IRSN research programs concerning reactor safety

International Nuclear Information System (INIS)

Bardelay, J.

2005-01-01

This paper is made up of 3 parts. The first part briefly presents the missions of IRSN (French research institute on nuclear safety), the second part reviews the research works currently led by IRSN in the following fields : -) the assessment of safety computer codes, -) thermohydraulics, -) reactor ageing, -) reactivity accidents, -) loss of coolant, -) reactor pool dewatering, -) core meltdown, -) vapor explosion, and -) fission product release. In the third part, IRSN is shown to give a major importance to experimental programs led on research or test reactors for collecting valid data because of the complexity of the physical processes that are involved. IRSN plans to develop a research program concerning the safety of high or very high temperature reactors. (A.C.)

Development of safety analysis technology for integral reactor; evaluation on safety concerns of integral reactor

Energy Technology Data Exchange (ETDEWEB)

Kim, Hee Chul; Kim, Woong Sik; Lee, J. H. [Korea Institute of Nuclear Safety, Taejeon (Korea)

2002-03-01

The Nuclear Desalination Plant (NDP) is being developed to produce electricity and fresh water, and is expected to locate near population zone. In the aspect of safety, it is required to protect the public and environment from the possible releases of fission products and to prevent the fresh water from the contamination of radioactivity. Thus, in this study, the safety characteristics of the integral reactor adopting passive and inherent safety features significantly different from existing nuclear power plants were investigated. Also, safety requirements applicable to the NDP were analyzed based on the regulatory requirements for current light water reactor and advanced reactor designs, and user requirements for small-medium size reactors. Based on these analyses, some safety concerns to be considered in the design stage have been identified and discussed. They include the use of proven technology for new safety features, systematic event classification and selection, strengthening containment function, and the safety impacts on desalination-related systems. The study presents the general safety requirements applicable to licensing of an integral reactor and suggests additional regulatory requirements, which need to be developed, based on the direction to resolution of the safety concerns. The efforts to identify and technically resolve the safety concerns in the design stage will provide the early confidence of SMART safety and the technical basis to evaluate the safety to designers and reviewers in the future. Suggestion on the development of additional regulatory requirements will contribute for the regulator to taking actions for licensing of an integral reactor. 66 refs., 5 figs., 24 tabs. (Author)

Nutrition labelling is a trade policy issue: lessons from an analysis of specific trade concerns at the World Trade Organization.

Science.gov (United States)

Thow, Anne Marie; Jones, Alexandra; Hawkes, Corinna; Ali, Iqra; Labonté, Ronald

2017-01-12

Interpretive nutrition labels provide simplified nutrient-specific text and/or symbols on the front of pre-packaged foods, to encourage and enable consumers to make healthier choices. This type of labelling has been proposed as part of a comprehensive policy response to the global epidemic of non-communicable diseases. However, regulation of nutrition labelling falls under the remit of not just the health sector but also trade. Specific Trade Concerns have been raised at the World Trade Organization's Technical Barriers to Trade Committee regarding interpretive nutrition labelling initiatives in Thailand, Chile, Indonesia, Peru and Ecuador. This paper presents an analysis of the discussions of these concerns. Although nutrition labelling was identified as a legitimate policy objective, queries were raised regarding the justification of the specific labelling measures proposed, and the scientific evidence for effectiveness of such measures. Concerns were also raised regarding the consistency of the measures with international standards. Drawing on policy learning theory, we identified four lessons for public health policy makers, including: strategic framing of nutrition labelling policy objectives; pro-active policy engagement between trade and health to identify potential trade issues; identifying ways to minimize potential 'practical' trade concerns; and engagement with the Codex Alimentarius Commission to develop international guidance on interpretative labelling. This analysis indicates that while there is potential for trade sector concerns to stifle innovation in nutrition labelling policy, care in how interpretive nutrition labelling measures are crafted in light of trade commitments can minimize such a risk and help ensure that trade policy is coherent with nutrition action. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Mothers' Concerns for Personal Safety and Privacy While Breastfeeding: An Unexplored Phenomenon.

Science.gov (United States)

Rosen-Carole, Casey; Allen, Katherine; Fagnano, Maria; Dozier, Ann; Halterman, Jill

2018-04-01

Preliminary qualitative research in upstate NY shows new mothers are worried about safety while breastfeeding. Little is known regarding prevalence of these concerns and their effect on breastfeeding outcomes. (1) Determine frequency of breastfeeding safety and privacy concerns; (2) Explore their association with breastfeeding outcomes. Mothers were surveyed immediately and 1-month postpartum about breastfeeding goals; both surveys addressed privacy and safety concerns at home, work, and in public. Outcome data included breastfeeding intent, exclusivity, and duration. Breastfeeding/non-breastfeeding mothers were compared using Chi-square and multivariate analyses. A total of 279 women enrolled. Of these 82.8% initiated breastfeeding; at 1-month 72% provided any breast milk, and 44% were exclusively breastfeeding. About 99% felt safe breastfeeding at home; 25% reported privacy concerns; and 5% felt "vulnerable or unsafe" while breastfeeding. At 1-month, 49% agreed there was a safe place to breastfeed/express milk at work (20% unsure). Non-breastfeeding mothers expressed more safety concerns outside home/at work: 18% breastfeeding versus 28% non-breastfeeding outside home; 27% breastfeeding versus 40% non-breastfeeding at work. Nearly 54% who reported feeling vulnerable/unsafe with breastfeeding initiated breastfeeding, compared with 86% not reporting this concern (p = 0.008). Fewer women initiating breastfeeding reported vulnerability/safety (3% breastfeeding versus 14% non-breastfeeding, p = 0.008) or privacy (22% breastfeeding versus 40% non-breastfeeding, p = 0.19) concerns. Associations held after controlling for age, race, parity, insurance, geography, and marital-status. Significant associations between initiation, privacy, and safety concerns did not extend to duration or exclusivity. Many breastfeeding women reported safety and privacy concerns, especially outside the home and at work, which may influence breastfeeding initiation. Further study

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns.

Science.gov (United States)

Tetteh, Raymond A; Yankey, Barbara A; Nartey, Edmund T; Lartey, Margaret; Leufkens, Hubert G M; Dodoo, Alexander N O

2017-04-01

Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present challenges in the implementation and use of PrEP. The aim of this review is to discuss safety concerns observed in completed clinical trials on the use of PrEP. We performed a literature search on PrEP in PubMed, global advocacy for HIV prevention (Aids Vaccine Advocacy Coalition) database, clinical trials registry " http://www.clinicaltrials.gov " and scholar.google, using combination search terms 'pre-exposure prophylaxis', 'safety concerns in the use of pre-exposure prophylaxis', 'truvada use as PrEP', 'guidelines for PrEP use', 'HIV pre-exposure prophylaxis' and 'tenofovir' to identify clinical trials and literature on PrEP. We present findings associated with safety issues on the use of PrEP based on a review of 11 clinical trials on PrEP with results on safety and efficacy as at April 2016. We also reviewed findings from routine real-life practice reports. The pharmacological intervention for PrEP was tenofovir disoproxil fumarate/emtricitabine in a combined form as Truvada ® or tenofovir as a single entity. Both products are efficacious for PrEP and seem to have a good safety profile. Regular monitoring is recommended to prevent long-term toxic effects. The main adverse effects observed with PrEP are gastrointestinal related; basically mild to moderate nausea, vomiting and diarrhea. Other adverse drug effects worth monitoring are liver enzymes, renal function and bone mineral density. PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials. It is recommended for widespread use but adherence monitoring and real-world safety surveillance are critical in the post-marketing phase to ensure that the benefits

Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

Science.gov (United States)

Vujić, Mario; Pollak, Lea

2015-12-01

The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

International antiterrorist conventions concerning the safety of air transport

Directory of Open Access Journals (Sweden)

Jacek BARCIK

2008-01-01

Full Text Available In this article the international law regulations are presented concerning the civilian safety of the air transport. The history concerning air terrorism and international antiterrorist conventions was described in detail, involving The Chicago Convention, The Tokyo Convention, The Hague Convention and Montreal Convention.

A primer of drug safety surveillance: an industry perspective. Part II: Product labeling and product knowledge.

Science.gov (United States)

Allan, M C

1992-01-01

To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part II of this series discusses specific issues regarding product labeling, such as developing the labeling, changing the labeling, and the legal as well as commercial ramifications of the contents of the labeling. An adverse event report scenario is further analyzed and suggestions are offered for maintaining the product labeling as an accurate reflection of the drug safety surveillance data. This article also emphasizes the necessity of product knowledge in adverse event database management. Both scientific and proprietary knowledge are required. Acquiring product knowledge is a part of the day-to-day activities of drug safety surveillance. A knowledge of the history of the product may forestall adverse publicity, as shown in the illustration. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered

Willingness to pay for safety label on sugar and vegetable oil among ...

African Journals Online (AJOL)

This study investigates willingness to pay for safety label on sugar and vegetable oil among households in South – Western Nigeria. In all, 390 consumers comprising 180 from Oyo and 210 from Lagos were sampled. Data collected include socio-economic, market and food safety information variables using structured ...

Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

Directory of Open Access Journals (Sweden)

Benjamin Hixon

2017-02-01

Full Text Available Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC. The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9% of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%. The three most frequently reported labeling changes were warnings (68.7%, precautions (58.6%, and patient package insert/medication guide (23.2%. Case reports resulted in the greatest number of documented literature types (n = 791, followed by randomized controlled trials (n = 76, and case control/cohort studies (n = 74. Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%, compared to LOE A (17.1%, and LOE C (14.1% (p = 0.007. Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Research

Pre-Exposure Prophylaxis for HIV Prevention : Safety Concerns

NARCIS (Netherlands)

Tetteh, Raymond A; Yankey, Barbara A; Nartey, Edmund T; Lartey, Margaret; Leufkens, Hubert G M; Dodoo, Alexander N O

Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present

Food safety concerns of fast food consumers in urban Ghana.

Science.gov (United States)

Omari, Rose; Frempong, Godfred

2016-03-01

In Ghana, out-of-home ready-to-eat foods including fast food generally have been associated with food safety problems. Notwithstanding, fast food production and consumption are increasing in Ghana and therefore this study sought to determine the food safety issues of importance to consumers and the extent to which they worry about them. First, through three focus group discussions on consumers' personal opinions about food safety issues, some emergent themes were obtained, which were used to construct an open-ended questionnaire administered face-to-face to 425 respondents systematically sampled from 20 fast food restaurants in Accra. Findings showed that most fast food consumers were concerned about food hazards such as pesticide residue in vegetables, excessive use of artificial flavour enhancers and colouring substances, bacterial contamination, migrated harmful substances from plastic packages, and general unhygienic conditions under which food is prepared and sold. Consumers also raised concerns about foodborne diseases such as cholera, typhoid, food poisoning, diarrhoea, bird flu and swine flu. The logistic regression model showed that being male increased the likelihood of worrying about general food safety issues and excessive use of flavour enhancers than in females while being youthful increased the likelihood of being worried about typhoid fever than in older consumers. These findings imply that consumers in urban Ghana are aware and concerned about current trends of food safety and foodborne disease challenges in the country. Therefore, efforts targeted at improving food safety and reducing incidences of foodborne diseases should not only focus on public awareness creation but should also design more comprehensive programmes to ensure the making of food safety rules and guidelines and enforcing compliance to facilitate availability and consumers' choice of safe foods. Copyright © 2015 Elsevier Ltd. All rights reserved.

'Speaking up' about patient safety concerns and unprofessional behaviour among residents: validation of two scales.

Science.gov (United States)

Martinez, William; Etchegaray, Jason M; Thomas, Eric J; Hickson, Gerald B; Lehmann, Lisa Soleymani; Schleyer, Anneliese M; Best, Jennifer A; Shelburne, Julia T; May, Natalie B; Bell, Sigall K

2015-11-01

To develop and test the psychometric properties of two new survey scales aiming to measure the extent to which the clinical environment supports speaking up about (a) patient safety concerns and (b) unprofessional behaviour. Residents from six large US academic medical centres completed an anonymous, electronic survey containing questions regarding safety culture and speaking up about safety and professionalism concerns. Confirmatory factor analysis supported two separate, one-factor speaking up climates (SUCs) among residents; one focused on patient safety concerns (SUC-Safe scale) and the other focused on unprofessional behaviour (SUC-Prof scale). Both scales had good internal consistency (Cronbach's α>0.70) and were unique from validated safety and teamwork climate measures (rspeaking up behaviour about safety and professionalism concerns (r=0.21, pspeaking up behaviour among residents. These two scales may fill an existing gap in residency and safety culture assessments by measuring the openness of communication about safety and professionalism concerns, two important aspects of safety culture that are under-represented in existing metrics. 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.

Food colors: Existing and emerging food safety concerns.

Science.gov (United States)

Oplatowska-Stachowiak, Michalina; Elliott, Christopher T

2017-02-11

Food colors are added to different types of commodities to increase their visual attractiveness or to compensate for natural color variations. The use of these additives is strictly regulated in the European Union, the United States, and many other countries worldwide. There is a growing concern about the safety of some commonly used legal food colorants and there is a trend to replace the synthetic forms with natural products. Additionally, a number of dyes with known or suspected genotoxic or carcinogenic properties have been shown to be added illegally to foods. Robust monitoring programs based on reliable detection methods are required to assure the food is free from harmful colors. The aim of this review is to present an up to date status of the various concerns arising from use of color additives in food. The most important food safety concerns in the field of food colors are lack of uniform regulation concerning legal food colors worldwide, possible link of artificial colors to hyperactive behavior, replacement of synthetic colors with natural ones, and the presence of harmful illegal dyes-both known but also new, emerging ones in food. The legal status of food color additives in the EU, United States, and worldwide is summarized. The reported negative health effects of both legal and illegal colors are presented. The European Rapid Alert System for Food and Feed notifications and US import alerts concerning food colors are analyzed and trends in fraudulent use of color additives identified. The detection methods for synthetic colors are also reviewed.

Aviation Safety Concerns for the Future

Science.gov (United States)

Smith, Brian E.; Roelen, Alfred L. C.; den Hertog, Rudi

2016-01-01

The Future Aviation Safety Team (FAST) is a multidisciplinary international group of aviation professionals that was established to identify possible future aviation safety hazards. The principle was adopted that future hazards are undesirable consequences of changes, and a primary activity of FAST became identification and prioritization of possible future changes affecting aviation. Since 2004, FAST has been maintaining a catalogue of "Areas of Change" (AoC) that could potentially influence aviation safety. The horizon for such changes is between 5 to 20 years. In this context, changes must be understood as broadly as possible. An AoC is a description of the change, not an identification of the hazards that result from the change. An ex-post analysis of the AoCs identified in 2004 demonstrates that changes catalogued many years previous were directly implicated in the majority of fatal aviation accidents over the past ten years. This paper presents an overview of the current content of the AoC catalogue and a subsequent discussion of aviation safety concerns related to these possible changes. Interactions among these future changes may weaken critical functions that must be maintained to ensure safe operations. Safety assessments that do not appreciate or reflect the consequences of significant interaction complexity will not be fully informative and can lead to inappropriate trade-offs and increases in other risks. The FAST strongly encourages a system-wide approach to safety risk assessment across the global aviation system, not just within the domain for which future technologies or operational concepts are being considered. The FAST advocates the use of the "Areas of Change" concept, considering that several possible future phenomena may interact with a technology or operational concept under study producing unanticipated hazards.

Identifying Facilitators and Barriers for Patient Safety in a Medicine Label Design System Using Patient Simulation and Interviews

DEFF Research Database (Denmark)

Dieckmann, Peter; Clemmensen, Marianne Hald; Sørensen, Trine Kart

2016-01-01

Objectives Medicine label design plays an important role in improving patient safety. This study aimed at identifying facilitators and barriers in a medicine label system to prevent medication errors in clinical use by health care professionals. Methods The study design is qualitative and explora......Objectives Medicine label design plays an important role in improving patient safety. This study aimed at identifying facilitators and barriers in a medicine label system to prevent medication errors in clinical use by health care professionals. Methods The study design is qualitative...... of the system and some inconsistencies (different meaning of colors) posed challenges, when considered with the actual application context, in which there is little time to get familiar with the design features. Conclusions For optimizing medicine labels and obtaining the full benefit of label design features...

Open-label extension studies: do they provide meaningful information on the safety of new drugs?

Science.gov (United States)

Day, Richard O; Williams, Kenneth M

2007-01-01

The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. If undertaken primarily to gather more patient-years of exposure to the new drug in order to understand and gain confidence in its safety profile, open-label extension studies can play a useful and legitimate role in drug development and therapeutics. However, this can only occur if the open-label extension study is designed, executed, analysed and reported competently. Most of the value accrued in open-label extension studies is gained from a refinement in the perception of the expected incidence of adverse effects that have most likely already been identified as part of the preclinical and clinical trial programme. We still have to rely heavily on post-marketing safety surveillance systems to alert us to type B (unpredictable) adverse reactions because open-label extension studies are unlikely to provide useful information about these types of often serious and relatively rare adverse reactions. Random allocation into test and control groups is needed to produce precise incidence data on pharmacologically expected, or type A, adverse effects. Some increased confidence about incidence rates might result from the open-label extension study; however, as these studies are essentially uncontrolled and biased, the data are not of great value. Other benefits have been proposed to be gained from open-label extension studies. These include ongoing access to an effective but otherwise unobtainable medicine by the volunteers who participated in the phase III pivotal trials. However, there are unappreciated ethical issues about the appropriateness of enrolling patients whose response to previous treatment is uncertain, largely because treatment allocation in the preceding randomised, double-blind, controlled trial has not been revealed at the

Driving and dementia: Efficient approach to driving safety concerns in family practice.

Science.gov (United States)

Lee, Linda; Molnar, Frank

2017-01-01

To provide primary care physicians with an approach to driving safety concerns when older persons present with memory difficulties. The approach is based on an accredited memory clinic training program developed by the Centre for Family Medicine Primary Care Collaborative Memory Clinic. One of the most challenging aspects of dementia care is the assessment of driving safety. Drivers with dementia are at higher risk of motor vehicle collisions, yet many drivers with mild dementia might be safely able to continue driving for several years. Because safe driving is dependent on multiple cognitive and functional skills, clinicians should carefully consider many factors when determining if cognitive concerns affect driving safety. Specific findings on corroborated history and office-based cognitive testing might aid in the physician's decisions to refer for comprehensive on-road driving evaluation and whether to notify transportation authorities in accordance with provincial reporting requirements. Sensitive communication and a person-centred approach are essential. Primary care physicians must consider many factors when determining if cognitive concerns might affect driving safety in older drivers. Copyright© the College of Family Physicians of Canada.

Mining FDA drug labels using an unsupervised learning technique--topic modeling.

Science.gov (United States)

Bisgin, Halil; Liu, Zhichao; Fang, Hong; Xu, Xiaowei; Tong, Weida

2011-10-18

The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering "topics" that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that might arise from specific

Mining FDA drug labels using an unsupervised learning technique - topic modeling

Science.gov (United States)

2011-01-01

Background The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. Method In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering “topics” that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. Results The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that

Psychometrics of the AAN Caregiver Driving Safety Questionnaire and contributors to caregiver concern about driving safety in older adults.

Science.gov (United States)

Carvalho, Janessa O; Springate, Beth; Bernier, Rachel A; Davis, Jennifer

2018-03-01

ABSTRACTBackground:The American Academy of Neurology (AAN) updated their practice parameters in the evaluation of driving risk in dementia and developed a Caregiver Driving Safety Questionnaire, detailed in their original manuscript (Iverson Gronseth, Reger, Classen, Dubinsky, & Rizzo, 2010). They described four factors associated with decreased driving ability in dementia patients: history of crashes or citations, informant-reported concerns, reduced mileage, and aggressive driving. An informant-reported AAN Caregiver Driving Safety Questionnaire was designed with these elements, and the current study was the first to explore the factor structure of this questionnaire. Additionally, we examined associations between these factors and cognitive and behavioral measures in patients with mild cognitive impairment or early Alzheimer's disease and their informants. Exploratory factor analysis revealed a four-component structure, consistent with the theory behind the AAN scale composition. These four factor scores also were significantly associated with performance on cognitive screening instruments and informant reported behavioral dysfunction. Regressions revealed that behavioral dysfunction predicted caregiver concerns about driving safety beyond objective patient cognitive dysfunction. In this first known quantitative exploration of the scale, our results support continued use of this scale in office driving safety assessments. Additionally, patient behavioral changes predicted caregiver concerns about driving safety over and above cognitive status, which suggests that caregivers may benefit from psychoeducation about cognitive factors that may negatively impact driving safety.

Design concepts and safety concerns of the small and medium size reactors (SMR)

International Nuclear Information System (INIS)

Seul, Kwang Won; Lee, Jae Hun; Kim, Hho Jung

1998-01-01

The small and medium size reactors (SMR) and interface facilities such as desalination plant are expected to be located near the population area because of restrictions in transporting the plant products such as fresh water to long distance area. To protect the public around the plant facility from the possible release of radioactive materials, the design development of the SMR is focusing on an enhancement of the safety and reliability as well as the economics. In this study, the major safety concepts of the SMR designs significantly different from the current PWR designs are investigated and the safety concerns applicable to the integrated SMR design of Korea (called SMART), were identified. Those safety issues include the use of proven technology, application of strengthening defense in depth, event categorization and selection, simplification of emergency planning, determination of accident source terms and so on. The efforts to resolve the safety concerns in the design stage will provide an improvement of the safety of the SMART design

CONSUMER DEMAND FOR AND ATTITUDES TOWARD ALTERNATIVE BEEF LABELING STRATEGIES IN FRANCE, GERMANY, AND THE UK

OpenAIRE

Roosen, Jutta; Lusk, Jayson L.; Fox, John A.

2001-01-01

A wide array of food safety scares and breakdowns have led to loss of consumer confidence in the quality and safety of beef products. To counteract such concerns, firms and regulators have the ability to utilize brands or labels to signal quality. Utilizing a mail survey in France, Germany, and the United Kingdom, we analyzed consumer preferences for alternative beef labeling strategies. Using an ordered probit model and a double bounded logit model, we estimate consumer preferences for alter...

Long-term criticality safety concerns associated with surplus fissile material disposition

International Nuclear Information System (INIS)

Choi, J.S.

1995-01-01

A substantial inventory of surplus fissile material would result from ongoing and planned dismantlement of US and Russian nuclear weapons. This surplus fissile material could be dispositioned by irradiation in nuclear reactors, and the resulting spent MOx fuel would be similar in radiation characteristics to regular LWR spent UO2 fuel. The surplus fissile material could also be immobilized into high-level waste forms, such as borosilicate glass, synroc, or metal-alloy matrix. The MOx spent fuel, or the immobilized waste forms, could then be directly disposed of in a geologic repository. Long-term criticality safety concerns arise because the fissile contents (i.e., Pu-239 and its decay daughter U-235) in these waste forms are higher than in LWR spent UO2 fuel. MOx spent fuel could contain 3 to 4 wt% of reactor-grade plutonium, compared to only 0.9 wt% of plutonium in LWR spent UO2 fuel. At some future time (tens of thousand of years), when the waste forms had deteriorated due to intruding groundwater, the water could mix with the long-lived fissile materials to form into a critical system. If the critical system is self-sustaining, somewhat like the natural-occurring reactor in OKLO, fission products produced could readily be available for dissolution and release out to the accessible environment, adversely affecting public health and safety. This paper will address ongoing activities to evaluate long-term criticality safety concerns associated with disposition of fissile material in a geologic setting. Issues to be addressed include the identification of a worst-case water-intrusion scenario and waste-form geometries which present the most concern for long-term criticality safety; and suggests of technical solutions for such concerns

Safety of telmisartan in patients with arterial hypertension - An open-label observational study

NARCIS (Netherlands)

Michel, Martin C.; Bohner, Herbert; Köster, Jürgen; Schäfers, Rafael; Heemann, Uwe

2004-01-01

Objective: To determine whether age, gender, concomitant disease and/or previous or present antihypertensive medication affect the safety or antihypertensive efficacy of telmisartan in the treatment of arterial hypertension. Study Design and Methods: In this large-scale, open-label postmarketing

The safety concept of the Federal Government concerning waste management

International Nuclear Information System (INIS)

Pfaffelhuber, J.K.

1976-01-01

The safety concept of the FRG concerning waste management is based on the ultimate aim of having in operation until 1985 nuclear power plants with a capacity of approx. 45,000 MWe, i.e. 50 nuclear power plants with an annual fuel consumption of 1,500 tons. A critical survey shows that there is still a great number of questions to be solved, concerning the fuel cycle in particular in terms of industrial standards, and that various problems ought to be the subject of R and D activities. Activities in the field of waste management so far are concerned only with project studies and details of project definition studies. On the one hand, the principles of the safety concept for waste management are to make possible and to guarantee the operation of nuclear facilities, and on the other hand, they are to subject those facilities which serve the purpose of waste disposal to similar safety regulations as the nuclear power plants are subjected to. The integrated waste disposal system of the Federal government for CWRs until the mid eighties is described. R+D activities are still necessary, in particular concerning reprocessing techniques, techniques in the reprocessing of Pu, the conditioning of highly active wastes, testing final storage techniques, and in the field of retention of gaseous radioactive nuclides (iodine, krypton, tritium) and of safeguarding waste disposal parks against terrorists and sabotage. The legal basis for the protection of the citizen is the Atomic Energy Act and its ordinances, EURATOM basic standards, and ICRP recommendations, some of which were tightened up for the FRG. Some recommendations of the Strahlenschutzkommision - radiation exposure, storage and separation of 85 Kr, 129 J, 131 J, and 133 Xe - are dealt with in detail. (HPH/LN) [de

Shelf life and safety concerns of bakery products--a review.

Science.gov (United States)

Smith, James P; Daifas, Daphne Phillips; El-Khoury, Wassim; Koukoutsis, John; El-Khoury, Anis

2004-01-01

Bakery products are an important part of a balanced diet and, today, a wide variety of such products can be found on supermarket shelves. This includes unsweetened goods (bread, rolls, buns, crumpets, muffins and bagels), sweet goods (pancakes, doughnuts, waffles and cookies) and filled goods (fruit and meat pies, sausage rolls, pastries, sandwiches, cream cakes, pizza and quiche). However, bakery products, like many processed foods, are subject to physical, chemical and microbiological spoilage. While physical and chemical spoilage limits the shelf life of low and intermediate moisture bakery products, microbiological spoilage by bacteria, yeast and molds is the concern in high moisture products i.e., products with a water activity (a(w)) > 0.85. Furthermore, several bakery products also have been implicated infoodborne illnesses involving Salmonella spp., Listeria monoctyogenes and Bacillus cereus, while Clostridium botulinum is a concern in high moisture bakery products packaged under modified atmospheres. This extensive review is divided into two parts. Part I focuses on the spoilage concerns of low, intermediate and high moisture bakery products while Part II focuses on the safety concerns of high moisture bakery products only. In both parts, traditional and novel methods of food preservation that can be used by the bakery industry to extend the shelf life and enhance the safety of products are discussed in detail.

Summary of Tiger Team Assessment and Technical Safety Appraisal recurring concerns in the Operations Area

International Nuclear Information System (INIS)

1993-01-01

Fourteen Tiger Team Assessment and eight Technical Safety Appraisal (TSA) final reports have been received and reviewed by the DOE Training Coordination Program during Fiscal Year 1992. These assessments and appraisals included both reactor and non-reactor nuclear facilities in their reports. The Tiger Team Assessments and TSA reports both used TSA performance objectives, and list ''concerns'' as a result of their findings. However, the TSA reports categorized concerns into the following functional areas: (1) Organization and Administration, (2) Radiation Protection, (3) Nuclear Criticality Safety, (4) Occupational Safety, (5) Engineering/Technical Support, (6) Emergency Preparedness, (7) Safety Assessments, (8) Quality Verification, (9) Fire Protection, (10) Environmental Protection, and (11) Energetic Materials Safety. Although these functional areas match most of the TSA performance objectives, not all of the TSA performance objectives are addressed. For example, the TSA reports did not include Training, Maintenance, and Operations as functional areas. Rather, they included concerns that related to these topics throughout the 11 functional areas identified above. For consistency, the Operations concerns that were identified in each of the TSA report functional areas have been included in this summary with the corresponding TSA performance objective

CONSUMER WILLINGNESS TO PAY FOR SAFETY LABELS IN NIGERIA: A CASE STUDY OF POTASSIUM BROMATE IN BREAD

Directory of Open Access Journals (Sweden)

O Oni

2006-05-01

Full Text Available The study analysed consumer willingness to pay for safety labels in Nigeria by a case study of potassium bromate in bread” in Benin City, Edo State. It specifi cally investigates factors that promote willingness to pay for label among consumers of bread in Benin City, Edo State. Data used for the study were obtained through a well-structured questionnaire from 200 respondents. Both descriptive analytical methods and probit regression models were used for the analysis. The study revealed that 73% of the respondents are in their active working age with 50 percent of the respondent being male and female respectively. 67 percent of the respondents are married with 55 percent having an average of 5 members per household. 99 percent of the respondents are educated i.e. they have the capability of being able to read and write. Respondents purchased bread mainly from hawkers (60% with about 60% of them being aware of the presence of bromate in bread. 40% of the consumers used labeling as a way of identifying bromate free bread. Other methods reported deal with differences in price of bread with same weight, aroma and taste. Result also revealed that 60% of the respondents got to know about the negative effect of bromate from news (both print and mass media. Econometric results show that variables like education, gender, income, prior knowledge of bromate and perception held by respondents of negative implications of bromate signifi cantly infl uence the willingness to pay for safety labels. Education, gender, income and prior knowledge of bromate positively infl uence the probability of consumers’ decision to pay for safety label, while price of bread and confi dence and perception held by respondents of negative implications of bromate on human health infl uence consumers willingness to pay more for safety labels. The study, thus, suggests a defi ned market for bread purchases, community based awareness programme and extension of National Agency

Predicament of Chinese legislation on genetically modified food (GMF) labeling management and solutions - from the perspective of the new food safety law.

Science.gov (United States)

Li, Wei; Li, Han

2017-11-01

This paper considers the background of Article 69 of the newly revised Food Safety Law in China in combination with the current situation of Chinese legislation on GMF labeling management, compared with a foreign genetically modified food labeling management system, revealing deficiencies in the Chinese legislation with respect to GMF labeling management, and noting that institutions should properly consider the GMF labeling management system in China. China adheres to the principle of mandatory labeling based on both product and processes in relation to GMFs and implements a system of process-centered mandatory labeling under a negotiation-construction form. However, China has not finally defined the supervision mode of mandatory labeling of GMFs through laws, and this remains a challenge for GMF labeling management when two mandatory labeling modes coexist. Since April 2015 and October 1, 2015 when the Food Safety Law was revised and formally implemented respectively, the applicable judicial interpretations and enforcement regulations have not made applicable revisions and only principle-based terms have been included in the Food Safety Law, it is still theoretically and practically difficult for mandatory labeling of GMFs in juridical practices and conflicts between the principle of GMF labeling and the purpose that safeguards consumers' right to know remain. The GMF labeling system should be legislatively and practically improved to an extent that protects consumers' right to know. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

Safety concerns and suggested design approaches to the HTGR Reformer process concept

Energy Technology Data Exchange (ETDEWEB)

Green, R.C.

1981-09-01

This report is a safety review of the High Temperature Gas-Cooled Reactor Reformer Application Study prepared by Gas-Cooled Reactor Associates (GCRA) of La Jolla, California. The objective of this review was to identify safety concerns and suggests design approaches to minimize risk in the High Temperature Gas-Cooled Reactor Reformer (HTGR-R) process concept.

Safety concerns and suggested design approaches to the HTGR Reformer process concept

International Nuclear Information System (INIS)

Green, R.C.

1981-09-01

This report is a safety review of the High Temperature Gas-Cooled Reactor Reformer Application Study prepared by Gas-Cooled Reactor Associates (GCRA) of La Jolla, California. The objective of this review was to identify safety concerns and suggests design approaches to minimize risk in the High Temperature Gas-Cooled Reactor Reformer (HTGR-R) process concept

List of reports from BMFT, CEA, EPRI, JSTA and USNRC concerning reactor safety research

International Nuclear Information System (INIS)

1982-02-01

This list reviews reports from the Federal Republic of Germany, from France from Japan and from the United States of America concerning special problems in the field of reactor safety research. According to the cooperation in the Gesellschaft fuer Reaktorsicherheit (GRS). The list pursues the following order: Country of origin, problem area concerned, according to the Reactor Safety Research Programm of the BMFT, reporting organization. The list of reports appears quarterly. (orig.) [de

Social media in health--what are the safety concerns for health consumers?

Science.gov (United States)

Lau, Annie Y S; Gabarron, Elia; Fernandez-Luque, Luis; Armayones, Manuel

Recent literature has discussed the unintended consequences of clinical information technologies (IT) on patient safety, yet there has been little discussion about the safety concerns in the area of consumer health IT. This paper presents a range of safety concerns for consumers in social media, with a case study on YouTube. We conducted a scan of abstracts on 'quality criteria' related to YouTube. Five areas regarding the safety of YouTube for consumers were identified: (a) harmful health material targeted at consumers (such as inappropriate marketing of tobacco or direct-to-consumer drug advertising); (b) public display of unhealthy behaviour (such as people displaying self-injury behaviours or hurting others); (c) tainted public health messages (i.e. the rise of negative voices against public health messages); (d) psychological impact from accessing inappropriate, offensive or biased social media content; and (e) using social media to distort policy and research funding agendas. The examples presented should contribute to a better understanding about how to promote a safe consumption and production of social media for consumers, and an evidence-based approach to designing social media interventions for health. The potential harm associated with the use of unsafe social media content on the Internet is a major concern. More empirical and theoretical studies are needed to examine how social media influences consumer health decisions, behaviours and outcomes, and devise ways to deter the dissemination of harmful influences in social media.

LMFBR conceptual design study: an overview of environmental and safety concerns

International Nuclear Information System (INIS)

Brenchley, D.L.

1981-06-01

The US Department of Energy (DOE) initiated the Liquid Metal Fast Breeder (LMFBR) Conceptual Design Study (CDS) with the objective of maintaining a viable breeder option. The project is scheduled to be completed in FY-1981 but decisions regarding plant construction will be delayed until at least 1985. This report provides a review of the potential environmental and safety engineering concerns for the CDS and recommends specific action for the Environmental and Safety Engineering Division of DOE

LMFBR conceptual design study: an overview of environmental and safety concerns

Energy Technology Data Exchange (ETDEWEB)

Brenchley, D.L.

1981-06-01

The US Department of Energy (DOE) initiated the Liquid Metal Fast Breeder (LMFBR) Conceptual Design Study (CDS) with the objective of maintaining a viable breeder option. The project is scheduled to be completed in FY-1981 but decisions regarding plant construction will be delayed until at least 1985. This report provides a review of the potential environmental and safety engineering concerns for the CDS and recommends specific action for the Environmental and Safety Engineering Division of DOE.

21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

European consumers and beef safety

DEFF Research Database (Denmark)

Van Wezemael, Lynn; Verbeke, Wim; Kügler, Jens Oliver

2010-01-01

European beef consumption has been gradually declining during the past decades, while consumers' concerns about beef safety have increased. This paper explores consumer perceptions of and interest in beef safety and beef safety information, and their role in beef safety assessment and the beef...... consumption decision making process. Eight focus group discussions were performed with a total of 65 beef consumers in four European countries. Content analysis revealed that European consumers experienced difficulties in the assessment of the safety of beef and beef products and adopted diverging uncertainty...... reduction strategies. These include the use of colour, labels, brands and indications of origin as cues signalling beef safety. In general, consumer trust in beef safety was relatively high, despite distrust in particular actors....

Safety concerns in composite manufacturing and machining

Science.gov (United States)

Asmatulu, Eylem; Alonayni, Abdullah; Alamir, Mohammed

2018-03-01

Because of the superior properties, composites have been used in many industrial applications, including aerospace, wind turbines, ships, cars, fishing rods, storage tanks, swimming pool panels, and baseball bats. Each application may require different combinations of reinforcements and matrices, which make the manufacturing safety even more challenging while working on these substances. In this study, safety issues in composite manufacturing and machining were investigated in detail, and latest developments were provided for workers. The materials most frequently used in composite manufacturing, such as matrix (polyester, vinylester, phenolic, epoxies, methyl ethyl ketone peroxide, benzoil peroxide, hardeners, and solvents), and reinforcement materials (carbon, glass and Kevlar fibers, honeycomb and foams) can be highly toxic to human body. These materials can also be very toxic to the environment when dumped out uncontrollably, creating major future health and environmental concerns. Throughout the manufacturing process, workers inhale vapors of the liquid matrix, hardeners and solvents / thinners, as well as reinforcement materials (chopped fibers and particles) in airborne. Milling, cutting and machining of the composites can further increase the toxic inhalations of airborne composite particles, resulting in major rashes, irritation, skin disorders, coughing, severe eye and lung injury and other serious illnesses. The major portions of these hazardous materials can be controlled using appropriate personal protective equipment for the chemicals and materials used in composite manufacturing and machining. This study provides best possible safety practices utilized in composite manufacturing facilities for workers, engineers and other participants.

International Implications of Labeling Foods Containing Engineered Nanomaterials.

Science.gov (United States)

Grieger, Khara D; Hansen, Steffen Foss; Mortensen, Ninell P; Cates, Sheryl; Kowalcyk, Barbara

2016-05-01

To provide greater transparency and comprehensive information to consumers regarding their purchase choices, the European Parliament and the Council have mandated via Regulation 1169/2011 that foods containing engineered nanomaterials (ENMs) be labeled. This review covers the main concerns related to the use of ENMs in foods and the potential impacts that this type of food labeling might have on diverse stakeholder groups, including those outside the European Union (EU), e.g., in the United States. We also provide recommendations to stakeholders for overcoming existing challenges related to labeling foods containing ENMs. The revised EU food labeling requirements will likely result in a number of positive developments and a number of challenges for stakeholders in both EU and non-EU countries. Although labeling of foods containing ENMs will likely improve transparency, provide more information to facilitate consumer decisions, and build trust among food safety authorities and consumers, critical obstacles to the successful implementation of these labeling requirements remain, including the need for (i) harmonized information requirements or regulations between countries in different regions of the world, (ii) clarification of the regulatory definitions of the ENMs to be used for food labeling, (iii) robust techniques to detect, measure, and characterize diverse ENMs in food matrices, and (iv) clarification of the list of ENMs that may be exempt from labeling requirements, such as several food additives used for decades. We recommend that food industries and food safety authorities be more proactive in communicating with the public and consumer groups regarding the potential benefits and risks of using ENMs in foods. Efforts should be made to improve harmonization of information requirements between countries to avoid potential international trade barriers.

Statement on safety requirements concerning the long-term operation of the Muehleberg nuclear power station

International Nuclear Information System (INIS)

2012-12-01

This report published by the Swiss Federal Nuclear Safety Inspectorate ENSI investigates the safety requirements with respect to the long-term operation of the Muehleberg nuclear power station in Switzerland. Relevant international requirements and Swiss legal stipulations concerning the long-term operation of the power station are stated. The management of aging processes is looked at. The regular verification of the integrity of various plant components such as containments, piping, steam generation system, etc. is looked at in detail. The state-of-the-art concerning deterministic accident analyses and refitting technology are discussed, as are automated safety systems. The applicable laws, decrees and guidelines are listed in appendices

Shoe concerns and foot problems of wearers of safety footwear.

Science.gov (United States)

Marr, S J; Quine, S

1993-05-01

In Australia workers in many industries are required to wear safety footwear (footwear incorporating a steel toe cap). An investigation of the problems reported by 321 workers (70 per cent male) employed in a broad range of work activities and required to wear safety footwear was conducted in 1990 and 1991. Respondents were interviewed by a professionally trained podiatrist using a structured questionnaire followed by a foot examination. An extremely high percentage (91 per cent) of subjects reported one or more foot problems (which were verified by the podiatrist), and most considered that the safety footwear either caused the problem or adversely affected an existing foot condition. The main shoe concerns reported were excessive heat (65 per cent of all respondents), inflexible soles (52 per cent), weight (48 per cent) and pressure from steel toe cap (47 per cent). Certain gender differences were identified. General recommendations are made.

76 FR 78929 - Establishing Timeframes for Implementation of Product Safety Labeling Changes; Request for Comments

Science.gov (United States)

2011-12-20

... labeling; (2) supply chain issues; and, (3) other issues. FDA may use the information received to develop...? B. Supply Chain Issues 3. What are the supply chain factors (including storage, shipping, and..., or whether the new safety information describes a newly identified risk, or strengthens a risk...

Safety concerns us all

CERN Multimedia

SC/GS/S

2004-01-01

In spite of periodic safety inspections, risks can never be entirely excluded. The Safety Commission invites you to inform your supervisor or Territorial Safety Officer (TSO) of any hazardous situations you may be aware of. Actions to be taken following the fall of two windowpanes A few weeks ago, a windowpane fell from the third floor of an office building, causing minor damage to a car parked outside. No one was hurt in the incident. The putty holding the window in place had gradually deteriorated over time, and strong winds undoubtedly triggered the incident. A few weeks later, a sudden draft caused a window on the fifth floor of the same building to shatter and fall to the ground below. No one was hurt and there was no material damage. The incident was caused by a fan set into the opening window: as the window slammed shut, the weight of the fan caused the glass to break. What can we do to improve safety? examine the windows of our offices and workshops and report any problems or faults, such as dam...

Automated discovery of safety and efficacy concerns for joint & muscle pain relief treatments from online reviews.

Science.gov (United States)

Adams, David Z; Gruss, Richard; Abrahams, Alan S

2017-04-01

Product issues can cost companies millions in lawsuits and have devastating effects on a firm's sales, image and goodwill, especially in the era of social media. The ability for a system to detect the presence of safety and efficacy (S&E) concerns early on could not only protect consumers from injuries due to safety hazards, but could also mitigate financial damage to the manufacturer. Prior studies in the field of automated defect discovery have found industry-specific techniques appropriate to the automotive, consumer electronics, home appliance, and toy industries, but have not investigated pain relief medicines and medical devices. In this study, we focus specifically on automated discovery of S&E concerns in over-the-counter (OTC) joint and muscle pain relief remedies and devices. We select a dataset of over 32,000 records for three categories of Joint & Muscle Pain Relief treatments from Amazon's online product reviews, and train "smoke word" dictionaries which we use to score holdout reviews, for the presence of safety and efficacy issues. We also score using conventional sentiment analysis techniques. Compared to traditional sentiment analysis techniques, we found that smoke term dictionaries were better suited to detect product concerns from online consumer reviews, and significantly outperformed the sentiment analysis techniques in uncovering both efficacy and safety concerns, across all product subcategories. Our research can be applied to the healthcare and pharmaceutical industry in order to detect safety and efficacy concerns, reducing risks that consumers face using these products. These findings can be highly beneficial to improving quality assurance and management in joint and muscle pain relief. Copyright © 2017 Elsevier B.V. All rights reserved.

Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study.

NARCIS (Netherlands)

Leonardi, C.; Strober, B.; Gottlieb, A.B.; Elewski, B.E.; Ortonne, J.P.; Kerkhof, P.C.M. van de; Chiou, C.F.; Dunn, M.; Jahreis, A.

2010-01-01

BACKGROUND: In two previous phase 3 studies, up to 60 weeks of etanercept therapy significantly improved the symptoms of psoriasis and was well tolerated. OBJECTIVE: To evaluate the long-term safety of etanercept in an open-label extension study for up to 72 weeks in patients with moderate-to-severe

Engineering Hematopoietic Cells for Cancer Immunotherapy: Strategies to Address Safety and Toxicity Concerns.

Science.gov (United States)

Resetca, Diana; Neschadim, Anton; Medin, Jeffrey A

2016-09-01

Advances in cancer immunotherapies utilizing engineered hematopoietic cells have recently generated significant clinical successes. Of great promise are immunotherapies based on chimeric antigen receptor-engineered T (CAR-T) cells that are targeted toward malignant cells expressing defined tumor-associated antigens. CAR-T cells harness the effector function of the adaptive arm of the immune system and redirect it against cancer cells, overcoming the major challenges of immunotherapy, such as breaking tolerance to self-antigens and beating cancer immune system-evasion mechanisms. In early clinical trials, CAR-T cell-based therapies achieved complete and durable responses in a significant proportion of patients. Despite clinical successes and given the side effect profiles of immunotherapies based on engineered cells, potential concerns with the safety and toxicity of various therapeutic modalities remain. We discuss the concerns associated with the safety and stability of the gene delivery vehicles for cell engineering and with toxicities due to off-target and on-target, off-tumor effector functions of the engineered cells. We then overview the various strategies aimed at improving the safety of and resolving toxicities associated with cell-based immunotherapies. Integrating failsafe switches based on different suicide gene therapy systems into engineered cells engenders promising strategies toward ensuring the safety of cancer immunotherapies in the clinic.

Safety concerns for superconducting magnets of upcoming fusion experiments

International Nuclear Information System (INIS)

Turner, L.R.

1983-01-01

-Several fusion experiments being constructed (Tore Supra) or contemplated (DCT 8, Alcator DCT) feature superconducting coils. These coils introduce the following safety concerns: 1. Internally Cooled Conductor (ICC). ICC's are found to be highly stable against short heat pulses, even when the coolant is stagnant or moving at low steady-state velocity. However, a large heat pulse is certain to quench the conductor. Thus, determining the stability limits is vital. 2. Helium II Cooling. Helium II has both unique advantages as a coolant and unique safety problems. 3. Shorted Turns. In magnets with shorts from operational accidents, the current can switch back and forth between the short and the shorted turns, as those alternatively go normal and superconducting. 4. Hybrid Superconducting-Normal Conducting Coil System. The possibility of unequal currents in the different magnets and thus of unexpected forces on the superconducting magnets is much greater than for an all-superconducting system. Analysis of these problems are presented

The health and safety concerns of immigrant women workers in the Toronto sportswear industry.

Science.gov (United States)

Gannagé, C M

1999-01-01

Immigrant women's conditions of work have worsened with new government and managerial strategies to restructure the Canadian apparel industry. Changes in occupational health and safety legislation have both given and taken away tools that immigrant women workers could use to improve the quality of their working lives. The author outlines a methodology for eliciting the health and safety concerns of immigrant women workers.

The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An Open-Label, 52-Week Study.

Science.gov (United States)

Yataba, Ikuko; Otsuka, Noboru; Matsushita, Isao; Matsumoto, Hideo; Hoshino, Yuichi

2016-08-01

The newly developed S-flurbiprofen plaster (SFPP) is a tape-type patch that shows innovative percutaneous absorption. This study was designed to evaluate the safety of a long-term 52-week SFPP application to osteoarthritis (OA) patients. This was a multi-center, open-label, uncontrolled prospective study that included 201 OA patients. SFPP at 40 mg/day was applied to the site of pain in 101 patients and at 80 mg/day (2 patches) in 100 patients at a total of 301 sites for 52 weeks. The affected sites assessed included the knee (192), lumbar spine (66), cervical spine (26), and others (17). Drug safety was evaluated by medical examination, laboratory tests, and examination of vital signs. Efficacy was evaluated by the patient's and clinician's global assessments and clinical symptoms. Most patients (80.1 %) completed the 52-week SFPP application. The majority of drug-related adverse events (AEs) included mild dermatitis at the application sites and occurred in 46.8 % of the sites. No photosensitive dermatitis was observed. Systemic AEs occurred in 9.0 % of the patients; a serious AE (gastric ulcer hemorrhage) occurred in one patient. No clinically significant changes in the laboratory tests and vital signs were observed. The efficacy evaluation showed an improvement from 2 weeks after the SFPP application, which continued during the 52 weeks' treatment. No apparent safety concerns were observed, even during the long-term SFPP application. Therefore, SFPP could be an additional pharmacotherapy in OA treatment.

Reporter Concerns in 300 Mode-Related Incident Reports from NASA's Aviation Safety Reporting System

Science.gov (United States)

McGreevy, Michael W.

1996-01-01

A model has been developed which represents prominent reporter concerns expressed in the narratives of 300 mode-related incident reports from NASA's Aviation Safety Reporting System (ASRS). The model objectively quantifies the structure of concerns which persist across situations and reporters. These concerns are described and illustrated using verbatim sentences from the original narratives. Report accession numbers are included with each sentence so that concerns can be traced back to the original reports. The results also include an inventory of mode names mentioned in the narratives, and a comparison of individual and joint concerns. The method is based on a proximity-weighted co-occurrence metric and object-oriented complexity reduction.

List of reports concerning reactor safety research from BMFT, CEA, EPRI, JSTA, and USNRC

International Nuclear Information System (INIS)

1982-12-01

This list reviews reports from the Federal Republic of Germany, from France, from Japan and from the United States of America concerning special problems in the field of Reactor Safety Research. According to the cooperation of the Bundesminister fuer Forschung und Technologie (BMFT) with the Commissariat a l'Energie Atomique (CEA), the Japan Science and Technologie Agency (JSTA), the Electric Power Research Institute (EPRI) and the United States Nuclear Regulatory Commission, these Reports are available in the Gesellschaft fuer Reaktorsicherheit (GRS). The list pursues the following order: Country of origin, problem area concerned, according to the Reactor Safety Research Programm of the BMFT, reporting organization. The list of reports appears quarterly. (orig./HP) [de

Soil Fumigant Labels - Dazomet

Science.gov (United States)

Updated labels include new safety requirements for buffer zones and related measures. Find information from the Pesticide Product Labeling System (PPLS) for products such as Basamid G, manufactured by Amvac.

Na-Al silicates in washing agents. Synthesis and analysis of labelled sodium aluminium silicate for an investigation of the environmental behaviour of SASIL

Energy Technology Data Exchange (ETDEWEB)

Graffmann, G; Roland, W A; Schmid, R D; Smolka, H G [Henkel K.G.a.A., Duesseldorf (Germany, F.R.); Schneider, J; Vogg, H [Kernforschungszentrum Karlsruhe G.m.b.H. (Germany, F.R.). Lab. fuer Isotopentechnik

1979-04-01

The evaluation of the human and environmental safety of the phosphate substitute SASIL made it necessary to develop methods for the preparation and analysis of labeled SASIL. Indium and Chromium-51 proved to be useful labeling elements. Labeled SASIL in environmental-, laboratory- and technical samples was detected by neutron activation analysis, ..gamma..-scintillation counting and X-ray fluorescence. Using these methods, important questions concerning the environmental behaviour of SASIL could be answered.

Guideline for examination concerning the evaluation of safety in light water power reactor installations

International Nuclear Information System (INIS)

1978-01-01

This guideline was drawn up as the guide for examination when the safety evaluation of nuclear reactors is carried out at the time of approving the installation of light water power reactors. Accordingly in case of the examination of safety, it must be confirmed that the contents of application are in conformity with this guideline. If they are in conformity, it is judged that the safety evaluation of the policy in the basic design of a reactor facility is adequate, and also that the evaluation concerning the separation from the public in surroundings is adequate as the condition of location of the reactor facility. This guideline is concerned with light water power reactors now in use, but the basic concept may be the reference for the examination of the other types of reactors. If such a case occurs that the safety evaluation does not conform to this guideline, it is not excluded when the appropriate reason is clarified. The purpose of safety evaluation, the scope to be evaluated, the selection of the events to be evaluated, the criteria for judgement, the matters taken into consideration at the time of analysis, the concrete events of abnormal transient change and accident in operation, and the concrete events of serious accident and hypothetic accident are stipulated. The explanation and two appendices are attached. (Kako, I.)

Soil Fumigant Labels - Methyl Bromide

Science.gov (United States)

Search soil fumigant pesticide labels by EPA registration number, product name, or company, and follow the link to The Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.

ED accreditation update. Physicians, medical staff may report safety concerns without fear of disciplinary action.

Science.gov (United States)

2007-11-01

Educating your staff about The Joint Commission's requirements for concerns about hospital safety and quality of care requires the ED manager to set a tone of openness and cooperation, while at the same time emphasizing your department's role in addressing such concerns: * The ED should be the first place that staff members communicate quality and safety concerns. It is only when a problem is not addressed that they should take the issue to hospital administration and, if necessary, The Joint Commission. * A single event should not trigger a report to The Joint Commission, unless it is unusually serious. Otherwise, only a series of events should trigger a report. * Reassure your staff that you care about what is reported and will act quickly on it. Educate your staff about the reporting forms, and follow up with random audits to ensure compliance.

Summary of Tiger Team Assessment and Technical Safety Appraisal recurring concerns in the Maintenance Area

International Nuclear Information System (INIS)

1993-01-01

Tiger Team Assessments and Technical Safety Appraisals (TSA) were reviewed and evaluated for concerns in the Maintenance Area (MA). Two hundred and thirty one (231) maintenance concerns were identified by the Tiger Team Assessments and TSA reports. These recurring concerns appear below. A summary of the Noteworthy Practices that were identified and a compilation of the maintenance concerns for each performance objective that were not considered as recurring are also included. Where the Tiger Team Assessment and TSA identified the operating contractor or facility by name, the concern has been modified to remove the name while retaining the intent of the comment

Physician attitudes towards pharmacological cognitive enhancement: safety concerns are paramount.

Directory of Open Access Journals (Sweden)

Opeyemi C Banjo

2010-12-01

Full Text Available The ethical dimensions of pharmacological cognitive enhancement have been widely discussed in academic circles and the popular media, but missing from the conversation have been the perspectives of physicians - key decision makers in the adoption of new technologies into medical practice. We queried primary care physicians in major urban centers in Canada and the United States with the aim of understanding their attitudes towards cognitive enhancement. Our primary hypothesis was that physicians would be more comfortable prescribing cognitive enhancers to older patients than to young adults. Physicians were presented with a hypothetical pharmaceutical cognitive enhancer that had been approved by the regulatory authorities for use in healthy adults, and was characterized as being safe, effective, and without significant adverse side effects. Respondents overwhelmingly reported increasing comfort with prescribing cognitive enhancers as the patient age increased from 25 to 65. When asked about their comfort with prescribing extant drugs that might be considered enhancements (sildenafil, modafinil, and methylphenidate or our hypothetical cognitive enhancer to a normal, healthy 40 year old, physicians were more comfortable prescribing sildenafil than any of the other three agents. When queried as to the reasons they answered as they did, the most prominent concerns physicians expressed were issues of safety that were not offset by the benefit afforded the individual, even in the face of explicit safety claims. Moreover, many physicians indicated that they viewed safety claims with considerable skepticism. It has become routine for safety to be raised and summarily dismissed as an issue in the debate over pharmacological cognitive enhancement; the observation that physicians were so skeptical in the face of explicit safety claims suggests that such a conclusion may be premature. Thus, physician attitudes suggest that greater weight be placed upon the

76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

Science.gov (United States)

2011-04-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

Soil Fumigant Labels - Chloropicrin

Science.gov (United States)

Search by EPA registration number, product name, or company name, and follow the link to the Pesticide Product Label System (PPLS) for details on each fumigant. Updated labels include new safety requirements for buffer zones and related measures.

Soil Fumigant Labels - Dimethyl Disulfide (DMDS)

Science.gov (United States)

Search by EPA registration number, product name, or company and follow the link to the Pesticide Product Labeling System (PPLS) for label details. Updated labels include new safety requirements for buffer zones and related measures.

International Implications of Labeling Foods Containing Engineered Nanomaterials

DEFF Research Database (Denmark)

Grieger, Khara D.; Hansen, Steffen Foss; Mortensen, Ninell P.

2016-01-01

To provide greater transparency and comprehensive information to consumers regarding their purchase choices, the European Parliament and the Council have mandated via Regulation 1169/2011 that foods containing engineered nanomaterials (ENMs) be labeled. This review covers the main concerns related...... additives used for decades. We recommend that food industries and food safety authorities be more proactive in communicating with the public and consumer groups regarding the potential benefits and risks of using ENMs in foods. Efforts should be made to improve harmonization of information requirements...... between countries to avoid potential international trade barriers....

Ordinance of 14 March 1983 concerning the Federal Commission for the Safety of Nuclear Installations

International Nuclear Information System (INIS)

1983-01-01

The Frederal Council issued a new Ordinance concerning the Federal Commission for the Safety of Nuclear Installations. This Ordinance replaces an Ordinance of 13 June 1960 and takes into account the distribution of tasks decided several years ago between the Commission, which operates on a part-time basis, and the principal Division for the Safety of Nuclear Installations attached to the Federal Office of Energy. (NEA) [fr

Safety assessments and public concern for genetically modified food products: the American view.

Science.gov (United States)

Harlander, Susan K

2002-01-01

In the relatively short time since their commercial introduction in 1996, genetically modified (GM) crops have been rapidly adopted in the United States GM crops are regulated through a coordinated framework developed in 1992 and administered by three agencies-the US Department of Agriculture (USDA) that ensures the products are safe to grow, the Environmental Protection Agency (EPA) that ensures the products are safe for the environment, and the Food and Drug Administration (FDA) that ensures the products are safe to eat. Rigorous food and environmental safety assessments must be completed before GM crops can be commercialized. Fifty-one products have been reviewed by the FDA, including several varieties of corn, soybeans, canola, cotton, rice, sugar beets, potatoes, tomatoes, squash, papaya, and flax. Because FDA considers these crops "substantially equivalent" to their conventional counterparts, no special labeling is required for GM crops in the United States and they are managed as commodities with no segregation or identity preservation. GM crops have thus made their way through commodity distribution channels into thousands of ingredients used in processed foods. It has been estimated that 70% to 85% of processed foods on supermarket shelves in the United States today contain one or more ingredients potentially derived from GM crops. The food industry and retail industry have been monitoring the opinions of their consumers on the GM issue for the past several years. Numerous independent groups have also surveyed consumer concerns about GM foods. The results of these surveys are shared and discussed here.

Report on the handling of safety information concerning flammable gases and ferrocyanide at the Hanford waste tanks

International Nuclear Information System (INIS)

1990-07-01

This report discusses concerns safety issues, and management at Hanford Tank Farm. Concerns center on the issue of flammable gas generation which could ignite, and on possible exothermic reactions of ferrocyanide compounds which were added to single shell tanks in the 1950's. It is believed that information concerning these issues has been mis-handled and the problems poorly managed

Report on the handling of safety information concerning flammable gases and ferrocyanide at the Hanford waste tanks

Energy Technology Data Exchange (ETDEWEB)

1990-07-01

This report discusses concerns safety issues, and management at Hanford Tank Farm. Concerns center on the issue of flammable gas generation which could ignite, and on possible exothermic reactions of ferrocyanide compounds which were added to single shell tanks in the 1950's. It is believed that information concerning these issues has been mis-handled and the problems poorly managed. (CBS)

Green fluorescent protein labeling of Listeria, Salmonella, and Escherichia coli O157:H7 for safety-related studies.

Directory of Open Access Journals (Sweden)

Li Ma

Full Text Available Many food safety-related studies require tracking of introduced foodborne pathogens to monitor their fate in complex environments. The green fluorescent protein (GFP gene (gfp provides an easily detectable phenotype so has been used to label many microorganisms for ecological studies. The objectives of this study were to label major foodborne pathogens and related bacteria, including Listeria monocytogenes, Listeria innocua, Salmonella, and Escherichia coli O157:H7 strains, with GFP and characterize the labeled strains for stability of the GFP plasmid and the plasmid's effect on bacterial growth. GFP plasmids were introduced into these strains by a CaCl(2 procedure, conjugation or electroporation. Stability of the label was determined through sequential propagation of labeled strains in the absence of selective pressure, and rates of plasmid-loss were calculated. Stability of the GFP plasmid varied among the labeled species and strains, with the most stable GFP label observed in E. coli O157:H7. When grown in nonselective media for two consecutive subcultures (ca. 20 generations, the rates of plasmid loss among labeled E. coli O157:H7, Salmonella and Listeria strains ranged from 0%-30%, 15.8%-99.9% and 8.1%-93.4%, respectively. Complete loss (>99.99% of the plasmid occurred in some labeled strains after five consecutive subcultures in the absence of selective pressure, whereas it remained stable in others. The GFP plasmid had an insignificant effect on growth of most labeled strains. E. coli O157:H7, Salmonella and Listeria strains can be effectively labeled with the GFP plasmid which can be stable in some isolates for many generations without adversely affecting growth rates.

Patient identification and tube labelling

DEFF Research Database (Denmark)

van Dongen-Lases, Edmée C; Cornes, Michael P; Grankvist, Kjell

2016-01-01

of phlebotomy procedures with the CLSI H3-A6 guideline was unacceptably low, and that patient identification and tube labelling are amongst the most critical steps in need of immediate attention and improvement. The process of patient identification and tube labelling is an essential safety barrier to prevent...... patient identity mix-up. Therefore, the EFLM Working Group aims to encourage and support worldwide harmonisation of patient identification and tube labelling procedures in order to reduce the risk of preanalytical errors and improve patient safety. With this Position paper we wish to raise awareness...... and provide recommendations for proper patient and sample identification procedures....

Occupational Safety and Health Concerns in Logging: A Cross-Sectional Assessment in Virginia

Directory of Open Access Journals (Sweden)

Sunwook Kim

2017-11-01

Full Text Available Increased logging mechanization has helped improve logging safety and health, yet related safety risks and concerns are not well understood. A cross-sectional study was completed among Virginia loggers. Participants (n = 122 completed a self-administered questionnaire focusing on aspects of safety and health related to logging equipment. Respondents were at a high risk of workplace injuries, with reported career and 12-month injury prevalences of 51% and 14%, respectively. Further, nearly all (98% respondents reported experiencing musculoskeletal symptoms. Over half (57.4% of respondents reported symptoms related to diesel exhaust exposure in their career. Few (15.6%, however, perceived their jobs to be dangerous. Based on the opinions and suggestions of respondents, three priority areas were identified for interventions: struck-by/against hazards, situational awareness (SA during logging operations, and visibility hazards. To address these hazards, and to have a broader and more substantial positive impact on safety and health, we discuss the need for proactive approaches such as incorporating proximity technologies in a logging machine or personal equipment, and enhancing logging machine design to enhance safety, ergonomics, and SA.

Enacting laws concerning radiation safety management for students using X-rays and electron beams under 1 MeV

International Nuclear Information System (INIS)

Nishizawa, Kunihide; Shibata, Michihiro; Saze, Takuya

2004-01-01

Laws concerning radiation safety management were analyzed from the point of view of defining precisely what is meant by radiation and what is meant by the subject. There are no laws to protect students from radiation hazards when using X-rays and electron beams under 1 MeV for research and/or education. The Law concerning Technical Standards for Preventing Radiation Hazards gives the authorities the power to enact new rules and regulations that will protect the students. The Radiation Council must take charge for enactment of all laws regarding radiation safety management. (author)

ENSI’s synopsis concerning the enhancement of safety margins; Zusammenfassung des ENSI zur Erhöhung der Sicherheitsmargen

Energy Technology Data Exchange (ETDEWEB)

NONE

2015-06-15

This press release issued by the Swiss Federal Nuclear Safety Inspectorate ENSI discusses the results of its probabilistic safety analysis on the safety margins for Swiss nuclear power stations that was made after the Fukushima nuclear accident. External incidents such as earthquakes and flooding and their impact on the power stations are analysed by the ERSIM project concerning the enhancement of safety margins. Three shut-down scenarios are discussed. The safety margins with respect to earthquakes and flooding for all four nuclear power station sites are discussed in detail.

Factors to Consider When Balancing Campus Safety Concerns with Students' Civil Rights

Science.gov (United States)

Ingersoll, Julia S.

2017-01-01

On April 16, 2007, a student at Virginia Tech University, known to be mentally ill, went on a rampage shooting 49 people on campus before taking his own life. When it was over, 32 people were dead, and the concept of a safe campus was forever changed. The incident revealed the inherent conflicts between campus safety concerns and students' civil…

Genetically Modified Food Labeling in China: In Pursuit of a Rational Path.

Science.gov (United States)

Zhu, Xiao; Roberts, Michael T; Wu, Kaijie

2016-08-01

Facing a tension between the increasing use of genetically engineered or modified food and consumer concerns over the risks associated with GMOs, China has established a GM food labeling regime through regulations-known as Agro-GMO regulations-to protect consumers' right to know. However, the design and enforcement of this GM food labeling regime is problematic. As a result, the labeling regime is ineffective and inconsistent, leaving consumers' rights unprotected. As the recently amended Food Safety Law in China requires GM food labeling for the first time, this article argues that China should replace the current Agro-GMO food labeling scheme with a special regulatory scheme. A comparative analysis of the GM food labeling systems in the European Union and United States, coupled with a rigorous examination of the problems and barriers of GM food labeling in China, sets a solid foundation by which to propose changes to incorporate into a special regulatory scheme. To this end, this article engages in such an analysis and recommends practical steps to guide the enactment of a special regulatory scheme. The recommendations comport with China's unique legal and political culture, but also could be used by other national regulatory regimes who permit use of GM food while also being committed to improving consumers' right to know.

Adverse drug reaction labelling for atomoxetine, methylphenidate and modafinil

DEFF Research Database (Denmark)

Aagaard, Lise; Hansen, Ebba Holme

2013-01-01

Medical product information contains information about efficacy and safety for marketed pharmaceuticals. Three studies have compared safety labelling for different therapeutic categories in different countries and detected large variations in a number of reported adverse drug reactions (ADRs......). The rapid increase in use of medications for treatment of ADHD symptoms has created concern due to lack of information about effects from long-term use. The aim of this study was to compare ADR information in product information (PI)/summary of product characteristics (SPC) for oral formulations...... of atomoxetine, methylphenidate and modafinil marketed by the same pharmaceutical companies in Australia, Denmark and the United States. Discrepancies in listed ADRs were defined as types of ADRs (system organ class) not listed in all countries. For ADRs where discrepancies were detected, we extracted...

The root cause of patient safety concerns in an Internet pharmacy.

Science.gov (United States)

Montoya, Isaac D

2008-07-01

The Internet has become a revolutionary technology that affords worldwide opportunities never seen before. One such opportunity is the purchase of drugs over the Internet and the business of Internet pharmacies which has become prolific. Associated with this proliferation is the concern for patient safety. Numerous studies have shown that drugs purchased over the Internet come from pharmacies in a country other than the one where the patient resides and these pharmacies are not licensed, sometimes provide drugs without a prescription and that are not of the same composition as they should be, and do not provide adequate directions to the patient. In addition, the packaging of the drugs may be compromised resulting in altered medication. This paper examines the root cause of patient safety issues in Internet pharmacies. A review of the literature including the marketing literature was conducted. Healthcare marketing concepts guide business owners to identify patients' wants and distinguish them from their needs. Marketing principles detail aggressive marketing strategies within an organization's mission and in an ethical manner. Some Internet pharmacies misinterpret proven marketing principles and become overly aggressive in the market place focusing only on sales and profit rather than focusing on patient safety and long-term success of the Internet pharmacy.

Soil Fumigant Labels - Metam Sodium/Potassium

Science.gov (United States)

Search by EPA registration number, product name, or company; and follow the link to the Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.

Off-label biologic regimens in psoriasis: a systematic review of efficacy and safety of dose escalation, reduction, and interrupted biologic therapy.

Directory of Open Access Journals (Sweden)

Elizabeth A Brezinski

Full Text Available OBJECTIVES: While off-label dosing of biologic treatments may be necessary in selected psoriasis patients, no systematic review exists to date that synthesizes the efficacy and safety of these off-label dosing regimens. The aim of this systematic review is to evaluate efficacy and safety of off-label dosing regimens (dose escalation, dose reduction, and interrupted treatment with etanercept, adalimumab, infliximab, ustekinumab, and alefacept for psoriasis treatment. DATA SOURCES AND STUDY SELECTION: We searched OVID Medline from January 1, 1990 through August 1, 2011 for prospective clinical trials that studied biologic therapy for psoriasis treatment in adults. Individual articles were screened for studies that examined escalated, reduced, or interrupted therapy with etanercept, adalimumab, infliximab, ustekinumab, or alefacept. DATA SYNTHESIS: A total of 23 articles with 12,617 patients matched the inclusion and exclusion criteria for the systematic review. Data were examined for primary and secondary efficacy outcomes and adverse events including infections, malignancies, cardiovascular events, and anti-drug antibodies. The preponderance of data suggests that continuous treatment with anti-TNF agents and anti-IL12/23 agent was necessary for maintenance of disease control. Among non-responders, dose escalation with etanercept, adalimumab, ustekinumab, and alefacept typically resulted in greater efficacy than standard dosing. Dose reduction with etanercept and alefacept resulted in reduced efficacy. Withdrawal of the examined biologics led to an increase in disease activity; efficacy from retreatment did not result in equivalent initial response rates for most biologics. Safety data on off-label dosing regimens are limited. CONCLUSION: Dose escalation in non-responders generally resulted in increased efficacy in the examined biologics used to treat moderate-to-severe psoriasis. Continuous treatment with anti-TNF agents and anti-IL12/23 agent

Consumer Choices and Motives for Eco-Labeled Products in China: An Empirical Analysis Based on the Choice Experiment

Directory of Open Access Journals (Sweden)

Qing Liu

2017-02-01

Full Text Available Based on choice experiments conducted via face-to-face interviews with 435 participants in four provincial areas of China (Shanghai, Zhejiang, Jiangsu, and Guangdong, Chinese consumers’ preferences and motives for purchasing eco-labeled rice are examined in this study. The heterogeneous effects of each motivating channel are also investigated. The results reveal positive correlations between premiums for eco-labeled rice and consumers’ concerns about food safety and the environment, suggesting that health benefits and environmental considerations are the two critical motivations. The willingness to pay for eco-labeled rice does not increase with consumers’ knowledge of the different production standards indicated by each eco-label. Individual characteristics that determine each class are further explored through a seemingly irrelevant regression to identify the target group of consumers for policy-makers.

Parental safety concerns--a barrier to sport and physical activity in children?

Science.gov (United States)

Boufous, Soufiane; Finch, Caroline; Bauman, Adrian

2004-10-01

To examine the extent to which parents and carers perceive injury and safety risks as serious enough to prevent or discourage their children, aged 5-12 years, from participating in sports/physical activity and to identify factors that influence these perceptions. An analysis of the 2001 New South Wales Child Health Survey. More than one-quarter of parents/ carers of active children aged 5-12 years reported discouraging or preventing children from playing a particular sport (34.7% for boys and 16.6% for girls) because of injury and safety concerns. In boys, the most frequently discouraged sport was rugby league (23.2%), followed by rugby union (7.5%) and Australian rules football (2.8%). Among girls, the most frequently discouraged activities were rollerblading (2.7%), rugby league (2.3%) and soccer (2.1%). Multivariate analysis shows that factors independently associated with parents' decision to prevent/discourage their child from engaging in sport/physical activity include their child's age and gender, language spoken at home, presence of disability, and the respondent's relation to the child. Efforts need to be made to modify some sports/ activities, such as football codes, in order to minimise injury and to ensure that children continue enjoying their favourite activity well into adulthood. Guidelines designed to promote physical activity among children and young adolescents need to take into account parental concerns regarding the associated risk of injury.

Safety of Repeated Open-Label Treatment Courses of Intravenous Ofatumumab, a Human Anti-CD20 Monoclonal Antibody, in Rheumatoid Arthritis

DEFF Research Database (Denmark)

Quattrocchi, Emilia; Ostergaard, Mikkel; Taylor, Peter C.

2016-01-01

Objectives To investigate the safety of ofatumumab retreatment in rheumatoid arthritis. Methods Patients with active rheumatoid arthritis participating in two phase III trials (OFA110635 and OFA110634) and a phase II extension trial (OFA111752) received individualised open-label ofatumumab retrea...

Consumer preferences for food allergen labeling.

Science.gov (United States)

Marra, Carlo A; Harvard, Stephanie; Grubisic, Maja; Galo, Jessica; Clarke, Ann; Elliott, Susan; Lynd, Larry D

2017-01-01

Food allergen labeling is an important tool to reduce risk of exposure and prevent anaphylaxis for individuals with food allergies. Health Canada released a Canadian food allergen labeling regulation (2008) and subsequent update (2012) suggesting that research is needed to guide further iterations of the regulation to improve food allergen labeling and reduce risk of exposure. The primary objective of this study was to examine consumer preferences in food labeling for allergy avoidance and anaphylaxis prevention. A secondary objective was to identify whether different subgroups within the consumer population emerged. A discrete choice experiment using a fractional factorial design divided into ten different versions with 18 choice-sets per version was developed to examine consumer preferences for different attributes of food labeling. Three distinct subgroups of Canadian consumers with different allergen considerations and food allergen labeling needs were identified. Overall, preferences for standardized precautionary and safety symbols at little or no increased cost emerged. While three distinct groups with different preferences were identified, in general the results revealed that the current Canadian food allergen labeling regulation can be improved by enforcing the use of standardized precautionary and safety symbols and educating the public on the use of these symbols.

Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients

NARCIS (Netherlands)

Kroes, R.; Renwick, A.G.; Feron, V.; Galli, C.L.; Gibney, M.; Greim, H.; Guy, R.H.; Lhuguenot, J.C.; Sandt, J.J.M. van de

2007-01-01

The threshold of toxicological concern (TTC) has been used for the safety assessment of packaging migrants and flavouring agents that occur in food. The approach compares the estimated oral intake with a TTC value derived from chronic oral toxicity data for structurally-related compounds.

76 FR 37291 - Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Correction

Science.gov (United States)

2011-06-27

.... FDA-2011-F-0171] Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Correction... certain articles of food sold from vending machines. The document published with several errors including... FURTHER INFORMATION CONTACT: Daniel Y. Reese, Center for Food Safety and Applied Nutrition (HFS-820), Food...

Who was concerned about radiation, food safety, and natural disasters after the great East Japan earthquake and Fukushima catastrophe? A nationwide cross-sectional survey in 2012.

Science.gov (United States)

Sugimoto, Takashi; Shinozaki, Tomohiro; Naruse, Takashi; Miyamoto, Yuki

2014-01-01

Disaster-related concerns by sub-populations have not been clarified after the great East Japan earthquake and the Fukushima nuclear power plant incidents. This paper assesses who was concerned about radiation, food safety, and natural disasters among the general population in order to buffer such concerns effectively. The hypothesis that women, parents, and family caregivers were most concerned about radiation, food safety, and natural disaster was tested using a varying-intercept multivariable logistic regression with 5809 responses from a nationwide cross-sectional survey random-sampled in March 2012. Many people were at least occasionally concerned about radiation (53.5%), food safety (47.3%), and about natural disaster (69.5%). Women were more concerned than men about radiation (OR = 1.67; 95% CI = 1.35-2.06), food safety (1.70; 1.38-2.10), and natural disasters (1.74; 1.39-2.19). Parents and family care needs were not significant. Married couples were more concerned about radiation (1.53; 1.33-1.77), food safety (1.38; 1.20-1.59), and natural disasters (1.30; 1.12-1.52). Age, child-cohabitation, college-completion, retirement status, homemaker status, and the house-damage certificate of the last disaster were also associated with at least one concern. Participants from the Kanto region were more concerned about radiation (2.08; 1.58-2.74) and food safety (1.30; 1.07-1.59), which demonstrate similar positive associations to participants from Tohoku where a disaster relief act was invoked (3.36; 2.25-5.01 about radiation, 1.49; 1.08-2.06 about food safety). Sectioning the populations by gender and other demographics will clarify prospective targets for interventions, allow for a better understanding of post-disaster concerns, and help communicate relevant information effectively.

Who was concerned about radiation, food safety, and natural disasters after the great East Japan earthquake and Fukushima catastrophe? A nationwide cross-sectional survey in 2012.

Directory of Open Access Journals (Sweden)

Takashi Sugimoto

Full Text Available BACKGROUND: Disaster-related concerns by sub-populations have not been clarified after the great East Japan earthquake and the Fukushima nuclear power plant incidents. This paper assesses who was concerned about radiation, food safety, and natural disasters among the general population in order to buffer such concerns effectively. METHODS: The hypothesis that women, parents, and family caregivers were most concerned about radiation, food safety, and natural disaster was tested using a varying-intercept multivariable logistic regression with 5809 responses from a nationwide cross-sectional survey random-sampled in March 2012. RESULTS: Many people were at least occasionally concerned about radiation (53.5%, food safety (47.3%, and about natural disaster (69.5%. Women were more concerned than men about radiation (OR = 1.67; 95% CI = 1.35-2.06, food safety (1.70; 1.38-2.10, and natural disasters (1.74; 1.39-2.19. Parents and family care needs were not significant. Married couples were more concerned about radiation (1.53; 1.33-1.77, food safety (1.38; 1.20-1.59, and natural disasters (1.30; 1.12-1.52. Age, child-cohabitation, college-completion, retirement status, homemaker status, and the house-damage certificate of the last disaster were also associated with at least one concern. Participants from the Kanto region were more concerned about radiation (2.08; 1.58-2.74 and food safety (1.30; 1.07-1.59, which demonstrate similar positive associations to participants from Tohoku where a disaster relief act was invoked (3.36; 2.25-5.01 about radiation, 1.49; 1.08-2.06 about food safety. CONCLUSIONS: Sectioning the populations by gender and other demographics will clarify prospective targets for interventions, allow for a better understanding of post-disaster concerns, and help communicate relevant information effectively.

Figuring Out Food Labels (For Kids)

Science.gov (United States)

... First Aid & Safety Doctors & Hospitals Videos Recipes for Kids Kids site Sitio para niños How the Body Works ... English Español Figuring Out Food Labels KidsHealth / For Kids / Figuring Out Food Labels What's in this article? ...

Biosimilars: From Extrapolation into Off Label Use.

Science.gov (United States)

Zhao, Sizheng; Nair, Jagdish R; Moots, Robert J

2017-01-01

Biologic drugs have revolutionised the management of many inflammatory conditions. Patent expirations have stimulated development of highly similar but non-identical molecules, the biosimilars. Extrapolation of indications is a key concept in the development of biosimilars. However, this has been met with concerns around mechanisms of action, equivalence in efficacy and immunogenicity, which are reviewed in this article. Narrative overview composed from literature search and the authors' experience. Literature search included Pubmed, Web of Science, and online document archives of the Food and Drug Administration and European Medicines Agency. The concepts of biosimilarity and extrapolation of indications are revisited. Concerns around extrapolation are exemplified using the biosimilar infliximab, CT-P13, focusing on mechanisms of action, immunogenicity and trial design. The opportunities and cautions for using biologics and biosimilars in unlicensed inflammatory conditions are reviewed. Biosimilars offer many potential opportunities in improving treatment access and increasing treatment options. The high cost associated with marketing approval means that many bio-originators may never become licenced for rarer inflammatory conditions, despite clinical efficacy. Biosimilars, with lower acquisition cost, may improve access for off-label use of biologics in the management of these patients. They may also provide opportunities to explore off-label treatment of conditions where biologic therapy is less established. However, this potential advantage must be balanced with the awareness that off-label prescribing can potentially expose patients to risky and ineffective treatments. Post-marketing surveillance is critical to developing long-term evidence to provide assurances on efficacy as well as safety. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Posiva's application for a decision in principle concerning a disposal facility for spent nuclear fuel. STUK's statement and preliminary safety appraisal

International Nuclear Information System (INIS)

Ruokola, E.

2000-03-01

In May 1999, Posiva Ltd submitted to the Government an application, pursuant to the Nuclear Energy Act, for a Decision in Principle on a disposal facility for spent nuclear fuel from the Finnish nuclear power plants. The Ministry of Trade and Industry requested the Radiation and Nuclear Safety Authority (STUK) to draw up a preliminary safety appraisal concerning the proposed disposal facility. In the beginning of this report, STUK's statement to the Ministry and Industry concerning the proposed disposal facility is given. In that statement, STUK concludes that the Decision in Principle is currently justified from the standpoint of safety. The statement is followed by a safety appraisal, where STUK deems, how the proposed disposal concept, site and facility comply with the safety requirements included in the Government's Decision (478/1999). STUK's preliminary safety appraisal was supported by contributions from a number of outside experts. A collective opinion by an international group of ten distinguished experts is appended to this report. (orig.)

Discussion on posting and labeling for radioprotection

International Nuclear Information System (INIS)

Suzuki, Fabio F.

2009-01-01

The radioprotection aims the protection of people against exposure to ionizing radiation or radioactive substances as well as the safety of radiation sources. As ionizing radiation is not perceived by human senses, the warning signs and labels on radiation sources and the safety posters in controlled and supervised areas have an important role to keep the doses and risks as low as reasonably achievable, to prevent radiological accidents and to mitigate their consequences. In Brazil, several technical regulations require such safety labels and posters, however, despite their importance, there is quite few guidance about their format or contents. In this paper the posting and labeling requirements for radiological control existing in Brazilian technical regulations are discussed, confronting them with national, foreign and international technical standards and by drawing up a parallel with requirements of technical regulations from other countries. Changes are suggested in some parts of the national regulations, to prevent some differences in the current guidance, allowing the optimization of posting and labeling programs of radiological facilities. (author)

Nuclear safety. Concerns about the nuclear power reactors in Cuba

International Nuclear Information System (INIS)

Wells, Jim; Aloise, Gene; Flaherty, Thomas J.; Fitzgerald, Duane; Zavala, Mario; Hayward, Mary Alice

1992-09-01

the atmosphere, contains defective welds. Another said that reactor operator trainees have received training on inadequate reactor simulators. In contrast, a representative of the Cuban government told us that Cuba wants to build its reactor in accordance with safety standards. Also, according to information provided to us by a representative of the Russian government, Cuba's reactor has been constructed according to safety rules that take into account, among other things, the possible impacts of an earthquake. State Department, NRC, and DOE officials have expressed a number of concerns about the construction and operation of Cuba's nuclear power reactors. According to State Department officials, the United States maintains a comprehensive embargo on any U.S. transactions with Cuba and discourages other countries from providing assistance, except for safety purposes, to Cuba's nuclear power program. The United States would prefer that the construction of the reactors never be completed and wants Cuba to sign the Non-Proliferation Treaty or the Treaty of Tlatelolco, both of which bind signatories to blanket nonproliferation commitments for their entire nuclear program, before the United States considers reversing its policy of discouraging other countries from assisting Cuba with the construction of the reactors. The United States has asked Russia to cease providing any nuclear assistance until Cuba has signed either treaty. NRC officials are aware of, but could not verify, the Cuban emigres' allegations of safety deficiencies because available information was limited. They said, however, that if the allegations were true, the cited deficiencies could affect the safety of the reactors operation. In addition, they expressed concern about the ability of Cuba's industrial infrastructure to support the nuclear power reactors, the lack of a regulatory structure, the adequacy of training for reactor operators, the quality of the civil construction, and the design of the

What Drives Adoption of National Labels as Global Reference Labels? A Case Study With the JPI.

Science.gov (United States)

Yoshida, Shimon; Matsui, Rie; Kikuchi, Chikara

2018-01-01

Pharmaceutical labeling describes the safe and effective use of an approved product. Such information may be provided to consumers and/or health care physicians, and available online or in the pack in a variety of different formats according to local or regional regulations. Depending on the Health Authority (HA), content within a nationally approved label is generally reliant on two primary sources, a Company Core Data Sheet (CCDS), and the text approved by the Health Authority. Content in the nationally approved label may differ from the CCDS for a variety of reasons. In some countries, HAs require the Marketing Authorization Holder (MAH) to base their national label on an already approved label in a "major market" economy, only approving changes to the label when there is evidence that the major market has already approved. In this paper, we examine recent steps taken by the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) to change labeling regulation in Japan in the context of the recently communicated national strategy, and assess whether this may impact on uptake of the J-PI as a reference label. Decreases in approval times by PMDA for new products, development of basic principles on multiregional clinical trials, greater transparency of content on the PMDA website, and increasing outreach to other Asian Agencies in recent years are highlighted. Labeling harmonization across regions, particularly of safety-related information, represents a key factor in promoting patient safety and risk communication, and is a worthy topic for future ICH consideration.

What determines consumer attention to nutrition labels?

NARCIS (Netherlands)

Bialkova, S.E.; Trijp, van J.C.M.

2010-01-01

To identify the key determinants of consumer attention to nutrition labels, visual search tasks (present – absent; one – two targets) were used as an effective experimental tool. The main manipulation concerned: set size (number of labels on front of pack); label characteristics (display size,

Health and safety concerns of textiles with nanomaterials

Science.gov (United States)

Almeida, L.; Ramos, D.

2017-10-01

There is a growing concern related to the effects of nanomaterials in health and safety.Nanotechnologies are already present in many consumer products, including textiles. “Nanotextiles” can be considered as traditional textiles with the incorporation of nanoparticles. They present often functionalities such as antibacterial, ultraviolet radiation protection, water and dirt repellency, self-cleaning or flame retardancy. Nanoparticles can be released from the textile materials due to different effects (abrasion and other mechanical stresses, sweat, irradiation, washing, temperature changes, etc.). It is then expectable that “nanotextiles” may release individual nanoparticles, agglomerates of nanoparticles or small particles of textile with or without nanoparticles, depending on the type of integration of the nanoparticles in textiles. The most important exposure route of the human body to nanoparticles in case of textiles is skin contact. Several standards are being developed under the auspices of the European Committee for Standardization. In this paper, it is presented the development and application of a test method to evaluate the skin exposure to nanoparticles, to evaluate the transfer of the nanoparticles from the textile to the skin by the effect of abrasion and sweat.

Parental concern about vaccine safety in Canadian children partially immunized at age 2: a multivariable model including system level factors.

Science.gov (United States)

MacDonald, Shannon E; Schopflocher, Donald P; Vaudry, Wendy

2014-01-01

Children who begin but do not fully complete the recommended series of childhood vaccines by 2 y of age are a much larger group than those who receive no vaccines. While parents who refuse all vaccines typically express concern about vaccine safety, it is critical to determine what influences parents of 'partially' immunized children. This case-control study examined whether parental concern about vaccine safety was responsible for partial immunization, and whether other personal or system-level factors played an important role. A random sample of parents of partially and completely immunized 2 y old children were selected from a Canadian regional immunization registry and completed a postal survey assessing various personal and system-level factors. Unadjusted odds ratios (OR) and adjusted ORs (aOR) were calculated with logistic regression. While vaccine safety concern was associated with partial immunization (OR 7.338, 95% CI 4.138-13.012), other variables were more strongly associated and reduced the strength of the relationship between concern and partial immunization in multivariable analysis (aOR 2.829, 95% CI 1.151-6.957). Other important factors included perceived disease susceptibility and severity (aOR 4.629, 95% CI 2.017-10.625), residential mobility (aOR 3.908, 95% CI 2.075-7.358), daycare use (aOR 0.310, 95% CI 0.144-0.671), number of needles administered at each visit (aOR 7.734, 95% CI 2.598-23.025) and access to a regular physician (aOR 0.219, 95% CI 0.057-0.846). While concern about vaccine safety may be addressed through educational strategies, this study suggests that additional program and policy-level strategies may positively impact immunization uptake.

Sports injuries, drowning and exposure to radiation concern Canada Safety Council meeting

International Nuclear Information System (INIS)

Oliver, Caroline.

1979-01-01

Hazards associated with surface sports, aquatic sports and exposure to radiation were considered at a meeting of the Canada Safety Council in late 1979. The session on radiation noted that 6 of 20000 radiation workers wearing dosimeters were exposed to a dose in excess of 5 rem, the annual limit set by the Atomic Energy Control Board. Radiographers were in the job classification receiving the highest doses of ionizing radiation. Concern was expressed for the emission of damaging radiation from broken mercury vapour lamps. Increased regulation rather than training was seen as the most effective solution. (T.I.)

A decade of e-cigarettes: Limited research & unresolved safety concerns.

Science.gov (United States)

Kaisar, Mohammad Abul; Prasad, Shikha; Liles, Tylor; Cucullo, Luca

2016-07-15

It is well known that tobacco consumption is a leading cause of preventable deaths worldwide and has been linked to major diseases ranging from cancer to chronic obstructive pulmonary disease, atherosclerosis, stroke and a host of neurological/neurodegenerative disorders. In the past decade a number of alternative vaping products have hit the market, rapidly gaining consumers especially among the younger population. Electronic nicotine delivery systems or e-cigarettes have become the sought-after product due to the belief that they are much safer than traditional cigarettes. However, inadequate research and lack of regulatory guidelines for both the manufacturing process and the content of the vaping solution of the e-cigarette has become a major concern. Highly debated and unresolved questions such as whether e-cigarettes may help smokers quit and whether e-cigarettes will promote the use of nicotine among non-smokers add to the confusion of the safety of e-cigarettes. In this review article, we summarize the current understanding (and lack thereof) of the potential health impacts of e-cigarettes. We will also highlight the most recent studies (in vivo/in vitro) which seem to conflict with the broad safety claims put forward by the manufacturers. Finally, we provide potential solutions to overcome the research gap of the short and long-term health impact of e-cigarettes. Published by Elsevier Ireland Ltd.

A decade of e-cigarettes: Limited research & unresolved safety concerns

International Nuclear Information System (INIS)

Kaisar, Mohammad Abul; Prasad, Shikha; Liles, Tylor; Cucullo, Luca

2016-01-01

It is well known that tobacco consumption is a leading cause of preventable deaths worldwide and has been linked to major diseases ranging from cancer to chronic obstructive pulmonary disease, atherosclerosis, stroke and a host of neurological/neurodegenerative disorders. In the past decade a number of alternative vaping products have hit the market, rapidly gaining consumers especially among the younger population. Electronic nicotine delivery systems or e-cigarettes have become the sought-after product due to the belief that they are much safer than traditional cigarettes. However, inadequate research and lack of regulatory guidelines for both the manufacturing process and the content of the vaping solution of the e-cigarette has become a major concern. Highly debated and unresolved questions such as whether e-cigarettes may help smokers quit and whether e-cigarettes will promote the use of nicotine among non-smokers add to the confusion of the safety of e-cigarettes. In this review article, we summarize the current understanding (and lack thereof) of the potential health impacts of e-cigarettes. We will also highlight the most recent studies (in vivo/in vitro) which seem to conflict with the broad safety claims put forward by the manufacturers. Finally, we provide potential solutions to overcome the research gap of the short and long-term health impact of e-cigarettes.

A Decade of e-Cigarettes: Limited Research & Unresolved Safety Concerns

Science.gov (United States)

Kaisar, Mohammad Abul; Prasad, Shikha; Liles, Tylor; Cucullo, Luca

2016-01-01

It is well known that tobacco consumption is a leading cause of preventable deaths worldwide and has been linked to major diseases ranging from cancer to chronic obstructive pulmonary disease, atherosclerosis, stroke and a host of neurological/neurodegenerative disorders. In the past decade a number of alternative vaping products have hit the market, rapidly gaining consumers especially among the younger population. Electronic nicotine delivery systems or e-cigarettes have become the sought-after product due to the belief that they are much safer than traditional cigarettes. However, inadequate research and lack of regulatory guidelines for both the manufacturing process and the content of the vaping solution of the e-cigarette has become a major concern. Highly debated and unresolved questions such as whether e-cigarettes may help smokers quit and whether e-cigarettes will promote the use of nicotine among non-smokers add to the confusion of the safety of e-cigarettes. In this review article, we summarize the current understanding (and lack thereof) of the potential health impacts of e-cigarettes. We will also highlight the most recent studies (in vivo/in vitro) which seem to conflict with the broad safety claims put forward by the manufacturers. Finally, we provide potential solutions to overcome the research gap of the short and long-term health impact of e-cigarettes. PMID:27477296

Car Seat Safety

Science.gov (United States)

... Staying Safe Videos for Educators Search English Español Car Seat Safety KidsHealth / For Parents / Car Seat Safety ... certified child passenger safety technician.) Guidelines for Choosing Car Seats Choose a seat with a label that ...

Study concerning the power plant control and safety equipment by integrated distributed systems

International Nuclear Information System (INIS)

Optea, I.; Oprea, M.; Stanescu, P.

1995-01-01

The paper deals with the trends existing in the field of nuclear control and safety equipment and systems, proposing a high-efficiency integrated system. In order to enhance the safety of the plant and reliability of the structure system and components, we present a concept based on the latest computer technology with an open, distributed system, connected by a local area network with high redundancy. A modern conception for the control and safety system is to integrate all the information related to the reactor protection, active engineered safeguard and auxiliary systems parameters, offering a fast flow of information between all the agencies concerned so that situations can be quickly assessed. The integrated distributed control is based on a high performance operating system for realtime applications, flexible enough for transparent networking and modular for demanding configurations. The general design considerations for nuclear reactors instrumentation reliability and testing methods for real-time functions under dynamic regime are presented. Taking into account the fast progress in information technology, we consider the replacement of the old instrumentation of Cernavoda-1 NPP by a modern integrated system as an economical and efficient solution for the next units. (Author) 20 Refs

Gender differences and demographic influences in perceived concern for driver safety and support for impaired driving countermeasures.

Science.gov (United States)

Butters, Jennifer; Mann, Robert E; Wickens, Christine M; Boase, Paul

2012-12-01

Driving safety, impaired driving, and legislation to address these concerns remain important issues. It is imperative countermeasures be targeted toward the most appropriate groups. This paper explores the potential relationship between gender and driving attitudes toward safety issues and impaired-driving countermeasures. The data are from the 2007 Impaired Driving Survey commissioned by Transport Canada and Mothers Against Drunk Driving (MADD) Canada. The survey is a, stratified by region, telephone survey of 1,514 Canadian drivers 18years of age and older with a valid driver's license who had driven within the past 30days. The findings illustrate a consistent impact of gender on these issues. Other variables were also identified as relevant factors although less consistently. Current findings suggest that strategies for building support for interventions, or for changing risk perception/concern for risky driving behaviors should be tailored by gender to maximize the potential for behavior change. This information may assist program and policy developers through the identification of more or less receptive target groups. Future research directions are also presented. Copyright © 2012 National Safety Council and Elsevier Ltd. All rights reserved.

Nordic projects concerning nuclear safety

International Nuclear Information System (INIS)

Soerensen, H.C.

1988-11-01

The report describes the nature of the work done in the first half of 1988 within the field of nuclear safety (1985-89) under the Nordic program for 1985-89. Five programmes and their documentation, are described and complete lists of addresses and of persons involved is given. (AB)

9 CFR 317.4 - Labeling approval.

Science.gov (United States)

2010-01-01

... undue economic hardship; and (iv) An unfair competitive advantage would not result from the granting of... Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY... approval to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, and...

Socializing Young People to Ethics via Play Experience: Browser Games and Parental Concerns for Safety Online

Directory of Open Access Journals (Sweden)

Divina Meigs

2009-01-01

Full Text Available This paper considers an online game and its relation to safety and privacy, in order to examine social and ethical issues raised by parental concern over harmful content. To gain real insights on the responsibility of adults, it develops a hands-on approach that takes into account the major stakeholders, especially young people and the related circle of people around them. Therefore the research question that is raised is: how do browser games provide reassurance to parents about their children’s safety and privacy? The issue of safety online is explored in three parts, using an ethnographic research framework: it explores a specific online game, it provides a profile of participants, it analyses their types of actions in relation to safety and privacy, and discusses the results in terms of incidence of risk, peer-monitoring and community control. The findings show that there is a rather strong tendency to self-regulation, but that tendency is partly due to a strong presence of mediating adults and peers. The results are discussed in terms of incidence of risk, peer-monitoring and networked means of control on the one hand, and in terms of scientific contribution to socialization theory on the other hand. They lead to final considerations on the repertoire of ethical strategies set up online and its meaning for the concerns of adults towards online risk as well as the need for policies on regulation and self-regulation. They also lead to extensions on the socialization to norms and the appropriation of ethics by young people.

Safety, Pharmacokinetics, Immunogenicity, and Biodistribution of (186)Re-Labeled Humanized Monoclonal Antibody BIWA 4 (Bivatuzumab( in Patients with Early-Stage Breast Cancer.

NARCIS (Netherlands)

Koppe, M.; Schaijk, F. van; Roos, J.C.; Leeuwen, P.; Heider, K.H.; Kuthan, H.; Bleichrodt, R.P.

2004-01-01

The aim of this prospective study was to evaluate the safety, pharmacokinetics, immunogenicity, and biodistribution of (186)Re-labeled humanized anti-CD44v6 monoclonal antibody (MAb( BIWA 4 (Bivatuzumab( in 9 patients with early-stage breast cancer. Radioimmunoscintigraphy (RIS( was performed within

78 FR 24211 - Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling...

Science.gov (United States)

2013-04-24

... Labeling Design to Minimize Medication Errors.'' In Title I of the Food and Drug Administration Amendments..., dose designations, and error-prone label and packaging designs. Among these measures, FDA agreed that... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0401...

Sustainability labels on food products

DEFF Research Database (Denmark)

Grunert, Klaus G; Hieke, Sophie; Wills, Josephine

2014-01-01

of sustainability was limited, but understanding of four selected labels (Fair Trade, Rainforest Alliance, Carbon Footprint, and Animal Welfare) was better, as some of them seem to be self-explanatory. The results indicated a low level of use, no matter whether use was measured as self-reported use of different......This study investigates the relationship between consumer motivation, understanding and use of sustainability labels on food products (both environmental and ethical labels), which are increasingly appearing on food products. Data was collected by means of an online survey implemented in the UK......, France, Germany, Spain, Sweden, and Poland, with a total sample size of 4408 respondents. Respondents expressed medium high to high levels of concern with sustainability issues at the general level, but lower levels of concern in the context of concrete food product choices. Understanding of the concept...

The U.S. commercial air tour industry: a review of aviation safety concerns.

Science.gov (United States)

Ballard, Sarah-Blythe

2014-02-01

The U.S. Title 14 Code of Federal Regulations defines commercial air tours as "flight[s] conducted for compensation or hire in an airplane or helicopter where a purpose of the flight is sightseeing." The incidence of air tour crashes in the United States is disproportionately high relative to similar commercial aviation operations, and air tours operating under Part 91 governance crash significantly more than those governed by Part 135. This paper reviews the government and industry response to four specific areas of air tour safety concern: surveillance of flight operations, pilot factors, regulatory standardization, and maintenance quality assurance. It concludes that the government and industry have successfully addressed many of these tenet issues, most notably by: advancing the operations surveillance infrastructure through implementation of en route, ground-based, and technological surveillance methods; developing Aeronautical Decision Making and cue-based training programs for air tour pilots; consolidating federal air tour regulations under Part 136; and developing public-private partnerships for raising maintenance operating standards and improving quality assurance programs. However, opportunities remain to improve air tour safety by: increasing the number and efficiency of flight surveillance programs; addressing pilot fatigue with more restrictive flight hour limitations for air tour pilots; ensuring widespread uptake of maintenance quality assurance programs, especially among high-risk operators not currently affiliated with private air tour safety programs; and eliminating the 25-mile exception allowing Part 91 operators to conduct commercial air tours without the safety oversight required of Part 135 operators.

16 CFR 1203.34 - Product certification and labeling by manufacturers (including importers).

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by... COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS Certification § 1203.34 Product certification and labeling by manufacturers (including importers). (a) Form of permanent...

How to Read a Nutrition Facts Label

Medline Plus

Full Text Available ... Behavior School & Family Life First Aid & Safety Doctors & Hospitals Videos Recipes for Kids Kids site Sitio para ... nutricionales (video) Most packaged foods come with a Nutrition Facts label. These labels have a lot of important ... Policy Permissions Guidelines Privacy Policy & Terms of Use Notice ...

Safety and effectiveness of a circumferential clip-based vascular closure device for hemostasis in off-label applications: Comparison with standard applications

Energy Technology Data Exchange (ETDEWEB)

Lee, Seung Chan; Kim, Chang Won [Dept. of Radiology, Pusan National University School of Medicine, Pusan National University Hospital, Busan (Korea, Republic of); Jeon, Ung Bae [Dept. of Radiology, Pusan National University School of Medicine, Yangsan Pusan National University Hospital, Yangsan (Korea, Republic of)

2016-09-15

We investigated the efficacy and safety of a circumferential nitinol clip based arterial closure device following arteriotomy, especially in off-label applications. Consecutive patients who underwent the procedure with arteriotomy from January 2011 to February 2014 were included in this study. We defined standard use as the use of StarClose for retrograde puncture of the common femoral artery (CFA) and off-label use as the use of StarClose for retrograde puncture of the superficial femoral artery (SFA), antegrade puncture of the CFA or SFA, puncture of the brachial artery or puncture of the vascular graft. The procedures performed included percutaneous transluminal angioplasty and thrombolysis. Technical success was defined as complete hemostasis achieved within 3 minute after the closure. Complications, and laboratory findings associated with coagulation function, were also investigated. There were 146 cases of standard applications and 111 cases of off-label applications. Technical success was achieved in all cases. The off-label group comprised the use of StarClose for retrograde puncture of the SFA (n = 19), antegrade puncture of the CFA or SFA (n = 74), brachial artery puncture (n = 5), larger sheath than 6 Fr (n = 7) and vascular graft puncture (n = 6). Minor complications were noted in both groups (standard group: 7.5%, off-label group: 2.7%). Off-label use of StarClose is safe and feasible.

Safety and effectiveness of a circumferential clip-based vascular closure device for hemostasis in off-label applications: Comparison with standard applications

International Nuclear Information System (INIS)

Lee, Seung Chan; Kim, Chang Won; Jeon, Ung Bae

2016-01-01

We investigated the efficacy and safety of a circumferential nitinol clip based arterial closure device following arteriotomy, especially in off-label applications. Consecutive patients who underwent the procedure with arteriotomy from January 2011 to February 2014 were included in this study. We defined standard use as the use of StarClose for retrograde puncture of the common femoral artery (CFA) and off-label use as the use of StarClose for retrograde puncture of the superficial femoral artery (SFA), antegrade puncture of the CFA or SFA, puncture of the brachial artery or puncture of the vascular graft. The procedures performed included percutaneous transluminal angioplasty and thrombolysis. Technical success was defined as complete hemostasis achieved within 3 minute after the closure. Complications, and laboratory findings associated with coagulation function, were also investigated. There were 146 cases of standard applications and 111 cases of off-label applications. Technical success was achieved in all cases. The off-label group comprised the use of StarClose for retrograde puncture of the SFA (n = 19), antegrade puncture of the CFA or SFA (n = 74), brachial artery puncture (n = 5), larger sheath than 6 Fr (n = 7) and vascular graft puncture (n = 6). Minor complications were noted in both groups (standard group: 7.5%, off-label group: 2.7%). Off-label use of StarClose is safe and feasible

List of reports from the BMFT, CEA, EPRI, JSTA and USNRC concerning reactor safety research

International Nuclear Information System (INIS)

1981-09-01

This list reviews reports from the Federal Republic of Germany, from France, from Japan and from the United States of America concerning special Problems in the field of Reactor Safety Research. According to the cooperation of the Bundesminister fuer Forschung und Technologie (BMFT) with the Commissariat a l'Energie Atomique (CEA) the Japan Science and Technology Agency (JSTA) the Electric Power Research Institute (EPRI) and the United States Nuclear Regulatory Commission these reports are available in the Gesellschaft fuer Reaktorsicherheit (GRS). The list pursues the following order: Country of origin, problem area concerned, according to the Reactor Saftety Research Program of the BMFT, reporting organization. The list of reports appears quarterly. (orig./HP) [de

Items to be reflected to the nuclear power safety measures in Japan (concerning the examination, design and operation management) (excluding the items to be reflected to the standards)

Energy Technology Data Exchange (ETDEWEB)

1980-10-01

In connection with the Three Mile Island nuclear power accident in March, 1979, in the United States, in order to introduce the lessons from it in the nuclear power safety regulations in Japan, 52 items to be reflected to the nuclear power safety measures were chosen by the Nuclear Safety Commission. Of these, 16 items were examined by the Committee on Examination of Reactor Safety. It was decided that these results would be introduced in the nuclear safety regulations, by the Nuclear Safety Commission. The following 16 items are described. For the examination, four items concerning the automatic operation of safety systems and others; for the design, five items concerning a small rupture accident, the monitoring of the state of primary coolant, control room layout and others; for the operation management, seven items concerning the inspection at the time of repair, the prevention of faulty handlings by operators and others.

[Preliminary results of an open-label observational study evaluating the efficacy and safety of Prolia used in women with postmenopausal osteoporosis].

Science.gov (United States)

Ershova, O B; Lesniak, O M; Belova, K Iu; Nazarova, A V; Manovitskaia, A V; Musaeva, T M; Musraev, R M; Nurlygaianov, R Z; Rozhinskaia, L Ia; Skripnikova, I A; Toroptsova, N V

2014-01-01

To evaluate the efficacy and safety of Denosumab (Prolia), a first-line osteoporosis (OP) medication that is a fully human monoclonal antibody to the receptor activator of nuclear factor xB ligand (RANKL), within an open-label observational study. Patients aged 50 years or older with postmenopausal OP, who were treated with Prolia in clinical practice, were examined. The concentrations of the bone resorption (BR) marker of C-terminal telopeptide and other laboratory indicators (total serum calcium, total alkaline phosphatase, and creatinine) were measured following 3 months. Adverse drug reactions were recorded. Three months after initiation of the investigation, there was a significant decrease in the BR marker C-terminal telopeptide (by 89%; p<0.0001). There were rare adverse reactions: hypocalcemia in 3 (5.9%) patients, arthralgias in 2 (3.9%), and eczema in 1 (1.9%). There were neither serious adverse events nor study withdrawal cases. The preliminary results of the open-label study of Prolia in postmenopausal OP suggest that the significantly lower BR activity determines the efficacy of this drug and its high safety.

A better carbon footprint label

DEFF Research Database (Denmark)

Thøgersen, John; Nielsen, Kristian S.

2016-01-01

, participants saw the original Carbon Trust label and in the other condition they saw the same label, but with traffic light colors added to communicate the product’s relative performance in terms of carbon footprint. All included attributes were found to have a significant impact on consumer choices....... As expected, price and carbon footprint were negatively related to choice. Further, participants preferred organic to non-organic coffee and certification by a public authority. The effect of the carbon label is significantly stronger the more environmentally concerned the consumer is. Using colors...... to indicate relative carbon footprint significantly increases carbon label effectiveness. Hence, a carbon footprint label is more effective if it uses traffic light colors to communicate the product’s relative performance....

16 CFR 1211.24 - Product certification and labeling by manufacturers.

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by manufacturers. 1211.24 Section 1211.24 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT... § 1211.24 Product certification and labeling by manufacturers. (a) Form of permanent label of...

Items to be reflected to the nuclear power safety measures in Japan (concerning the examination, design and operation management) (excluding the items to be reflected to the standards)

International Nuclear Information System (INIS)

1980-01-01

In connection with the Three Mile Island nuclear power accident in March, 1979, in the United States, in order to introduce the lessons from it in the nuclear power safety regulations in Japan, 52 items to be reflected to the nuclear power safety measures were chosen by the Nuclear Safety Commission. Of these, 16 items were examined by the Committee on Examination of Reactor Safety. It was decided that these results would be introduced in the nuclear safety regulations, by the Nuclear Safety Commission. The following 16 items are described. For the examination, four items concerning the automatic operation of safety systems and others; for the design, five items concerning a small rupture accident, the monitoring of the state of primary coolant, control room layout and others; for the operation management, seven items concerning the inspection at the time of repair, the prevention of faulty handlings by operators and others. (J.P.N.)

THE INFLUENCE OF MEDIA EXPOSURE, SAFETY AND HEALTH CONCERNS, AND SELF-EFFICACY ON ENVIRONMENTAL ATTITUDES TOWARDS ELECTRONIC GREEN PRODUCTS

Directory of Open Access Journals (Sweden)

Iman Khalid A. Qader

2011-07-01

Full Text Available As the high-tech industry evolves at a rapid pace, vast amounts of hazardous materials are used in fuelling its global expansion. These rapid changes in production processes are significantly depleting natural resources. With the surge of popular interest and awareness pertaining to environmental issues, organisations may be in peril if consumers' attitudes towards their products are ignored. This study intends to understand consumers' environmental attitudes towards electronic green products and to identify the effect of three factors, namely, media exposure, safety and health concerns, and self- efficacy, on this attitude. Data were collected via a self-administered questionnaire among 170 respondents in a public university. The results of the study indicated that safety and health concerns as well as self-efficacy had significant positive impacts on consumers' environmental attitudes. Surprisingly, however, media exposure did not exhibit any significant influence on consumers' environmental attitude. It is recommended that campaign and awareness projects focus on safety and health issues. Additionally, media should play a more active role in increasing environmental awareness among consumers.

HTGR safety research concerns at NRC

International Nuclear Information System (INIS)

Minogue, R.B.

1982-01-01

A general discussion of HTGR technical and safety-related problems is given. The broad areas of current research programs specific to the Fort St. Vrain reactor and applicable to HTGR technology are summarized

Quality assurance, information tracking, and consumer labeling

International Nuclear Information System (INIS)

Caswell, Julie A. . E-mail caswell@resecon.umass.edu

2006-01-01

Reducing marine-based public health risk requires strict control of several attributes of seafood products, often including location and conditions of catch or aquaculture, processing, and handling throughout the supply chain. Buyers likely will also be interested in other attributes of these products such as eco-friendliness or taste. Development of markets for improved safety, as well as for other quality attributes, requires an effective certification and tracking of these attributes as well as their communication to buyers. Several challenges must be met if labeling, particularly consumer labeling, is to support the development of markets for improved seafood safety

Surveys of research projects concerning nuclear facility safety financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1991

International Nuclear Information System (INIS)

1992-09-01

Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1988

International Nuclear Information System (INIS)

1989-11-01

Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1987

International Nuclear Information System (INIS)

1988-06-01

Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

10 CFR 34.35 - Labeling, storage, and transportation.

Science.gov (United States)

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Labeling, storage, and transportation. 34.35 Section 34.35 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Equipment § 34.35 Labeling, storage, and transportation. (a...

75 FR 71344 - Uniform Compliance Date for Food Labeling Regulations

Science.gov (United States)

2010-11-23

.... FSIS-2010-0031] RIN 0583-AD Uniform Compliance Date for Food Labeling Regulations AGENCY: Food Safety... regulations that require changes in the labeling of meat and poultry food products. Many meat and poultry... for new food labeling regulations is consistent with FDA's approach in this regard. FDA is also...

The Swedish Nuclear Power Inspectorate's Regulations concerning Safety in connection with the Disposal of Nuclear Material and Nuclear Waste. General Recommendations concerning the Application of the Swedish Nuclear Power Inspectorate's Regulations above

International Nuclear Information System (INIS)

2002-06-01

An english translation of the original Swedish regulations concerning the safety in disposal of nuclear wastes is published in this booklet, together with recommendations on how these regulations can be applied

New safety valve addresses environmental concerns

International Nuclear Information System (INIS)

Taylor, J.; Austin, R.

1992-01-01

This paper reports that Conoco Pipeline is using a unique relief valve to reduce costs while improving environmental protection at its facilities. Conoco Pipeline Co. Inc. began testing new relief valves in 1987 to present over-pressuring its pipelines while enhancing the safety, environmental integrity and profitability of its pipelines. Conoco worked jointly with Rupture Pin Technology Inc., Oklahoma City, to seek a solution to a series of safety, environmental, and operational risks in the transportation of crude oil and refined products through pipelines. Several of the identified problems were traced to a single equipment source: the reliability of rupture discs used at pipeline stations to relieve pressure by diverting flow to tanks during over-pressure conditions. Conoco's corporate safety and environmental policies requires solving problems that deal with exposure to hydrocarbon vapors, chemical spills or the atmospheric release of fugitive emissions, such as during rupture disc maintenance. The company had used rupture pin valves as vent relief devices in conjunction with development by Rick Austin of inert gas methods to protect the inner casing wall and outer carrier pipeline wall in pipeline road crossings. The design relies on rupture pin valves set at 5 psi to isolate vent openings from the atmosphere prior to purging the annular space between the pipeline and casing with inert gas to prevent corrosion. Speciality Pipeline Inspection and Engineering Inc., Houston, is licensed to distribute the equipment for the new cased-crossing procedure

The development and evaluation of options for improving future U.K. blood component labelling--outcome of the 2013 U.K. hospital survey.

Science.gov (United States)

Nightingale, M J; Brazier, A M; McArthur, K; Jones, J; Cardigan, R; Lodge, L; Maclennan, S

2014-04-01

U.K. blood component labels have evolved to accommodate a plethora of information. Concern has, however, been expressed that current U.K. labelling is too 'cluttered', detracting from the clarity of critical information. This prompted a holistic review of labelling and available information technology (IT) with the aim of improving the situation. A survey was circulated requiring U.K. hospital participants to rank each item of information on the label according to its 'criticality' and assess three novel 'future' and one 'transition' prototype labels. Prototypes were based on applicable regulatory standards, best practice guidance, international benchmark data and U.K. expert input. The prototypes support steps towards 'full face' label printing and utilise 2D and quick response (QR) barcodes. Two-hundred eleven completed surveys were received identifying 110 contributing hospitals with 41% from clinical staff, 37% from transfusion laboratory staff and 22% from transfusion practitioners. There was excellent agreement between the three groups on the critical information, i.e., blood group, expiry date, blood component name, unique donation identification number (DIN) and blood component volume but far less on the other information, especially the various warning messages. Of the 'future' labels, option 3 (closest to the current 'quadrant model') was most popular. Option 1, with its additional inverted section replicating critical information was least popular and prompted significant safety concerns. The prototype labels correctly identified the critical items of information and extensive comments confirmed that this was more prominently and clearly displayed. Laboratory staff commented that the transition label was essential to enable IT systems to be adapted. © 2014 The Authors. Transfusion Medicine © 2014 British Blood Transfusion Society.

Health and safety concerns os migrant workers: the experience of tunisian workers in modena, Italy

Directory of Open Access Journals (Sweden)

Faïçal Daly

2004-06-01

Full Text Available This paper examines the relatively under-researched field of healthand safety of migrant workers, with special reference to Tunisian construction workers in the city of Modena in the Italian region of Emilia-Romagna. The empirical material comes from questionnaires and interviews with Tunisian migrants, plus smaller numbers of interviews with employers and trade union representatives in Modena. The paper starts by critically reviewing the scattered literature onthe health and safety of minority workers, most of which refers to the United States and the United Kingdom. The discussion then moves to a consideration of migrant health and safety questions in the contexts of racism, discrimination, social class, working conditions, labour market segmentation and (non- regulation. Specialattention is given to the failed role of trade unions in defending the rights of minority workers, in advanced countries generally and in Italy in particular. A case study is then made of the construction sector in Italy, enriched by personal accounts of the experiences of Tunisian migrant workers in Modena. Employer and tradeunion interviews reveal a lack of concern and ability to tackle the relevant issues. Barriers to health and safety awareness training are outlined. In the conclusion, recommendations are made for policy initiatives in this area.

Response to ONS/EH-OA concerns

International Nuclear Information System (INIS)

Rice, P.D.

1991-01-01

The DOE's independent Office of Nuclear Safety (ONS) conducted an independent assessment of WSRC's readiness for K-Reactor restart. DOE-ONS identified six areas of concern, with specific findings in each area. The six concerns deal with: (1) Technical Specification surveillance, (2) human factors issues, (3) emergency lighting, (4) fire protection issues, (5) the Unreviewed Safety Question process, and (6) the critique process. This report addresses each of these six concerns and Westinghouse's actions to resolve them

Aviation Safety: FAA and DOD Response to Similar Safety Concerns

National Research Council Canada - National Science Library

2002-01-01

.... The Federal Aviation Administration (FAA) and the military services often face common safety issues as they oversee the operation of similar aircraft or even dissimilar aircraft that use common parts and materials...

Food-allergic consumers' labelling preferences: a cross-cultural comparison

NARCIS (Netherlands)

Cornelisse-Vermaat, J.R.; Voordouw, J.; Yiakoumaki, V.; Theodoridis, G.; Frewer, L.J.

2008-01-01

Background: Recent changes in European food safety legislation have resulted in the implementation of statutory requirements regarding the traceability and labelling of 12 food allergens. This article describes research conducted to establish if current food labelling practices are perceived to be

16 CFR 1500.125 - Labeling requirements for accompanying literature.

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling requirements for accompanying literature. 1500.125 Section 1500.125 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature...

The Fetal Alcohol Syndrome Public Awareness Campaign, 1979: Progress Report Concerning the Advance Notice of Proposed Rulemaking on Warning Labels on Containers of Alcoholic Beverages and Addendum.

Science.gov (United States)

Department of the Treasury, Washington, DC.

This report provides expert opinion on the problems of fetal alcohol syndrome (FAS) and ways to inform the public of teratogenic risk of alcohol consumption during pregnancy. In the absence of firm evidence that moderate drinking of alcoholic beverages leads to FAS and uncertainty concerning the effectiveness of labeling of alcoholic beverages, a…

Surveys of research projects concerning nuclear facility safety, financed by the Bundesminister des Innern. 9th annual report on SR-projects 1984

International Nuclear Information System (INIS)

1985-06-01

The FRG's Ministry of the Interior finances studies, expertises and investigations in the field of nuclear safety. The results of such work are meant to clarify questions left open concerning the execution of licensing procedures for nuclear facilities. The GRS (Reactor Safety Company) regularly provides information on the state of such studies, on the authority of the Ministry of the Interior. Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig./HP) [de

Safety concerns related to modular/prefabricated building construction.

Science.gov (United States)

Fard, Maryam Mirhadi; Terouhid, Seyyed Amin; Kibert, Charles J; Hakim, Hamed

2017-03-01

The US construction industry annually experiences a relatively high rate of fatalities and injuries; therefore, improving safety practices should be considered a top priority for this industry. Modular/prefabricated building construction is a construction strategy that involves manufacturing of the whole building or some of its components off-site. This research focuses on the safety performance of the modular/prefabricated building construction sector during both manufacturing and on-site processes. This safety evaluation can serve as the starting point for improving the safety performance of this sector. Research was conducted based on Occupational Safety and Health Administration investigated accidents. The study found 125 accidents related to modular/prefabricated building construction. The details of each accident were closely examined to identify the types of injury and underlying causes. Out of 125 accidents, there were 48 fatalities (38.4%), 63 hospitalized injuries (50.4%), and 14 non-hospitalized injuries (11.2%). It was found that, the most common type of injury in modular/prefabricated construction was 'fracture', and the most common cause of accidents was 'fall'. The most frequent cause of cause (underlying and root cause) was 'unstable structure'. In this research, the accidents were also examined in terms of corresponding location, occupation, equipment as well as activities during which the accidents occurred. For improving safety records of the modular/prefabricated construction sector, this study recommends that future research be conducted on stabilizing structures during their lifting, storing, and permanent installation, securing fall protection systems during on-site assembly of components while working from heights, and developing training programmes and standards focused on modular/prefabricated construction.

9 CFR 317.300 - Nutrition labeling of meat or meat food products.

Science.gov (United States)

2010-01-01

... Labeling § 317.300 Nutrition labeling of meat or meat food products. (a) Nutrition labeling shall be... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Nutrition labeling of meat or meat food products. 317.300 Section 317.300 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE...

Cause for Concern: A Mixed-Methods Study of Campus Safety and Security Practices in United States-Mexico Border Institutions of Higher Education

Science.gov (United States)

Holmes, Ryan Clevis

2014-01-01

Campus safety has been a source of concern since the 1990s. However, in 2007, the tragedy at the Virginia Polytechnic and State University sent a sense of alarm through many institutions of higher education. Immediately following this tragedy, institutions across the country began to evaluate and question their safety and security practices. While…

Eco-Labeled Seafood: Determinants for (Blue Green Consumption

Directory of Open Access Journals (Sweden)

Malin Jonell

2016-09-01

Full Text Available Eco-certification has become an increasingly popular market-based tool in the endeavor to reduce negative environmental impacts from fisheries and aquaculture. In this study, we aimed at investigating which psychological consumer characteristics influence demand for eco-labeled seafood by correlating consumers’ stated purchasing of eco-labeled seafood to nine variables: environmental knowledge regarding seafood production, familiarity with eco-labels, subjective knowledge, pro-environmental self-identification, sense of personal responsibility, concern for negative environmental impacts from seafood production, perceived consumer effectiveness, gender and education. Questionnaires were distributed to consumers in Stockholm, Sweden, and the data were tested with multiple regression analysis using linear modeling and model averaging (n = 371. Two variables were the best predictors of stated purchasing of eco-labeled seafood: (i recognition and understanding of eco-labels for seafood (Marine Stewardship Council, Fish for Life, Aquaculture Stewardship Council and KRAV; and (ii concern for negative environmental impacts associated with seafood production. Meanwhile, consumer environmental knowledge was a weaker predictor. Results from this study suggest that strengthening the emotional component of consumer decision-making and improving the level of consumer familiarity with seafood eco-labels could stimulate more pro-environmental seafood consumption.

The home electronic media environment and parental safety concerns: relationships with outdoor time after school and over the weekend among 9-11 year old children.

Science.gov (United States)

Wilkie, Hannah J; Standage, Martyn; Gillison, Fiona B; Cumming, Sean P; Katzmarzyk, Peter T

2018-04-05

Time spent outdoors is associated with higher physical activity levels among children, yet it may be threatened by parental safety concerns and the attraction of indoor sedentary pursuits. The purpose of this study was to explore the relationships between these factors and outdoor time during children's discretionary periods (i.e., after school and over the weekend). Data from 462 children aged 9-11 years old were analysed using generalised linear mixed models. The odds of spending > 1 h outdoors after school, and > 2 h outdoors on a weekend were computed, according to demographic variables, screen-based behaviours, media access, and parental safety concerns. Interactions with sex and socioeconomic status (SES) were explored. Boys, low SES participants, and children who played on their computer for  1 h outside after school than girls, high SES children and those playing on a computer for ≥2 h, respectively. Counterintuitive results were found for access to media devices and crime-related safety concerns as both of these were positively associated with time spent outdoors after school. A significant interaction for traffic-related concerns*sex was found; higher road safety concerns were associated with lower odds of outdoor time after school in boys only. Age was associated with weekend outdoor time, which interacted with sex and SES; older children were more likely to spend > 2 h outside on weekends but this was only significant among girls and high SES participants. Our results suggest that specific groups of children are less likely to spend their free time outside, and it would seem that only prolonged recreational computer use has a negative association with children's outdoor time after school. Further research is needed to explore potential underlying mechanisms, and parental safety concerns in more detail.

College Rampage Renews School Safety Concerns

Science.gov (United States)

Maxwell, Lesli A.

2007-01-01

Coming just four days before the anniversary of the Columbine school shootings, the mass slayings by a student gunman at Virginia Polytechnic Institute last week revived vexing questions and raised familiar fears for educators across the country who grapple daily with ensuring the safety of their students and staffs. The April 16 killings provoked…

Development of the international status of science and technology concerning methods and tools for operational and long-term safety cases

International Nuclear Information System (INIS)

Seher, Holger; Beuth, Thomas; Bracke, Guido; Kock, Ingo; Mayer, Kim-Marisa; Moog, Helge C.; Uhlmann, Stephan; Weyand, Torben

2016-09-01

The project ''development of the international status of science and technology concerning methods and tools for operational and long-term safety cases'' covers the following key aspects: global aspects of the methodology for scenario assumption for the operational phase following closure, potential analysis of the derives safety cases for the project Gorleben, determination of the solid phase composition of high-level radioactive wastes using geochemical modeling calculations, search for an adequate approach for the calculation of density and viscosity of saline solutions for the future use in GRS computer codes, international approaches for an integral analysis for the host rocks clay and granite in relation to the safety requirements of BMUB.

16 CFR 1205.36 - Product certification and labeling by importers.

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by importers. 1205.36 Section 1205.36 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR WALK-BEHIND POWER LAWN MOWERS Certification § 1205.36 Product...

16 CFR 1205.35 - Product certification and labeling by manufacturers.

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by manufacturers. 1205.35 Section 1205.35 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR WALK-BEHIND POWER LAWN MOWERS Certification § 1205.35 Product...

Posiva's application for a decision in principle concerning a disposal facility for spent nuclear fuel. STUK's statement and preliminary safety appraisal

Energy Technology Data Exchange (ETDEWEB)

Ruokola, E. [ed.

2000-03-01

In May 1999, Posiva Ltd submitted to the Government an application, pursuant to the Nuclear Energy Act, for a Decision in Principle on a disposal facility for spent nuclear fuel from the Finnish nuclear power plants. The Ministry of Trade and Industry requested the Radiation and Nuclear Safety Authority (STUK) to draw up a preliminary safety appraisal concerning the proposed disposal facility. In the beginning of this report, STUK's statement to the Ministry and Industry concerning the proposed disposal facility is given. In that statement, STUK concludes that the Decision in Principle is currently justified from the standpoint of safety. The statement is followed by a safety appraisal, where STUK deems, how the proposed disposal concept, site and facility comply with the safety requirements included in the Government's Decision (478/1999). STUK's preliminary safety appraisal was supported by contributions from a number of outside experts. A collective opinion by an international group of ten distinguished experts is appended to this report. (orig.)

India's power program and its concern over environmental safety

International Nuclear Information System (INIS)

Prasad, G.E.; Mittra, J.

2001-01-01

India's need of electrical power is enormous and per capita consumption of power is to be increased at least by ten times to reach the level of world average. Thermal Power generation faces two fold problems. First, there is scarcity of good quality fuel and second, increasing environmental pollution. India's self reliant, three stage, 'closed-fuel-cycle' nuclear power program is promising better solution to the above problems. To ensure Radiation Protection and Safety of Radiation Sources, Indian Nuclear Power program emphasizes upon design and engineering safety by incorporating necessary safety features in the design, operational safety through structured training program and typically through software packages to handle rare unsafe events and regulation by complying safety directives. A health survey among the radiation workers indicates that there is no extra threat to the public from nuclear power program. Based on latest technology, as available in case of nuclear power option, it is quite possible to meet high energy requirement with least impact on the environment.. (authors)

The impact of nutritional labels and socioeconomic status on energy intake. An experimental field study.

Science.gov (United States)

Crockett, Rachel A; Jebb, Susan A; Hankins, Matthew; Marteau, Theresa M

2014-10-01

There is some evidence for paradoxical effects of nutritional labelling on energy intake particularly amongst restrained eaters and those with a higher body mass index (BMI) resulting in greater consumption of energy from foods with a positive health message (e.g. "low-fat") compared with the same foods, unlabelled. This study aimed to investigate, in a UK general population sample, the likelihood of paradoxical effects of nutritional labelling on energy intake. Participants (n = 287) attended a London cinema and were offered a large tub of salted or toffee popcorn. Participants were randomised to receive their selected flavour with one of three labels: a green low-fat label, a red high-fat label or no label. Participants watched two film clips while completing measures of demographic characteristics, emotional state and taste of the popcorn. Following the experiment, popcorn consumption was measured. There were no main effects of nutritional labelling on consumption. Contrary to predictions neither BMI nor weight concern moderated the effect of label on consumption. There was a three-way interaction between low-fat label, weight concern and socioeconomic status (SES) such that weight-concerned participants of higher SES who saw a low-fat label consumed more than weight unconcerned participants of similar SES (t = -2.7, P = .04). By contrast, weight-concerned participants of lower SES seeing either type of label, consumed less than those seeing no label (t = -2.04, P = .04). Nutritional labelling may have different effects in different socioeconomic groups. Further studies are required to understand fully the possible contribution of food labelling to health inequalities. Copyright © 2014 Elsevier Ltd. All rights reserved.

Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry of the Interior

International Nuclear Information System (INIS)

1986-05-01

Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig./HP) [de

A safety concern related to CANDU moderator subcooling and status of KAERI moderator circulation test (MCT) experiments

International Nuclear Information System (INIS)

Rhee, Bo W.; Kim, Hyoung T.; Kim, Tongbeum; Im, Sunghyuk

2015-01-01

The flow inside the moderator tank of a CANDU-6 reactor during full power steady state operation has been suspected to be operating in the buoyancy/inertial driven mixed convection regime as illustrated in the middle figure. At some regions of the moderator tank where the buoyancy driven upward flow and the inertial momentum driven downward flows interface counter-currently, there exist some interface regions between these two flows like the middle one, and the local temperatures at these interface regions are known to oscillate with different amplitude at various fluctuation frequencies as shown. According to a numerical simulation of the moderator flow and temperature distribution at full power steady state carried out by previous researches showed that any small disturbances in the flow or temperature may initiate the system unstable and aggravate the asymmetric flow and temperature patterns. The tests at the 3-D Moderator Test Facility (MTF) that is a representative scaled-down of CANDU reactors, reproduced the expected and observed moderator behavior in the reactor as well as the local temperature fluctuations arising from the delicate balance of forced and buoyancy induced flow. This observation raised a safety concern as the local moderator temperature at some regions showed fluctuations with an amplitude that may jeopardize the safety margin, i.e. the difference between the available subcooling and the subcooling requirement. The scope of this paper is to review the basis of the safety concern related to this moderator subcooling and local temperature fluctuation and describe the current status of MCT erection and some of the experiments carried so far

India's power programs and its concern over environmental safety

International Nuclear Information System (INIS)

Prasad, G.E.; Mittra, J.; Sarma, M.S.R.

2000-01-01

India's need for electrical power is enormous and per capita consumption of power is to be increased at least by 10 times to reach the level of the world average. Thermal power generation faces two-fold problems. First, there is scarcity of good quality fuel and second, increasing environmental pollution. India 's self reliant, . three stage, 'closed-fuel-cycle' nuclear power program is promising a better solution to the above problems. To ensure Radiation Protection and Safety of Radiation Sources, the Indian Nuclear Power program emphasizes upon design and engineering safety by incorporating' necessary safety features in the design, operational safety through a structured training program and typically through software packages to handle rare unsafe events and regulation by complying safety directives. A health survey among the radiation workers indicates that there is no extra threat to the public from the nuclear power program. Based on the latest technology, as available in case of the nuclear power option, it is quite possible to meet high energy requirements with least impact on the environment. (authors)

Ayurveda formulations: A roadmap to address the safety concerns

Directory of Open Access Journals (Sweden)

Kishor Patwardhan

2017-10-01

Full Text Available It is a matter of serious concern that the number of case reports pointing at a possible association between the clinical toxicity and the use of Ayurveda formulations is increasing significantly over the years in scientific medical literature. Though most of these cases are connected with the presence of heavy metals such as lead, mercury and arsenic in these formulations, there are also reports suggesting toxicity due to the presence of toxic chemicals of herbal origin. In the year 2008, the Government of India took an initiative of establishing the National Pharmacovigilance Programme for Ayurveda, Siddha and Unani drugs in a structured way. However, due to lack of sustained support, this program has now become defunct. This issue is of vital importance and needs to be addressed effectively on a priority basis. In this communication, we propose the following crucial policy interventions to be introduced at different levels: a. Amendments to Drug and Cosmetic Act, b. Issuing consumer guidelines, c. Issuing prescription guidelines, d. Issuing clinical monitoring guidelines, e. Implementation of good manufacturing guidelines, f. Promoting documentation of clinical safety, g. Identifying the sources of contamination, and, h. Provision for stringent punishment. If these policy interventions are taken up and implemented, a significant positive change in the scenario can be expected in the near future.

It’s all about safety signs!

CERN Multimedia

2013-01-01

Their first occurrence may date back to the Egyptian hieroglyphs, but today they can be found everywhere: on our clothes labels as care labels, in train stations and airports to guide us, during the Olympics to identify various sports, on our dashboards, etc.   Safety wise, they are used to indicate a danger, a prohibition, an obligation, a safety exit, firefighting equipment, etc. The HSE Unit has decided to update the 150 safety signs used on the CERN site and, to correspond with this, recently published a Safety Guideline GS-1-0-1, available on the Safety Unit website. The Guideline contains more than 150 safety signs as well as diverse information regarding the meaning of the signs, their location and how to use them. The Guideline will shortly be completed with a new Safety Rule that will replace the former Security Code A3, “Safety colours and safety signs”. Please be informed that you also have the option to create new safety signs, provided that you first g...

Food Safety Concerns and other Factors Affecting Iran’s Pistachio Exports to EU, Australia, and Japan

OpenAIRE

Ashktorab, Niloofar; Saghaian, Sayed Hossein; Shahnoushi, Naser

2013-01-01

In this paper, the impact of food safety concerns on Iran’s pistachio export demand was investigated. Panel data and panel cointegration analyses were used to estimate the export demand function of Iran’s pistachio nuts to the European Union (EU), Japan, and Australia for the period of 1997 to 2006 so that the relationship between factors affecting Iran’s pistachio exports can be examined. The results show the existence of long-run relationships among the variables that have a significant imp...

16 CFR 1211.25 - Product certification and labeling by importers.

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by importers. 1211.25 Section 1211.25 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT... § 1211.25 Product certification and labeling by importers. (a) General. The importer of any automatic...

Progress report concerning safety research for nuclear reactor facilities

International Nuclear Information System (INIS)

1978-01-01

Examination and evaluation of safety research results for nuclear reactor facilities have been performed, as more than a year has elapsed since the plan had been initiated in April, 1976, by the special sub-committee for the safety of nuclear reactor facilities. The research is carried out by being divided roughly into 7 items, and seems to be steadily proceeding, though it does not yet reach the target. The above 7 items include researches for (1) criticality accident, (2) loss of coolant accident, (3) safety for light water reactor fuel, (4) construction safety for reactor facilities, (5) reduction of release of radioactive material, (6) safety evaluation based on the probability theory for reactor facilities, and (7) aseismatic measures for reactor facilities. With discussions on the progress and the results of the research this time, research on the behaviour on fuel in abnormal transients including in-core and out-core experiments has been added to the third item, deleting the power-cooling mismatch experiment in Nuclear Safety Research Reactor of JAERI. Also it has been decided to add two research to the seventh item, namely measured data collection, classification and analysis, and probability assessment of failures due to an earthquake. For these 7 items, the report describes the concrete contents of research to be performed in fiscal years of 1977 and 1978, by discussing on most rational and suitable contents conceivable at present. (Wakatsuki, Y.)

Food safety--who is responsible?

Science.gov (United States)

Rollin, Bernard E

2006-01-01

Though scientists believe that issues of risk can be handled without appeal to values in general or ethics in particular, this is demonstrably false. The very notion of risk is enmeshed in a complex of social ethics. This is clearly true with regard to food safety. With this in mind, it is plausible to affirm that responsibility for food safety at a given point in the chain from producer to consumer rests with the person or entity under whose control the management of that risk most plausibly lies. This principle is illustrated with various examples and with clear cases of industry shouldering and avoiding responsibility. An additional ethical concern relevant to food safety arises from genetically modified foods. Given that the situation here is uncertain and risk unknown, it is hard to see who is responsible for managing such risks. It is arguable that this situation militates in favor of labeling, since consumers are in effect research subjects. The reasonable moral approach to risk we have outlined is jeopardized by the societal tendency towards "victimology" and abrogation of personal responsibility. In such a world, it is incumbent on industry to educate the public with regard to consumer minimization of food safety risks, the impossibility of zero-risk situations, and the economic costs to freedom of protectionism.

Testing for Giftedness: The Pros, Cons and Concerns.

Science.gov (United States)

Shaughnessy, Michael F.; Fickling, Kris L.

1993-01-01

This paper reviews the advantages and disadvantages of testing for giftedness, the repercussions of testing and not testing, issues concerning intelligence quotients, and the effects of labeling children. (JDD)

Safety risks with investigational drugs: Pharmacy practices and perceptions in the veterans affairs health system.

Science.gov (United States)

Cruz, Jennifer L; Brown, Jamie N

2015-06-01

Rigorous practices for safe dispensing of investigational drugs are not standardized. This investigation sought to identify error-prevention processes utilized in the provision of investigational drug services (IDS) and to characterize pharmacists' perceptions about safety risks posed by investigational drugs. An electronic questionnaire was distributed to an audience of IDS pharmacists within the Veteran Affairs Health System. Multiple facets were examined including demographics, perceptions of medication safety, and standard processes used to support investigational drug protocols. Twenty-one respondents (32.8% response rate) from the Northeast, Midwest, South, West, and Non-contiguous United States participated. The mean number of pharmacist full-time equivalents (FTEs) dedicated to the IDS was 0.77 per site with 0.2 technician FTEs. The mean number of active protocols was 22. Seventeen respondents (81%) indicated some level of concern for safety risks. Concerns related to the packaging of medications were expressed, most notably lack of product differentiation, expiration dating, barcodes, and choice of font size or color. Regarding medication safety practices, the majority of sites had specific procedures in place for storing and securing drug supply, temperature monitoring, and prescription labeling. Repackaging bulk items and proactive error-identification strategies were less common. Sixty-seven percent of respondents reported that an independent double check was not routinely performed. Medication safety concerns exist among pharmacists in an investigational drug service; however, a variety of measures have been employed to improve medication safety practices. Best practices for the safe dispensing of investigational medications should be developed in order to standardize these error-prevention strategies.

Predictors of Likelihood of Speaking Up about Safety Concerns in Labour and Delivery

Science.gov (United States)

Lyndon, Audrey; Sexton, J. Bryan; Simpson, Kathleen Rice; Rosenstein, Alan; Lee, Kathryn A.; Wachter, Robert M.

2011-01-01

Background Despite widespread emphasis on promoting “assertive communication” by caregivers as essential to patient safety improvement efforts, fairly little is known about when and how clinicians speak up to address safety concerns. In this cross-sectional study we use a new measure of speaking up to begin exploring this issue in maternity care. Methods We developed a scenario-based measure of clinician’s assessment of potential harm and likelihood of speaking up in response to perceived harm. We embedded this scale in a survey with measures of safety climate, teamwork climate, disruptive behaviour, work stress, and personality traits of bravery and assertiveness. The survey was distributed to all registered nurses and obstetricians practicing in two US Labour & Delivery units. Results The response rate was 54% (125 of 230 potential respondents). Respondents were experienced clinicians (13.7 ± 11 years in specialty). Higher perception of harm, respondent role, specialty experience, and site predicted likelihood of speaking up when controlling for bravery and assertiveness. Physicians rated potential harm in common clinical scenarios lower than nurses did (7.5 vs. 8.4 on 2–10 scale; p<0.001). Some participants (12%) indicated they were unlikely to speak up despite perceiving high potential for harm in certain situations. Discussion This exploratory study found nurses and physicians differed in their harm ratings, and harm rating was a predictor of speaking up. This may partially explain persistent discrepancies between physicians and nurses in teamwork climate scores. Differing assessments of potential harms inherent in everyday practice may be a target for teamwork intervention in maternity care. PMID:22927492

Adolescent Homosexuality and Concerns Regarding Disclosure.

Science.gov (United States)

Harrison, Therese W.

2003-01-01

With threats of being labeled abnormal or facing rejection, homosexual adolescents are pressured to hide their sexual identities. To provide optimal anticipatory guidance and support, professionals must understand the natural development of sexual attraction and the disclosure concerns and risks for developing homosexual adolescents (e.g., risk…

New Automated System Available for Reporting Safety Concerns | Poster

Science.gov (United States)

A new system has been developed for reporting safety issues in the workplace. The Environment, Health, and Safety’s (EHS’) Safety Inspection and Issue Management System (SIIMS) is an online resource where any employee can report a problem or issue, said Siobhan Tierney, program manager at EHS.

On the Issue of Regional Policy in the Sphere of Ecological Safety (Based on the Documents Concerning the Republic of Kalmykia

Directory of Open Access Journals (Sweden)

Elza I. Mantaeva

2018-03-01

Full Text Available The regional government should provide ecological safety in order to ensure stable social and economic development of the country. The article outlines theoretical approach and recommendations on practice concerning ecological issues, investigates state policy aiming to preserve nature and analyses sources of threat to ecological safety in the region. The modern paradigm of the country’s and region’s development is characterized by the combination of ecological and economic policy. The ecological policy providing measures for efficient use of natural resources, their protection and restoration is implemented in the economic strategy of highly developed countries and encourages stable social and economic development of the country and the region. Some researchers assert that Russia’s most regions do not possess sufficient resources necessary to implement structural shifts which can eliminate the main threats to ecological safety. The Republic of Kalmykia can be included into this list. It is rich in natural resources but they are not restored due to the lack of regulation for efficient consumption. The main concerns of the republic are water supply, desertification, and pollution of atmosphere, waste disposal, and protection of wildlife and environment, preservation of hunting ground, forest management. The republic generates no electricity so it is delivered by neighboring regions. The republic should use the renewable ways of producing energy which can contribute to the energy and ecological safety and can attract new investment funds. There is an urgent need for stricter state regulation to ensure socioeconomic development and ecological safety in Kalmykia.

Is there a price premium for energy efficiency labels? Evidence from the Introduction of a Label in Korea

International Nuclear Information System (INIS)

Park, Ju Young

2017-01-01

This study examines the price premium from Korea's Energy Efficiency Grade Label. The Korean government recently began energy certification of televisions, providing a setting to analyze a possible price effect of the new label. Hedonic regression results seem to show that a price premium exists for products with the Energy Efficiency Grade Label. However, potential unobserved heterogeneity is a concern. Difference-in-difference and fixed-effects models are used to capture the net effect of the label by controlling for time and product differences. The results suggest that any price premium does not result from the energy efficiency label itself. Instead, energy-efficient products already had higher prices before the introduction of the energy efficiency label. The finding turns our attention to the importance of careful design of labeling programs. - Highlights: • The study examines the price premium from Korea's Energy Efficiency Grade Label. • Difference-in-difference and fixed-effects models are used to address potential unobserved heterogeneity and to capture the net effect of the label by controlling for time and product differences. • The result suggests that any price premium does not result from the energy efficiency label itself; instead, energy-efficient products already have higher prices before the introduction of the energy efficiency label. • The finding turns our attention to the importance of careful design of labeling programs.

75 FR 52601 - Food Labeling; Labeling of Food Made From AquAdvantage Salmon; Public Hearing; Request for Comments

Science.gov (United States)

2010-08-26

... summary of an oral presentation: Juanita Yates, Center for Food Safety and Applied Nutrition, Food and... Part II Department of Health and Human Services Food and Drug Administration Food Labeling... 26, 2010 / Notices#0;#0; [[Page 52602

Labeling of Cosmetic Products

Directory of Open Access Journals (Sweden)

Nicola Lionetti

2018-03-01

Full Text Available The labeling of cosmetic products provides a set of obligations, as reported in the Regulation 1223/2009, which came into force in Europe in July 2013. The indications reported on the label are intended to enable the clear identification of the functionality and proper use of cosmetics, ensure the protection of the consumer from the commercial aspects and, above all, from the safety point of view. Moreover, it should allow quick tracing of the product details and all info of toxicological relevance. However, the misuse of this tool often leads, on one side, to confusion among cosmetics, pharmaceuticals, medical devices, and biocides. On the other side, it gives rise to fanciful interpretations by a huge number of web users, who pretend to be able to judge the quality of a cosmetic product just by reading the ingredients list. This article points out the concrete purpose of cosmetic labels, in order to shed light on the use of certain categories of ‘controversial’ ingredients and on the real quality concepts of cosmetic products. Indeed, when properly interpreted, cosmetic labels represent a good tool for the professional investigation of adverse reactions to cosmetics.

Production of neutrons in particle accelerators: a PNRI safety concern

International Nuclear Information System (INIS)

Garcia, Corazon M.; Cayabo, Lynette B.; Artificio, Thelma P.; Melendez, Johnylen V.; Piquero, Myrna E.; Parami, Vangeline K.

2002-09-01

In the safety assessment made for the first cyclotron facility in the Philippines, that is the cyclotron in the P.E.T. (Positron Emission Tomography) center of the St. Luke's Medical Center, the concern on the production of neutrons associated with the operation of particle accelerators has been identified. This takes into consideration the principles in the operation of particle accelerators and the associated production of neutrons resulting from their operation, the hazards and risks in their operation. The Bureau of Health Devices and Technology (BHDT) of the Department of Health in the Philippines regulates and controls the presently existing six (6) linear accelerators distributed in different hospitals in the country, being classified as x-ray producing devices. From the results of this study, it is evident that the production of neutrons from the operation of accelerators, produces neutrons and that activation due to neutrons can form radioactive materials. The PNRI (Philippine Nuclear Research Institute) being mandated by law to regulate and control any equipment or devices producing or utilizing radioactive materials should take the proper steps to subject all accelerator facilities and devices in the Philippines such as linear accelerators under its regulatory control in the same manner as it did with the first cyclotron in the country. (Author)

What do Australian consumers, pharmacists and prescribers think about documenting indications on prescriptions and dispensed medicines labels?: A qualitative study.

Science.gov (United States)

Garada, Mona; McLachlan, Andrew J; Schiff, Gordon D; Lehnbom, Elin C

2017-11-15

Documenting the indication on prescriptions and dispensed medicines labels is not standard practice in Australia. However, previous studies that have focused on the content and design of dispensed medicines labels, have suggested including the indication as a safety measure. The aim of this study was to investigate the perspectives of Australian consumers, pharmacists and prescribers on documenting the indication on prescriptions and dispensed medicines labels. Semi-structured interviews were conducted and mock-up of dispensed medicines labels were designed for participants. Consumers (n = 19) and pharmacists (n = 7) were recruited by convenience sample at community pharmacies in Sydney (Australia) and prescribers (n = 8), including two medical students, were recruited through snowballing. Thirty-four participants were interviewed. Most participants agreed that documenting the indication would be beneficial especially for patients who are forgetful or take multiple medications. Participants also believed it would improve consumers' medication understanding and adherence. Prescribers and pharmacists believed it could help reduce prescribing and dispensing errors by matching the drug/dosage to the correct indication. Prescribers refrained from documenting the indication to protect patients' privacy; however, most patients did not consider documenting the indication as a breach of privacy. Prescribers raised concerns about the extra time to include indications on prescriptions and best language to document indications, using plain language as opposed to medical terminology. All interviewed stakeholders identified numerous benefits of documenting the indication on prescriptions and dispensed medicines labels. Whether these potential benefits can be realized remains unknown and addressing prescribers' concern regarding the time involved in documenting the indication on prescriptions remains a challenge for vendors of electronic medication management systems.

What do Australian consumers, pharmacists and prescribers think about documenting indications on prescriptions and dispensed medicines labels?: A qualitative study

Directory of Open Access Journals (Sweden)

Mona Garada

2017-11-01

Full Text Available Abstract Background Documenting the indication on prescriptions and dispensed medicines labels is not standard practice in Australia. However, previous studies that have focused on the content and design of dispensed medicines labels, have suggested including the indication as a safety measure. The aim of this study was to investigate the perspectives of Australian consumers, pharmacists and prescribers on documenting the indication on prescriptions and dispensed medicines labels. Methods Semi-structured interviews were conducted and mock-up of dispensed medicines labels were designed for participants. Consumers (n = 19 and pharmacists (n = 7 were recruited by convenience sample at community pharmacies in Sydney (Australia and prescribers (n = 8, including two medical students, were recruited through snowballing. Results Thirty-four participants were interviewed. Most participants agreed that documenting the indication would be beneficial especially for patients who are forgetful or take multiple medications. Participants also believed it would improve consumers’ medication understanding and adherence. Prescribers and pharmacists believed it could help reduce prescribing and dispensing errors by matching the drug/dosage to the correct indication. Prescribers refrained from documenting the indication to protect patients’ privacy; however, most patients did not consider documenting the indication as a breach of privacy. Prescribers raised concerns about the extra time to include indications on prescriptions and best language to document indications, using plain language as opposed to medical terminology. Conclusions All interviewed stakeholders identified numerous benefits of documenting the indication on prescriptions and dispensed medicines labels. Whether these potential benefits can be realized remains unknown and addressing prescribers’ concern regarding the time involved in documenting the indication on prescriptions

Juvenile Animal Testing: Assessing Need and Use in the Drug Product Label.

Science.gov (United States)

Baldrick, Paul

2018-01-01

Juvenile animal testing has become an established part of drug development to support safe clinical use in the human pediatric population and for eventual drug product label use. A review of European Paediatric Investigation Plan decisions showed that from 2007 to mid-2017, 229 drugs had juvenile animal work requested, almost exclusively incorporating general toxicology study designs, in rat (57.5%), dog (8%), mouse (4.5%), monkey (4%), pig (2%), sheep (1%), rabbit (1%), hamster (0.5%), and species not specified (21.5%). A range of therapeutic areas were found, but the most common areas were infectious diseases (15%), endocrinology (13.5%), oncology (13%), neurology (11%), and cardiovascular diseases (10%). Examination of major clinical indications within these therapeutic areas showed some level of consistency in the species of choice for testing and the pediatric age that required support. Examination of juvenile animal study findings presented in product labels raises questions around how useful the data are to allow prescribing the drug to a child. It is hopeful that the new ICH S11 guideline "Nonclinical Safety Testing in Support of Development of Pediatric Medicines" currently in preparation will aid drug developers in clarifying the need for juvenile animal studies as well as in promoting a move away from toxicology studies with a conventional design. This would permit more focused testing to examine identified areas of toxicity or safety concerns and clarify the presentation/interpretation of juvenile animal study findings for proper risk assessment by a drug prescriber.

Concern for older parts

International Nuclear Information System (INIS)

Titus, E.; Spink, T.; Cookson, B.; Tenera, L.P.

1992-01-01

For the last half decade, regulatory expectations of the procurement process for nuclear commercial-grade safety-related materials have increase. The changes have been driven by concern for fraudulent or misrepresented parts and the loss of original equipment manufacturers. The industry responded to these concerns by developing improved procurement programs that changed how parts were specified and received and provided for verification of attributes that were critical to the successful performance of safety functions(s). Like its counterparts, Duquesne Light Company (DLCo), Beaver Valley power station began applying these enhanced requirements to procurements initiated after January 1, 1990, in response to the Nuclear Management and Resources Council initiative on dedication. Procurements prior to this data were not subject to the new requirements

Regulatory overview report 2013 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2014-06-01

The Swiss Federal Nuclear Safety Inspectorate (ENSI) acting as the regulatory body of the Swiss Federation assesses and monitors nuclear facilities in Switzerland: these include five nuclear power plants, the interim storage facilities based at each plant, the Central Interim Storage Facility (ZWILAG) at Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI) and the two universities of Basel and Lausanne. Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the overview required concerning nuclear safety. It ensures that the facilities comply with regulations. Its regulatory responsibilities include the transport of radioactive materials from and to nuclear facilities and the preparations for a deep geological repository for nuclear waste. ENSI maintains its own emergency organisation, an integral part of the national emergency structure. It provides the public with information on particular events in nuclear facilities. This Surveillance Report describes operational experience, systems technology, radiological protection and management in all the nuclear facilities. Generic issues relevant to all facilities such as probabilistic safety analyses are described. In 2013, the five nuclear power plants in Switzerland (Beznau Units 1 and 2, Muehleberg, Goesgen and Leibstadt) were all operated safely and had complied with their approved operating conditions. The nuclear safety at all plants was rated as being good. 34 events were reported. During operation, no reactor scrams were recorded. On the INES scale, ranging from 0-7, ENSI rated all reportable events as Level 0. The ENSI safety evaluation reflects both reportable events and the results of the approximately 460 inspections conducted during 2013. ZWILAG consists of several storage halls, a conditioning plant and a plasma plant. At the end of 2013, the cask storage hall

Read the Label First: Protect Your Pets

Science.gov (United States)

Learn about the importance of reading pet products labels before purchasing and using any product to insure the safety of your pets. Find tips for ways to reduce the changes of pets accessing potentially dangerous products.

9 CFR 355.32 - Labeling required.

Science.gov (United States)

2010-01-01

... CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; INSPECTION, CERTIFICATION, AND... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling required. 355.32 Section 355.32 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY...

9 CFR 355.36 - Obsolete labels.

Science.gov (United States)

2010-01-01

... CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; INSPECTION, CERTIFICATION, AND... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Obsolete labels. 355.36 Section 355.36 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY...

Safety Issues Concerning the Medical Use of Cannabis and Cannabinoids

Directory of Open Access Journals (Sweden)

Mark A Ware

2005-01-01

Full Text Available Safety issues are a major barrier to the use of cannabis and cannabinoid medications for clinical purposes. Information on the safety of herbal cannabis may be derived from studies of recreational cannabis use, but cannabis exposure and effects may differ widely between medical and recreational cannabis users. Standardized, quality-controlled cannabinoid products are available in Canada, and safety profiles of approved medications are available through the Canadian formulary. In the present article, the evidence behind major safety issues related to cannabis use is summarized, with the aim of promoting informed dialogue between physicians and patients in whom cannabinoid therapy is being considered. Caution is advised in interpreting these data, because clinical experience with cannabinoid use is in the early stages. There is a need for long-term safety monitoring of patients using cannabinoids for a wide variety of conditions, to further guide therapeutic decisions and public policy.

Safety regulations concerning instrumentation and control systems for research reactors

International Nuclear Information System (INIS)

El-Shanshoury, A.I.

2009-01-01

A brief study on the safety and reliability issues related to instrumentation and control systems in nuclear reactor plants is performed. In response, technical and strategic issues are used to accomplish instrumentation and control systems safety. For technical issues there are ; systems aspects of digital I and C technology, software quality assurance, common-mode software, failure potential, safety and reliability assessment methods, and human factors and human machine interfaces. The strategic issues are the case-by-case licensing process and the adequacy of the technical infrastructure. The purpose of this work was to review the reliability of the safety systems related to these technical issues for research reactors

On-site preparation of technetium-99m labeled human serum albumin for clinical application

International Nuclear Information System (INIS)

Wang Yuhfeng; Chuang Meihua; Cham Thauming; Chung Meiing; Chiu Jainnshiun

2007-01-01

Technetium-99m labeled human serum albumin (Tc-99m HSA) is an important radiopharmaceutical for clinical applications, such as cardiac function tests or protein-losing gastroenteropathy assessment. However, because of transfusion-induced infectious diseases, the safety of serum products is a serious concern. In this context, serum products acquired from patients themselves are the most ideal tracer. However, the development of rapid separation and easy clinical labeling methods is not yet well established. Under such situation, products from the same ethnic group or country are now recommended by the World Health Organization as an alternative preparation. This article describes the on-site preparation of Tc-99m HSA from locally supplied serum products. Different formulations were prepared and the labeling efficiency and stability were examined. Radio-labeling efficiencies were more than 90% in all preparation protocols, except for one that omitted the stannous solution. The most cost-effective protocol contained HSA 0.1 mg, treated with stannous fluoride 0.2 mg, and mixed with Tc-99m pertechnetate 30 mCi. A biodistribution study was performed in rats using a gamma camera immediately after intravenous administration of radiolabeled HSA. Tissue/organ uptake was obtained by measuring the radioactivity in organs after sacrificing the rats at timed intervals. The biologic half-life was about 32 min, determined from sequential venous blood collections. These data indicate that our preparation of Tc-99m HSA is useful and potentially applicable clinically. In addition, this on-site preparation provides the possibility of labeling a patient's own serum for subsequent clinical application. (author)

Rethinking School Safety in the Age of Empire: Militarization, Mental Health, and State Violence

Directory of Open Access Journals (Sweden)

Laura Jordan Jaffee

2018-02-01

Full Text Available Calls for stricter gun control and mental health screening often come on the heels of school shootings, which have raised national concerns about school safety. The implication is that people with psychiatric disabilities are dangerous or threatening, and that preventing them from owning guns will make schools safer. This paper challenges this assumption by considering dominant discourses about school safety and mental health alongside the increasing militarization of U.S. schools. Advocating reducing violence by identifying individuals with psychiatric disabilities—or those labelled with mental illnesses presumed to render them dangerous—erases the profound state violence schools engender in the service of empire while perpetuating ableist assumptions about people with psychiatric disabilities. In the age of empire and endless imperialist war, we need to challenge prevailing conceptions of both school safety and mental health.

Evaluation of Four Bedside Test Systems for Card Performance, Handling and Safety.

Science.gov (United States)

Giebel, Felix; Picker, Susanne M; Gathof, Birgit S

2008-01-01

SUMMARY: OBJECTIVE: Pretransfusion ABO compatibility testing is a simple and required precaution against ABO-incompatible transfusion, which is one of the greatest threats in transfusion medicine. While distinct agglutination is most important for correct test interpretation, protection against infectious diseases and ease of handling are crucial for accurate test performance. Therefore, the aim of this study was to evaluate differences in test card design, handling, and user safety. DESIGN: Four different bedside test cards with pre-applied antibodies were evaluated by 100 medical students using packed red blood cells of different ABO blood groups. Criteria of evaluation were: agglutination, labelling, handling, and safety regarding possible user injuries. Criteria were rated subjectively according to German school notes ranging from 1 = very good to 6 = very bad/insufficient. RESULTS: Overall, all cards received very good/good marks. The ABO blood group was identified correctly in all cases. Three cards (no. 1, no. 3, no. 4) received statistically significant (p labelling (1.5 vs. 2.2-2.4), handling (1.9-2.0 vs. 2.5), and user safety (2.5 vs. 3.4). Analysis of card self-explanation revealed no remarkable differences. CONCLUSION: Despite good performance of all card systems tested, the best results when including all criteria evaluated were obtained with card no. 4 (particularly concerning clear agglutination), followed by cards no. 2, no. 1, and no. 3.

Microbial status and product labelling of 58 original tattoo inks

DEFF Research Database (Denmark)

Høgsberg, T; Saunte, D M; Frimodt-møller, Niels

2011-01-01

and labelled according to REACH as if they were plain chemicals. Objective  The objective of this study was to check the microbial product safety of unopened and opened tattoo ink stock bottles. Packaging, labelling, preservation, sterility and contamination with micro-organisms were studied. Methods  Physical......-pathogenic environmental bacteria. Yeast or moulds were detected in none of the samples. A total of 31% of the manufacturers informed only about the brand name. No information about content, sterility, risks or expiry date was indicated on the label. A total of 42% claimed sterility of their inks. A total of 54% labelled...

Label and label-free based surface-enhanced Raman scattering for pathogen bacteria detection: A review.

Science.gov (United States)

Liu, Yu; Zhou, Haibo; Hu, Ziwei; Yu, Guangxia; Yang, Danting; Zhao, Jinshun

2017-08-15

Rapid, accurate detection of pathogen bacteria is a highly topical research area for the sake of food safety and public health. Surface-enhanced Raman scattering (SERS) is being considered as a powerful and attractive technique for pathogen bacteria detection, due to its sensitivity, high speed, comparatively low cost, multiplexing ability and portability. This contribution aims to give a comprehensive overview of SERS as a technique for rapid detection of pathogen bacteria based on label and label-free strategies. A brief tutorial on SERS is given first of all. Then we summarize the recent trends and developments of label and label-free based SERS applied to detection of pathogen bacteria, including the relatively complete interpretation of SERS spectra. In addition, multifunctional SERS platforms for pathogen bacteria in matrix are discussed as well. Furthermore, an outlook of the work done and a perspective on the future directions of SERS as a reliable tool for real-time pathogen bacteria detection are given. Copyright © 2017 Elsevier B.V. All rights reserved.

Geological disposal of nuclear waste: II. From laboratory data to the safety analysis – Addressing societal concerns

International Nuclear Information System (INIS)

Grambow, Bernd; Bretesché, Sophie

2014-01-01

Highlights: • Models for repository safety can only partly be validated. • Long term risks need to be translated in the context of societal temporalities. • Social sciences need to be more strongly involved into safety assessment. - Abstract: After more than 30 years of international research and development, there is a broad technical consensus that geologic disposal of highly-radioactive waste will provide for the safety of humankind and the environment, now, and far into the future. Safety analyses have demonstrated that the risk, as measured by exposure to radiation, will be of little consequence. Still, there is not yet an operating geologic repository for highly-radioactive waste, and there remains substantial public concern about the long-term safety of geologic disposal. In these two linked papers, we argue for a stronger connection between the scientific data (paper I, Grambow et al., 2014) and the safety analysis, particularly in the context of societal expectations (paper II). In this paper (II), we assess the meaning of the technical results and derived models (paper I) for the determination of the long-term safety of a repository. We consider issues of model validity and their credibility in the context of a much broader historical, epistemological and societal context. Safety analysis is treated in its social and temporal dimensions. This perspective provides new insights into the societal dimension of scenarios and risk analysis. Surprisingly, there is certainly no direct link between increased scientific understanding and a public position for or against different strategies of nuclear waste disposal. This is not due to the public being poorly informed, but rather due to cultural cognition of expertise and historical and cultural perception of hazards to regions selected to host a geologic repository. The societal and cultural dimension does not diminish the role of science, as scientific results become even more important in distinguishing

Introduction of a pet food safety law in Japan

Directory of Open Access Journals (Sweden)

Katsuaki Sugiura

2009-06-01

Full Text Available In response to a growing concern among Japanese people over the safety of pet food marketed in Japan, a Pet Food Safety Law was approved by the Diet in June 2008 and will be enforced in June 2009. The law obliges manufacturers and importers of pet food to observe the standards for production methods and labelling and compositional specifications set by the Ministry of the Environment (MoE and the Ministry of Agriculture, Forestry and Fisheries (MAFF. The law also obliges manufacturers, importers and distributors (excluding retailers of pet food to keep records of the name and quantity of pet food manufactured, imported and distributed. Within the compositional specifications, maximum residue limits have been established for aflatoxin B1 and certain organophosphorus pesticides and chemical preservatives. The establishment of standards for other mycotoxins, heavy metals, organochloride pesticides and other additives is scheduled for the near future.

9 CFR 317.308 - Labeling of meat or meat food products with number of servings.

Science.gov (United States)

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of meat or meat food products with number of servings. 317.308 Section 317.308 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 317.308 Labeling of meat or meat food products with number of servings. The label of...

Effectively managing public concerns about immunization safety

Directory of Open Access Journals (Sweden)

2002-01-01

Full Text Available Los beneficios de la vacunación frente a las enfermedades prevenibles de este modo son muy superiores a sus mínimos riesgos. Con el fin de mantener o fortalecer los programas nacionales de vacunación, los trabajadores de todos los niveles de la salud pública deberían recibir formación sobre los temas relacionados con la vacunación y estar preparados para responder a las dudas planteadas por el público. Una respuesta rápida y franca a los temores del público acerca de las vacunas podría garantizar la integridad de los programas de vacunación en todo el continente americano, según el documento "Directrices para enfrentarse a los temores sobre la seguridad de las vacunaciones" (Guidelines for Managing Immunization Safety Concerns, elaborado por la División de Vacunas e Inmunización de la Organización Panamericana de la Salud (OPS y resumido aquí. Todo acontecimiento médico que se considere posiblemente relacionado con una vacuna debe ser investigado en el ámbito local. Si su distribución temporal y los síntomas respaldan la sospecha de que pueda estar relacionado con una vacuna, se debe iniciar una investigación más formal y, una vez finalizada, el acontecimiento debe ser clasificado en una de las cuatro categorías siguientes: 1 relacionado con el programa, 2 relacionado con la vacuna, 3 no relacionado, o 4 desconocido (investigación no concluyente. Dependiendo de la categoría a la que haya sido asignado el acontecimiento, las acciones posteriores pueden consistir en tranquilizar a los padres, a los cuidadores y a otros adultos; comunicarse con el público y con otros trabajadores de la salud; instaurar tratamiento; corregir los errores del programa, como pueden ser la manipulación de la vacuna, su almacenamiento, su administration o los problemas relacionados con la jeringuilla; comentar con los fabricantes problemas relacionados con la calidad y eficacia de la vacuna; retirar la vacuna del mercado, o iniciar nuevas

Nuclear safety in Slovak Republic. Status of safety improvements

International Nuclear Information System (INIS)

Toth, A.

1999-01-01

Status of the safety improvements at Bohunice V-1 units concerning WWER-440/V-230 design upgrading were as follows: supplementing of steam generator super-emergency feed water system; higher capacity of emergency core cooling system; supplementing of automatic links between primary and secondary circuit systems; higher level of secondary system automation. The goal of the modernization program for Bohunice V-1 units WWER-440/V-230 was to increase nuclear safety to the level of the proposals and IAEA recommendations and to reach probability goals of the reactor concerning active zone damage, leak of radioactive materials, failures of safety systems and damage shields. Upgrading program for Mochovce NPP - WWER-440/V-213 is concerned with improving the integrity of the reactor pressure vessel, steam generators 'leak before break' methods applied for the NPP, instrumentation and control of safety systems, diagnostic systems, replacement of in-core monitoring system, emergency analyses, pressurizers safety relief valves, hydrogen removal system, seismic evaluations, non-destructive testing, fire protection. Implementation of quality assurance has a special role in improvement of operational safety activities as well as safety management and safety culture, radiation protection, decommissioning and waste management and training. The Year 2000 problem is mentioned as well

Blood specimen labelling errors: Implications for nephrology nursing practice.

Science.gov (United States)

Duteau, Jennifer

2014-01-01

Patient safety is the foundation of high-quality health care, as recognized both nationally and worldwide. Patient blood specimen identification is critical in ensuring the delivery of safe and appropriate care. The practice of nephrology nursing involves frequent patient blood specimen withdrawals to treat and monitor kidney disease. A critical review of the literature reveals that incorrect patient identification is one of the major causes of blood specimen labelling errors. Misidentified samples create a serious risk to patient safety leading to multiple specimen withdrawals, delay in diagnosis, misdiagnosis, incorrect treatment, transfusion reactions, increased length of stay and other negative patient outcomes. Barcode technology has been identified as a preferred method for positive patient identification leading to a definitive decrease in blood specimen labelling errors by as much as 83% (Askeland, et al., 2008). The use of a root cause analysis followed by an action plan is one approach to decreasing the occurrence of blood specimen labelling errors. This article will present a review of the evidence-based literature surrounding blood specimen labelling errors, followed by author recommendations for completing a root cause analysis and action plan. A failure modes and effects analysis (FMEA) will be presented as one method to determine root cause, followed by the Ottawa Model of Research Use (OMRU) as a framework for implementation of strategies to reduce blood specimen labelling errors.

Definitive closure of nuclear power plants. Aspects concerning physical safety

International Nuclear Information System (INIS)

Rodriguez, C.; Puntarulo, L.; Canibano, J.

1988-01-01

This paper analyzes the various safety requirements that must be fulfilled by nuclear power plants for their operation without restrictions, such as safeguards, nuclear safety and physical protection. Physical protection, the subject most extensively dealt by the authors, is defined as safety measures aimed at providing protection against deliberate hostile deeds, such as robberies or non-authorized transport of radioactive materials or sabotage in nuclear facilities, performed either by individuals or by groups of individuals. (Author)

Ethical considerations and proposed guidelines for the use of radio frequency identification: especially concerning its use for promoting public safety and national security.

Science.gov (United States)

Anderson, Amber McKee; Labay, Vladimir

2006-04-01

Radio Frequency Identification (RFID) is quickly growing in its applications. A variety of uses for the technology are beginning to be developed, including chips which can be used in identification cards, in individual items, and for human applications, allowing a chip to be embedded under the skin. Such chips could provide numerous benefits ranging from day-to-day convenience to the increased ability of the federal government to adequately ensure the safety of its citizens. However, there are also valid concerns about the potential of this technology to infringe on privacy, creating fears of a surveillance society. These are concerns that must be addressed quickly, with sensitivity to individual interests and societal welfare, allowing humanity to reap the benefits of convenience and safety without paying an unacceptable price in the loss of privacy.

Considerations concerning the reliability of reactor safety equipment

International Nuclear Information System (INIS)

Furet, J.; Guyot, Ch.

1967-01-01

A review is made of the circumstances which favor a good collection of maintenance data at the C.E.A. The large amount of data to be treated has made necessary the use of a computer for analyzing automatically the results collected. Here, only particular aspects of the reliability from the point of view of the electronics used for nuclear reactor control will be dealt with: sale and unsafe failures; probability of survival (in the case of reactor safety); availability. The general diagrams of the safety assemblies which have been drawn up for two types of reactor (power reactor and low power experimental reactor) are given. Results are presented of reliability analysis which could be applied to the use of functional modular elements, developed industrially in France. Improvement of this reliability appears to be fairly limited by an increase in the redundancy; on the other hand it is shown how it may be very markedly improved by the use of automatic tests with different frequencies for detecting unsafe failures rates of measurements for the sub-assemblies and for the logic sub-assemblies. Finally examples are given to show the incidence of the complexity and of the use of different technologies in reactor safety equipment on the reliability. (authors) [fr

Patient safety: Safety culture and patient safety ethics

DEFF Research Database (Denmark)

Madsen, Marlene Dyrløv

2006-01-01

,demonstrating significant, consistent and sometimes large differences in terms of safety culture factors across the units participating in the survey. Paper 5 is the results of a study of the relation between safety culture, occupational health andpatient safety using a safety culture questionnaire survey......Patient safety - the prevention of medical error and adverse events - and the initiative of developing safety cultures to assure patients from harm have become one of the central concerns in quality improvement in healthcare both nationally andinternationally. This subject raises numerous...... challenging issues of systemic, organisational, cultural and ethical relevance, which this dissertation seeks to address through the application of different disciplinary approaches. The main focus of researchis safety culture; through empirical and theoretical studies to comprehend the phenomenon, address...

Australian Consumers' Concerns and Preferences for Food Policy Alternatives

OpenAIRE

Umberger, Wendy J.; Scott, Emily M.; Stringer, Randy

2008-01-01

Results from a 2007 Australian consumer survey conducted at a large farmers market are used to explore the hypothesis that consumers who are more concerned about certain types of food labeling information, particularly information related to food production attributes, are more likely to support policies which help develop farmers markets and support mandatory labeling policies. Product information and attributes such as Country-of-Origin, No Growth Hormones Used, Free Range and Animals Treat...

An open-label extension study of the safety and efficacy of risperidone in children and adolescents with autistic disorder.

Science.gov (United States)

Kent, Justine M; Hough, David; Singh, Jaskaran; Karcher, Keith; Pandina, Gahan

2013-12-01

The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders. In this 6 month (26 week) open-label extension (OLE) study, patients (5-17 years of age, who completed the previous fixed-dose, 6 week, double-blind [DB] phase) were flexibly dosed with risperidone based on body weight. The maximum allowed dose was 1.25 mg/day for those weighing 20 to autistic, psychiatric, and behavioral disorders. Patients experienced some additional improvement in irritability and related behaviors. This phase-4 study is registered at ClinicalTrials.gov (NCT00576732).

Alcoholism among Hispanics--A Growing Concern.

Science.gov (United States)

Garcia, Rolando

1979-01-01

A major concern to anyone involved in the alcoholism field is the basic understanding of alcoholism as a disease that Hispanics have not yet completely accepted. Hispanics have usually labeled the use of alcoholic beverages as being embedded into Hispanic culture and have viewed alcoholism as an individual weakness to be endured in silence. (NQ)

Drug safety: Pregnancy rating classifications and controversies.

Science.gov (United States)

Wilmer, Erin; Chai, Sandy; Kroumpouzos, George

2016-01-01

This contribution consolidates data on international pregnancy rating classifications, including the former US Food and Drug Administration (FDA), Swedish, and Australian classification systems, as well as the evidence-based medicine system, and discusses discrepancies among them. It reviews the new Pregnancy and Lactation Labeling Rule (PLLR) that replaced the former FDA labeling system with narrative-based labeling requirements. PLLR emphasizes on human data and highlights pregnancy exposure registry information. In this context, the review discusses important data on the safety of most medications used in the management of skin disease in pregnancy. There are also discussions of controversies relevant to the safety of certain dermatologic medications during gestation. Copyright © 2016 Elsevier Inc. All rights reserved.

Pesticide Health and Safety Information

Science.gov (United States)

Animal Health Safe Use Practices Pest Control Food Safety Low Risk Pesticides Integrated Pest Management directed by the product label. Pesticides may be ingested if stored improperly in food or beverage ; Environment Human Health Animal Health Safe Use Practices Food Safety Environment Air Water Soil Wildlife

An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia

Directory of Open Access Journals (Sweden)

Pandina Gahan

2012-06-01

Full Text Available Abstract Background Data on the long-term efficacy, safety, and tolerability of risperidone in adolescents with schizophrenia are limited. The objective of this study was to evaluate the efficacy and safety of maintenance risperidone treatment in adolescents with schizophrenia. Methods This open-label study of adolescents aged 13 to 17 years with schizophrenia was a single extension study of two short-term double-blind risperidone studies and also enrolled subjects directly in open-label risperidone treatment. The risperidone dose was flexible and ranged from 2 to 6 mg/day. Most subjects enrolled for 6 months; a subset enrolled for 12 months. Assessment tools included the Positive and Negative Syndrome Scale total and factor scores, Clinical Global Impressions, Children’s Global Assessment Scale, adverse event (AE monitoring, vital signs, laboratory testing, and extrapyramidal symptom rating scales. Results A total of 390 subjects were enrolled; 48 subjects had received placebo in a previous double-blind study; 292 subjects had received risperidone as part of their participation in one of two previous controlled studies; and 50 subjects were enrolled directly for this study. A total of 279 subjects enrolled for 6 months of treatment, and 111 subjects enrolled for 12 months of treatment. Overall, 264 (67.7% subjects completed this study: 209 of the 279 subjects (75% in the 6-month group and 55 of the 111 subjects (50% in the 12-month group. The median mode dose was 3.8 mg/day. At 6 months, all three groups experienced improvement from open-label baseline in symptoms of schizophrenia as well as general assessments of global functioning. Improvements were generally maintained for the duration of treatment. The most common AEs (≥10% of subjects were somnolence, headache, weight increase, hypertonia, insomnia, tremor, and psychosis. Potentially prolactin-related AEs (PPAEs were reported by 36 (9% subjects. The AE profile in this study was

Measuring and improving patient safety through health information technology: The Health IT Safety Framework.

Science.gov (United States)

Singh, Hardeep; Sittig, Dean F

2016-04-01

Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety

Losing nuclear expertise - A safety concern

International Nuclear Information System (INIS)

Ziakova, M.

2002-01-01

Full text: Since the mid of eighties several important changes in human beings behaviour, which influence nuclear field, can be observed - the loss of interest in studying technical disciplines (namely nuclear), strong pressure of environmental movements, stagnation of electricity consumption and deregulation of electric markets. All these factors create conditions which are leading to the decrease of job positions related to the nuclear field connected particularly with research, design and engineering. Loss of interest in studying nuclear disciplines together with the decrease of number of job positions has led to the declining of university enrolments, closing of university departments and research reactors. In this manner just a very small number of appropriately educated new experts are brought In the same moment the additional internal factor - the relative ageing of the human workforce on both sites operators of nuclear facilities and research and engineering organisations can be observed. All these factors, if not addressed properly, could lead to the loss of nuclear expertise and the loss of nuclear expertise represents the direct thread to the nuclear safety. The latest studies have shown that at present NPPs cannot be replaced by other kinds of electric sources and in no case by renewable ones in an efficient manner. Therefore it is necessary to carefully manage knowledge gathered in the nuclear field during the years and to keep on the nuclear safety research, education and training to ensure and upgrade safe and reliable operation of existing and future nuclear facilities. This is responsibility of both the governments of the states using nuclear applications and owners of nuclear facilities. (author)

Reading the small print - labelling recommendations for orthopaedic implants.

Science.gov (United States)

Haene, Roger A; Sandhu, Ranbir S; Baxandall, Richard

2009-11-01

There exist, currently, no clear guidelines regarding standards for surgical implant labelling. Dimensions of the laminar flow canopies in orthopaedic use fixes the distance at which implant labels can be read. Mistakes when reading the label on an implant box can pose health risks for patients, and financial consequences for medical institutions. Using scientifically validated tools such as the Snellen Chart Formula, a theoretical minimum standard for text on implant labels was reached. This theoretical standard was then tested under real operating conditions. After discovering a minimum practical standard for implant labels, the authors then audited current labels in use on a wide range of orthopaedic implant packages. Furthermore, other non-text-related labelling problems were also noted. There is a definite minimum standard which should be observed when implant labels are manufactured. Implants in current use bear labels on the packaging that are of an insufficient standard to ensure patient safety in theatre. The authors have established text parameters that will increase the legibility of implant labels. In the interests of improving risk management in theatre, therefore, the authors propose a standard for orthopaedic implant labelling, and believe this will provide a useful foundation for further discussion between the orthopaedic community and implant manufacturers.

A Phase Ib open label, randomized, safety study of SANGUINATE™ in patients with sickle cell anemia

Directory of Open Access Journals (Sweden)

Hemant Misra

Full Text Available Abstract Background: Treatment of sickle cell anemia is a challenging task and despite the well understood genetic and biochemical pathway of sickle hemoglobin, current therapy continues to be limited to the symptomatic treatment of pain, supplemental oxygen, antibiotics, red blood cell transfusions and hydroxyurea. SANGUINATE is a carbon monoxide releasing molecule and oxygen transfer agent under clinical development for the treatment of sickle cell anemia and comorbidities. Methods: An open-label randomized Phase Ib study was performed in adult sickle cell anemia patients. Two dose levels of SANGUINATE were compared to hydroxyurea in 24 homozygotes for Hb SS. Twelve subjects received either a low dose (160 mg/kg of SANGUINATE or 15 mg/kg hydroxyurea. Another 12 subjects received either a high dose (320 mg/kg of SANGUINATE or 15 mg/kg hydroxyurea. The primary endpoint was the safety of SANGUINATE versus hydroxyurea in sickle cell anemia patients. Secondary endpoints included determination of the plasma pharmacokinetics and assessment of hematologic measurements. Results: Musculoskeletal related adverse events were the most common. Transient troponin I levels increased in three patients, one of whom had an increase in tricuspid regurgitant velocity; however, no clinical signs were noted. Following an assessment of vital signs, tricuspid regurgitant velocity, electrocardiogram, serum biochemistry, hematology, urinalysis, and analysis of reported adverse events, SANGUINATE was found to be safe in stable sickle cell anemia patients. Conclusions: The clinical trial met its primary objective of demonstrating an acceptable safety profile for SANGUINATE in patients with sickle cell anemia. This trial established the safety of SANGUINATE at both dose levels and permitted its advance to Phase II trials.

Improved compliance with the World Health Organization Surgical Safety Checklist is associated with reduced surgical specimen labelling errors.

Science.gov (United States)

Martis, Walston R; Hannam, Jacqueline A; Lee, Tracey; Merry, Alan F; Mitchell, Simon J

2016-09-09

A new approach to administering the surgical safety checklist (SSC) at our institution using wall-mounted charts for each SSC domain coupled with migrated leadership among operating room (OR) sub-teams, led to improved compliance with the Sign Out domain. Since surgical specimens are reviewed at Sign Out, we aimed to quantify any related change in surgical specimen labelling errors. Prospectively maintained error logs for surgical specimens sent to pathology were examined for the six months before and after introduction of the new SSC administration paradigm. We recorded errors made in the labelling or completion of the specimen pot and on the specimen laboratory request form. Total error rates were calculated from the number of errors divided by total number of specimens. Rates from the two periods were compared using a chi square test. There were 19 errors in 4,760 specimens (rate 3.99/1,000) and eight errors in 5,065 specimens (rate 1.58/1,000) before and after the change in SSC administration paradigm (P=0.0225). Improved compliance with administering the Sign Out domain of the SSC can reduce surgical specimen errors. This finding provides further evidence that OR teams should optimise compliance with the SSC.

Shelf Life of Food Products: From Open Labeling to Real-Time Measurements.

Science.gov (United States)

Corradini, Maria G

2018-03-25

The labels currently used on food and beverage products only provide consumers with a rough guide to their expected shelf lives because they assume that a product only experiences a limited range of predefined handling and storage conditions. These static labels do not take into consideration conditions that might shorten a product's shelf life (such as temperature abuse), which can lead to problems associated with food safety and waste. Advances in shelf-life estimation have the potential to improve the safety, reliability, and sustainability of the food supply. Selection of appropriate kinetic models and data-analysis techniques is essential to predict shelf life, to account for variability in environmental conditions, and to allow real-time monitoring. Novel analytical tools to determine safety and quality attributes in situ coupled with modern tracking technologies and appropriate predictive tools have the potential to provide accurate estimations of the remaining shelf life of a food product in real time. This review summarizes the necessary steps to attain a transition from open labeling to real-time shelf-life measurements.

30 CFR 56.4402 - Safety can use.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Safety can use. 56.4402 Section 56.4402 Mineral... and Combustible Liquids and Gases § 56.4402 Safety can use. Small quantities of flammable liquids drawn from storage shall be kept in safety cans labeled to indicate the contents. ...

30 CFR 57.4402 - Safety can use.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Safety can use. 57.4402 Section 57.4402 Mineral... Flammable and Combustible Liquids and Gases § 57.4402 Safety can use. Small quantities of flammable liquids drawn from storage shall be kept in safety cans labeled to indicate the contents. ...

Precautionary labelling of foods for allergen content: are we ready for a global framework?

Science.gov (United States)

2014-01-01

Food allergy appears to be on the rise with the current mainstay of treatment centred on allergen avoidance. Mandatory allergen labelling has improved the safety of food for allergic consumers. However an additional form of voluntary labelling (termed precautionary allergen labelling) has evolved on a wide range of packaged goods, in a bid by manufacturers to minimise risk to customers, and the negative impact on business that might result from exposure to trace amounts of food allergen present during cross-contamination during production. This has resulted in near ubiquitous utilisation of a multitude of different precautionary allergen labels with subsequent confusion amongst many consumers as to their significance. The global nature of food production and manufacturing makes harmonisation of allergen labelling regulations across the world a matter of increasing importance. Addressing inconsistencies across countries with regards to labelling legislation, as well as improvement or even banning of precautionary allergy labelling are both likely to be significant steps forward in improved food safety for allergic families. This article outlines the current status of allergen labelling legislation around the world and reviews the value of current existing precautionary allergen labelling for the allergic consumer. We strongly urge for an international framework to be considered to help roadmap a solution to the weaknesses of the current systems, and discuss the role of legislation in facilitating this. PMID:24791183

Precautionary labelling of foods for allergen content: are we ready for a global framework?

Science.gov (United States)

Allen, Katrina J; Turner, Paul J; Pawankar, Ruby; Taylor, Stephen; Sicherer, Scott; Lack, Gideon; Rosario, Nelson; Ebisawa, Motohiro; Wong, Gary; Mills, E N Clare; Beyer, Kirsten; Fiocchi, Alessandro; Sampson, Hugh A

2014-01-01

Food allergy appears to be on the rise with the current mainstay of treatment centred on allergen avoidance. Mandatory allergen labelling has improved the safety of food for allergic consumers. However an additional form of voluntary labelling (termed precautionary allergen labelling) has evolved on a wide range of packaged goods, in a bid by manufacturers to minimise risk to customers, and the negative impact on business that might result from exposure to trace amounts of food allergen present during cross-contamination during production. This has resulted in near ubiquitous utilisation of a multitude of different precautionary allergen labels with subsequent confusion amongst many consumers as to their significance. The global nature of food production and manufacturing makes harmonisation of allergen labelling regulations across the world a matter of increasing importance. Addressing inconsistencies across countries with regards to labelling legislation, as well as improvement or even banning of precautionary allergy labelling are both likely to be significant steps forward in improved food safety for allergic families. This article outlines the current status of allergen labelling legislation around the world and reviews the value of current existing precautionary allergen labelling for the allergic consumer. We strongly urge for an international framework to be considered to help roadmap a solution to the weaknesses of the current systems, and discuss the role of legislation in facilitating this.

'Extreme' porn? The implications of a label

OpenAIRE

Jones, Steve

2016-01-01

Despite its prevalence, the term ‘extreme’ has received little critical attention. ‘Extremity’ is routinely employed in ways that imply its meanings are self-evident. However, the adjective itself offers no such clarity. This article focuses on one particular use of the term – ‘extreme porn’ – in order to illustrate a broader set of concerns about the pitfalls of labelling. The label ‘extreme’ is typically employed as a substitute for engaging with the term’s supposed referents (here, pornogr...

Radiation safety concerns during interventional radiology

International Nuclear Information System (INIS)

Victor Raj, D.; Livingstone, Roshan Samuel

2001-01-01

Interventional radiological procedures are on the increase by virtue of the fact that these procedures replace highly invasive surgical and other procedures. Radiation dose to patients and hospital workers are of significance since these procedures tend to impart large dose to them. Moreover, long term risk from radiation absorbed by patients is of concern since the life expectancy of major fraction of patients is long after undergoing the procedure. This study intends to measure radiation dose imparted to patients as well as personnel- radiologists, technologists, nurses, etc. and estimate the risk factor involved

Nuclear safety in France in 2001

International Nuclear Information System (INIS)

Anon.

2002-01-01

This article presents the milestones of 2001 concerning nuclear safety in France: 1) the new organization of nuclear safety in France, IPSN (institute of protection and nuclear safety) and OPRI (office for protection against ionizing radiation) have merged into an independent organization: IRSN (institute of radiation protection and nuclear safety); 2) a draft bill has been proposed by the government to impose to nuclear operators new obligations concerning the transfer of information to the public; 3) nuclear safety authorities have drafted a new procedure in order to cope with the demand concerning modification of nuclear fuel management particularly the increase of the burn-up; 4) new evolutions concerning the management of a major nuclear crisis as a consequence of the terrorist attack on New-york and the accident at the AZF plant in Toulouse; 5) a point is made concerning the work of the WENRA association about the harmonization of the nuclear safety policies of its different members. (A.C.)

Off-label psychopharmacologic prescribing for children: History supports close clinical monitoring

Directory of Open Access Journals (Sweden)

Fegert Joerg M

2008-09-01

Full Text Available Abstract The review presents pediatric adverse drug events from a historical perspective and focuses on selected safety issues associated with off-label use of medications for the psychiatric treatment of youth. Clinical monitoring procedures for major psychotropic drug classes are reviewed. Prior studies suggest that systematic treatment monitoring is warranted so as to both minimize risk of unexpected adverse events and exposures to ineffective treatments. Clinical trials to establish the efficacy and safety of drugs currently being used off-label in the pediatric population are needed. In the meantime, clinicians should consider the existing evidence-base for these drugs and institute close clinical monitoring.

9 CFR 317.309 - Nutrition label content.

Science.gov (United States)

2010-01-01

... consumed,” provided that preparation and cooking instructions are clearly stated. (4) For products in... method of cooking and other preparation shall be specified prominently on the label. (c) The declaration... Section 317.309 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE...

Use and reimbursement of off-label drugs in pediatric anesthesia: the Italian experience.

Science.gov (United States)

Salvo, Ida; Landoni, Giovanni; Mucchetti, Marta; Cabrini, Luca; Pani, Luca

2014-06-01

Most of the drugs used in anesthesia are off-label in children even if they present solid clinical evidence in adults. This lack of authorization is caused by multiple factors including the difficulty in conducting research in this area (due to the ethical concerns and/or the low number of available participants, the high variability of the outcome measures) and the lack of economic interest of the pharmaceutical companies (due to the limited market). Define a list of medicinal products commonly used off-label in pediatrics anesthesia to be reimbursed by Italian National Health System. We hereby describe the methodological framework used to allow reimbursed use of a list of medicinal products, widely used off-label in pediatric patients, ensuring the best therapeutic results with the lowest possible risk for children. A task force of pediatric anesthesiologists from Italy petitioned the Italian Medicines Agency (AIFA) to allow a number of commonly utilized but off-label drugs for pediatric anesthesia to be reimbursed for specific indications. For each drug, both the supporting literature and expert opinion were used, and the resulting list of drugs allowed to be used/reimbursed officially by AIFA was significantly expanded. This paper documents one approach to the problem of off-label use of drugs for pediatric patients that can be a model for future efforts. Continuous efforts are needed from government institutions and sponsors on drug development and on drug approval process in pediatrics, as research on drug effectiveness and safety is mandatory in children as in adults. At the same time, clinicians must become more familiar with the drug-approval process, participate to sponsored trials, and perform ztrials themselves. © 2014 John Wiley & Sons Ltd.

Raspberry ketone in food supplements – High intake, few toxicity data – A cause for safety concern?

DEFF Research Database (Denmark)

Bredsdorff, Lea; Wedebye, Eva Bay; Nikolov, Nikolai Georgiev

2015-01-01

Raspberry ketone (4-(4-hydroxyphenyl)-2-butanone) is marketed on the Internet as a food supplement. The recommended intake is between 100 and 1400 mg per day. The substance is naturally occurring in raspberries (up to 4.3 mg/kg) and is used as a flavouring substance. Toxicological studies...... on raspberry ketone are limited to acute and subchronic studies in rats. When the lowest recommended daily dose of raspberry ketone (100 mg) as a food supplement is consumed, it is 56 times the established threshold of toxicological concern (TTC) of 1800 μg/day for Class 1 substances. The margin of safety (MOS......) based on a NOAEL of 280 mg/kg bw/day for lower weight gain in rats is 165 at 100 mg and 12 at 1400 mg. The recommended doses are a concern taking into account the TTC and MOS. Investigations of raspberry ketone in quantitative structure-activity relationship (QSAR) models indicated potential cardiotoxic...

Brief report: Associations between in-person and electronic bullying victimization and missing school because of safety concerns among U.S. high school students.

Science.gov (United States)

Steiner, Riley J; Rasberry, Catherine N

2015-08-01

Although associations between bullying and health risk behaviors are well-documented, research on bullying and education-related outcomes, including school attendance, is limited. This study examines associations between bullying victimization (in-person and electronic) and missing school because of safety concerns among a nationally representative sample of U.S. high school students. We used logistic regression analyses to analyze data from the 2013 national Youth Risk Behavior Survey of students in grades 9-12. In-person and electronic victimization were each associated with increased odds of missing school due to safety concerns compared to no bullying victimization. Having been bullied both in-person and electronically was associated with greater odds of missing school compared to electronic bullying only for female students and in-person bullying only for male students. Collaborations between health professionals and educators to prevent bullying may improve school attendance. Published by Elsevier Ltd.

Efficacy and safety of long-acting pasireotide in Japanese patients with acromegaly or pituitary gigantism: results from a multicenter, open-label, randomized, phase 2 study.

Science.gov (United States)

Tahara, Shigeyuki; Murakami, Mami; Kaneko, Tomomi; Shimatsu, Akira

2017-07-28

A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism. Medically naïve or inadequately controlled patients (on somatostatin analogues or dopamine agonists) were included. Primary end point was the proportion of all patients who achieved biochemical control (mean growth hormone [GH] levelsacromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg. The median age was 52 years (range, 31-79) and 20 patients were males. At month 3, 18.2% of patients (6/33; 90% confidence interval: 8.2%, 32.8%) had biochemical control (21.2% [7/33] when including a patient with mean GHacromegaly or pituitary gigantism.

Information and Communication Technologies for the Safety and Security of Fish and Fishery Products

Directory of Open Access Journals (Sweden)

Liliana Mihaela MOGA

2017-06-01

Full Text Available The food industry is becoming more customer-oriented and needs faster response times to deal with food scandals and incidents. Good traceability systems help to minimize the production and distribution of unsafe or poor quality products, thereby minimizing the potential for bad publicity, liability, and recalls. The current food labelling systems cannot guarantee that the food is authentic, good quality and safe. Therefore, traceability is applied as a tool to assist in the assurance of food safety and quality as well as to achieve consumer confidence. This paper presents comprehensive information about traceability systems and the evolution concerning the actors involved and the information about safety and quality in the food supply chain administrated within the systems. Some inventive factors, which influence the traceability systems adoption, are underlined.

Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1989. (14. annual report on SR-projects)

International Nuclear Information System (INIS)

1990-11-01

Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

Exposures Resulting in Safety and Health Concerns for Child Laborers in Less Developed Countries

Directory of Open Access Journals (Sweden)

Derek G. Shendell

2016-01-01

Full Text Available Objectives. Worldwide, over 200 million children are involved in child labor, with another 20 million children subjected to forced labor, leading to acute and chronic exposures resulting in safety and health (S&H risks, plus removal from formal education and play. This review summarized S&H issues in child labor, including forced or indentured domestic labor as other sectors of child labor. Specifically, we focused on exposures leading to S&H risks. Methods. We used PubMed, Scopus, Science Direct, and Google Scholar. References were in English, published in 1990–2015, and included data focused on exposures and S&H concerns of child labor. Results. Seventy-six journal articles were identified, 67 met criteria, 57 focused on individual countries, and 10 focused on data from multiple countries (comparing 3–83 countries. Major themes of concern were physical exposures including ergonomic hazards, chemical exposure hazards, and missed education. Childhood labor, especially forced, exploitative labor, created a significant burden on child development, welfare, and S&H. Conclusions. More field researche data emphasizing longitudinal quantitative effects of exposures and S&H risks are needed. Findings warranted developing policies and educational interventions with proper monitoring and evaluation data collection, plus multiple governmental, international organization and global economic reform efforts, particularly in lower-income, less developed countries.

Safety and proliferation concerns as constraints on nuclear power

International Nuclear Information System (INIS)

Gordon, L.

1981-01-01

Issues of safety and proliferation with respect to the nuclear option are discussed in this chapter. The basic premises underlying the author's analysis are: energy supply and use is a means to promote desired forms of development and not an end in itself; avoidance of nuclear mysticiam; avoidance of permanent discrimination; recognition of incommensurables; technological sophistication; and nuclear proliferation motivations apart from nuclear power development. A rational energy planner in a developing country will have to weigh carefully the interwoven factors of comparative costs and safety. Apart from cost considerations, the principal motivation for developing nuclear power is energy security

9 CFR 381.409 - Nutrition label content.

Science.gov (United States)

2010-01-01

... basis of “as consumed,” provided that preparation and cooking instructions are clearly stated. (4) For... method of cooking and other preparation shall be specified prominently on the label. (c) The declaration... Section 381.409 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE...

Machine and Woodworking Tool Safety. Module SH-24. Safety and Health.

Science.gov (United States)

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on machine and woodworking tool safety is one of 50 modules concerned with job safety and health. This module discusses specific practices and precautions concerned with the efficient operation and use of most machine and woodworking tools in use today. Following the introduction, 13 objectives (each keyed to a page in the…

78 FR 8362 - Energy Labeling Rule

Science.gov (United States)

2013-02-06

... process. Specifically, it urged the Commission to direct brick-and-mortar retailers to ``affirmatively... equipment in brick-and-mortar stores, the revision will ensure that such consumers have the same label.... First, in response to Earthjustice's concerns, the final rule (Sec. 305.14(b)(2)) states that brick-and...

16 CFR 1702.13 - Labeling and packaging samples.

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling and packaging samples. 1702.13 Section 1702.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION...

Fire safety of wood construction

Science.gov (United States)

Robert H. White; Mark A. Dietenberger

2010-01-01

Fire safety is an important concern in all types of construction. The high level of national concern for fire safety is reflected in limitations and design requirements in building codes. These code requirements and related fire performance data are discussed in the context of fire safety design and evaluation in the initial section of this chapter. Because basic data...

Vaccine Safety

Science.gov (United States)

... During Pregnancy Frequently Asked Questions about Vaccine Recalls Historical Vaccine Safety Concerns FAQs about GBS and Menactra ... CISA Resources for Healthcare Professionals Evaluation Current Studies Historical Background 2001-12 Publications Technical Reports Vaccine Safety ...

Situation of the environmental surveillance and situation of the water table and rivers labelling around nuclear sites and old radioactive waste storages. Report for the high committee for the transparency and information on nuclear safety

International Nuclear Information System (INIS)

2008-01-01

The High Committee for the openness and information on nuclear safety (H.C.T.I.S.N.) requested a study at I.R.S.N. concerning the situation of the surveillance of media and their quality and the diffusion of this information near the public, the identification of ground water or rivers that would present a radiological or chemical labelling, the link of these elements with the future national network of the radioactivity measurement in environment. This assessment must also allow to take stock of the situation relative to the surveillance of the quality of ground water that flow out of the level of old radioactive waste storages, especially registered in the ANDRA inventory. I.R.S.N. chose to limit its contribution: to the sites housing nuclear base installations and nuclear base installations that have been classified secret that come under the Minister in charge of energy; to old radioactive wastes storages located in these installations. (N.C.)

Implementing the Comprehensive Unit-Based Safety Program (CUSP) to Improve Patient Safety in an Academic Primary Care Practice.

Science.gov (United States)

Pitts, Samantha I; Maruthur, Nisa M; Luu, Ngoc-Phuong; Curreri, Kimberly; Grimes, Renee; Nigrin, Candace; Sateia, Heather F; Sawyer, Melinda D; Pronovost, Peter J; Clark, Jeanne M; Peairs, Kimberly S

2017-11-01

While there is growing awareness of the risk of harm in ambulatory health care, most patient safety efforts have focused on the inpatient setting. The Comprehensive Unit-based Safety Program (CUSP) has been an integral part of highly successful safety efforts in inpatient settings. In 2014 CUSP was implemented in an academic primary care practice. As part of CUSP implementation, staff and clinicians underwent training on the science of safety and completed a two-question safety assessment survey to identify safety concerns in the practice. The concerns identified by team members were used to select two initial safety priorities. The impact of CUSP on safety climate and teamwork was assessed through a pre-post comparison of results on the validated Safety Attitudes Questionnaire. Ninety-six percent of staff completed science of safety training as part of CUSP implementation, and 100% of staff completed the two-question safety assessment. The most frequently identified safety concerns were related to medications (n = 11, 28.2), diagnostic testing (n = 9, 25), and communication (n = 5, 14). The CUSP team initially prioritized communication and infection control, which led to standardization of work flows within the practice. Six months following CUSP implementation, large but nonstatistically significant increases were found for the percentage of survey respondents who reported knowledge of the proper channels for questions about patient safety, felt encouraged to report safety concerns, and believed that the work setting made it easy to learn from the errors of others. CUSP is a promising tool to improve safety climate and to identify and address safety concerns within ambulatory health care. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.

Identifying Food Safety Concerns when Communication Barriers Exist

Science.gov (United States)

Neal, Jack A.; Dawson, Mary; Madera, Juan M.

2011-01-01

Abstract: Students must be prepared to lead a diverse workforce. The objective of this study was to establish a teaching method that helps students identify barriers to food safety while working in a simulated environment with communication barriers. This study employed a perspective taking exercise based upon the principles of social learning…

Are modern health worries, environmental concerns, or paranormal beliefs associated with perceptions of the effectiveness of complementary and alternative medicine?

Science.gov (United States)

Jeswani, Mamta; Furnham, Adrian

2010-09-01

To investigate to what extent paranormal beliefs, modern health worries (MHWs), and environmental concerns were related to beliefs about, and behaviour associated with complementary and alternative medicine (CAM). Of the participants, 150 completed a four-part questionnaire measuring use and perception of CAM, MHWs, paranormal beliefs, and environmental concerns. A factor analysis on the CAM questions revealed three clear components, labelled efficacy of CAM, attitudes to CAM, and safety of CAM. Age, total MHWs, paranormal beliefs, and environmental concerns were used as predictor variables in regression analyses with efficacy as criterion variable. Age was found to be a significantly related to efficacy of CAM. When total MHW score, paranormal belief score, and environmental concern score were added to the model, the r(2) increased by 29%. Environmental concern did not significantly relate to efficacy but spiritualism beliefs did. A factor analysis of the MHW scale items revealed nine factors. Out of these, radiation, doctors playing God, disasters, and epidemics, as well as harmful rays and air contaminants significantly predict belief in the efficacy of CAM. Overall, older people, with more MHWs, and who believe in the paranormal are more likely to believe that CAM works, possibly because of a more intuitive, 'holistic', thinking style. Limitations of the study are considered.

Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study.

Science.gov (United States)

Ogata, Atsushi; Amano, Koichi; Dobashi, Hiroaki; Inoo, Masayuki; Ishii, Tomonori; Kasama, Tsuyoshi; Kawai, Shinichi; Kawakami, Atsushi; Koike, Tatsuya; Miyahara, Hisaaki; Miyamoto, Toshiaki; Munakata, Yasuhiko; Murasawa, Akira; Nishimoto, Norihiro; Ogawa, Noriyoshi; Ojima, Tomohiro; Sano, Hajime; Shi, Kenrin; Shono, Eisuke; Suematsu, Eiichi; Takahashi, Hiroki; Tanaka, Yoshiya; Tsukamoto, Hiroshi; Nomura, Akira

2015-05-01

To evaluate the longterm safety and efficacy of subcutaneous tocilizumab (TCZ-SC) as monotherapy in patients with rheumatoid arthritis (RA). Of 346 patients who received 24 weeks of double-blind treatment with either TCZ-SC monotherapy, 162 mg every 2 weeks (q2w); or intravenous TCZ (TCZ-IV) monotherapy, 8 mg/kg every 4 weeks; 319 patients continued to receive TCZ-SC q2w in the 84-week open-label extension (OLE) of the MUSASHI study (JAPICCTI-101117). Efficacy, safety, and immunogenicity were evaluated for all patients treated with TCZ during 108 weeks. The proportions of patients who achieved American College of Rheumatology 20/50/70 responses, low disease activity [28-joint Disease Activity Score (DAS28) ≤ 3.2], or remission (DAS28 < 2.6) at Week 24 were maintained until Week 108. The incidences of adverse events and serious adverse events were 498.3 and 16.9 per 100 patient-years (PY), respectively. The overall safety of TCZ-SC monotherapy was similar to that of TCZ-IV monotherapy. Rates of injection site reactions (ISR) through 108 weeks remained similar to rates through 24 weeks. ISR were mild and did not cause any patient withdrawals. No serious hypersensitivity events (including anaphylactic reactions) occurred. Anti-TCZ antibodies were present in 2.1% of patients treated with TCZ-SC monotherapy. TCZ-SC monotherapy maintained a favorable safety profile and consistent efficacy throughout the 108-week study. Like TCZ-IV, TCZ-SC could provide an additional treatment option for patients with RA.

41 CFR 102-80.30 - What are Federal agencies' responsibilities concerning lead?

Science.gov (United States)

2010-07-01

... agencies' responsibilities concerning lead? 102-80.30 Section 102-80.30 Public Contracts and Property... PROPERTY 80-SAFETY AND ENVIRONMENTAL MANAGEMENT Safety and Environmental Management Lead § 102-80.30 What are Federal agencies' responsibilities concerning lead? Federal agencies have the following...

Ordinance concerning the filing of transport of nuclear fuel materials

International Nuclear Information System (INIS)

1987-01-01

This Order provides provisions concerning nuclear fuel substances requiring notification (nuclear fuel substance, material contaminated with nuclear fuel substances, fissionable substances, etc.), procedure for notification (to prefectural public safety commission), certificate of transpot (issued via public safety commission), instructions (speed of vehicle for transporting nuclear fuel substances, parking of vehicle, place for loading and unloading of nuclear fuel substances, method for loading and unloading, report to police, measures for disaster prevention during transport, etc.), communication among members of public safety commission (for smooth transport), notification of alteration of data in transport certificate (application to be submitted to public safety commission), application of reissue of transport certificate, return of transport certificate, inspection concerning transport (to be performed by police), submission of report (to be submitted by refining facilities manager, processing facilities manager, nuclear reactor manager, master of foreign nuclear powered ship, reprocessing facilities manager, waste disposal facilities manager; concerning stolen or missing nuclear fuel substances, traffic accident, unusual leakage of nuclear fuel substances, etc.). (Nogami, K.)

Health-related claims on food labels in Australia: understanding environmental health officers' roles and implications for policy.

Science.gov (United States)

Condon-Paoloni, Deanne; Yeatman, Heather R; Grigonis-Deane, Elizabeth

2015-01-01

Health and related claims on food labels can support consumer education initiatives that encourage purchase of healthier foods. A new food Standard on Nutrition, Health and Related Claims became law in January 2013. Implementation will need careful monitoring and enforcement to ensure that claims are truthful and have meaning. The current study explored factors that may impact on environmental health officers' food labelling policy enforcement practices. The study used a mixed-methods approach, using two previously validated quantitative questionnaire instruments that provided measures of the level of control that the officers exercised over their work, as well as qualitative, semi-structured, in-depth interviews. Local government; Australia. Thirty-seven officers in three Australian states participated in semi-structured in-depth interviews, as well as completing the quantitative questionnaires. Senior and junior officers, including field officers, participated in the study. The officers reported a high level of autonomy and control of their work, but also a heavy workload, dominated by concerns for public health and food safety, with limited time for monitoring food labels. Compliance of labels with proposed health claims regulations was not considered a priority. Lipsky's theory of street-level bureaucracy was used to enhance understanding of officers' work practices. Competing priorities affect environmental health officers' monitoring and enforcement of regulations. Understanding officers' work practices and their perceptions of enforcement is important to increase effectiveness of policy implementation and hence its capacity to augment education initiatives to optimize health benefits.

Driving safety: concerns and experiences of parents of adolescent drivers with type 1 diabetes.

Science.gov (United States)

Cox, Daniel J; Gonder-Frederick, Linda A; Shepard, Jaclyn A; Campbell, Laura K; Vajda, Karen A

2012-09-01

Driving is a dangerous activity for adolescents, perhaps being even more precarious for adolescents with type 1 diabetes due to the possibility of extreme blood glucose (BG). There is no available data on adolescent driving safety concerns and type 1 diabetes. To begin addressing this issue, we surveyed parents regarding their observations and concerns. Seventy-two parents (87.5% mothers) of adolescent drivers aged 16-19 with type 1 diabetes provided analyzable data. Females comprised 36% of their adolescents, with 74% using pump therapy. In the past year, 13 and 84% of parents reported that their adolescent had experienced severe or moderate disruptive hypoglycemia, respectively. Over half (56%) of the parents reported moderate to extreme worry about how diabetes impacted their adolescent's driving, while only 21% of parents thought their adolescents had similar concerns (p = 0.037). Almost one third (31%) of parents thought their adolescent need not treat low BG until it fell below 70 mg/dL, 13% thought their adolescent could safely drive with BG below 65 mg/dL. And, 31 and 14% of parents, respectively, reported their adolescent had been in a collision or stopped by the police in the past year, which they attributed to both hypo- and hyperglycemia. Adolescents reportedly took steps to prevent hypo- and hyperglycemia while driving, but more aggressively avoided hypoglycemia (p < 0.001). While this data is limited, lacking a non-diabetic control group and randomized sample, it does suggest that driving and adolescent type 1 diabetes deserve further attention and investigation. © 2012 John Wiley & Sons A/S.

Multiple system responses program: Identification of concerns related to a number of specific regulatory issues

International Nuclear Information System (INIS)

Murphy, G.A.; Casada, M.L.; Palko, L.E.; Roberts, M.W.

1989-10-01

This document describes the activities and results of the Multiple System Responses (MSR) program conducted by the Nuclear Operations Analysis Center (NOAC) at Oak Ridge National Laboratory (ORNL). The objective of the MSR program was to gather and review documentation for several unresolved safety issues and related programs of interest, and from that documentation, describe any additional potential safety concerns. The MSR program provides information that will aid the NRC staff in making an assessment of the relative safety significance of the concerns through the established prioritization process. Judgments were not made regarding the validity of the concerns expressed by others. Rather, the concerns were documented and potential safety issues were developed and defined as specifically as possible. Twenty-one potential safety issues were developed from the documented concerns. Additional information was gathered to support the NRC efforts in reviewing these issues for prioritization. 73 refs., 2 tabs

An open-label extension study to evaluate the safety of ropinirole prolonged release in Chinese patients with advanced Parkinson's disease.

Science.gov (United States)

Zhang, Zhenxin; Wang, Jian; Zhang, Xiaoying; Chen, Shengdi; Wang, Zhenfu; Zhang, Baorong; Liu, Chunfeng; Qu, Qiumin; Cheng, Yan; Zhu, Rongxuan; Li, Jie; Hu, Jingqiu; Cai, Meng

2015-04-01

This open-label extension (OLE) study evaluated the safety profile of ropinirole prolonged release (PR) administered for 24 weeks as adjunctive to levodopa in Chinese patients with advanced Parkinson's disease (PD). This was a 24 week, flexible-dose, OLE study in Chinese patients with advanced PD who received 24 week treatment with ropinirole PR in the preceding double-blind (DB), phase III study (NCT01154166) and had no break in receiving study treatment while switching from the DB study to the OLE study. In the OLE study, patients received ropinirole PR once daily, starting with 2 mg/d and increasing up to 8 mg/d at week 4 (2 mg increment/week); if tolerable, the dose could be further increased in 4 mg increments up to 24 mg/d according to clinical judgment. There were no efficacy assessments. Safety assessments included monitoring adverse events (AEs), neurological examination, Gambling Symptom Assessment Scale questionnaire, liver chemistry, and laboratory tests. Of the 295 enrolled patients, 282 completed the study. The most common reason for withdrawal was AEs (n = 9, 3.1%). The mean duration to ropinirole PR treatment was 173.1 days and an overall median daily dose of ropinirole was 8 mg (range: 2-24 mg). Overall, 114 (38.6%) patients experienced on-treatment AEs; the most frequent reported AEs ( ≥ 2%) were dyskinesia (6.1%), dizziness (4.1%), nausea (3.4%), hallucinations (3.4%), somnolence (2.7%) and decreased weight (2.4%). Sixty-eight patients (23.1%) experienced treatment-related AEs. Six patients experienced serious AEs (SAEs), of which hallucination was determined to be a treatment-related SAE. There were no other significant safety findings. No new safety signals for ropinirole were identified. The safety profile of ropinirole was consistent with the preceding DB study and also with the established safety profile for ropinirole. Results support the long-term use of ropinirole PR as an adjunctive to levodopa in Chinese patients

Rooting out institutional corruption to manage inappropriate off-label drug use.

Science.gov (United States)

Rodwin, Marc A

2013-01-01

Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. © 2013 American Society of Law, Medicine & Ethics, Inc.

Safety

International Nuclear Information System (INIS)

2001-01-01

This annual report of the Senior Inspector for the Nuclear Safety, analyses the nuclear safety at EDF for the year 1999 and proposes twelve subjects of consideration to progress. Five technical documents are also provided and discussed concerning the nuclear power plants maintenance and safety (thermal fatigue, vibration fatigue, assisted control and instrumentation of the N4 bearing, 1300 MW reactors containment and time of life of power plants). (A.L.B.)

Medical Students Raising Concerns.

Science.gov (United States)

Druce, Maralyn R; Hickey, Andrea; Warrens, Anthony N; Westwood, Olwyn M R

2016-09-16

After a number of high-profile incidents and national reports, it has become clear that all health professionals and all medical students must be able to raise concerns about a colleague's behavior if this behavior puts patients, colleagues, or themselves at risk.Detailed evidence from medical students about their confidence to raise concerns is limited, together with examples of barriers, which impair their ability to do so. We describe a questionnaire survey of medical students in a single-center, examining self-reported confidence about raising concerns in a number of possible scenarios. Thematic analysis was applied to comments about barriers identified.Although 80% of respondents felt confident to report a patient safety issue, students were less confident around issues of probity, attitude, and conduct. This needs to be addressed to create clear mechanisms to raise concerns, as well as support for students during the process.

Consumer Food Security and Labeling Intervention on Food Products through Public Policies in Romania

Directory of Open Access Journals (Sweden)

Dacinia Crina Petrescu

2018-02-01

Full Text Available The correct understanding of consumers’ food labeling knowledge and perceptions is a prerequisite to develop and implement coherent and appropriate food safety policies. One objective of the paper was to discover how often consumers access and use specific food label information. Another objective was to explore stakeholders’ preferences for several public policy options relevant for food safety. In this respect, a survey on a sample of 312 Romanian consumers and the evaluation of several public policy options by four stakeholder groups (food producers and sellers, doctors, fitness trainers, and consumers were carried out. The results revealed that the most frequently read types of information on the label were “expiration date” and “price”, closely followed by “quantity” and “brand”. Among tested public policies, those related to the traffic light labels and to the social interest messages with health claims were rewarded with high scores by investigated stakeholders. Although nutrition has a decisive impact on health state, nutrition information was not frequently read by people, thus justifying the implementation of a public policy meant to enhance consumers’ interest in and reading frequency of nutrition information on food label.

16 CFR 1500.15 - Labeling of fire extinguishers.

Science.gov (United States)

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling of fire extinguishers. 1500.15 Section 1500.15 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT...)(1), the signal word “Danger” and the statement of hazard “Poisonous gases formed when used to...

Governing GMOs: The (Counter Movement for Mandatory and Voluntary Non-GMO Labels

Directory of Open Access Journals (Sweden)

Carmen Bain

2014-12-01

Full Text Available Since 2012 the anti-GMO (genetically modified organism movement has gained significant grassroots momentum in its efforts to require mandatory GMO food labels through state-level ballot and legislative efforts. Major food and agriculture corporations are opposed to mandatory GMO labels and have successfully defeated most of these initiatives. Nevertheless, these battles have garnered significant media attention and re-energized the debate over GMO crops and foods. In this paper, we argue that one of the most significant outcomes of this fight is efforts by food retailers and value-based food companies to implement voluntary non-GMO labels and brands. We draw on the governance and political consumerism literature to explore (counter movement efforts for mandatory labels and how these efforts are being institutionalized through private voluntary governance institutions. Our assessment is based on in-depth, semi-structured interviews with key informants from consumer and environmental organizations, agriculture and biotech companies, and government regulatory agencies, as well as a content analysis of food industry websites. A growing number of food retailers recognize the reputational and economic value that new niche markets for non-GMO foods can offer, while the anti-GMO movement views these efforts as a step in the direction of mandatory GMO labels. We conclude that voluntary labels may act to settle the labeling debate by mollifying agri-food industry concerns about mandatory labeling and meeting the desire of political consumers for greater choice and transparency but without addressing the broader social and environmental sustainability concerns that drives the anti-GMO movement in the first place.

Off-Label Drug Use in Pediatric Practice: Unsolved Problems

Directory of Open Access Journals (Sweden)

A. R. Titova

2015-01-01

Full Text Available The widespread «off-label» drug use and the prescribing of unlicensed medicines in pediatric practice is a major health problem. The authors discuss actual regulatory and legal issues of «off-label» drug use in children in the US, Europe and Russia. The results of different population-based studies from many countries, showing the structure and frequency of «off-label» drug use in children, are summarized in this article. It is shown that such practice increases the risk of adverse drug reactions. The authors offer practical recommendations for a safer use of drugs in pediatric practice. The priority issue is conducting high quality clinical trials with the participation of children, improving national pharmacovigilance and the monitoring of off-label drug use, developing pediatric formularies, improving doctors’ knowledge and awareness of safety and efficacy of medicines in pediatric population.

Brief report: the impact of changing from DSM-IV 'Asperger's' to DSM-5 'autistic spectrum disorder' diagnostic labels on stigma and treatment attitudes.

Science.gov (United States)

Ohan, Jeneva L; Ellefson, Sarah E; Corrigan, Patrick W

2015-10-01

In the DSM-5, 'Asperger's Disorder' was incorporated into 'Autistic Spectrum Disorder' (ASD). One key concern in this change has been that the ASD label will increase negative attitudes relative to the Asperger's label. To test this, we asked 465 American adults to read a vignette describing a child with autistic symptoms that included an ASD label, an Asperger's label, or no label, and rate their stigma and treatment attitudes (help-seeking and perceived effectiveness). Contrary to predictions, label did not impact stigma. Label did impact treatment attitudes, with greater help-seeking and perceived treatment effectiveness for both Asperger's and ASD labels. In sum, concern that the ASD label will increase negative perceptions, at least amongst the general public, is not supported.

Electroabsorption modulators used for all-optical signal processing and labelling

DEFF Research Database (Denmark)

Xu, Lin

2004-01-01

This thesis concerns the applications of semiconductor components, primarily electroabsorption modulators (EAMs), in optical signal processing and labelling for future all optical communication networks. An introduction to electroabsorption modulators is given and several mechanisms that form...... function of an EAM is frequency dependent and the main improvement from an EAM-based regenerator is the enhancement of the ER and the suppression of the noise in a space bit. Applications of EAMs in optical label processing using various orthogonal labelling schemes are discussed. Through EAM...... encoding are –25.6/-28.1 dBm and –23.7/-21 dBm, respectively. Using an EAM for optical label insertion and a MZ-SOA for optical label erasure and payload regeneration in the ASK(10 Gb/s)/ Frequency Shift Keying (312 Mb/s) orthogonal modulation format, the complete functionality of a network node including...

Indium-111 oxine labelling of white blood cells

International Nuclear Information System (INIS)

Lavender, J.P.; Silvester, D.J.; Goldman, J.; Hammersmith Hospital, London

1978-01-01

Following work done by Professor John McAfee and Mathew Thakur at the MRS Cyclotron Unit a method is available for labelling cells with indium-111 which results in a stable intracellular marker. The method uses indium-111-8 hydroxyquinoline (111In oxine) which is a lipoid soluble complex which goes across the cell membrane and results in the deposition of indium into various subcellular structures. It has been applied to various preparations of white cells, platelets and also malignant cells. Autologous granulocytes have been used to identify inflammatory lesions in 35 patients. By similar means autologous lymphocytes can also be labelled and reinfused. Lymphocytes have been shown in animals to circulate from the blood via the lymphatic system and then returning to the blood once more. The same phenomenon can be seen in man using indium labelled lymphocytes. Lymph nodes become visible at between 12 and 18 hours and recirculation of labelled cells can be shown on the blood activity curves. Certain problems arise concerning cell behaviour after labelling which appear due to irradiation of cells rather than chemical toxicity. (author)

Industrial radiography in the Philippines: safety concerns

International Nuclear Information System (INIS)

David, Jocelyn L.; Artificio, Thelma P.; Cerbolles, Justina S.; Caseria, Estrella S.; Agron, Inocencio A.

2005-01-01

Industrial radiography utilizes the highest activity (5.55 tera becquerel (TBq) to 7.4 TBq) among the various mobile application of radioisotopes. It is highly possible that radiographers exceed the annual dose limits for workers occupationally exposed to radiation (as prescribed in the Code of PNRI Regulations part 3) if they do not give cautious consideration to the factors that determine the radiation dose, namely: the gamma source dose rates, time distance and shielding. To enhance the safety culture among radiographers, various strategies are recommended to be undertaken by the Philippine Nuclear Research Institute as well as the licensed companies undertaking activities in industrial radiography. (Authors)

9 CFR 317.400 - Exemption from nutrition labeling.

Science.gov (United States)

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Exemption from nutrition labeling. 317.400 Section 317.400 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... people and produces no more than the following amounts of pounds of the product qualifying the firm for...

9 CFR 381.500 - Exemption from nutrition labeling.

Science.gov (United States)

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Exemption from nutrition labeling. 381.500 Section 381.500 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... business is any single-plant facility or multi-plant company/firm that employs 500 or fewer people and...

On the labelling of insuline and insuline derivatives with tritium and carbon-14

International Nuclear Information System (INIS)

Uschkoreit, J.

1979-01-01

Two different labelling methods were investigated. By means of the Wilzbach labelling with diaminosuberoylinsuline the insuline is irreversibly altered. As a second method the reductive methylation was used, in doing so it was possible to distinguish between mono and dimethylated parts of the reaction product by using C-14 labelled formaldehyde. Furthermore four N,N-dimethylated insuline derivatives were isolated with yields of 25 until 35%. By using C-14 and h-3 labelled reagents insuline can be labelled doubly. Moreover N-terminal amino groups could be protected irreversibly with this method. Furthermore structure-function investigations and investigations concerning the insuline metabolism were done. (SPI) [de

Modulation of Brain Activity with Noninvasive Transcranial Direct Current Stimulation (tDCS): Clinical Applications and Safety Concerns

Science.gov (United States)

Zhao, Haichao; Qiao, Lei; Fan, Dongqiong; Zhang, Shuyue; Turel, Ofir; Li, Yonghui; Li, Jun; Xue, Gui; Chen, Antao; He, Qinghua

2017-01-01

Transcranial direct current stimulation (tDCS) is a widely-used tool to induce neuroplasticity and modulate cortical function by applying weak direct current over the scalp. In this review, we first introduce the underlying mechanism of action, the brief history from discovery to clinical scientific research, electrode positioning and montages, and parameter setup of tDCS. Then, we review tDCS application in clinical samples including people with drug addiction, major depression disorder, Alzheimer's disease, as well as in children. This review covers the typical characteristics and the underlying neural mechanisms of tDCS treatment in such studies. This is followed by a discussion of safety, especially when the current intensity is increased or the stimulation duration is prolonged. Given such concerns, we provide detailed suggestions regarding safety procedures for tDCS operation. Lastly, future research directions are discussed. They include foci on the development of multi-tech combination with tDCS such as with TMS and fMRI; long-term behavioral and morphological changes; possible applications in other research domains, and more animal research to deepen the understanding of the biological and physiological mechanisms of tDCS stimulation. PMID:28539894

Status of the indoor climate labelling scheme in Denmark

DEFF Research Database (Denmark)

Witterseh, Thomas

2002-01-01

The impartial Indoor Climate Labelling, ICL, originally introduced in Denmark to reduce emissions from building materials and products used in the indoor environment, is still developing and consolidating its position. The ICL benefits from an expansion of the product areas covered and a still...... increasing number of labelled products. The product area of furniture is now included, making a total of ten different product areas. Approximately 100 different groups of products are included, which individually covers a number of specific products. An increasing number of manufacturers apply...... for the Indoor Climate Label, due to a growing concern about the indoor environment among architects, consulting and planning engineers and private consumers. This shows that the concept is now working as originally intended. A goal for the ICL is to develop a method for labelling of the overall indoor...

Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study

Directory of Open Access Journals (Sweden)

Zhao JP

2017-08-01

significantly (P<0.0001. At 6 months, PP1M had a positive impact on medication satisfaction, adherence, and increased preference for LAIs. Treatment-emergent adverse events (TEAEs were reported by 181 (51.3% patients (TEAEs ≥5%: extrapyramidal disorder [15.3%], akathisia [10.5%], blood prolactin increase [8.8%], insomnia [5.4%]. A total of 8 deaths were reported, including 4 completed suicides.Conclusion: Long-term treatment with PP1M was efficacious, and no new safety concerns were identified in Chinese patients with schizophrenia. Overall, the results were comparable with observations from previous studies. Keywords: Chinese, long-acting injectables, open-label, paliperidone palmitate, PANSS, schizophrenia 

9 CFR 355.34 - Labels, approval of, by Administrator.

Science.gov (United States)

2010-01-01

... INSPECTION AND CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; INSPECTION... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labels, approval of, by Administrator. 355.34 Section 355.34 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF...

Precautionary labelling of foods for allergen content: are we ready for a global framework?

OpenAIRE

Allen, Katrina J; Turner, Paul J; Pawankar, Ruby; Taylor, Stephen; Sicherer, Scott; Lack, Gideon; Rosario, Nelson; Ebisawa, Motohiro; Wong, Gary; Mills, E N Clare; Beyer, Kirsten; Fiocchi, Alessandro; Sampson, Hugh A

2014-01-01

16/02/15 meb. OA paper Ok to add. DOI and copyright added. ? 2014 Allen et al.; licensee BioMed Central Ltd.Food allergy appears to be on the rise with the current mainstay of treatment centred on allergen avoidance. Mandatory allergen labelling has improved the safety of food for allergic consumers. However an additional form of voluntary labelling (termed precautionary allergen labelling) has evolved on a wide range of packaged goods, in a bid by manufacturers to minimise risk to custome...

Annual Safety Report 1981

International Nuclear Information System (INIS)

1982-09-01

A safety report from Section K (Nuclear Physics) of the Dutch National Institute for Nuclear and High Energy Physics is presented for 1981. The report begins with general matters concerning safety policy at NIKHEF, licences and expenditure. Works accidents (none of them radiological) are detailed and accident prevention considered. The measurement programme for neutron radiation in the vicinity of the accelerator is described and the results are discussed. The means and results of personnel dosimetry are also presented. The report is concluded with a list of publications concerning safety aspects at NIKHEF. (C.F.)

The Influence of Sugar-Sweetened Beverage Health Warning Labels on Parents' Choices.

Science.gov (United States)

Roberto, Christina A; Wong, Diandra; Musicus, Aviva; Hammond, David

2016-02-01

US states have introduced bills requiring sugar-sweetened beverages (SSBs) to display health warning labels. This study examined how such labels may influence parents and which labels are most impactful. In this study, 2381 demographically and educationally diverse parents participated in an online survey. Parents were randomly assigned to 1 of 6 conditions: (1) no warning label (control); (2) calorie label; or (3-6) 1 of 4 text versions of a warning label (eg, Safety Warning: Drinking beverages with added sugar[s] contributes to obesity, diabetes, and tooth decay). Parents chose a beverage for their child in a vending machine choice task, rated perceptions of different beverages, and indicated interest in receiving beverage coupons. Regression analyses controlling for frequency of beverage purchases were used to compare the no warning label group, calorie label group, and all warning label groups combined. Significantly fewer parents chose an SSB for their child in the warning label condition (40%) versus the no label (60%) and calorie label conditions (53%). Parents in the warning label condition also chose significantly fewer SSB coupons, believed that SSBs were less healthy for their child, and were less likely to intend to purchase SSBs. All P values parents' understanding of health harms associated with overconsumption of such beverages and may reduce parents' purchase of SSBs for their children. Copyright © 2016 by the American Academy of Pediatrics.

Microbial status and product labelling of 58 original tattoo inks.

Science.gov (United States)

Høgsberg, T; Saunte, D M; Frimodt-Møller, N; Serup, J

2013-01-01

European Council resolutions on tattoo ink introduce sterility and preservation of inks to protect customers. Inks used in Denmark are typically purchased over the internet from international suppliers and manufacturers from the US and the UK. In Denmark tattoo inks are regulated and labelled according to REACH as if they were plain chemicals. The objective of this study was to check the microbial product safety of unopened and opened tattoo ink stock bottles. Packaging, labelling, preservation, sterility and contamination with micro-organisms were studied. Physical inspection and culture of bacteria and fungi. Six of 58 unopened stock bottles (10%) were contaminated with bacteria and one of six samples (17%) of previously used stock bottles was contaminated. The bacterial species represented bacteria considered pathogenic in humans as well as non-pathogenic environmental bacteria. Yeast or moulds were detected in none of the samples. A total of 31% of the manufacturers informed only about the brand name. No information about content, sterility, risks or expiry date was indicated on the label. A total of 42% claimed sterility of their inks. A total of 54% labelled a maximum period of durability of typically 2-3 years. The physical sealing was leaking in 28% of the products. The European Council resolutions regarding safety of tattoo inks are not effective. Stock bottles of tattoo ink may contain bacteria pathogenic to humans and environmental bacteria, and packaging, labelling and preservation of inks are of inadequate quality. Claim of sterility can be erroneous. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

Regulatory oversight report 2008 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2009-04-01

This annual report issued by the Swiss Federal Nuclear Inspectorate (ENSI) reports on the work carried out by the Inspectorate in 2008. This report reviews the regulatory activities in the four Swiss nuclear power stations and in four further nuclear installations in various Swiss research facilities. It deals with topics such as operational details, technologies in use, radiation protection, radioactive wastes, emergency dispositions, personnel and provides an assessment of operations from the safety point of view. Also, the transportation of nuclear materials - both nuclear fuels and nuclear wastes - is reported on. General topics discussed include probabilistic safety analyses and accident management, earthquake damage analysis and agreements on nuclear safety. The underground disposal of highly-radioactive nuclear wastes and work done in the rock laboratories are discussed, as are proposals for additional nuclear power stations

Off-label utilization of antipsychotics | Zullino | African Journal of ...

African Journals Online (AJOL)

Objective: The newer atypical antipsychotics are prescribed because of their enhanced safety profiles and their larger pharmacological profile in comparison to the conventional antipsychotics. This has led to broad off-label utilisation. The aim of the present survey was to study the prescribing practice of hospital psychiatrists ...

76 FR 69481 - Testing and Labeling Pertaining to Product Certification

Science.gov (United States)

2011-11-08

... 1107 Testing and Labeling Pertaining to Product Certification; Final Rule #0;#0;Federal Register / Vol... Pertaining to Product Certification AGENCY: Consumer Product Safety Commission. ACTION: Final rule. SUMMARY... that the product complies with the certification requirements under section 14(a) of the Consumer...

SAFETY

CERN Multimedia

Niels Dupont

2013-01-01

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

Pharmaceuticals labelled with stable isotopes

International Nuclear Information System (INIS)

Krumbiegel, P.

1986-11-01

The relatively new field of pharmaceuticals labelled with stable isotopes is reviewed. Scientific, juridical, and ethical questions are discussed concerning the application of these pharmaceuticals in human medicine. 13 C, 15 N, and 2 H are the stable isotopes mainly utilized in metabolic function tests. Methodical contributions are given to the application of 2 H, 13 C, and 15 N pharmaceuticals showing new aspects and different states of development in the field under discussion. (author)

Developing patient safety in dentistry.

Science.gov (United States)

Pemberton, M N

2014-10-01

Patient safety has always been important and is a source of public concern. Recent high profile scandals and subsequent reports, such as the Francis report into the failings at Mid Staffordshire, have raised those concerns even higher. Mortality and significant morbidity associated with the practice of medicine has led to many strategies to help improve patient safety, however, with its lack of associated mortality and lower associated morbidity, dentistry has been slower at systematically considering how patient safety can be improved. Recently, several organisations, researchers and clinicians have discussed the need for a patient safety culture in dentistry. Strategies are available to help improve patient safety in healthcare and deserve further consideration in dentistry.

Pharmaceutical quality of "party pills" raises additional safety concerns in the use of illicit recreational drugs.

Science.gov (United States)

Young, Simon A; Thrimawithana, Thilini R; Antia, Ushtana; Fredatovich, John D; Na, Yonky; Neale, Peter T; Roberts, Amy F; Zhou, Huanyi; Russell, Bruce

2013-06-14

To determine the content and release kinetics of 1-benzylpiperazine (BZP) and 1-(3-trifluoromethyl-phenyl)piperazine (TFMPP) from "party pill" formulations. From these data, the possible impact of pharmaceutical quality upon the safety of such illicit formulations may be inferred. The amount of BZP and TFMPP in party pill formulations was determined using a validated HPLC method. The in-vitro release kinetics of selected party pill brands were determined using a USP dissolution apparatus (75 rpm, 37.5 degrees Celsius). The release data were then fitted to a first order release model using PLOT software and the time taken to achieve 90% release reported. Many of the tested party pill brands contained amounts of BZP and TFMPP that varied considerably from that stated on the packaging; including considerable TFMPP content in some brands not labelled to contain this drug. Dissolution studies revealed that there was considerable variability in the release kinetics between brands; in one case 90% release required >30 minutes. Lack of quality control in party pill manufacture may have led to the toxic effects reported by users unaware of the true content and release of drug from pills. More stringent regulation in the manufacture and quality control of "new generation party pills" is essential to the harm reduction campaign.

Phenomenology of men with body dysmorphic disorder concerning penis size compared to men anxious about their penis size and to men without concerns: a cohort study.

Science.gov (United States)

Veale, David; Miles, Sarah; Read, Julie; Troglia, Andrea; Carmona, Lina; Fiorito, Chiara; Wells, Hannah; Wylie, Kevan; Muir, Gordon

2015-03-01

Men with body dysmorphic disorder (BDD) may be preoccupied with the size or shape of the penis, which may be causing significant shame or impairment. Little is known about the characteristics and phenomenology of such men and whether they can be differentiated from men with small penis anxiety (SPA) (who do not have BDD), and men with no penile concerns. Twenty-six men with BDD, 31 men with SPA, and 33 men without penile concerns were compared on psychopathology, experiences of recurrent imagery, avoidance and safety-seeking behaviours. Men with BDD had significantly higher scores than both the SPA group and no penile concern group for measures of imagery, avoidance, safety seeking and general psychopathology. The groups differed on the phenomenology of BDD specific to penile size preoccupation clearly from the worries of SPA, which in turn were different to those of the men without concerns. The common avoidance and safety seeking behaviours were identified in such men that may be used clinically. Copyright © 2014 Elsevier Ltd. All rights reserved.

Nuclear safety in Slovak Republic. Regulatory aspects of NPP nuclear safety

International Nuclear Information System (INIS)

Lipar, M.

1999-01-01

Regulatory Authority (UJD) is appointed by the Slovak Republic National Council as an Executive Authority for nuclear safety supervision. Nuclear safety legislation, organisation and resources of UJD, its role and responsibilities are described together with its inspection and licensing functions and International cooperation concerning improvements of safety effectiveness. Achievements of UJD are listed in detail

Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study.

Science.gov (United States)

Olde Rikkert, Marcel G M; Verhey, Frans R; Blesa, Rafael; von Arnim, Christine A F; Bongers, Anke; Harrison, John; Sijben, John; Scarpini, Elio; Vandewoude, Maurits F J; Vellas, Bruno; Witkamp, Renger; Kamphuis, Patrick J G H; Scheltens, Philip

2015-01-01

The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration (Souvenir I and Souvenir II) showed that memory performance was improved in drug-naïve mild AD patients, whereas no effects on cognition were observed in a 24-week RCT (S-Connect) in mild to moderate AD patients using AD medication. Souvenaid was well-tolerated in all RCTs. In this 24-week open-label extension (OLE) study to the 24-week Souvenir II RCT, long-term safety and intake adherence of the medical food Souvenaid was evaluated. Patients with mild AD (n = 201) received Souvenaid once-daily during the OLE. Main outcome parameters were safety and product intake adherence. The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter. Compared to the RCT, a similar (low) incidence and type of adverse events was observed, being mainly (68.3%) of mild intensity. Pooled data (RCT and OLE) showed that 48-week use of Souvenaid was well tolerated with high intake adherence (96.1%). Furthermore, a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention. Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence. The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled, double-blind RCT.

The TSN bill concerning transparency and safety in the nuclear sector

International Nuclear Information System (INIS)

Leger, M.; Lahorgue, M.B.; Strohl, P.

2009-01-01

This document gathers together 3 articles whose common purpose is to shed light on the 13. June 2006 French law on transparency and safety in the nuclear sector. This law is fundamental because it gave, for the first time, the legal definitions of basic concepts like nuclear safety, public information or transparency. It also gave a series of principles on which the right in nuclear activities, has to rely: the principle of precaution, the principle of prevention, the principle of remedial action, the principle of who pollutes has to pay, and the principle of public information. The law gives also a clear scheme of the roles and responsibilities in the nuclear sector: the state, the government, the nuclear safety authority, the nuclear facility operator and the land (on which the nuclear facility stands) owner. (A.C.)

Packaging and labeling of pharmaceutical products obtained from the internet.

Science.gov (United States)

Veronin, Michael

2011-02-15

For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping

Safety; Avertissement

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-07-01

This annual report of the Senior Inspector for the Nuclear Safety, analyses the nuclear safety at EDF for the year 1999 and proposes twelve subjects of consideration to progress. Five technical documents are also provided and discussed concerning the nuclear power plants maintenance and safety (thermal fatigue, vibration fatigue, assisted control and instrumentation of the N4 bearing, 1300 MW reactors containment and time of life of power plants). (A.L.B.)

Safety and Efficacy of 188-Rhenium-Labeled Antibody to Melanin in Patients with Metastatic Melanoma

Directory of Open Access Journals (Sweden)

M. Klein

2013-01-01

Full Text Available There is a need for effective “broad spectrum” therapies for metastatic melanoma which would be suitable for all patients. The objectives of Phase Ia/Ib studies were to evaluate the safety, pharmacokinetics, dosimetry, and antitumor activity of 188Re-6D2, a 188-Rhenium-labeled antibody to melanin. Stage IIIC/IV metastatic melanoma (MM patients who failed standard therapies were enrolled in both studies. In Phase Ia, 10 mCi 188Re-6D2 were given while unlabeled antibody preload was escalated. In Phase Ib, the dose of 188Re-6D2 was escalated to 54 mCi. SPECT/CT revealed 188Re-6D2 uptake in melanoma metastases. The mean effective half-life of 188Re-6D2 was 12.4 h. Transient HAMA was observed in 9 patients. Six patients met the RECIST criteria for stable disease at 6 weeks. Two patients had durable disease stabilization for 14 weeks and one for 22 weeks. Median overall survival was 13 months with no dose-limiting toxicities. The data demonstrate that 188Re-6D2 was well tolerated, localized in melanoma metastases, and had antitumor activity, thus warranting its further investigation in patients with metastatic melanoma.

Israeli Arab and Jewish youth knowledge and opinion about alcohol warning labels: pre-intervention data.

Science.gov (United States)

Weiss, S

1997-01-01

This article presents baseline data on the opinion toward alcohol beverage warning labels and on levels of knowledge of the risks discussed in the contents of the labels prior to the labels' introduction, and on levels of knowledge of additional alcohol-related hazards not included in the proposed warning labels, among a sample of 3065 adolescents of four religions living in the northern region of Israel. About 2220 Arab participants (Moslems, Christians and Druze) and 845 Jewish respondents answered in the winter of 1996 a Hebrew version of an American questionnaire, which had been used to measure levels of knowledge of the label in the United States. More respondents were in favour of warning labels on alcohol containers than on advertisements. Arabs as a group were more in favour of warning labels on alcohol containers than Jews. The initial knowledge levels among the participants were not very high, especially concerning the item 'Drinking impairs the ability to operate machinery' (74.4%) which is included on the proposed warning label, and concerning two hazards which are not included: 'Drinking increases risk of cancer' (54.6%) and 'Drinking increases risk of high blood pressure' (60.4%). Abstainers knew more than drinkers that 'Pregnant women should not drink', 'Drinking increases risk of cancer' and 'Alcohol in combination with other drugs is hazardous'. Implications for public health are discussed and alternative warning messages that might be used to inform the Israeli public of several less well-known hazards are suggested.

Nuclear power plant safe operation principles and some topics concerning systems reliability analysis

International Nuclear Information System (INIS)

Borsky, M.; Kreim, R.; Stanicek, J.

1997-01-01

General safety criteria are specified, and nuclear power plant equipment is classified into systems either important or unimportant for nuclear safety. The former class is subdivided into safety systems and safety related systems. The safety requirements concern earthquakes, storms, fires, floods, man-induced events, and equipment failures. The actual state of systems important for safety is described. (M.D.)

Food Safety as a contributor to Food Security: global policy concerns & challenges

Directory of Open Access Journals (Sweden)

Vijay Kumar Chattu

2015-12-01

Full Text Available The theme for World Health Day campaign for this year 2015 is “Food safety: from farm to plate, make food safe”. The day focuses on demonstrating the importance of food safety along the whole length of the food chain in a globalized world, from production and transport, to preparation and consumption (1. Everyone needs food and needs it every day either plant sources or animal sources or both. The food we eat must be nutritious and safe but we often ignore or overlook the issue of food safety. Many cases of food borne diseases either acute poisoning or chronic exposure are largely under reported. In this globalized world, though the food chain extends over thousands of miles from different continents, an error or contamination in one country can affect the health of consumers on the other part of the world. To ensure full impact, these actions must build on principles of government stewardship, engagement of civil society, (2.According to UN, access to a safe and secure food supply is a basic human right. Food safety and food security are interrelated concepts which have an impact on the health outcomes and quality of human lives. As per Food and Agricultural Organization (FAO, Food security is a situation that exists when all people, at all times, have physical, social and economic access to sufficient, safe and nutritious food that meets their dietary needs and food preferences for an active and healthy life, (3. Based on the definition of Food security, four food security dimensions can be identified: food availability, economic and physical access to food, food utilization and stability over time. Apart from that food security is also affected by Poverty and Climate change.Food safety is an umbrella term that encompasses many aspects like food items handling, preparation and storage of food to prevent illness and injury. The other important issues are chemical, microphysical and microbiological aspects of food safety, (4. Control of

Guide to the declaration procedure and coding system for criteria concerning significant events related to safety, radiation protection or the environment, applicable to basic nuclear installations and the transport of radioactive materials

International Nuclear Information System (INIS)

Lacoste, Andre-Claude

2005-01-01

This guide notably contains various forms associated with the declaration of significant events, and explanations to fill them in: significant event declaration form for a basic nuclear installation, significant event declaration form for radioactive material transport, significant event report for a basic nuclear installation, significant event report for radioactive material transport, declaration criteria for significant events related to the safety of non-PWR basic nuclear installations, declaration criteria for significant events related to PWR safety, significant events declared further to events resulting in group 1 unavailability and non-compliance with technical operating specifications, declaration criteria for significant events concerning radiation protection for basic nuclear installations, declaration criteria for significant events concerning environmental protection, applicable to basic nuclear installations, and declaration criteria for significant events concerning radioactive material transport

Technical Safety Appraisal of the Rocky Flats Plant

Energy Technology Data Exchange (ETDEWEB)

Brown, Blake P.

1989-01-01

This report provides the results of a Technical Safety Appraisal (TSA) of the Rocky Flats Plant (RFP) conducted November 14 to 18 and November 28 to December 9, 1988. This appraisal covered the effectiveness and improvements in the RFP safety program across the site, evaluating progress to date against standards of accepted practice. The appraisal included coverage of the timeliness and effectiveness of actions taken in response to the recommendations/concerns in three previous Technical Safety Appraisals (TSAs) of RFP Bldg. 707 conducted in July 1986, Bldgs. 771/774 conducted in October/November 1986, and Bldgs. 776/777 conducted in January/February 1988. Results of this appraisal are given in Section IV for each of 14 technical safety areas at RFP. These results include a discussion, conclusions and any new safety concerns for each technical safety area. Appendix A contains a description of the system for categorizing concerns, and the concerns are tabulated in Appendix B. Appendix C reports on the evaluation of the contractor's actions and the current status of each of the 230 recommendations and concerns contained in the three previous TSA reports.

Nanotechnology in sustainable agriculture: Present concerns and ...

African Journals Online (AJOL)

Nanotechnology in sustainable agriculture: Present concerns and future aspects. ... of those living in developing countries face daily food shortages as a result of ... applications in agricultural, food, and water safety that could have significant ...

Food Safety as a contributor to Food Security: global policy concerns & challenges

Directory of Open Access Journals (Sweden)

Vijay Kumar Chattu

2015-12-01

Microphysical particles such as glass and metal can be hazardous and cause serious injury to consumers. Pathogenic bacteria, viruses and toxins produced by microorganisms are all possible contaminants of food and impact food safety. Like food security, food safety is also effected by poverty and climate change. Hence Foo

Safety KPIs - Monitoring of safety performance

Directory of Open Access Journals (Sweden)

Andrej Lališ

2014-09-01

Full Text Available This paper aims to provide brief overview of aviation safety development focusing on modern trends represented by implementation of Safety Key Performance Indicators. Even though aviation is perceived as safe means of transport, it is still struggling with its complexity given by long-term growth and robustness which it has reached today. Thus nowadays safety issues are much more complex and harder to handle than ever before. We are more and more concerned about organizational factors and control mechanisms which have potential to further increase level of aviation safety. Within this paper we will not only introduce the concept of Key Performance Indicators in area of aviation safety as an efficient control mechanism, but also analyse available legislation and documentation. Finally we will propose complex set of indicators which could be applied to Czech Air Navigation Service Provider.

Social responsibility and work conditions: building a reference label, Démarche T®.

Science.gov (United States)

Biquand, Sylvain; Zittel, Benoit

2012-01-01

Corporate Social Responsibility (CSR) is now considered in large and global companies and the recent publication of the ISO 26000 standard clarifies the targets. Based on our consultancy's experience for fifteen years in ergonomics mainly in French small and medium enterprises, we developed a label to coax and value efforts of companies in dealing with health and safety at the work place as required by ISO 26000 paragraph 6.4. The formal approach of ISO describes what should be achieved but gives no cue on how actual conditions of work should be improved. The label, called Démarche T (ie Process W where W stands for work) aims the management of work conditions as a process, giving visibility and credit to companies for their continuous involvement in the matter. We describe the items and processes that are part of our assessment. We first conduct an ergonomic diagnosis including the analysis of records on health, physical and psychological well-being, observations at the workplace and interviews with the workers. This diagnosis is followed by recommendations. The fulfillment of these is assessed yearly. Items under assessment include: - ergonomics, health and safety in the companies statements and their impact in actual project management; - relations with workers through the committee for health and safety; - actual results on health, safety and work conditions. On a local level, we give the companies passing the label a competitive edge in recruiting better candidates motivated by good work conditions, and help them fulfill ISO 26000 requirements, an increasingly decisive advantage to benefit from public regional and European support. Our paper describes the diagnosis and follow-up process.

Advanced Test Reactor Safety Basis Upgrade Lessons Learned Relative to Design Basis Verification and Safety Basis Management

International Nuclear Information System (INIS)

G. L. Sharp; R. T. McCracken

2004-01-01

The Advanced Test Reactor (ATR) is a pressurized light-water reactor with a design thermal power of 250 MW. The principal function of the ATR is to provide a high neutron flux for testing reactor fuels and other materials. The reactor also provides other irradiation services such as radioisotope production. The ATR and its support facilities are located at the Test Reactor Area of the Idaho National Engineering and Environmental Laboratory (INEEL). An audit conducted by the Department of Energy's Office of Independent Oversight and Performance Assurance (DOE OA) raised concerns that design conditions at the ATR were not adequately analyzed in the safety analysis and that legacy design basis management practices had the potential to further impact safe operation of the facility.1 The concerns identified by the audit team, and issues raised during additional reviews performed by ATR safety analysts, were evaluated through the unreviewed safety question process resulting in shutdown of the ATR for more than three months while these concerns were resolved. Past management of the ATR safety basis, relative to facility design basis management and change control, led to concerns that discrepancies in the safety basis may have developed. Although not required by DOE orders or regulations, not performing design basis verification in conjunction with development of the 10 CFR 830 Subpart B upgraded safety basis allowed these potential weaknesses to be carried forward. Configuration management and a clear definition of the existing facility design basis have a direct relation to developing and maintaining a high quality safety basis which properly identifies and mitigates all hazards and postulated accident conditions. These relations and the impact of past safety basis management practices have been reviewed in order to identify lessons learned from the safety basis upgrade process and appropriate actions to resolve possible concerns with respect to the current ATR safety

Production and uses of 14C-labelled rice straw in organic matter decomposition studies

International Nuclear Information System (INIS)

Capistrano, R.F.; Neue, H.N.U.

1987-01-01

A new systematic procedure in labeling rice homogenously with 14 CO 2 to maturity is described. It uses a modified plant growth chamber equipped with provisions for the growth requirements of rice as well as, the decontamination and safety aspects of labeling process. Uses of 14 C-labeled rice straw are described. Sample preparation using a new wet combustion set-up a high vacuum preparation line, concomitant with instruments as liquid scintillation counter, vibrating reed electrometer and radiogaschromatograph is also discussed. The turnover and behavior of 14 C-labeled rice straw in organic matter decomposition experiments on wetland soils, upland soils, greenhouse set-up and controlled laboratory conditions are concurrent researches that make use of the produced 14 C-labeled straw. Initial results are discussed. (Auth.) 16 refs.; 14 figs.; 2 tabs

Survey of safety practices among hospital laboratories in Oromia Regional State, Ethiopia.

Science.gov (United States)

Sewunet, Tsegaye; Kebede, Wakjira; Wondafrash, Beyene; Workalemau, Bereket; Abebe, Gemeda

2014-10-01

Unsafe working practices, working environments, disposable waste products, and chemicals in clinical laboratories contribute to infectious and non-infectious hazards. Staffs, the community, and patients are less safe. Furthermore, such practices compromise the quality of laboratory services. We conducted a study to describe safety practices in public hospital laboratories of Oromia Regional State, Ethiopia. Randomly selected ten public hospital laboratories in Oromia Regional State were studied from Oct 2011- Feb 2012. Self-administered structured questionnaire and observation checklists were used for data collection. The respondents were heads of the laboratories, senior technicians, and safety officers. The questionnaire addressed biosafety label, microbial hazards, chemical hazards, physical/mechanical hazards, personal protective equipment, first aid kits and waste disposal system. The data was analyzed using descriptive analysis with SPSS version16 statistical software. All of the respondents reported none of the hospital laboratories were labeled with the appropriate safety label and safety symbols. These respondents also reported they may contain organisms grouped under risk group IV in the absence of microbiological safety cabinets. Overall, the respondents reported that there were poor safety regulations or standards in their laboratories. There were higher risks of microbial, chemical and physical/mechanical hazards. Laboratory safety in public hospitals of Oromia Regional State is below the standard. The laboratory workers are at high risk of combined physical, chemical and microbial hazards. Prompt recognition of the problem and immediate action is mandatory to ensure safe working environment in health laboratories.

Food labels: consumer’s information or consumer’s confusion

Directory of Open Access Journals (Sweden)

Monier-Dilhan Sylvette

2018-03-01

Full Text Available This paper synthesizes findings of published research on the impact of food labels on consumers’ willingness to pay and focuses on the consumers’ rationales when deciding to purchase organic food. The first issue refers to one aspect of the proliferation of quality labels in the agro-food sector: the coexistence of two signs on one product and the consequences of this coexistence on the value of each sign. In the context of the competition between national brands and private labels through public quality labels, it has been shown that the willingness to pay for a quality sign decreases when it is combined with another one on the same product. The second concern is a two-fold issue: the characterization of “organics food consumers” in terms of socio-demographics characteristics and consumers’ purchasing motives. The more consistent result is that consumers with higher levels of education are more likely to purchase organic products. The three main reasons for buying organic products are considerations related to health, product quality, and environmental protection. The proliferation of signs about quality is a topical issue related to the emergence of sustainability issues that highlight labels linked to agro-ecological practices. The question of the effectiveness of the informational role of labels remains relevant.

Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period.

Science.gov (United States)

Kadowaki, Takashi; Kondo, Kazuoki; Sasaki, Noriyuki; Miyayama, Kyoko; Yokota, Shoko; Terata, Ryuji; Gouda, Maki

2017-09-01

To assess the efficacy and safety of teneligliptin as add-on to insulin monotherapy in patients with type 2 diabetes mellitus (T2DM). In a 16-week, double-blind period, 148 Japanese T2DM patients with inadequate glycemic control with insulin and diet/exercise therapies were randomized to placebo or teneligliptin 20 mg. In a subsequent 36-week, open-label period, all patients received teneligliptin once daily. The primary outcome measure was change in HbA1c at the end of the double-blind period. The difference between placebo and teneligliptin in change in HbA1c in the double-blind period (least squares mean ± SE) was -0.80% ± 0.11%; teneligliptin was superior (ANCOVA, P 1). The HbA1c-lowering effect of teneligliptin was maintained throughout the open-label period. The incidence of adverse events was 53.5% with placebo and 44.2% with teneligliptin in the double-blind period, 66.7% in the placebo/teneligliptin group in the open-label period, and 77.9% in the teneligliptin/teneligliptin group over both double-blind/open-label periods. The incidence of hypoglycemic symptoms was 11.1% in the placebo/teneligliptin group in the open-label period and 27.3% in the teneligliptin/teneligliptin group over both double-blind/open-label periods. Teneligliptin was effective and well tolerated in Japanese T2DM patients with inadequate glycemic control. NCT02081599.

Steel Erection Safety. Module SH-39. Safety and Health.

Science.gov (United States)

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on steel erection safety is one of 50 modules concerned with job safety and health. This module identifies typical jobsite hazards encountered by steel erectors, as well as providing safe job procedures for general and specific construction activities. Following the introduction, 11 objectives (each keyed to a page in the text)…

Valuing Information on GM Foods in the Presence of Country-of-Origin Labels

OpenAIRE

Jing Xie; Hyeyoung Kim; Lisa House

2013-01-01

Information on production methods (genetic modification (GM) or organic production) and locations (country of origin) are commonly found on food package labels. Both pieces of information may be used as a proxy for food safety and (perceived) quality by consumers. Our study investigates the interactive effects between information on production method and country-of-origin labeling (COOL) by conducting choice experiments in the European Union, United States and Japan. This study also investig...

76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

Science.gov (United States)

2011-01-04

... guidance, including memoranda and letters, may no longer be relied upon to the extent they are inconsistent... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the...

Radiation Safety in the Neonatal Intensive Care Unit: Too Little or Too Much Concern?

Directory of Open Access Journals (Sweden)

Cheng-Chung Yu

2010-12-01

Full Text Available With rising numbers of extremely premature infants in the neonatal intensive care unit (NICU who require multiple radiologic examinations for their complex medical conditions, concerns the risk of radiation exposure become a more prevalent issue. The biological effects from cumulative doses of both primary and secondary radiation can be particularly troubling for very premature babies due to their inherent sensitivity to both iatrogenic and environmental insults. Similarly, radiologic studies performed in the NICU pose potentially significant exposure risks to caretakers and to the families of patients often present in the NICU during these examinations. The purpose of this article is to critically review the available literature regarding current exposure rates in the NICU, address the validity of radiation exposure concerns, and suggest areas for improvement. With few exceptions, studies reveal that there were only low doses of radiation derived from any single radiographic examination in standard NICUs and that the radiation dosage used was in compliance with recommendations made by the Commission of European Communities (EC and International Commission on Radiological Protection (ICRP. However, there were wide variations in the radiation dose per single examination (mean entrance skin doses ranged from 15 to 73.6 μGy and in the frequency (mean ranged from 3.2 to 31 examinations per infant of those examinations. Studies also reported low secondary exposure rates from scatter radiation to others present in the NICU during radiographic examinations. Key to limiting unnecessary radiation exposure in the NICU is the employment of proper radiation techniques and safety measures. Thus, adhering to recommendations made by the EC and ICRP can help to reduce the anxiety of patients' families and medical staff regarding their risks from the effects of ionizing radiation in the NICU.

9 CFR 381.116 - Wording on labels of immediate containers.

Science.gov (United States)

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Wording on labels of immediate containers. 381.116 Section 381.116 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... the container: Provided, however, That there is, immediately to the right or left of such principal...

Leadership and Management for Safety. General Safety Requirements

International Nuclear Information System (INIS)

2016-01-01

This Safety Requirements publication establishes requirements that support Principle 3 of the Fundamental Safety Principles in relation to establishing, sustaining and continuously improving leadership and management for safety and an integrated management system. It emphasizes that leadership for safety, management for safety, an effective management system and a systemic approach (i.e. an approach in which interactions between technical, human and organizational factors are duly considered) are all essential to the specification and application of adequate safety measures and to the fostering of a strong safety culture. Leadership and an effective management system will integrate safety, health, environmental, security, quality, human-and-organizational factor, societal and economic elements. The management system will ensure the fostering of a strong safety culture, regular assessment of performance and the application of lessons from experience. The publication is intended for use by regulatory bodies, operating organizations (registrants and licensees) and other organizations concerned with facilities and activities that give rise to radiation risks

Thermal reactor safety

International Nuclear Information System (INIS)

1980-06-01

Information is presented concerning new trends in licensing; seismic considerations and system structural behavior; TMI-2 risk assessment and thermal hydraulics; statistical assessment of potential accidents and verification of computational methods; issues with respect to improved safety; human factors in nuclear power plant operation; diagnostics and activities in support of recovery; LOCA transient analysis; unresolved safety issues and other safety considerations; and fission product transport

Thermal reactor safety

Energy Technology Data Exchange (ETDEWEB)

1980-06-01

Information is presented concerning new trends in licensing; seismic considerations and system structural behavior; TMI-2 risk assessment and thermal hydraulics; statistical assessment of potential accidents and verification of computational methods; issues with respect to improved safety; human factors in nuclear power plant operation; diagnostics and activities in support of recovery; LOCA transient analysis; unresolved safety issues and other safety considerations; and fission product transport.

77 FR 48105 - Federal Motor Vehicle Safety Standards; Motorcycle Helmets

Science.gov (United States)

2012-08-13

... [Docket No. NHTSA-2012-0112] Federal Motor Vehicle Safety Standards; Motorcycle Helmets AGENCY: National... Vehicle Safety Standard for motorcycle helmets. Specifically, the final rule amended the helmet labeling... compliance test procedures of FMVSS No. 218, Motorcycle helmets, in order to make it more difficult to...

An open-label, two-period comparative study on pharmacokinetics and safety of a combined ethinylestradiol/gestodene transdermal contraceptive patch

Directory of Open Access Journals (Sweden)

Zhang C

2017-03-01

Full Text Available Chao Zhang,1 Haiyan Li,2 Xin Xiong,1 Suodi Zhai,1 Yudong Wei,2 Shuang Zhang,2 Yuanyuan Zhang,1 Lin Xu,2 Li Liu1 1Department of Pharmacy, 2Institute of Clinical Trial, Peking University Third Hospital, Beijing, People’s Republic of China Abstract: We investigated the pharmacokinetics and safety profiles of a newly developed combined ethinylestradiol (EE/gestodene (GSD transdermal contraceptive patch after a single-dose administration and compared with the market available tablet formulation in healthy adult subjects. An open-label, two-period comparative study was conducted in 12 healthy women volunteers. A single dose of the study combined EE/GE transdermal contraceptive patch and oral tablet (Milunet® were administered. Blood samples at different time points after dose were collected, and concentrations were analyzed. A reliable, highly sensitive and accurate high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC/MS/MS assay method was developed in this study to determine the plasma concentrations of EE and GSD. Compared to the tablet, the study patch had a significantly decreased maximum plasma concentration (Cmax, extended time to reach the Cmax and half-life, as well as increased clearance and apparent volume of distribution. The half-lives of EE and GSD of the patch were 3.3 and 2.2 times, respectively, than the half-life of the tablet. The areas under the plasma concentration–time curve (AUCs of EE and GSD of the patch were 8.0 and 16.2 times, respectively, than the AUC of the tablet. No severe adverse event was observed during the whole study, and the general safety was acceptable. In conclusion, compared to the oral tablet Milunet, the study contraceptive patch was well tolerated and showed potent drug exposure, significant extended half-life and stable drug concentrations. Keywords: pharmacokinetics, safety, ethinylestradiol/gestodene, transdermal contraceptive patch

Modeling activity recognition of multi resident using label combination of multi label classification in smart home

Science.gov (United States)

Mohamed, Raihani; Perumal, Thinagaran; Sulaiman, Md Nasir; Mustapha, Norwati; Zainudin, M. N. Shah

2017-10-01

Pertaining to the human centric concern and non-obtrusive way, the ambient sensor type technology has been selected, accepted and embedded in the environment in resilient style. Human activities, everyday are gradually becoming complex and thus complicate the inferences of activities when it involving the multi resident in the same smart environment. Current works solutions focus on separate model between the resident, activities and interactions. Some study use data association and extra auxiliary of graphical nodes to model human tracking information in an environment and some produce separate framework to incorporate the auxiliary for interaction feature model. Thus, recognizing the activities and which resident perform the activity at the same time in the smart home are vital for the smart home development and future applications. This paper will cater the above issue by considering the simplification and efficient method using the multi label classification framework. This effort eliminates time consuming and simplifies a lot of pre-processing tasks comparing with previous approach. Applications to the multi resident multi label learning in smart home problems shows the LC (Label Combination) using Decision Tree (DT) as base classifier can tackle the above problems.

Safety management - policy, analysis and implementation

International Nuclear Information System (INIS)

Allen, F.R.

1993-01-01

The nuclear industry is moving towards a period of ever increasing emphasis on business performance and profitability. Safety has, of course, always been a major concern of management in the nuclear industry and elsewhere. The civil aviation industry , for example, has had a similar concern for safety. Other industry sectors are also developing safety management as a response to events within and outside their sectors. In this paper the way that the risk management process as a whole is being addressed is looked at. Can we use risk management, initially a safety-orientated tool, to improve business performance? (author)

Oh β s concerns surface after spill

International Nuclear Information System (INIS)

Anon.

1984-01-01

A spill of uranium- and radium-contaminated water from a reservoir at the Key Lake Mine in northern Saskatchewan in early January 1984 created extensive public concern. Now attention is being focussed on the issue of worker safety

The first symposium of Research Center for Radiation Safety, NIRS. Perspective of future studies of radiation safety

International Nuclear Information System (INIS)

Shimo, Michikuni

2002-03-01

This paper summarizes presentations given in the title symposium, held at the Conference Room of National Institute of Radiological Sciences (NIRS) on November 29 and 30, 2001. Contained are Introductory remarks: Basic presentations concerning exposure dose in man; Environmental levels of radiation and radioactivity, environmental radon level and exposure dose, and radiation levels in the specific environment (like in the aircraft): Special lecture (biological effects given by space environment) concerning various needs for studies of radiation safety; Requirement for open investigations, from the view of utilization, research and development of atomic energy, from the clinical aspect, and from the epidemiological aspect: Special lecture (safety in utilization of atomic energy and radiation-Activities of Nuclear Safety Commission of Japan) concerning present state and perspective of studies of radiation safety; Safety of radiation and studies of biological effects of radiation-perspective, and radiation protection and radiation safety studies: Studies in the Research Center for Radiation Safety; Summary of studies in the center, studies of the biological effects of neutron beam, carcinogenesis by radiation and living environmental factors-complicated effects, and studies of hereditary effects: Panel discussion (future direction of studies of radiation safety for the purpose of the center's direction): and concluding remarks. (N.I.)

A long-term, open-label safety study of single-entity hydrocodone bitartrate extended release for the treatment of moderate to severe chronic pain

Directory of Open Access Journals (Sweden)

Nalamachu S

2014-11-01

Full Text Available Srinivas Nalamachu,1,2 Richard L Rauck,3 Martin E Hale,4 Orlando G Florete Jr,5 Cynthia Y Robinson,6 Stephen J Farr,6 1International Clinical Research Institute, Overland Park, KS, USA; 2Kansas University Medical Center, Kansas City, KS, USA; 3Carolinas Pain Institute, Center for Clinical Research, Wake Forest University School of Medicine, Winston-Salem, NC, USA; 4Gold Coast Research, LLC, Weston, FL, USA; 5Institute of Pain Management, Jacksonville, FL, USA; 6Zogenix, Inc., Emeryville, CA, USA Objective: To evaluate the long-term safety, tolerability, and effectiveness of single-entity extended-release hydrocodone in opioid-experienced subjects with moderate to severe chronic pain not receiving adequate pain relief or experiencing intolerable side effects from their current opioid. Methods: This multicenter, open-label study started with a conversion/titration phase (≤6 weeks where subjects (n=638 were converted to individualized doses (range 20–300 mg of extended-release hydrocodone dosed every 12 hours, followed by a 48-week maintenance phase (n=424. The primary objective (safety and tolerability and the secondary objective (long-term efficacy as measured by change in average pain score; 0= no pain, 10= worst imaginable pain were monitored throughout the study. Results: Subjects were treated for a range of chronic pain etiologies, including osteoarthritis, low back pain, and neuropathic and musculoskeletal conditions. The mean hydrocodone equivalent dose at screening was 68.9±62.2 mg/day and increased to 139.5±81.7 mg/day at the start of the maintenance phase. Unlimited dose adjustments were permitted at the investigator's discretion during the maintenance phase, reflecting typical clinical practice. No unexpected safety issues were reported. Common adverse events during the conversion/titration and maintenance phases, respectively, were constipation (11.3% and 12.5%, nausea (10.7% and 9.9%, vomiting (4.1% and 9.7%, and somnolence (7

Fisheries and aquaculture industries involvement to control product health and quality safety to satisfy consumer-driven objectives on retail markets in Europe.

Science.gov (United States)

Roth, Eva; Rosenthal, Harald

2006-01-01

Over the past years the export of agricultural and fishery products from developing countries has substantially increased to markets within the OECD. Retailers and importers are expanding their international operations to meet consumer demands for year-round delivery of products. Moreover, consumers have become increasingly concerned about the safety of food, including those derived from aquatic resources [FAO/NACA/WHO Joint Study Group, 1999. Report food safety issues associated with products from aquaculture. WHO Technical Report Series No 883: VII, pp. 1-55]. Governments and leading businesses are responding by imposing new safety regulations and standards to the international food system (e.g. HACCP, EUREP-GAP), product liability and labeling [Reilly, A., Howgate, P., Käferstein, F., 1997. Safety hazards and the application of HACCP in aquaculture. In: Proceedings of the Second International Conference on Fish Inspection and Quality Control: A Global Focus, Arlington, VA, 19-24 May 1996. Technomic Publishing, Lancaster, PA, pp. 353-373]. Initial concerns for imports of aquacultural products from developing to industrialized countries focussed on bacterial contamination [Buras, N. 1993. Microbial safety of produce from wastewater-fed aquaculture. In: Pullin, R.V.C., Rosenthal, H., MacLean, J.L.(Eds.), Proceedings of ICLARM Conferences, vol. 31, pp. 285-295]. Today, if trade opportunities are to be maintained, these countries must adapt to a full array of regulations and standards. This paper describes four scenarios in aquaculture and fishing product trade between developing countries and countries in the European Union.

Fisheries and aquaculture industries involvement to control product health and quality safety to satisfy consumer-driven objectives on retail markets in Europe

International Nuclear Information System (INIS)

Roth, Eva; Rosenthal, Harald

2006-01-01

Over the past years the export of agricultural and fishery products from developing countries has substantially increased to markets within the OECD. Retailers and importers are expanding their international operations to meet consumer demands for year-round delivery of products. Moreover, consumers have become increasingly concerned about the safety of food, including those derived from aquatic resources [FAO/NACA/WHO Joint Study Group, 1999. Report food safety issues associated with products from aquaculture. WHO Technical Report Series No 883: VII, pp. 1-55]. Governments and leading businesses are responding by imposing new safety regulations and standards to the international food system (e.g. HACCP, EUREP-GAP), product liability and labeling [Reilly, A., Howgate, P., Kaeferstein, F., 1997. Safety hazards and the application of HACCP in aquaculture. In: Proceedings of the Second International Conference on Fish Inspection and Quality Control: A Global Focus, Arlington, VA, 19-24 May 1996. Technomic Publishing, Lancaster, PA, pp. 353-373]. Initial concerns for imports of aquacultural products from developing to industrialized countries focussed on bacterial contamination [Buras, N. 1993. Microbial safety of produce from wastewater-fed aquaculture. In: Pullin, R.V.C., Rosenthal, H., MacLean, J.L.(Eds.), Proceedings of ICLARM Conferences, vol. 31, pp. 285-295]. Today, if trade opportunities are to be maintained, these countries must adapt to a full array of regulations and standards. This paper describes four scenarios in aquaculture and fishing product trade between developing countries and countries in the European Union

Fisheries and aquaculture industries involvement to control product health and quality safety to satisfy consumer-driven objectives on retail markets in Europe

Energy Technology Data Exchange (ETDEWEB)

Roth, Eva [University of South Denmark, Department of Environmental and Business Economics, Niels Bohrs vej 9, DK-6700 Esbjerg (Denmark); Institute for Marine Research, University Kiel, Duesternbrooker Weg 20, 24105 Kiel (Germany); Rosenthal, Harald [University of South Denmark, Department of Environmental and Business Economics, Niels Bohrs vej 9, DK-6700 Esbjerg (Denmark); Institute for Marine Research, University Kiel, Duesternbrooker Weg 20, 24105 Kiel (Germany)

2006-07-01

Over the past years the export of agricultural and fishery products from developing countries has substantially increased to markets within the OECD. Retailers and importers are expanding their international operations to meet consumer demands for year-round delivery of products. Moreover, consumers have become increasingly concerned about the safety of food, including those derived from aquatic resources [FAO/NACA/WHO Joint Study Group, 1999. Report food safety issues associated with products from aquaculture. WHO Technical Report Series No 883: VII, pp. 1-55]. Governments and leading businesses are responding by imposing new safety regulations and standards to the international food system (e.g. HACCP, EUREP-GAP), product liability and labeling [Reilly, A., Howgate, P., Kaeferstein, F., 1997. Safety hazards and the application of HACCP in aquaculture. In: Proceedings of the Second International Conference on Fish Inspection and Quality Control: A Global Focus, Arlington, VA, 19-24 May 1996. Technomic Publishing, Lancaster, PA, pp. 353-373]. Initial concerns for imports of aquacultural products from developing to industrialized countries focussed on bacterial contamination [Buras, N. 1993. Microbial safety of produce from wastewater-fed aquaculture. In: Pullin, R.V.C., Rosenthal, H., MacLean, J.L.(Eds.), Proceedings of ICLARM Conferences, vol. 31, pp. 285-295]. Today, if trade opportunities are to be maintained, these countries must adapt to a full array of regulations and standards. This paper describes four scenarios in aquaculture and fishing product trade between developing countries and countries in the European Union.

30 CFR 47.73 - Providing labels and MSDSs to customers.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Providing labels and MSDSs to customers. 47.73 Section 47.73 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR EDUCATION AND... MSDSs to customers. For a hazardous chemical produced at the mine, the operator must provide customers...

Regional aviation safety organisations : enhancing air transport safety through regional cooperation

NARCIS (Netherlands)

Ratajczyk, Mikołaj Andrzej

2014-01-01

Aviation safety is of global concern. Yet 43% of countries worldwide lack the expertise and administrative capacity to ensure effective safety oversight of the aviation activities for which they are responsible under international law. With air traffic predicted to double in the next 15 years and

Co-Labeling for Multi-View Weakly Labeled Learning.

Science.gov (United States)

Xu, Xinxing; Li, Wen; Xu, Dong; Tsang, Ivor W

2016-06-01

It is often expensive and time consuming to collect labeled training samples in many real-world applications. To reduce human effort on annotating training samples, many machine learning techniques (e.g., semi-supervised learning (SSL), multi-instance learning (MIL), etc.) have been studied to exploit weakly labeled training samples. Meanwhile, when the training data is represented with multiple types of features, many multi-view learning methods have shown that classifiers trained on different views can help each other to better utilize the unlabeled training samples for the SSL task. In this paper, we study a new learning problem called multi-view weakly labeled learning, in which we aim to develop a unified approach to learn robust classifiers by effectively utilizing different types of weakly labeled multi-view data from a broad range of tasks including SSL, MIL and relative outlier detection (ROD). We propose an effective approach called co-labeling to solve the multi-view weakly labeled learning problem. Specifically, we model the learning problem on each view as a weakly labeled learning problem, which aims to learn an optimal classifier from a set of pseudo-label vectors generated by using the classifiers trained from other views. Unlike traditional co-training approaches using a single pseudo-label vector for training each classifier, our co-labeling approach explores different strategies to utilize the predictions from different views, biases and iterations for generating the pseudo-label vectors, making our approach more robust for real-world applications. Moreover, to further improve the weakly labeled learning on each view, we also exploit the inherent group structure in the pseudo-label vectors generated from different strategies, which leads to a new multi-layer multiple kernel learning problem. Promising results for text-based image retrieval on the NUS-WIDE dataset as well as news classification and text categorization on several real-world multi

Food Safety & Standards

Institute of Scientific and Technical Information of China (English)

无

2005-01-01

@@ An increasing number of people have realized that food safety is an important issue for public health. It not only concerns public health and safety, but also has direct influence on national economic progress and social development. The development and implementation of food safety standards play a vital role in protecting public health, as well as in standardizing and facilitating the sound development of food production and business.

Criticality Safety Support to a Project Addressing SNM Legacy Items at LLNL

International Nuclear Information System (INIS)

Pearson, J S; Burch, J G; Dodson, K E; Huang, S T

2005-01-01

The programmatic, facility and criticality safety support staffs at the LLNL Plutonium Facility worked together to successfully develop and implement a project to process legacy (DNFSB Recommendation 94-1 and non-Environmental, Safety, and Health (ES and H) labeled) materials in storage. Over many years, material had accumulated in storage that lacked information to adequately characterize the material for current criticality safety controls used in the facility. Generally, the fissionable material mass information was well known, but other information such as form, impurities, internal packaging, and presence of internal moderating or reflecting materials were not well documented. In many cases, the material was excess to programmatic need, but such a determination was difficult with the little information given on MC and A labels and in the MC and A database. The material was not packaged as efficiently as possible, so it also occupied much more valuable storage space than was necessary. Although safe as stored, the inadequately characterized material posed a risk for criticality safety noncompliances if moved within the facility under current criticality safety controls. A Legacy Item Implementation Plan was developed and implemented to deal with this problem. Reasonable bounding conditions were determined for the material involved, and criticality safety evaluations were completed. Two appropriately designated glove boxes were identified and criticality safety controls were developed to safely inspect the material. Inspecting the material involved identifying containers of legacy material, followed by opening, evaluating, processing if necessary, characterizing and repackaging the material. Material from multiple containers was consolidated more efficiently thus decreasing the total number of stored items to about one half of the highest count. Current packaging requirements were implemented. Detailed characterization of the material was captured in databases

Nuclear Safety

International Nuclear Information System (INIS)

1978-09-01

In this short paper it has only been possible to deal in a rather general way with the standards of safety used in the UK nuclear industry. The record of the industry extending over at least twenty years is impressive and, indeed, unique. No other industry has been so painstaking in protection of its workers and in its avoidance of damage to the environment. Headings are: introduction; how a nuclear power station works; radiation and its effects (including reference to ICRP, the UK National Radiological Protection Board, and safety standards); typical radiation doses (natural radiation, therapy, nuclear power programme and other sources); safety of nuclear reactors - design; key questions (matters of concern which arise in the public mind); safety of operators; safety of people in the vicinity of a nuclear power station; safety of the general public; safety bodies. (U.K.)

76 FR 42686 - DOE Response to Recommendation 2011-1 of the Defense Nuclear Facilities Safety Board, Safety...

Science.gov (United States)

2011-07-19

... examples of a failed safety culture.'' The Department disagrees with this categorization and believes the... Safety Board, Safety Culture at the Waste Treatment and Immobilization Plant AGENCY: Department of Energy... Recommendation 2011-1, concerning Safety Culture at the Waste Treatment and Immobilization Plant, to the...

Industrial safety management with emphasis on construction safety

International Nuclear Information System (INIS)

Bhattacharya, R.

2016-01-01

Safety professionals, line managers, team leaders and concerned workers today eagerly discuss to find out the best safety approach for their workplace. Some research suggested that behaviour based and comprehensive ergonomics approaches lead in average reduction of injuries. This article discusses 'the science and engineering' behind improvement in industrial safety aspects particularly at construction sites through various safety approaches. A high degree of commitment to safety by the project management and rigorous and proactive measures are essential to prevent accidents at construction sites particularly in DAE units because of its sensitivity. Persistent efforts by the project management are needed for sustainable and committed safety at work place. The number of fatalities occurring from construction work in DAE units is sometimes disturbing and fall of person from height and through openings are the major causes for serious accidents

Carbon-11 labeled diacylglycerol for signal transduction imaging by positron CT. Evaluation of the quality and safety for clinical use

Energy Technology Data Exchange (ETDEWEB)

Fujii, Ryou [Nishijin Hospital, Kyoto (Japan); Imahori, Yoshio; Ido, Tatsuo [and others

1995-02-01

To elucidate the synaptic transmission in the neural system, we have been developing fundamental studies for intracellular signaling. For clinical application of carbon-11 labeled diacylglycerol (1-[1-{sup 11}C]butyryl-2-palmitoyl-rac-glycerol: {sup 11}C-DAG) using positron emission computed tomography (PET), we evaluated the quality and the safety of {sup 11}C-DAG as the solution for injection. As a result, {sup 11}C-DAG was synthesized within 50 minutes, including the preparation step for injection. The half life time and energy spectrum of {sup 11}C-DAG were the same as the physical character of carbon-11, and other radioisotopes were not detected. In the quality control, {sup 11}C-DAG solution was negative in the examination of bacterial contamination and the pyrogen test in three successive synthesis procedures. In the acute toxicity test by administration of {sup 11}C-DAG and 100 {mu}mol/kg of non-radioactive DAG to the rat intravenously, the systemic condition of the rat was not changed and no abnormalities were found in any organ 24 hours after administration. These findings indicated the safety of {sup 11}C-DAG solution. Clinical application of {sup 11}C-DAG using positron emission tomography may be useful to elucidate the dysfunction of intracellular signaling in disorders of higher cortical function such as Alzheimer disease. (author).

An open-label Optional Titration Trial to Evaluate the Efficacy ...

African Journals Online (AJOL)

An eight-week open-label optional titration trial to evaluate the efficacy, tolerability and safety of Valsartan 80 mg/ & 160 mg once daily was carried out in patients with mild to moderate essential hypertension at the Lagos University Teaching Hospital. There was a significant reduction in both systolic and diastolic blood ...

Description of present practice concerning the safety criteria for nuclear power plants

International Nuclear Information System (INIS)

1977-01-01

In the description at hand, the authors portray how the aims defined in the safety criteria are reached, and they make proposals for improvement. Basic principles, acceptances and requirements, with which the experts of TUeV and GRS involved in licensing procedures work at the moment, are compiled. This description of present practice has to be adapted perhaps to the existing scientific knowledge at the time. In order that an optimal behaviour as regards safety is reached by the employees in nuclear power plants, criterion 2.5 requires the following measures: the places of work and the work routine in nuclear power plants are to be organized in such a way, that they offer the conditions for the optimal behaviour of employees as regards safety. (orig./HP) [de

European demands for food quality and safety

OpenAIRE

Bulatsyk, Sofiya; Yavorska, Nadiya

2017-01-01

In this article was investigated regulations and other normative documents of the European Union concerning food quality and safety and was arranged EU demands regards to food safety. There were determined the basic business concerns of the domestic enterprises in the process of manufacturing and marketing food products

EPR safety. Consideration of the internal and external hazards in the safety studies

International Nuclear Information System (INIS)

Gueguin, H.

2008-04-01

The author presents the main points of the Preliminary Safety Report of EDF on the EPR reactor safety. It concerns the considerations of the internal (fire, flood, explosions, pipes failures) and external (earthquakes, airplane falls, explosions, exceptional natural disasters, extreme meteorological conditions) damages. It presents how the safety report takes into account the aggression. (A.L.B.)

Safety program of the Oak Ridge National Laboratory: a different approach

International Nuclear Information System (INIS)

Burger, G.H.

1981-01-01

The uniqueness and therefore different approach to Oak Ridge National Laboratory's safety program is not a result of elimination of the usual industrial safety organization, but results from the three organizations which supplement it and the areas of safety concerns that they cover. While industrial safety is primarily concerned with day-to-day routine worker activities (wearing of safety glasses and hard hats, adherence to electrical safety work procedures, proper safety lockout and tagout of equipment for maintenance activities, etc.), the other organizations, the Office of Operational Safety, Division Safety Officers and Radiation Control Officers, and the Laboratory director's Review Committees, are concerned with themuch broader spectrum of the total work environment. These organizations are concerned not only with the day-to-day worker activities but the design and conduction of all operations from a process viewpoint. The emphasis of these groups is assuring first that operations, experiments, facilities, etc., are designed properly and then secondly operated properly to assure safety of the operators, Laboratory population, and the public. Responsibilities of the three safety organizations constituting operational or process safety are described and discussed

Cardiovascular safety of non-steroidal anti-inflammatory drugs among healthy individuals

DEFF Research Database (Denmark)

Fosbøl, Emil Loldrup; Køber, Lars; Torp-Pedersen, Christian

2010-01-01

Studies have raised concern on the cardiovascular safety of NSAIDs. We studied safety of NSAID therapy in a nationwide cohort of healthy individuals.......Studies have raised concern on the cardiovascular safety of NSAIDs. We studied safety of NSAID therapy in a nationwide cohort of healthy individuals....

Label Review Training: Module 1: Label Basics, Page 21

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about types of labels.

Label Review Training: Module 1: Label Basics, Page 22

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about what labels require review.

Label Review Training: Module 1: Label Basics, Page 19

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This section covers supplemental distributor labeling.

US nuclear safety. Review and experience

International Nuclear Information System (INIS)

Hanauer, S.H.

1977-01-01

The paper deals with the evolution of reactor safety principles, design bases, regulatory requirements, and experience in the United States. Safety concerns have evolved over the years, from reactivity transients and shut-down systems, to blowdowns and containment, to severe design basis accidents and mitigating systems, to the performance of actual materials, systems and humans. The primary safety concerns of one epoch have been superseded in considerable measure by those of later times. Successive plateaus of technical understanding are achieved by solutions being found to earlier problems. Design studies, research, operating experience and regulatory imperatives all contribute to the increased understanding and thus to the safety improvements adopted and accepted. The improvement of safety with time, and the ability of existing reactors to operate safely in the face of new concerns, has confirmed the correctness and usefulness of the defence-in-depth approach and safety margins used in safety design in the United States of America. A regulatory programme such as the one in the United States justifies its great cost by its important contributions to safety. Yet only the designers, constructors and operators of nuclear power plants can actually achieve public safety. The regulatory programme audits, assesses and spot-checks the actual work. Since neither materials nor human beings are flawless, mistakes will be made; that is why defence-in-depth and safety margins are provided. The regulatory programme should enhance safety by decreasing the frequency of uncorrected mistakes. Maintenance of public safety also requires technical and managerial competence and attention in the organizations responsible for nuclear plants as well as regulatory organizations. (author)

Label Review Training: Module 1: Label Basics, Page 15

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about the consequences of improper labeling.

Label Review Training: Module 1: Label Basics, Page 14

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about positive effects from proper labeling.

Label Review Training: Module 1: Label Basics, Page 18

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This section discusses the types of labels.

Label Review Training: Module 1: Label Basics, Page 26

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about mandatory and advisory label statements.

Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal

Directory of Open Access Journals (Sweden)

Lemoine P

2011-07-01

Full Text Available Patrick Lemoine1, Doron Garfinkel2, Moshe Laudon3, Tali Nir3, Nava Zisapel3,41The Clinique Lyon-Lumière, Meyzieu, France; 2Geriatric-Palliative Department, Shoham Geriatric Medical Center, Pardes Hanna, Israel; 3Neurim Pharmaceuticals Ltd, Tel-Aviv, Israel; 4Department of Neurobiology Faculty of Life Sciences, Tel Aviv University, Tel Aviv, IsraelBackground: Prolonged-release melatonin (PRM 2 mg is indicated for insomnia in patients aged 55 years and older. A recent double-blind placebo-controlled study demonstrated 6-month efficacy and safety of PRM in insomnia patients aged 18–80 and lack of withdrawal and rebound symptoms upon discontinuation.Objective: To investigate the efficacy, safety, and withdrawal phenomena associated with 6–12 months PRM treatment.Methods: Data from a prospective 6–12-month open-label study of 244 community dwelling adults with primary insomnia, who had participated in a placebo-controlled, double-blind dose-ranging trial of PRM. Patients received PRM nightly, followed by a 2-week withdrawal period. Main outcome measures were patient-reported sleep quality ratings (diary, adverse events, vital signs, and laboratory tests recorded at each visit, and withdrawal symptoms (CHESS-84 [Check-list Evaluation of Somatic Symptoms]. Nocturnal urinary 6-sulfatoxymelatonin excretion, a measure of the endogenous melatonin production, was assessed upon discontinuing long-term PRM.Results: Of the 244 patients, 36 dropped out, 112 completed 6 months of treatment, and the other 96 completed 12 months of treatment. The mean number of nights by which patients reported sleep quality as "good" or "very good" was significantly higher during PRM than before treatment. There was no evidence of tolerance to PRM. Discontinuation of PRM was not associated with rebound insomnia or withdrawal symptoms; on the contrary, residual benefit was observed. PRM was well tolerated, and there was no suppression of endogenous melatonin production

Nuclear safety cooperation for Soviet designed reactors

International Nuclear Information System (INIS)

Reisman, A.W.; Horak, W.C.

1995-01-01

The nuclear accident at the Chernobyl nuclear power plant in 1986 first alerted the West to the significant safety risks of Soviet designed reactors. Five years later, this concern was reaffirmed when the IAEA, as a result of a review by an international team of nuclear safety experts, announced that it did not believe the Kozloduy nuclear power plants in Bulgaria could be operated safely. To address these safety concerns, the G-7 summit in Munich in July 1992 outlined a five point program to address the safety problems of Soviet Designed Reactors: operational safety improvement; near-term technical improvements to plants based on safety assessment; enhancing regulatory regimes; examination of the scope for replacing less safe plants by the development of alternative energy sources and the more efficient use of energy; and upgrading of the plants of more recent design. As of early 1994, over 20 countries and international organizations have pledged hundreds of millions of dollars in financial assistance to improve safety. This paper summarizes these assistance efforts for Soviet designed reactors, draws lessons learned from these activities, and offers some options for better addressing these concerns

Label Review Training: Module 1: Label Basics, Page 24

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This page is about which labels require review.

Label Review Training: Module 1: Label Basics, Page 27

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. See examples of mandatory and advisory label statements.

Label Review Training: Module 1: Label Basics, Page 17

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. See an overview of the importance of labels.

Research notes : are safety corridors really safe? Evaluation of the corridor safety improvement program.

Science.gov (United States)

1998-08-26

High accident frequencies on Oregons highway corridors are of concern to the Oregon Department of Transportation (ODOT). : ODOT adopted the Corridor Safety Improvement Program as part of an overall program of safety improvements using federal and ...

Label Review Training: Module 1: Label Basics, Page 23

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Lists types of labels that do not require review.

Risk communication activities toward nuclear safety in Tokai: your safety is our safety

International Nuclear Information System (INIS)

Tsuchiya, T.

2007-01-01

As several decades have passed since the construction of nuclear power plants began, residents have become gradually less interested in nuclear safety. The Tokai criticality accident in 1909, however, had roused residents in Tokai-Mura to realize that they live with nuclear technology risks. To prepare a field of risk communication, the Tokai-Mura C 3 project began as a pilot research project supported by NISA. Alter the project ended, we are continuing risk. communication activities as a non-profit organisation. The most important activity of C 3 project is the citizen's inspection programme for nuclear related facilities. This programme was decided by participants who voluntarily applied to the project. The concept of the citizen's inspection programme is 'not the usual facility tours'. Participants are involved from the planning stage and continue to communicate with workers of the inspected nuclear facility. Since 2003, we have conducted six programmes for five nuclear related organisations. Participants evaluated that radiation protection measures were near good but there were some problems concerning the worker's safety and safety culture, and proposed a mixture of advice based on personal experience. Some advice was accepted and it did improve the facility's safety measures. Other suggestions were not agreed upon by nuclear organisations. The reason lies in the difference of concept between the nuclear expert's 'safety' and the citizen's 'safety'. Residents do not worry about radiation only, but also about the facility's safety as a whole including the worker's safety. They say, 'If the workers are not safe, you also are unable to protect us'. Although the disagreement remained, the participants and the nuclear industry learned much about each other. Participating citizens received a substantial amount of knowledge about the nuclear industry and its safety measures, and feel the credibility and openness of the nuclear industry. On the other hand, the nuclear

Safety Climate of Commercial Vehicle Operation

Science.gov (United States)

2010-03-01

Enhancing the safety culture within trucking and motor coach industries has become a key area of concern given the potential impact it has on crashes and overall safety. Many organizations recognize that safety is compromised if the culture within th...

Label Review Training: Module 1: Label Basics, Page 16

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about the importance of labels and the role in enforcement.

[Off-label drug use of the misoprostol in gynecology & obstetrics: From a medico-economics benefit to a potential legal risk].

Science.gov (United States)

Decamps-Mini, D; Pelofi, J; Treisser, A

2015-06-01

The scandal of the Mediator® case led the legislature to take measures in order to regulate off-label drugs prescriptions. Indeed the law issued in December 29th, 2011 on strengthening the safety of drugs and all derivative health products came to pave the way for an "over-cautious" practice of medicine in line with the precautionary principle erected as a constitutional principle. The supervision of off-label prescribing has had a direct impact on the exercise of the medical profession and has resurrected the issues related to the freedom of prescription, the obligation to provide information to patients and in general their whole responsibility. It is important to mention that the prescribing act is part of the freedom and the strict prerogative of those skilled in the art: the physician in this case. The off-label prescription is commonly accepted in certain specialties, such as anesthesia and intensive care, oncology or pediatrics where it is even subject of a memorandum of use because of concerns regarding the availability of forms adapted to children. However, the physician must ensure that no appropriate therapeutic alternative is available and inform the patient, fundamental principle of the right to respect for the will of the person. Off-label use of the prostaglandin-E1 analogue misoprostol in obstetrics and gynecology is a good example. In fact, this drug obtained a marketing authorization for the treatment or prevention of peptic ulcers and other stomach disorders, is commonly used off-label when inducing labour or intrauterine device insertion. These are the issues that need to be clarify and carefully assessed in order to help physicians to understand the impact of the law and the state of the jurisprudence on the exercise of their profession. Copyright © 2015. Published by Elsevier SAS.

Safety concerns and hidden agenda behind HPV vaccines: another generation of drug-dependent society?

Science.gov (United States)

Khatami, Mahin

2016-12-01

Analyses of data and hidden agenda behind repeated failed outcomes of cancer research and therapy, status of American health, safety concerns for HPV vaccines and future research considerations are summarized in this commentary. A closer look at cancer science reveals that highly power structure (system) in medical establishment vs. anti-system and chaos in cancer research ('medical/scientific ponzi schemes') is potent recipe for failed therapeutics that kills patients but generates huge corporate profit. American health status ranks last among other developed nations despite the highest amount that USA invests in healthcare. This is a wake-up call to make sure that the evil part of human being does not prevent the health services that the public deserves. Otherwise, 'it does not matter how many resources you have, if you don't know, or don't want to know, how to use them, they will never be enough'. Answer to cancer and improved public health is possible only by switching the current corruptive and abusive culture of 'who you know' to a culture of 'what you know'. Policy makers and professionals in decision making roles are urged to return to common sense and logics that our Forefathers used to serve the public.

Radiation safety concerns and diagnostic reference levels for computed tomography scanners in Tamil Nadu

International Nuclear Information System (INIS)

Livingstone, Roshan S.; Dinakaran, Paul M.

2011-01-01

Radiation safety in computed tomography (CT) scanners is of concern due its widespread use in the field of radiological imaging. This study intends to evaluate radiation doses imparted to patients undergoing thorax, abdomen and pelvic CT examinations and formulate regional diagnostic reference levels (DRL) in Tamil Nadu, South India. In-site CT dose measurement was performed in 127 CT scanners in Tamil Nadu for a period of 2 years as a part of the Atomic Energy Regulatory Board (AERB)-funded project. Out of the 127 CT scanners,13 were conventional; 53 single-slice helical scanners (SSHS); 44 multislice CT (MSCT) scanners; and 17 refurbished scanners. CT dose index (CTDI) was measured using a 32-cm polymethyl methacrylate (PMMA)-body phantom in each CT scanner. Dose length product (DLP) for different anatomical regions was generated using CTDI values. The regional DRLs for thorax, abdomen and pelvis examinations were 557, 521 and 294 mGy cm, respectively. The mean effective dose was estimated using the DLP values and was found to be 8.04, 6.69 and 4.79 mSv for thorax, abdomen and pelvic CT examinations, respectively. The establishment of DRLs in this study is the first step towards optimization of CT doses in the Indian context. (author)

Operational safety reliability research

International Nuclear Information System (INIS)

Hall, R.E.; Boccio, J.L.

1986-01-01

Operating reactor events such as the TMI accident and the Salem automatic-trip failures raised the concern that during a plant's operating lifetime the reliability of systems could degrade from the design level that was considered in the licensing process. To address this concern, NRC is sponsoring the Operational Safety Reliability Research project. The objectives of this project are to identify the essential tasks of a reliability program and to evaluate the effectiveness and attributes of such a reliability program applicable to maintaining an acceptable level of safety during the operating lifetime at the plant

Collection of laws and ordinances concerning regulation of atomic energy, 1989 edition. 1989 ed.

International Nuclear Information System (INIS)

1989-01-01

The collection of the laws and ordinances concerning the regulation of atomic energy, 1989 edition, was published by the Nuclear Safety Bureau, Science and Technology Agency. First, the abbreviated expressions of 56 laws and ordinances are shown. The contents are divided into Part 1: Fundamental laws and ordinances, Part 2: Regulation of nuclear source materials, nuclear fuel materials and nuclear reactors, Part 3: Prevention of radiation injuries due to radioactive isotopes and others, and Part 4: Related laws and ordinances. In Part 1, Atomic Energy Fundamental Act, Act of Institution of Atomic Energy Commission and Nuclear Safety Commission of Japan, Law Concerning the Technical Standard for Prevention of Radiation Injuries and 9 others are included. In Part 2, Law Concerning Regulation of Nuclear Source Materials, Nuclear Fuel Materials and Nuclear Reactors and 45 others are included. In Part 3, Law Concerning Prevention of Radiation Injuries Due to Radioisotopes and Others and 25 others are included. In Part 4, Electricity Enterprises Act, Road Transport and Vehicles Act, Ships' Safety Law, Labor Safety and Hygiene Law, Japan Atomic Energy Research Institute Law and 29 others are included. The contents are those as of November 30, 1988. (Kako, I.)

Efficient Multi-Label Feature Selection Using Entropy-Based Label Selection

Directory of Open Access Journals (Sweden)

Jaesung Lee

2016-11-01

Full Text Available Multi-label feature selection is designed to select a subset of features according to their importance to multiple labels. This task can be achieved by ranking the dependencies of features and selecting the features with the highest rankings. In a multi-label feature selection problem, the algorithm may be faced with a dataset containing a large number of labels. Because the computational cost of multi-label feature selection increases according to the number of labels, the algorithm may suffer from a degradation in performance when processing very large datasets. In this study, we propose an efficient multi-label feature selection method based on an information-theoretic label selection strategy. By identifying a subset of labels that significantly influence the importance of features, the proposed method efficiently outputs a feature subset. Experimental results demonstrate that the proposed method can identify a feature subset much faster than conventional multi-label feature selection methods for large multi-label datasets.

14C-labeled lignins as substrates for the study of lignin biodegradation and transformation

International Nuclear Information System (INIS)

Crawford, R.L.; Robinson, L.E.; Chen, A.M.

1980-01-01

Methods, both classical and isotopic, for quantifying lignin degradation are reviewed. Preparation and chemical characterization of 14 C-labeled lignins (both synthetic and plant-synthesized) are reviewed, with emphasis on the utilization of these 14 C-labeled substrates in biodegradation and biotransformation experiments. The scientific literature is reviewed concerning the use of 14 C-lignins to examine the following: microbial groups that are able to degrade lignins; lignin degradation in natural environments; biochemistry and microbial physiology of lignin degradation; biodegradability of industrial lignins and their by-products; and screening for industrially valuable, lignin-modifying microorganisms. Recent results obtained in our laboratory concerning lignin degradation by eubacteria are presented. Future directions for 14 C-methodology are examined

Safety and Efficacy of Memantine in Children with Autism: Randomized, Placebo-Controlled Study and Open-Label Extension.

Science.gov (United States)

Aman, Michael G; Findling, Robert L; Hardan, Antonio Y; Hendren, Robert L; Melmed, Raun D; Kehinde-Nelson, Ola; Hsu, Hai-An; Trugman, Joel M; Palmer, Robert H; Graham, Stephen M; Gage, Allyson T; Perhach, James L; Katz, Ephraim

2017-06-01

Abnormal glutamatergic neurotransmission is implicated in the pathophysiology of autism spectrum disorder (ASD). In this study, the safety, tolerability, and efficacy of the glutamatergic N-methyl-d-aspartate (NMDA) receptor antagonist memantine (once-daily extended-release [ER]) were investigated in children with autism in a randomized, placebo-controlled, 12 week trial and a 48 week open-label extension. A total of 121 children 6-12 years of age with Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR)-defined autistic disorder were randomized (1:1) to placebo or memantine ER for 12 weeks; 104 children entered the subsequent extension trial. Maximum memantine doses were determined by body weight and ranged from 3 to 15 mg/day. There was one serious adverse event (SAE) (affective disorder, with memantine) in the 12 week study and one SAE (lobar pneumonia) in the 48 week extension; both were deemed unrelated to treatment. Other AEs were considered mild or moderate and most were deemed not related to treatment. No clinically significant changes occurred in clinical laboratory values, vital signs, or electrocardiogram (ECG). There was no significant between-group difference on the primary efficacy outcome of caregiver/parent ratings on the Social Responsiveness Scale (SRS), although an improvement over baseline at Week 12 was observed in both groups. A trend for improvement at the end of the 48 week extension was observed. No improvements in the active group were observed on any of the secondary end-points, with one communication measure showing significant worsening with memantine compared with placebo (p = 0.02) after 12 weeks. This trial did not demonstrate clinical efficacy of memantine ER in autism; however, the tolerability and safety data were reassuring. Our results could inform future trial design in this population and may facilitate the investigation of memantine ER for other clinical applications.

Topical points of community policy concerning nuclear safety relevant to the Internal Market

International Nuclear Information System (INIS)

Schroeder, M.

1991-01-01

Starting with the Internal Market concept, the lecture describes general and specific expectations directed to the nuclear community from a point of view of nuclear safety, and analyzes those aspects of nuclear safety, EC policy focuses on. There are the following chapters: 1. Selection of sites for nuclear installations, 2. installation and reactor safety, 3. radioactive waste management, 4. decommissioning of nuclear installations, 5. radioactive waste storage, 6. coping with nuclear accidents and other radiological emergency situations. Sophistication of public health and environmental protection within the framework of the EURATOM Treaty is seen in connection with interim and final storage as well as reprocessing of radioactive waste, and with the decommissioning of nuclear facilities on the basis of section 30 ff., and installation and reactor safety on the basis of section 203 EURATOM Treaty. Improving the protection of public health in particular is possible and necessary in order to make the EURATOM community into a proper nuclear community of law. (orig./HSCH) [de

Safety campaigns. TIS Launches New Safety Information Campaign

CERN Multimedia

2001-01-01

Need to start a new installation and worried about safety aspects? Or are you newly responsible for safety matters in a CERN building? Perhaps you're simply interested in how to make the working environment safer for yourself and your colleagues. Whatever the case, a new information campaign launched by TIS this week can help. The most visible aspects of the new campaign will be posters distributed around the Laboratory treating a different subject each month. The Web site - http://safety.cern.ch/ - which provides all safety related information. But these are not the only aspects of the new campaign. Members of the TIS/GS group, whose contact details can be found on the safety web site, are available to give information and advice on a one-to-one basis at any time. The campaign's launch has been timed to coincide with European Safety Week, organized by the European Agency for Safety and Health at Work and the subject treated in the first posters is safety inspection. This particular topic only concerns thos...

Multi-label Learning with Missing Labels Using Mixed Dependency Graphs

KAUST Repository

Wu, Baoyuan; Jia, Fan; Liu, Wei; Ghanem, Bernard; Lyu, Siwei

2018-01-01

This work focuses on the problem of multi-label learning with missing labels (MLML), which aims to label each test instance with multiple class labels given training instances that have an incomplete/partial set of these labels (i.e., some

Patient safety in the clinical laboratory: a longitudinal analysis of specimen identification errors.

Science.gov (United States)

Wagar, Elizabeth A; Tamashiro, Lorraine; Yasin, Bushra; Hilborne, Lee; Bruckner, David A

2006-11-01

Patient safety is an increasingly visible and important mission for clinical laboratories. Attention to improving processes related to patient identification and specimen labeling is being paid by accreditation and regulatory organizations because errors in these areas that jeopardize patient safety are common and avoidable through improvement in the total testing process. To assess patient identification and specimen labeling improvement after multiple implementation projects using longitudinal statistical tools. Specimen errors were categorized by a multidisciplinary health care team. Patient identification errors were grouped into 3 categories: (1) specimen/requisition mismatch, (2) unlabeled specimens, and (3) mislabeled specimens. Specimens with these types of identification errors were compared preimplementation and postimplementation for 3 patient safety projects: (1) reorganization of phlebotomy (4 months); (2) introduction of an electronic event reporting system (10 months); and (3) activation of an automated processing system (14 months) for a 24-month period, using trend analysis and Student t test statistics. Of 16,632 total specimen errors, mislabeled specimens, requisition mismatches, and unlabeled specimens represented 1.0%, 6.3%, and 4.6% of errors, respectively. Student t test showed a significant decrease in the most serious error, mislabeled specimens (P patient safety projects. Trend analysis demonstrated decreases in all 3 error types for 26 months. Applying performance-improvement strategies that focus longitudinally on specimen labeling errors can significantly reduce errors, therefore improving patient safety. This is an important area in which laboratory professionals, working in interdisciplinary teams, can improve safety and outcomes of care.

Hydrogen Technologies Safety Guide

Energy Technology Data Exchange (ETDEWEB)

Rivkin, C. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Burgess, R. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Buttner, W. [National Renewable Energy Lab. (NREL), Golden, CO (United States)

2015-01-01

The purpose of this guide is to provide basic background information on hydrogen technologies. It is intended to provide project developers, code officials, and other interested parties the background information to be able to put hydrogen safety in context. For example, code officials reviewing permit applications for hydrogen projects will get an understanding of the industrial history of hydrogen, basic safety concerns, and safety requirements.

Study on safety of a nuclear ship having an integral marine water reactor. Intelligent information database program concerned with thermal-hydraulic characteristics

International Nuclear Information System (INIS)

Inasaka, Fujio; Nariai, Hideki; Kobayashi, Michiyuki; Murata, Hiroyuki; Aya, Izuo

2001-01-01

As a high economical marine reactor with sufficient safety functions, an integrated type marine water reactor has been considered most promising. At the National Maritime Research Institute, a series of the experimental studies on the thermal-hydraulic characteristics of an integrated/passive-safety type marine water reactor such as the flow boiling of a helical-coil type steam generator, natural circulation of primary water under a ship rolling motion and flashing-condensation oscillation phenomena in pool water has been conducted. This current study aims at making use of the safety analysis or evaluation of a future marine water reactor by developing an intelligent information database program concerned with the thermal-hydraulic characteristics of an integral/passive-safety reactor on the basis of the above-mentioned valuable experimental knowledge. Since the program was created as a Windows application using the Visual Basic, it is available to the public and can be easily installed in the operating system. Main functions of the program are as follows: (1) steady state flow boiling analysis and determination of stability limit for any helical-coil type once-through steam generator design. (2) analysis and comparison with the flow boiling data, (3) reference and graphic display of the experimental data, (4) indication of the knowledge information such as analysis method and results of the study. The program will be useful for the design of not only the future integrated type marine water reactor but also the small sized water reactor. (author)

Safety concerning the alteration in fuel material usage (new installation of the uranium enrichment pilot plant) at Ningyo Pass Mine of Power Reactor and Nuclear Fuel Development Corporation

International Nuclear Information System (INIS)

1978-01-01

A report of the Committee on Examination of Nuclear Fuel Safety was presented to the Atomic Energy Commission of Japan, which is concerned with the safety in the alteration of fuel material usage (new installation of the uranium enrichment pilot plant) at the Ningyo Pass Mine. Its safety was confirmed. The alteration, i.e. installation of the uranium enrichment pilot plant, is as follows. Intended for the overall test of centrifugal uranium enrichment technology, the pilot plant includes a two-storied main building of about 9,000 m 2 floor space, containing centrifuges, UF 6 equipment, etc., a uranium storage of about 1,000 m 2 floor space, and a waste water treatment facility, two-storied with about 300 m 2 floor space. The contents of the examination are safety of the facilities, criticality control, radiation control, waste treatment, and effects of accidents on the surrounding environment. (Mori, K

Investigating drug repositioning opportunities in FDA drug labels through topic modeling.

Science.gov (United States)

Bisgin, Halil; Liu, Zhichao; Kelly, Reagan; Fang, Hong; Xu, Xiaowei; Tong, Weida

2012-01-01

Drug repositioning offers an opportunity to revitalize the slowing drug discovery pipeline by finding new uses for currently existing drugs. Our hypothesis is that drugs sharing similar side effect profiles are likely to be effective for the same disease, and thus repositioning opportunities can be identified by finding drug pairs with similar side effects documented in U.S. Food and Drug Administration (FDA) approved drug labels. The safety information in the drug labels is usually obtained in the clinical trial and augmented with the observations in the post-market use of the drug. Therefore, our drug repositioning approach can take the advantage of more comprehensive safety information comparing with conventional de novo approach. A probabilistic topic model was constructed based on the terms in the Medical Dictionary for Regulatory Activities (MedDRA) that appeared in the Boxed Warning, Warnings and Precautions, and Adverse Reactions sections of the labels of 870 drugs. Fifty-two unique topics, each containing a set of terms, were identified by using topic modeling. The resulting probabilistic topic associations were used to measure the distance (similarity) between drugs. The success of the proposed model was evaluated by comparing a drug and its nearest neighbor (i.e., a drug pair) for common indications found in the Indications and Usage Section of the drug labels. Given a drug with more than three indications, the model yielded a 75% recall, meaning 75% of drug pairs shared one or more common indications. This is significantly higher than the 22% recall rate achieved by random selection. Additionally, the recall rate grows rapidly as the number of drug indications increases and reaches 84% for drugs with 11 indications. The analysis also demonstrated that 65 drugs with a Boxed Warning, which indicates significant risk of serious and possibly life-threatening adverse effects, might be replaced with safer alternatives that do not have a Boxed Warning. In

Regulatory oversight report 2007 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2008-04-01

This annual report issued by the Swiss Federal Nuclear Inspectorate (HSK) reports on the work carried out by the Inspectorate in 2007. This report reviews the regulatory activities in the four Swiss nuclear power stations and in four further nuclear installations in various Swiss research facilities. It deals with topics such as operational details, technologies in use, radiation protection, radioactive wastes, emergency dispositions and personnel and provides an assessment of operations from the point of view of safety. Also, the transportation of nuclear materials - both nuclear fuels and nuclear wastes - is reported on. General topics discussed include probabilistic safety analyses and accident management. Finally, the disposal of nuclear wastes and work done in the rock laboratories in Switzerland is commented on

Protocol between the Nuclear Protection and Safety Bureau of Portugal and the Nuclear Energy Commission of Spain on Technical Information concerning Nuclear Installations in Border Areas

International Nuclear Information System (INIS)

1980-01-01

This Protocol was concluded under the Agreement of the same date on the safety of nuclear installations in border areas. Its purpose is to prescribe the type of information referred to in the Agreement. It lays down in detail all the documents to be supplied concerning the siting, construction, operation and decommissioning of nuclear installations, including the geological, seismological, meteorological, hydrological and ecological aspects of the sites concerned, for purposes of environmental protection; the characteristics of the projected installations and emergency plans must also be provided. Similarly to the Agreement, this Protocol will remain in force for a period of ten years. (NEA) [fr

Multi-label Learning with Missing Labels Using Mixed Dependency Graphs

KAUST Repository

Wu, Baoyuan

2018-04-06

This work focuses on the problem of multi-label learning with missing labels (MLML), which aims to label each test instance with multiple class labels given training instances that have an incomplete/partial set of these labels (i.e., some of their labels are missing). The key point to handle missing labels is propagating the label information from the provided labels to missing labels, through a dependency graph that each label of each instance is treated as a node. We build this graph by utilizing different types of label dependencies. Specifically, the instance-level similarity is served as undirected edges to connect the label nodes across different instances and the semantic label hierarchy is used as directed edges to connect different classes. This base graph is referred to as the mixed dependency graph, as it includes both undirected and directed edges. Furthermore, we present another two types of label dependencies to connect the label nodes across different classes. One is the class co-occurrence, which is also encoded as undirected edges. Combining with the above base graph, we obtain a new mixed graph, called mixed graph with co-occurrence (MG-CO). The other is the sparse and low rank decomposition of the whole label matrix, to embed high-order dependencies over all labels. Combining with the base graph, the new mixed graph is called as MG-SL (mixed graph with sparse and low rank decomposition). Based on MG-CO and MG-SL, we further propose two convex transductive formulations of the MLML problem, denoted as MLMG-CO and MLMG-SL respectively. In both formulations, the instance-level similarity is embedded through a quadratic smoothness term, while the semantic label hierarchy is used as a linear constraint. In MLMG-CO, the class co-occurrence is also formulated as a quadratic smoothness term, while the sparse and low rank decomposition is incorporated into MLMG-SL, through two additional matrices (one is assumed as sparse, and the other is assumed as low

IAEA activities in nuclear safety: future perspectives. Spanish Nuclear Safety Council, Madrid, 28 May 1998

International Nuclear Information System (INIS)

ElBaradei, M.

1998-01-01

The document represents the conference given by the Director General of the IAEA at the Spanish Nuclear Safety Council in Madrid, on 28 May 1998, on Agency's activities in nuclear safety. The following aspects are emphasized: Agency's role in creating a legally binding nuclear safety regime, non-binding safety standards, services provided by the Agency to assist its Member States in the Application of safety standards, Agency's nuclear safety strategy, and future perspective concerning safety aspects related to radioactive wastes, residues of past nuclear activities, and security of radiological sources

NASA Aviation Safety Reporting System (ASRS)

Science.gov (United States)

Connell, Linda J.

2017-01-01

The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 1.4 million reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 6,000 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides selected de-identified report information through the online ASRS Database at http:asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation will discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

Review of activities concerning sodium water reaction in LMFBR

International Nuclear Information System (INIS)

Rajput, A.K.

1984-01-01

This paper presents a review of activities concerning safety engineering programme for steam generators of FBT reactor in India. Leak rate and its effect and leak detection system are briefly discussed

Leadership and Management for Safety. General Safety Requirements (Arabic Edition)

International Nuclear Information System (INIS)

2016-01-01

This Safety Requirements publication establishes requirements that support Principle 3 of the Fundamental Safety Principles in relation to establishing, sustaining and continuously improving leadership and management for safety and an integrated management system. It emphasizes that leadership for safety, management for safety, an effective management system and a systemic approach (i.e. an approach in which interactions between technical, human and organizational factors are duly considered) are all essential to the specification and application of adequate safety measures and to the fostering of a strong safety culture. Leadership and an effective management system will integrate safety, health, environmental, security, quality, human-and-organizational factors, societal and economic elements. The management system will ensure the fostering of a strong safety culture, regular assessment of performance and the application of lessons from experience. The publication is intended for use by regulatory bodies, operating organizations and other organizations concerned with facilities and activities that give rise to radiation risks.

Leadership and Management for Safety. General Safety Requirements (Chinese Edition)

International Nuclear Information System (INIS)

2016-01-01

This Safety Requirements publication establishes requirements that support Principle 3 of the Fundamental Safety Principles in relation to establishing, sustaining and continuously improving leadership and management for safety and an integrated management system. It emphasizes that leadership for safety, management for safety, an effective management system and a systemic approach (i.e. an approach in which interactions between technical, human and organizational factors are duly considered) are all essential to the specification and application of adequate safety measures and to the fostering of a strong safety culture. Leadership and an effective management system will integrate safety, health, environmental, security, quality, human-and-organizational factors, societal and economic elements. The management system will ensure the fostering of a strong safety culture, regular assessment of performance and the application of lessons from experience. The publication is intended for use by regulatory bodies, operating organizations and other organizations concerned with facilities and activities that give rise to radiation risks.

Leadership and Management for Safety. General Safety Requirements (French Edition)

International Nuclear Information System (INIS)

2016-01-01

This Safety Requirements publication establishes requirements that support Principle 3 of the Fundamental Safety Principles in relation to establishing, sustaining and continuously improving leadership and management for safety and an integrated management system. It emphasizes that leadership for safety, management for safety, an effective management system and a systemic approach (i.e. an approach in which interactions between technical, human and organizational factors are duly considered) are all essential to the specification and application of adequate safety measures and to the fostering of a strong safety culture. Leadership and an effective management system will integrate safety, health, environmental, security, quality, human-and-organizational factors, societal and economic elements. The management system will ensure the fostering of a strong safety culture, regular assessment of performance and the application of lessons from experience. The publication is intended for use by regulatory bodies, operating organizations and other organizations concerned with facilities and activities that give rise to radiation risks.

Leadership and Management for Safety. General Safety Requirements (Spanish Edition)

International Nuclear Information System (INIS)

2017-01-01

his Safety Requirements publication establishes requirements that support Principle 3 of the Fundamental Safety Principles in relation to establishing, sustaining and continuously improving leadership and management for safety and an integrated management system. It emphasizes that leadership for safety, management for safety, an effective management system and a systemic approach (i.e. an approach in which interactions between technical, human and organizational factors are duly considered) are all essential to the specification and application of adequate safety measures and to the fostering of a strong safety culture. Leadership and an effective management system will integrate safety, health, environmental, security, quality, human-and-organizational factors, societal and economic elements. The management system will ensure the fostering of a strong safety culture, regular assessment of performance and the application of lessons from experience. The publication is intended for use by regulatory bodies, operating organizations and other organizations concerned with facilities and activities that give rise to radiation risks.

Label it or ban it? Public perceptions of nano-food labels and propositions for banning nano-food applications

Science.gov (United States)

Chuah, Agnes S. F.; Leong, Alisius D.; Cummings, Christopher L.; Ho, Shirley S.

2018-02-01

The future of nano-food largely hinges on public perceptions and willingness to accept this novel technology. The present study utilizes the scientific literacy model and psychometric paradigm as the key theoretical frameworks to examine the factors influencing public support for labeling and banning of nano-food in Singapore. Using data collected from a nationally representative survey of 1001 respondents, the findings demonstrated that attitudes toward technology, preference for natural product, science knowledge, and risk perception were found to substantially affect public support for both labeling and banning of nano-food. Conversely, attention to food safety news on traditional media and attention to nano-news on new media were only associated with public support for labeling of nano-food. Similarly, benefit perception was only significantly associated with public support for banning of nano-food. Theoretically, these findings support the growing body of literature that argues for the significant role played by predispositions, media use, science knowledge, and risk and benefit perceptions on attitude formation toward nano-food. It serves as the pioneering piece to address the aspect of banning in the field of nano-food. Practically, insights drawn from this study could aid relevant stakeholders in enlisting effecting strategies to convey the benefits of nano-food while mitigating the risk perceptions among the public.

Food safety concerns deriving from the use of silver based food packaging materials: a case study.

Directory of Open Access Journals (Sweden)

Alessandra ePezzuto

2015-10-01

Full Text Available The formulation of innovative packaging solutions, exerting a functional antimicrobial role in slowing down food spoilage, is expected to have a significant impact on the food industry, allowing both the maintenance of food safety criteria for longer periods and the reduction of food waste. Different materials are considered able to exert the required antimicrobial activity, among which are materials containing silver. However, challenges exist in the application of silver to food contact materials due to knowledge gaps in the production of ingredients, stability of delivery systems in food matrices and health risks caused by the same properties which also offer the benefits. Aims of the present study were to test the effectiveness and suitability of two packaging systems, one of which contained silver, for packaging and storing Stracchino cheese, a typical Italian fresh cheese, and to investigate if there was any potential for consumers to be exposed to silver, via migration from the packaging to the cheese. Results did not show any significant difference in the effectiveness of the packaging systems on packaged Stracchino cheese, excluding that the active packaging systems exerted an inhibitory effect on the growth of spoilage microorganisms. Moreover, silver migrated into the cheese matrix throughout the storage time (24 days. Silver levels in cheese finally exceeded the maximum established level for the migration of a non-authorised substance through a functional barrier (Commission Regulation (EC No. 450/2009. This result poses safety concerns and strongly suggests the need for more research aimed at better characterizing the new packaging materials in terms of their potential impacts on human health and the environment.

The safety of methadone hydrochloride.

Science.gov (United States)

Swegle, John M; Wensel, David D

2008-01-01

Methadone is an interesting analgesic for multiple reasons. The unique properties of the agent, low cost and widespread availability have led to increases in methadone prescribing. Despite advantages, methadone is challenging to work with, particularly in patients with high opioid requirements. Recent concerns regarding cardiac arrhythmias and respiratory depression have led to changes in the labeling of methadone. This editorial highlights some of these concerns and provides some recommendations for the appropriate use of methadone in the setting of pain.

Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or Older.

Science.gov (United States)

Schwarz, Tino F; Aggarwal, Naresh; Moeckesch, Beate; Schenkenberger, Isabelle; Claeys, Carine; Douha, Martine; Godeaux, Olivier; Grupping, Katrijn; Heineman, Thomas C; Fauqued, Marta Lopez; Oostvogels, Lidia; Van den Steen, Peter; Lal, Himal

2017-12-12

The immunogenicity and safety of an adjuvanted herpes zoster subunit (HZ/su) vaccine when coadministered with a quadrivalent seasonal inactivated influenza vaccine (IIV4) was investigated in a phase 3, open-label, randomized clinical trial in adults aged ≥50 years. Subjects were randomized 1:1 to receive either HZ/su (varicella zoster virus glycoprotein E; AS01B Adjuvant System) and IIV4 at day 0 followed by a second HZ/su dose at month 2 (coadministration group), or IIV4 at month 0 and HZ/su at months 2 and 4 (control group). The primary objectives were the HZ/su vaccine response rate in the coadministration group and the noninferiority of the antibody responses to HZ/su and IIV4 in the coadministration compared with the control group. Safety information was collected throughout the duration of the study. A total of 413 subjects were vaccinated in the coadministration group and 415 in the control group. The HZ/su vaccine response rate in the coadministration group was 95.8% (95% confidence interval, 93.3%-97.6%) and the anti-glycoprotein E GMCControl/Coadmin ratio was 1.08 (.97-1.20). The primary noninferiority objectives were met. No safety concerns were observed. No interference in the immune responses to either vaccine was observed when the vaccines were coadministered, and no safety concerns were identified. NCT01954251. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

Optimization method concerning target conflicts between safety aspects and occupational safety aspects in nuclear power plant operations

International Nuclear Information System (INIS)

Mueller, W.

1991-01-01

The simplified cost-benefit analysis has not been considered for applications in nuclear engineering with complex decisions between safety aspects and occupational safety aspects. The extended cost-benefit analysis encounters problems with non-monetary criteria. Solutions are in sight, however with a subjective element. A major problem in implementing the method is the psychological barrier as against an evaluation of human life. The multi-attribute utility analysis overcomes the difficulties of the extended cost-benefit analysis, however, it also creates new problems on account of the complicated construction of the utility functions. The problems are solved most elegantly with the multi-criteria outranking analysis, the only disadvantage possibly being less transparency at first sight. (orig./HP) [de

Safety at CERN

CERN Document Server

2009-01-01

Safety is an integral part of our working lives, and should be in our minds whatever job we do at CERN. Ultimately, safety is the responsibility of the Director General – your safety is my concern. That’s why I have this week appointed a new Safety Policy Committee (SAPOCO) that reflects the new Organizational structure of CERN. CERN’s Staff Rules and Regulations clearly lay out in chapter 3 the scope of safety at CERN as well as my responsibilities and yours in safety matters. At CERN, safety is considered in the broadest sense, encompassing occupational Health and Safety, environmental protection, and the safety of equipment and installations. It is my responsibility to put appropriate measures in place to ensure that these conditions are met. And it is the responsibility of us all to ensure that we are fully conversant with safety provisions applicable in our areas of work and that we comply with them. The appointment of a n...

Safety after extended repeated use of ulipristal acetate for uterine fibroids

DEFF Research Database (Denmark)

Fauser, Bart C J M; Donnez, Jacques; Bouchard, Philippe

2017-01-01

OBJECTIVE: To assess long term safety of extended repeated 3-month courses of ulipristal acetate (UPA) 10 mg/day, for up to 8 courses, with focus on endometrial and laboratory safety parameters. METHODS: This long-term, multi-center, open-label cohort, follow up study consisted of up to 8 consecu...

The Role of OSHA in Safety and Health. Module SH-02. Safety and Health.

Science.gov (United States)

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on the role of OSHA (Occupational Safety and Health Act) in Safety and Health is one of 50 modules concerned with job safety and health. This module looks at the OSHA Act, its aims, and the rights and responsibilities of employers and workers under the Act. Following the introduction, 16 objectives (each keyed to a page in the…

Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: testing an European Food Safety Authority-tiered approach.

Science.gov (United States)

Speijers, Gerrit; Bottex, Bernard; Dusemund, Birgit; Lugasi, Andrea; Tóth, Jaroslav; Amberg-Müller, Judith; Galli, Corrado L; Silano, Vittorio; Rietjens, Ivonne M C M

2010-02-01

This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (ii) Adequate characterization and description of the botanical parts and preparation methodology used is needed. Safety of a botanical ingredient cannot be assumed only relying on the long-term safe use of other preparations of the same botanical. (iii) Because of possible adulterations, misclassifications, replacements or falsifications, and restorations, establishment of adequate quality control is necessary. (iv) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (v) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (vi) Adequate data and methods for appropriate exposure assessment are often missing. (vii) Safety regulations concerning toxic contaminants have to be complied with. The application of the guidance approach can result in the conclusion that safety can be presumed, that the botanical ingredient is of safety concern, or that further data are needed to assess safety.

Overview of the environmental concerns of coal transportation

Energy Technology Data Exchange (ETDEWEB)

Bertram, K.; Dauzvardis, P.; Fradkin, L.; Surles, T.

1980-02-01

More than 30 environmental concerns were analyzed for the transportation of coal by rail, roads (trucks), high voltage transmission lines (that is, from mine-mouth generating plants to distribution networks), coal slurry pipelines, and barges. The following criteria were used to identify these problems: (1) real physical environmetal impacts for which control technologies must be developed, or regulation made effective where control technologies presently exist; (2) the level of impact is uncertain, although the potential impact may be moderate to high; (3) the concerns identified by the first two criteria are specific to or exacerbated by coal transportation. Generic transportation problems are not included. The significant environmental problems identified as a result of this study are: (1) rail transport - community traffic disruption and human health, safety, and habitat destruction; (2) coal haul roads - road degradation, traffic congestion and safety, air quality, and noise; (3) high voltage transmission lines - changed land use without local benefits, biological health and safety effects, and disruption of world weather patterns; (4) slurry pipelines - water availability, water quality, and possible spills from non-water slurry pipelines; and (5) barge transport - impacts common to all barge traffic. (DMC)

Food Safety as a contributor to Food Security: global policy concerns & challenges

OpenAIRE

Vijay Kumar Chattu

2015-01-01

The theme for World Health Day campaign for this year 2015 is “Food safety: from farm to plate, make food safe”. The day focuses on demonstrating the importance of food safety along the whole length of the food chain in a globalized world, from production and transport, to preparation and consumption (1). Everyone needs food and needs it every day either plant sources or animal sources or both. The food we eat must be nutritious and safe but we often ignore or overlook the issue of food safet...

Possible artefacts in thin layer chromatography of tritium-labelled hydrocortisone

International Nuclear Information System (INIS)

Sofronie, E.

1982-12-01

Artefacts appearing in thin layer chromatography of tritium labelled hydrocortisone are reported. Evidences are presented that these artefacts cause misleading results concerning radiocheemical purity determiniation. Finally, it is reported a rapid and efficient chromatographic technique allowing the elimination of these artefacts and obtaining of an accurate value for radiochemical purity. (author)

Maturing safety in the UK

International Nuclear Information System (INIS)

Debenham, A.; Kovan, D.

1994-01-01

AEA Technology provides UK nuclear industry with technical services and R+D support, concentrating on plant performance, safety and environmental issues. Today, safety has a new set of priorities, reflected by a more demanding regulatory regime which takes account of concerns such as human factors, severe accidents, risks during plant outages, the need for improving safety culture, etc

Prevalence and determinants of non-standard motorcycle safety helmets amongst food delivery workers in Selangor and Kuala Lumpur.

Science.gov (United States)

Kulanthayan, S; See, Lai Git; Kaviyarasu, Y; Nor Afiah, M Z

2012-05-01

Almost half of the global traffic crashes involve vulnerable groups such as pedestrian, cyclists and two-wheeler users. The main objective of this study was to determine the factors that influence standard of the safety helmets used amongst food delivery workers by presence of Standard and Industrial Research Institute of Malaysia (SIRIM) certification label. A cross sectional study was conducted amongst 150 food delivery workers from fast food outlets in the vicinity of Selangor and Kuala Lumpur. During observation, safety helmets were classified as standard safety helmet in the presence of SIRIM label and non-standard in the absence of the label. They were approached for questionnaire participation once consent was obtained and were requested to exchange their safety helmet voluntarily with a new one after the interview. Data analysis was carried out using SPSS. Chi square and logistic regression analysis was applied to determine the significance and odds ratio of the variables studied, respectively (penetration test, age, education level, knowledge, crash history, types of safety helmet, marital status and years of riding experience) against the presence of SIRIM label. The response rate for this study was 85.2%. The prevalence of non-standard helmets use amongst fast food delivery workers was 55.3%. Safety helmets that failed the penetration test had higher odds of being non-standard helmets compared with safety helmets passing the test. Types of safety helmet indicated half-shell safety helmets had higher odds to be non-standard safety helmets compared to full-shell safety helmets. Riders with more years of riding experience were in high odds of wearing non-standard safety helmets compared to riders with less riding experience. Non-standard (non-SIRIM approved) helmets were more likely to be half-shell helmets, were more likely to fail the standards penetration test, and were more likely to be worn by older, more experienced riders. The implications of these

Fundamental Safety Principles

International Nuclear Information System (INIS)

Abdelmalik, W.E.Y.

2011-01-01

This work presents a summary of the IAEA Safety Standards Series publication No. SF-1 entitled F UDAMENTAL Safety PRINCIPLES p ublished on 2006. This publication states the fundamental safety objective and ten associated safety principles, and briefly describes their intent and purposes. Safety measures and security measures have in common the aim of protecting human life and health and the environment. These safety principles are: 1) Responsibility for safety, 2) Role of the government, 3) Leadership and management for safety, 4) Justification of facilities and activities, 5) Optimization of protection, 6) Limitation of risks to individuals, 7) Protection of present and future generations, 8) Prevention of accidents, 9)Emergency preparedness and response and 10) Protective action to reduce existing or unregulated radiation risks. The safety principles concern the security of facilities and activities to the extent that they apply to measures that contribute to both safety and security. Safety measures and security measures must be designed and implemented in an integrated manner so that security measures do not compromise safety and safety measures do not compromise security.

Indium-111 labelled platelets: experimental and clinical studies

International Nuclear Information System (INIS)

Gjerloeff Schmidt, K.

1985-10-01

The object of the present study became to develop a method of effective and gentle isolation and 111-In labelling of human platelets, as well as to employ these platelets in human clinical studies with the object of elucidating a number of physiological and pathophysiological mechanisms and processes in which platelets take part. 111-In-oxine presents obvious advantages over 51-Cr-sodium chromate; a high labelling efficiency, and more advantageous physical properties (a half life of 68 hours (against the half life of 28 days for 51-Cr) and considerably more effective gamma emission), making external registration by means of a gamma camera possible. Considering the role played by platelets in the development of atherosclerosis and its thromboembolic complications, in the early phases of deep venous thrombosis, and in graft rejection, it is natural that attempts have been made to use 111-In-labelled platelets for scintigraphic and kinetic evaluation of thromboembolic processes. Accumulation of 111-In-labelled platelets at sites of vessel wall injury, on pulmonary emboli (presumably on deep vein thrombi as well), and on catheter material has been demonstrated. Beyond this, the number of publications concerning the use of 111-In-labelled platelets for visualization of atherosclerosis, venous thromboembolism, arterial grafts, intracardiac thrombi, aortic aneurysms, renal allograft rejection, and other situations in which platelet thromboembolism takes place, provides evidence that a tool has finally been found for the study of their nature and response to therapeutic intervention. (eg)

When zero is greater than one: consumer misinterpretations of nutrition labels.

Science.gov (United States)

Graham, Dan J; Mohr, Gina S

2014-12-01

Front-of-package (FOP) nutrition labels are increasingly used by food manufacturers. A call to regulate the content and format of these labels resulted in recommendations by the Institute of Medicine (IOM) for standardized FOP labels that clearly communicate packaged foods' healthfulness. It is currently unclear how consumers would interpret and use these proposed labels. This research addresses psychological factors affecting the efficacy of FOP label use. It was hypothesized that IOM's proposed 0- to 3-point rating scale would produce the zero-comparison effect, leading to more favorable evaluations than are warranted for the least healthful products (i.e., those earning zero nutritional points). In two studies (Study 1, n = 68; Study 2, n = 101), participants evaluated products containing FOP labels on the basis of IOM recommendations. Primary outcomes were perceived product healthfulness and purchase intentions. Study 1 demonstrated that less-healthful products were rated by study participants to be equally healthful as more-healthful products. The relationship between FOP rating and purchase intentions was mediated by perceived healthfulness. Biases in product healthfulness ratings were exacerbated for consumers with higher (vs. lower) health concern. Study 2 demonstrated that by changing the rating scale from 0-3 to 1-4, consumers avoid the zero-comparison effect and accurately evaluate products' healthfulness. This research has implications for theory and policy in the domains of nutrition labeling and consumer health. Specifically, FOP labels can help consumers identify healthful options, but products receiving zero nutritional points may be misidentified as healthful; a simple label modification can prevent this confusion.

Enhancing operational safety

Energy Technology Data Exchange (ETDEWEB)

Wiebe, J S

1997-09-01

The presentation briefly considers the following aspects concerning enhancing operational safety of NPP: licensed control room supervision, reactivity changes, personnel access to control room, simulator training.

Safety first. Yes, but which safety?; Primat der Sicherheit. Ja, aber welche Sicherheit ist gemeint?

Energy Technology Data Exchange (ETDEWEB)

Roehlig, Klaus-Juergen [Technische Univ. Clausthal, Clausthal-Zellerfeld (Germany). Inst. fuer Endlagerforschung; Eckhardt, Anne [risicare GmbH, Zollikerberg (Switzerland)

2017-09-01

The site selection law in Germany and the final report of the final repository commission state the central objective to find a repository site that will guarantee safety for the next million of years. Decision makers, concerned and interested people have obviously different opinions and acceptance criteria with respect to the tools for the demonstration of safety (safety case). Possible solutions for a broad acceptance of safety definitions are discussed.

Lumbar epidural catheter placement in the presence of low back tattoos: a review of the safety concerns.

Science.gov (United States)

Welliver, Dawn; Welliver, Mark; Carroll, Tammy; James, Peggy

2010-06-01

Current fashion in body art includes low back tattoos of varying designs and colors, a trend that presents unique concerns for anesthesia providers. Does the placement of epidural catheters risk the introduction of tattoo pigment dyes into the epidural space through the process of coring? Are there specific risks associated with tattoo dyes and epidural needle placement? We performed a comprehensive review of the literature using multiple search databases with the intent to form guidelines for practice using a level of evidence taxonomy. The available evidence does not identify any specific risks associated with epidural catheter placement through low back tattoos, although tissue coring with tissue transport to deeper sites has been confirmed. Continued investigation is necessary before comprehensive practice guidelines regarding the practice of placing epidural needles and catheters through lumbar tattoos can be developed. We suggest avoidance of piercing tattoos when performing epidural punctures until there is sound evidence of short-term and long-term safety.

9 CFR 355.35 - Label information to be displayed on principal panel.

Science.gov (United States)

2010-01-01

... AND VOLUNTARY INSPECTION AND CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Label information to be displayed on principal panel. 355.35 Section 355.35 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE...

Synthesis of positron labeled photoactive compounds: 18F labeled aryl azides for positron labeling of biochemical molecules

International Nuclear Information System (INIS)

Hashizume, Kazunari; Hashimoto, Naota; Miyake, Yoshihiro

1995-01-01

The authors have prepared various [ 18 F] fluorine labeled aryl azides as a novel photoactive compounds suitable for positron labeling of biochemical molecules. The introduction of fluorine substituents to aryl azides can be expected to have dramatic effects on their nature and reactivity toward photolysis. Positron labeled reagents for labeling proteins or peptides have recently attracted considerable attention due to their wide applicability in biochemistry and positron emission tomography (PET). Various labeled azide compounds are often used in biochemistry for radiolabeling biological molecules by photolysis, but there have been no reports on the preparation or use of fluorine-18 labeled azides. The authors now report a novel synthesis of 18 F-labeled aryl azides which will have wide application in the biochemistry and nuclear medicine as a means for 18 F-fluorine labeling for proteins, peptides, and nucleic acids. 2 tabs

Results of a phase I/II open-label, safety and efficacy trial of coagulation factor IX (recombinant), albumin fusion protein in haemophilia B patients.

Science.gov (United States)

Martinowitz, U; Lissitchkov, T; Lubetsky, A; Jotov, G; Barazani-Brutman, T; Voigt, C; Jacobs, I; Wuerfel, T; Santagostino, E

2015-11-01

rIX-FP is a coagulation factor IX (recombinant), albumin fusion protein with more than fivefold half-life prolongation over other standard factor IX (FIX) products available on the market. This prospective phase II, open-label study evaluated the safety and efficacy of rIX-FP for the prevention of bleeding episodes during weekly prophylaxis and assessed the haemostatic efficacy for on-demand treatment of bleeding episodes in previously treated patients with haemophilia B. The study consisted of a 10-14 day evaluation of rIX-FP pharmacokinetics (PK), and an 11 month safety and efficacy evaluation period with subjects receiving weekly prophylaxis treatment. Safety was evaluated by the occurrence of related adverse events, and immunogenic events, including development of inhibitors. Efficacy was evaluated by annualized spontaneous bleeding rate (AsBR), and the number of injections to achieve haemostasis. Seventeen subjects participated in the study, 13 received weekly prophylaxis and 4 received episodic treatment only. No inhibitors were detected in any subject. The mean and median AsBR were 1.25, and 1.13 respectively in the weekly prophylaxis arm. All bleeding episodes were treated with 1 or 2 injections of rIX-FP. Three prophylaxis subjects who were treated on demand prior to study entry had >85% reduction in AsBR compared to the bleeding rate prior to study entry. This study demonstrated the efficacy for weekly routine prophylaxis of rIX-FP to prevent spontaneous bleeding episodes and for the treatment of bleeding episodes. In addition no safety issues were detected during the study and an improved PK profile was demonstrated. © 2015 CSL Behring. Haemophilia published by John Wiley & Sons Ltd.

Aviation safety and ICAO

NARCIS (Netherlands)

Huang, Jiefang

2009-01-01

The thesis addresses the issue of aviation safety under the rule of law. Aviation safety is a global concern. While air transport is considered a safe mode of travel, it is susceptible to inherent risks of flight, the use of force, and terrorist acts. Consequently, within the framework of the

Tritium labelling of testosteron by selective hydrogenation of dihydrotestosteron

International Nuclear Information System (INIS)

Postolache, Cristian; Matei, Lidia; Simion, Elena; Barna, Catalina; Condac, Eduard

2002-01-01

Elemental tritium is obtained during the decontamination process of the moderator from Cernavoda Nuclear Power Plant. It might be stocked for use in controlled fusion, in a relatively far future, or, it might be immediately used as raw material in the synthesis of labelled compounds with important economic value. Labelling of testosteron with tritium was necessary for the carrying out of radiometric and molecular biology studies concerning androgen dependent diseases. Testosteron was labelled by selective hydrogenation of 1,2 dihydrotestosteron acetate. The forerunner was synthesized in two steps: 1) esterification of testosteron using acetic anhydride, and 2) selective dehydrogenation with 2,6-dichloro-3,5-dicyan-1,4 quinone (DDQ) of the ester formed in the first step. Testosteron acetate was synthesized and purified with yields of 73%, and 80%, respectively. The dehydrogenation process was characterized by yields of 82% for synthesis and 33% for purification. The tritium labelled hormone was obtained in two steps: 1) selective hydrogenation of Δ 1 - testosteron acetate in the presence of T 2 gas, at low pressure, and 2) hydrolysis of the ester at basic pH. The raw product obtained was purified by preparative thin layer chromatography. The physical and chemical characterization of labelled testosteron reveals a radiochemical purity higher than 98% and a specific activity of 53.4 Ci/mmol. (authors)

Mixed Map Labeling

Directory of Open Access Journals (Sweden)

Maarten Löffler

2016-12-01

Full Text Available Point feature map labeling is a geometric visualization problem, in which a set of input points must be labeled with a set of disjoint rectangles (the bounding boxes of the label texts. It is predominantly motivated by label placement in maps but it also has other visualization applications. Typically, labeling models either use internal labels, which must touch their feature point, or external (boundary labels, which are placed outside the input image and which are connected to their feature points by crossing-free leader lines. In this paper we study polynomial-time algorithms for maximizing the number of internal labels in a mixed labeling model that combines internal and external labels. The model requires that all leaders are parallel to a given orientation θ ∈ [0, 2π, the value of which influences the geometric properties and hence the running times of our algorithms.

Consumer use and understanding of labelling information on edible marijuana products sold for recreational use in the states of Colorado and Washington.

Science.gov (United States)

Kosa, Katherine M; Giombi, Kristen C; Rains, Caroline B; Cates, Sheryl C

2017-05-01

In 2014, the states of Colorado and Washington began allowing retail sales of marijuana for recreational use. The regulatory agencies in these states have implemented specific labelling requirements for edible marijuana products sold for recreational use to help address concerns such as delayed activation time, accidental ingestion, and proper dosing. We conducted 12 focus groups with 94 adult consumers and nonconsumers of edibles in Denver and Seattle to collect information on their use and understanding of labelling information on edible marijuana products sold for recreational use. Specifically, we asked participants about the usefulness, attractiveness, ease of comprehension, relevancy, and acceptability of the label information. Some focus group participants look for and read specific information, such as the potency profile and serving size statement, but do not read or were unfamiliar with other labelling features. The focus groups revealed that participants have some concerns about the current labelling of edibles. In particular, participants were concerned that there is too much information on the labels so consumers may not read the label, there is no obvious indication that the product contains marijuana (e.g., a Universal Symbol), and the information on consumption advice is not clear. Participants in both locations suggested that education in a variety of formats, such as web- and video-based education, would be useful in informing consumers about the possible risks of edibles. The focus group findings suggest that improvements are needed in the labelling of edibles to prevent unintentional ingestion among adult nonusers and help ensure proper dosing and safe consumption among adult users. These findings, along with lessons learned from Colorado and Washington, can help inform the labelling of edibles as additional states allow the sale of edibles for recreational use. Copyright © 2017 Elsevier B.V. All rights reserved.

Applying Systems Thinking to Law Enforcement Safety: Recommendation for a Comprehensive Safety Management Framework

Science.gov (United States)

2015-12-01

injuries can also lead to other significant health concerns such as depression and absenteeism , which impact organizational productivity and safety...injuries is important: (1) to determine the impact of costs such as lost wages, medical expenses and insurance claims, as well as productivity ... production and operational safety; and a sustaining institutional culture.53 Safety is often not the primary goal of organizations, as other business or

Eco-labelling of shampoos, shower gels and foam baths.

Science.gov (United States)

Klaschka, Ursula; Liebig, Markus; Knacker, Thomas

2007-01-01

Environmental issues of personal care products have been met with little attention in the past. Monitoring data as well as preliminary environmental risk assessments indicate that some ingredients in personal care products might be relevant pollutants in the environment. Following the precautionary principle, eco-labelling is proposed as an effective tool for source control of one major group of personal care products, shampoos, shower gels and foam baths (SSBs). Eco-labelling is a soft, but effective market driven and product specific approach to lower discharge of environmentally detrimental substances. Products that fulfil the criteria proposed help to minimise the impact of SSBs on the environment. Available assessment tools for dangerous substances (e.g. current legislation on environmental risk assessments and classification, and labelling, eco-labelling criteria for similar products, the calculation of the critical dilution volume) were adapted and integrated into the criteria for the eco-labelling of SSBs. A short outline of the eco-labelling criteria developed for SSBs is provided. The basic criteria concern the effects of the substances discharged into the waste water during and after use. Products with an eco-label award may exclusively contain substances for which basic information about their effects on the environment is available. They may not contain persistent, bioaccumulating, toxic or ecotoxicological substances. In addition, the basic criteria include requirements for the container and consumer information. The basic criteria for eco-labelling SSBs are based on the actual state of science and are at the same time as simple and transparent as possible to ensure the best applicability. SSBs that comply with the described basic criteria can contribute to a lower chemical burden of waste water treatment plants and surface water. The proposal for basic criteria described should stimulate discussion on eco-labelling of SSBs. It should help to pass

Validity of your safety awareness training

CERN Multimedia

DG Unit

2010-01-01

AIS is setting up an automatic e-mail reminder system for safety training. You are invited to forward this message to everyone concerned. Reminder: Please check the validity of your Safety courses Since April 2009 the compulsory basic Safety awareness courses (levels 1, 2 and 3) have been accessible on a "self-service" basis on the web (see CERN Bulletin). Participants are required to pass a test at the end of each course. The test is valid for 3 years so courses must be repeated on a regular basis. A system of automatic e-mail reminders already exists for level 4 courses on SIR and will be extended to the other levels shortly. The number of levels you are required to complete depends on your professional category. Activity Personnel concerned Level 1 Level 2 Level 3 Level 4     Basic safety Basic Safety ...

Off-label use analysis of novel antiepileptic drugs in Sichuan area: a multicenter survey in pediatric patients

Directory of Open Access Journals (Sweden)

CAI Qian-yun

2012-10-01

Full Text Available Objective To investigate current status and safety about off-label use of levetiracetam, topiramate, oxcarbazepine, lamotrigine among pediatric patients in Sichuan area, so as to provide baseline data for formulating guidelines of off-label drug use. Methods Medical records of pediatric epileptic patients receiving antiepileptic drugs (AEDs from July 2010 to November 2011 were collected at the following hospitals: West China Second University Hospital of Sichuan University, Chengdu Women's and Children's Central Hospital and Sichuan Provincial People's Hospital. The numbers of patients receiving AEDs and novel AEDs were calculated. Off-label drug use and the category of off-label drug use were judged according to the indications listed in drug instructions. The incidence of off-label drug use was calculated. The patients receiving novel AEDs were devided into on-label and off-label use groups; the clinical characteristics of these two groups were summarized and adverse reactions of two groups were compared by using χ2 test. Results During the study period, there were totally 854 patients receiving AEDs including 670 patients receiving novel AEDs. Among 670 patients 406 patients off-label use group received off-label use of novel AEDs, accounting for 47.54% (406/854 of the total patients receiving AEDs and 60.60% (406/670 of patients receiving novel AEDs. When compared with on-label use group, off-label use group had more younger patients, more patients with single-drug use and more patients with generalized epilepsy or epileptic syndrome. The rates of off-label using drug were levetiracetam 78.50% (157/200, topiramate 79.81% (253/317, oxcarbazepine 21.32% (42/197 and lamotrigine 33.33% (21/63. The off-label use of levetiracetam and topiramate occured in all three aspects: age, single-drug use and seizure type. The adverse reaction rates of off-label use were oxcarbazepine 16.67% (7/42, topiramate 14.81% (36/243, levetiracetam 10.60% (16

Fiber-optic Fourier transform infrared spectroscopy for remote label-free sensing of medical device surface contamination

Science.gov (United States)

Hassan, Moinuddin; Tan, Xin; Welle, Elissa; Ilev, Ilko

2013-05-01

As a potential major source of biochemical contamination, medical device surfaces are of critical safety concerns in the clinical practice and public health. The development of innovative sensing methods for accurate and real-time detection of medical device surface contamination is essential to protect patients from high risk infection. In this paper, we demonstrate an alternative fiber-optic Fourier Transform Infrared (FTIR) spectroscopy based sensing approach for remote, non-contact, and label-free detection of biochemical contaminants in the mid-infrared (mid-IR) region. The sensing probe is designed using mid-IR hollow fibers and FTIR measurements are carried out in reflection mode. Bovine Serum Albumin (BSA) and bacterial endotoxin of different concentrations under thoroughly dry condition are used to evaluate the detection sensitivity. The devised system can identify ≤0.0025% (≤4 × 1011 molecules) BSA and 0.5% (0.5 EU/ml) endotoxin concentration. The developed sensing approach may be applied to detect various pathogens that pose public health threats.

Food Labels

Science.gov (United States)

... Staying Safe Videos for Educators Search English Español Food Labels KidsHealth / For Teens / Food Labels What's in ... to have at least 95% organic ingredients. Making Food Labels Work for You The first step in ...

Safety of High Speed Magnetic Levitation Transportation Systems: Preliminary Safety Review of the Transrapid Maglev System

Science.gov (United States)

1990-11-01

The safety of various magnetically levitated trains under development for possible : implementation in the United States is of direct concern to the Federal Railroad : Administration. This report, one in a series of planned reports on maglev safety, ...

Label Review Training: Module 1: Label Basics, Page 25

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review: clarity, accuracy, consistency with EPA policy, and enforceability.

Label Review Training: Module 1: Label Basics, Page 29

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This page is a quiz on Module 1.

Food control concept: Food safety/ingestion issues

International Nuclear Information System (INIS)

Armstrong, B.

1995-01-01

This talk outlines the issues in food safety/ingestion in the case of radiation accidents at nuclear power plants and how emergency preparedness plans can/should be tailored. The major topics are as follows: In Washington: food safety/ingestion issues exist at transition between response and regulatory worlds; agricultural concerns; customer concerns; Three Mile Island: detailed maps; development of response procedures; development of tools; legal issues

Procedure for the preparation of tritium-labelled insulins

International Nuclear Information System (INIS)

Bienert, M.; Haensicke, A.; Beyermann, M.; Kaufmann, K.D.; Oehlke, J.; Klauschenz, E.; Bespalowa, S.; Titov, M.; Pleiss, U.

1986-01-01

This invention is concerned with a procedure for the preparation of specific 3 H-labelled insulins with sequences of human, bovine or porcine insulins and without simultaneous chemical modifications of the insulin. On the basis of this procedure a 3 H 2 -Typ (B26)-insulin can be obtained in good yield and purity with a specific radioactivity appropriate to biopharmaceutical and pharmacokinetic purposes in medicine and pharmaceutical industry, resp

Safety evaluation status report for the prototype license application safety analysis report

International Nuclear Information System (INIS)

1989-07-01

The US Nuclear Regulatory Commission (NRC) staff and consultants reviewed a Prototype License Application Safety Analysis Report (PLASAR) submitted by the US Department of Energy (DOE) for the earth-mounded concrete bunker (EMCB) alternative method of low-level radioactive waste disposal. The NRC reviewers relied extensively on the Standard Review Plan (SRP), Rev.1 (NUREG-1200), to evaluate the acceptability of the information provided in the EMCB PLASAR. The NRC staff selected certain review areas in the PLASAR for development of safety evaluation report input to provide examples of safety assessments that are necessary as part of a licensing review. Because of the fictitious nature of the assumed disposal site, and the decision to limit the review to essentially first-round review status, the NRC staff report is labeled a ''Safety Evaluation Status Report'' (SESR). Appendix A comprises the NRC review comments and questions on the information that DOE submitted in the PLASAR. The NRC concentrated its review on the design and operations-related portions of the EMCB PLASAR

Cell labelling. Granule and platelet kinetics. Recent concepts

International Nuclear Information System (INIS)

Najean, Y.; Dresch, C.; Dassin, E.

Some unsolved problems are reviewed concerning the lifetime of blood platelets, with special reference to excessive platelet consumption and its possible correction by anti-aggregation agents, in many vascular diseases. Regarding the production of platelets it is considered that the 75 Se-methionine labelling method alone offers a quantitative approach to the process and could be used for the physiological study of thrombopoietic factors. A short chapter is devoted to a survey of the points of agreement and disagreement regarding the lifetime of polynuclear cells and a tentative analysis of the reasons explaining the quite different results obtained with DFP and radiochromium labelling. Finally the methods used to study granule formation are criticized, though it is acknowledged that certain ideas useful in physiopathology have emerged from these different procedures [fr

Nutrition Labeling

DEFF Research Database (Denmark)

Grunert, Klaus G

2013-01-01

because consumers will avoid products that the label shows to be nutritionally deficient, but also because food producers will try to avoid marketing products that appear, according to the label, as nutritionally problematic, for example, because of a high content of saturated fat or salt. Nutrition......Nutrition labeling refers to the provision of information on a food product’s nutritional content on the package label. It can serve both public health and commercial purposes. From a public health perspective, the aim of nutrition labeling is to provide information that can enable consumers...... to make healthier choices when choosing food products. Nutrition labeling is thus closely linked to the notion of the informed consumer, that chooses products according to their aims, on the basis of the information at their disposal. Because many consumers are assumed to be interested in making healthy...

Safety report concerning Melusine (after power increase to 4 MW). Descriptive part. Volumes 1 and 2

International Nuclear Information System (INIS)

Baas, C.; Delcroix, V.; Jacquemain, M.; Marouby, R.; Meunier, C.; De Robien, E.; Rossillon, F.

1967-03-01

Construction of Melusine was started in January 1957, It first diverged on July 1, 1958. It operated at: 1 MW from March 1959; 1.4 MW from April 1960; 2 MW from September 1961; 4 MW from December 1965. Various modifications have been made since the reactor was built. They concern: - the addition of a hot cell. - the effluents: 2 reservoirs of 15 m 3 for liquid waste have been installed. The resin regeneration equipment has been completely modified. - the building: offices have been added - experimental zones have been set up in the hall - the electrical supply. - the cooling and purification circuits (installation of a second exchanger, replacement of the primary pumps, creation of a hot layer, etc... ). - the fuel elements (at the moment of the MTR type enriched to 90 per cent). - the swimming-pool (which has been partially equipped with a stainless steel coating). - the core (placing of 'stools', of a diving-board, etc...). - the ventilation: the hall has been de-pressurized during normal working in the event of an accident, the hall can be isolated and a safety circuit can be started up. A chimney has been installed. - the hall (which has been strengthened and sealed more effectively). - the control electronics (modification of the principle, and which are now entirely transistorized). So many changes have been made that the reactor now bears only a slight resemblance to the initial model. It has appeared necessary to make a brief review of these improvements in order to be able to judge more effectively the installations present safety characteristics; these latter are furthermore fairly well known as a result of the experiments carried out not only by the Thermal Transfer Service in Grenoble but also at Cadarache (Cabri) and Toulon (the work of Mr. PASCOUET). (authors) [fr

An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics.

Science.gov (United States)

Johnson, Jeremy R; Lossignol, Dominique; Burnell-Nugent, Mary; Fallon, Marie T

2013-08-01

Chronic pain in patients with advanced cancer poses a serious clinical challenge. The Δ9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (U.S. Adopted Name, nabiximols; Sativex(®)) is a novel cannabinoid formulation currently undergoing investigation as an adjuvant therapy for this treatment group. This follow-up study investigated the long-term safety and tolerability of THC/CBD spray and THC spray in relieving pain in patients with advanced cancer. In total, 43 patients with cancer-related pain experiencing inadequate analgesia despite chronic opioid dosing, who had participated in a previous three-arm (THC/CBD spray, THC spray, or placebo), two-week parent randomized controlled trial, entered this open-label, multicenter, follow-up study. Patients self-titrated THC/CBD spray (n=39) or THC spray (n=4) to symptom relief or maximum dose and were regularly reviewed for safety, tolerability, and evidence of clinical benefit. The efficacy end point of change from baseline in mean Brief Pain Inventory-Short Form scores for "pain severity" and "worst pain" domains showed a decrease (i.e., improvement) at each visit in the THC/CBD spray patients. Similarly, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 scores showed a decrease (i.e., improvement) from baseline in the domains of insomnia, pain, and fatigue. No new safety concerns associated with the extended use of THC/CBD spray arose from this study. This study showed that the long-term use of THC/CBD spray was generally well tolerated, with no evidence of a loss of effect for the relief of cancer-related pain with long-term use. Furthermore, patients who kept using the study medication did not seek to increase their dose of this or other pain-relieving medication over time, suggesting that the adjuvant use of cannabinoids in cancer-related pain could provide useful benefit. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc

78 FR 66826 - Prior Label Approval System: Generic Label Approval

Science.gov (United States)

2013-11-07

... raising of animals, such as ``no antibiotics administered'' or ``vegetarian fed''; (4) instructional or... Standards and Labeling Policy Book includes animal production claims; omega fatty acid guidance; allergen... inclusion of Country of Origin Labeling on all labels; the production and sale of labels by USDA; developing...

Electronic Health Record-Related Safety Concerns: A Cross-Sectional Survey of Electronic Health Record Users

Science.gov (United States)

Pajunen, Tuuli; Saranto, Kaija; Lehtonen, Lasse

2016-01-01

systematic assessments of EHR risks before harmful events occur. An EHR training program should be compulsory for all EHR users in order to address EHR safety concerns resulting from the failure to use HIT appropriately. PMID:27154599

Bacterial quality and safety of packaged fresh leafy vegetables at the retail level in Finland.

Science.gov (United States)

Nousiainen, L-L; Joutsen, S; Lunden, J; Hänninen, M-L; Fredriksson-Ahomaa, M

2016-09-02

Consumption of packaged fresh leafy vegetables, which are convenient ready-to-eat products, has increased during the last decade. The number of foodborne outbreaks associated with these products has concurrently increased. In our study, (1) label information, (2) O2/CO2 composition, (3) bacterial quality and (4) safety of 100 fresh leafy vegetables at the retail level were studied in Finland during 2013. Bacterial quality was studied using aerobic bacteria (AB) and coliform bacteria (CB) counts, and searching for the presence of Escherichia coli, Listeria and Yersinia. The safety was studied by the presence of Salmonella, ail-positive Yersinia, stx-positive E. coli (STEC) and Listeria monocytogenes using PCR and culturing. Important label information was unavailable on several packages originating from different companies. The packaging date was missing on all packages and the date of durability on 83% of the packages. Storage temperature was declared on 62% of the packages and 73% of the packages contained information about prewashing. The batch/lot number was missing on 29% of the packages. Very low oxygen (O2) (vegetable samples varying between 6.2 and 10.6 and 4.2-8.3logcfu/g, respectively. In most of the samples, the AB and CB counts exceeded 10(8) and 10(6)cfu/g, respectively. A positive correlation was observed between the AB and CB counts. E. coli was isolated from 15% of the samples and Yersinia from 33%. L. monocytogenes was isolated from two samples and ail-positive Y. enterocolitica in one. Using PCR, STEC was detected in seven samples, and Salmonella and ail-positive Y. enterocolitica in two samples each. The AB and CB mean values of products originating from different companies varied widely. High AB and CB counts and pathogenic bacteria were detected in ready-to-eat products not needing washing before use. Our study shows that the bacterial quality and safety of packaged fresh leafy vegetables is poor and label information on the packages is

[MR implant labelling and its use in clinical MRI practice].

Science.gov (United States)

Mühlenweg, M; Schaefers, G

2015-08-01

Before a magnetic resonance imaging (MRI) examination, implants in patients must be cleared for MR safety in order to exclude the risk of possible severe injuries and implant malfunction in an MR environment. The general contraindication for measurements of patients with implants still applies; however, in the recent past a way has been found to legally circumvent this contraindication. For this purpose special conditions are required: explicit implant identification and the original manufacturer's labelling are necessary, the required conditions for conditionally MR safe implants must be assured and a risk-benefit analysis with appropriate explanation to the patient has to be performed. This process can be very complex as the implants are often poorly documented and detailed information on the implant MR labelling is also often outdated or not easy to interpret. This article provides information about legal and normative principles of MR measurement of patients with implants. The possible physical interactions with implants will be briefly dealt with as well as possible strategies for better identification and investigation of implants and MR labelling. General approaches for minimizing the risk will be discussed using some examples. The second part deals with the content of MR implant labelling and the current test standards. Furthermore, the additional information from the operating instructions of the MR scanner that are necessary for the interpretation of the MR implant labelling, will be explained. The article concludes with an explanation of the current pattern for MR labelling of implants from the U.S. Food and Drug Administration (FDA) and an exemplary application.

MR implant labelling and its use in clinical MRI practice

International Nuclear Information System (INIS)

Muehlenweg, M.; Schaefers, G.

2015-01-01

Before a magnetic resonance imaging (MRI) examination, implants in patients must be cleared for MR safety in order to exclude the risk of possible severe injuries and implant malfunction in an MR environment. The general contraindication for measurements of patients with implants still applies; however, in the recent past a way has been found to legally circumvent this contraindication. For this purpose special conditions are required: explicit implant identification and the original manufacturer's labelling are necessary, the required conditions for conditionally MR safe implants must be assured and a risk-benefit analysis with appropriate explanation to the patient has to be performed. This process can be very complex as the implants are often poorly documented and detailed information on the implant MR labelling is also often outdated or not easy to interpret. This article provides information about legal and normative principles of MR measurement of patients with implants. The possible physical interactions with implants will be briefly dealt with as well as possible strategies for better identification and investigation of implants and MR labelling. General approaches for minimizing the risk will be discussed using some examples. The second part deals with the content of MR implant labelling and the current test standards. Furthermore, the additional information from the operating instructions of the MR scanner that are necessary for the interpretation of the MR implant labelling, will be explained. The article concludes with an explanation of the current pattern for MR labelling of implants from the U.S. Food and Drug Administration (FDA) and an exemplary application. (orig.) [de

Examination of the evidence for off-label use of gabapentin.

Science.gov (United States)

Mack, Alicia

2003-01-01

(1) Describe the relevance of off-label use of gabapentin to managed care pharmacy; (2) summarize recent FDA warnings and media reports related to off-label gabapentin use; (3) review medical information pertaining to the off-label use of gabapentin; (4) outline alternatives to off-label use of gabapentin in an evidence-based fashion, where literature exists to support such alternatives; and (5) encourage key clinicians and decision makers in managed care pharmacy to develop and support programs that restrict the use of gabapentin to specific evidence-based situations. Gabapentin is approved by the U.S. Food and Drug Administration (FDA) for adjunctive therapy in treatment of partial seizures and postherpetic neuralgia. Various off-label (unapproved) uses have been reported, and the use of gabapentin for off-label purposes has reportedly exceeded use for FDAapproved indications. Pharmaceutical marketing practices and physician dissatisfaction with currently available pharmacological treatment options may be key factors that contribute to this prescribing trend. Recently, the media has focused on these issues, noting that many cases of reported safety and effectiveness of gabapentin for off-label use may have been fabricated. A thorough review of the medical and pharmacy literature related to off-label use of gabapentin was performed, and a summary of the literature for the following conditions is presented: bipolar disorder, peripheral neuropathy, diabetic neuropathy, complex regional pain syndrome, attention deficit disorder, restless legs syndrome, trigeminal neuralgia, periodic limb movement disorder of sleep, migraine headaches, and alcohol withdrawal syndrome. A common theme in the medical literature for gabapentin is the prevalence of open-label studies and a lack of randomized controlled clinical trials for all but a small number of indications. In the majority of circumstances where it has reported potential for.off-label. use, gabapentin is not the optimal

Regulatory oversight report 2012 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2013-04-01

The Swiss Federal Nuclear Safety Inspectorate (ENSI) assesses and monitors nuclear facilities in Switzerland. These include the five nuclear power plants, the interim storage facilities based at each plant, the Central Interim Storage Facility (ZWILAG) and the nuclear facilities at the Paul Scherrer Institute (PSI), at the Federal Institute of Technology in Lausanne (EPFL) and at the University of Basel. Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the required overview of nuclear safety in the relevant facilities. It ensures that the facilities comply with the regulations and operate as required by law. Its regulatory responsibilities also include the transport of radioactive materials from and to nuclear facilities and the preparations for a deep geological repository for nuclear waste. ENSI maintains its own emergency organisation. It formulates and updates its own guidelines which stipulate the criteria for evaluating the current activities and future plans of the operators of nuclear facilities. ENSI produces regular reports on its regulatory activities and nuclear safety in Swiss nuclear facilities. It fulfils its statutory obligation to provide the public with information on particular events and findings in nuclear facilities. In 2012, the five nuclear power plants in Switzerland were all operated safely. 34 events were reported; on the international INES scale of 0 to 7, ENSI rated 33 events as Level 0 and 1 as Level 1. ENSI evaluates the safety of each nuclear power plant as part of a systematic safety evaluation taking account of both reportable events and other findings, in particular the results of more than 400 inspections conducted by ENSI during 2012. ZWILAG consists of several interim storage halls, a conditioning plant and an incineration/melting plant. At the end of 2012, the cask storage hall contained 40 transport/storage casks

Labelling and Marketing of Bivalve and Gastropod Molluscs Retailed in Sardinia, Italy Between 2009 and 2013.

Science.gov (United States)

Meloni, Domenico

2015-05-28

The aim of the present survey was to investigate the correct enforcement of the Community rules on the labelling and marketing of bivalve and gastropod molluscs retailed in Sardinia, Italy between 2009 and 2013. A total of 1500 packages and labels for live bivalve and gastropod molluscs were considered. A total of 375 labels (25%) presented non-compliance concerning the wrong trade name and additional wrong or missing information. The highest percentage of anomalous labels has been detected in small-scale retail shops (35%) and open-air markets (25%) compared with the big retailing chains (20%). The 5% of packages were not in compliance with the European Community rules on packaging of bivalve and gastropod molluscs. The high percentage of non-compliance with the European regulations on labelling results is a strong limitation for the consumers and highlights the need to improve the control system about labelling of seafood products.

Safety Features of Material and Personnel Movement Devices. Module SH-25. Safety and Health.

Science.gov (United States)

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on safety features of material and personnel movement devices is one of 50 modules concerned with job safety and health. This module covers safe conditions and operating practices for conveyors, elevators, escalators, moving walks, manlifts, forklifts, and motorized hand trucks. Following the introduction, 10 objectives (each…

Environmental contaminants of emerging concern in seafood - European database on contaminant levels

DEFF Research Database (Denmark)

Vandermeersch, Griet; Lourenço, Helena Maria; Alvarez-Muñoz, Diana

2015-01-01

Marine pollution gives rise to concern not only about the environment itself but also about the impact on food safety and consequently on public health. European authorities and consumers have therefore become increasingly worried about the transfer of contaminants from the marine environment...... to seafood.So-called "contaminants of emerging concern" are chemical substances for which no maximum levels have been laid down in EU legislation, or substances for which maximum levels have been provided but which require revision. Adequate information on their presence in seafood is often lacking and thus...... potential risks cannot be excluded. Assessment of food safety issues related to these contaminants has thus become urgent and imperative. A database (www.ecsafeseafooddbase.eu), containing available information on the levels of contaminants of emerging concern in seafood and providing the most recent data...

SimLabel: a graphical user interface to simulate continuous wave EPR spectra from site-directed spin labeling experiments.

Science.gov (United States)

Etienne, E; Le Breton, N; Martinho, M; Mileo, E; Belle, V

2017-08-01

Site-directed spin labeling (SDSL) combined with continuous wave electron paramagnetic resonance (cw EPR) spectroscopy is a powerful technique to reveal, at the residue level, structural transitions in proteins. SDSL-EPR is based on the selective grafting of a paramagnetic label on the protein under study, followed by cw EPR analysis. To extract valuable quantitative information from SDSL-EPR spectra and thus give reliable interpretation on biological system dynamics, numerical simulations of the spectra are required. Such spectral simulations can be carried out by coding in MATLAB using functions from the EasySpin toolbox. For non-expert users of MATLAB, this could be a complex task or even impede the use of such simulation tool. We developed a graphical user interface called SimLabel dedicated to run cw EPR spectra simulations particularly coming from SDSL-EPR experiments. Simlabel provides an intuitive way to visualize, simulate, and fit such cw EPR spectra. An example of SDSL-EPR spectra simulation concerning the study of an intrinsically disordered region undergoing a local induced folding is described and discussed. We believe that this new tool will help the users to rapidly obtain reliable simulated spectra and hence facilitate the interpretation of their results. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.