor (HSC) program for Virginia. The intent of the HSC program is to address safety concerns through a combination of law enforcement, education, and engineering coun...

THC:CBD in Daily Practice: Available Data from UK, Germany and Spain.

PubMed

Fernández, Óscar

2016-01-01

From the time Sativex (THC:CBD) oromucosal spray first became available in European Union countries in 2010 for the management of treatment-resistant multiple sclerosis (MS) spasticity, data from daily practice have been collected through various projects. A retrospective registry study and a prospective safety study of THC:CBD oromucosal spray are reported. The most recent analysis of a retrospective registry established in the United Kingdom (UK), Germany and Switzerland, which collected safety data on more than 900 patients, has indicated a positive risk-benefit profile for THC:CBD oromucosal spray during long-term use. Long-term continuation rates were 68% (mean follow-up time 1 year) and the mean dose was 5.4 sprays/day. No new safety concerns were identified, and adverse events of special interest for a cannabis-based medicine were limited. The UK registry has since been closed but remains open in Germany and Switzerland. A prospective safety study undertaken in Spain involved 207 patients from 13 specialized MS centres who had been prescribed THC:CBD oromucosal spray. The findings aligned closely with the UK/German/Swiss registry data in terms of 1-year continuation rates (64.7%), mean daily dose (6.6 sprays/day) and safety profile, including no evidence of addiction, abuse or misuse. The homogeneity between these observational studies supports the interest in THC:CBD oromucosal spray for management of MS spasticity in daily practice. © 2016 S. Karger AG, Basel.

76 FR 23524 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago... safety zone from Brandon Road Lock and Dam to Lake Michigan. This proposed safety zone will cover 77.... This TIR established a 77 mile long safety zone from Brandon Road Lock to Lake Michigan in Chicago, IL...

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

Metzler, D.; Gibb, J.P.; Glover, W.A.

Compliance with the mandate of the Uranium Mill Tailings Radiation Control Act (UMTRCA) at Uranium Mill Tailings Remedial Action (UMTRA) Project sites requires implementation of a groundwater remedial action plan that meets the requirements of Subpart B of the US Environmental Protection Agency`s proposed groundwater protection standards (40 CFR 192). The UMTRA Groundwater Project will ensure that unacceptable current risk or potential risk to the public health, safety and the environment resulting from the groundwater contamination attributable to the UMTRA sites, is mitigated in a timely and cost-efficient manner. For each UMTRA processing site and vicinity property where contamination exists,more » a groundwater remedial action plan must be developed that identifies hazardous constituents and establishes acceptable concentration limits for the hazardous constituents as either (a) alternate concentration limits (ACL), (b) maximum concentration limits (MCLs), (c) supplemental standards, or (d) background groundwater quality levels. Project optimization is a strategy that will aggressively work within the current regulatory framework using all available options to meet regulatory requirements. This strategy is outlined within.« less

Exposure assessment of workers in printed electronics workplace.

PubMed

Lee, Ji Hyun; Sohn, Eun Kyung; Ahn, Jin Soo; Ahn, Kangho; Kim, Keun Soo; Lee, Jong Hwan; Lee, Taik Min; Yu, Il Je

2013-07-01

Printed electronics uses converging technologies, such as printing, fine mechanics, nanotechnology, electronics and other new technologies. Consequently, printed electronics raises additional health and safety concerns to those experienced in the traditional printing industry. This study investigated two printed electronics workplaces based on a walk-through survey and personal and area sampling. All the printed electronics operations were conducted in a cleanroom. No indication of exposure to excess silver nanoparticles or carbon nanotubes (CNTs) was found. While the organic solvents were lower than current occupational exposure limits, there was a lack of engineering controls, such as local exhaust ventilation, correct enclosure and duct connections. There was also an insufficient quantity of personal protective equipment, and some organic solvents not described in the safety data sheets (SDSs) were detected in the air samples. Plus, the cleaning work, a major emissions operation, was not conducted within a hood, and the cleaning waste was not properly disposed of. Therefore, the present exposure assessment results from two printed electronics workplaces suggest that the printed electronics industry needs to take note of the occupational safety and health risks and hazards already established by the traditional printing industry, along with new risks and hazards originating from converging technologies such as nanotechnology.

Accounting for interim safety monitoring of an adverse event upon termination of a clinical trial.

PubMed

Dallas, Michael J

2008-01-01

Upon termination of a clinical trial that uses interim evaluations to determine whether the trial can be stopped, a proper statistical analysis must account for the interim evaluations. For example, in a group-sequential design where the efficacy of a treatment regimen is evaluated at interim stages, and the opportunity to stop the trial based on positive efficacy findings exists, the terminal p-value, point estimate, and confidence limits of the outcome of interest must be adjusted to eliminate bias. While it is standard practice to adjust terminal statistical analyses due to opportunities to stop for "positive" findings, adjusting due to opportunities to stop for "negative" findings is also important. Stopping rules for negative findings are particularly useful when monitoring a specific rare serious adverse event in trials designed to show safety with respect to the event. In these settings, establishing conservative stopping rules are appropriate, and therefore accounting for the interim monitoring can have a substantial effect on the final results. Here I present a method to account for interim safety monitoring and illustrate its usefulness. The method is demonstrated to have advantages over methodology that does not account for interim monitoring.

Baking soda as an abrasive in toothpastes: Mechanism of action and safety and effectiveness considerations.

PubMed

Hara, Anderson T; Turssi, Cecilia P

2017-11-01

Toothpastes can be formulated with different abrasive systems, depending on their intended clinical application. This formulation potentially affects their effectiveness and safety and, therefore, requires proper understanding. In this article, the authors focused on abrasive aspects of toothpastes containing sodium bicarbonate (baking soda), which have gained considerable attention because of their low abrasivity and good compatibility, while providing clinical effectiveness (further detailed in the other articles of this special issue). The authors first appraised the role of toothpaste abrasivity on tooth wear, exploring some underlying processes and the existing methods to determine toothpaste abrasivity. The authors reviewed the available data on the abrasivity of toothpastes containing baking soda and reported a summary of findings highlighting the clinical implications. On the basis of the collected evidence, baking soda has an intrinsic low-abrasive nature because of its comparatively lower hardness in relation to enamel and dentin. Baking soda toothpastes also may contain other ingredients, which can increase their stain removal effectiveness and, consequently, abrasivity. Even those formulations have abrasivity well within the safety limit regulatory agencies have established and, therefore, can be considered safe. Copyright © 2017 American Dental Association. Published by Elsevier Inc. All rights reserved.

Filgotinib for the treatment of rheumatoid arthritis.

PubMed

Taylor, Peter C; Abdul Azeez, Maha; Kiriakidis, Serafim

2017-10-01

Biologics were the first targeted therapies for rheumatoid arthritis (RA), having in common high clinical efficacy. Being proteins, they are administered parenterally. The first oral targeted small molecules approved for RA are competitive inhibitors of the Janus kinase (JAK) enzyme family which mediate signalling for a cytokine subset important in RA pathogenesis. Areas covered: Several JAK inhibitors have been developed with differing selectivity for the four JAK enzymes with a view to generating oral, multi-cytokine inhibitors. Here we review the pharmacology and clinical trial data for efficacy and safety of filgotinib, an investigational selective JAK1 inhibitor. We contextualise the contemporary approach to RA management and substantial unmet needs that remain. Expert opinion: The selectivity of filgotinib for JAK1 may have theoretical advantages in terms of limiting toxicity. However, establishing whether this is so before larger numbers of patients are exposed in phase III and beyond in the real word setting, will be difficult. Filgotinib clinical trial data to date has been encouraging with rapid, sustained efficacy with promising safety and tolerability. We are likely to see an expanding choice of approved JAK inhibitors in the clinic but it may not be straightforward to distinguish safety and efficacy differences.

Safety Assessment of Dangerous Goods Transport Enterprise Based on the Relative Entropy Aggregation in Group Decision Making Model

PubMed Central

Wu, Jun; Li, Chengbing; Huo, Yueying

2014-01-01

Safety of dangerous goods transport is directly related to the operation safety of dangerous goods transport enterprise. Aiming at the problem of the high accident rate and large harm in dangerous goods logistics transportation, this paper took the group decision making problem based on integration and coordination thought into a multiagent multiobjective group decision making problem; a secondary decision model was established and applied to the safety assessment of dangerous goods transport enterprise. First of all, we used dynamic multivalue background and entropy theory building the first level multiobjective decision model. Secondly, experts were to empower according to the principle of clustering analysis, and combining with the relative entropy theory to establish a secondary rally optimization model based on relative entropy in group decision making, and discuss the solution of the model. Then, after investigation and analysis, we establish the dangerous goods transport enterprise safety evaluation index system. Finally, case analysis to five dangerous goods transport enterprises in the Inner Mongolia Autonomous Region validates the feasibility and effectiveness of this model for dangerous goods transport enterprise recognition, which provides vital decision making basis for recognizing the dangerous goods transport enterprises. PMID:25477954

Safety assessment of dangerous goods transport enterprise based on the relative entropy aggregation in group decision making model.

PubMed

Wu, Jun; Li, Chengbing; Huo, Yueying

2014-01-01

Safety of dangerous goods transport is directly related to the operation safety of dangerous goods transport enterprise. Aiming at the problem of the high accident rate and large harm in dangerous goods logistics transportation, this paper took the group decision making problem based on integration and coordination thought into a multiagent multiobjective group decision making problem; a secondary decision model was established and applied to the safety assessment of dangerous goods transport enterprise. First of all, we used dynamic multivalue background and entropy theory building the first level multiobjective decision model. Secondly, experts were to empower according to the principle of clustering analysis, and combining with the relative entropy theory to establish a secondary rally optimization model based on relative entropy in group decision making, and discuss the solution of the model. Then, after investigation and analysis, we establish the dangerous goods transport enterprise safety evaluation index system. Finally, case analysis to five dangerous goods transport enterprises in the Inner Mongolia Autonomous Region validates the feasibility and effectiveness of this model for dangerous goods transport enterprise recognition, which provides vital decision making basis for recognizing the dangerous goods transport enterprises.

Analysis of acoustic data for hybrid and electric vehicles measured on hemi-anechoic chambers

DOT National Transportation Integrated Search

2015-04-01

The Pedestrian Safety Enhancement Act of 2010 requires the National Highway Traffic Safety : Administration to conduct a rulemaking to establish a Federal Motor Vehicle Safety Standard requiring an alert sound for pedestrians to be emitted by electri...

We are all safer : NTSB-inspired improvements in transportation safety : second edition

DOT National Transportation Integrated Search

1998-07-01

The National Transportation Safety Board (NTSB) was established by Congress in 1967 to investigate and determine the causes of accidents in all modes of transportation. Since then, the Safety Board has investigated more than 110,000 aviation accident...

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. ...

16 CFR § 1102.2 - Purpose.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Background and Definitions § 1102.2 Purpose. This... establishment and maintenance of a Publicly Available Consumer Product Safety Information Database (also referred to as the “Database”) on the safety of consumer products and other products or substances...

16 CFR 1102.2 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-01-01

... CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10, 2011) Background and Definitions § 1102.2... establishment and maintenance of a Publicly Available Consumer Product Safety Information Database (also referred to as the “Database”) on the safety of consumer products and other products or substances...

29 CFR 1910.11 - Scope and purpose.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.11... to safety or health are adopted by any incorporations by reference of standards prescribed elsewhere...

29 CFR 1910.11 - Scope and purpose.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.11... to safety or health are adopted by any incorporations by reference of standards prescribed elsewhere...

29 CFR 1910.12 - Construction work.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Adoption and Extension of Established Federal Standards § 1910.12... occupational safety and health standards under section 6 of the Act and shall apply, according to the...

Highway safety corridors : national experiences and a possible framework for Virginia.

DOT National Transportation Integrated Search

2003-01-01

On March 22, 2003, Governor Mark Warner approved Senate Bill 1093 (SB 1093). SB1093 establishes a highway safety corridor (HSC) program for the Commonwealth. The program will attempt to address safety concerns through a combination of law enforcement...

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. ...

Impact of travel patterns and driving behavior on crash involvement.

DOT National Transportation Integrated Search

1983-07-21

This study was conducted to obtain statistically valid data on a variety of highway safety issues, such as attitudes toward drunk driving, use of safety belts and child safety seats, and to establish data regarding driving patterns. The study design ...

Review and analysis of community traffic safety programs. Volume 2, Appendices

DOT National Transportation Integrated Search

1994-01-01

A Community Traffic Safety Program (CTSP) is an established unit in the community, sustained over time, that has public and private input and participation to an action plan to solve one or more of the community's traffic safety problems. Currently, ...

A case of industrial safety appraisal for extension of service life of GTK-10-4 gas turbines used at gas transmission stations

NASA Astrophysics Data System (ADS)

Rybnikov, A. I.; Kovalev, A. G.; Kryukov, I. I.; Leont'ev, S. A.; Moshnikov, A. V.

2017-04-01

It is shown that the extended life and enhanced operational reliability of parts and subassemblies of the most popular GTK-10-4 gas transmission plants are determined by the enhanced efficiency of the control over technical condition and operational safety of turbine plants in conformity with industrial safety requirements imposed on gas pipeline compressor stations. It has been established that the materials of parts and subassemblies of gas turbine plants with different, especially with maximal operating time, shall be exposed to NDT for the purpose of determining the actual mechanical characteristics of these materials with different operating time and calculating residual life. The analysis of damageability and operating conditions has helped to identify parts and subassemblies for repair or replacement with the highest frequency of unacceptable defects. These parts and subassemblies have been shown to include base members of the axial compressor (AC), a turbine housing, an axial compressor rotor, high- and low-pressure turbine (HPT and LPT) discs, a 12-part holder, the housing of the holder of HPT and LPT guiding blades, a sealed baffler, and working and guiding AC, LPT and HPT blades. The most typical operational defects have been enumerated and analyzed. It has been determined that the primary task of the industrial safety appraisal for extending the life of GTK-10-4 with limit-exceeding operating time is to thoroughly examine HPT and LPT discs with more than 130,000 hours of operating time and establish by DT methods characteristics of materials for evaluation, taking account of their degradation, and residual life of critical turbine elements. In addition, it has been shown that the service life of HP turbine discs can be extended by replacing the disc material (EP-428 12% chromium steel) with a material with a higher linear expansion factor that somewhat exceeds the expansion factor of EI-893 nickel alloy used to melt out working blades.

9 CFR 96.2 - Prohibition of casings due to African swine fever and bovine spongiform encephalopathy.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Safety and Inspection Service at 9 CFR 310.22 and the Food and Drug Administration at 21 CFR 189.5. (3... food in accordance with the requirements established by the Food Safety and Inspection Service at 9 CFR... establishment does not receive or process any live swine and uses only pork and pork products that originate in...

77 FR 37362 - Implementation of the Middle Class Tax Relief and Job Creation Act of 2012; Establishment of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-21

...] Implementation of the Middle Class Tax Relief and Job Creation Act of 2012; Establishment of a Public Safety... public safety answering points (PSAPs) as required by the ``Middle Class Tax Relief and Job Creation Act... Objectives of, the Proposed Rules 21. The ``Middle Class Tax Relief and Job Creation Act of 2012'' requires...

Traceability of Software Safety Requirements in Legacy Safety Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

How can traceability of software safety requirements be created for legacy safety critical systems? Requirements in safety standards are imposed most times during contract negotiations. On the other hand, there are instances where safety standards are levied on legacy safety critical systems, some of which may be considered for reuse for new applications. Safety standards often specify that software development documentation include process-oriented and technical safety requirements, and also require that system and software safety analyses are performed supporting technical safety requirements implementation. So what can be done if the requisite documents for establishing and maintaining safety requirements traceability are not available?

Microbiological Safety of Kitchen Sponges Used in Food Establishments

PubMed Central

Bacha, Ketema

2016-01-01

Kitchen sponges are among the possible sources of contaminants in food establishments. The main purpose of the current study was, therefore, to assess the microbiological safety of sponges as it has been used in selected food establishments of Jimma town. Accordingly, the microbiological safety of a total of 201 kitchen sponges randomly collected from food establishments was evaluated against the total counts of aerobic mesophilic bacteria (AMB), Enterobacteriaceae, coliforms, and yeast and molds. The mean counts of aerobic mesophilic bacteria ranged from 7.43 to 12.44 log CFU/mm3. The isolated genera were dominated by Pseudomonas (16.9%), Bacillus (11.1%), Micrococcus (10.6%), Streptococcus (7.8%), and Lactobacillus (6%) excluding the unidentified Gram positive rods (4.9%) and Gram negative rods (9.9%). The high microbial counts (aerobic mesophilic bacteria, coliforms, Enterobacteriaceae, and yeast and molds) reveal the existence of poor kitchen sponge sanitization practice. Awareness creation training on basic hygienic practices to food handlers and periodic change of kitchen sponges are recommended. PMID:27840819

Corneal injury to ex vivo eyes exposed to a 3.8-micron laser

NASA Astrophysics Data System (ADS)

Fyffe, James G.; Randolph, Donald Q.; Winston, Golda C. H.; Johnson, Thomas E.

2005-04-01

As a consequence of the enormous expansion of laser use in medicine, industry and research, specific safety standards must be developed that appropriately address eye protection. The purpose of this study is to establish injury thresholds to the cornea for 3.8 micron 8 microsecond laser light pulses and to investigate a possible replacement model to live animal testing. Previous studies of pulsed energy absorption at 3.8 microns were performed using rhesus monkey cornea and were at pulse durations two orders of magnitude different than the 8 microsecond pulses used in this study. Ex-vivo pig eyes were exposed at varying energies and evaluated to establish the statistical threshold for corneal damage. Histology was used to determine the extent of damage to the cornea. It is expected that the results will be used to assist in the establishment of safety standards for laser use and offer an alternative to future animal use in establishment of safety standards.

Older, vulnerable patient view: a pilot and feasibility study of the patient measure of safety (PMOS) with patients in Australia.

PubMed

Taylor, Natalie; Hogden, Emily; Clay-Williams, Robyn; Li, Zhicheng; Lawton, Rebecca; Braithwaite, Jeffrey

2016-06-08

The UK-developed patient measure of safety (PMOS) is a validated tool which captures patient perceptions of safety in hospitals. We aimed (1) to investigate the extent to which the PMOS is appropriate for use with stroke, acute myocardial infarction (AMI) and hip fracture patients in Australian hospitals and (2) to pilot the PMOS for use in a large-scale, national study 'Deepening our Understanding of Quality in Australia' (DUQuA). Stroke, AMI and hip fracture patients (n=34) receiving care in 3 wards in 1 large hospital. 2 phases were conducted. First, a 'think aloud' study was used to determine the validity of PMOS with this population in an international setting, and to make amendments based on patient feedback. The second phase tested the revised measure to establish the internal consistency reliability of the revised subscales, and piloted the recruitment and administration processes to ensure feasibility of the PMOS for use in DUQuA. Of the 43 questions in the PMOS, 13 (30%) were amended based on issues patients highlighted for improvement in phase 1. In phase 2, a total of 34 patients were approached and 29 included, with a mean age of 71.3 years (SD=16.39). Internal consistency reliability was established using interitem correlation and Cronbach's α for all but 1 subscale. The most and least favourably rated aspects of safety differed between the 3 wards. A study log was categorised into 10 key feasibility factors, including liaising with wards to understand operational procedures and identify patterns of patient discharge. Capturing patient perceptions of care is crucial in improving patient safety. The revised PMOS is appropriate for use with vulnerable older adult groups. The findings from this study have informed key decisions made for the deployment of this measure as part of the DUQuA study. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Indicators of School Crime and Safety: 2012. NCES 2013-036/NCJ 241446

ERIC Educational Resources Information Center

Robers, Simone; Kemp, Jana; Truman, Jennifer

2013-01-01

Establishing reliable indicators of the current state of school crime and safety across the nation and regularly updating and monitoring these indicators is important in ensuring the safety of our nation's students. This is the aim of "Indicators of School Crime and Safety." This report is the fifteenth in a series of annual publications…

10 CFR 1.15 - Atomic Safety and Licensing Board Panel.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Atomic Safety and Licensing Board Panel. 1.15 Section 1.15... Panels, Boards, and Committees § 1.15 Atomic Safety and Licensing Board Panel. The Atomic Safety and Licensing Board Panel, established pursuant to section 191 of the Atomic Energy Act of 1954, as amended...

10 CFR 2.321 - Atomic Safety and Licensing Boards.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Atomic Safety and Licensing Boards. 2.321 Section 2.321... § 2.321 Atomic Safety and Licensing Boards. (a) The Commission or the Chief Administrative Judge may establish one or more Atomic Safety and Licensing Boards, each comprised of three members, one of whom will...

10 CFR 1.15 - Atomic Safety and Licensing Board Panel.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Atomic Safety and Licensing Board Panel. 1.15 Section 1.15... Panels, Boards, and Committees § 1.15 Atomic Safety and Licensing Board Panel. The Atomic Safety and Licensing Board Panel, established pursuant to section 191 of the Atomic Energy Act of 1954, as amended...

10 CFR 1.15 - Atomic Safety and Licensing Board Panel.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Atomic Safety and Licensing Board Panel. 1.15 Section 1.15... Panels, Boards, and Committees § 1.15 Atomic Safety and Licensing Board Panel. The Atomic Safety and Licensing Board Panel, established pursuant to section 191 of the Atomic Energy Act of 1954, as amended...

10 CFR 1.15 - Atomic Safety and Licensing Board Panel.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Atomic Safety and Licensing Board Panel. 1.15 Section 1.15... Panels, Boards, and Committees § 1.15 Atomic Safety and Licensing Board Panel. The Atomic Safety and Licensing Board Panel, established pursuant to section 191 of the Atomic Energy Act of 1954, as amended...

10 CFR 2.321 - Atomic Safety and Licensing Boards.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Atomic Safety and Licensing Boards. 2.321 Section 2.321... § 2.321 Atomic Safety and Licensing Boards. (a) The Commission or the Chief Administrative Judge may establish one or more Atomic Safety and Licensing Boards, each comprised of three members, one of whom will...

10 CFR 1.15 - Atomic Safety and Licensing Board Panel.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Atomic Safety and Licensing Board Panel. 1.15 Section 1.15... Panels, Boards, and Committees § 1.15 Atomic Safety and Licensing Board Panel. The Atomic Safety and Licensing Board Panel, established pursuant to section 191 of the Atomic Energy Act of 1954, as amended...

76 FR 77561 - Atomic Safety and Licensing Board; In the Matter of Progress Energy Florida, Inc.; (Levy County...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-13

...] Atomic Safety and Licensing Board; In the Matter of Progress Energy Florida, Inc.; (Levy County Nuclear... Statements) This Atomic Safety and Licensing Board hereby gives notice that it will accept oral or written..., Inc.; Establishment of Atomic Safety and Licensing Board, 74 FR 9113 (Mar. 2, 2009) (ADAMS Accession...

75 FR 39166 - Safety Zone; San Francisco Giants Baseball Game Promotion, San Francisco, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

...-AA00 Safety Zone; San Francisco Giants Baseball Game Promotion, San Francisco, CA AGENCY: Coast Guard... Francisco Giants Baseball Game Promotion. This safety zone is established to ensure the safety of... Game Promotion on July 16, 2010, on the navigable waters of McCovey Cove, in San Francisco Bay, off of...

40 CFR 30.18 - Hotel and motel fire safety.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Hotel and motel fire safety. 30.18... EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS Pre-Award Requirements § 30.18 Hotel and motel fire safety. The Hotel and Motel Fire Safety Act of 1990 (Public Law 101-391) establishes a number of fire...

40 CFR 30.18 - Hotel and motel fire safety.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Hotel and motel fire safety. 30.18... EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS Pre-Award Requirements § 30.18 Hotel and motel fire safety. The Hotel and Motel Fire Safety Act of 1990 (Public Law 101-391) establishes a number of fire...

40 CFR 30.18 - Hotel and motel fire safety.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Hotel and motel fire safety. 30.18... EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS Pre-Award Requirements § 30.18 Hotel and motel fire safety. The Hotel and Motel Fire Safety Act of 1990 (Public Law 101-391) establishes a number of fire...

49 CFR 214.353 - Training and qualification of roadway workers who provide on-track safety for roadway work groups.

Code of Federal Regulations, 2010 CFR

2010-10-01

... RAILROAD WORKPLACE SAFETY Roadway Worker Protection § 214.353 Training and qualification of roadway workers... workers who provide for the on-track safety of groups of roadway workers through establishment of working...) All the on-track safety training and qualification required of the roadway workers to be supervised...

10 CFR Appendix A to Part 851 - Worker Safety and Health Functional Areas

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Worker Safety and Health Functional Areas A Appendix A to Part 851 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Pt. 851, App. A Appendix A to Part 851—Worker Safety and Health Functional Areas This appendix establishes the mandatory requirements...

77 FR 74784 - Safety Zone for Recovery Operations for East Jefferson Street Train Derailment, Mantua Creek...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-18

... 1625-AA00 Safety Zone for Recovery Operations for East Jefferson Street Train Derailment, Mantua Creek... establishing a safety zone one mile north and one mile south of the East Jefferson Street Railroad Bridge... materials into Mantua Creek and the surrounding air. This regulation is necessary to provide for the safety...

76 FR 35106 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-16

...-AA00 Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago..., DHS. ACTION: Final rule. SUMMARY: The Coast Guard is establishing a permanent safety zone from Brandon... Safety Zones; Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary...

40 CFR 30.18 - Hotel and motel fire safety.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Hotel and motel fire safety. 30.18... EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS Pre-Award Requirements § 30.18 Hotel and motel fire safety. The Hotel and Motel Fire Safety Act of 1990 (Public Law 101-391) establishes a number of fire...

76 FR 51271 - Implementing a Nationwide, Broadband, Interoperable Public Safety Network in the 700 MHz Band

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-18

... Docket 07-100; FCC 11-6] Implementing a Nationwide, Broadband, Interoperable Public Safety Network in the... interoperable public safety broadband network. The establishment of a common air interface for 700 MHz public safety broadband networks will create a foundation for interoperability and provide a clear path for the...

75 FR 37722 - Safety Zone; July Fireworks Display in Captain of the Port, Puget Sound AOR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

...-AA00 Safety Zone; July Fireworks Display in Captain of the Port, Puget Sound AOR AGENCY: Coast Guard... rule established a temporary safety zone on the waters of Port Gardner Bay, Washington in support of... positioning of the display. The safety zone is necessary to protect the maritime public from dangers...

78 FR 74010 - Safety Zone: Sausalito Lighted Boat Parade Fireworks Display, San Francisco Bay, Sausalito, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-10

...-AA00 Safety Zone: Sausalito Lighted Boat Parade Fireworks Display, San Francisco Bay, Sausalito, CA... temporary safety zone in the navigable waters of the San Francisco Bay off of Spinnaker Point near Sausalito... safety zone is established to help protect participants and spectators from the dangers associated with...

76 FR 20530 - Safety Zone; Boom Days, Buffalo Outer Harbor, Buffalo, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

...[deg]51'47.61'' W (NAD 83). (b) Effective period. This regulation will be effective and the safety zone...-AA00 Safety Zone; Boom Days, Buffalo Outer Harbor, Buffalo, NY AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone in the Buffalo Outer...

78 FR 59313 - Safety Zones; Captain of the Port Boston Fireworks Display Zones, Boston Harbor, Boston, MA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-26

...-AA00 Safety Zones; Captain of the Port Boston Fireworks Display Zones, Boston Harbor, Boston, MA AGENCY... establish six permanent safety zones throughout Boston Inner Harbor to be enforced during fireworks displays. These six permanent safety zones would expedite public notification of a fireworks event and ensure the...

78 FR 39992 - Safety Zone; Feast of Lanterns Fireworks Display, Pacific Grove, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-03

...-AA00 Safety Zone; Feast of Lanterns Fireworks Display, Pacific Grove, CA AGENCY: Coast Guard, DHS... zone in the navigable waters near Lover's Point Park in the Pacific Grove, CA in support of The Feast of Lanterns Fireworks Event on July 27, 2013. This safety zone is established to ensure the safety of...

40 CFR 30.18 - Hotel and motel fire safety.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Hotel and motel fire safety. 30.18... EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS Pre-Award Requirements § 30.18 Hotel and motel fire safety. The Hotel and Motel Fire Safety Act of 1990 (Public Law 101-391) establishes a number of fire...

Curriculum and Evaluation Guide for Safety Education Programs. Research and Evaluation Report Series No. 40.00.

ERIC Educational Resources Information Center

Lowry, Carlee S.

Designed to assist Bureau of Indian Affairs school officials in the identification of safety education program needs, this evaluation guide focuses upon the basic operational components in a safety education program. The means for establishing an evaluation design for safety education are presented via a flexible model appropriate for most…

78 FR 36662 - Safety Zone; Fairport Harbor Mardi Gras, Lake Erie, Fairport, OH

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

...-AA00 Safety Zone; Fairport Harbor Mardi Gras, Lake Erie, Fairport, OH AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Lake Erie, Fairport Harbor, OH. This safety zone is intended to restrict vessels from a portion of Lake Erie during...

77 FR 39638 - Safety Zone; Barbara Harder Wedding Fireworks, Lake Erie, Lake View, NY

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-05

...-AA00 Safety Zone; Barbara Harder Wedding Fireworks, Lake Erie, Lake View, NY AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Lake Erie, Lake View, NY. This safety zone is intended to restrict vessels from a portion of Lake Erie...

16 CFR 1018.14 - Non-Commission established advisory committees.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Non-Commission established advisory committees. 1018.14 Section 1018.14 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL ADVISORY COMMITTEE MANAGEMENT Establishment of Advisory Committees § 1018.14 Non-Commission established advisory...

Food hygiene and safety measures among food handlers in street food shops and food establishments of Dessie town, Ethiopia: A community-based cross-sectional study

PubMed Central

Adane, Metadel; Teka, Brhanu; Gismu, Yirga; Halefom, Goitom

2018-01-01

Introduction In sub-Saharan Africa foodborne disease and foodborne disease outbreaks are frequently ascribed to poor personal hygiene of street food vendors and food handlers in food establishments. Evidence on the level of food hygiene practices and food safety measures among food handlers is required for proper planning and implementation of targeted interventions. In this study, we aimed to determine the level of food hygiene and safety measures among street food vendors and food handlers in food establishments of Dessie Town, Ethiopia. Method A community-based cross-sectional study was performed in Dessie town, Ethiopia from December 2013 to June 2014. Data were collected using a pre-tested structured questionnaire and an observational checklist by a trained data collector among 116 food handlers from 116 food establishments and 19 food handlers from 19 street food vendors. Multivariable logistic regression analysis with 95% confidence interval (CI) was used to identify the factors significantly associated with good level of food hygiene and safety practices. Result Almost three-quarter (72%; 84/116) of food handlers in food establishments had a good level of food hygiene and safety practices compared to nearly half (53%; 10/19) of street food vendors. However, this difference was not statistically significant. Average monthly income of >$21 US (adjusted odds ratio [AOR] = 3.2; 95%CI: 1.3–7.7), availability of service training (AOR = 6.7; 95%CI: 1.8–25), wearing a gown during food handling (AOR = 19; 95%CI: 6.8–51) and medical checkup (AOR = 5.2; 95%CI: 2.1–13) were significantly associated with good levels of food hygiene and safety measures. Conclusion Comprehensive health education and promotion programs through continuous training on food hygiene and safety, with promotion of wearing gown during food handling, regular medical checkups of food handlers and programs that enhance the monthly income of food handlers are promising strategies for promoting proper food handling practices in Dessie town, Ethiopia. PMID:29723288

Human induced pluripotent stem cells and their use in drug discovery for toxicity testing.

PubMed

Scott, Clay W; Peters, Matthew F; Dragan, Yvonne P

2013-05-10

Predicting human safety risks of novel xenobiotics remains a major challenge, partly due to the limited availability of human cells to evaluate tissue-specific toxicity. Recent progress in the production of human induced pluripotent stem cells (hiPSCs) may fill this gap. hiPSCs can be continuously expanded in culture in an undifferentiated state and then differentiated to form most cell types. Thus, it is becoming technically feasible to generate large quantities of human cell types and, in combination with relatively new detection methods, to develop higher-throughput in vitro assays that quantify tissue-specific biological properties. Indeed, the first wave of large scale hiSC-differentiated cell types including patient-derived hiPSCS are now commercially available. However, significant improvements in hiPSC production and differentiation processes are required before cell-based toxicity assays that accurately reflect mature tissue phenotypes can be delivered and implemented in a cost-effective manner. In this review, we discuss the promising alignment of hiPSCs and recently emerging technologies to quantify tissue-specific functions. We emphasize liver, cardiovascular, and CNS safety risks and highlight limitations that must be overcome before routine screening for toxicity pathways in hiSC-derived cells can be established. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Gallium poisoning: a rare case report.

PubMed

Ivanoff, Chris S; Ivanoff, Athena E; Hottel, Timothy L

2012-02-01

The authors present a case of a college student who suffered acute gallium poisoning as a result of accidental exposure to gallium halide complexes. This is extremely rare and has never been reported in the literature. Acute symptoms after the incident, which initially presented as dermatitis and appeared relatively not life-threatening, rapidly progressed to dangerous episodes of tachycardia, tremors, dyspnea, vertigo, and unexpected black-outs. Had there been effective emergency medical care protocols, diagnostic testing, treatment and antidotes, the latent manifestations of irreversible cardiomyopathy may have been prevented. Given how quickly exposure led to morbidity, this article aims to raise an awareness of the toxic potential of gallium. This has particular relevance for workers involved in the production of semiconductors where there is a potential for accidental exposure to gallium by-products during device processing. It may also have implications for dentists who use gallium alloys to replace mercury containing amalgam. In the absence of threshold limit values and exposure limits for humans, as well as emergency medical guidelines for treatment of poisoning, the case calls on the National Institute for Occupational Safety and Health and the Occupational Safety and Health Administration to establish guidelines and medical management protocols specific for gallium. Copyright © 2011 Elsevier Ltd. All rights reserved.

An overview of animal models for assessing synthetic vitreous fibers (SVFs) safety.

PubMed

Johnson, N F

1994-12-01

Synthetic vitreous fibers (SVFs) are materials with many important commercial applications. The fibrous nature of the SVFs raises concerns about their potential human health hazards. However, sufficient epidemiological data do not exist to establish the hazardous nature of all SVFs. In addition, the cellular and molecular mechanisms underlying the induction of pulmonary lesions are only partially understood. Without sufficient evidence to associate fiber exposure and lung disease, animal bioassays have been used to identify specific hazardous fibers. These bioassays include inhalation exposures, intratracheal instillation, and intracavitary injection (intrapleural and intraperitoneal). Inhalation exposures of animals most closely represent the human experience, but these exposures are costly and time-consuming to conduct. Intratracheal and intracavitary administrations of fiber are alternatives to inhalation exposures; however, they do not represent human exposures and can give false positive results. The limitations of the noninhalation approaches must be considered when addressing the potential for a respirable fiber to induce human lung disease. In addition, when the results from inhalation exposures do not agree with the alternative animal assays, most weight should be given to the animal inhalation assays because of the limitations of the alternative approaches. To determine the safety of SVFs, both the inhalation and noninhalation approaches are suggested.

Toxic Element Contamination of Natural Health Products and Pharmaceutical Preparations

PubMed Central

Genuis, Stephen J.; Schwalfenberg, Gerry; Siy, Anna-Kristen J.; Rodushkin, Ilya

2012-01-01

Background Concern has recently emerged regarding the safety of natural health products (NHPs)–therapies that are increasingly recommended by various health providers, including conventional physicians. Recognizing that most individuals in the Western world now consume vitamins and many take herbal agents, this study endeavored to determine levels of toxic element contamination within a range of NHPs. Methods Toxic element testing was performed on 121 NHPs (including Ayurvedic, traditional Chinese, and various marine-source products) as well as 49 routinely prescribed pharmaceutical preparations. Testing was also performed on several batches of one prenatal supplement, with multiple samples tested within each batch. Results were compared to existing toxicant regulatory limits. Results Toxic element contamination was found in many supplements and pharmaceuticals; levels exceeding established limits were only found in a small percentage of the NHPs tested and none of the drugs tested. Some NHPs demonstrated contamination levels above preferred daily endpoints for mercury, cadmium, lead, arsenic or aluminum. NHPs manufactured in China generally had higher levels of mercury and aluminum. Conclusions Exposure to toxic elements is occurring regularly as a result of some contaminated NHPs. Best practices for quality control–developed and implemented by the NHP industry with government oversight–is recommended to guard the safety of unsuspecting consumers. PMID:23185404

49 CFR 374.315 - Transportation of passengers with disabilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY... part 36), incorporating the guidelines established by the Architectural and Transportation Barriers...

Threats to the health care safety net.

PubMed

Taylor, T B

2001-11-01

The American health care safety net is threatened due to inadequate funding in the face of increasing demand for services by virtually every segment of our society. The safety net is vital to public safety because it is the sole provider for first-line emergency care, as well as for routine health care of last resort, through hospital emergency departments (ED), emergency medical services providers (EMS), and public/free clinics. Despite the perceived complexity, the causes and solutions for the current crisis reside in simple economics. During the last two decades health care funding has radically changed, yet the fundamental infrastructure of the safety net has change little. In 1986, the Emergency Medical Treatment and Active Labor Act established federally mandated safety net care that inadvertently encouraged reliance on hospital EDs as the principal safety net resource. At the same time, decreasing health care funding from both private and public sources resulted in declining availability of services necessary to support this shift in demand, including hospital inpatient beds, EDs, EMS providers, on-call specialists, hospital-based nurses, and public hospitals/clinics. The result has been ED/hospital crowding and resource shortages that at times limit the ability to provide even true emergency care and threaten the ability of the traditional safety net to protect public health and safety. This paper explores the composition of the American health care safety net, the root causes for its disintegration, and offers short- and long-term solutions. The solutions discussed include restructuring of disproportionate share funding; presumed (deemed) eligibility for Medicaid eligibility; restructuring of funding for emergency care; health care for foreign nationals; the nursing shortage; utilization of a "health care resources commission"; "episodic (periodic)" health care coverage; best practices and health care services coordination; and government and hospital providers' roles. There is a base amount of funding that must be available to the American health care safety net to maintain its infrastructure and provide appropriate growth, research, development, and expansion of services. Fall below this level and the infrastructure will eventually crumble. America must patch the safety net with short-term funding and repair it with long-term health care policy and environmental changes.

Global harmonization of food safety regulation from the perspective of Korea and a novel fast automatic product recall system.

PubMed

Sohn, Mun-Gi; Oh, Sangsuk

2014-08-01

Efforts have been made for global harmonization of food safety regulations among countries through international organizations such as WTO and WHO/FAO. Global harmonization of food safety regulations is becoming increasingly important for Korean consumers because more than half of food and agricultural products are imported and consumed. Through recent reorganization of the Korean government, a consolidated national food safety authority-the Ministry of Food and Drug Safety (MFDS)-has been established for more efficient food safety control and better communication with consumers. The Automatic Sales Blocking System (ASBS), which blocks the sales of the recalled food products at the point of sale, has been implemented at over 40,000 retail food stores around the nation using state-of-the art information and communication technology (ICT) for faster recall of adulterated food products, and the e-Food Safety Control System has been developed for more efficient monitoring of national food safety surveillance situations. The National Food Safety Information Service was also established for monitoring and collecting food safety information and incidents worldwide, and shares relevant information with all stakeholders. The new approaches adopted by the Korean Food Safety Authority are expected to enhance public trust with regard to food safety issues and expedite the recall process of adulterated products from the market. © 2013 Society of Chemical Industry.

75 FR 63203 - Advisory Committee on Construction Safety and Health (ACCSH); Notice of Reestablishment of Charter

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-14

.... ACCSH is a continuing advisory committee established under Section 107 of the Contract Work Hours and... Occupational Safety and Health Act of 1970 (29 U.S.C. 656), section 107 of the Contract Work Hours and Safety...

49 CFR 214.337 - On-track safety procedures for lone workers.

Code of Federal Regulations, 2013 CFR

2013-10-01

... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection... performing routine inspection or minor correction may use individual train detection to establish on-track... worker retains an absolute right to use on-track safety procedures other than individual train detection...

49 CFR 214.337 - On-track safety procedures for lone workers.

Code of Federal Regulations, 2012 CFR

2012-10-01

... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection... performing routine inspection or minor correction may use individual train detection to establish on-track... worker retains an absolute right to use on-track safety procedures other than individual train detection...

49 CFR 214.337 - On-track safety procedures for lone workers.

Code of Federal Regulations, 2014 CFR

2014-10-01

... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection... performing routine inspection or minor correction may use individual train detection to establish on-track... worker retains an absolute right to use on-track safety procedures other than individual train detection...

49 CFR 214.337 - On-track safety procedures for lone workers.

Code of Federal Regulations, 2011 CFR

2011-10-01

... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection... performing routine inspection or minor correction may use individual train detection to establish on-track... worker retains an absolute right to use on-track safety procedures other than individual train detection...