Evolution of approaches to viral safety issues for biological products.

Science.gov (United States)

Lubiniecki, Anthony S

2011-01-01

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) Approaches to viral safety issues for biological products have evolved during the past 50+ years. The first cell culture products (viral vaccines) relied largely on the use of in vitro and in vivo virus screening assays that were based upon infectivity of adventitious viral agents. The use of Cohn fractionation and pasteurization by manufacturers of plasma derivatives introduced the concepts that purification and treatment with physical and chemical agents could greatly reduce the risk of viral contamination of human albumin and immunoglobulin products. But the limitations of such approaches became clear for thermolabile products that were removed early in fractionation such as antihemophilic factors, which transmitted hepatitis viruses and HIV-1 to some product recipients. These successes and limitations were taken into account by the early developers of recombinant DNA (rDNA)-derived cell culture products and by regulatory agencies, leading to the utilization of cloning technology to reduce/eliminate contamination due to human viruses and purification technologies to physically remove and inactivate adventitious and endogenous viruses, along with cell banking and cell bank characterization for adventitious and endogenous viruses, viral screening of biological raw materials, and testing of cell culture harvests, to ensure virus safety. Later development and incorporation of nanofiltration technology in the manufacturing process provided additional assurance of viral clearance for safety of biotechnology products. These measures have proven very effective at preventing iatrogenic infection of recipients of biotechnology products; however, viral contamination of production cell cultures has

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

Science.gov (United States)

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

Laboratory Safety in the Biology Lab.

Science.gov (United States)

Ritch, Donna; Rank, Jane

2001-01-01

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

Biologic agents therapy for Saudi children with rheumatic diseases: indications and safety.

Science.gov (United States)

Al-Mayouf, Sulaiman M; Alenazi, Abdullatif; AlJasser, Hind

2016-06-01

To report the indications and safety of biologic agents in childhood rheumatic diseases at a tertiary hospital. Children with rheumatic diseases treated with biologic agents at King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia, from January 2001 to December 2011 were included. All patients were reviewed for: demographic characteristics, diagnosis, concomitant treatment and indications of using biologic agents, age at start of therapy and side effects during the treatment period. In all, 134 children (89 female) with various rheumatic diseases were treated with biologic agents. Mean age at starting biologic treatment was 9.3 (4.25-14) years and mean therapy duration was 14.7 (3-88) months. Juvenile idiopathic arthritis (JIA) was the most frequent diagnosis (70.1%) followed by systemic lupus erythematosus (12.7%) and vasculitis (4.5%). All patients received concomitant therapy (corticosteroids and disease-modifying antirheumatic drugs). In total, 273 treatments with biologic agents were used, (95 etanercept, 52 rituximab, 47 adalimumab, 37 infliximab, 23 anakinra, 10 tocilizumab and nine abatacept). Therapy was switched to another agent in 57 (42.5%) patients, mainly because of inefficacy (89.4%) or adverse event (10.6%). A total of 95 (34.8%) adverse events were notified; of these, the most frequent were infusion-related reactions (33.7%) followed by infections (24.2%) and autoantibody positivity (10.6%). One patient developed macrophage activation syndrome. Biologic agents were used in children with a range of rheumatic diseases. Of these, the most frequent was JIA. Off-label use of biologic agents in our cohort is common. These agents seem safe. However, they may associated with various adverse events. Sequential therapy seems well tolerated. However, this should be carefully balanced and considered on an individual basis. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

Biological Agents

Science.gov (United States)

... E-Tools Safety and Health Topics / Biological Agents Biological Agents This page requires that javascript be enabled ... 202) 693-2300 if additional assistance is required. Biological Agents Menu Overview In Focus: Ebola Frederick A. ...

Biological effects of electromagnetic fields and recently updated safety guidelines for strong static magnetic fields

International Nuclear Information System (INIS)

Yamaguchi-Sekino, Sachiko; Sekino, Masaki; Ueno, Shoogo

2011-01-01

Humans are exposed daily to artificial and naturally occurring magnetic fields that originate from many different sources. We review recent studies that examine the biological effects of and medical applications involving electromagnetic fields, review the properties of static and pulsed electromagnetic fields that affect biological systems, describe the use of a pulsed electromagnetic field in combination with an anticancer agent as an example of a medical application that incorporates an electromagnetic field, and discuss the recently updated safety guidelines for static electromagnetic fields. The most notable modifications to the 2009 International Commission on Non-Ionizing Radiation Protection guidelines are the increased exposure limits, especially for those who work with or near electromagnetic fields (occupational exposure limits). The recommended increases in exposure were determined using recent scientific evidence obtained from animal and human studies. Several studies since the 1994 publication of the guidelines have examined the effects on humans after exposure to high static electromagnetic fields (up to 9.4 tesla), but additional research is needed to ascertain further the safety of strong electromagnetic fields. (author)

IINFLUENCE OF FREEZING AND PROLONGED STORAGE OF EXPRESSED BREAST MILK ON ITS NUTRITIVE, BIOLOGICAL VALUES AND MICROBIOLOGICAL SAFETY

Directory of Open Access Journals (Sweden)

O. L. Lukoyanova

2011-01-01

Full Text Available Evaluation of prolonged storage of breast milk safety for nutrition of newborns remains actual problem of modern nutritiology. Objectives: to evaluate an influence of freezing and prolonged storage of expressed breast milk on its nutritive, biological values and microbiological safety. Methods: samples of expressed breast milk (native samples and after 1 and 3 months of storage in containers Philips AVENT in t -18°С were analyzed; levels of secretory IgA, lysozyme, transforming growth factor (TGF β1, potassium, calcium, magnesium, pH, buffer capacity and bacterial cells were detected. Results: there is no statistically significant influence of low temperature and prolonged storage of expressed breast milk on levels of secretory IgA, lysozyme, TGF β1 and bacterial cells. Potassium and calcium levels significantly decreased (on about 10% and 20% accordingly, pH increased, and buffer capacity of milk lowered after freezing during 3 months. Conclusion: children’s feeding with native and expressed breast milk defrosted after 3 months of storage is equal in nutritive and biological values and microbiological safety.

Synthetic biology and occupational risk.

Science.gov (United States)

Howard, John; Murashov, Vladimir; Schulte, Paul

2017-03-01

Synthetic biology is an emerging interdisciplinary field of biotechnology that involves applying the principles of engineering and chemical design to biological systems. Biosafety professionals have done an excellent job in addressing research laboratory safety as synthetic biology and gene editing have emerged from the larger field of biotechnology. Despite these efforts, risks posed by synthetic biology are of increasing concern as research procedures scale up to industrial processes in the larger bioeconomy. A greater number and variety of workers will be exposed to commercial synthetic biology risks in the future, including risks to a variety of workers from the use of lentiviral vectors as gene transfer devices. There is a need to review and enhance current protection measures in the field of synthetic biology, whether in experimental laboratories where new advances are being researched, in health care settings where treatments using viral vectors as gene delivery systems are increasingly being used, or in the industrial bioeconomy. Enhanced worker protection measures should include increased injury and illness surveillance of the synthetic biology workforce; proactive risk assessment and management of synthetic biology products; research on the relative effectiveness of extrinsic and intrinsic biocontainment methods; specific safety guidance for synthetic biology industrial processes; determination of appropriate medical mitigation measures for lentiviral vector exposure incidents; and greater awareness and involvement in synthetic biology safety by the general occupational safety and health community as well as by government occupational safety and health research and regulatory agencies.

Efficacy and Safety Data of Subsequent Entry Biologics Pertinent to Nephrology Practice: A Systematic Review

Directory of Open Access Journals (Sweden)

Judith Genevieve Marin

2014-12-01

Full Text Available Background: Subsequent entry biologics (SEBs may soon be a reality in Canadian nephrology practice. Understanding the worldwide experience with these agents will be valuable to Canadian clinicians. Objectives: To compare the efficacy and safety data between SEBs used in nephrology practice and their reference biologic. Design: Systematic review. Sources of information: Ovid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, Cochrane Central Register of Controlled Trials. Patients: Adult patients with chronic kidney disease (CKD. Methods: Our systematic review follows the process outlined by Cochrane Reviews. For efficacy data, all randomized controlled trials (RCTs, quasi-RCTs and observational trials in nephrology practice were included. For safety data, case series, case reports, review articles in nephrology practice and pharmacovigilance programs were included as well. Results: Only epoetin SEBs trials were published in the literature. Ten studies involving three different epoetin SEBs (epoetin zeta, HX575 and epoetin theta were included. The mean epoetin dose used did not differ significantly between the SEBs and the reference product. For epoetin zeta and epoetin theta, the mean hemoglobin levels achieved in the studies were similar between the SEBs and the reference epoetin. The HX 575 studies reported a mean absolute change in hemoglobin within the predefined equivalence margin, when compared with the reference biologic. In terms of safety data, 2 cases of pure-red-cell aplasia were linked to the subcutaneous administration of HX 575. Otherwise, the rate of adverse drug reactions was similar when epoetin SEBs were compared with the reference biologic. Limitations: Our analysis is limited by the paucity of information available on SEB use in nephrology with the exception of epoetin SEBs. Methodological flaw was found in one of the epoetin zeta studies which accounted for 45% of pooled

[Side effects of biologic therapies in psoriasis].

Science.gov (United States)

Altenburg, A; Augustin, M; Zouboulis, C C

2018-04-01

The introduction of biologics has revolutionized the treatment of moderate to severe plaque psoriasis. Due to the continuous expansion of biological therapies for psoriasis, it is particularly important to acknowledge efficacy and safety of the compounds not only in clinical trials but also in long-term registry-based observational studies. Typical side effects and significant risks of antipsoriatic biologic therapies considering psoriatic control groups are presented. A selective literature search was conducted in PubMed and long-term safety studies of the psoriasis registries PsoBest, PSOLAR and BADBIR were evaluated. To assess the long-term safety of biologics, the evaluation of the course of large patient cohorts in long-term registries is of particular medical importance. Newer biologic drugs seem to exhibit a better safety profile than older ones.

Assessment of radiation safety awareness and attitude toward biological effect of radiation for employees in nuclear workplace

International Nuclear Information System (INIS)

Youngchuay, U.; Jetawattana, S.; Toeypho, V.; Eso, J.

2016-01-01

This study demonstrated a potential relevance of data pertaining to the interaction of awareness in radiation biology and their attitude towards radiation hazards. The obtained information is useful in ascertaining the effectiveness of the ongoing radiation safety program and will be further used to determine the relationships between the radiation effective dose and cytogenetic approach in these groups of workers. (author)

MICROBIOLOGICAL SAFETY BIBLIOGRAPHY

Science.gov (United States)

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

[Biological agents].

Science.gov (United States)

Amano, Koichi

2009-03-01

There are two types of biological agents for the treatment of rheumatoid arthritis (RA); monoclonal antibodies and recombinant proteins. Among the latter, etanercept, a recombinant fusion protein of soluble TNF receptor and IgG was approved in 2005 in Japan. The post-marketing surveillance of 13,894 RA patients revealed the efficacy and safety profiles of etanercept in the Japanese population, as well as overseas studies. Abatacept, a recombinant fusion protein of CTLA4 and IgG, is another biological agent for RA. Two clinical trials disclosed the efficacy of abatacept for difficult-to-treat patients: the AIM for MTX-resistant cases and the ATTAIN for patients who are resistant to anti-TNF. The ATTEST trial suggested abatacept might have more acceptable safety profile than infliximab. These biologics are also promising for the treatment of RA for not only relieving clinical symptoms and signs but retarding structural damage.

Health and safety manual

International Nuclear Information System (INIS)

1980-02-01

The manual consists of the following chapters: general policies and administration; the Environmental Health and Safety Department; the Medical Services Department: biological hazards; chemical safety; confined space entry; cryogenic safety; electrical safety; emergency plans; engineering and construction; evacuations, trenching, and shoring; fire safety; gases, flammable and compressed; guarding, mechanical; ladders and scaffolds, work surfaces; laser safety; materials handling and storage; noise; personal protective equipment; pressure safety; radiation safety, ionizing and non-ionizing; sanitation; seismic safety; training, environmental health and safety; tools, power and hand-operated; traffic and transportation; and warning signs and devices

[Knowledge and adherence to bio-safety measures and biological accidents by nursing students during their clinical practice].

Science.gov (United States)

Merino-de la Hoz, Felicitas; Durá-Ros, María Jesús; Rodríguez-Martín, Elías; González-Gómez, Silvia; Mariano López-López, Luis; Abajas-Bustillo, Rebeca; de la Horra-Gutiérrez, Inmaculada

2010-01-01

To identify the degree of knowledge and performance of bio-safety measures by nursing students and knowing the type of biological accidents suffered during their clinical practice. A cross-sectional study was conducted on the students of three Nursing courses held in May of 2008. Data was collected by an anonymous self-administered questionnaire, with a return of 54%. A total of 97% of students seemed to know the standard biosafety measures, and all of them (100%) stated that those measures must be applied to every patient. However, the reality of clinical practice shows that biosafety measures are only partially applied. An average of 60.2% implement the personal hygiene measures, 66.1% use physical barriers, and 44% use sharp materials safely. Around 32.25% of the students have suffered some biological accident, with a greater incidence in the second year: administering injections (24%), drawing blood samples with Venojet needles (18%) and recapping used needles (17%). The high level of knowledge shown by the students on standard precautions is not always shown in clinical practice. There are significant deficiencies in student safety practices: recapping of used needles continues to be one of the most common risk practices carried out. Copyright (c) 2009 Elsevier España, S.L. All rights reserved.

Ontology-supported research on vaccine efficacy, safety and integrative biological networks.

Science.gov (United States)

He, Yongqun

2014-07-01

While vaccine efficacy and safety research has dramatically progressed with the methods of in silico prediction and data mining, many challenges still exist. A formal ontology is a human- and computer-interpretable set of terms and relations that represent entities in a specific domain and how these terms relate to each other. Several community-based ontologies (including Vaccine Ontology, Ontology of Adverse Events and Ontology of Vaccine Adverse Events) have been developed to support vaccine and adverse event representation, classification, data integration, literature mining of host-vaccine interaction networks, and analysis of vaccine adverse events. The author further proposes minimal vaccine information standards and their ontology representations, ontology-based linked open vaccine data and meta-analysis, an integrative One Network ('OneNet') Theory of Life, and ontology-based approaches to study and apply the OneNet theory. In the Big Data era, these proposed strategies provide a novel framework for advanced data integration and analysis of fundamental biological networks including vaccine immune mechanisms.

Treating moderate to severe psoriasis - best use of biologics.

LENUS (Irish Health Repository)

Lynch, Maeve

2014-02-01

This review focuses on the efficacy, safety and best use of biologic agents in moderate-to-severe psoriasis. Recommendations from two recent guidelines are summarised. The NICE Guidelines 2012 provide recommendations on best practice for prescribing biologics. The German S3 Guidelines are based on a systematic review of published studies and report the efficacy of biologics and guidelines for treatment. Data on the safety of biologics are available for up to 5 years in psoriasis and are on the whole reassuring. Registry data is evolving and will provide data on safety to help inform long-term monitoring of patients with psoriasis on biologics agents. New anti-interleukin-17 (IL17) and anti-IL17RA biologics are in Phase 3 clinical trials and may prove to be more effective than existing biologics.

Biological agents in polyarticular juvenile idiopathic arthritis

DEFF Research Database (Denmark)

Amarilyo, Gil; Tarp, Simon; Foeldvari, Ivan

2016-01-01

BACKGROUND AND OBJECTIVE: Although various biological agents are in use for polyarticular juvenile idiopathic arthritis (pJIA), head-to-head trials comparing the efficacy and safety among them are lacking. We aimed to compare the efficacy and safety of biological agents in pJIA using all currently...

Review of the ethnobotany, chemistry, biological activity and safety of the botanical dietary supplement Morinda citrifolia (noni).

Science.gov (United States)

Pawlus, Alison D; Kinghorn, Douglas A

2007-12-01

Morinda citrifolia, commonly called noni, has a long history as a medicinal plant and its use as a botanical dietary supplement has grown tremendously in recent years. This has prompted a concomitant increase in research on the phytochemical constituents and biological activity of noni. A relatively large number of scientific publications on noni have been published in recent years, including a number of review articles. The goals of this review are to provide an updated categorization of the phytochemical constituents found in noni and to provide perspective for its extensive utilization as a major botanical dietary supplement. Included herein are a comprehensive list of known ethnobotanical uses and common names of M. citrifolia, a brief summary of relevant biological studies and a discussion of the safety of noni as a supplement.

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.)

Psoriasis : implications of biologics

NARCIS (Netherlands)

Lecluse, L.L.A.

2010-01-01

Since the end of 2004 several specific immunomodulating therapies: ‘biologic response modifiers’ or ‘biologics’ have been registered for moderate to severe psoriasis in Europe. This thesis is considering the implications of the introduction of the biologics for psoriasis patients, focusing on safety

21 CFR 610.11 - General safety.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false General safety. 610.11 Section 610.11 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS General Provisions § 610.11 General safety. A general safety test... for administration to humans. The general safety test is required in addition to other specific tests...

Biological effects of radiation human health and safety

International Nuclear Information System (INIS)

1977-05-01

The biological hazards of nuclear energy usage are a growing source of public concern. The medical profession may well be expected to contribute to public debate on the issue. This document, therefore, attempts a balanced review of the known and suspected human biological consequences of exposure to different types of ionizing radiation, emphasizing in particular the nuclear industry

Silica diatom shells tailored with Au nanoparticles enable sensitive analysis of molecules for biological, safety and environment applications

KAUST Repository

Onesto, V.; Villani, M.; Coluccio, M. L.; Majewska, R.; Alabastri, A.; Battista, E.; Schirato, A.; Calestani, D.; Coppedé , N.; Cesarelli, M.; Amato, F.; Di Fabrizio, Enzo M.; Gentile, F.

2018-01-01

Diatom shells are a natural, theoretically unlimited material composed of silicon dioxide, with regular patterns of pores penetrating through their surface. For their characteristics, diatom shells show promise to be used as low cost, highly efficient drug carriers, sensor devices or other micro-devices. Here, we demonstrate diatom shells functionalized with gold nanoparticles for the harvesting and detection of biological analytes (bovine serum albumin—BSA) and chemical pollutants (mineral oil) in low abundance ranges, for applications in bioengineering, medicine, safety, and pollution monitoring.

Silica diatom shells tailored with Au nanoparticles enable sensitive analysis of molecules for biological, safety and environment applications

KAUST Repository

Onesto, V.

2018-04-19

Diatom shells are a natural, theoretically unlimited material composed of silicon dioxide, with regular patterns of pores penetrating through their surface. For their characteristics, diatom shells show promise to be used as low cost, highly efficient drug carriers, sensor devices or other micro-devices. Here, we demonstrate diatom shells functionalized with gold nanoparticles for the harvesting and detection of biological analytes (bovine serum albumin—BSA) and chemical pollutants (mineral oil) in low abundance ranges, for applications in bioengineering, medicine, safety, and pollution monitoring.

[Measures for counteracting of biological terrorism in the Russian Federation].

Science.gov (United States)

Onishchenko, G G

2005-01-01

The article deals with topicality of the problem of ensuring biological safety in Russia. The necessity of a unified state policy aimed at the realization of the concept of biological safety is grounded. In particular, the expediency of the state support of research programs is emphasized. The organizational and practical measures, carried out by the Ministry of Health and Social Development in this field, are analyzed. The list of prospective measures for the organization of effective state regulation in the field of ensuring the biological safety of the country is given.

FDA Regulation of Follow-On Biologics

Science.gov (United States)

2009-02-24

opening a pathway for the approval of follow-on biologics. A biologic is a preparation, such as a drug or a vaccine , that is made from living...2006 Drug Trend Report, April 2006, p. 38. C Biologic vs. Follow-on Biologic A biologic is a preparation, such as a drug or a vaccine , that is...doc9496/s1695.pdf. 19 Thijs J. Giezen, Aukje K. Mantel-Teeuwisse, and Sabine M. J. M. Straus, et al., “Safety-related regulatory actions for biologicals

EFSA Panel on Biological Hazards (BIOHAZ); Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2011 update)

DEFF Research Database (Denmark)

Hald, Tine

) assessment was developed by EFSA for its own use to provide a generic risk assessment approach applicable across EFSA’s scientific Panels, for biological agents notified for intentional use in the whole food chain. The safety of unambiguously defined biological agents at the highest taxonomic unit......EFSA is requested to assess the safety of a broad range of biological agents (including microorganisms and viruses) in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS...

Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA)

DEFF Research Database (Denmark)

Leuschner, R. G. K.; Robinson, T. P.; Hugas, M.

2010-01-01

Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA) to notified biological agents aiming at simplifying risk assessments across different scientific Panels and Units. The aim of this review is to outline the implementation...... and value of the QPS assessment for EFSA and to explain its principles such as the unambiguous identity of a taxonomic unit, the body of knowledge including potential safety concerns and how these considerations lead to a list of biological agents recommended for QPS which EFSA keeps updated through...

[Establishment of Quality Control System of Nucleic Acid Detection for Ebola Virus in Sierra Leone-China Friendship Biological Safety Laboratory].

Science.gov (United States)

Wang, Qin; Zhang, Yong; Nie, Kai; Wang, Huanyu; Du, Haijun; Song, Jingdong; Xiao, Kang; Lei, Wenwen; Guo, Jianqiang; Wei, Hejiang; Cai, Kun; Wang, Yanhai; Wu, Jiang; Gerald, Bangura; Kamara, Idrissa Laybohr; Liang, Mifang; Wu, Guizhen; Dong, Xiaoping

2016-03-01

The quality control process throughout the Ebola virus nucleic acid detection in Sierra Leone-China Friendship Biological Safety Laboratory (SLE-CHN Biosafety Lab) was described in detail, in order to comprehensively display the scientific, rigorous, accurate and efficient practice in detection of Ebola virus of first batch detection team in SLE-CHN Biosafety Lab. Firstly, the key points of laboratory quality control system was described, including the managements and organizing, quality control documents and information management, instrument, reagents and supplies, assessment, facilities design and space allocation, laboratory maintenance and biosecurity. Secondly, the application of quality control methods in the whole process of the Ebola virus detection, including before the test, during the test and after the test, was analyzed. The excellent and professional laboratory staffs, the implementation of humanized management are the cornerstone of the success; High-level biological safety protection is the premise for effective quality control and completion of Ebola virus detection tasks. And professional logistics is prerequisite for launching the laboratory diagnosis of Ebola virus. The establishment and running of SLE-CHN Biosafety Lab has landmark significance for the friendship between Sierra Leone and China, and the lab becomes the most important base for Ebola virus laboratory testing in Sierra Leone.

Usage, biological activity, and safety of selected botanical dietary supplements consumed in the United States

Directory of Open Access Journals (Sweden)

P. Annécie Benatrehina

2018-04-01

Full Text Available In view of the continuous growth of the botanical dietary supplement industry and the increased popularity of lesser known or exotic botanicals, recent findings are described on the phytochemical composition and biological activities of five selected fruits consumed in the United States, namely, açaí, noni, mangosteen, black chokeberry, and maqui berry. A review of the ethnomedicinal uses of these plants has revealed some similarities ranging from wound-healing to the treatment of fever and infectious diseases. Laboratory studies on açaí have shown both its antioxidant and anti-inflammatory activities in vitro, and more importantly, its neuroprotective properties in animals. Anthraquinones and iridoid glucosides isolated from noni fruit induce the phase II enzyme quinone reductase (QR, and noni fruit juice exhibited antitumor and antidiabetic activities in certain animal models. Antitumorigenic effects of mangosteen in animal xenograft models of human cancers have been attributed to its xanthone content, and pure α-mangostin was shown to display antineoplastic activity in mice despite a reported low oral bioavailability. Work on the less extensively investigated black chokeberry and maqui berry has focused on recent isolation studies and has resulted in the identification of bioactive secondary metabolites with QR-inducing and hydroxyl-radical scavenging properties. On the basis of the safety studies and toxicity case reports described herein, these fruits may be generally considered as safe. However, cases of adulteration found in a commercialized açaí product and some conflicting results from mangosteen safety studies warrant further investigation on the safety of these marketed botanical dietary supplements. Keywords: Açaí, Noni, Mangosteen, Black chokeberry, Maqui berry

Adapting to Biology: Maintaining Container-Closure System Compatibility with the Therapeutic Biologic Revolution.

Science.gov (United States)

Degrazio, Dominick

Many pharmaceutical companies are transitioning their research and development drug product pipeline from traditional small-molecule injectables to the dimension of evolving therapeutic biologics. Important concerns associated with this changeover are becoming forefront, as challenges develop of varying complexity uncommon with the synthesis and production of traditional drugs. Therefore, alternative measures must be established that aim to preserve the efficacy and functionality of a biologic that might not be implemented for small molecules. Conserving protein stability is relative to perpetuating a net equilibrium of both intrinsic and extrinsic factors. Key to sustaining this balance is the ability of container-closure systems to maintain their compatibility with the ever-changing dynamics of therapeutic biologics. Failure to recognize and adjust the material properties of packaging components to support compatibility with therapeutic biologics can compromise patient safety, drug productivity, and biological stability. This review will examine the differences between small-molecule drugs and therapeutic biologics, lay a basic foundation for understanding the stability of therapeutic biologics, and demonstrate potential sources of container-closure systems' incompatibilities with therapeutic biologics at a mechanistic level. Many pharmaceutical companies are transitioning their research and development drug product pipeline from traditional small-molecule injectables to recombinantly derived therapeutic biologics. Concerns associated with this transformation are becoming prominent, as therapeutic biologics are uncharacteristic to small-molecule drugs. Maintaining the stability of a therapeutic biologic is a combination of balancing intrinsic factors and external elements within the biologic's microenvironment. An important aspect of this balance is relegated to the overall compatibility of primary, parenteral container-closure systems with therapeutic biologics

Biological safety of nasal thallium-201 administration. A preclinical study for olfacto-scintigraphy

International Nuclear Information System (INIS)

Washiyama, Kohshin; Shiga, Hideaki; Hirota, Kyoko

2011-01-01

Nasal administration of thallium-201 ( 201 Tl) has previously been shown to be useful for the assessment of olfactory nerve connectivity in vivo. We assessed the biological effects of nasal 201 Tl administration in mice to determine its safety before conducting clinical trials on humans. 201 Tl uptake was evaluated in normal mice (n=5) in vivo by using a high-resolution gamma camera and radiography 15 min, 1, 2 and 9 d after administration of 201 TlCl to the right side of the nasal cavity (10 μl 201 TlCl per nostril, 74 MBq/ml). Murine olfactory epithelial thickness (n=5) was measured 9 d following nasal administration of 201 TlCl. We assessed the odor detection ability of normal mice (n=8) following nasal administration of 201 TlCl to both sides of the nasal cavity, by observing cycloheximide solution avoidance behavior. We subsequently administrated 201 TlCl (n=4) or saline (n=4) to both nostrils to assess the odor detection ability of mice following bilateral olfactory nerve transection. 201 Tl uptake by the nasal cavity decreased immediately following nasal administration of 201 Tl in normal mice. Nasal administration of 201 Tl did not affect the olfactory epithelial thickness or the odor detection ability of normal mice. Recovery of odor detection ability following olfactory nerve transection was not significantly different between mice nasally administered with 201 Tl, and mice administered with saline. Thus, nasal administration of 201 Tl for the diagnosis of traumatic olfactory impairment did not produce harmful biological effects in vivo. (author)

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

Directory of Open Access Journals (Sweden)

Lin-Chau Chang

Full Text Available Standardised MedDRA Queries (SMQs have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA and Biologics License Application (BLA submissions to the United States Food and Drug Administration (USFDA.We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed.A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59% of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18% of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated. Most searches (75% of 227 searches with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process.SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

Science.gov (United States)

Chang, Lin-Chau; Mahmood, Riaz; Qureshi, Samina; Breder, Christopher D

2017-01-01

Standardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA). We used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed. A comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process. SMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.

Housing & woodworking: latest trends & impacts

Science.gov (United States)

Urs Buehlmann; Matt Bumgardner; Karen. Koenig

2014-01-01

Trends in housing and other construction-related sectors continue to have a significant impact on the wood products industry, particularly cabinetry, furniture, millwork and components. This fifth annual survey assesses the market conditions for secondary woodworking manufacturers involved in construction-based sectors and includes information on their status and...

Woodworking & housing: Positive trends and actions

Science.gov (United States)

Urs Buehlmann; Matt Bumgardner; Karen. Koenig

2016-01-01

This exclusive study looks at the housing market's impact on woodworking businesses and the actions taken to increase wood product sales. A majority of the woodworking industry remains intrinsically tied to the housing industry, particularly businesses involved in producing cabinetry, furniture, millwork and components. For that reason, construction market...

Consumer preferences for kitchen cabinets made from red alder: a comparison to other hardwoods.

Science.gov (United States)

David L. Nicholls; Geoffrey H. Donovan; Joseph. Roos

2004-01-01

In Alaska, red alder (Alnus rubra Bong.) is an abundant but commercially underutilized species despite having properties suitable for higher value products, including furniture and cabinetry. However, it laces the name recognition of mote traditional hardwoods. Our research measured the effect of this lack of familiarity on consumer preferences...

Laboratory Safety Manual for Alabama Schools. Bulletin 1975. No. 20.

Science.gov (United States)

Alabama State Dept. of Education, Montgomery.

This document presents the Alabama State Department of Education guidelines for science laboratory safety, equipment, storage, chemical safety, rocket safety, electrical safety, safety with radioisotopes, and safety with biologicals. Also included is a brief bibliography, a teacher's checklist, a listing of laser facts and regulations, and a…

Biologic and Conventional Systemic Therapies Show Similar Safety and Efficacy in Elderly and Adult Patients With Moderate to Severe Psoriasis.

Science.gov (United States)

Garber, Caren; Plotnikova, Natalia; Au, Shiu-chung; Sorensen, Eric P; Gottlieb, Alice

2015-08-01

Despite the aging population, few studies have documented the treatment of geriatric psoriasis. The purpose of this study is to compare the efficacy, safety, and prescribing patterns of biologics and conventional systemic medications in elderly versus adult psoriasis. All patient visits coded for psoriasis or psoriatic arthritis (ICD-9 696.1 or 696.0) at the Tufts Medical Center General Dermatology Clinic from January 1, 2008, to March 1, 2015 were included in this retrospective cohort study. The outcome measure used was the validated simple-measure for assessing psoriasis activity (S-MAPA), the product of the physician's global assessment and the body surface area. 194 patients who underwent 278 treatment courses were included in the study. 48 patients were included in the elderly cohort (≥ 65 years old) and 146 in the adult cohort (18-64 years old). There was no significant difference in S-MAPA improvement at 12 weeks between the two cohorts when treated with biologics (42.92% improvement in adults, 48.77% in elderly; P=0.498) or conventional systemics (43.96% and 51.82%, respectively; P=0.448). Within the elderly cohort, there was no significant difference in efficacy of biologics versus conventional systemics at any time point. Topical prescription rates were significantly higher in the elderly cohort ( P=0.004) while biologic prescription rates were significantly lower ( P=0.014) despite the same baseline S-MAPA in both age groups. For both biologics and conventional systemics, there was no statistically significant intergroup difference in the rate of adverse events ( P=0.322 for biologics; P=0.581 for conventional systemics) or infection ( P=0.753 for biologics; P=0.828 for conventional systemics). Within the elderly cohort, there was a higher rate of adverse events with conventional systemic treatment than with biologic treatment ( P=0.033). This study provides preliminary evidence to suggest that biologic and conventional systemic therapies are similarly

Effects of open-air temperature on air temperature inside biological safety cabinet.

Science.gov (United States)

Umemura, Masayuki; Shigeno, Katsuro; Yamamura, Keiko; Osada, Takashi; Soda, Midori; Yamada, Kiyofumi; Ando, Yuichi; Wakiya, Yoshifumi

2011-02-14

In Japan, biological safety cabinets (BSCs) are normally used by medical staff while handling antineoplastic agents. We have also set up a class II B2 BSC at the Division of Chemotherapy for Outpatients. The air temperature inside this BSC, however, decreases in winter. We assumed that this decrease is caused by the intake of open-air. Therefore, we investigated the effects of low open-air temperature on the BSC temperature and the time of admixtures of antineoplastic agents. The studies were conducted from January 1 to March 31, 2008. The outdoor air temperature was measured in the shade near the intake nozzle of the BSC and was compared with the BSC temperature. The correlation between the outdoor air temperature and the BSC temperature, the dissolution time of cyclophosphamide (CPA) and gemcitabine (GEM), and accurate weight measurement of epirubicin (EPI) solution were investigated for low and normal BSC temperatures. The BSC temperature was correlated with the open-air temperature for open-air temperatures of 5-20°C (p air is drawn from outdoors. We showed that the BSC temperature affects the dissolution rate of antineoplastic agents. Further, we suggested that the BSC temperature drop might delay the affair of the admixtures of antineoplastic agents and increase the waiting time of outpatients for chemotherapy.

Safety and effectiveness of tacrolimus add-on therapy for rheumatoid arthritis patients without an adequate response to biological disease-modifying anti-rheumatic drugs (DMARDs): Post-marketing surveillance in Japan.

Science.gov (United States)

Takeuchi, Tsutomu; Ishida, Kota; Shiraki, Katsuhisa; Yoshiyasu, Takashi

2018-01-01

Post-marketing surveillance (PMS) was conducted to assess the safety and effectiveness of tacrolimus (TAC) add-on therapy for patients with rheumatoid arthritis (RA) and an inadequate response to biological disease-modifying anti-rheumatic drugs (DMARDs). Patients with RA from 180 medical sites across Japan were registered centrally with an electronic investigation system. The observational period was 24 weeks from the first day of TAC administration concomitantly with biological DMARDs. Safety and effectiveness populations included 624 and 566 patients, respectively. Patients were predominantly female (81.1%), with a mean age of 61.9 years. Overall, 125 adverse drug reactions (ADRs) occurred in 94 patients (15.1%), and 15 serious ADRs occurred in 11 patients (1.8%). These incidences were lower compared with previously reported incidences after TAC treatment in PMS, and all of the observed ADRs were already known. A statistically significant improvement was observed in the primary effectiveness variable of Simplified Disease Activity Index after TAC treatment; 62.7% of patients achieved remission or low disease activity at week 24. TAC is well tolerated and effective when used as an add-on to biological DMARDs in Japanese patients with RA who do not achieve an adequate response to biological DMARDs in a real-world clinical setting.

Experience With Laser Safety In The USA--A Review

Science.gov (United States)

Sliney, David H.

1986-10-01

Following several research programs in the 1960's aimed at studying the adverse biological effects of lasers and other optical radiation sources, laser occupational exposure limits were set and general safety standards were developed. Today, the experience from laser accidents and the development of new lasers and new applications have altered the format of the exposure limits and the safety procedures. It is critically important to distinguish between different biological injury mechanisms. The biological effects of ultraviolet radiation upon the skin and eye are additive over a period of at least one workday, and require different safety procedures. The scattered UV irradiance from excimer lasers may be quite hazardous, depending upon wavelength and action spectra. Since laser technology is young, the exposure of an individual in natural sunlight must be studied to evaluate the potential for chronic effects. The safety measures necessary in the use of lasers depend upon a hazard evaluation. The appropriate control measures and alternate means of enclosure, baffling, and operational control measures are presented. Present laser safety standards are explained briefly. Eye protective techniques and eyewear are considered for a variety of sources. The optical properties of enclosure materials are also discussed.

Establishing a national biological laboratory safety and security monitoring program.

Science.gov (United States)

Blaine, James W

2012-12-01

The growing concern over the potential use of biological agents as weapons and the continuing work of the Biological Weapons Convention has promoted an interest in establishing national biological laboratory biosafety and biosecurity monitoring programs. The challenges and issues that should be considered by governments, or organizations, embarking on the creation of a biological laboratory biosafety and biosecurity monitoring program are discussed in this article. The discussion focuses on the following questions: Is there critical infrastructure support available? What should be the program focus? Who should be monitored? Who should do the monitoring? How extensive should the monitoring be? What standards and requirements should be used? What are the consequences if a laboratory does not meet the requirements or is not willing to comply? Would the program achieve the results intended? What are the program costs? The success of a monitoring program can depend on how the government, or organization, responds to these questions.

Woodworking & housing: impacts & actions

Science.gov (United States)

Matt Bumgardner; Urs Buehlmann; Karen. Koenig

2015-01-01

The woodworking industry relies heavily on the construction-based markets, particularly those companies involved in cabinetry, furniture, millwork and components. Market conditions, trends and investments all have an impact. It's against this backdrop, that the sixth annual housing market study was conducted in early 2015. A joint effort by Virginia Tech, the U.S...

Hardwood genetics and tree improvement - A Midwest USA perspective

Science.gov (United States)

C. H. Michler; R. Meilan; K. E. Woeste; P. M. Pijut; D. Jacobs; P. Aldrich; J. Glaubitz

2005-01-01

Fine hardwood trees in the Central Hardwoods region of the United States are an important resource for the furniture, cabinetry, flooring, modular home, and paneling manufacturing industries. Consumers find wood from these trees to be very desirable because of quality factors such as grain, strength and color. To enhance wood production, tree improvement programs can...

Integrated Biological Control

International Nuclear Information System (INIS)

JOHNSON, A.R.

2002-01-01

Biological control is any activity taken to prevent, limit, clean up, or remediate potential environmental, health and safety, or workplace quality impacts from plants, animals, or microorganisms. At Hanford the principal emphasis of biological control is to prevent the transport of radioactive contamination by biological vectors (plants, animals, or microorganisms), and where necessary, control and clean up resulting contamination. Other aspects of biological control at Hanford include industrial weed control (e.g.; tumbleweeds), noxious weed control (invasive, non-native plant species), and pest control (undesirable animals such as rodents and stinging insects; and microorganisms such as molds that adversely affect the quality of the workplace environment). Biological control activities may be either preventive (apriori) or in response to existing contamination spread (aposteriori). Surveillance activities, including ground, vegetation, flying insect, and other surveys, and apriori control actions, such as herbicide spraying and placing biological barriers, are important in preventing radioactive contamination spread. If surveillance discovers that biological vectors have spread radioactive contamination, aposteriori control measures, such as fixing contamination, followed by cleanup and removal of the contamination to an approved disposal location are typical response functions. In some cases remediation following the contamination cleanup and removal is necessary. Biological control activities for industrial weeds, noxious weeds and pests have similar modes of prevention and response

Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

Science.gov (United States)

Goddard, Allison; Borovicka, Judy H; West, Dennis P; Evens, Andrew M; Laumann, Anne

2011-01-01

This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

Efficacy and safety of biological and targeted-synthetic DMARDs: a systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis

NARCIS (Netherlands)

Sepriano, Alexandre; Regel, Andrea; van der Heijde, Désirée; Braun, Jürgen; Baraliakos, Xenofon; Landewé, Robert; van den Bosch, Filip; Falzon, Louise; Ramiro, Sofia

2017-01-01

To update the evidence for the efficacy and safety of (b)biological and (ts)targeted-synthetic disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) to inform the 2016 update of the Assessment of SpondyloArthritis international Society/European League

Agrobacterium-mediated transformation of black cherry for flowering control and insect resistance

Science.gov (United States)

Ying Wang; Paula M. Pijut

2014-01-01

Black cherry is one of the most valuable hardwood species for cabinetry, furniture, and veneer. The goal of this study was to develop transgenic black cherry plants with reproductive sterility and enhanced insect resistance. Black cherry TERMINAL FLOWER 1 (PsTFL1) was overexpressed under the control of the CaMV 35S promoter in black cherry via

New set of Chemical Safety rules

CERN Multimedia

HSE Unit

2011-01-01

A new set of four Safety Rules was issued on 28 March 2011: Safety Regulation SR-C ver. 2, Chemical Agents (en); General Safety Instruction GSI-C1, Prevention and Protection Measures (en); General Safety Instruction GSI-C2, Explosive Atmospheres (en); General Safety Instruction GSI-C3, Monitoring of Exposure to Hazardous Chemical Agents in Workplace Atmospheres (en). These documents form part of the CERN Safety Rules and are issued in application of the “Staff Rules and Regulations” and of document SAPOCO 42. These documents set out the minimum requirements for the protection of persons from risks to their occupational safety and health arising, or likely to arise, from the effects of hazardous chemical agents that are present in the workplace or used in any CERN activity. Simultaneously, the HSE Unit has published seven Safety Guidelines and six Safety Forms. These documents are available from the dedicated Web page “Chemical, Cryogenic and Biological Safety&...

Public attitudes toward legally coerced biological treatments of criminals.

Science.gov (United States)

Berryessa, Colleen M; Chandler, Jennifer A; Reiner, Peter

2016-12-01

How does the public view the offer of a biological treatment in lieu of prison for criminal offenders? Using the contrastive vignette technique, we explored this issue, using mixed-methods analysis to measure concerns regarding changing the criminal's personality, the coercive nature of the offer, and the safety of the proposed treatment. Overall, we found that of the three variables, the safety of the pill had the strongest effect on public acceptance of a biological intervention. Indeed, it was notable that the public was relatively sanguine about coercive offers of biological agents, as well as changing the personality of criminals. While respondents did not fully endorse such coercive offers, neither were they outraged by the use of biological treatments of criminals in lieu of incarceration. These results are discussed in the context of the retributive and rehabilitative sentiments of the public, and legal jurisprudence in the arena of human rights law.

Investigative safety science as a competitive advantage for Pharma.

Science.gov (United States)

Moggs, Jonathan; Moulin, Pierre; Pognan, Francois; Brees, Dominique; Leonard, Michele; Busch, Steve; Cordier, Andre; Heard, David J; Kammüller, Michael; Merz, Michael; Bouchard, Page; Chibout, Salah-Dine

2012-09-01

Following a US National Academy of Sciences report in 2007 entitled "Toxicity Testing of the 21st Century: a Vision and a Strategy," significant advances within translational drug safety sciences promise to revolutionize drug discovery and development. The purpose of this review is to outline why investigative safety science is a competitive advantage for the pharmaceutical industry. The article discusses the essential goals for modern investigative toxicologists including: cross-species target biology; molecular pathways of toxicity; and development of predictive tools, models and biomarkers that allow discovery researchers and clinicians to anticipate safety problems and plan ways to address them, earlier than ever before. Furthermore, the article emphasizes the importance of investigating unanticipated clinical safety signals through a combination of mechanistic preclinical studies and/or molecular characterization of clinical samples from affected organs. The traditional boundaries between pharma industry teams focusing on safety/efficacy and preclinical/clinical development are rapidly disappearing in favor of translational safety science-centric organizations with a vision of bringing more effective medicines forward safely and quickly. Comparative biology and mechanistic toxicology approaches facilitate: i) identifying translational safety biomarkers; ii) identifying new drug targets/indications; and iii) mitigating off-target toxicities. These value-adding safety science contributions will change traditional toxicologists from side-effect identifiers to drug development enablers.

Infusing Outdoor Field Experiences into the Secondary Biology Curriculum.

Science.gov (United States)

Owens, Ginny

1984-01-01

To offer students biological field experiences, teachers should use their own basic skills, be enthusiastic motivators, participate in community programs/courses/workshops to acquire additional skills/knowledge for outdoor biological education, plan outdoor excursions with safety considerations in mind, and use available resources for classroom…

Chemical compositional, biological, and safety studies of a novel maple syrup derived extract for nutraceutical applications.

Science.gov (United States)

Zhang, Yan; Yuan, Tao; Li, Liya; Nahar, Pragati; Slitt, Angela; Seeram, Navindra P

2014-07-16

Maple syrup has nutraceutical potential given the macronutrients (carbohydrates, primarily sucrose), micronutrients (minerals and vitamins), and phytochemicals (primarily phenolics) found in this natural sweetener. We conducted compositional (ash, fiber, carbohydrates, minerals, amino acids, organic acids, vitamins, phytochemicals), in vitro biological, and in vivo safety (animal toxicity) studies on maple syrup extracts (MSX-1 and MSX-2) derived from two declassified maple syrup samples. Along with macronutrient and micronutrient quantification, thirty-three phytochemicals were identified (by HPLC-DAD), and nine phytochemicals, including two new compounds, were isolated and identified (by NMR) from MSX. At doses of up to 1000 mg/kg/day, MSX was well tolerated with no signs of overt toxicity in rats. MSX showed antioxidant (2,2-diphenyl-1-picrylhydrazyl (DPPH) assay) and anti-inflammatory (in RAW 264.7 macrophages) effects and inhibited glucose consumption (by HepG2 cells) in vitro. Thus, MSX should be further investigated for potential nutraceutical applications given its similarity in chemical composition to pure maple syrup.

Chemical Compositional, Biological, and Safety Studies of a Novel Maple Syrup Derived Extract for Nutraceutical Applications

Science.gov (United States)

2015-01-01

Maple syrup has nutraceutical potential given the macronutrients (carbohydrates, primarily sucrose), micronutrients (minerals and vitamins), and phytochemicals (primarily phenolics) found in this natural sweetener. We conducted compositional (ash, fiber, carbohydrates, minerals, amino acids, organic acids, vitamins, phytochemicals), in vitro biological, and in vivo safety (animal toxicity) studies on maple syrup extracts (MSX-1 and MSX-2) derived from two declassified maple syrup samples. Along with macronutrient and micronutrient quantification, thirty-three phytochemicals were identified (by HPLC-DAD), and nine phytochemicals, including two new compounds, were isolated and identified (by NMR) from MSX. At doses of up to 1000 mg/kg/day, MSX was well tolerated with no signs of overt toxicity in rats. MSX showed antioxidant (2,2-diphenyl-1-picrylhydrazyl (DPPH) assay) and anti-inflammatory (in RAW 264.7 macrophages) effects and inhibited glucose consumption (by HepG2 cells) in vitro. Thus, MSX should be further investigated for potential nutraceutical applications given its similarity in chemical composition to pure maple syrup. PMID:24983789

Spinal cordd biological safety comparison of intensity modulated radiotherapy and conventional radiation therapy

International Nuclear Information System (INIS)

Xilinbaoleri; Xu Wanlong; Chen Gang; Liu Hao; Wang Ruozheng; Bai Jingping

2010-01-01

Objective: To compare the spine intensity modulated radiation therapy (IMRT) and the conventional radiation therapy on the beagle spinal cord neurons, in order to prove the biological safety of IMRT of the spinal cord. Methods: Twelve selected purebred beagles were randomly divided into 2 groups. A beagle clinical model of tumor was mimiced in the ninth and tenth thoracic vertebrae. Then the beagles were irradiated by 2 different models of intensity modulated radiotherapy and conventional radiation therapy, with the total irradiation doses of 50 and 70 Gy. The samples of spinal cord were taken out from the same position of the nine and tenth thoracic vertebrae at the third month after radiation.All the samples were observed by the electron microscope, and the Fas and HSP70 expression in spinal cord neurons were evaluated by immunohistochemistry method. Terminal deoxynucleatidyl transferase mediated dUTP nick and labeling (TUNEL) technique was used to examine the apoptotic cells in the spinal cord. Results: The neurons in the spinal cord of IMRT group were mainly reversible injury, and those in the conventional radiation therapy were mainly apoptosis. Compared with the conventional radiation therapy group [50 Gy group, (7.3 ± 1.1)%; 70 Gy group, (11.3 ± 1.4)%], the apoptosis rate of the spinal cord neurons of the intensity modulated radiotherapy group [50 Gy group, (1.2 ± 0.7)%; 70 Gy group (2.5 ± 0.8)%] was much lower[(50 Gy group, t=0.022, P<0.05; 70 Gy group, t=0.017, P<0.05)]. The expression levels of Fas in the IMPT group (50 Gy group, 4.6 ± 0.8; 70 Gy group, 7.4 ± 1.1) were also much lowerthan those in the other group (50 Gy group, 15.1 ± 6.4; 70 Gy group, 19.3 ± 7.6. 50 Gy group, t=0.231, P<0.05; 70 Gy group, t=0.457, P<0.05), while the expression levels of HSP70 in the IMPT group (50 Gy group, 9.1 ± 0.8; 70 Gy group, 7.3 ± 1.4)were much higher than those in the conventional radiation therapy group (50 Gy group, 2.1 ± 0.9; 70 Gy group, 1.7 ± 0

Safety and reliability assessment

International Nuclear Information System (INIS)

1979-01-01

This report contains the papers delivered at the course on safety and reliability assessment held at the CSIR Conference Centre, Scientia, Pretoria. The following topics were discussed: safety standards; licensing; biological effects of radiation; what is a PWR; safety principles in the design of a nuclear reactor; radio-release analysis; quality assurance; the staffing, organisation and training for a nuclear power plant project; event trees, fault trees and probability; Automatic Protective Systems; sources of failure-rate data; interpretation of failure data; synthesis and reliability; quantification of human error in man-machine systems; dispersion of noxious substances through the atmosphere; criticality aspects of enrichment and recovery plants; and risk and hazard analysis. Extensive examples are given as well as case studies

Scientific Opinion on Risk Assessment of Synthetic Biology.

Science.gov (United States)

Epstein, Michelle M; Vermeire, Theo

2016-08-01

In 2013, three Scientific Committees of the European Commission (EC) drafted Scientific Opinions on synthetic biology that provide an operational definition and address risk assessment methodology, safety aspects, environmental risks, knowledge gaps, and research priorities. These Opinions contribute to the international discussions on the risk governance for synthetic biology developments. Copyright © 2016 Elsevier Ltd. All rights reserved.

Biological Terrorism: US Policies to Reduce Global Biothreats

Science.gov (United States)

2008-09-01

program for pro- jects that advance BEP objectives. Global Cooperation to develop bio- safety and pathogen security stan- dards that are consistent with...security. The Organization for Economic Cooperation and Development ( OECD ) has recently developed voluntary biosecurity guidelines for implementation...Abbreviations AG Australia Group BEP Biosecurity Engagement Program BSL Biosafety level BWC Biological Weapons Convention BWC-ISU Biological Weapons

Radiation protection and the safety of radiation sources

International Nuclear Information System (INIS)

1996-01-01

These Safety Fundamentals cover the protection of human beings against ionizing radiation (gamma and X rays and alpha, beta and other particles that can induce ionization as they interact with biological materials), referred to herein subsequently as radiation, and the safety of sources that produce ionizing radiation. The Fundamentals do not apply to non-ionizing radiation such as microwave, ultraviolet, visible and infrared radiation. They do not apply either to the control of non-radiological aspects of health and safety. They are, however, part of the overall framework of health and safety

Biomonitoring at the UK Health and Safety Laboratory.

Science.gov (United States)

Cocker, J; Jones, K; Morton, J; Mason, H J

2007-05-01

The UK Health and Safety Laboratory (HSL) provides research and analytical support to the Health and Safety Executive, other Government Departments and employers. In the area of biomonitoring HSL conducts research studies and provides an analytical service for regular surveillance of worker exposure to hazardous substances. This paper gives brief examples of how data from such studies can be used to develop biological monitoring guidance values for isocyanates, polycyclic aromatic hydrocarbons and hexavalent chromium. In addition, a study of occupational exposure to copper chrome arsenic wood preservatives is briefly described to show how biological monitoring can be used for post-approval surveillance of a biocide.

Safety and preliminary evidence of biologic efficacy of a mammaglobin-a DNA vaccine in patients with stable metastatic breast cancer.

Science.gov (United States)

Tiriveedhi, Venkataswarup; Tucker, Natalia; Herndon, John; Li, Lijin; Sturmoski, Mark; Ellis, Matthew; Ma, Cynthia; Naughton, Michael; Lockhart, A Craig; Gao, Feng; Fleming, Timothy; Goedegebuure, Peter; Mohanakumar, Thalachallour; Gillanders, William E

2014-12-01

Mammaglobin-A (MAM-A) is overexpressed in 40% to 80% of primary breast cancers. We initiated a phase I clinical trial of a MAM-A DNA vaccine to evaluate its safety and biologic efficacy. Patients with breast cancer with stable metastatic disease were eligible for enrollment. Safety was monitored with clinical and laboratory assessments. The CD8 T-cell response was measured by ELISPOT, flow cytometry, and cytotoxicity assays. Progression-free survival (PFS) was described using the Kaplan-Meier product limit estimator. Fourteen subjects have been treated with the MAM-A DNA vaccine and no significant adverse events have been observed. Eight of 14 subjects were HLA-A2(+), and the CD8 T-cell response to vaccination was studied in detail. Flow cytometry demonstrated a significant increase in the frequency of MAM-A-specific CD8 T cells after vaccination (0.9% ± 0.5% vs. 3.8% ± 1.2%; P cells (41 ± 32 vs. 215 ± 67 spm; P cell responses, and preliminary evidence suggests improved PFS. Additional studies are required to define the potential of the MAM-A DNA vaccine for breast cancer prevention and/or therapy. ©2014 American Association for Cancer Research.

EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), 2013. Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2013 update)

DEFF Research Database (Denmark)

Licht, Tine Rask; Baggesen, Dorte Lau

EFSA is requested to assess the safety of a broad range of biological agents in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide...... a harmonised generic pre-assessment to support safety risk assessments performed by EFSA’s scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended), and the completeness of the body of knowledge...... is the one in the most recently published scientific opinion. The 2013 update reviews previously assessed microorganisms including bacteria, yeasts, filamentous fungi, oomycetes and viruses used for plant protection purposes. All taxonomic units previously recommended for the QPS list had their status...

Space Biology and Medicine. Volume 4; Health, Performance, and Safety of Space Crews

Science.gov (United States)

Dietlein, Lawrence F. (Editor); Pestov, Igor D. (Editor)

2004-01-01

Volume IV is devoted to examining the medical and associated organizational measures used to maintain the health of space crews and to support their performance before, during, and after space flight. These measures, collectively known as the medical flight support system, are important contributors to the safety and success of space flight. The contributions of space hardware and the spacecraft environment to flight safety and mission success are covered in previous volumes of the Space Biology and Medicine series. In Volume IV, we address means of improving the reliability of people who are required to function in the unfamiliar environment of space flight as well as the importance of those who support the crew. Please note that the extensive collaboration between Russian and American teams for this volume of work resulted in a timeframe of publication longer than originally anticipated. Therefore, new research or insights may have emerged since the authors composed their chapters and references. This volume includes a list of authors' names and addresses should readers seek specifics on new information. At least three groups of factors act to perturb human physiological homeostasis during space flight. All have significant influence on health, psychological, and emotional status, tolerance, and work capacity. The first and most important of these factors is weightlessness, the most specific and radical change in the ambient environment; it causes a variety of functional and structural changes in human physiology. The second group of factors precludes the constraints associated with living in the sealed, confined environment of spacecraft. Although these factors are not unique to space flight, the limitations they entail in terms of an uncomfortable environment can diminish the well-being and performance of crewmembers in space. The third group of factors includes the occupational and social factors associated with the difficult, critical nature of the

[Hygiene and security management in medical biology laboratory].

Science.gov (United States)

Vinner, E; Odou, M F; Fovet, B; Ghnassia, J C

2013-06-01

Risk management in Medical Biology Laboratory (MBL) which includes hygiene and waste management, is an integrated process to the whole MBL organisation. It is composed of three stages: risks factors identification, grading and prioritization, and their evaluation in the system. From the legislation and NF EN ISO 15189 standard's requirements viewpoint, prevention and protection actions to implement are described, at premises level, but also at work station environment's one (human resources and equipments) towards biological, chemical, linked to gas, to ionizing or non ionizing radiations and fire riks, in order not to compromise patients safety, employees safety, and quality results. Then, although NF EN 15189 standard only enacts requirements in terms of prevention, curative actions after established blood or chemical exposure accident are defined.

Postharvest biology and technology research and development ...

African Journals Online (AJOL)

STORAGESEVER

2008-09-03

Sep 3, 2008 ... The applications of biological control agents in pre- and post-harvest operations and .... production, with regards to food safety, operator health and the ... and to work out sustainable compliance modalities for small-scale ...

Safety assessment of Linum usitatissimum (Linn.) Ingestion in New ...

African Journals Online (AJOL)

Background: The therapeutic safety of herbal medicine is a major concern for consumers and users. After studying the effects of linseed on hair growth in rabbits, the turn is to evaluate its safety by the observation of some clinical, biological and anatomo-pathological aspects. Materials and Methods: A study was conducted ...

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

Science.gov (United States)

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

2010-01-01

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

Risk assessment of medical devices: evaluation of microbiological and toxicological safety

International Nuclear Information System (INIS)

Dorpema, J.W.

1995-01-01

Safety assessment of medical devices includes sterilization and biological evaluation or biocompatability testing. Sterilization by ETO gas is criticised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program. (Author)

Evaluation of DoD Biological Safety and Security Implementation

Science.gov (United States)

2016-04-27

advanced development, efficient production, and timely distribution. Critical Reagent Program products include antibodies, inactivated antigens , genomic...effects to the economy, communicability, low infectious dose, and a history of or current interest in weaponization based on threat reporting. The...unwarranted by the threat. Recommendation #3. Biological Personnel Reliability Program [BPRP] Maintain use of the BPRP tailored to bio -defense work; balance

MedWatch Safety Alerts for Human Medical Products

Data.gov (United States)

U.S. Department of Health & Human Services — MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts...

Development of biological treatment of high concentration sodium nitrate waste liquid

International Nuclear Information System (INIS)

Ogawa, Naoki; Kuroda, Kazuhiko; Shibata, Katsushi; Kawato, Yoshimi; Meguro, Yoshihiro; Takahashi, Kuniaki

2009-01-01

An electrolytic reduction, chemical reduction, and biological reduction have been picked up as a method of nitrate liquid waste treatment system exhausted from the reprocessing process. As a result of comparing them, it was shown that the biological treatment was the most excellent method in safety and the economy. (author)

Biological agents and respiratory infections: Causative mechanisms and practice management.

Science.gov (United States)

Takayanagi, Noboru

2015-09-01

Biological agents are increasingly being used to treat patients with immune-mediated inflammatory disease. In Japan, currently approved biological agents for patients with rheumatoid arthritis (RA) include tumor necrosis factor inhibitors, interleukin-6 receptor-blocking monoclonal antibody, and T-cell costimulation inhibitor. Rheumatologists have recognized that safety issues are critical aspects of treatment decisions in RA. Therefore, a wealth of safety data has been gathered from a number of sources, including randomized clinical trials and postmarketing data from large national registries. These data revealed that the most serious adverse events from these drugs are respiratory infections, especially pneumonia, tuberculosis, nontuberculous mycobacteriosis, and Pneumocystis jirovecii pneumonia, and that the most common risk factors associated with these respiratory infections are older age, concomitant corticosteroid use, and underlying respiratory comorbidities. Because of this background, in 2014, the Japanese Respiratory Society published their consensus statement of biological agents and respiratory disorders. This review summarizes this statement and adds recent evidence, especially concerning respiratory infections in RA patients, biological agents and respiratory infections, and practice management of respiratory infections in patients treated with biological agents. To decrease the incidence of infections and reduce mortality, we should know the epidemiology, risk factors, management, and methods of prevention of respiratory infections in patients receiving biological agents. Copyright © 2015 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

Aerospace Medicine and Biology: A Continuing Bibliography. Supplement 483

Science.gov (United States)

1999-01-01

Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion.

[Patient identification errors and biological samples in the analytical process: Is it possible to improve patient safety?].

Science.gov (United States)

Cuadrado-Cenzual, M A; García Briñón, M; de Gracia Hills, Y; González Estecha, M; Collado Yurrita, L; de Pedro Moro, J A; Fernández Pérez, C; Arroyo Fernández, M

2015-01-01

Patient identification errors and biological samples are one of the problems with the highest risk factor in causing an adverse event in the patient. To detect and analyse the causes of patient identification errors in analytical requests (PIEAR) from emergency departments, and to develop improvement strategies. A process and protocol was designed, to be followed by all professionals involved in the requesting and performing of laboratory tests. Evaluation and monitoring indicators of PIEAR were determined, before and after the implementation of these improvement measures (years 2010-2014). A total of 316 PIEAR were detected in a total of 483,254 emergency service requests during the study period, representing a mean of 6.80/10,000 requests. Patient identification failure was the most frequent in all the 6-monthly periods assessed, with a significant difference (Perrors. However, we must continue working with this strategy, promoting a culture of safety for all the professionals involved, and trying to achieve the goal that 100% of the analytical and samples are properly identified. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Handbook of laboratory health and safety measures

International Nuclear Information System (INIS)

Pal, S.B.

1985-01-01

Eighteen chapters deal with all kinds of possible health and safety hazards, chemical, physical and biological, arising in laboratories. Two chapters, on X-ray hazards - diagnostic and therapeutic, and radiation protection in radionuclide investigations, respectively are indexed separately. (U.K.)

Proceedings of the 6. Argentine congress on radiation protection and nuclear safety

International Nuclear Information System (INIS)

1998-01-01

The 6th Argentine Congress on Radiation Protection and Nuclear Safety was organized by the Radioprotection Argentine Society, in Buenos Aires, between the 22 and 24 of september of 1998. In this event, were presented almost 66 papers in the following sessions, about these subjects: 1.- Safety in nuclear installations. 2.- Control of nuclear material and physical protection of nuclear installations. 3.- Programs of quality assurance. 4.- Training, technical information and public information. 5.- Physical dosimetry. 6.- Physical dosimetry and occupational radiation protection. 7.- Exposure of the natural radiation. 8.- Environmental radiological safety. 9.- Biological effects of the ionizing radiations and biological dosimetry. 10.- Radiological protection of the medical practice and the radiological emergencies. 11.- Radioactive wastes management. 12.- Transport of radioactive materials

Results of activities of the State Office for Nuclear Safety in state supervision of nuclear safety of nuclear facilities and radiation protection in 2003

International Nuclear Information System (INIS)

Kovar, P.

2004-01-01

The report summarises results of activities of the State Office for Nuclear Safety (SUJB) in the supervision of nuclear safety and radiation protection in the Czech Republic. The first part of the report evaluates nuclear safety of nuclear installations and contains information concerning the results of supervision of radiation protection in 2003 in the Czech Republic. The second part of the report describes new responsibilities of the SUJB in the domain of nuclear, chemical, bacteriological (biological) and toxin weapons ban. (author)

Radiation Safety of Electromagnetic Waves

International Nuclear Information System (INIS)

Hussein, A.Z.

2009-01-01

The wide spread of Electromagnetic Waves (EMW) through the power lines, multimedia, communications, devices, appliances, etc., are well known. The probable health hazards associated with EMW and the radiation safety criteria are to be reviewed. However, the principles of the regulatory safety are based on radiation protection procedure, intervention to combat the relevant risk and to mitigate consequences. The oscillating electric magnetic fields (EMF) of the electromagnetic radiation (EMR) induce electrical hazards. The extremely high power EMR can cause fire hazards and explosions of pyrotechnic (Rad Haz). Biological hazards of EMF result as dielectric heat, severe burn, as well as the hazards of eyes. Shielding is among the technical protective measures against EMR hazards. Others are limitation of time of exposure and separation distance apart of the EMR source. Understanding and safe handling of the EMR sources are required to feel safety.

A New Method for the Evaluation of Vaccine Safety Based on Comprehensive Gene Expression Analysis

Directory of Open Access Journals (Sweden)

Haruka Momose

2010-01-01

Full Text Available For the past 50 years, quality control and safety tests have been used to evaluate vaccine safety. However, conventional animal safety tests need to be improved in several aspects. For example, the number of test animals used needs to be reduced and the test period shortened. It is, therefore, necessary to develop a new vaccine evaluation system. In this review, we show that gene expression patterns are well correlated to biological responses in vaccinated rats. Our findings and methods using experimental biology and genome science provide an important means of assessment for vaccine toxicity.

The effect of network biology on drug toxicology

DEFF Research Database (Denmark)

Gautier, Laurent; Taboureau, Olivier; Audouze, Karine Marie Laure

2013-01-01

Introduction: The high failure rate of drug candidates due to toxicity, during clinical trials, is a critical issue in drug discovery. Network biology has become a promising approach, in this regard, using the increasingly large amount of biological and chemical data available and combining...... it with bioinformatics. With this approach, the assessment of chemical safety can be done across multiple scales of complexity from molecular to cellular and system levels in human health. Network biology can be used at several levels of complexity. Areas covered: This review describes the strengths and limitations...... of network biology. The authors specifically assess this approach across different biological scales when it is applied to toxicity. Expert opinion: There has been much progress made with the amount of data that is generated by various omics technologies. With this large amount of useful data, network...

Applicaiton and characteristics of food irradiation on food safety

International Nuclear Information System (INIS)

Ha Yiming

2010-01-01

Irradiation is one of non-thermal processing technology. Physical, chemical and biology effects were induced by the interaction of ionization irradiation and materials and acting on materials or food, then, food molecular was modified by rays and the harmful substances in it degraded. Irradiation is an effective method to improve food safety and extend the shelf life of food. In the article, the status of food safety at home and abroad in recently years was summarized, and the characteristic and application areas of irradiation technology in food safety were synthetically analyzed. (author)

Central Safety Department. Annual report 1986

International Nuclear Information System (INIS)

Kiefer, H.; Koenig, L.A.

1987-03-01

The Safety Officer and the Security Officer are responsible for radiation protection and technical safety, both conventional and nuclear, for the physical protection as well as the safeguards of nuclear materials and radioactive substances within the Kernforschungszentrum Karlsruhe GmbH (KfK). To fulfill these functions they rely on the assistance of the Central Safety Department. The Central Safety Department is responsible for handling all problems of radiation protection, safety and security of the institutes and departments of the Karlsruhe Nuclear Research Center, for waste water activity measurements and environmental monitoring of the whole area of the Center, and for research and development work mainly focusing on nuclear safety and radiation protection measures. The r+d work concentrates on the following aspects: physical and chemical behavior of biologically particularly active radionuclides, behavior of HT in the air/plant/soil system, biophysics of multicellular systems, improvement in radiation protection measurement and personnel dosimetry. The report gives details of the different duties, indicates the results of 1986 routine tasks and reports about results of investigations and developments of the working groups of the Department. (orig.) [de

Safety and environmental aspect uranium mining and extraction in Kalan, Kalimantan

International Nuclear Information System (INIS)

Mudiar Masdja; Tampubolon, P.; Sihombing, W.

1996-01-01

Safety in uranium mining and extraction in Kalan, Kalimantan, Batan's activities, has been observed by concerning about personnel safety, monitoring of the work place and radiation surveillance. the personnel safety includes procurements of personnel protective equipment, work clothes, and washing facility. monitoring of the work place covers climate (temperature, humidity) noise frequency, poisonous gases, and tailing management. Radiation surveillance measures Rn gas and radioactive dust . Environmental assessment of Kalan site consist of physical, biological and cultural environments. The physical assessment mayor area such as water and air qualities, morphology and climatology. the biological assessment examines flora, fauna and aquatic biota. The culture assessment collect data of human population and distribution, occupation and income level, education, health and public perception. Guidelines for environmental management and monitoring have been documented and they have in Kalan site. (author). 8 refs; 3 tabs; 3 figs

A Holistic Approach to Protection and Safety

International Nuclear Information System (INIS)

Yankovich, L.T.

2017-01-01

Natural Ecosystems Undergo Inherent Fluctuations and Changes that are Related to Physical, Geological, Biological and other Natural Processes Associated with the Cycles of Life and the Earth. In other words, the effects of human activities must be evaluated in the context of the 'baseline' processes that are inherent to and imposed on natural ecosystems. The IAEA has established ahierarchy of Safety Standards, consisting of a set of ''Safety Fundamentals'' at the highest level, followed by ''Requirements'', then recommendations or ''guidance''. Human activities involving the use of radiation and radioactive substances can cause radiation exposure to people and the environment. This exposure should be regulated and monitored in accordance with international safety standards and national legislation

Health effects of radiation and the implications for radiation safety

International Nuclear Information System (INIS)

Gonzalez, A.J.; Anderer, J.

1991-01-01

In this Paper two elements of a multiphase analysis of radiation exposures in the living environment - the human health effects of ionizing radiation and the implications for radiation safety policy and practices - are presented. Part 1 draws together the current state of scientific knowledge and insight about the human health effects of radiation, describing these in terms of known cause-related deterministic effects and of the estimated incidence of stochastic effects as defined by biostatistics and biological models. The 1988 UNSCEAR report provides an authoritative basis for such an examination. Part 2 explores some of the major implications that the state-of-the-art of radiation biology has - or should have - for radiation safety policy and practices. (author)

Gold nanoparticles prepared by laser ablation in aqueous biocompatible solutions: assessment of safety and biological identity for nanomedicine applications

Directory of Open Access Journals (Sweden)

Correard F

2014-11-01

Full Text Available Florian Correard,1,2 Ksenia Maximova,3 Marie-Anne Estève,1,2 Claude Villard,1 Myriam Roy,4 Ahmed Al-Kattan,3 Marc Sentis,3 Marc Gingras,4 Andrei V Kabashin,3 Diane Braguer1,2 1Aix Marseille Université, INSERM, CR02 UMR_S911, Marseille, France; 2APHM, Hôpital Timone, Marseille, France; 3Aix Marseille Université, CNRS, LP3 UMR 7341, Marseille, France; 4Aix Marseille Université, CNRS, CINAM, UMR 7325 Marseille, France Abstract: Due to excellent biocompatibility, chemical stability, and promising optical properties, gold nanoparticles (Au-NPs are the focus of research and applications in nanomedicine. Au-NPs prepared by laser ablation in aqueous biocompatible solutions present an essentially novel object that is unique in avoiding any residual toxic contaminant. This paper is conceived as the next step in development of laser-ablated Au-NPs for future in vivo applications. The aim of the study was to assess the safety, uptake, and biological behavior of laser-synthesized Au-NPs prepared in water or polymer solutions in human cell lines. Our results showed that laser ablation allows the obtaining of stable and monodisperse Au-NPs in water, polyethylene glycol, and dextran solutions. The three types of Au-NPs were internalized in human cell lines, as shown by transmission electron microscopy. Biocompatibility and safety of Au-NPs were demonstrated by analyzing cell survival and cell morphology. Furthermore, incubation of the three Au-NPs in serum-containing culture medium modified their physicochemical characteristics, such as the size and the charge. The composition of the protein corona adsorbed on Au-NPs was investigated by mass spectrometry. Regarding composition of complement C3 proteins and apolipoproteins, Au-NPs prepared in dextran solution appeared as a promising drug carrier. Altogether, our results revealed the safety of laser-ablated Au-NPs in human cell lines and support their use for theranostic applications. Keywords: protein

Central Safety Department, annual report 1987

International Nuclear Information System (INIS)

Kiefer, H.; Koenig, L.A.

1988-02-01

The Central Safety Department is responsible for handling all problems of radiation protection, safety and security of the institutes and departments of the Karlsruhe Nuclear Research Center, for waste water activity measurements and environmental monitoring of the whole area of the Center, and for research and development work mainly focusing on nuclear safety and radiation protection measures. The r+d work concentrates on the following aspects: physical and chemical behaviour of biologically particularly active radionuclides, behaviour of HT in the air/plan/soil system, biophysics of multicellular systems, improvement in radiation protection measurement and personnel dosimetry. This report gives details of the different duties, indicates the results of 1987 routine tasks and reports about results of investigations and developments of the working groups of the Department. (orig./HP) [de

Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.

Science.gov (United States)

Ishii-Watabe, Akiko; Hirose, Akihiko; Katori, Noriko; Hashii, Norikata; Arai, Susumu; Awatsu, Hirotoshi; Eiza, Akira; Hara, Yoshiaki; Hattori, Hideshi; Inoue, Tomomi; Isono, Tetsuya; Iwakura, Masahiro; Kajihara, Daisuke; Kasahara, Nobuo; Matsuda, Hiroyuki; Murakami, Sei; Nakagawa, Taishiro; Okumura, Takehiro; Omasa, Takeshi; Takuma, Shinya; Terashima, Iyo; Tsukahara, Masayoshi; Tsutsui, Maiko; Yano, Takahiro; Kawasaki, Nana

2015-10-01

Biologics manufacturing technology has made great progress in the last decade. One of the most promising new technologies is the single-use system, which has improved the efficiency of biologics manufacturing processes. To ensure safety of biologics when employing such single-use systems in the manufacturing process, various issues need to be considered including possible extractables/leachables and particles arising from the components used in single-use systems. Japanese pharmaceutical manufacturers, together with single-use suppliers, members of the academia and regulatory authorities have discussed the risks of using single-use systems and established control strategies for the quality assurance of biologics. In this study, we describe approaches for quality risk management when employing single-use systems in the manufacturing of biologics. We consider the potential impact of impurities related to single-use components on drug safety and the potential impact of the single-use system on other critical quality attributes as well as the stable supply of biologics. We also suggest a risk-mitigating strategy combining multiple control methods which includes the selection of appropriate single-use components, their inspections upon receipt and before releasing for use and qualification of single-use systems. Communication between suppliers of single-use systems and the users, as well as change controls in the facilities both of suppliers and users, are also important in risk-mitigating strategies. Implementing these control strategies can mitigate the risks attributed to the use of single-use systems. This study will be useful in promoting the development of biologics as well as in ensuring their safety, quality and stable supply.

Aerospace Medicine and Biology: A Continuing Bibliography With Indexes. Supplement 497

Science.gov (United States)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP#2000-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention.

Food Safety and Nutrition Information for Kids and Teens

Science.gov (United States)

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Food Home Food Resources for You Consumers Kids & Teens ... More sharing options Linkedin Pin it Email Print Food Safety & Nutrition Information for Kids and Teens Fun & ...

Regulatory Anatomy: How "Safety Logics" Structure European Transplant Medicine.

Science.gov (United States)

Hoeyer, Klaus

2015-07-01

This article proposes the term "safety logics" to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of "safety" produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape.

Severe and acute complications of biologics in psoriasis.

Science.gov (United States)

Oussedik, Elias; Patel, Nupur U; Cash, Devin R; Gupta, Angela S; Feldman, Steven R

2017-12-01

Biologic therapies have revolutionized the approach to immune-mediated diseases such as psoriasis. Due to their favorable safety profiles and excellent efficacy, biologic agents are considered the gold standard for moderate-to-severe psoriasis. The aim of this paper is to saliently review the severe and acute complications of the Food and Drug Administration (FDA) approved biologic agents for psoriasis. Reviewed agents include tumor necrosis factor alpha inhibitors (etanercept, infliximab, and adalimumab), interleukin 12/23 inhibitors (ustekinumab), and interleukin 17 (IL-17) inhibitors (secukinumab and ixekizumab). While malignancies, serious infections, and major adverse cardiovascular events have been reported, their association with biologic therapy are not hypothesized as causal. However, IL-17 inhibitors appear to cause exacerbations and new cases of inflammatory bowel disease. While more long-term studies are warranted in understanding the biologic's long-term side effect profile, short-term studies have confirmed that the biologics are some of the safest treatment options for psoriasis. Nevertheless, certain populations yield higher risk to acute complications with the biologics than others - physicians must use their judgement and vigilance when monitoring and treating patients undergoing therapy with biological agents.

Comparative biological hazards of chemical pollutants and radiation

International Nuclear Information System (INIS)

Mukherjee, R.N.

1978-01-01

Chemical pollutants from conventional energy and industrial sources released to the environment presumably pose a hazard to man's health and environmental resources. Insufficient knowledge of their detailed mechanisms of interaction with the biological systems seems to provide the greatest drawback in current attempts for realistic assessment of the health risks of chemical pollutants in the short and long terms. Nevertheless, their detrimental health consequences are becoming more and more apparent as a result of recent epidemiological surveys of workers in conventional energy installations and of the chronically exposed general public. So far nuclear power has succeeded in achieving a remarkable health safety record. In view of its projected expansion, research on biological effects of low-level radiation and radionuclides should continue to re-evaluate the health safety consequences. However, a projection from past experiences together with continued efforts to improvements of health safety aspects seem to justify an expectation that the proposed expansions in the nuclear power programme should not have an unfavourable impact on the environment. The potential hazards and challenges from the associated radiation in man's environment have proved manageable. More attention now needs to be paid urgently to safeguard human health and environment against the chemical pollutants

Comparative biological hazards of chemical pollutants and radiation

Energy Technology Data Exchange (ETDEWEB)

Mukherjee, R N [International Atomic Energy Agency, Vienna (Austria). Div. of Life Sciences

1978-06-01

Chemical pollutants from conventional energy and industrial sources released to the environment presumably pose a hazard to man's health and environmental resources. Insufficient knowledge of their detailed mechanisms of interaction with the biological systems seems to provide the greatest drawback in current attempts for realistic assessment of the health risks of chemical pollutants in the short and long terms. Nevertheless, their detrimental health consequences are becoming more and more apparent as a result of recent epidemiological surveys of workers in conventional energy installations and of the chronically exposed general public. So far nuclear power has succeeded in achieving a remarkable health safety record. In view of its projected expansion, research on biological effects of low-level radiation and radionuclides should continue to re-evaluate the health safety consequences. However, a projection from past experiences together with continued efforts to improvements of health safety aspects seem to justify an expectation that the proposed expansions in the nuclear power programme should not have an unfavourable impact on the environment. The potential hazards and challenges from the associated radiation in man's environment have proved manageable. More attention now needs to be paid urgently to safeguard human health and environment against the chemical pollutants.

Validation of cross-contamination control in biological safety cabinet for biotech/pharmaceutical manufacturing process.

Science.gov (United States)

Hu, Shih-Cheng; Shiue, Angus; Tu, Jin-Xin; Liu, Han-Yang; Chiu, Rong-Ben

2015-12-01

For class II, type A2 biological safety cabinets (BSC), NSF/ANSI Standard 49 should be conformed in cabinet airflow velocity derivation, particle contamination, and aerodynamic flow properties. However, there exists a potential problem. It has been built that the cabinet air flow stabilize is influenced by the quantity of downflow of air and the height above the cabinet exhaust opening. Three air downflow quantities were compared as an operating apparatus was placed from 20 to 40 cm above the bench of the cabinet. The results show that the BSC air downflow velocity is a function of increased sampling height, displaying that containment is improvingly permitted over product protection as the sampling height decreases. This study investigated the concentration gradient of particles at various heights and downflow air quantity from the bench of the BSC. Experiment results indicate that performance near the bench was better than in the rest of the BSC. In terms of height, the best cleanliness was measured at a height of 10 cm over the bench; it reduced actually with add in height. The empirical curves accommodate, founded on the concentration gradient of particle created was elaborated for evaluating the particle concentration at different heights and downflow air quantity from the source of the bench of the BSC. The particle image velocimetry system applied for BSC airflow research to fix amount of airflow patterns and air distribution measurement and results of measurements show how obstructions can greatly influence the airflow and contaminant transportation in a BSC.

Biological substantiation of antipsychotic-associated pneumonia: Systematic literature review and computational analyses.

Science.gov (United States)

Sultana, Janet; Calabró, Marco; Garcia-Serna, Ricard; Ferrajolo, Carmen; Crisafulli, Concetta; Mestres, Jordi; Trifirò', Gianluca

2017-01-01

Antipsychotic (AP) safety has been widely investigated. However, mechanisms underlying AP-associated pneumonia are not well-defined. The aim of this study was to investigate the known mechanisms of AP-associated pneumonia through a systematic literature review, confirm these mechanisms using an independent data source on drug targets and attempt to identify novel AP drug targets potentially linked to pneumonia. A search was conducted in Medline and Web of Science to identify studies exploring the association between pneumonia and antipsychotic use, from which information on hypothesized mechanism of action was extracted. All studies had to be in English and had to concern AP use as an intervention in persons of any age and for any indication, provided that the outcome was pneumonia. Information on the study design, population, exposure, outcome, risk estimate and mechanism of action was tabulated. Public repositories of pharmacology and drug safety data were used to identify the receptor binding profile and AP safety events. Cytoscape was then used to map biological pathways that could link AP targets and off-targets to pneumonia. The literature search yielded 200 articles; 41 were included in the review. Thirty studies reported a hypothesized mechanism of action, most commonly activation/inhibition of cholinergic, histaminergic and dopaminergic receptors. In vitro pharmacology data confirmed receptor affinities identified in the literature review. Two targets, thromboxane A2 receptor (TBXA2R) and platelet activating factor receptor (PTAFR) were found to be novel AP target receptors potentially associated with pneumonia. Biological pathways constructed using Cytoscape identified plausible biological links potentially leading to pneumonia downstream of TBXA2R and PTAFR. Innovative approaches for biological substantiation of drug-adverse event associations may strengthen evidence on drug safety profiles and help to tailor pharmacological therapies to patient risk

[Safety in the Microbiology laboratory].

Science.gov (United States)

Rojo-Molinero, Estrella; Alados, Juan Carlos; de la Pedrosa, Elia Gómez G; Leiva, José; Pérez, José L

2015-01-01

The normal activity in the laboratory of microbiology poses different risks - mainly biological - that can affect the health of their workers, visitors and the community. Routine health examinations (surveillance and prevention), individual awareness of self-protection, hazard identification and risk assessment of laboratory procedures, the adoption of appropriate containment measures, and the use of conscientious microbiological techniques allow laboratory to be a safe place, as records of laboratory-acquired infections and accidents show. Training and information are the cornerstones for designing a comprehensive safety plan for the laboratory. In this article, the basic concepts and the theoretical background on laboratory safety are reviewed, including the main legal regulations. Moreover, practical guidelines are presented for each laboratory to design its own safety plan according its own particular characteristics. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Illuminating Cell Biology

Science.gov (United States)

2002-01-01

NASA's Ames Research Center awarded Ciencia, Inc., a Small Business Innovation Research contract to develop the Cell Fluorescence Analysis System (CFAS) to address the size, mass, and power constraints of using fluorescence spectroscopy in the International Space Station's Life Science Research Facility. The system will play an important role in studying biological specimen's long-term adaptation to microgravity. Commercial applications for the technology include diverse markets such as food safety, in situ environmental monitoring, online process analysis, genomics and DNA chips, and non-invasive diagnostics. Ciencia has already sold the system to the private sector for biosensor applications.

Evaluation of the effectiveness and safety of the thermo-treatment process to dispose of recombinant DNA waste from biological research laboratories.

Science.gov (United States)

Li, Meng-Nan; Zheng, Guang-Hong; Wang, Lei; Xiao, Wei; Fu, Xiao-Hua; Le, Yi-Quan; Ren, Da-Ming

2009-01-01

The discharge of recombinant DNA waste from biological laboratories into the eco-system may be one of the pathways resulting in horizontal gene transfer or "gene pollution". Heating at 100 degrees C for 5-10 min is a common method for treating recombinant DNA waste in biological research laboratories in China. In this study, we evaluated the effectiveness and the safety of the thermo-treatment method in the disposal of recombinant DNA waste. Quantitative PCR, plasmid transformation and electrophoresis technology were used to evaluate the decay/denaturation efficiency during the thermo-treatment process of recombinant plasmid, pET-28b. Results showed that prolonging thermo-treatment time could improve decay efficiency of the plasmid, and its decay half-life was 2.7-4.0 min during the thermo-treatment at 100 degrees C. However, after 30 min of thermo-treatment some transforming activity remained. Higher ionic strength could protect recombinant plasmid from decay during the treatment process. These results indicate that thermo-treatment at 100 degrees C cannot decay and inactivate pET-28b completely. In addition, preliminary results showed that thermo-treated recombinant plasmids were not degraded completely in a short period when they were discharged into an aquatic environment. This implies that when thermo-treated recombinant DNAs are discharged into the eco-system, they may have enough time to re-nature and transform, thus resulting in gene diffusion.

Evaluation of the effectiveness and safety of the thermo-treatment process to dispose of recombinant DNA waste from biological research laboratories

International Nuclear Information System (INIS)

Li Mengnan; Zheng Guanghong; Wang Lei; Xiao Wei; Fu Xiaohua; Le Yiquan; Ren Daming

2009-01-01

The discharge of recombinant DNA waste from biological laboratories into the eco-system may be one of the pathways resulting in horizontal gene transfer or 'gene pollution'. Heating at 100 deg. C for 5-10 min is a common method for treating recombinant DNA waste in biological research laboratories in China. In this study, we evaluated the effectiveness and the safety of the thermo-treatment method in the disposal of recombinant DNA waste. Quantitative PCR, plasmid transformation and electrophoresis technology were used to evaluate the decay/denaturation efficiency during the thermo-treatment process of recombinant plasmid, pET-28b. Results showed that prolonging thermo-treatment time could improve decay efficiency of the plasmid, and its decay half-life was 2.7-4.0 min during the thermo-treatment at 100 deg. C. However, after 30 min of thermo-treatment some transforming activity remained. Higher ionic strength could protect recombinant plasmid from decay during the treatment process. These results indicate that thermo-treatment at 100 deg. C cannot decay and inactivate pET-28b completely. In addition, preliminary results showed that thermo-treated recombinant plasmids were not degraded completely in a short period when they were discharged into an aquatic environment. This implies that when thermo-treated recombinant DNAs are discharged into the eco-system, they may have enough time to re-nature and transform, thus resulting in gene diffusion

[Evaluation of the safety of innovative drugs against viruses and infectious agents].

Science.gov (United States)

Kobayashi, Tetsu; Yusa, Keisuke; Kawasaki, Nana

2013-01-01

Recently, several novel cellular therapy products and biological drugs are being developed to treat various previously untreatable diseases. One of the most important issues regarding these innovations is how to ensure safety over infectious agents, including viruses and prions, in the earliest treatments with these products. The object of this study is a risk assessment of cases of human infectious with the agents and to present a sample risk management plan based on a collaboration among the National Institute of Health Sciences, universities, marketing authorization holders, and scientific societies. There are three subjects of study: (1) the viral safety of cellular therapy products, (2) the viral safety of biological drugs, and (3) the safety of prions. In this report, we describe the objects of the study, the project members, the study plan outline, and the ongoing plans. The results of the viral risk identification and the risk analysis of cellular therapy products will also be described, based on a review of the literature and case reports obtained during the first year of this project.

Biological effects of exposure to low frequency electric and magnetic fields

International Nuclear Information System (INIS)

Ahnstroem, G.

1992-10-01

The biological effects of exposure to low frequency electric and magnetic fields are reviewed with the objective of summarizing effects directly relevant to considerations of the health and safety of exposed people

Safe-by-Design : from Safety to Responsibility

NARCIS (Netherlands)

van de Poel, I.R.; Robaey, Z.H.

2017-01-01

Safe-by-design (SbD) aims at addressing safety issues already during the R&D and design phases of new technologies. SbD has increasingly become popular in the last few years for addressing the risks of emerging technologies like nanotechnology and synthetic biology. We ask to what extent SbD

[Food safety of GMOs].

Science.gov (United States)

Joudrier, P

2009-01-01

In this presentation, we review the complexity of the different biological events which occur during life cell cycles. Indeed transgenesis is not an unknown event for cells. In the second part of this article, the complex and complete evaluation process destined to assure the food safety of GMOs, before they are released on the market, is describd. Some ansers to questions frequently asked about the GMOs are given. It is concludedthat GMOs are probably more safe than their conventional non-GM counterpart.

DNA microarray technology in nutraceutical and food safety.

Science.gov (United States)

Liu-Stratton, Yiwen; Roy, Sashwati; Sen, Chandan K

2004-04-15

The quality and quantity of diet is a key determinant of health and disease. Molecular diagnostics may play a key role in food safety related to genetically modified foods, food-borne pathogens and novel nutraceuticals. Functional outcomes in biology are determined, for the most part, by net balance between sets of genes related to the specific outcome in question. The DNA microarray technology offers a new dimension of strength in molecular diagnostics by permitting the simultaneous analysis of large sets of genes. Automation of assay and novel bioinformatics tools make DNA microarrays a robust technology for diagnostics. Since its development a few years ago, this technology has been used for the applications of toxicogenomics, pharmacogenomics, cell biology, and clinical investigations addressing the prevention and intervention of diseases. Optimization of this technology to specifically address food safety is a vast resource that remains to be mined. Efforts to develop diagnostic custom arrays and simplified bioinformatics tools for field use are warranted.

Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs.

Science.gov (United States)

Charles-Schoeman, Christina; Burmester, Gerd; Nash, Peter; Zerbini, Cristiano A F; Soma, Koshika; Kwok, Kenneth; Hendrikx, Thijs; Bananis, Eustratios; Fleischmann, Roy

2016-07-01

Biological disease-modifying antirheumatic drugs (bDMARDs) have shown diminished clinical response following an inadequate response (IR) to ≥1 previous bDMARD. Here, tofacitinib was compared with placebo in patients with an IR to conventional synthetic DMARDs (csDMARDs; bDMARD-naive) and in patients with an IR to bDMARDs (bDMARD-IR). Data were taken from phase II and phase III studies of tofacitinib in patients with rheumatoid arthritis (RA). Patients received tofacitinib 5 or 10 mg twice daily, or placebo, as monotherapy or with background methotrexate or other csDMARDs. Efficacy endpoints and incidence rates of adverse events (AEs) of special interest were assessed. 2812 bDMARD-naive and 705 bDMARD-IR patients were analysed. Baseline demographics and disease characteristics were generally similar between treatment groups within subpopulations. Across subpopulations, improvements in efficacy parameters at month 3 were generally significantly greater for both tofacitinib doses versus placebo. Clinical response was numerically greater with bDMARD-naive versus bDMARD-IR patients (overlapping 95% CIs). Rates of safety events of special interest were generally similar between tofacitinib doses and subpopulations; however, patients receiving glucocorticoids had more serious AEs, discontinuations due to AEs, serious infection events and herpes zoster. Numerically greater clinical responses and incidence rates of AEs of special interest were generally reported for tofacitinib 10 mg twice daily versus tofacitinib 5 mg twice daily (overlapping 95% CIs). Tofacitinib demonstrated efficacy in both bDMARD-naive and bDMARD-IR patients with RA. Clinical response to tofacitinib was generally numerically greater in bDMARD-naive than bDMARD-IR patients. The safety profile appeared similar between subpopulations. (NCT00413660, NCT00550446, NCT00603512, NCT00687193, NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385). Published by the BMJ Publishing Group Limited

Application of Proteomics in Food Technology and Food Biotechnology: Process Development, Quality Control and Product Safety

Directory of Open Access Journals (Sweden)

Dajana Gašo-Sokač

2010-01-01

Full Text Available Human food is a very complex biological mixture and food processing and safety are very important and essential disciplines. Proteomics technology using different high-performance separation techniques such as two-dimensional gel electrophoresis, one-dimensional and multidimensional chromatography, combined with high-resolution mass spectrometry has the power to monitor the protein composition of foods and their changes during the production process. The use of proteomics in food technology is presented, especially for characterization and standardization of raw materials, process development, detection of batch-to-batch variations and quality control of the final product. Further attention is paid to the aspects of food safety, especially regarding biological and microbial safety and the use of genetically modified foods.

Food safety hazards in Georgian Tushuri Guda cheese

Directory of Open Access Journals (Sweden)

Avtandil Korakhashvili

2016-09-01

Full Text Available Scientific-research work provides a timely and valuable review of the progress being made in the greater understanding of the factors contributing to Tushuri Guda cheese making and how this experience may be applied to producing better and more consistent products with food safety HACCP system requirements. The HACCP study in this variety of cheese covers all types of food safety hazards, like biological, chemical and physical, but unfortunately it needs a more precise definition. It did not include clarification of cleaning and sanitation operations in accordance with modern standards, sanitation of grasslands and meadows. All of that are covered by the plant Good Manufacturing Practices (GMPs procedures and Good Hygiene Practices (GHPs for the obtaining of maximal food safety results.

Yearly plan of safety research on environmental radioactivity for 1996 - 2000

International Nuclear Information System (INIS)

1996-01-01

'Yearly Plan of Safety Research on Environmental Radioactivity' proposed from the special meeting for safety research of environmental radioactivity on December 14, 1995 was investigated by Nuclear Safety Commission. And the safety research of environmental radioactivity in Japan was decided to be pursued according to the plan. The contents of this plan consisted of the purpose and the contents of research as well as the research period and the facilities to be done for each theme. The following themes were included; 1) study on environment·radiation dose and study on radiation exposure reduction. 2) study on biological effects of radiation. 3) study on internal exposure by specified nuclides. 4) study on medical measures for acute radiation exposure. 5) study on assessment of nuclear safety. 6) investigation on radioactivities released from various nuclear facilities in Japan to demonstrate their safety. (M.N.)

Occupational safety and health textbook for radiological personnel employed in structural material testing

International Nuclear Information System (INIS)

Abraham, J.

1981-01-01

The comprehensive textbook for X-ray and radiological testing personnel includes requirements and rules of occupational safety and health on the basis of Hungarian and international (mainly German) literature. In the chapter Fundamentals, X-ray and radioactive radiations, their measurements and biological effects, doses etc are described. In the chapter Occupational safety and health, the jobs representing radiation hazards are listed and safety regulations for them are reported. Finally, information for prevention and first aid is presented. Control questions are added to each part. The Appendix contains safety standards and regulations, information on legal aspects of safety and radiation protection as well as recommendations. (Sz.J.)

Effectiveness and safety of tofacitinib in rheumatoid arthritis: a cohort study.

Science.gov (United States)

Machado, Marina Amaral de Ávila; Moura, Cristiano Soares de; Guerra, Steve Ferreira; Curtis, Jeffrey R; Abrahamowicz, Michal; Bernatsky, Sasha

2018-03-23

Tofacitinib is the first oral Janus kinase inhibitor approved for the treatment of rheumatoid arthritis (RA). We compared the effectiveness and safety of tofacitinib, disease-modifying antirheumatic drugs (DMARDs), tumor necrosis factor inhibitors (TNFi), and non-TNF biologics in patients with RA previously treated with methotrexate. We used MarketScan® databases (2011-2014) to study methotrexate-exposed patients with RA who were newly prescribed tofacitinib, DMARDs other than methotrexate, and biologics. The date of first prescription was defined as the cohort entry. The therapy was considered effective if all of the following criteria from a claims-based algorithm were achieved at the first year of follow-up: high adherence, no biologic or tofacitinib switch or addition, no DMARD switch or addition, no increase in dose or frequency of index drug, no more than one glucocorticoid joint injection, and no new/increased oral glucocorticoid dose. The safety outcome was serious infections requiring hospitalization. Non-TNF biologics comprised the reference group. We included 21,832 patients with RA, including 0.8% treated with tofacitinib, 24.7% treated with other DMARDs, 61.2% who had started therapy with TNFi, and 13.3% treated with non-TNF biologics. The rates of therapy effectiveness were 15.4% for tofacitinib, 11.1% for DMARDs, 18.6% for TNFi, and 19.8% for non-TNF biologics. In adjusted analyses, tofacitinib and non-TNF biologics appeared to have similar effectiveness rates, whereas DMARD initiators were less effective than non-TNF biologics. We could not clearly establish if tofacitinib was associated with a higher rate of serious infections. In patients with RA previously treated with methotrexate, our comparisons of tofacitinib with non-TNF biologics, though not definitive, did not demonstrate differences with respect to hospitalized infections or effectiveness.

Biologicals versus biosimilars the future ahead

Directory of Open Access Journals (Sweden)

A Singhal

2015-01-01

Full Text Available Biosimilars are highly similar versions of already authorized innovator biological therapies. They demonstrate no clinically meaningful difference with their innovator products in terms of efficacy, safety and quality characteristics and biological activity. Biosimilars have demonstrated growing acceptance and use, especially in the developing countries due to severe cost constraints. Global market for Indian non-innovator products is approximately worth USD 1.5 Billion/annum with an annual growth rate of 27%. Estimated exports of Indian biopharmaceutical products have been increasing at a rate of 47%. In India, there is a good acceptance of non-innovator healthcare products amongst healthcare professionals and patients. Several home grown biopharmaceutical industries are now actively developing and marketing non innovator products in India.

Institutional Oversight of Occupational Health and Safety for Research Programs Involving Biohazards.

Science.gov (United States)

Dyson, Melissa C; Carpenter, Calvin B; Colby, Lesley A

2017-06-01

Research with hazardous biologic materials (biohazards) is essential to the progress of medicine and science. The field of microbiology has rapidly advanced over the years, partially due to the development of new scientific methods such as recombinant DNA technology, synthetic biology, viral vectors, and the use of genetically modified animals. This research poses a potential risk to personnel as well as the public and the environment. Institutions must have appropriate oversight and take appropriate steps to mitigate the risks of working with these biologic hazards. This article will review responsibilities for institutional oversight of occupational health and safety for research involving biologic hazards.

Switching of biologics in psoriasis: Reasons and results.

Science.gov (United States)

Honda, Hiromi; Umezawa, Yoshinori; Kikuchi, Sota; Yanaba, Koichi; Fukuchi, Osamu; Ito, Toshihiro; Nobeyama, Yoshimasa; Asahina, Akihiko; Nakagawa, Hidemi

2017-09-01

Efficacy and safety profiles of biologics have been established for moderate to severe psoriasis. However, inefficacy or adverse events sometimes require changing the treatment to other biologics. Here, we examine the effectiveness of this strategy. We retrospectively investigated cases requiring switching biologics. We enrolled 275 psoriatic patients treated with biologics between January 2010 and December 2014 in our hospital. Of these, 51 required a switch to another biologic. First-line therapies were infliximab (IFX, n = 26), adalimumab (ADA, n = 18) and ustekinumab (UST, n = 7), and second-line therapies were IFX (n = 5), ADA (n = 21) and UST (n = 25). Reasons for switching were inefficacy (n = 38), adverse events (n = 11) and others (n = 2). The details were primary failure (n = 15), secondary failure (n = 23) and infusion reactions (n = 8). In 49 patients who switched biologics due to inefficacy and adverse events, the mean Psoriasis Area and Severity Index (PASI) score at week 16 was 4.3 for first-line therapies and 2.9 for second-line therapies (P < 0.05). Switching to a second biologic therapy to address the first's inefficacy or adverse events often results in significant improvement in moderate to severe psoriasis. © 2017 Japanese Dermatological Association.

Radiological and nuclear safety- evolution, standards and similarity

International Nuclear Information System (INIS)

Soman, S.D.

1996-01-01

With the realisation of potential for severe health affects after the discovery of x-rays and radioactivity, the radiation protection aspect became focus of interest for medical users from the beginning of this century. With the activities of International Commission on Radiological Protection (ICRP), the standards evolved during all these years based on epidemiological data and radio-biological research. The current standards are the ICRP recommendations of 1990. Based on these, internationally harmonised standards for protection against ionising radiation and safety of radioactive sources were brought out by IAEA in 1994. The nuclear safety (implies safety of nuclear power plants) came into prominence when large scale units were designed and operated since mid 1950s. The philosophy in nuclear safety has evolved in past 2-3 decades taking into account the lessons learned from accidents, mainly Three Mile Island (1979) and Chernobyl-4 (1986). These current nuclear safety standards are incorporated in INSAG reports, particularly INSAG-3. This paper brings out salient features of these evolutions, current standards and similarity of radiation and nuclear safety standards in their present form. (author). 7 refs., 10 tabs

Supporting read-across using biological data.

Science.gov (United States)

Zhu, Hao; Bouhifd, Mounir; Donley, Elizabeth; Egnash, Laura; Kleinstreuer, Nicole; Kroese, E Dinant; Liu, Zhichao; Luechtefeld, Thomas; Palmer, Jessica; Pamies, David; Shen, Jie; Strauss, Volker; Wu, Shengde; Hartung, Thomas

2016-01-01

Read-across, i.e. filling toxicological data gaps by relating to similar chemicals, for which test data are available, is usually done based on chemical similarity. Besides structure and physico-chemical properties, however, biological similarity based on biological data adds extra strength to this process. In the context of developing Good Read-Across Practice guidance, a number of case studies were evaluated to demonstrate the use of biological data to enrich read-across. In the simplest case, chemically similar substances also show similar test results in relevant in vitro assays. This is a well-established method for the read-across of e.g. genotoxicity assays. Larger datasets of biological and toxicological properties of hundreds and thousands of substances become increasingly available enabling big data approaches in read-across studies. Several case studies using various big data sources are described in this paper. An example is given for the US EPA's ToxCast dataset allowing read-across for high quality uterotrophic assays for estrogenic endocrine disruption. Similarly, an example for REACH registration data enhancing read-across for acute toxicity studies is given. A different approach is taken using omics data to establish biological similarity: Examples are given for stem cell models in vitro and short-term repeated dose studies in rats in vivo to support read-across and category formation. These preliminary biological data-driven read-across studies highlight the road to the new generation of read-across approaches that can be applied in chemical safety assessment.

Annual report 1988 of the Central Safety Department

International Nuclear Information System (INIS)

Koelzer, W.; Urban, M.

1989-04-01

The Central Safety Department is responsible for handling all problems of radiation protection, safety and security of the institutes and departments of the Karlsruhe Nuclear Research Center, for waste water activity measurements and environmental monitoring of the whole area of the Center, and for research and development work mainly focusing on nuclear safety and radiation protection measures. The r+d work concentrates on the following aspects: physical and chemical behavior of biologically particularly active radionuclides, behavior of tritium in the air/plant/soil system, biophysics of multicellular systems, improvement in radiation protection measurement and personnel dosimetry. This report gives details of the different duties, indicates the results of 1988 routine tasks and reports about results of investigations and developments of the working groups of the Department. The reader is referred to the English translation of the Table of Contents and of Chapter 1 describing the duties and organization of the Central Safety Department. (orig./HP) [de

Safety of pressurized water reactors: problems and corresponding studies

International Nuclear Information System (INIS)

Cogne, F.

1976-01-01

The author recalls the safety problems subject to researches in the CEA, either because of their importance or because studies made abroad were not sufficiently developed or were classified or in order to acquire an independent judgement when safety is concerned. Those problems and studies are submitted referring to the 3 existing shields between man and dangerous materials: fuel element can, thermal shield, (pressure vessel and pipes), biological shield of which the behaviour is studied in connection with outside aggressions such as earthquakes, plane crashes, chemical explosions.. [fr

Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals.

Science.gov (United States)

Zmurko, Joanna; Vasey, Douglas B; Donald, Claire L; Armstrong, Alison A; McKee, Marian L; Kohl, Alain; Clayton, Reginald F

2018-02-01

Ensuring the virological safety of biologicals is challenging due to the risk of viral contamination of raw materials and cell banks, and exposure during in-process handling to known and/or emerging viral pathogens. Viruses may contaminate raw materials and biologicals intended for human or veterinary use and remain undetected until appropriate testing measures are employed. The outbreak and expansive spread of the mosquito-borne flavivirus Zika virus (ZIKV) poses challenges to screening human- and animal -derived products used in the manufacture of biologicals. Here, we report the results of an in vitro study where detector cell lines were challenged with African and Asian lineages of ZIKV. We demonstrate that this pathogen is robustly detectable by in vitro assay, thereby providing assurance of detection of ZIKV, and in turn underpinning the robustness of in vitro virology assays in safety testing of biologicals.

Regulatory measures of BARC Safety Council to control radiation exposure in BARC Facilities

International Nuclear Information System (INIS)

Rajdeep; Jolly, V.M.; Jayarajan, K.

2018-01-01

Bhabha Atomic Research Centre is involved in multidisciplinary research and developmental activities, related to peaceful use of nuclear energy including societal benefits. BARC facilities at different parts of India include nuclear fuel fabrication facilities, research reactors, nuclear recycle facilities and various Physics, Chemistry and Biological laboratories. BARC Safety Council (BSC) is the regulatory body for BARC facilities and takes regulatory measures for radiation protection. BSC has many safety committees for radiation protection including Operating Plants Safety Review Committee (OPSRC), Committee to Review Applications for Authorization of Safe Disposal of Radioactive Wastes (CRAASDRW) and Design Safety Review Committees (DSRC) in 2 nd tier and Unit Level Safety Committees (ULSCs) in 3 rd tier under OPSRC

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 4: suitability of taxonomic units notified to EFSA until March 2016

OpenAIRE

EFSA Panel on Biological Hazards (BIOHAZ); Allende, Ana; Bolton, Declan; Chemaly, Marianne; Davies, Robert; Fernandez Escamez, Pablo Salvador; Girones, Rosina; Herman, Lieve; Koutsoumanis, Konstantinos; Lindqvist, Roland; Nørrung, Birgit; Ricci, Antonia; Robertson, Lucy; Ru, Giuseppe; Sanaa, Moez

2016-01-01

EFSA was requested to assess the safety of a broad range of biological agents in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide a harmonised generic preassessment to support safety risk assessments performed by EFSA's scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate ...

Aerospace Medicine and Biology: A Continuing Bibliography With Indexes. Supplement 486

Science.gov (United States)

1999-01-01

In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 492

Science.gov (United States)

1999-01-01

This report lists reports, articles and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion.

Restructuring of University Laboratories within the Scope of Occupational Health and Safety

OpenAIRE

Ordu, Kamil Musa; Çivi Bilir, Gülçin

2018-01-01

Laboratory safety is major of importance tooccupational health and safety, which manages, and responds to all issues andconcerns surrounding physical, biological, ergonomic, electrical, chemical, andother standard operating procedures. In this work, laboratory design and equipment,which are arranged according to precautions that are taken against to allhazards regarding to work environment or personal expose at the workenvironments in laboratories that are already exist or will be established...

New treatments for psoriasis: which biologic is best?

Science.gov (United States)

Nelson, Andrew A; Pearce, Daniel J; Fleischer, Alan B; Balkrishnan, Rajesh; Feldman, Steven R

2006-01-01

Psoriasis is a chronic, debilitating disease affecting not only the skin, but also having a significant impact on a patient's quality of life. The treatment of severe psoriasis is quite challenging due to the chronic, relapsing nature of the disease and the difficulties inherent in treatment planning. Though the biologics are perhaps the most promising of available psoriasis treatments, the decision to institute a given therapy may be fraught with complexity for the clinician. Patients now hear of these promising new treatments for psoriasis via print, television and radio advertising; they frequently come to their physician asking if they are eligible for any of these agents and, if so, 'which biologic is best?'. This paper attempts to determine the ideal biologic agent based upon several parameters: FDA- and EU-approved indications, therapeutic efficacy, impact on quality of life, cost-effectiveness, and safety profile. Certainly the physician is central to medical decision-making, though ultimately patient preference may play the largest role in determining the 'best' biologic agent. There is no single ideal biologic for all patients and a physician's job is to educate patients on the relative advantages and disadvantages of each agent. Through informed discussion, the clinician can help each individual patient decide which biologic agent is ideal for them.

Applied radiation biology and protection

International Nuclear Information System (INIS)

Granier, R.; Gambini, D.-J.

1990-01-01

This book grew out of a series of courses in radiobiology and radiation protection which were given to students in schools for radiology technicians, radiation safety officers and to medical students. Topics covered include the sources of ionizing radiation and their interactions with matter; the detection and measurement of ionizing radiation; dosimetry; the biological effects of ionizing radiation; the effects of ionizing radiation on the human body; natural radioexposure; medical radio-exposure; industrial radioexposure of electronuclear origin; radioexposure due to experimental nuclear explosions; radiation protection; and accidents with external and/or internal radio-exposure. (UK)

1978 annual report of the safety department

International Nuclear Information System (INIS)

Kiefer, H.; Koelzer, W.

1979-04-01

The Safety Officer and the Security Officer, respectively, are responsible for radiation protection and technical safety, both conventional and nuclear, for the physical protection as well as the security of nuclear materials and radioactive substances within the Kernforschungszentrum Karlsruhe GmbH. (KfK). To fulfill these functions they rely on the assitance of the Safety Department. The duties of this Department cover tasks relative to radiation protection, safety and security on behalf of the institutes and departments of KfK and environmental monitoring for the whole Karlsruhe Nuclear Research Center as well as research and development work, mainly performed under the Nuclear Safety Project and the Nuclear Safeguards Project. The centers of interest of r and d activities are: investigation of the atmospheric diffusion of nuclear pollutants on the micro- and meso-scales, evaluation of the radiological consequences of accidents in reactors under probabilistic aspects, studies of the physical and chemical behavior of radionuclides with particularly high biological effectiveness in the environment, implementation of nuclear fuel safequarding systems, improvements in radiation protection measurement technology. This report gives details of the different duties, indicates the results of 1978 routine tasks, and reports about new results of investigations and developments of the working groups of the Department. (orig.) [de

Annual Report 1979 of the Safety Department

International Nuclear Information System (INIS)

Kiefer, H.; Koelzer, W.; Koenig, L.A.

1980-04-01

The Safety Officer and the Security Officer, respectively, are responsible for radiation protection and technical safety, both conventional and nuclear, for the physical protection as well as the security of nuclear materials and radioactive substances within the Kernforschungszentrum Karlsruhe GmbH. (KfK). To fulfill these functions they rely on the assistance of the Safety Department. The duties of this Department cover tasks relative to radiation protection, safety and security on behalf of the institutes and departments of KfK and environmental monitoring for the whole Karlsruhe Nuclear Research Center as well as research and development work, mainly performed under the Nuclear Safety Project and the Nuclear Safeguards Project. The centers of interest of r and d activities are: investigation of the atmospheric diffusion of nuclear pollutants on the micro- and meso-scales, evaluation of the radiological consequences of accidents in reactors under probabilistic aspects, studies of the physical and chemical behavior of radionuclides with particularly high biological effectiveness in the environment, implemantation of nuclear fuel safeguarding systems, improvements in radiation protection measurement technology. This report gives details of the different duties, indicates the results of 1979 routine tasks, and reports about results of investigations and developments of the working groups of the Department. (orig.) [de

Safety issues and updates under MR environments

Energy Technology Data Exchange (ETDEWEB)

Kim, Soo Jung; Kim, Kyung Ah, E-mail: bellenina@daum.net

2017-04-15

Highlights: • Unexpected biological effects can occur within stronger magnetic fields. • MR safety for MR conditional items is not guaranteed beyond the tested conditions. • Updated knowledge about MR-related safety is important for a safe MR environment. - Abstract: Magnetic resonance (MR) imaging is a useful imaging tool with superior soft tissue contrast for diagnostic evaluation. The MR environments poses unique risks to patients and employees differently from ionizing radiation exposure originated from computed tomography and plain x-ray films. The technology associated with MR system has evolved continuously since its introduction in the late 1970s. MR systems have advanced with static magnetic fields, faster and stronger gradient magnetic fields and more powerful radiofrequency transmission coils. Higher field strengths of MR offers greater signal to noise capability and better spatial resolution, resulting in better visualization of anatomic detail, with a reduction in scan time. With the rapid evolution of technology associated with MR, we encounter new MR-related circumstances and unexpected dangerous conditions. A comprehensive update of our knowledge about MR safety is necessary to prevent MR-related accidents and to ensure safety for patients and staff associated with MR. This review presents an overview about MR-related safety issues and updates.

Striking balance between expedited review and expecting efficacious anticancer drug and biologics: An ongoing challenge

Directory of Open Access Journals (Sweden)

Krishnan Vengadaragava Chary

2017-01-01

Full Text Available Objective: The objective of this study is to assess the postmarketing status: Efficacy and safety drugs and biologics related with cancer approved under expedited review. Methods: This observational, analytical study was carried between January and April 2016 by the Department of Pharmacology and Medical Oncology, Saveetha Medical College. Drugs approved under expedited review, fast-track status and its association with anti-cancer effects, postmarketing efficacy and safety, propensity to induce the second tumor was noted. Drug approval status and average time of review process were obtained from the United States-Food and Drug Administration (FDA, Center for Drugs and Biologics Center (Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Postmarketing adverse events and safety issues were collected FDA adverse effects reporting system. Further, evidence efficacy and safety of drugs were taken from various meta-analysis, reports on BioMed journals, and Cochrane systematic reviews. Results: In the last 5 years, 166 products were approved by expedited review. Out of 166, 48 (28.9% drugs/biologics are anticancer drugs and drugs used in precancerous conditions. The average time of review varies from19 months to 8.2 months. Out of these 48 molecules, 37 (77% molecules received serious adverse event alert. Positive correlation is seen between average time of review and number of adverse events reported. Seven (14.5% drugs were proven to induce second tumor among receivers. Conclusion: Although expedited review facilitates faster approval of drugs; selection and assessment criteria should be stringent to prevent clinical failure, serious adverse effects of such drugs exposed to many individuals. Focus should be given developing chemosensitizing molecule and evaluation of metronomic regimen which is being more optimistic in current cancer therapeutics.

Safety and clinical efficacy of some radiation-sterilized medical products and pharmaceuticals

International Nuclear Information System (INIS)

Kulkarni, R.D.; Gopal, N.G.S.

1975-01-01

Medical products and pharmaceuticals must conform to certain minimum physico-chemical microbiological and biological requirements. The biological requirements comprise principally testing for toxicity, safety, and pyrogens. Besides the above-mentioned criteria, there are two other important characteristics, viz. clinical efficacy and tolerance in animal and/or human beings. These latter requirements, expected from the final product released for general human use, are not carried out routinely. In the present-day pharmaceutical and medical technology, numerous mew products are appearing, many of them requiring radiation sterilization as they are not stable towards the other conventional methods of sterilization. While the post-irradiation physicochemical changes in a product may not be significant, the bio-availability or biological activity of the product may be affected to a more significant extent. Some evidence of this has recently been reported. Hence, it is desirable to carry out studies on safety as well as clinical efficacy on irradiated products. This paper describes some studies on plastic-based medical products, a pharmaceutical raw material, a typical infusion fluid such as normal saline, antibiotics and their ointments. (author)

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...

FOOD safety and hygiene - Systematic layout planning of food processes

NARCIS (Netherlands)

Van Donk, DP; Gaalman, G

2004-01-01

Hygiene and food safety have been dealt with from different fields of science such as biology and health, and from different angles such as HACCP and GMP. Little systematically ordered knowledge is available for the analysis of a layout, taking hygienic factors into account. HACCP and GMP are

The application of biological motion research: biometrics, sport, and the military.

Science.gov (United States)

Steel, Kylie; Ellem, Eathan; Baxter, David

2015-02-01

The body of research that examines the perception of biological motion is extensive and explores the factors that are perceived from biological motion and how this information is processed. This research demonstrates that individuals are able to use relative (temporal and spatial) information from a person's movement to recognize factors, including gender, age, deception, emotion, intention, and action. The research also demonstrates that movement presents idiosyncratic properties that allow individual discrimination, thus providing the basis for significant exploration in the domain of biometrics and social signal processing. Medical forensics, safety garments, and victim selection domains also have provided a history of research on the perception of biological motion applications; however, a number of additional domains present opportunities for application that have not been explored in depth. Therefore, the purpose of this paper is to present an overview of the current applications of biological motion-based research and to propose a number of areas where biological motion research, specific to recognition, could be applied in the future.

Follow-on biologics: competition in the biopharmaceutical marketplace.

Science.gov (United States)

Devine, Joshua W; Cline, Richard R; Farley, Joel F

2006-01-01

To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. A search using Medline, International Pharmaceutical Abstracts, Med Ad News, F-D-C Reports/Pink Sheets, and Google index directories was conducted with terms such as biologic, biopharmaceutical, generic, and follow-on. Articles pertaining to the follow-on biologic debate. By the authors. Over the past decade, the biopharmaceutical market has experienced substantial growth in the number of product approvals and sales. In contrast with prescription medications, biologic agents currently lack an abbreviated regulatory approval process. Evidence from the Drug Price Competition and Patent Term Restoration Act of 1984 suggests that reducing barriers to generic competition in the pharmaceutical market successfully increases generic market penetration and reduces overall prices to consumers. Although scientific and regulatory dissimilarities between biopharmaceuticals and other medications exist, a follow-on biologic approval process has the potential to play an important role in containing growth in pharmaceutical spending. In addition to biopharmaceutical and generic biopharmaceutical manufacturers, stakeholders with a vested interest in this debate include individual consumers who continue to bear the burden of spending increases in the pharmaceutical market. The debate over a follow-on process likely will be difficult as parties seek a balance between incentives for biopharmaceutical innovation, consumer safety, and affordability of existing biologic products.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 489

Science.gov (United States)

1999-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 498

Science.gov (United States)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

Annual report 1982 of the Central Safety Department

International Nuclear Information System (INIS)

Kiefer, H.; Koelzer, W.; Koenig, L.A.

1983-04-01

The Safety Officer and the Security Officer are responsible for radiation protection and technical safety, both conventional and nuclear, for the physical protection as well as the safeguards of nuclear materials and radioactive substances within the Kernforschungszentrum Karlsruhe GmbH (KfK). To fulfill these functions they rely on the assistance of the Safety Department. The duties of this Department cover tasks relative to radiation protection, safety and security on behalf of the institutes and departments of KfK and environmental monitoring for the whole Karlsruhe Nuclear Research Center as well as research and development work, mainly performed under the Nuclear Safety Project. The centers of interest of r + d activities are: investigation of the atmospheric diffusion of nuclear pollutants on the micro- and meso-scales, evaluation of the radiological consequences of accidents in reactors under probabilistic aspects, studies of the physical and chemical behavior of radionuclides with particularly high biological effectiveness in the environment, improvements in radiation protection measurement technology. This report gives details of the different duties, indicates the results of 1982 routine tasks and reports about results of investigations and developments of the working groups of the Department. The reader is referred to the English translation of the Table of Contents and of Chapter 1 describing the duties and organization of the Central Safety Department. (orig.) [de

Preliminary report on safety aspects on nuclear power generation in Sri Lanka

International Nuclear Information System (INIS)

Jayamanne, D.; Fernando, W.L.W.; Ariyadasa

1988-01-01

This document is intended as background information on nuclear energy to contribute to Sri Lanka's comparative study of alternative sources of energy. This study has considered the safety and environmental effects of nuclear power reactors. Basic concepts of nuclear physics are introduced and providing and appreciation of safety considerations and safety aspects of nuclear power plants and the personnel. Radioactive waste management, storage and disposal are also discussed. Natural radiation levels in Sri Lanka are provided as well as information on biological effects of radiation especially occupational exposure licensing procedures for nuclear power plants are outlined strategy for public awareness of nuclear power is proposed

Biological safety evaluation of the modified urinary catheter

Energy Technology Data Exchange (ETDEWEB)

Kowalczuk, Dorota, E-mail: dorota.kowalczuk@umlub.pl [Department of Medicinal Chemistry, Medical University of Lublin, Jaczewskiego 4, 20-090 Lublin (Poland); Przekora, Agata; Ginalska, Grazyna [Department of Biochemistry and Biotechnology, Medical University of Lublin, Chodzki 1, 20-093 Lublin (Poland)

2015-04-01

The purpose of this study was to evaluate in vitro safety of the novel tosufloxacin (TOS)-treated catheters with the prolonged antimicrobial activity. The test samples of silicone latex catheter were prepared by the immobilization of TOS on chitosan (CHIT)-coated catheter by means of covalent bonds and non-covalent interactions. Each step of the modification process of catheter surface was observed using ATR–Fourier transform infrared spectroscopy. In vitro cytotoxicity of the modified and unmodified catheters was assessed by direct and indirect tests in accordance with ISO standards using green monkey kidney (GMK) cell line. The MTT, lactate dehydrogenase activity (LDH), WST-8, Sulforhodamine B (SRB) test results and microscopic observation clearly indicated that unmodified silicone latex catheters decrease cell metabolic activity, act as a cytotoxic agent causing cell lysis and induce cell death through necrotic or apoptotic process. We suggest that chitosan coat with TOS immobilized limits leaching of harmful agents from silicone latex material, which significantly enhances survivability of GMK cells and therefore is quite a good protection against the cytotoxic effect of this material. - Highlights: • Characterization of the novel antimicrobial urinary catheters • Monitoring of the catheter modification by FTIR analysis • Confirmation of high cytotoxicity of latex-based catheter used in urological practice • Chitosan-coated and tosufloxacin-treated catheter is less toxic than the untreated one. • The proposed surface modification protects cells against latex-induced death.

Safety of Traditional Arab Herbal Medicine

Directory of Open Access Journals (Sweden)

Bashar Saad

2006-01-01

Full Text Available Herbal remedies are widely used for the treatment and prevention of various diseases and often contain highly active pharmacological compounds. Many medicinal herbs and pharmaceutical drugs are therapeutic at one dose and toxic at another. Toxicity related to traditional medicines is becoming more widely recognized as these remedies become popular in the Mediterranean region as well as worldwide. Most reports concerning the toxic effects of herbal medicines are associated with hepatotoxicity although reports of other toxic effects including kidney, nervous system, blood, cardiovascular and dermatologic effects, mutagenicity and carcinogenicity have also been published in the medical literature. This article presents a systematic review on safety of traditional Arab medicine and the contribution of Arab scholars to toxicology. Use of modern cell biological, biochemical, in vitro and in vivo techniques for the evaluation of medicinal plants safety is also discussed.

Biological aspects of tissue-engineered cartilage.

Science.gov (United States)

Hoshi, Kazuto; Fujihara, Yuko; Yamawaki, Takanori; Harai, Motohiro; Asawa, Yukiyo; Hikita, Atsuhiko

2018-04-01

Cartilage regenerative medicine has been progressed well, and it reaches the stage of clinical application. Among various techniques, tissue engineering, which incorporates elements of materials science, is investigated earnestly, driven by high clinical needs. The cartilage tissue engineering using a poly lactide scaffold has been exploratorily used in the treatment of cleft lip-nose patients, disclosing good clinical results during 3-year observation. However, to increase the reliability of this treatment, not only accumulation of clinical evidence on safety and usefulness of the tissue-engineered products, but also establishment of scientific background on biological mechanisms, are regarded essential. In this paper, we reviewed recent trends of cartilage tissue engineering in clinical practice, summarized experimental findings on cellular and matrix changes during the cartilage regeneration, and discussed the importance of further studies on biological aspects of tissue-engineered cartilage, especially by the histological and the morphological methods.

Clinical impact of concomitant immunomodulators on biologic therapy: Pharmacokinetics, immunogenicity, efficacy and safety.

Science.gov (United States)

Xu, Zhenhua; Davis, Hugh M; Zhou, Honghui

2015-03-01

Immune-mediated inflammatory diseases encompass a variety of different clinical syndromes, manifesting as either common diseases such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD) and psoriasis, or rare diseases such as cryopyrin-associated periodic syndromes. The therapy for these diseases often involves the use of a wide range of drugs including nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, immunomodulators, and biologic therapies. Due to the abundance of relevant clinical data, this article provides a general overview on the clinical impact of the concomitant use of immunomodulators and biologic therapies, with a focus on anti-tumor necrosis factor-α agents (anti-TNFα), for the treatment of RA and Crohn's disease (CD). Compared to biologic monotherapy, concomitant use of immunomodulators (methotrexate, azathioprine, and 6-mercaptopurine) often increases the systemic exposure of the anti-TNFα agent and decreases the formation of antibodies to the anti-TNFα agent, consequently enhancing clinical efficacy. Nevertheless, long-term combination therapy with immunomodulators and anti-TNFα agents may be associated with increased risks of serious infections and malignancies. Therefore, the determination whether combination therapy is suitable for a patient should always be based on an individualized benefit-risk evaluation. More research should be undertaken to identify and validate prognostic markers for predicting patients who would benefit the most and those who are at greater risk from combination therapy with immunomodulators and anti-TNFα agents. © 2015, The American College of Clinical Pharmacology.

Bioseguridad in Mexico: Pursuing Security between Local and Global Biologies.

Science.gov (United States)

Wanderer, Emily Mannix

2017-09-01

In the aftermath of the 2009 outbreak of H1N1 influenza, scientists in Mexico sought to develop bioseguridad, that is, to protect biological life in Mexico by safely conducting research on infectious disease. Drawing on ethnographic research in laboratories and with scientists in Mexico, I look at how scientists make claims about local differences in regulations, infrastructure, bodies, and culture. The scientists working with infectious microbes sought to establish how different microbial ecologies, human immune systems, and political and regulatory systems made the risks of research different in Mexico from other countries. In developing bioseguridad, the idea of globalized biology that animates many public health projects was undermined as scientists attended to the elements of place that affected human health and safety. Scientists argued for the importance of local biologies, generating tension with global public health projects and regulations premised on the universality of biology. © 2016 by the American Anthropological Association.

Defining safety culture and the nexus between safety goals and safety culture. 4. Enhancing Safety Culture Through the Establishment of Safety Goals

International Nuclear Information System (INIS)

Tateiwa, Kenji; Miyata, Koichi; Yahagi, Kimitoshi

2001-01-01

Safety culture is the perception of each individual and organization of a nuclear power plant that safety is the first priority, and at Tokyo Electric Power Company (TEPCO), we have been practicing it in everyday activities. On the other hand, with the demand for competitiveness of nuclear power becoming even more intense these days, we need to pursue efficient management while maintaining the safety level at the same time. Below, we discuss how to achieve compatibility between safety culture and efficient management as well as enhance safety culture. Discussion at Tepco: safety culture-nurturing activities such as the following are being implemented: 1. informing the employees of the 'Declaration of Safety Promotion' by handing out brochures and posting it on the intranet home page; 2. publishing safety culture reports covering stories on safety culture of other industry sectors, recent movements on safety culture, etc.; 3. conducting periodic questionnaires to employees to grasp how deeply safety culture is being established; 4. carrying out educational programs to learn from past cases inside and outside the nuclear industry; 5. committing to common ownership of information with the public. The current status of safety culture in Japan sometimes seems to be biased to the quest of ultimate safety; rephrasing it, there have been few discussions regarding the sufficiency of the quantitative safety level in conjunction with the safety culture. Safety culture is one of the most crucial foundations guaranteeing the plant's safety, and for example, the plant safety level evaluated by probabilistic safety assessment (PSA) could be said to be valid only on the ground that a sound and sufficient safety culture exists. Although there is no doubt that the safety culture is a fundamental and important attitude of an individual and organization that keeps safety the first priority, the safety culture in itself should not be considered an obstruction to efforts to implement

Current safety practices in nano-research laboratories in China.

Science.gov (United States)

Zhang, Can; Zhang, Jing; Wang, Guoyu

2014-06-01

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

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 488

Science.gov (United States)

1999-01-01

This report lists reports, articles and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract.

DRDC Ottawa working standard for biological dosimetry

International Nuclear Information System (INIS)

Segura, T.M.; Prud'homme-Lalonde, L.; Thorleifson, E.; Lachapelle, S.; Mullins, D.; Qutob, S.; Wilkinson, D.

2005-07-01

This Standard provides quality assurance, quality control, and evaluation of the performance criteria for the purpose of accreditation of the Radiation Biology laboratory at Defence Research and Development Canada - Ottawa (DRDC Ottawa) using biological dosimetry to predict radiation exposure doses. The International Standard (ISO 19238) and the International Atomic Energy Association (IAEA) Technical Report Series No. 405 are used as guiding documents in preparation of this working document specific to the DRDC Ottawa Radiation Biology Laboratory. This Standard addresses: 1. The confidentiality of personal information, for the customer and the service laboratory; 2. The laboratory safety requirements; 3. The calibration sources and calibration dose ranges useful for establishing the reference dose-effect curves allowing the dose estimation from chromosome aberration frequency, and the minimum detection levels; 4. Transportation criteria for shipping of test samples to the laboratory; 5. Preparation of samples for analysis; 6. The scoring procedure for unstable chromosome aberrations used for biological dosimetry; 7. The criteria for converting a measured aberration frequency into an estimate of absorbed dose; 8. The reporting of results; 9. The quality assurance and quality control plan for the laboratory; and 10. Informative annexes containing examples of a questionnaire, instructions for customers, a data sheet for recording aberrations, a sample report and other supportive documents. (author)

DRDC Ottawa working standard for biological dosimetry

Energy Technology Data Exchange (ETDEWEB)

Segura, T M; Prud' homme-Lalonde, L [Defence Research and Development Canada, Ottawa, Ontario (Canada); Thorleifson, E [Health Canada, Gatineau, Quebec (Canada); Lachapelle, S; Mullins, D [JERA Consulting (Canada); Qutob, S [Health Canada, Gatineau, Quebec (Canada); Wilkinson, D

2005-07-15

This Standard provides quality assurance, quality control, and evaluation of the performance criteria for the purpose of accreditation of the Radiation Biology laboratory at Defence Research and Development Canada - Ottawa (DRDC Ottawa) using biological dosimetry to predict radiation exposure doses. The International Standard (ISO 19238) and the International Atomic Energy Association (IAEA) Technical Report Series No. 405 are used as guiding documents in preparation of this working document specific to the DRDC Ottawa Radiation Biology Laboratory. This Standard addresses: 1. The confidentiality of personal information, for the customer and the service laboratory; 2. The laboratory safety requirements; 3. The calibration sources and calibration dose ranges useful for establishing the reference dose-effect curves allowing the dose estimation from chromosome aberration frequency, and the minimum detection levels; 4. Transportation criteria for shipping of test samples to the laboratory; 5. Preparation of samples for analysis; 6. The scoring procedure for unstable chromosome aberrations used for biological dosimetry; 7. The criteria for converting a measured aberration frequency into an estimate of absorbed dose; 8. The reporting of results; 9. The quality assurance and quality control plan for the laboratory; and 10. Informative annexes containing examples of a questionnaire, instructions for customers, a data sheet for recording aberrations, a sample report and other supportive documents. (author)

Annual report 1985 of the KfK Central Safety Department

International Nuclear Information System (INIS)

Kiefer, H.; Koelzer, W.; Koenig, L.A.

1986-04-01

The Central Safety Department is responsible for handling all problems of radiation protection, safety and security of the institutes and departments of the Karlsruhe Nuclear Research Center, for waste water activity measurements and environmental monitoring of the whole area of the Center, and for research and development work mainly focusing on nuclear safety and radiation protection measures. The r+d work concentrates on the following aspects: physical and chemical behavior of biologically particularly active radionuclides, behavior of HT in the air/plant/soil system, biophysics of multicellular systems, improvement in radiation protection measurement and personnel dosimetry. This report gives details of the different duties, indicates the results of 1985 routine tasks and reports about results of investigations and developments of the working groups of the Department. The reader is referred to the English translation of the Table of Contents and of Chapter 1 describing the duties and organization of the Central Safety Department. (orig./HP) [de

Recognizing Job Health Hazards. Module SH-08. Safety and Health.

Science.gov (United States)

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

This student module on recognizing job health hazards is one of 50 modules concerned with job safety and health. This module presents the four general categories of environmental conditions or stresses: chemical, physical, biological, and ergonomic. Following the introduction, 14 objectives (each keyed to a page in the text) the student is…

Biologics in the management of ulcerative colitis – comparative safety and efficacy of TNF-α antagonists

Directory of Open Access Journals (Sweden)

Fausel R

2015-01-01

Full Text Available Rebecca Fausel,1 Anita Afzali1,2 1Division of Gastroenterology, Department of Medicine, University of Washington, Seattle, WA, USA; 2Inflammatory Bowel Disease Program, UW Medicine – Harborview Medical Center, Seattle, WA, USA Abstract: Ulcerative colitis can cause debilitating symptoms and complications such as colonic strictures, colonic dysplasia, colorectal cancer, and toxic megacolon or perforation. Goals of treatment in ulcerative colitis include resolution of gastrointestinal symptoms, healing of colonic mucosa, and prevention of disease complications. Our treatment armamentarium has expanded dramatically over the past 10 years, and we now have multiple biologic agents approved for the treatment of moderate-severe disease, in addition to conventional therapies such as 5-aminosalicylates, thiopurines, and corticosteroids. In this review, we will provide a detailed discussion of the three tumor necrosis factor-alpha (TNF-α inhibitors currently approved for treatment of ulcerative colitis: infliximab, adalimumab, and golimumab. All three agents are effective for inducing and maintaining clinical response and remission in patients with ulcerative colitis, and they have comparable safety profiles. There are no head-to-head trials comparing their efficacy, and the choice of agent is most often based on insurance coverage, route of administration, and patient preference. Combination therapy with an immunomodulator is proven to be more effective than anti-TNF monotherapy, and patients who lose response to an anti-TNF agent should undergo dose intensification in order to regain clinical response. Despite therapeutic optimization, a significant percentage of patients will not achieve clinical remission with anti-TNF agents, and so newer therapies are on the horizon. Keywords: ulcerative colitis, inflammatory bowel disease, infliximab, adalimumab, golimumab

Biologics in spine arthrodesis.

Science.gov (United States)

Kannan, Abhishek; Dodwad, Shah-Nawaz M; Hsu, Wellington K

2015-06-01

Spine fusion is a tool used in the treatment of spine trauma, tumors, and degenerative disorders. Poor outcomes related to failure of fusion, however, have directed the interests of practitioners and scientists to spinal biologics that may impact fusion at the cellular level. These biologics are used to achieve successful arthrodesis in the treatment of symptomatic deformity or instability. Historically, autologous bone grafting, including iliac crest bong graft harvesting, had represented the gold standard in spinal arthrodesis. However, due to concerns over potential harvest site complications, supply limitations, and associated morbidity, surgeons have turned to other bone graft options known for their osteogenic, osteoinductive, and/or osteoconductive properties. Current bone graft selection includes autograft, allograft, demineralized bone matrix, ceramics, mesenchymal stem cells, and recombinant human bone morphogenetic protein. Each pose their respective advantages and disadvantages and are the focus of ongoing research investigating the safety and efficacy of their use in the setting of spinal fusion. Rh-BMP2 has been plagued by issues of widespread off-label use, controversial indications, and a wide range of adverse effects. The risks associated with high concentrations of exogenous growth factors have led to investigational efforts into nanotechnology and its application in spinal arthrodesis through the binding of endogenous growth factors. Bone graft selection remains critical to successful fusion and favorable patient outcomes, and orthopaedic surgeons must be educated on the utility and limitations of various biologics in the setting of spine arthrodesis.

Raman imaging from microscopy to macroscopy: Quality and safety control of biological materials

Science.gov (United States)

Raman imaging can analyze biological materials by generating detailed chemical images. Over the last decade, tremendous advancements in Raman imaging and data analysis techniques have overcome problems such as long data acquisition and analysis times and poor sensitivity. This review article introdu...

Nonclinical safety strategies for stem cell therapies

Energy Technology Data Exchange (ETDEWEB)

Sharpe, Michaela E., E-mail: michaela_sharpe@yahoo.com [Investigative Toxicology, Drug Safety Research and Development, Pfizer Ltd, Ramsgate Road, Sandwich, CT13 9NJ (United Kingdom); Morton, Daniel [Exploratory Drug Safety, Drug Safety Research and Development, Pfizer Inc, Cambridge, 02140 (United States); Rossi, Annamaria [Investigative Toxicology, Drug Safety Research and Development, Pfizer Ltd, Ramsgate Road, Sandwich, CT13 9NJ (United Kingdom)

2012-08-01

Recent breakthroughs in stem cell biology, especially the development of the induced pluripotent stem cell techniques, have generated tremendous enthusiasm and efforts to explore the therapeutic potential of stem cells in regenerative medicine. Stem cell therapies are being considered for the treatment of degenerative diseases, inflammatory conditions, cancer and repair of damaged tissue. The safety of a stem cell therapy depends on many factors including the type of cell therapy, the differentiation status and proliferation capacity of the cells, the route of administration, the intended clinical location, long term survival of the product and/or engraftment, the need for repeated administration, the disease to be treated and the age of the population. Understanding the product profile of the intended therapy is crucial to the development of the nonclinical safety study design.

Nonclinical safety strategies for stem cell therapies

International Nuclear Information System (INIS)

Sharpe, Michaela E.; Morton, Daniel; Rossi, Annamaria

2012-01-01

Recent breakthroughs in stem cell biology, especially the development of the induced pluripotent stem cell techniques, have generated tremendous enthusiasm and efforts to explore the therapeutic potential of stem cells in regenerative medicine. Stem cell therapies are being considered for the treatment of degenerative diseases, inflammatory conditions, cancer and repair of damaged tissue. The safety of a stem cell therapy depends on many factors including the type of cell therapy, the differentiation status and proliferation capacity of the cells, the route of administration, the intended clinical location, long term survival of the product and/or engraftment, the need for repeated administration, the disease to be treated and the age of the population. Understanding the product profile of the intended therapy is crucial to the development of the nonclinical safety study design.

Safety: Science and technique in social problems

International Nuclear Information System (INIS)

Smit, W.A.

1982-01-01

The author describes in a simple and clearly written Dutch text the relationship between scientific and technical knowledge and the social problems concerning the safety of nuclear energy. He begins with the cooling system of reactors and the safety aspects of the associated pumps. He uses this example to illustrate that the quantative determination of failure risks need not necessarily be relevant for judging the acceptance of the risk but is always relevant as a method of judging the effect of technical improvements on safety values. The author then considers the radiological effects of the operation of a nuclear plant by presenting the doses of radioactivity released if a reactor is operating normally, if there are technical problems and in the case of accidents. The corresponding biological effects on man are also presented and in an appendix the radiological consequences of reactor accidents are considered in some detail. He describes a number of models used in such calculations - for metereological distribution, dosimetry for internal radiation, cancer induction - to illustrate the margins of uncertainty in the predictions. According to the author safety aspects should not just be seen as a purely technical problem, starting with the fact that nuclear energy is desirable and then ensuring that all required safety regulations are met. Safety aspects are a social problem and should be considered by first discussing whether nuclear energy is acceptable, taking into consideration such consequences as the effects of possible accidents and the long term effects of reactor operation. (C.F.)

Biological and chemical standardization of a hop (Humulus lupulus) botanical dietary supplement.

Science.gov (United States)

Krause, Elizabeth; Yuan, Yang; Hajirahimkhan, Atieh; Dong, Huali; Dietz, Birgit M; Nikolic, Dejan; Pauli, Guido F; Bolton, Judy L; van Breemen, Richard B

2014-06-01

Concerned about the safety of conventional estrogen replacement therapy, women are using botanical dietary supplements as alternatives for the management of menopausal symptoms such as hot flashes. Before botanical dietary supplements can be evaluated clinically for safety and efficacy, botanically authenticated and standardized forms are required. To address the demand for a standardized, estrogenic botanical dietary supplement, an extract of hops (Humulus lupulus L.) was developed. Although valued in the brewing of beer, hop extracts are used as anxiolytics and hypnotics and have well-established estrogenic constituents. Starting with a hop cultivar used in the brewing industry, spent hops (the residue remaining after extraction of bitter acids) were formulated into a botanical dietary supplement that was then chemically and biologically standardized. Biological standardization utilized the estrogen-dependent induction of alkaline phosphatase in the Ishikawa cell line. Chemical standardization was based on the prenylated phenols in hops that included estrogenic 8-prenylnaringenin, its isomer 6-prenylnaringenin, and pro-estrogenic isoxanthohumol and its isomeric chalcone xanthohumol, all of which were measured using high-performance liquid chromatography-tandem mass spectrometry. The product of this process was a reproducible botanical extract suitable for subsequent investigations of safety and efficacy. Copyright © 2014 John Wiley & Sons, Ltd.

Methods for open innovation on a genome-design platform associating scientific, commercial, and educational communities in synthetic biology.

Science.gov (United States)

Toyoda, Tetsuro

2011-01-01

Synthetic biology requires both engineering efficiency and compliance with safety guidelines and ethics. Focusing on the rational construction of biological systems based on engineering principles, synthetic biology depends on a genome-design platform to explore the combinations of multiple biological components or BIO bricks for quickly producing innovative devices. This chapter explains the differences among various platform models and details a methodology for promoting open innovation within the scope of the statutory exemption of patent laws. The detailed platform adopts a centralized evaluation model (CEM), computer-aided design (CAD) bricks, and a freemium model. It is also important for the platform to support the legal aspects of copyrights as well as patent and safety guidelines because intellectual work including DNA sequences designed rationally by human intelligence is basically copyrightable. An informational platform with high traceability, transparency, auditability, and security is required for copyright proof, safety compliance, and incentive management for open innovation in synthetic biology. GenoCon, which we have organized and explained here, is a competition-styled, open-innovation method involving worldwide participants from scientific, commercial, and educational communities that aims to improve the designs of genomic sequences that confer a desired function on an organism. Using only a Web browser, a participating contributor proposes a design expressed with CAD bricks that generate a relevant DNA sequence, which is then experimentally and intensively evaluated by the GenoCon organizers. The CAD bricks that comprise programs and databases as a Semantic Web are developed, executed, shared, reused, and well stocked on the secure Semantic Web platform called the Scientists' Networking System or SciNetS/SciNeS, based on which a CEM research center for synthetic biology and open innovation should be established. Copyright © 2011 Elsevier Inc

Nuclear and radiation safety of the centralized spent fuel storage facility in Ukraine

International Nuclear Information System (INIS)

Grigorash, O.V.; Dibach, O.M.; Panchenko, A.V.; Shugajlo, Ol-r P.; Kovbasenko, YU.P.; Vishemyirskij, M.P.; Bogorad, V.I.; Belykh, D.O.; Shendrovich, V.Ya.

2017-01-01

The paper presents the analysis of ensuring nuclear and radiation safety in the management of spent nuclear fuel at the Centralized SFSF and activities planned for Centralized SFSF life cycle stages. There are results of comparing requirements of U.S. regulatory documents used by the HOLTEC Company to design Centralized SFSF equipment staff with relevant requirements of Ukrainian regulations, results based on analysis of the most important factors of Centralized SFSF safety (strength and reliability, nuclear safety, thermal regimes and biological protection) and verified expert calculations of the SSTC NRS. The paper includes issues to be considered in further implementation of Centralized SFSF project.

[Occupational risks among public safety and security forces].

Science.gov (United States)

Candura, S M; Verni, P; Minelli, C M; Rosso, G L; Cappelli, M I; Strambi, S; Martellosio, V

2006-01-01

The present paper tries to identify the occupational risk factors (physical, chemical, biological, psychological), variable depending on jobs and tasks, to which the heterogeneous public safety/security workers are exposed. The fight against criminality and public order maintenance imply (sometimes fatal) traumatic risks, and expose to psychophysical and sensorial tiring, unfavourable macro- and microclimatic conditions, the risk of baropathy (air navigation, underwater activities), noise (generated by firearms and several other sources), vibrations and shakings (automatic weapons, transport vehicles), the risk of electric injury, ionizing (X and gamma rays) and non-inonizing (ultraviolet rays, microwaves and radiofrequencies, electromagnetic fields) radiations. Chemical hazards include carbon monoxide and other combustion products (fires, urban traffic), substances released in chemical accidents, tear gases, lead (firing grounds, metal works, environmental pollution), solvents, lubrificants and cutting oils (mechanic repair and maintenance), laboratory materials and reagents, irritant and/or sensitizing agents contained in gloves. The main biological risks are tetanus, blood-borne diseases (viral hepatitis, AIDS), aerogenous diseases (e.g., tuberculosis, Legionnaire's disease, epidemic cerebrospinal meningitis), dog- or horse-transmitted zoonosis. Finally, emotional, psychosomatic and behavioural stress-related disorders (e.g., burn-out syndrome, post-traumatic stress disorder) are typically frequent. The presence of numerous and diversified hazards among public safety/security forces imposes the adoption of occupational medicine measures, including risk assessment, health education, technical and environmental prevention, personal protective devices, sanitary surveillance and biological monitoring, clinical interventions (diagnosis, therapy and rehabilitation of occupational accidents and illnesses), prompt medico-legal evaluation of occupational

New therapies versus first-generation biologic drugs in psoriasis: a review of adverse events and their management.

Science.gov (United States)

Carrascosa, J M; Del-Alcazar, E

2018-04-01

Biologic drugs have revolutionized the treatment of moderate to severe psoriasis in recent years because of their high efficacy and low risk of toxicity. However, even within the group of biologic therapies, there are differences related to the different mechanisms of action. Areas covered: We review the main adverse events associated with the biologic agents currently available for the treatment of psoriasis and the new inhibitors targeting the p19 subunit of interleukin (IL) 23 and the IL-17A receptor. This review covers injection site reactions, infections, cardiovascular events, demyelinating disorders, tumours, class effects secondary adverse events, immunogenicity, safety in pregnancy and vaccines efficacy. Expert commentary: More than a decade after the first approval of biologic drugs for use in psoriasis, the good safety profile of these drugs is one of the main justifications and incentives for their long-term use. The emergence of new pharmacological groups has made it possible to avoid some of the class effects of first-generation biologic agents and the new therapies appear to pose less risk of reactivation of latent infections, such as hepatitis B virus and tuberculosis. However, they are associated with new adverse effects related to their mechanism of action, including candidiasis and the risk of exacerbation or onset of inflammatory bowel disease.

ENHANCING FOOD SAFETY AND STABILITY THROUGH IRRADIATION: A REVIEW

Directory of Open Access Journals (Sweden)

Manzoor Ahmad Shah

2014-04-01

Full Text Available Food irradiation is one of the non thermal food processing methods. It is the process of exposing food materials to the controlled amounts of ionizing radiations such as gamma rays, X-rays and accelerated electrons, to improve microbiological safety and stability. Irradiation disrupts the biological processes that lead to decay of food quality. It is an effective tool to reduce food-borne pathogens, spoilage microorganisms and parasites; to extend shelf-life and for insect disinfection. The safety and consumption of irradiated foods have been extensively studied at national levels and in international cooperations and have concluded that foods irradiated under appropriate technologies are both safe and nutritionally adequate. Specific applications of food irradiation have been approved by national legislations of more than 55 countries worldwide. This review aims to discuss the applications of irradiation in food processing with the emphasis on food safety and stability.

Safety assessment of silica and zinc oxide nanoparticles

OpenAIRE

An, Seong Soo A; Kim, Meyoung-Kon

2014-01-01

Seong Soo A An,1 Meyoung-Kon Kim2 1Department of Bionanotechnology, Gachon Medical Research Institute, Gachon University, Seongnam, Gyeonggi, Korea; 2Department of Biochemistry and Molecular Biology, Korea University Medical School and College, Seoul, KoreaThe current volume is a special issue focusing on a safety assessment of nanoparticles, from their physicochemical properties to government regulations. It features twenty-five papers, discussing general issues with the possible harmfulness...

Safety and health in the petrochemical industry in Map Ta Phut, Thailand.

Science.gov (United States)

Langkulsen, Uma; Vichit-Vadakan, Nuntavarn; Taptagaporn, Sasitorn

2011-01-01

Petrochemical industries are known as sources of many toxic chemicals. Safety and health risks of the petrochemical workers employed at Map Ta Phut Industrial Estate, located in Rayong, Thailand, are potentially high. The research materials consisted of documents emanating from statutory reports on safety in working with toxic chemicals and the results of interviews by questionnaire among 457 petrochemical workers regarding occupational health and safety issues. Most of workers who were working with toxic chemicals had knowledge and awareness of health risks and chemical hazards at work. We found that safe behavior at work through read the safety information among operational workers less than non-operational workers around 10%. Most of workers had perceived occupational health and safety management in their companies. Some companies revealed that they had not been performing biological monitoring of blood or urine for their health examination reports and that workplace exposure monitoring had not correlated well with health examination of workers. Our study suggested that occupational health and safety for petrochemical industries requires standards and guidelines for workers' health surveillance aimed at protection of workers.

Environmental safety evaluation in test sea disposal of low-level radioactive wastes

International Nuclear Information System (INIS)

1979-01-01

The study results on the environmental safety in the test sea disposal of low-level wastes by Subcommittee on Radioactive Waste Safety Technology in Nuclear Safety Commission are given in connection with the test disposal of radioactive wastes into sea reported by the Nuclear Safety Bureau. The Subcommittee concludes that the effect of the test disposal of radioactive wastes into sea on the environment is extremely small. The contents are as follows. The full text of the report; attached data, (1) prediction of the concentrations of radioactive nuclides in sea, (2) calculation of the concentrations of radioactive nuclides in marine life with biological paths, and (3) estimation of exposure dose in general people; references (1) radiation exposure of the personnel engaged in sea disposal, (2) the effect of a sea disaster during ocean transport. (J.P.N.)

Field Application of the Micro Biological Survey Method for the Assessment of the Microbiological Safety of Different Water Sources in Horn of Africa and the Evaluation of the Effectiveness of Moringa Oleifera in Drinking Water Purification.

Science.gov (United States)

Losito, Francesca; Arienzo, Alyexandra; Somma, Daniela; Murgia, Lorenza; Stalio, Ottavia; Zuppi, Paolo; Rossi, Elisabetta; Antonini, Giovanni

2017-06-23

Water monitoring requires expensive instrumentations and skilled technicians. In developing Countries as Africa, the severe economic restrictions and lack of technology make water safety monitoring approaches applied in developed Countries, still not sustainable. The need to develop new methods that are suitable, affordable, and sustainable in the African context is urgent. The simple, economic and rapid Micro Biological Survey (MBS) method does not require an equipped laboratory nor special instruments and skilled technicians, but it can be very useful for routine water analysis. The aim of this work was the application of the MBS method to evaluate the microbiological safety of different water sources and the effectiveness of different drinking water treatments in the Horn of Africa. The obtained results have proved that this method could be very helpful to monitor water safety before and after various purification treatments, with the aim to control waterborne diseases especially in developing Countries, whose population is the most exposed to these diseases. In addition, it has been proved that Moringa oleifera water treatment is ineffective in decreasing bacterial load of Eritrea water samples.

[Chemical, physical and biological risks in law enforcement].

Science.gov (United States)

Magrini, Andrea; Grana, Mario; Vicentini, Laura

2014-01-01

Chemical, physical and biological risks among public safety and security forces. Law enforcement personnel, involved in routine tasks and in emergency situations, are exposed to numerous and several occupational hazards (chemical, physical and biological) whith likely health and security consequences. These risks are particularly high when the organization and preparation are inadequate, there is a lacking or insufficient coordination, information, education and communication and safety and personal protective equipment are inadequate or insufficient. Despite the objective difficulties, caused by the actual special needs related to the service performed or the organizational peculiarities, the risk identification and assessment is essential for worker health and safety of personnel, as provided for by Legislative Decree no. 81/2008. Chemical risks include airborne pollutants due to vehicular traffic (carbon monoxide, ultrafine particles, benzene, polycyclic aromatic hydrocarbons, aldehydes, nitrogen and sulfur oxides, lead), toxic gases generated by combustion process following fires (aromatic hydrocarbons, PAHs, dioxins and furans, biphenyls, formaldehyde, metals and cyanides), substances emitted in case of chemical accidents (solvents, pesticides, toxic gases, caustics), drugs (methylamphetamine), riot control agents and self-defence spray, lead at firing ranges, and several materials and reagents used in forensic laboratory. The physical hazards are often caused by activities that induce biomechanical overload aid the onset of musculoskeletal disorders, the use of visual display terminals and work environments that may expose to heat stress and discomfort, high and low pressure, noise, vibrations, ionizing and non-ionizing radiation. The main biological risks are blood-borne diseases (viral hepatitis, AIDS), airborne diseases (eg, tuberculosis, meningitis, SARS, anthrax), MRSA, and vector-borne diseases. Many of these risk factors are unavoidable or are not

10 CFR Appendix A to Part 851 - Worker Safety and Health Functional Areas

Science.gov (United States)

2010-01-01

... particular emphasis on biological select agents. (6) Establishes an immunization policy for personnel working... and environment, safety, and health protection organizations. (1) Contractors must provide the... establishing and maintaining a safe and healthful workplace. (f) A record, containing any medical, health...

Indicators of club management practices and biological measurements of patrons' drug and alcohol use.

Science.gov (United States)

Byrnes, Hilary F; Miller, Brenda A; Johnson, Mark B; Voas, Robert B

2014-12-01

Electronic music and dance events in nightclubs attract patrons with heavy alcohol/drug use. Public health concerns are raised from risks related to these behaviors. Practices associated with increased risk in these club settings need to be identified. The relationship between club management practices and biological measures of patrons' alcohol/drug use is examined. Observational data from 25 events across six urban clubs were integrated with survey data (N = 738 patrons, 42.8% female) from patrons exiting these events, 2010-2012. Five indicators of club management practices were examined using mixed model regressions: club security, bar crowding, safety signs, serving intoxicated patrons, and isolation. Analyses revealed that serving intoxicated patrons and safety signs were related to substance use. Specifically, serving intoxicated patrons was related to heavy alcohol and drug use at exit, while safety signs were marginally related to less exit drug use. CONCLUSIONS/IMPORTANCE: Findings indicate observable measures in nightclubs provide important indicators for alcohol/drug use, suggesting practices to target. Study strengths include the use of biological measures of substance use on a relatively large scale. Limitations and future directions are discussed.

Creating biological nanomaterials using synthetic biology

International Nuclear Information System (INIS)

Rice, MaryJoe K; Ruder, Warren C

2014-01-01

Synthetic biology is a new discipline that combines science and engineering approaches to precisely control biological networks. These signaling networks are especially important in fields such as biomedicine and biochemical engineering. Additionally, biological networks can also be critical to the production of naturally occurring biological nanomaterials, and as a result, synthetic biology holds tremendous potential in creating new materials. This review introduces the field of synthetic biology, discusses how biological systems naturally produce materials, and then presents examples and strategies for incorporating synthetic biology approaches in the development of new materials. In particular, strategies for using synthetic biology to produce both organic and inorganic nanomaterials are discussed. Ultimately, synthetic biology holds the potential to dramatically impact biological materials science with significant potential applications in medical systems. (review)

Creating biological nanomaterials using synthetic biology.

Science.gov (United States)

Rice, MaryJoe K; Ruder, Warren C

2014-02-01

Synthetic biology is a new discipline that combines science and engineering approaches to precisely control biological networks. These signaling networks are especially important in fields such as biomedicine and biochemical engineering. Additionally, biological networks can also be critical to the production of naturally occurring biological nanomaterials, and as a result, synthetic biology holds tremendous potential in creating new materials. This review introduces the field of synthetic biology, discusses how biological systems naturally produce materials, and then presents examples and strategies for incorporating synthetic biology approaches in the development of new materials. In particular, strategies for using synthetic biology to produce both organic and inorganic nanomaterials are discussed. Ultimately, synthetic biology holds the potential to dramatically impact biological materials science with significant potential applications in medical systems.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 494

Science.gov (United States)

1999-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. The NASA CASI price code table, addresses of organizations, and document availability information are included before the abstract section. Two indexes--subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 504

Science.gov (United States)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-2000-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. Two indexes- subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 490

Science.gov (United States)

1999-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. Two indexes-subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 487

Science.gov (United States)

1999-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. Two indexes-subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography With Indexes. Supplement 502

Science.gov (United States)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-2000-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. Two indexes-subject and author are included after the abstract section.

No longer "if," but "when": the coming abbreviated approval pathway for follow-on biologics.

Science.gov (United States)

Kelly, Jeremiah J; David, Michael

2009-01-01

Abbreviated approval of follow-on biologics involves answering complex scientific, legal, and policy questions. The Food and Drug Administration (FDA or the Agency) asserts that it lacks the statutory authority to approve follow-on versions of biologics licensed under Section 351 of the Public Health Service Act (PHSA). Despite persuasive arguments to the contrary the one hundred and tenth Congress entertained four legislative proposals to give FDA this authority, each markedly different. It is no longer a question of "if," but "when" FDA will receive authority to review and license abbreviated applications for follow-on biologics. Any legislation in the one hundred and eleventh Congress must determine: (1) if FDA should be granted authority to develop an abbreviated pathway through rulemaking or guidance; (2) if human clinical trials should be mandatory or discretionary; (3) the feasibility of interchangeability determinations in light of patient safety concerns; (4) the duration of marketing exclusivity for associated products; (5) which products are eligible for follow-on approval; and (6) the degree to which uniformity is achievable between the FD&C Act and the PHSA. This paper recommends the one hundred and eleventh Congress strike a balance between patient safety, incentives for product innovation, price competition, and the need for a flexible, transparent process that capitalizes on FDA's growing expertise with follow-on biologics approvals under Section 505(b)(2) of the FD&C Act.

Proceedings of the 3. Regional Meeting on Radiological and Nuclear Safety. Radiological protection in Latin America and the Caribbean. Vol. 1,2

International Nuclear Information System (INIS)

1996-08-01

Two volumes contain more than 183 complete papers presented during the Third Regional Meeting on Radiological Protection and Nuclear Safety held on 23-27 October, 1995 in Cusco-Peru. Latin american specialist talk about nuclear safety and radiological protection, radiation natural exposure, biological effect of radiation, radiotherapy and medical radiological safety, radiological safety in industry and research. Also we deal with subjects related to radiological safety of nuclear and radioactive facilities, radioactive waste management, radioactive material transport, environmental radiological monitoring program, radiological emergency and accidents, instruments and dosimetry, basic safety standards of protection against radiation

Nuclear safety culture and nuclear safety supervision

International Nuclear Information System (INIS)

Chai Jianshe

2013-01-01

In this paper, the author reviews systematically and summarizes up the development process and stage characteristics of nuclear safety culture, analysis the connotation and characteristics of nuclear safety culture, sums up the achievements of our country's nuclear safety supervision, dissects the challenges and problems of nuclear safety supervision. This thesis focused on the relationship between nuclear safety culture and nuclear safety supervision, they are essential differences, but there is a close relationship. Nuclear safety supervision needs to introduce some concepts of nuclear safety culture, lays emphasis on humanistic care and improves its level and efficiency. Nuclear safety supervision authorities must strengthen nuclear safety culture training, conduct the development of nuclear safety culture, make sure that nuclear safety culture can play significant roles. (author)

Improving the cost-effectiveness, trade and safety of biological control for agricultural insect pests using nuclear techniques

Science.gov (United States)

If appropriately applied, biological control offers one of the most promising, environmentally sound, and sustainable control tactics for arthropod pests and weeds for application as part of an integrated pest management (IPM) approach. Public support for biological control as one of the preferred m...

Radiation Safety Culture in Medicine AFROSAFE_R_A_D

International Nuclear Information System (INIS)

Nyabanda, R.

2017-01-01

Ionizing radiation that include X-rays and Gamma rays Radio waves, infrared and visible light carries sufficient energy to free electrons from atoms or molecules. Becquerel first person to discover evidence of radioactivity, who shared a Nobel Prize for physics in 1903 with Marie and Pierre Curie. Prof Sievert and Louis Harold Gray are the Medical physicists who had major contribution in the study of the biological effects of radiation. Ionizing radiation causes displacement of an electron which can inflict damage on DNA either directly or indirectly. A radiation-safety campaign developed by the radiation health workers in Africa. Radiosensitive organs is highest in cells which are highly mitotic or undifferentiated. E.g basal epidermis, bone marrow, thymus, gonads, and lens cells. Relatively low radiosensitivity in muscle, bones, and nervous system tissues. A radiation-safety campaign developed by the radiation health workers in Africa. AFROSAFE Strategies Strengthen radiation protection of patients, health workers and public, Promote safe and appropriate use of ionizing radiation in medicine. Foster improvement of the benefit-risk dialogue with patients and the public. Enhance the safety and quality of radiological procedures in medicine, Promote safety in radiological equipment and facilities and Promote research in radiation protection and safety

Safety balance: Analysis of safety systems

International Nuclear Information System (INIS)

Delage, M.; Giroux, C.

1990-12-01

Safety analysis, and particularly analysis of exploitation of NPPs is constantly affected by EDF and by the safety authorities and their methodologies. Periodic safety reports ensure that important issues are not missed on daily basis, that incidents are identified and that relevant actions are undertaken. French safety analysis method consists of three principal steps. First type of safety balance is analyzed at the normal start-up phase for each unit including the final safety report. This enables analysis of behaviour of units ten years after their licensing. Second type is periodic operational safety analysis performed during a few years. Finally, the third step consists of safety analysis of the oldest units with the aim to improve the safety standards. The three steps of safety analysis are described in this presentation in detail with the aim to present the objectives and principles. Examples of most recent exercises are included in order to illustrate the importance of such analyses

Biological monitoring results for cadmium exposed workers.

Science.gov (United States)

McDiarmid, M A; Freeman, C S; Grossman, E A; Martonik, J

1996-11-01

As part of a settlement agreement with the Occupational Safety and Health Administration (OSHA) involving exposure to cadmium (Cd), a battery production facility provided medical surveillance data to OSHA for review. Measurements of cadmium in blood, cadmium in urine, and beta 2-microglobulin in urine were obtained for more than 100 workers over an 18-month period. Some airborne Cd exposure data were also made available. Two subpopulations of this cohort were of primary interest in evaluating compliance with the medical surveillance provisions of the Cadmium Standard. These were a group of 16 workers medically removed from cadmium exposure due to elevations in some biological parameter, and a group of platemakers. Platemaking had presented a particularly high exposure opportunity and had recently undergone engineering interventions to minimize exposure. The effect on three biological monitoring parameters of medical removal protection in the first group and engineering controls in platemakers is reported. Results reveal that both medical removal from cadmium exposures and exposure abatement through the use of engineering and work practice controls generally result in declines in biological monitoring parameters of exposed workers. Implications for the success of interventions are discussed.

Aspects of the political economy of development and synthetic biology.

Science.gov (United States)

Wellhausen, Rachel; Mukunda, Gautam

2009-12-01

What implications might synthetic biology's potential as a wholly new method of production have for the world economy, particularly developing countries? Theories of political economy predict that synthetic biology can shift terms of trade and displace producers in developing countries. Governments, however, retain the ability to mitigate negative changes through social safety nets and to foster adaptation to some changes through research, education and investment. We consider the effects the synthetic production of otherwise naturally derived molecules are likely to have on trade and investment, particularly in developing countries. Both rubber in Malaysia and indigo dyes in India provide historical examples of natural molecules that faced market dislocations from synthetic competitors. Natural rubber was able to maintain significant market share, while natural indigo vanished from world markets. These cases demonstrate the two extremes of the impact synthetic biology might have on naturally derived products. If developing countries can cushion the pain of technological changes by providing producers support as they retool or exit, the harmful effects of synthetic biology can be mitigated while its benefits can still be captured.

Safety recommendations in magnetic resonance imaging (MRI)

International Nuclear Information System (INIS)

Nikolaou, K.I.; Plataniotis, T.N; Syrgiamiotis, G.V.; Dousi, M.; Panou, T.; Georgiadis, K.; Bougias, C.

2008-01-01

Full text: In order to discuss the long-term biological effects of MRI in the radiological department, all the components of the acquisition process must be considered. Those elements include: the main magnetic field, time varying magnetic fields and radio-frequency fields (RF). Also must be referred other types of hazards obtained by the utilization of contrast materials as gadolinium or pregnancy. The primary concern with the static magnetic field is the possibility of potential biological effects. The majority of studies show no effects on cell growth and morphology at field strengths below 2T. Data accumulated by the National Institute for Occupational Safety, the World Health Organization, and the US State Department, show no evidence of leukemia or other carcinogenesis. The secondary concern of the effects of the main magnetic field is the hazards associated with the sitting of MR systems. The static magnetic field has no respect for the confines of conventional walls, floors or ceilings. Some reversible effects have been noted on Electrocardiogram gating (ECG) at these field strengths. An increase in the amplitude of the T-wave can be noted on an ECG due to the magnetohydrodynamic effect. This is produced when a conductive fluid, such as blood, moves across a magnetic field. Some reversible biological effects including fatigue, headaches, hypotension and accounts of irritability have been observed on human subjects exposed to 2T and above. As yet, there are no known biological effects of MRI on fetuses. Also MR facilities have established individual guidelines for pregnant employees in the MR environment. Ferromagnetic metal objects can become airborne as projectiles in the presence of a strong static magnetic field. Metallic implants pose serious effects which include torque, heating and artifacts on MR images.There have been a large number of studies performed on the biological effects from Time-varying magnetic field (TVMF), since they exist around power

Safety and immunogenicity of Onderstepoort Biological Products’ Rift Valley fever Clone 13 vaccine in sheep and goats under field conditions in Senegal

Directory of Open Access Journals (Sweden)

Modou M. Lo

2015-05-01

Full Text Available This blinded field safety study was conducted in Senegal to assess safety and immunogenicity of administration of the registered dose of Rift Valley fever virus (RVFV Clone 13 vaccine (Onderstepoort Biological Products to sheep and goats of West African breeds under natural conditions. A total of 267 small ruminants (220 sheep, 47 goats were included; half received RVFV Clone 13 vaccine at the recommended dose and half received the diluent (as placebo only. The study was performed on three commercial farms in the northern and eastern region of Senegal in accordance with veterinary good clinical practices. The animals were observed daily for 3 days after vaccination, and then weekly for 1 year. In both sheep and goats vaccinated against RVFV seroconversion rates above 70% were recorded. No seroconversion related to RVFV was observed in placebo-treated animals. No statistically significant differences were determined between placebo and vaccinated groups for mean rectal temperatures for the first 3 days after administration (p > 0.05. No abnormal clinical signs related to treatment were noted, and only one slight injection site reaction was observed in one vaccinated animal for 2 days after vaccination. Out of 176 births assessed over 1 year (93 from the vaccinated group, 83 from the placebo group, 9 were abnormal in the placebo group and 3 in the vaccinated group (p > 0.05. The frequency of adverse events was similar in the placebo and vaccinated groups. RVFV Clone 13 vaccine administered according to the manufacturer’s instructions was safe and well tolerated in West African breeds of sheep and goats, including animals of approximately 6 months of age and pregnant females, under field conditions in Senegal. Antibody levels persisted up to 1 year after vaccination.

The Effects of Occupational Health and Safety Risk Factors on Job Satisfaction in Hotel Enterprises

OpenAIRE

Gonca Kilic; Murat Selim Selvi

2009-01-01

Occupational health and safety risk factors can have direct or indirect effects on levels of organizational commitment, job satisfaction, and the job productivity of workers in service companies as well as other types of industries. In this paper, the effects of physical, biological, chemical and socio-psychological risk factors, related to occupational safety and health, encountered in hotel enterprises on job satisfaction were investigated. Questionnaire survey was conducted as a data colle...

CTLA-4 blockade with ipilimumab: biology, safety, efficacy, and future considerations

International Nuclear Information System (INIS)

Camacho, Luis H

2015-01-01

Melanoma remains a critical public health problem worldwide. Patients with stage IV disease have very poor prognosis and their 1-year survival rate is only 25%. Until recently, systemic treatments with a positive impact on overall survival (OS) had remained elusive. In recent years, the United States Food and Drug Administration (FDA) – approved several novel agents targeting the RAS/RAF/MEK/ERK pathway (vemurafenib, dabrafenib, and trametinib) – critical in cell division and proliferation of melanoma, and an immune checkpoint inhibitor (ipilimumab) directed against the cytotoxic T lymphocyte Antigen - (CTLA-4). Moreover, recent reports of clinical trials studying other immune checkpoint modulating agents will most likely result in their FDA approval within the next months. This review focuses on ipilimumab, its safety and efficacy, and future considerations. Ipilimumab has demonstrated a positive OS impact after a several-year follow-up. It is also recognized that due to its mechanism of action, the response patterns to ipilimumab can differ from those observed in patients following treatment with conventional cytotoxic agents and even the most recently approved BRAF inhibitors. Most patients (84.8%) experience drug-related adverse events (AEs) of any grade; most of these are mild to moderate and immune mediated. However, a minority of patients may also experience severe and life-threatening AEs. In clinical studies, AEs were managed according to guidelines that emphasized close clinical monitoring and early use of corticosteroids when appropriate. Preliminary results have taught us the potential greater toxicity when in combination with vemurafenib, and the greater antitumor efficacy when combined with nivolumab, a monoclonal antibody directed against programmed death receptor-1 (PD-1), another immune checkpoint inhibitor. Future challenges include the optimization of dosing and toxicities when used as a single agent, and studying the safety and efficacy of

Safety margins in deterministic safety analysis

International Nuclear Information System (INIS)

Viktorov, A.

2011-01-01

The concept of safety margins has acquired certain prominence in the attempts to demonstrate quantitatively the level of the nuclear power plant safety by means of deterministic analysis, especially when considering impacts from plant ageing and discovery issues. A number of international or industry publications exist that discuss various applications and interpretations of safety margins. The objective of this presentation is to bring together and examine in some detail, from the regulatory point of view, the safety margins that relate to deterministic safety analysis. In this paper, definitions of various safety margins are presented and discussed along with the regulatory expectations for them. Interrelationships of analysis input and output parameters with corresponding limits are explored. It is shown that the overall safety margin is composed of several components each having different origins and potential uses; in particular, margins associated with analysis output parameters are contrasted with margins linked to the analysis input. While these are separate, it is possible to influence output margins through the analysis input, and analysis method. Preserving safety margins is tantamount to maintaining safety. At the same time, efficiency of operation requires optimization of safety margins taking into account various technical and regulatory considerations. For this, basic definitions and rules for safety margins must be first established. (author)

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 6: suitability of taxonomic units notified to EFSA until March 2017

NARCIS (Netherlands)

Ricci, Antonia; Allende, Ana; Bolton, Declan; Chemaly, Marianne; Davies, Robert; Girones, Rosina; Koutsoumanis, Kostas; Lindqvist, Roland; Nørrung, Birgit; Robertson, Lucy; Ru, Giuseppe; Fernandez Escamez, Pablo Salvador; Sanaa, Moez; Simmons, Marion; Skandamis, Panagiotis; Snary, Emma; Speybroeck, Niko; Kuile, Ter Benno; Threlfall, John; Wahlström, Helene; Cocconcelli, Pier Sandro; Peixe, Luisa; Maradona, Miguel Prieto; Querol, Amparo; Suarez, Juan Evaristo; Sundh, Ingvar; Vlak, Just; Correia, Sandra; Herman, Lieve

2017-01-01

The qualified presumption of safety (QPS) concept was developed to provide a harmonised generic pre-evaluation to support safety risk assessments of biological agents performed by EFSA's scientific Panels. The identity, body of knowledge, safety concerns and antimicrobial resistance of valid

External Events Excluding Earthquakes in the Design of Nuclear Power Plants. Safety Guide

International Nuclear Information System (INIS)

2008-01-01

This Safety Guide provides recommendations and guidance on design for the protection of nuclear power plants from the effects of external events (excluding earthquakes), i.e. events that originate either off the site or within the boundaries of the site but from sources that are not directly involved in the operational states of the nuclear power plant units. In addition, it provides recommendations on engineering related matters in order to comply with the safety objectives and requirements established in the IAEA Safety Requirements publication, Safety of Nuclear Power Plants: Design. It is also applicable to the design and safety assessment of items important to the safety of land based stationary nuclear power plants with water cooled reactors. Contents: 1. Introduction; 2. Application of safety criteria to the design; 3. Design basis for external events; 4. Aircraft crash; 5. External fire; 6. Explosions; 7. Asphyxiant and toxic gases; 8. Corrosive and radioactive gases and liquids; 9. Electromagnetic interference; 10. Floods; 11. Extreme winds; 12. Extreme meteorological conditions; 13. Biological phenomena; 14. Volcanism; 15. Collisions of floating bodies with water intakes and UHS components; Annex I: Aircraft crashes; Annex II: Detonation and deflagration; Annex III: Toxicity limits.

System safety education focused on flight safety

Science.gov (United States)

Holt, E.

1971-01-01

The measures necessary for achieving higher levels of system safety are analyzed with an eye toward maintaining the combat capability of the Air Force. Several education courses were provided for personnel involved in safety management. Data include: (1) Flight Safety Officer Course, (2) Advanced Safety Program Management, (3) Fundamentals of System Safety, and (4) Quantitative Methods of Safety Analysis.

Labor unions and safety climate: perceived union safety values and retail employee safety outcomes.

Science.gov (United States)

Sinclair, Robert R; Martin, James E; Sears, Lindsay E

2010-09-01

Although trade unions have long been recognized as a critical advocate for employee safety and health, safety climate research has not paid much attention to the role unions play in workplace safety. We proposed a multiple constituency model of workplace safety which focused on three central safety stakeholders: top management, ones' immediate supervisor, and the labor union. Safety climate research focuses on management and supervisors as key stakeholders, but has not considered whether employee perceptions about the priority their union places on safety contributes contribute to safety outcomes. We addressed this gap in the literature by investigating unionized retail employee (N=535) perceptions about the extent to which their top management, immediate supervisors, and union valued safety. Confirmatory factor analyses demonstrated that perceived union safety values could be distinguished from measures of safety training, workplace hazards, top management safety values, and supervisor values. Structural equation analyses indicated that union safety values influenced safety outcomes through its association with higher safety motivation, showing a similar effect as that of supervisor safety values. These findings highlight the need for further attention to union-focused measures related to workplace safety as well as further study of retail employees in general. We discuss the practical implications of our findings and identify several directions for future safety research. 2009 Elsevier Ltd. All rights reserved.

Linking Safety Analysis to Safety Requirements

DEFF Research Database (Denmark)

Hansen, Kirsten Mark

Software for safety critical systems must deal with the hazards identified by safety analysistechniques: Fault trees, event trees,and cause consequence diagrams can be interpreted as safety requirements and used in the design activity. We propose that the safety analysis and the system design use...

Safety of Research Reactors. Safety Requirements

International Nuclear Information System (INIS)

2010-01-01

The main objective of this Safety Requirements publication is to provide a basis for safety and a basis for safety assessment for all stages in the lifetime of a research reactor. Another objective is to establish requirements on aspects relating to regulatory control, the management of safety, site evaluation, design, operation and decommissioning. Technical and administrative requirements for the safety of research reactors are established in accordance with these objectives. This Safety Requirements publication is intended for use by organizations engaged in the site evaluation, design, manufacturing, construction, operation and decommissioning of research reactors as well as by regulatory bodies

The value of closed-circuit rebreathers for biological research

Science.gov (United States)

Pyle, Richrad L.; Lobel, Phillip S.; Tomoleoni, Joseph

2016-01-01

Closed-circuit rebreathers have been used for underwater biological research since the late 1960s, but have only started to gain broader application within scientific diving organizations within the past two decades. Rebreathers offer certain specific advantages for such research, especially for research involving behavior and surveys that depend on unobtrusive observers or for a stealthy approach to wildlife for capture and tagging, research that benefits from extended durations underwater, and operations requiring access to relatively deep (>50 m) environments (especially in remote locations). Although many institutions have been slow to adopt rebreather technology within their diving programs, recent developments in rebreather technology that improve safety, standardize training requirements, and reduce costs of equipment and maintenance, will likely result in a trend of increasing utilization of rebreathers for underwater biological research.

Proceedings of the 6. Argentine congress on radiation protection and nuclear safety; Actas del 6. congreso argentino de proteccion radiologica y seguridad nuclear

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-12-31

The 6th Argentine Congress on Radiation Protection and Nuclear Safety was organized by the Radioprotection Argentine Society, in Buenos Aires, between the 22 and 24 of september of 1998. In this event, were presented almost 66 papers in the following sessions, about these subjects: 1.- Safety in nuclear installations. 2.- Control of nuclear material and physical protection of nuclear installations. 3.- Programs of quality assurance. 4.- Training, technical information and public information. 5.- Physical dosimetry. 6.- Physical dosimetry and occupational radiation protection. 7.- Exposure of the natural radiation. 8.- Environmental radiological safety. 9.- Biological effects of the ionizing radiations and biological dosimetry. 10.- Radiological protection of the medical practice and the radiological emergencies. 11.- Radioactive wastes management. 12.- Transport of radioactive materials

Initiating Joint Chinese-U.S. Activities on Biological Safety and Global Health Security

OpenAIRE

Center on Contemporary Conflict

2014-01-01

Performer: National Academy of Sciences (NAS) Principal Investigator: Benjamin J. Rusek Cost: $125,000 Fiscal Year(s): 2014-2015 China is critically important to international health and biological security efforts, yet awareness and implementation of biosafety and biosecurity practices are inconsistent among life science researchers and others working with pathogens and dual-use biotechnology in China. In late 2012, the Committee on International Security and Arms ...

Aerospace Medicine and Biology: A Continuing Bibliography With Indexes. Supplement 499

Science.gov (United States)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP#1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth#s atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. The NASA CASI price code table, addresses of organizations, and document availability information are included before the abstract section. Two indexes-subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 485

Science.gov (United States)

1999-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP-1999-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. The NASA CASI price code table, addresses of organizations, and document availability information are included before the abstract section. Two indexes-subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography With Indexes. Supplement 506

Science.gov (United States)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP#2000-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth's atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. The NASA CASI price code table, addresses of organizations, and document availability information are included before the abstract section. Two indexes- subject and author are included after the abstract section.

Aerospace Medicine and Biology: A Continuing Bibliography with Indexes. Supplement 496

Science.gov (United States)

2000-01-01

This supplemental issue of Aerospace Medicine and Biology, A Continuing Bibliography with Indexes (NASA/SP#2000-7011) lists reports, articles, and other documents recently announced in the NASA STI Database. In its subject coverage, Aerospace Medicine and Biology concentrates on the biological, physiological, psychological, and environmental effects to which humans are subjected during and following simulated or actual flight in the Earth#s atmosphere or in interplanetary space. References describing similar effects on biological organisms of lower order are also included. Such related topics as sanitary problems, pharmacology, toxicology, safety and survival, life support systems, exobiology, and personnel factors receive appropriate attention. Applied research receives the most emphasis, but references to fundamental studies and theoretical principles related to experimental development also qualify for inclusion. Each entry in the publication consists of a standard bibliographic citation accompanied, in most cases, by an abstract. The NASA CASI price code table, addresses of organizations, and document availability information are included before the abstract section. Two indexes#subject and author are included after the abstract section.

Hazard identification and risk assessment for biologics targeting the immune system.

Science.gov (United States)

Weir, Andrea B

2008-01-01

Biologic pharmaceuticals include a variety of products, such as monoclonal antibodies, fusion proteins and cytokines. Products in those classes include immunomodulatory biologics, which are intended to enhance or diminish the activity of the immune system. Immunomodulatory biologics have been approved by the U.S. FDA for a variety of indications, including cancer and inflammatory conditions. Prior to gaining approval for marketing, sponsoring companies for all types of products must demonstrate a product's safety in toxicology studies conducted in animals and show safety and efficacy in clinical trials conducted in patients. The overall goal of toxicology studies, which applies to immunomodulatory and other product types, is to identify the hazards that products pose to humans. Because biologics are generally highly selective for specific targets (receptors/epitopes), conducting toxicology studies in animal models with the target is essential. Such animals are referred to as pharmacologically relevant. Endpoints routinely included in toxicology studies, such as hematology, organ weight and histopathology, can be used to assess the effect of a product on the structure of the immune system. Additionally, specialized endpoints, such as immunophenotyping and immune function tests, can be used to define effects of immunomodulatory products on the immune system. Following hazard identification, risks posed to patients are assessed and managed. Risks can be managed through clinical trial design and risk communication, a practice that applies to immunomodulatory and other product types. Examples of risk management in clinical trial design include establishing a safe starting dose, defining the appropriate patient population and establishing appropriate patient monitoring. Risk communication starts during clinical trials and continues after product approval. A combination of hazard identification, risk assessment and risk management allows for drug development to proceed

Safety assessment of silica and zinc oxide nanoparticles

Directory of Open Access Journals (Sweden)

An SSA

2014-12-01

Full Text Available Seong Soo A An,1 Meyoung-Kon Kim2 1Department of Bionanotechnology, Gachon Medical Research Institute, Gachon University, Seongnam, Gyeonggi, Korea; 2Department of Biochemistry and Molecular Biology, Korea University Medical School and College, Seoul, KoreaThe current volume is a special issue focusing on a safety assessment of nanoparticles, from their physicochemical properties to government regulations. It features twenty-five papers, discussing general issues with the possible harmfulness of two different types of nanoparticles (NPs; silica (SiO2 and zinc oxide (ZnO. Six papers describe detailed analyses from 90-day repeated administrations of NPs, and finally there is a series of technical reports, formatted by the National Toxicology Program (NTP, dealing with safety issues regarding international cooperation with the OECD (Organisation for Economic Co-operation and Development Working Party on Manufactured Nanomaterials (WPMN.

Benefits and Costs of Biologically Contained Genetically Modified Tomatoes and Eggplants in Italy and Spain

Directory of Open Access Journals (Sweden)

Rolf A. Groeneveld

2011-08-01

Full Text Available In this paper we assess the benefits and costs of introducing biologically contained genetically modified (GM crops, with an application to the potential introduction of GM tomatoes and eggplants in Italy and Spain. Such crops possess both the standard beneficial GM traits, and they prevent introgression of transgenes from GM crops to their conventional or wild relatives, thereby adding to the safety of their cultivation. As a result, coexistence regulations for these crops are less stringent than for crops without biological containment. The potential adoption of biologically contained GM tomatoes and eggplants is assessed in a cost-benefit framework for Italy and Spain. We conclude that biological containment has considerable potential benefits if policy makers are willing to loosen the restrictions on the introduction of these varieties.

The future trends for research on quality and safety of animal products

Directory of Open Access Journals (Sweden)

Nigel D. Scollan

2010-01-01

Full Text Available Quality must now be considered as a convergence between consumers' wishes and needs and the intrinsic and extrinsic quality attributes of food products. The increasing number of quality attributes which must be considered, increasing globalisation and the heterogeneity in consumption habits between countries are making this convergence progressively more difficult. In parallel, science is rapidly evolving (with the advent of genomics for instance, and a growing number of applications is thus expected for the improvement of food safety and quality. Among the meat and fish quality attributes, colour is very important because it determines, at least in part, consumer choice. The key targets to ensure a satisfactory colour are animal nutrition and management for fish, processing and product conditioning for meat. Tenderness and flavour continue to be important issues for the consumer because eating remains a pleasure. They both determine quality experience which itself influences repetitive purchase. Meat tenderness is a very complex problem which can be solved only by a holistic approach involving all the factors from conception, animal breeding and production, muscle biology and slaughter practice to carcass processing and meat preparation at the consumer end. Today, safety and healthiness are among the most important issues. Unfortunately, animal products can potentially be a source of biological and chemical contamination for consumers. The introduction of both control strategies along the food chain and the development of a food safety management system, from primary production to the domestic environment, are key issues that must be achieved. Despite a high dietary supply of saturated fats by dairy and meat products, it is imperative that professionals involved in animal research and in the associated industry convey the positive nutritional contributions of animal products to both consumers and health professionals. The latter include protein

[Prevention of occupational accidents with biological material as per Green and Kreuter Model].

Science.gov (United States)

Manetti, Marcela Luisa; da Costa, João Carlos Souza; Marziale, Maria Helena Palucci; Trovó, Marli Elisa

2006-03-01

This study aimed at diagnosing the occurrence of occupational accidents deriving from exposition to biological substance among workers of a hospital from São Paulo, Brazil, analyzing the adopted safety measures and elaborating a flowchart of preventive actions according to the Health Promotion Model by Green and Kreuter. It is an exploratory study with data collected electronically from the website REPAT - Electronic Network for the Prevention of Occupational Accidents with biological substances. The strategy used by the hospital did not reduce the injures. Results were used to elaborate a flowchart of preventive actions in order to improve the workers' quality of life.

The 1994 list of limiting values. Safety and hygiene at work

International Nuclear Information System (INIS)

Pflaumbaum, W.; Kleine, H.; Barig, A.; Nies, E.; Blome, H.; Deiniger, C.; Christ, E.; Siekmann, H.; Fischer, S.; Kupfer, J.; Kaulbars, U.; Pfeiffer, W.; Kreutzkampf, F.; Zilligen, H.; Zinken, E.; Boerner, F.; Kloss, G.; Pfeiffer, B.

1994-09-01

This book contains the most important limiting values for chemical, biological and physical effects on persons relevant to safety and hygiene at work. The section on chemical effects falls into two chapters: maximum working site concentrations of hazardous substances (MAK and TRK values), and limiting and recommended values for hazardous substances in indoor and external air. Regarding biological effects, limiting values for exposure at work do not exist. Therefore, this section looks mainly at the basic demands on work places. The section on physical effects contains limiting values and explanations regarding the following areas: noise, vibration, thermal stress, radiation and biomechanical stress (lifting and carrying of heavy weights). (orig./MG) [de

[Perception of health and safety risks among workers pathology laboratories].

Science.gov (United States)

Alvarado-Cabrero, Isabel; Valencia-Cedillo, Raquel

2015-01-01

Health care workers are experiencing increasing numbers of occupational illnesses. Safety practices in anatomical pathology laboratories (APL) are crucial to prevent unnecessary exposures to both chemical and biological agents. The main goal of this study was to determine if pathologists perceptions and actual practice mirror regulatory guidelines. Current available recommendations for APL were reviewed and used to construct an online survey distributed to pathologists. The survey was completed by 121 participants. Eighty-seven (72 %) of respondents reported receiving inadequate safety training. Most pathologists (82 %) were not well-informed about biosafety practices. Sixty-three (52 %) participants felt that the risks of chemical and infectious disease exposures in the APL were low. Most respondents reported having a needle stick or cut (71 %). Eighty-six (71 %) of participants reported musculo skeletal problems. This study indicated that there is a need for improving training in anatomical pathology safety practices in Mexican laboratories as daily practices do not reflected current guidelines.

Tritium operating safety seminar, Los Alamos, New Mexico, July 30, 1975

International Nuclear Information System (INIS)

1976-03-01

A seminar for the exchange of information on tritium operating and safety problems was held at the Los Alamos Scientific Laboratory. The topics discussed are: (1) material use (tubing, lubricants, valves, seals, etc.); (2) hardware selection (valves, fittings, pumps, etc.); (3) biological effects; (4) high pressure; (5) operating procedures (high pressure tritium experiment at LLL); (6) incidents; and (7) emergency planning

Education of radiation safety specialists at Faculty of Medicine of Vilnius University

International Nuclear Information System (INIS)

Urbelis, A.; Surkiene, G.

2004-01-01

Vilnius University is the first institution of higher education in Lithuania that began to teach students on radiation safety. The special course of radiation hygiene was delivered to students in 1962-1992. In 1992 it was introduced residency of radiation hygiene and graduated students qualified for title of radiation hygiene specialist. The residency lasted one year and included six cycles: fundamentals of nuclear physics, statistics and noninfectious epidemiology, radiobiology, radiological research methods, controls of radiation safety and hygienic analysis of radiation safety. From 1994 Vilnius University has been educating and training professionals of public health. The specialists of radiation safety aren't been training as isolated branch. All courses is divided into two parts. The first one is included into bachelor, the second part - into master study. The bachelor study consists of 2 credits (16 hours for lectures and 32 hours for practical studies). The future bachelors study introduction of radiation safety, elements of nuclear physics, dose limit values, fundamentals of radiological protection, natural radiation. The master study consists of 2 credits (8 hours for lectures and 48 hours for practical studies). The future masters study specific problems of radiation safety in medicine and industry, the safety problems of nuclear power - stations, the problems of radioactive wastes, radiation biology, radiation risk. Radiation safety study model in Faculty of medicine of Vilnius University differs from study model in most European countries as it makes great play of radiation safety while usual model includes radiation safety as insignificant part of environmental health. (author)

Long term efficacy and safety of etanercept in the treatment of psoriasis and psoriatic arthritis

Directory of Open Access Journals (Sweden)

Kivelevitch D

2014-04-01

Full Text Available Dario Kivelevitch, Bobbak Mansouri, Alan Menter Department of Dermatology, Baylor University Medical Center, Dallas, TX, USA Abstract: Psoriasis is a chronic, immune-mediated inflammatory disease affecting both the skin and joints. Approximately 20% of patients suffer a moderate to severe form of skin disease and up to 30% have joint involvement. Standard therapies for psoriasis include topical medications, phototherapy, and both oral systemic and biological therapies whereas therapies for psoriatic arthritis include nonsteroidal anti-inflammatory drugs followed by disease modifying antirheumatic drugs and/or tumor necrosis factor (TNF-α inhibitors and interleukin-12/23p40 inhibitors. Treatment of both diseases is typically driven by disease severity. In the past decade, major advances in the understanding of the immunopathogenesis of psoriasis and psoriatic arthritis have led to the development of numerous biological therapies, which have revolutionized the treatment for moderate to severe plaque psoriasis and psoriatic arthritis. Anti-TNF-α agents are currently considered as first line biological therapies for the treatment of moderate to severe psoriasis and psoriatic arthritis. Currently approved anti-TNF-α agents include etanercept, adalimumab, and infliximab for psoriasis and psoriatic arthritis as well as golimumab and certolizumab for psoriatic arthritis. In this article, we aim to evaluate the long term safety and efficacy of etanercept in psoriasis and psoriatic arthritis. Keywords: psoriasis, psoriatic arthritis, etanercept, biological therapy, tumor necrosis factor, safety

Human factors in safety assessment. Safety culture assessment

International Nuclear Information System (INIS)

Zhang Li; Deng Zhiliang; Wang Yiqun; Huang Weigang

1996-01-01

This paper analyses the present conditions and problems in enterprises safety assessment, and introduces the characteristics and effects of safety culture. The authors think that safety culture must be used as a 'soul' to form the pattern of modern safety management. Furthermore, they propose that the human safety and synthetic safety management assessment in a system should be changed into safety culture assessment. Finally, the assessment indicators are discussed

Road Safety Education in a Science Course: Evaluation of "Science and the Road."

Science.gov (United States)

Gardner, Paul L.

1989-01-01

A traffic safety instructional package--"Science and the Road"--was assessed. It was designed by the Road Traffic Authority of Victoria (Australia) for use in tenth-grade science courses. Evaluation findings resulted in revision of the unit and implementation of more inservice courses for teachers lacking relevant biology and physics…

Self-sufficiency, free trade and safety.

Science.gov (United States)

Rautonen, Jukka

2010-01-01

The relationship between free trade, self-sufficiency and safety of blood and blood components has been a perennial discussion topic in the blood service community. Traditionally, national self-sufficiency has been perceived as the ultimate goal that would also maximize safety. However, very few countries are, or can be, truly self-sufficient when self-sufficiency is understood correctly to encompass the whole value chain from the blood donor to the finished product. This is most striking when plasma derived medicines are considered. Free trade of blood products, or competition, as such can have a negative or positive effect on blood safety. Further, free trade of equipment and reagents and several plasma medicines is actually necessary to meet the domestic demand for blood and blood derivatives in most countries. Opposing free trade due to dogmatic reasons is not in the best interest of any country and will be especially harmful for the developing world. Competition between blood services in the USA has been present for decades. The more than threefold differences in blood product prices between European blood services indicate that competition is long overdue in Europe, too. This competition should be welcomed but carefully and proactively regulated to avoid putting safe and secure blood supply at risk. Copyright 2009 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

Fundamental safety principles. Safety fundamentals

International Nuclear Information System (INIS)

2007-01-01

This publication states the fundamental safety objective and ten associated safety principles, and briefly describes their intent and purpose. The fundamental safety objective - to protect people and the environment from harmful effects of ionizing radiation - applies to all circumstances that give rise to radiation risks. The safety principles are applicable, as relevant, throughout the entire lifetime of all facilities and activities - existing and new - utilized for peaceful purposes, and to protective actions to reduce existing radiation risks. They provide the basis for requirements and measures for the protection of people and the environment against radiation risks and for the safety of facilities and activities that give rise to radiation risks, including, in particular, nuclear installations and uses of radiation and radioactive sources, the transport of radioactive material and the management of radioactive waste

Fundamental safety principles. Safety fundamentals

International Nuclear Information System (INIS)

2006-01-01

This publication states the fundamental safety objective and ten associated safety principles, and briefly describes their intent and purpose. The fundamental safety objective - to protect people and the environment from harmful effects of ionizing radiation - applies to all circumstances that give rise to radiation risks. The safety principles are applicable, as relevant, throughout the entire lifetime of all facilities and activities - existing and new - utilized for peaceful purposes, and to protective actions to reduce existing radiation risks. They provide the basis for requirements and measures for the protection of people and the environment against radiation risks and for the safety of facilities and activities that give rise to radiation risks, including, in particular, nuclear installations and uses of radiation and radioactive sources, the transport of radioactive material and the management of radioactive waste

Safety issues of tooth whitening using peroxide-based materials.

Science.gov (United States)

Li, Y; Greenwall, L

2013-07-01

In-office tooth whitening using hydrogen peroxide (H₂O₂) has been practised in dentistry without significant safety concerns for more than a century. While few disputes exist regarding the efficacy of peroxide-based at-home whitening since its first introduction in 1989, its safety has been the cause of controversy and concern. This article reviews and discusses safety issues of tooth whitening using peroxide-based materials, including biological properties and toxicology of H₂O₂, use of chlorine dioxide, safety studies on tooth whitening, and clinical considerations of its use. Data accumulated during the last two decades demonstrate that, when used properly, peroxide-based tooth whitening is safe and effective. The most commonly seen side effects are tooth sensitivity and gingival irritation, which are usually mild to moderate and transient. So far there is no evidence of significant health risks associated with tooth whitening; however, potential adverse effects can occur with inappropriate application, abuse, or the use of inappropriate whitening products. With the knowledge on peroxide-based whitening materials and the recognition of potential adverse effects associated with the procedure, dental professionals are able to formulate an effective and safe tooth whitening regimen for individual patients to achieve maximal benefits while minimising potential risks.

Management of safety, safety culture and self assessment

International Nuclear Information System (INIS)

Carnino, A.

2000-01-01

Safety management is the term used for the measures required to ensure that an acceptable level of safety is maintained throughout the life of an installation, including decommissioning. The safety culture concept and its implementation are described in part one of the paper. The principles of safety are now quite well known and are implemented worldwide. It leads to a situation where harmonization is being achieved as indicated by the entry into force of the Convention on Nuclear Safety. To go beyond the present nuclear safety levels, management of safety and safety culture will be the means for achieving progress. Recent events which took place in major nuclear power countries have shown the importance of the management and the consequences on safety. At the same time, electricity deregulation is coming and will impact on safety through reductions in staffing and in operation and maintenance cost at nuclear installations. Management of safety as well as its control and monitoring by the safety authorities become a key to the future of nuclear energy.(author)

Is synthetic biology mechanical biology?

Science.gov (United States)

Holm, Sune

2015-12-01

A widespread and influential characterization of synthetic biology emphasizes that synthetic biology is the application of engineering principles to living systems. Furthermore, there is a strong tendency to express the engineering approach to organisms in terms of what seems to be an ontological claim: organisms are machines. In the paper I investigate the ontological and heuristic significance of the machine analogy in synthetic biology. I argue that the use of the machine analogy and the aim of producing rationally designed organisms does not necessarily imply a commitment to mechanical biology. The ideal of applying engineering principles to biology is best understood as expressing recognition of the machine-unlikeness of natural organisms and the limits of human cognition. The paper suggests an interpretation of the identification of organisms with machines in synthetic biology according to which it expresses a strategy for representing, understanding, and constructing living systems that are more machine-like than natural organisms.

Safety assessment considerations for food and feed derived from plants with genetic modifications that modulate endogenous gene expression and pathways.

Science.gov (United States)

Kier, Larry D; Petrick, Jay S

2008-08-01

The current globally recognized comparative food and feed safety assessment paradigm for biotechnology-derived crops is a robust and comprehensive approach for evaluating the safety of both the inserted gene product and the resulting crop. Incorporating many basic concepts from food safety, toxicology, nutrition, molecular biology, and plant breeding, this approach has been used effectively by scientists and regulatory agencies for 10-15 years. Current and future challenges in agriculture include the need for improved yields, tolerance to biotic and abiotic stresses, and improved nutrition. The next generation of biotechnology-derived crops may utilize regulatory proteins, such as transcription factors that modulate gene expression and/or endogenous plant pathways. In this review, we discuss the applicability of the current safety assessment paradigm to biotechnology-derived crops developed using modifications involving regulatory proteins. The growing literature describing the molecular biology underlying plant domestication and conventional breeding demonstrates the naturally occurring genetic variation found in plants, including significant variation in the classes, expression, and activity of regulatory proteins. Specific examples of plant modifications involving insertion or altered expression of regulatory proteins are discussed as illustrative case studies supporting the conclusion that the current comparative safety assessment process is appropriate for these types of biotechnology-developed crops.

Behavioral integrity for safety, priority of safety, psychological safety, and patient safety : a team-level study

NARCIS (Netherlands)

Leroy, H.; Dierynck, B.; Anseel, F.; Simons, T.; Halbesleben, J.R.; McCaughey, D.; Savage, G.T.; Sels, L.

2012-01-01

This article clarifies how leader behavioral integrity for safety helps solve follower's double bind between adhering to safety protocols and speaking up about mistakes against protocols. Path modeling of survey data in 54 nursing teams showed that head nurse behavioral integrity for safety

Playground Safety

Science.gov (United States)

... Prevention Fall Prevention Playground Safety Poisoning Prevention Road Traffic Safety Sports Safety Get Email Updates To receive ... at the Consumer Product Safety Commission’s Playground Safety website . References U.S. Consumer Product Safety Commission. Injuries and ...

Niosomal encapsulation of ethambutol hydrochloride for increasing its efficacy and safety.

Science.gov (United States)

El-Ridy, Mohammed Shafik; Yehia, Soad Aly; Kassem, Mahfouz Abd-El-Megeid; Mostafa, Dina Mahmoud; Nasr, Essam Amin; Asfour, Marwa Hasanin

2015-01-01

Tuberculosis (TB) is a worldwide health concern. In 2011, about 8.7 million new cases developed TB and 1.4 million people died from it. Enhancement of ethambutol hydrochloride activity and safety in treatment of TB through niosomal encapsulation. Niosomes were prepared by the thin-film hydration method. They were characterized, investigated for in vitro release, lung disposition and in vivo biological evaluation. Entrapment efficiency of ethambutol hydrochloride ranged from 12.20% to 25.81%. Zeta potential values inferred stability of neutral and negatively charged formulations. In vitro release was biphasic. Lung targeting was increased by niosomal encapsulation. Biological evaluation revealed superiority of niosomal ethambutol hydrochloride over the free drug. Neutral and negatively charged niosomal vesicles are dispersed homogenously unlike positively charged vesicles. Niosomal encapsulation results in controlled drug release. Niosomal formulations targeted more drugs to mice lungs for a prolonged period of time resulting in: decreased root-specific lung weight, bacterial counts in lung homogenates and optimizing pathological effect on guinea pigs lungs, livers and spleens. Encapsulation of ethambutol hydrochloride in niosomal formulations for the treatment of TB provides higher efficacy and safety compared with the free drug.

More safety by improving the safety culture

International Nuclear Information System (INIS)

Laaksonen, J.

1993-01-01

In its meeting in 1986, after Chernobyl accident, the INSAG group concluded, that the most important reason for the accident was lack of safety culture. Later the group realized that the safety culture, if it is well enough, can be used as a powerful tool to assess and develop practices affecting safety in any country. A comprehensive view on the various aspects of safety culture was presented in the INSAG-4 report published in 1991. Finland was among the first nations include the concept of safety culture in its regulations. This article describes the roles of government and the regulatory body in creating a national safety culture. How safety culture is seen in the operation of a nuclear power plant is also discussed. (orig.)

JURISPRUDENTIAL EXAMINATION REGARDING BIOLOGICAL SAMPLING IN THE CASE OF CONVICTED PERSONS

Directory of Open Access Journals (Sweden)

Gabriela\tNEMŢOI

2015-12-01

Full Text Available Objectives: The research devotes particular attention to the timing of biological sampling in the case of convicted persons. The main idea of the research is the factual situation regarding the criminal case law, which is not unified; problematic that prevents the formation of the National System of Judicial Genetic Data. Materials and Methods: The study focuses on evaluating the two opinions of jurisprudence on the implementation of the text of the law (Law no. 76/2008. Results: The carried research on different cases has shown that legal text is not mandatory, but its application is arbitrary, at the discretion of the court, but, nevertheless, the biological sampling in the case of convicted persons disregards the form for penalty. Conclusions: In the context of the creation of the National System of Judicial Genetic Data is a control condition on the typology of criminal profiling, we believe that biological sampling should be a priority to ensure safety of the individual.

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...

Safety of nuclear power plants: Design. Safety requirements

International Nuclear Information System (INIS)

2000-01-01

The present publication supersedes the Code on the Safety of Nuclear Power Plants: Design (Safety Series No. 50-C-D (Rev. 1), issued in 1988). It takes account of developments relating to the safety of nuclear power plants since the Code on Design was last revised. These developments include the issuing of the Safety Fundamentals publication, The Safety of Nuclear Installations, and the present revision of various safety standards and other publications relating to safety. Requirements for nuclear safety are intended to ensure adequate protection of site personnel, the public and the environment from the effects of ionizing radiation arising from nuclear power plants. It is recognized that technology and scientific knowledge advance, and nuclear safety and what is considered adequate protection are not static entities. Safety requirements change with these developments and this publication reflects the present consensus. This Safety Requirements publication takes account of the developments in safety requirements by, for example, including the consideration of severe accidents in the design process. Other topics that have been given more detailed attention include management of safety, design management, plant ageing and wearing out effects, computer based safety systems, external and internal hazards, human factors, feedback of operational experience, and safety assessment and verification. This publication establishes safety requirements that define the elements necessary to ensure nuclear safety. These requirements are applicable to safety functions and the associated structures, systems and components, as well as to procedures important to safety in nuclear power plants. It is expected that this publication will be used primarily for land based stationary nuclear power plants with water cooled reactors designed for electricity generation or for other heat production applications (such as district heating or desalination). It is recognized that in the case of

Safety of nuclear power plants: Design. Safety requirements

International Nuclear Information System (INIS)

2004-01-01

The present publication supersedes the Code on the Safety of Nuclear Power Plants: Design (Safety Series No. 50-C-D (Rev. 1), issued in 1988). It takes account of developments relating to the safety of nuclear power plants since the Code on Design was last revised. These developments include the issuing of the Safety Fundamentals publication, The Safety of Nuclear Installations, and the present revision of various safety standards and other publications relating to safety. Requirements for nuclear safety are intended to ensure adequate protection of site personnel, the public and the environment from the effects of ionizing radiation arising from nuclear power plants. It is recognized that technology and scientific knowledge advance, and nuclear safety and what is considered adequate protection are not static entities. Safety requirements change with these developments and this publication reflects the present consensus. This Safety Requirements publication takes account of the developments in safety requirements by, for example, including the consideration of severe accidents in the design process. Other topics that have been given more detailed attention include management of safety, design management, plant ageing and wearing out effects, computer based safety systems, external and internal hazards, human factors, feedback of operational experience, and safety assessment and verification. This publication establishes safety requirements that define the elements necessary to ensure nuclear safety. These requirements are applicable to safety functions and the associated structures, systems and components, as well as to procedures important to safety in nuclear power plants. It is expected that this publication will be used primarily for land based stationary nuclear power plants with water cooled reactors designed for electricity generation or for other heat production applications (such as district heating or desalination). It is recognized that in the case of

Implementation of the safety culture for HANARO safety management

Energy Technology Data Exchange (ETDEWEB)

Wu, Jong Sup; Han, Gee Yang; Kim, Ik Soo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2008-11-15

Safety is the fundamental principal upon which a management system is based. The IAEA INSAG(International Nuclear Safety Group) states the general aims of a safety management system. One of which is to foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behavior in individuals and teams, so as to allow them to carry out their tasks safety. The safety culture activities have been implemented and the importance of a safety management in nuclear activities for a reactor application and utilization has also been emphasized for more than 10 years in HANARO which is a 30 MW multi purpose research reactor that achieved its first criticality in February 1995. The safety culture activities and implementation have been conducted continuously to enhance its safe operation such as the seminars and lectures related to safety matters, participation in international workshops and the development of safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture, the development of operational safety performance indicators (SPIs), the preparation of a safety text book and the development of an e Learning program for a safety education purpose.

Implementation of the safety culture for HANARO safety management

International Nuclear Information System (INIS)

Wu, Jong Sup; Han, Gee Yang; Kim, Ik Soo

2008-01-01

Safety is the fundamental principal upon which a management system is based. The IAEA INSAG(International Nuclear Safety Group) states the general aims of a safety management system. One of which is to foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behavior in individuals and teams, so as to allow them to carry out their tasks safety. The safety culture activities have been implemented and the importance of a safety management in nuclear activities for a reactor application and utilization has also been emphasized for more than 10 years in HANARO which is a 30 MW multi purpose research reactor that achieved its first criticality in February 1995. The safety culture activities and implementation have been conducted continuously to enhance its safe operation such as the seminars and lectures related to safety matters, participation in international workshops and the development of safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture, the development of operational safety performance indicators (SPIs), the preparation of a safety text book and the development of an e Learning program for a safety education purpose

Implementation of the safety culture for HANARO Safety Management

International Nuclear Information System (INIS)

Wu, Jongsup; Han, Geeyang; Kim, Iksoo

2008-01-01

Safety is the fundamental principal upon which the management system is based. The IAEA INSAG(International Nuclear Safety Group) states the general aims of the safety management system. One of which is to foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behavior in individuals and teams so as to allow them to carry out their tasks safety. The safety culture activities have been implemented and the importance of safety management in nuclear activities for a reactor application and utilization has also been emphasized more than 10 years in HANARO which is a 30 MW multi-purpose research reactor and achieved its first criticality in February 1995. The safety culture activities and implementations have been conducted continuously to enhance its safe operation like the seminars and lectures related to safety matters, participation in international workshops, the development of safety culture indicators, the survey on the attitude of safety culture, the development of operational safety performance indicators (SPIs), the preparation of a safety text book and the development of an e-Learning program for safety education. (author)

Nuclear safety

International Nuclear Information System (INIS)

Tarride, Bruno

2015-10-01

The author proposes an overview of methods and concepts used in the nuclear industry, at the design level as well as at the exploitation level, to ensure an acceptable safety level, notably in the case of nuclear reactors. He first addresses the general objectives of nuclear safety and the notion of acceptable risk: definition and organisation of nuclear safety (relationships between safety authorities and operators), notion of acceptable risk, deterministic safety approach and main safety principles (safety functions and confinement barriers, concept of defence in depth). Then, the author addresses the safety approach at the design level: studies of operational situations, studies of internal and external aggressions, safety report, design principles for important-for-safety systems (failure criterion, redundancy, failure prevention, safety classification). The next part addresses safety during exploitation and general exploitation rules: definition of the operation domain and of its limits, periodic controls and tests, management in case of incidents, accidents or aggressions

Formal Safety versus Real Safety: Quantitative and Qualitative Approaches to Safety Culture – Evidence from Estonia

Directory of Open Access Journals (Sweden)

Järvis Marina

2016-10-01

Full Text Available This paper examines differences between formal safety and real safety in Estonian small and medium-sized enterprises. The results reveal key issues in safety culture assessment. Statistical analysis of safety culture questionnaires showed many organisations with an outstanding safety culture and positive safety attitudes. However, qualitative data indicated some important safety weaknesses and aspects that should be included in the process of evaluation of safety culture in organisations.

Biological and haematological safety profile of oral amodiaquine and chloroquine in healthy volunteers with or without Plasmodium falciparum infection in northeast Tanzania.

Science.gov (United States)

Massaga, J J; Lusingu, J P; Makunde, R; Malebo, H M; Chile, M M; Akida, J A; Lemnge, M M; Rønn, A M; Theander, T G; Bygbjerg, I C; Kitua, A Y

2008-07-01

Amodiaquine (AQ), an effective antimalarial drug for uncomplicated malaria, has been greatly restricted after cases of life-threatening agranulocytosis and hepatic toxicity during prophylactic use. We conducted a hospital based open-label randomised clinical trial in 40 indigenous semi-immune healthy adult male volunteers with and without malaria parasites. The objective was to collect data on biological and haematological safety, tolerability, and parasitological efficacy to serve as baseline in the evaluation of the effectiveness of AQ preventive intermittent treatment against malaria morbidity in infants. Volunteers were stratified according to parasitaemia status and randomly assigned 20 participants each arm to three days treatment with either AQ or chloroquine (CQ). The level of difference of selected haematological and hepatological values pre-and post-trial were marginal and within the normal limits. Clinical adverse effects mostly mild and transient were noticed in 33.3% CQ treated-aparasitaemic, 23.8% of CQ treated-parasitaemic, 28.6% ofAQ-treated parasitaemic and 14.3% of aparasitaemic receiving AQ. Amodiaquine attained 100% parasitological clearance rate versus 70% in CQ-treated volunteers. The findings indicate that there was no agranulocytosis or hepatic toxicity suggesting that AQ may pose no public health risk in its wide therapeutic dosage uses. Larger studies are needed to exclude rare adverse effects.

The Biological Responses to Magnesium-Based Biodegradable Medical Devices

Directory of Open Access Journals (Sweden)

Lumei Liu

2017-11-01

Full Text Available The biocompatibility of Magnesium-based materials (MBMs is critical to the safety of biodegradable medical devices. As a promising metallic biomaterial for medical devices, the issue of greatest concern is devices’ safety as degrading products are possibly interacting with local tissue during complete degradation. The aim of this review is to summarize the biological responses to MBMs at the cellular/molecular level, including cell adhesion, transportation signaling, immune response, and tissue growth during the complex degradation process. We review the influence of MBMs on gene/protein biosynthesis and expression at the site of implantation, as well as throughout the body. This paper provides a systematic review of the cellular/molecular behavior of local tissue on the response to Mg degradation, which may facilitate a better prediction of long-term degradation and the safe use of magnesium-based implants through metal innovation.

Defining safety culture and the nexus between safety goals and safety culture. 1. An Investigation Study on Practical Points of Safety Management

International Nuclear Information System (INIS)

Hasegawa, Naoko; Takano, Kenichi; Hirose, Ayako

2001-01-01

In a report after the Chernobyl accident, the International Atomic Energy Agency indicated the definition and the importance of safety culture and the ideal organizational state where safety culture pervades. However, the report did not mention practical approaches to enhance safety culture. In Japan, although there had been investigations that clarified the consciousness of employees and the organizational climate in the nuclear power and railway industries, organizational factors that clarified the level of organization safety and practical methods that spread safety culture in an organization had not been studied. The Central Research Institute of the Electric Power Industry conducted surveys of organizational culture for the construction, chemical, and manufacturing industries. The aim of our study was to clarify the organizational factors that influence safety in an organization expressed in employee safety consciousness, commitment to safety activities, rate of accidents, etc. If these areas were clarified, the level of organization safety might be evaluated, and practical ways could be suggested to enhance the safety culture. Consequently, a series of investigations was conducted to clarify relationships among organizational climate, employee consciousness, safety management and activities, and rate of accidents. The questionnaire surveys were conducted in 1998-1999. The subjects were (a) managers of the safety management sections in the head offices of the construction, chemical, and manufacturing industries; (b) responsible persons in factories of the chemical and manufacturing industries; and (c) general workers in factories of the chemical and manufacturing industries. The number of collected data was (a) managers in the head office: 48 from the construction industry and 58 from the chemical and manufacturing industries, (b) responsible persons in factories: 567, and (c) general workers: from 29 factories. Items in the questionnaires were selected from

Priming patient safety: A middle-range theory of safety goal priming via safety culture communication.

Science.gov (United States)

Groves, Patricia S; Bunch, Jacinda L

2018-05-18

The aim of this paper is discussion of a new middle-range theory of patient safety goal priming via safety culture communication. Bedside nurses are key to safe care, but there is little theory about how organizations can influence nursing behavior through safety culture to improve patient safety outcomes. We theorize patient safety goal priming via safety culture communication may support organizations in this endeavor. According to this theory, hospital safety culture communication activates a previously held patient safety goal and increases the perceived value of actions nurses can take to achieve that goal. Nurses subsequently prioritize and are motivated to perform tasks and risk assessment related to achieving patient safety. These efforts continue until nurses mitigate or ameliorate identified risks and hazards during the patient care encounter. Critically, this process requires nurses to have a previously held safety goal associated with a repertoire of appropriate actions. This theory suggests undergraduate educators should foster an outcomes focus emphasizing the connections between nursing interventions and safety outcomes, hospitals should strategically structure patient safety primes into communicative activities, and organizations should support professional development including new skills and the latest evidence supporting nursing practice for patient safety. © 2018 John Wiley & Sons Ltd.

Developmental biology, the stem cell of biological disciplines.

Science.gov (United States)

Gilbert, Scott F

2017-12-01

Developmental biology (including embryology) is proposed as "the stem cell of biological disciplines." Genetics, cell biology, oncology, immunology, evolutionary mechanisms, neurobiology, and systems biology each has its ancestry in developmental biology. Moreover, developmental biology continues to roll on, budding off more disciplines, while retaining its own identity. While its descendant disciplines differentiate into sciences with a restricted set of paradigms, examples, and techniques, developmental biology remains vigorous, pluripotent, and relatively undifferentiated. In many disciplines, especially in evolutionary biology and oncology, the developmental perspective is being reasserted as an important research program.

Highway Safety Program Manual: Volume 3: Motorcycle Safety.

Science.gov (United States)

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

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

Safety of nuclear power plants: Operation. Safety requirements

International Nuclear Information System (INIS)

2004-01-01

The safety of a nuclear power plant is ensured by means of its proper siting, design, construction and commissioning, followed by the proper management and operation of the plant. In a later phase, proper decommissioning is required. This Safety Requirements publication supersedes the Code on the Safety of Nuclear Power Plants: Operation, which was issued in 1988 as Safety Series No. 50-C-O (Rev. 1). The purpose of this revision was: to restructure Safety Series No. 50-C-O (Rev. 1) in the light of the basic objectives, concepts and principles in the Safety Fundamentals publication The Safety of Nuclear Installations. To be consistent with the requirements of the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources. And to reflect current practice and new concepts and technical developments. Guidance on fulfillment of these Safety Requirements may be found in the appropriate Safety Guides relating to plant operation. The objective of this publication is to establish the requirements which, in the light of experience and the present state of technology, must be satisfied to ensure the safe operation of nuclear power plants. These requirements are governed by the basic objectives, concepts and principles that are presented in the Safety Fundamentals publication The Safety of Nuclear Installations. This publication deals with matters specific to the safe operation of land based stationary thermal neutron nuclear power plants, and also covers their commissioning and subsequent decommissioning

Safety of nuclear power plants: Operation. Safety requirements

International Nuclear Information System (INIS)

2003-01-01

The safety of a nuclear power plant is ensured by means of its proper siting, design, construction and commissioning, followed by the proper management and operation of the plant. In a later phase, proper decommissioning is required. This Safety Requirements publication supersedes the Code on the Safety of Nuclear Power Plants: Operation, which was issued in 1988 as Safety Series No. 50-C-O (Rev. 1). The purpose of this revision was: to restructure Safety Series No. 50-C-O (Rev. 1) in the light of the basic objectives, concepts and principles in the Safety Fundamentals publication The Safety of Nuclear Installations. To be consistent with the requirements of the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources. And to reflect current practice and new concepts and technical developments. Guidance on fulfillment of these Safety Requirements may be found in the appropriate Safety Guides relating to plant operation. The objective of this publication is to establish the requirements which, in the light of experience and the present state of technology, must be satisfied to ensure the safe operation of nuclear power plants. These requirements are governed by the basic objectives, concepts and principles that are presented in the Safety Fundamentals publication The Safety of Nuclear Installations. This publication deals with matters specific to the safe operation of land based stationary thermal neutron nuclear power plants, and also covers their commissioning and subsequent decommissioning

Safety of nuclear power plants: Operation. Safety requirements

International Nuclear Information System (INIS)

2000-01-01

The safety of a nuclear power plant is ensured by means of its proper siting, design, construction and commissioning, followed by the proper management and operation of the plant. In a later phase, proper decommissioning is required. This Safety Requirements publication supersedes the Code on the Safety of Nuclear Power Plants: Operation, which was issued in 1988 as Safety Series No. 50-C-O (Rev. 1). The purpose of this revision was: to restructure Safety Series No. 50-C-O (Rev. 1) in the light of the basic objectives, concepts and principles in the Safety Fundamentals publication The Safety of Nuclear Installations; to be consistent with the requirements of the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources; and to reflect current practice and new concepts and technical developments. Guidance on fulfillment of these Safety Requirements may be found in the appropriate Safety Guides relating to plant operation. The objective of this publication is to establish the requirements which, in the light of experience and the present state of technology, must be satisfied to ensure the safe operation of nuclear power plants. These requirements are governed by the basic objectives, concepts and principles that are presented in the Safety Fundamentals publication The Safety of Nuclear Installations. This publication deals with matters specific to the safe operation of land based stationary thermal neutron nuclear power plants, and also covers their commissioning and subsequent decommissioning

Relations between Intuitive Biological Thinking and Biological Misconceptions in Biology Majors and Nonmajors

Science.gov (United States)

Coley, John D.; Tanner, Kimberly

2015-01-01

Research and theory development in cognitive psychology and science education research remain largely isolated. Biology education researchers have documented persistent scientifically inaccurate ideas, often termed misconceptions, among biology students across biological domains. In parallel, cognitive and developmental psychologists have described intuitive conceptual systems—teleological, essentialist, and anthropocentric thinking—that humans use to reason about biology. We hypothesize that seemingly unrelated biological misconceptions may have common origins in these intuitive ways of knowing, termed cognitive construals. We presented 137 undergraduate biology majors and nonmajors with six biological misconceptions. They indicated their agreement with each statement, and explained their rationale for their response. Results indicate frequent agreement with misconceptions, and frequent use of construal-based reasoning among both biology majors and nonmajors in their written explanations. Moreover, results also show associations between specific construals and the misconceptions hypothesized to arise from those construals. Strikingly, such associations were stronger among biology majors than nonmajors. These results demonstrate important linkages between intuitive ways of thinking and misconceptions in discipline-based reasoning, and raise questions about the origins, persistence, and generality of relations between intuitive reasoning and biological misconceptions. PMID:25713093

Implementation of the safety culture for HANARO safety management

Energy Technology Data Exchange (ETDEWEB)

Wu, Jongsup; Han, Geeyang; Kim, Iksoo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2008-11-15

Safety is the fundamental principal upon which a management system is based. The IAEA INSAG (International Nuclear Safety Group) states the general aims of a safety management system. One of which is to foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behavior in individuals and teams, so as to allow them to carry out their tasks safely. The safety culture activities have been implemented and the importance of a safety management in nuclear activities for a reactor application and utilization has also been emphasized for more than 10 years in HANARO which is a 30MW multi-purpose research reactor that achieved its first criticality in February 1995. The safety culture activities and implementations have been conducted continuously to enhance its safe operation such as the seminars and lectures related to safety matters, participation in international workshops and the development of safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture, the development of operational safety performance indicators (SPIs), the preparation of a safety text book and the development of a e-learning program for a safety education purpose.

Implementation of the safety culture for HANARO safety management

International Nuclear Information System (INIS)

Wu, Jongsup; Han, Geeyang; Kim, Iksoo

2008-01-01

Safety is the fundamental principal upon which a management system is based. The IAEA INSAG (International Nuclear Safety Group) states the general aims of a safety management system. One of which is to foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behavior in individuals and teams, so as to allow them to carry out their tasks safely. The safety culture activities have been implemented and the importance of a safety management in nuclear activities for a reactor application and utilization has also been emphasized for more than 10 years in HANARO which is a 30MW multi-purpose research reactor that achieved its first criticality in February 1995. The safety culture activities and implementations have been conducted continuously to enhance its safe operation such as the seminars and lectures related to safety matters, participation in international workshops and the development of safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture, the development of operational safety performance indicators (SPIs), the preparation of a safety text book and the development of a e-learning program for a safety education purpose

The impact of masculinity on safety oversights, safety priority and safety violations in two male-dominated occupations

DEFF Research Database (Denmark)

Nielsen, Kent; Hansen, Claus D.; Bloksgaard, Lotte

2015-01-01

Background Although men have a higher risk of occupational injuries than women the role of masculinity for organizational safety outcomes has only rarely been the object of research. Aim The current study investigated the association between masculinity and safety oversights, safety priority......-related context factors (safety leadership, commitment of the safety representative, and safety involvement) and three safety-related outcome factors (safety violations, safety oversights and safety priority) were administered twice 12 months apart to Danish ambulance workers (n = 1157) and slaughterhouse workers...

6. Regional Congress on Radiation Protection and Safety; 3. Iberian and Latin American Congress on Radiological Protection Societies; Regional IRPA Congress. Book of abstracts

International Nuclear Information System (INIS)

2003-11-01

The 6th Regional Congress on Radiation Protection and Safety was organized by the Peruvian Radiation Protection Society and the Peruvian Institute of Nuclear Energy, held in Lima, Peru, between 9 and 13 of november of 2003. In this event, were presented 227 papers that were articulated in the following sessions: radiation natural exposure, biological effects of ionizing radiation, instruments and dosimetry, radiological emergency and accidents, occupational radiation protection, radiological protection in medical exposure, radiological environmental protection, legal aspects, standards and regulations, training, education and communication, radioactive waste management, radioactive material transport, nuclear safety and biological effects of non-ionizing radiation. (APC)

Review on biological degradation of mycotoxins

Directory of Open Access Journals (Sweden)

Cheng Ji

2016-09-01

Full Text Available The worldwide contamination of feeds and foods with mycotoxins is a significant problem. Mycotoxins pose huge health threat to animals and humans. As well, mycotoxins bring enormous economic losses in food industry and animal husbandry annually. Thus, strategies to eliminate or inactivate mycotoxins in food and feed are urgently needed. Traditional physical and chemical methods have some limitations such as limited efficacy, safety issues, losses in the nutritional value and the palatability of feeds, as well as the expensive equipment required to implement these techniques. Biological degradation of mycotoxins has shown promise because it works under mild, environmentally friendly conditions. Aflatoxin (AF, zearalenone (ZEA and deoxynivalenol (DON are considered the most economically important mycotoxins in terms of their high prevalence and significant negative effects on animal performance. Therefore, this review will comprehensively describe the biological degradation of AF, ZEA and DON by microorganisms (including fungi and bacteria and specific enzymes isolated from microbial systems that can convert mycotoxins with varied efficiency to non- or less toxic products. Finally, some strategies and advices on existing difficulties of biodegradation research are also briefly proposed in this paper.

Occupational Health and Safety: reflection on potential risks and the safety handling of nanomaterials

Directory of Open Access Journals (Sweden)

Guilherme Frederico Bernardo Lenz e Silva

2013-11-01

Full Text Available Every day the nanotechnology, that refers to a field whose theme is the control of matter on an atomic and molecular scale working with nanometric structures (<100 nm, is more present in the development of products and industrial processes. The particle manipulation of nanometric structures has created opportunities in the development of new products and materials. However, synthesis, handling, storage, stabilization and the incorporation of these materials, with nanometric dimensions, demand a new perspective of analysis and evaluation of old manufacturing processes, procedures and industrial devices, in order to guarantee collective and individual protection to workers and society. With the increasing of scale and production of nanoestrutuctured materials, a big part of labour community starts to be in contact with different nanomaterials (forms and ways. In this work the main aspects and involved risks of manufacture, storage, synthesis, stabilization and incorporation of nanomaterials on new products are evaluated in order to reduce, decrease and eliminate chemical, physical and biological risks for the employees. A bibliographic review was conducted about risk, safety and nanotechnology based on available English literature focusing safety and environmental agencies from different countries such as USA, Canada, EU (France, UK, Germany, Den-mark, Australia and Japan.

A Brief Introduction to Chinese Biological Biological

Institute of Scientific and Technical Information of China (English)

无

2005-01-01

Chinese Biological Abstracts sponsored by the Library, the Shanghai Institutes for Biological Sciences, the Biological Documentation and Information Network, all of the Chinese Academy of Sciences, commenced publication in 1987 and was initiated to provide access to the Chinese information in the field of biology.

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

Does Employee Safety Matter for Patients Too? Employee Safety Climate and Patient Safety Culture in Health Care.

Science.gov (United States)

Mohr, David C; Eaton, Jennifer Lipkowitz; McPhaul, Kathleen M; Hodgson, Michael J

2015-04-22

We examined relationships between employee safety climate and patient safety culture. Because employee safety may be a precondition for the development of patient safety, we hypothesized that employee safety culture would be strongly and positively related to patient safety culture. An employee safety climate survey was administered in 2010 and assessed employees' views and experiences of safety for employees. The patient safety survey administered in 2011 assessed the safety culture for patients. We performed Pearson correlations and multiple regression analysis to examine the relationships between a composite measure of employee safety with subdimensions of patient safety culture. The regression models controlled for size, geographic characteristics, and teaching affiliation. Analyses were conducted at the group level using data from 132 medical centers. Higher employee safety climate composite scores were positively associated with all 9 patient safety culture measures examined. Standardized multivariate regression coefficients ranged from 0.44 to 0.64. Medical facilities where staff have more positive perceptions of health care workplace safety climate tended to have more positive assessments of patient safety culture. This suggests that patient safety culture and employee safety climate could be mutually reinforcing, such that investments and improvements in one domain positively impacts the other. Further research is needed to better understand the nexus between health care employee and patient safety to generalize and act upon findings.

Relations between intuitive biological thinking and biological misconceptions in biology majors and nonmajors.

Science.gov (United States)

Coley, John D; Tanner, Kimberly

2015-03-02

Research and theory development in cognitive psychology and science education research remain largely isolated. Biology education researchers have documented persistent scientifically inaccurate ideas, often termed misconceptions, among biology students across biological domains. In parallel, cognitive and developmental psychologists have described intuitive conceptual systems--teleological, essentialist, and anthropocentric thinking--that humans use to reason about biology. We hypothesize that seemingly unrelated biological misconceptions may have common origins in these intuitive ways of knowing, termed cognitive construals. We presented 137 undergraduate biology majors and nonmajors with six biological misconceptions. They indicated their agreement with each statement, and explained their rationale for their response. Results indicate frequent agreement with misconceptions, and frequent use of construal-based reasoning among both biology majors and nonmajors in their written explanations. Moreover, results also show associations between specific construals and the misconceptions hypothesized to arise from those construals. Strikingly, such associations were stronger among biology majors than nonmajors. These results demonstrate important linkages between intuitive ways of thinking and misconceptions in discipline-based reasoning, and raise questions about the origins, persistence, and generality of relations between intuitive reasoning and biological misconceptions. © 2015 J. D. Coley and K. Tanner. CBE—Life Sciences Education © 2015 The American Society for Cell Biology. This article is distributed by The American Society for Cell Biology under license from the author(s). It is available to the public under an Attribution–Noncommercial–Share Alike 3.0 Unported Creative Commons License (http://creativecommons.org/licenses/by-nc-sa/3.0).

Treatment with biologic agents improves the prognosis of patients with rheumatoid arthritis and amyloidosis.

Science.gov (United States)

Kuroda, Takeshi; Tanabe, Naohito; Kobayashi, Daisuke; Sato, Hiroe; Wada, Yoko; Murakami, Shuichi; Saeki, Takako; Nakano, Masaaki; Narita, Ichiei

2012-07-01

Reactive amyloid A (AA) amyloidosis is a serious and life-threatening systemic complication of rheumatoid arthritis (RA). We evaluated the safety of therapy with anti-tumor necrosis factor and anti-interleukin 6 biologic agents in RA patients with reactive AA amyloidosis, together with prognosis and hemodialysis (HD)-free survival, in comparison with patients with AA amyloidosis without such therapy. One hundred thirty-three patients with an established diagnosis of reactive AA amyloidosis participated in the study. Clinical data were assessed from patient records at the time of amyloid detection and administration of biologics. Survival was calculated from the date when amyloid was first demonstrated histologically or the date when biologic therapy was started until the time of death or to the end of 2010 for surviving patients. Patients who had started HD were selected for inclusion only after the presence of amyloid was demonstrated. Fifty-three patients were treated with biologic agents (biologic group) and 80 were not (nonbiologic group). Survival rate was significantly higher in the biologic group than in the nonbiologic group. Nine patients in the biologics group and 33 in the nonbiologic group started HD. Biologic therapy had a tendency for reduced risk of initiation of HD without any statistical significance. Patients with amyloidosis have a higher mortality rate, but the use of biologic agents can reduce risk of death. The use of biologics may not significantly influence the HD-free survival rate.

Software Safety Risk in Legacy Safety-Critical Computer Systems

Science.gov (United States)

Hill, Janice L.; Baggs, Rhoda

2007-01-01

Safety Standards contain technical and process-oriented safety requirements. Technical requirements are those such as "must work" and "must not work" functions in the system. Process-Oriented requirements are software engineering and safety management process requirements. Address the system perspective and some cover just software in the system > NASA-STD-8719.13B Software Safety Standard is the current standard of interest. NASA programs/projects will have their own set of safety requirements derived from the standard. Safety Cases: a) Documented demonstration that a system complies with the specified safety requirements. b) Evidence is gathered on the integrity of the system and put forward as an argued case. [Gardener (ed.)] c) Problems occur when trying to meet safety standards, and thus make retrospective safety cases, in legacy safety-critical computer systems.

Proceedings of the 3. Regional Meeting on Radiological and Nuclear Safety, Regional Meeting on International Radiation Protection Association (IRPA)and 3. Peruvian Meeting on Radiological Protection

International Nuclear Information System (INIS)

1995-10-01

There we show works of the Third Regional Meeting on Radiological and Nuclear Safety held on 23-27 October, 1995 in Cusco-Peru. Latin americans specialists talk about nuclear safety and radiological protection, radiation natural exposure, biological effect of radiation, radiotherapy and medical radiological safety, radiological safety in industry and research. Also we deal with subjects related to radiological safety of nuclear and radioactive facilities, radioactive waste management, radioactive material transport, environmental radiological monitoring program, radiological emergency and accidents, instruments and dosimetry, basic safety standards of protection against radiation. More than 225 works were presented on the meeting

Safety assessment and verification for nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2001-01-01

This publication supports the Safety Requirements on the Safety of Nuclear Power Plants: Design. This Safety Guide was prepared on the basis of a systematic review of all the relevant publications including the Safety Fundamentals, Safety of Nuclear Power Plants: Design, current and ongoing revisions of other Safety Guides, INSAG reports and other publications that have addressed the safety of nuclear power plants. This Safety Guide also provides guidance for Contracting Parties to the Convention on Nuclear Safety in meeting their obligations under Article 14 on Assessment and Verification of Safety. The Safety Requirements publication entitled Safety of Nuclear Power Plants: Design states that a comprehensive safety assessment and an independent verification of the safety assessment shall be carried out before the design is submitted to the regulatory body. This publication provides guidance on how this requirement should be met. This Safety Guide provides recommendations to designers for carrying out a safety assessment during the initial design process and design modifications, as well as to the operating organization in carrying out independent verification of the safety assessment of new nuclear power plants with a new or already existing design. The recommendations for performing a safety assessment are suitable also as guidance for the safety review of an existing plant. The objective of reviewing existing plants against current standards and practices is to determine whether there are any deviations which would have an impact on plant safety. The methods and the recommendations of this Safety Guide can also be used by regulatory bodies for the conduct of the regulatory review and assessment. Although most recommendations of this Safety Guide are general and applicable to all types of nuclear reactors, some specific recommendations and examples apply mostly to water cooled reactors. Terms such as 'safety assessment', 'safety analysis' and 'independent

Developmental biology, the stem cell of biological disciplines

OpenAIRE

Gilbert, Scott F.

2017-01-01

Developmental biology (including embryology) is proposed as "the stem cell of biological disciplines.” Genetics, cell biology, oncology, immunology, evolutionary mechanisms, neurobiology, and systems biology each has its ancestry in developmental biology. Moreover, developmental biology continues to roll on, budding off more disciplines, while retaining its own identity. While its descendant disciplines differentiate into sciences with a restricted set of paradigms, examples, and techniques, ...

Reactor safety research and safety technology. Pt. 2

International Nuclear Information System (INIS)

Theenhaus, R.; Wolters, J.

1987-01-01

The state of HTR safety research work reached permits a comprehensive and reliable answer to be given to questions which have been raised by the reactor accident at Chernobyl, regarding HTR safety. Together with the probability safety analyses, the way to a safety concept suitable for an HTR is cleared; instructions are given for design optimisation with regard to safety technique and economy. The consequences of a graphite fire, the neutron physics design and the consequenes of the lack of a safety containment are briefly described. (DG) [de

Safety climate and safety behaviors in the construction industry: The importance of co-workers commitment to safety.

Science.gov (United States)

Schwatka, Natalie V; Rosecrance, John C

2016-06-16

There is growing empirical evidence that as safety climate improves work site safety practice improve. Safety climate is often measured by asking workers about their perceptions of management commitment to safety. However, it is less common to include perceptions of their co-workers commitment to safety. While the involvement of management in safety is essential, working with co-workers who value and prioritize safety may be just as important. To evaluate a concept of safety climate that focuses on top management, supervisors and co-workers commitment to safety, which is relatively new and untested in the United States construction industry. Survey data was collected from a cohort of 300 unionized construction workers in the United States. The significance of direct and indirect (mediation) effects among safety climate and safety behavior factors were evaluated via structural equation modeling. Results indicated that safety climate was associated with safety behaviors on the job. More specifically, perceptions of co-workers commitment to safety was a mediator between both management commitment to safety climate factors and safety behaviors. These results support workplace health and safety interventions that build and sustain safety climate and a commitment to safety amongst work teams.

Integration of radiation protection in safety management: sharing best practices between radiation protection and other safety areas

International Nuclear Information System (INIS)

Kockerols, Pierre; Fessler, Andreas

2008-01-01

Full text: The Institute for Reference Materials and Measurements (IRMM) located in Geel is one of the seven institutes of the Joint Research Centre of the European Commission (EC, DG JRC). The institute was founded in 1960 as a nuclear research centre, but has gradually shifted its activities to also include 'non-nuclear' domains, mainly in the areas of food safety and environmental surveillance. As the activities on the IRMM site are currently quite diversified, they necessitate the operation of nuclear controlled areas, accelerators, as well as bio safety restricted areas and chemical laboratories. Therefore, the care for occupational health and safety and for environmental protection has to take into consideration various types of hazards and threats. Recently an integrated management system according to ISO-9001, ISO-14001 and OHSAS-18001 was implemented. The integrated system combines 'vertically' quality, occupational health and safety and environmental issues and covers 'horizontally' the nuclear, biological and chemical fields. The paper outlines how the radiation protection can be included in an overall health, safety and environmental management system. It will give various practical examples where synergies can be applied: 1-) the overall policy; 2-) The assessment and ranking of all risks and the identification, in a combined way, of the appropriate prevention measures; 3-) The planning and review of related actions; 4-) The monitoring, auditing and registration of anomalies and incidents and the definition of corrective actions; 5-) The training of personnel based on lessons learned from past experiences; 6-) The organisation of an internal emergency plan dealing with nuclear and non-nuclear hazards. Based on these examples, the benefits of having an integrated approach are commented. In addition, the paper will illustrate how the recent ICRP fundamental recommendations and more particularly some of the principles of radiation protection such as

Safety

International Nuclear Information System (INIS)

1998-01-01

A brief account of activities carried out by the Nuclear power plants Jaslovske Bohunice in 1997 is presented. These activities are reported under the headings: (1) Nuclear safety; (2) Industrial and health safety; (3) Radiation safety; and Fire protection

How safe are the biologicals in treating asthma and rhinitis?

Directory of Open Access Journals (Sweden)

Cox Linda S

2009-10-01

Full Text Available Abstract A number of biological agents are available or being investigated for the treatment of asthma and rhinitis. The safety profiles of these biologic agents, which may modify allergic and immunological diseases, are still being elucidated. Subcutaneous allergen immunotherapy, the oldest biologic agent in current use, has the highest of frequency of the most serious and life-threatening reaction, anaphylaxis. It is also one of the only disease modifying interventions for allergic rhinitis and asthma. Efforts to seek safer and more effective allergen immunotherapy treatment have led to investigations of alternate routes of delivery and modified immunotherapy formulations. Sublingual immunotherapy appears to be associated with a lower, but not zero, risk of anaphylaxis. No fatalities have been reported to date with sublingual immunotherapy. Immunotherapy with modified formulations containing Th1 adjuvants, DNA sequences containing a CpG motif (CpG and 3-deacylated monophospholipid A, appears to provide the benefits of subcutaneous immunotherapy with a single course of 4 to 6 preseasonal injections. There were no serious treatment-related adverse events or anaphylaxis in the clinical trials of these two immunotherapy adjuvants. Omalizumab, a monoclonal antibody against IgE, has been associated with a small risk of anaphylaxis, affecting 0.09% to 0.2% of patients. It may also be associated with a higher risk of geohelminth infection in patients at high risk for parasitic infections but it does not appear to affect the response to treatment or severity of the infection. Clinical trials with other biologic agents that have targeted IL-4/IL-13, or IL-5, have not demonstrated any definite serious treatment-related adverse events. However, these clinical trials were generally done in small populations of asthma patients, which may be too small for uncommon side effects to be identified. There is conflicting information about the safety TNF

Safety Justification and Safety Case for Safety-critical Software in Digital Reactor Protection System

International Nuclear Information System (INIS)

Kwon, Kee-Choon; Lee, Jang-Soo; Jee, Eunkyoung

2016-01-01

Nuclear safety-critical software is under strict regulatory requirements and these regulatory requirements are essential for ensuring the safety of nuclear power plants. The verification & validation (V and V) and hazard analysis of the safety-critical software are required to follow regulatory requirements through the entire software life cycle. In order to obtain a license from the regulatory body through the development and validation of safety-critical software, it is essential to meet the standards which are required by the regulatory body throughout the software development process. Generally, large amounts of documents, which demonstrate safety justification including standard compliance, V and V, hazard analysis, and vulnerability assessment activities, are submitted to the regulatory body during the licensing process. It is not easy to accurately read and evaluate the whole documentation for the development activities, implementation technology, and validation activities. The safety case methodology has been kwon a promising approach to evaluate the level and depth of the development and validation results. A safety case is a structured argument, supported by a body of evidence that provides a compelling, comprehensible, and valid case that a system is safe for a given application in a given operating environment. It is suggested to evaluate the level and depth of the results of development and validation by applying safety case methodology to achieve software safety demonstration. A lot of documents provided as evidence are connected to claim that corresponds to the topic for safety demonstration. We demonstrated a case study in which more systematic safety demonstration for the target system software is performed via safety case construction than simply listing the documents

Safety Justification and Safety Case for Safety-critical Software in Digital Reactor Protection System

Energy Technology Data Exchange (ETDEWEB)

Kwon, Kee-Choon; Lee, Jang-Soo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of); Jee, Eunkyoung [KAIST, Daejeon (Korea, Republic of)

2016-10-15

Nuclear safety-critical software is under strict regulatory requirements and these regulatory requirements are essential for ensuring the safety of nuclear power plants. The verification & validation (V and V) and hazard analysis of the safety-critical software are required to follow regulatory requirements through the entire software life cycle. In order to obtain a license from the regulatory body through the development and validation of safety-critical software, it is essential to meet the standards which are required by the regulatory body throughout the software development process. Generally, large amounts of documents, which demonstrate safety justification including standard compliance, V and V, hazard analysis, and vulnerability assessment activities, are submitted to the regulatory body during the licensing process. It is not easy to accurately read and evaluate the whole documentation for the development activities, implementation technology, and validation activities. The safety case methodology has been kwon a promising approach to evaluate the level and depth of the development and validation results. A safety case is a structured argument, supported by a body of evidence that provides a compelling, comprehensible, and valid case that a system is safe for a given application in a given operating environment. It is suggested to evaluate the level and depth of the results of development and validation by applying safety case methodology to achieve software safety demonstration. A lot of documents provided as evidence are connected to claim that corresponds to the topic for safety demonstration. We demonstrated a case study in which more systematic safety demonstration for the target system software is performed via safety case construction than simply listing the documents.

New Safety rules

CERN Multimedia

Safety Commission

2008-01-01

The revision of CERN Safety rules is in progress and the following new Safety rules have been issued on 15-04-2008: Safety Procedure SP-R1 Establishing, Updating and Publishing CERN Safety rules: http://cern.ch/safety-rules/SP-R1.htm; Safety Regulation SR-S Smoking at CERN: http://cern.ch/safety-rules/SR-S.htm; Safety Regulation SR-M Mechanical Equipment: http://cern.ch/safety-rules/SR-M.htm; General Safety Instruction GSI-M1 Standard Lifting Equipment: http://cern.ch/safety-rules/GSI-M1.htm; General Safety Instruction GSI-M2 Standard Pressure Equipment: http://cern.ch/safety-rules/GSI-M2.htm; General Safety Instruction GSI-M3 Special Mechanical Equipment: http://cern.ch/safety-rules/GSI-M3.htm. These documents apply to all persons under the Director General’s authority. All Safety rules are available at the web page: http://www.cern.ch/safety-rules The Safety Commission

The role of probabilistic safety assessment and probabilistic safety criteria in nuclear power plant safety

International Nuclear Information System (INIS)

1992-01-01

The purpose of this Safety Report is to provide guidelines on the role of probabilistic safety assessment (PSA) and a range of associated reference points, collectively referred to as probabilistic safety criteria (PSC), in nuclear safety. The application of this Safety Report and the supporting Safety Practice publication should help to ensure that PSA methodology is used appropriately to assess and enhance the safety of nuclear power plants. The guidelines are intended for use by nuclear power plant designers, operators and regulators. While these guidelines have been prepared with nuclear power plants in mind, the principles involved have wide application to other nuclear and non-nuclear facilities. In Section 2 of this Safety Report guidelines are established on the role PSA can play as part of an overall safety assurance programme. Section 3 summarizes guidelines for the conduct of PSAs, and in Section 4 a PSC framework is recommended and guidance is provided for the establishment of PSC values

Safety of Nuclear Power Plants: Design. Specific Safety Requirements

International Nuclear Information System (INIS)

2012-01-01

On the basis of the principles included in the Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, this Safety Requirements publication establishes requirements applicable to the design of nuclear power plants. It covers the design phase and provides input for the safe operation of the power plant. It elaborates on the safety objective, safety principles and concepts that provide the basis for deriving the safety requirements that must be met for the design of a nuclear power plant. Contents: 1. Introduction; 2. Applying the safety principles and concepts; 3. Management of safety in design; 4. Principal technical requirements; 5. General plant design; 6. Design of specific plant systems.

Analyzing research trends on drug safety using topic modeling.

Science.gov (United States)

Zou, Chen

2018-04-06

Published drug safety data has evolved in the past decade due to scientific and technological advances in the relevant research fields. Considering that a vast amount of scientific literature has been published in this area, it is not easy to identify the key information. Topic modeling has emerged as a powerful tool to extract meaningful information from a large volume of unstructured texts. Areas covered: We analyzed the titles and abstracts of 4347 articles in four journals dedicated to drug safety from 2007 to 2016. We applied Latent Dirichlet allocation (LDA) model to extract 50 main topics, and conducted trend analysis to explore the temporal popularity of these topics over years. Expert Opinion/Commentary: We found that 'benefit-risk assessment and communication', 'diabetes' and 'biologic therapy for autoimmune diseases' are the top 3 most published topics. The topics relevant to the use of electronic health records/observational data for safety surveillance are becoming increasingly popular over time. Meanwhile, there is a slight decrease in research on signal detection based on spontaneous reporting, although spontaneous reporting still plays an important role in benefit-risk assessment. The topics related to medical conditions and treatment showed highly dynamic patterns over time.

Discussion on the safety classification of nuclear safety mechanical equipment

International Nuclear Information System (INIS)

Shen Wei

2010-01-01

The purpose and definition of the equipment safety classification in nuclear plant are introduced. The differences of several safety classification criterions are compared, and the object of safety classification is determined. According to the regulation, the definition and category of the safety functions are represented. The safety classification method, safety classification process, safety class interface, and the requirement for the safety class mechanical equipment are explored. At last, the relation of the safety classification between the mechanical and electrical equipment is presented, and the relation of the safety classification between mechanical equipment and system is also presented. (author)

Traceability of Software Safety Requirements in Legacy Safety Critical Systems

Science.gov (United States)

Hill, Janice L.

2007-01-01

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

Organization A Comprehensive System Of Insurance Coverage In The Potential Chemical And Biological Contamination Zone In Regions

Directory of Open Access Journals (Sweden)

Nina Vladimirovna Zaytseva

2014-12-01

Full Text Available The article provides a scientific rationale for an integrated approach to the provision of insurance coverage in the potential chemical and biological contamination zone. The following modern forms of chemical safety in the Russian Federation were considered: state reserve’s system, target program financing, state social insurance. The separate issue tackles the obligatory civil liability insurance for owners of dangerous objects. For improvement of the existing insurance protection system against emergency situations, risks were analyzed (shared on exogenous and endogenous. Among the exogenous risks including natural and climatic conditions of a region, its geographical arrangement, economic specialization, the seismic and terrorist risks were chosen and approaches to its solution were suggested. In endogenous risks’ group, the special focus is on wear and tear and obsolescence of hazardous chemical and biological object’s fixed assets. In case of high risk of an incident, it is suggested to increase in extent of insurance protection through self-insurance, a mutual insurance in the form of the organization of societies of a mutual insurance or the self-regulating organizations, and also development of voluntary insurance of a civil liability, both the owner of hazardous object, and regions of the Russian Federation and municipalities. The model of insurance coverage in the potential chemical and biological contamination zone is based on a differentiated approach to the danger level of the area. A matrix of adequate forms and types of insurance (required for insurance coverage of the population in the potential chemical and biological contamination zone was constructed. Proposed health risk management toolkit in the potential chemical and biological contamination zone will allow to use financial resources for chemical and biological safety in the regions more efficiently.

Safety design

International Nuclear Information System (INIS)

Kunitomi, Kazuhiko; Shiozawa, Shusaku

2004-01-01

JAERI established the safety design philosophy of the HTTR based on that of current reactors such as LWR in Japan, considering inherent safety features of the HTTR. The strategy of defense in depth was implemented so that the safety engineering functions such as control of reactivity, removal of residual heat and confinement of fission products shall be well performed to ensure safety. However, unlike the LWR, the inherent design features of the high-temperature gas-cooled reactor (HTGR) enables the HTTR meet stringent regulatory criteria without much dependence on active safety systems. On the other hand, the safety in an accident typical to the HTGR such as the depressurization accident initiated by a primary pipe rupture shall be ensured. The safety design philosophy of the HTTR considers these unique features appropriately and is expected to be the basis for future Japanese HTGRs. This paper describes the safety design philosophy and safety evaluation procedure of the HTTR especially focusing on unique considerations to the HTTR. Also, experiences obtained from an HTTR safety review and R and D needs for establishing the safety philosophy for the future HTGRs are reported

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.

Engineering nanomaterials-based biosensors for food safety detection.

Science.gov (United States)

Lv, Man; Liu, Yang; Geng, Jinhui; Kou, Xiaohong; Xin, Zhihong; Yang, Dayong

2018-05-30

Food safety always remains a grand global challenge to human health, especially in developing countries. To solve food safety pertained problems, numerous strategies have been developed to detect biological and chemical contaminants in food. Among these approaches, nanomaterials-based biosensors provide opportunity to realize rapid, sensitive, efficient and portable detection, overcoming the restrictions and limitations of traditional methods such as complicated sample pretreatment, long detection time, and relying on expensive instruments and well-trained personnel. In this review article, we provide a cross-disciplinary perspective to review the progress of nanomaterials-based biosensors for the detection of food contaminants. The review article is organized by the category of food contaminants including pathogens/toxins, heavy metals, pesticides, veterinary drugs and illegal additives. In each category of food contaminant, the biosensing strategies are summarized including optical, colorimetric, fluorescent, electrochemical, and immune- biosensors; the relevant analytes, nanomaterials and biosensors are analyzed comprehensively. Future perspectives and challenges are also discussed briefly. We envision that our review could bridge the gap between the fields of food science and nanotechnology, providing implications for the scientists or engineers in both areas to collaborate and promote the development of nanomaterials-based biosensors for food safety detection. Copyright © 2018 Elsevier B.V. All rights reserved.

HSE's safety assessment principles for criticality safety

International Nuclear Information System (INIS)

Simister, D N; Finnerty, M D; Warburton, S J; Thomas, E A; Macphail, M R

2008-01-01

The Health and Safety Executive (HSE) published its revised Safety Assessment Principles for Nuclear Facilities (SAPs) in December 2006. The SAPs are primarily intended for use by HSE's inspectors when judging the adequacy of safety cases for nuclear facilities. The revised SAPs relate to all aspects of safety in nuclear facilities including the technical discipline of criticality safety. The purpose of this paper is to set out for the benefit of a wider audience some of the thinking behind the final published words and to provide an insight into the development of UK regulatory guidance. The paper notes that it is HSE's intention that the Safety Assessment Principles should be viewed as a reflection of good practice in the context of interpreting primary legislation such as the requirements under site licence conditions for arrangements for producing an adequate safety case and for producing a suitable and sufficient risk assessment under the Ionising Radiations Regulations 1999 (SI1999/3232 www.opsi.gov.uk/si/si1999/uksi_19993232_en.pdf). (memorandum)

ITER safety

International Nuclear Information System (INIS)

Raeder, J.; Piet, S.; Buende, R.

1991-01-01

As part of the series of publications by the IAEA that summarize the results of the Conceptual Design Activities for the ITER project, this document describes the ITER safety analyses. It contains an assessment of normal operation effluents, accident scenarios, plasma chamber safety, tritium system safety, magnet system safety, external loss of coolant and coolant flow problems, and a waste management assessment, while it describes the implementation of the safety approach for ITER. The document ends with a list of major conclusions, a set of topical remarks on technical safety issues, and recommendations for the Engineering Design Activities, safety considerations for siting ITER, and recommendations with regard to the safety issues for the R and D for ITER. Refs, figs and tabs

Safety culture

International Nuclear Information System (INIS)

Keen, L.J.

2003-01-01

Safety culture has become a topic of increasing interest for industry and regulators as issues are raised on safety problems around the world. The keys to safety culture are organizational effectiveness, effective communications, organizational learning, and a culture that encourages the identification and resolution of safety issues. The necessity of a strong safety culture places an onus on all of us to continually question whether the safety measures already in place are sufficient, and are being applied. (author)

Safety Climate, Perceived Risk, and Involvement in Safety Management

OpenAIRE

Kouabenan , Dongo Rémi; Ngueutsa , Robert ,; Safiétou , Mbaye

2015-01-01

International audience; This article examines the relationship between safety climate, risk perception and involvement in safety management by first-line managers (FLM). Sixty-three FLMs from two French nuclear plants answered a questionnaire measuring perceived workplace safety climate, perceived risk, and involvement in safety management. We hypothesized that a positive perception of safety climate would promote substantial involvement in safety management, and that this effect would be str...

A vital legacy: Biological and environmental research in the atomic age

Energy Technology Data Exchange (ETDEWEB)

Vaughan, D. [ed.

1997-09-01

This booklet presents a summary of the five decades of biological and environmental research in the atomic age. It commemorates the contributions to science and society during these decades and concludes with a view to the years ahead. The Contents includes `Safety First: in the Shadow of a New Technology; A Healthy Citizenry: Gifts of the New Era; and Environmental Concerns: From Meteorology to Ecology`. The conclusion is titled `An Enduring Mandate: Looking to the Future`.

A Vital Legacy: Biological and Environmental Research in the Atomic Age

Science.gov (United States)

1997-09-01

This booklet presents a summary of the five decades of biological and environmental research in the atomic age. It commemorates the contributions to science and society during these decades and concludes with a view to the years ahead. The Contents includes Safety First: in the Shadow of a New Technology; A Healthy Citizenry: Gifts of the New Era; and Environmental Concerns: From Meteorology to Ecology. The conclusion is titled An Enduring Mandate: Looking to the Future.

10 CFR 70.62 - Safety program and integrated safety analysis.

Science.gov (United States)

2010-01-01

...; (iv) Potential accident sequences caused by process deviations or other events internal to the... have experience in nuclear criticality safety, radiation safety, fire safety, and chemical process... this safety program; namely, process safety information, integrated safety analysis, and management...

Safety Assessment for Research Reactors and Preparation of the Safety Analysis Report. Specific Safety Guide

Energy Technology Data Exchange (ETDEWEB)

NONE

2011-11-15

The IAEA's Statute authorizes the Agency to 'establish or adopt' standards of safety for protection of health and minimization of danger to life and property' - standards that the IAEA must use in its own operations, and which States can apply by means of their regulatory provisions for nuclear and radiation safety. The IAEA does this in consultation with the competent organs of the United Nations and with the specialized agencies concerned. A comprehensive set of high quality standards under regular review is a key element of a stable and sustainable global safety regime, as is the IAEA's assistance in their application. The IAEA commenced its safety standards programme in 1958. The emphasis placed on quality, fitness for purpose and continuous improvement has led to the widespread use of the IAEA standards throughout the world. The Safety Standards Series now includes unified Fundamental Safety Principles, which represent an international consensus on what must constitute a high level of protection and safety. With the strong support of the Commission on Safety Standards, the IAEA is working to promote the global acceptance and use of its standards. Standards are only effective if they are properly applied in practice. The IAEA's safety services encompass design, siting and engineering safety, operational safety, radiation safety, safe transport of radioactive material and safe management of radioactive waste, as well as governmental organization, regulatory matters and safety culture in organizations. These safety services assist Member States in the application of the standards and enable valuable experience and insights to be shared. Regulating safety is a national responsibility, and many States have decided to adopt the IAEA's standards for use in their national regulations. For parties to the various international safety conventions, IAEA standards provide a consistent, reliable means of ensuring the effective fulfilment of obligations under the conventions

Safety Assessment for Research Reactors and Preparation of the Safety Analysis Report. Specific Safety Guide

International Nuclear Information System (INIS)

2011-01-01

The IAEA's Statute authorizes the Agency to 'establish or adopt' standards of safety for protection of health and minimization of danger to life and property' - standards that the IAEA must use in its own operations, and which States can apply by means of their regulatory provisions for nuclear and radiation safety. The IAEA does this in consultation with the competent organs of the United Nations and with the specialized agencies concerned. A comprehensive set of high quality standards under regular review is a key element of a stable and sustainable global safety regime, as is the IAEA's assistance in their application. The IAEA commenced its safety standards programme in 1958. The emphasis placed on quality, fitness for purpose and continuous improvement has led to the widespread use of the IAEA standards throughout the world. The Safety Standards Series now includes unified Fundamental Safety Principles, which represent an international consensus on what must constitute a high level of protection and safety. With the strong support of the Commission on Safety Standards, the IAEA is working to promote the global acceptance and use of its standards. Standards are only effective if they are properly applied in practice. The IAEA's safety services encompass design, siting and engineering safety, operational safety, radiation safety, safe transport of radioactive material and safe management of radioactive waste, as well as governmental organization, regulatory matters and safety culture in organizations. These safety services assist Member States in the application of the standards and enable valuable experience and insights to be shared. Regulating safety is a national responsibility, and many States have decided to adopt the IAEA's standards for use in their national regulations. For parties to the various international safety conventions, IAEA standards provide a consistent, reliable means of ensuring the effective fulfilment of obligations under the conventions

MATHEMATICAL MODEL OF AUTOMATED REHABILITATION SYSTEM WITH BIOLOGICAL FEEDBACK FOR REHABILITATION AND DEVELOPMENT OF MUSCULOSKELETAL SYSTEM

Directory of Open Access Journals (Sweden)

Kirill A. Kalyashin

2013-01-01

Full Text Available In order to increase the efficiency and safety of rehabilitation of musculoskeletal system, the model and the algorithm for patient interaction with automated rehabilitation system with biological feedback was developed, based on registration and management of the second functional parameter, which prevents risks of overwork while intensive exercises.

IAEA Safety Standards

International Nuclear Information System (INIS)

2016-09-01

The IAEA Safety Standards Series comprises publications of a regulatory nature covering nuclear safety, radiation protection, radioactive waste management, the transport of radioactive material, the safety of nuclear fuel cycle facilities and management systems. These publications are issued under the terms of Article III of the IAEA’s Statute, which authorizes the IAEA to establish “standards of safety for protection of health and minimization of danger to life and property”. Safety standards are categorized into: • Safety Fundamentals, stating the basic objective, concepts and principles of safety; • Safety Requirements, establishing the requirements that must be fulfilled to ensure safety; and • Safety Guides, recommending measures for complying with these requirements for safety. For numbering purposes, the IAEA Safety Standards Series is subdivided into General Safety Requirements and General Safety Guides (GSR and GSG), which are applicable to all types of facilities and activities, and Specific Safety Requirements and Specific Safety Guides (SSR and SSG), which are for application in particular thematic areas. This booklet lists all current IAEA Safety Standards, including those forthcoming

78 FR 53790 - Public Forum-Safety Culture: Enhancing Transportation Safety

Science.gov (United States)

2013-08-30

... NATIONAL TRANSPORTATION SAFETY BOARD Public Forum--Safety Culture: Enhancing Transportation Safety On Tuesday and Wednesday, September 10-11, 2013, the National Transportation Safety Board (NTSB) will convene a forum titled, ``Safety Culture: Enhancing Transportation Safety.'' The forum will begin at 9:00...

Nuclear safety

International Nuclear Information System (INIS)

1991-02-01

This book reviews the accomplishments, operations, and problems faced by the defense Nuclear Facilities Safety Board. Specifically, it discusses the recommendations that the Safety Board made to improve safety and health conditions at the Department of Energy's defense nuclear facilities, problems the Safety Board has encountered in hiring technical staff, and management problems that could affect the Safety Board's independence and credibility

Auto Safety

Science.gov (United States)

... Safe Videos for Educators Search English Español Auto Safety KidsHealth / For Parents / Auto Safety What's in this ... by teaching some basic rules. Importance of Child Safety Seats Using a child safety seat (car seat) ...

LFR safety approach and main ELFR safety analysis results

International Nuclear Information System (INIS)

Bubelis, E.; Schikorr, M.; Frogheri, M.; Mansani, L.; Bandini, G.; Burgazzi, L.; Mikityuk, K.; Zhang, Y.; Lo Frano, R.; Forgione, N.

2013-01-01

LFR safety approach: → A global safety approach for the LFR reference plant has been assessed and the safety analyses methodology has been developed. → LFR follows the general guidelines of the Generation IV safety concept recommendations. Thus, improved safety and higher reliability are recognized as an essential priority. → The fundamental safety objectives and the Defence-in-Depth (DiD) approach, as described by IAEA Safety Guides, have been preserved. → The recommendations of the Risk and Safety Working Group (RSWG) of GEN-IV IF has been taken into account: • safety is to be “built-in” in the fundamental design rather than “added on”; • full implementation of the Defence-in-Depth principles in a manner that is demonstrably exhaustive, progressive, tolerant, forgiving and well-balanced; • “risk-informed” approach - deterministic approach complemented with a probabilistic one; • adoption of an integrated methodology that can be used to evaluate and document the safety of Gen IV nuclear systems - ISAM. In particular the OPT tool is the fundamental methodology used throughout the design process

Building Design Guidelines of Interior Architecture for Bio safety Levels of Biology Laboratories

International Nuclear Information System (INIS)

ElDib, A.A.

2014-01-01

This paper discusses the pivotal role of the Interior Architecture As one of the scientific disciplines minute to complete the Architectural Sciences, which relied upon the achievement and development of facilities containing scientific research laboratories, in terms of planning and design, particularly those containing biological laboratories using radioactive materials, adding to that, the application of the materials or raw materials commensurate with each discipline of laboratory and its work nature, and by the discussion the processing of design techniques and requirements of interior architecture dealing with Research Laboratory for electronic circuits an their applications with the making of its prototypes

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...

The association between EMS workplace safety culture and safety outcomes.

Science.gov (United States)

Weaver, Matthew D; Wang, Henry E; Fairbanks, Rollin J; Patterson, Daniel

2012-01-01

Prior studies have highlighted wide variation in emergency medical services (EMS) workplace safety culture across agencies. To determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, working conditions, stress recognition, and job satisfaction. A panel of medical directors, emergency medical technicians and paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Sixteen percent of all respondents reported experiencing an injury in the past three months, four of every 10 respondents reported an error or adverse event (AE), and 89% reported safety-compromising behaviors. Respondents reporting injury scored lower on five of the six domains of safety culture. Respondents reporting an error or AE scored lower for four of the six domains, while respondents reporting safety-compromising behavior had lower safety culture scores for five of the six domains. Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes.

Software quality assurance and software safety in the Biomed Control System

International Nuclear Information System (INIS)

Singh, R.P.; Chu, W.T.; Ludewigt, B.A.; Marks, K.M.; Nyman, M.A.; Renner, T.R.; Stradtner, R.

1989-01-01

The Biomed Control System is a hardware/software system used for the delivery, measurement and monitoring of heavy-ion beams in the patient treatment and biology experiment rooms in the Bevalac at the Lawrence Berkeley Laboratory (LBL). This paper describes some aspects of this system including historical background philosophy, configuration management, hardware features that facilitate software testing, software testing procedures, the release of new software quality assurance, safety and operator monitoring. 3 refs

Report of transparency and nuclear safety 2007 CEA Fontenay aux Roses

International Nuclear Information System (INIS)

2007-01-01

This report presents the activities of the CEA Center of Fontenay aux roses for the year 2007. After many years of decommissioning and dismantling of nuclear installations, the Center is now devoted (since 2005) to the development of research programmes on biology and biomedical technologies. The actions concerning the safety, the radiation protection, the significant events, the release control and the environmental impacts and the wastes stored on the center are discussed. (A.L.B.)

Environmental contamination by cyclophosphamide preparation: Comparison of conventional manual production in biological safety cabinet and robot-assisted production by APOTECAchemo.

Science.gov (United States)

Schierl, Rudolf; Masini, Carla; Groeneveld, Svenja; Fischer, Elke; Böhlandt, Antje; Rosini, Valeria; Paolucci, Demis

2016-02-01

The aim of this study was to compare environmental contamination of cyclophosphamide (CP) during 1 week of drug compounding by conventional manual procedure in a biological safety cabinet (BSC) with laminar airflow and a new robotic drug preparation system (APOTECAchemo). During four consecutive days, similar numbers of infusion bags with cyclophosphamide were prepared with both techniques in a cross-over design. Wipe samples (49 for BSC, 50 for APOTECAchemo) were taken at several locations (gloves, infusion bags, trays, BSC-benches, floor) in the pharmacy and analyzed for CP concentrations by GC-MSMS (LOD 0.2 ng/sample). The detection rate was 70% in the BSC versus 15% in APOTECAchemo. During manual preparation of admixtures using BSC contamination with CP was below 0.001 ng/cm(2) at most locations, but significant on gloves (0.0004-0.0967 ng/cm(2)) and the majority (70%) of infusion bags (preparation by APOTECAchemo, gloves (1 of 8: 0.0007 ng/cm(2)) and infusion bags (3 of 20: 0.0005, 0.0019, 0.0094 ng/cm(2)) were considerably less contaminated. Residual contamination was found on the surfaces under the dosing device in the compounding area (0.0293-0.1603 ng/cm(2)) inside the robotic system. Compared to outcomes of other studies, our results underline good manufacturing procedures in this pharmacy with low contamination for both techniques (BSC and APOTECAchemo). Comparison of both preparation procedures validated that contamination of infusion bags was much lower by using the robotic system. © The Author(s) 2014.

Transformational and passive leadership as cross-level moderators of the relationships between safety knowledge, safety motivation, and safety participation.

Science.gov (United States)

Jiang, Lixin; Probst, Tahira M

2016-06-01

While safety knowledge and safety motivation are well-established predictors of safety participation, less is known about the impact of leadership styles on these relationships. The purpose of the current study was to examine whether the positive relationships between safety knowledge and motivation and safety participation are contingent on transformational and passive forms of safety leadership. Using multilevel modeling with a sample of 171 employees nested in 40 workgroups, we found that transformational safety leadership strengthened the safety knowledge-participation relationship, whereas passive leadership weakened the safety motivation-participation relationship. Under low transformational leadership, safety motivation was not related to safety participation; under high passive leadership, safety knowledge was not related to safety participation. These results are discussed in light of organizational efforts to increase safety-related citizenship behaviors. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

Selecting of key safety parameters in reactor nuclear safety supervision

International Nuclear Information System (INIS)

He Fan; Yu Hong

2014-01-01

The safety parameters indicate the operational states and safety of research reactor are the basis of nuclear safety supervision institution to carry out effective supervision to nuclear facilities. In this paper, the selecting of key safety parameters presented by the research reactor operating unit to National Nuclear Safety Administration that can express the research reactor operational states and safety when operational occurrence or nuclear accident happens, and the interrelationship between them are discussed. Analysis shows that, the key parameters to nuclear safety supervision of research reactor including design limits, operational limits and conditions, safety system settings, safety limits, acceptable limits and emergency action level etc. (authors)

Pembangunan Kebun Biologi Wamena*[establishment of Wamena Biological Gardens

OpenAIRE

Rahmansyah, M; Latupapua, HJD

2003-01-01

The richness of biological resources (biodiversity) in mountainous area of Papua is an asset that has to be preserved.Exploitation of natural resources often cause damage on those biological assets and as genetic resources.Care has to be taken to overcome the situation of biological degradation, and alternate steps had been shaped on ex-situ biological conservation. Wamena Biological Gardens, as an ex-situ biological conservation, has been established to keep the high mountain biological and ...

Occupational Safety and Health Program at the West Valley Demonstration Project

International Nuclear Information System (INIS)

L. M. Calderon

1999-01-01

The West Valley Nuclear Services Co. LLC (WVNS) is committed to provide a safe, clean, working environment for employees, and to implement U.S. Department of Energy (DOE) requirements affecting worker safety. The West Valley Demonstration Project (WVDP) Occupational Safety and Health Program is designed to protect the safety, health, and well-being of WVDP employees by identifying, evaluating, and controlling biological, chemical, and physical hazards in the work place. Hazards are controlled within the requirements set forth in the reference section at the end of this report. It is the intent of the WVDP Occupational Safety and Health Program to assure that each employee is provided with a safe and healthy work environment. This report shows the logical path toward ensuring employee safety in planning work at the WVDP. In general, planning work to be performed safely includes: combining requirements from specific programs such as occupational safety, industrial hygiene, radiological control, nuclear safety, fire safety, environmental protection, etc.; including WVDP employees in the safety decision-making processes; pre-planning using safety support re-sources; and integrating the safety processes into the work instructions. Safety management principles help to define the path forward for the WVDP Occupational Safety and Health Program. Roles, responsibilities, and authority of personnel stem from these ideals. WVNS and its subcontractors are guided by the following fundamental safety management principles: ''Protection of the environment, workers, and the public is the highest priority. The safety and well-being of our employees, the public, and the environment must never be compromised in the aggressive pursuit of results and accomplishment of work product. A graded approach to environment, safety, and health in design, construction, operation, maintenance, and deactivation is incorporated to ensure the protection of the workers, the public, and the environment

Development trend of radiation biology research-systems radiation biology

International Nuclear Information System (INIS)

Min Rui

2010-01-01

Radiation biology research has past 80 years. We have known much more about fundamentals, processes and results of biology effects induced by radiation and various factors that influence biology effects wide and deep, however many old and new scientific problems occurring in the field of radiation biology research remain to be illustrated. To explore and figure these scientific problems need systemic concept, methods and multi dimension view on the base of considerations of complexity of biology system, diversity of biology response, temporal and spatial process of biological effects during occurrence, and complex feed back network of biological regulations. (authors)

Perceived organizational support for safety and employee safety voice: the mediating role of coworker support for safety.

Science.gov (United States)

Tucker, Sean; Chmiel, Nik; Turner, Nick; Hershcovis, M Sandy; Stride, Chris B

2008-10-01

In the present study, we modeled 2 sources of safety support (perceived organizational support for safety and perceived coworker support for safety) as predictors of employee safety voice, that is, speaking out in an attempt to change unsafe working conditions. Drawing on social exchange and social impact theories, we hypothesized and tested a mediated model predicting employee safety voice using a cross-sectional survey of urban bus drivers (n = 213) in the United Kingdom. Hierarchical regression analysis showed that perceived coworker support for safety fully mediated the relationship between perceived organizational support for safety and employee safety voice. This study adds to the employee voice literature by evaluating the important role that coworkers can play in encouraging others to speak out about safety issues. Implications for research and practice related to change-oriented safety communication are discussed.

Safety of Research Reactors. Specific Safety Requirements (French Edition)

International Nuclear Information System (INIS)

2017-01-01

This Safety Requirements publication establishes requirements for all main areas of safety for research reactors, with particular emphasis on requirements for design and operation. It explains the safety objectives and concepts that form the basis for safety and safety assessment for all stages in the lifetime of a research reactor. Technical and administrative requirements for the safety of new research reactors are established in accordance with these objectives and concepts, and they are to be applied to the extent practicable for existing research reactors. The safety requirements established in this publication for the management of safety and regulatory supervision apply to site evaluation, design, manufacturing, construction, commissioning, operation (including utilization and modification), and planning for decommissioning of research reactors (including critical assemblies and subcritical assemblies). The publication is intended for use by regulatory bodies and other organizations with responsibilities in these areas and in safety analysis, verification and review, and the provision of technical support.

Do-it-yourself biology: challenges and promises for an open science and technology movement.

Science.gov (United States)

Landrain, Thomas; Meyer, Morgan; Perez, Ariel Martin; Sussan, Remi

2013-09-01

The do-it-yourself biology (DIYbio) community is emerging as a movement that fosters open access to resources permitting modern molecular biology, and synthetic biology among others. It promises in particular to be a source of cheaper and simpler solutions for environmental monitoring, personal diagnostic and the use of biomaterials. The successful growth of a global community of DIYbio practitioners will depend largely on enabling safe access to state-of-the-art molecular biology tools and resources. In this paper we analyze the rise of DIYbio, its community, its material resources and its applications. We look at the current projects developed for the international genetically engineered machine competition in order to get a sense of what amateur biologists can potentially create in their community laboratories over the coming years. We also show why and how the DIYbio community, in the context of a global governance development, is putting in place a safety/ethical framework for guarantying the pursuit of its activity. And finally we argue that the global spread of DIY biology potentially reconfigures and opens up access to biological information and laboratory equipment and that, therefore, it can foster new practices and transversal collaborations between professional scientists and amateurs.

Relationships among Safety Climate, Safety Behavior, and Safety Outcomes for Ethnic Minority Construction Workers

Directory of Open Access Journals (Sweden)

Sainan Lyu

2018-03-01

Full Text Available In many countries, it is common practice to attract and employ ethnic minority (EM or migrant workers in the construction industry. This primarily occurs in order to alleviate the labor shortage caused by an aging workforce with a lack of new entrants. Statistics show that EM construction workers are more likely to have occupational fatal and nonfatal injuries than their local counterparts; however, the mechanism underlying accidents and injuries in this vulnerable population has been rarely examined. This study aims to investigate relationships among safety climate, safety behavior, and safety outcomes for EM construction workers. To this end, a theoretical research model was developed based on a comprehensive review of the current literature. In total, 289 valid questionnaires were collected face-to-face from 223 Nepalese construction workers and 56 Pakistani construction workers working on 15 construction sites in Hong Kong. Structural equation modelling was employed to validate the constructs and test the hypothesized model. Results show that there were significant positive relationships between safety climate and safety behaviors, and significant negative relationships between safety behaviors and safety outcomes for EM construction workers. This research contributes to the literature regarding EM workers by providing empirical evidence of the mechanisms by which safety climate affects safety behaviors and outcomes. It also provides insights in order to help the key stakeholders formulate safety strategies for EM workers in many areas where numerous EM workers are employed, such as in the U.S., the UK, Australia, Singapore, Malaysia, and the Middle East.

Relationships among Safety Climate, Safety Behavior, and Safety Outcomes for Ethnic Minority Construction Workers.

Science.gov (United States)

Lyu, Sainan; Hon, Carol K H; Chan, Albert P C; Wong, Francis K W; Javed, Arshad Ali

2018-03-09

In many countries, it is common practice to attract and employ ethnic minority (EM) or migrant workers in the construction industry. This primarily occurs in order to alleviate the labor shortage caused by an aging workforce with a lack of new entrants. Statistics show that EM construction workers are more likely to have occupational fatal and nonfatal injuries than their local counterparts; however, the mechanism underlying accidents and injuries in this vulnerable population has been rarely examined. This study aims to investigate relationships among safety climate, safety behavior, and safety outcomes for EM construction workers. To this end, a theoretical research model was developed based on a comprehensive review of the current literature. In total, 289 valid questionnaires were collected face-to-face from 223 Nepalese construction workers and 56 Pakistani construction workers working on 15 construction sites in Hong Kong. Structural equation modelling was employed to validate the constructs and test the hypothesized model. Results show that there were significant positive relationships between safety climate and safety behaviors, and significant negative relationships between safety behaviors and safety outcomes for EM construction workers. This research contributes to the literature regarding EM workers by providing empirical evidence of the mechanisms by which safety climate affects safety behaviors and outcomes. It also provides insights in order to help the key stakeholders formulate safety strategies for EM workers in many areas where numerous EM workers are employed, such as in the U.S., the UK, Australia, Singapore, Malaysia, and the Middle East.

Build green and conventional materials off-gassing tests: A final report

Energy Technology Data Exchange (ETDEWEB)

Piersol, P.

1995-12-31

Build Green is a certification program that will identify and label building products with a known recycled content. The introduction of these recycled materials has raised the concern that they may emit more indoor pollutants than conventional materials. This study addresses that concern by analyzing Build Green and conventional materials to assess their potential for off-gassing. The study involved emission tests of 37 materials including carpets, carpet undercushions, structural lumber, foundation material, insulation, drywall, fiberboard, counter tops, and cabinetry. The results presented in this report include comparisons of Build Green and conventional materials in terms of emissions of volatile organic compounds and formaldehyde, the material loading ratio, and discussion of the specific sources of the emissions.

Evaluation of Potential Biological Threats in Ukraine

International Nuclear Information System (INIS)

Pozdnyakova, L.; Slavina, N.; Pozdnyakov, S.

2007-01-01

Dilating of biological threats spectrum, EDI diffusion opportunities and routes, unpredictability of outbreaks connected with connatural, technogenic, terrorist factors determines constant monitoring and readiness for operative BPA indication and identification. Scientific analytical approach of existing and probable regional bio-threats evaluation is necessary for adequate readiness system creation and maintenance of medical counteraction tactics to probable biological threats. Basing on the international experience, we carry out analysis of a situation present in Ukraine and routes for the decisions. The basic directions are: - Evaluation of a reality for EDI penetration from abroad and presence of conditions for their further diffusion inside the country. - Revealing of presence and definition of connatural EDI foci biocenoses features and BPAs. - Appropriate level of biological safety and physical protection of bio-laboratories and pathogens collections maintenance. - Gene/molecular and phenotypical definition of EDI circulating strains. - Creation of the circulating EDI gene/ phenotypic characteristics regional data bank. - Ranging of EDI actual for area. - Introduction of GPT, mathematical modeling and forecasting for tactics development in case of technogenic accidents and connatural outbreaks. - Methodical basis and equipment improvement for BPA system indication for well-timed identification of natural, or modified agent. - Education and training The international cooperation in maintenance of biosafety and bioprotection within the framework of scientific programs, grants, exchange of experience, introduction of international standards and rules are among basic factors in the decision for creating system national biosafety for countries not included in EU and the NATO. (author)

Safety culture : a significant influence on safety in transportation

Science.gov (United States)

2017-08-01

An organizations safety culture can influence safety outcomes. Research and experience show that when safety culture is strong, accidents are less frequent and less severe. As a result, building and maintaining strong safety cultures should be a t...

Relations between Intuitive Biological Thinking and Biological Misconceptions in Biology Majors and Nonmajors

Science.gov (United States)

Coley, John D.; Tanner, Kimberly

2015-01-01

Research and theory development in cognitive psychology and science education research remain largely isolated. Biology education researchers have documented persistent scientifically inaccurate ideas, often termed "misconceptions," among biology students across biological domains. In parallel, cognitive and developmental psychologists…

Synthetic Biology: Putting Synthesis into Biology

Science.gov (United States)

Liang, Jing; Luo, Yunzi; Zhao, Huimin

2010-01-01

The ability to manipulate living organisms is at the heart of a range of emerging technologies that serve to address important and current problems in environment, energy, and health. However, with all its complexity and interconnectivity, biology has for many years been recalcitrant to engineering manipulations. The recent advances in synthesis, analysis, and modeling methods have finally provided the tools necessary to manipulate living systems in meaningful ways, and have led to the coining of a field named synthetic biology. The scope of synthetic biology is as complicated as life itself – encompassing many branches of science, and across many scales of application. New DNA synthesis and assembly techniques have made routine the customization of very large DNA molecules. This in turn has allowed the incorporation of multiple genes and pathways. By coupling these with techniques that allow for the modeling and design of protein functions, scientists have now gained the tools to create completely novel biological machineries. Even the ultimate biological machinery – a self-replicating organism – is being pursued at this moment. It is the purpose of this review to dissect and organize these various components of synthetic biology into a coherent picture. PMID:21064036

Application of a calculational model for thermal neutrons through biological shields

Energy Technology Data Exchange (ETDEWEB)

Hathout, A M [Nuclear engineering safety department, national center for nuclear safety and radiation, Nasr City Cairo, (Egypt)

1995-10-01

In this work a computational program, based on the Boltzmann transport integrodifferential equation, is applied. The scattering kernel is represented by the synthetic scattering model. The behaviour of thermal neutron in hydrogenous materials, which can be used as biological shields, are studied. These materials are water, polyethylene, Oak-Ridge concrete, ordinary concrete and manganese concrete. The data obtained are presented in tables. The results are analysed and compared with similar experimental values. Safety evaluation and environmental impact are discussed. 2 tabs.

Effects of Biologic Agents in Patients with Rheumatoid Arthritis and Amyloidosis Treated with Hemodialysis.

Science.gov (United States)

Kuroda, Takeshi; Tanabe, Naohito; Nozawa, Yukiko; Sato, Hiroe; Nakatsue, Takeshi; Kobayashi, Daisuke; Wada, Yoko; Saeki, Takako; Nakano, Masaaki; Narita, Ichiei

Objective Our objective was to examine the safety and effects of therapy with biologics on the prognosis of rheumatoid arthritis (RA) patients with reactive amyloid A (AA) amyloidosis on hemodialysis (HD). Methods Twenty-eight patients with an established diagnosis of reactive AA amyloidosis participated in the study. The survival was calculated from the date of HD initiation until the time of death, or up to end of June 2015 for the patients who were still alive. HD initiation was according to the program of HD initiation for systemic amyloidosis patients associated with RA. Results Ten patients had been treated with biologics before HD initiation for a mean of 28.2 months (biologic group), while 18 had not (non-biologic group). HD was initiated in patients with similar characteristics except for the tender joint count, swollen joint count, and disease activity score (DAS)28-C-reactive protein (CRP). History of biologics showed that etanercept was frequently used for 8 patients as the first biologic. There was no significant difference in the mortality rate according to a Kaplan-Meier analysis (p=0.939) and or associated risk of death in an age-adjusted Cox proportional hazards model (p=0.758) between both groups. Infections were significantly more frequent causes of death in the biologic group than in the non-biologic group (p=0.021). However, treatment with biologics improved the DAS28-CRP score (p=0.004). Conclusion Under the limited conditions of AA amyloidosis treated with HD, the use of biologics might affect infection and thus may not improve the prognosis. Strict infection control is necessary for the use of biologics with HD to improve the prognosis.

Total safety management: An approach to improving safety culture

International Nuclear Information System (INIS)

Blush, S.M.

1993-01-01

A little over 4 yr ago, Admiral James D. Watkins became Secretary of Energy. President Bush, who had appointed him, informed Watkins that his principal task would be to clean up the nuclear weapons complex and put the US Department of Energy (DOE) back in the business of producing tritium for the nation's nuclear deterrent. Watkins recognized that in order to achieve these objectives, he would have to substantially improve the DOE's safety culture. Safety culture is a relatively new term. The International Atomic Energy Agency (IAEA) used it in a 1986 report on the root causes of the Chernobyl nuclear accident. In 1990, the IAEA's International Nuclear Safety Advisory Group issued a document focusing directly on safety culture. It provides guidelines to the international nuclear community for measuring the effectiveness of safety culture in nuclear organizations. Safety culture has two principal aspects: an organizational framework conducive to safety and the necessary organizational and individual attitudes that promote safety. These obviously go hand in hand. An organization must create the right framework to foster the right attitudes, but individuals must have the right attitudes to create the organizational framework that will support a good safety culture. The difficulty in developing such a synergistic relationship suggests that achieving and sustaining a strong safety culture is not easy, particularly in an organization whose safety culture is in serious disrepair

Evolution of activities in international biological standardization since the early days of the Health Organisation of the League of Nations.

Science.gov (United States)

Sizaret, P

1988-01-01

The main activities in international biological standardization during the 18 years that followed the first international biological standardization meeting in London in 1921 were concerned with expressing the potencies of test preparations in comparison with reference materials. After the Second World War, however, it became clear that the testing of biological substances against international reference materials was only one among several measures for obtaining safe and potent products. The activities in international biological standardization were therefore widened so that, by the strict observance of specific manufacturing and control requirements, it was possible to gain further in safety and efficacy. At the end of 1987, 42 international requirements for biological substances were available and were being used as national requirements, sometimes after minor modification, by the majority of WHO's Member States. This is of utmost importance for the worldwide use of safe and potent biological products, including vaccines.

Safety for Users

CERN Multimedia

HR Department

2008-01-01

CERN welcomes more than 8000 Users every year. The PH Department as host to these scientific associates requires the highest safety standards. The PH Safety Office has published a Safety Flyer for Users. Important safety topics and procedures are presented. Although the Flyer is intended primarily to provide safety information for Users, the PH Safety Office invites all those on the CERN sites to keep a copy of the flyer as it gives guidance in matters of safety and explains what to do in the event of an emergency. Link: http://ph-dep.web.cern.ch/ph-dep/Safety/SafetyOffice.html PH-Safety Office PH Department

Safety for Users

CERN Multimedia

HR Department

2008-01-01

CERN welcomes more than 8000 Users every year. The PH Department as host to these scientific associates requires the highest safety standards. The PH Safety Office has published a safety flyer for Users. Important safety topics and procedures are presented. Although the flyer is intended primarily to provide safety information for Users, the PH Safety Office invites all those on the CERN sites to keep a copy of the flyer as it gives guidance in matters of safety and explains what to do in the event of an emergency. The flyer is available at: http://ph-dep.web.cern.ch/ph-dep/Safety/SafetyOffice.html PH-Safety Office PH Department

Food safety performance indicators to benchmark food safety output of food safety management systems.

Science.gov (United States)

Jacxsens, L; Uyttendaele, M; Devlieghere, F; Rovira, J; Gomez, S Oses; Luning, P A

2010-07-31

There is a need to measure the food safety performance in the agri-food chain without performing actual microbiological analysis. A food safety performance diagnosis, based on seven indicators and corresponding assessment grids have been developed and validated in nine European food businesses. Validation was conducted on the basis of an extensive microbiological assessment scheme (MAS). The assumption behind the food safety performance diagnosis is that food businesses which evaluate the performance of their food safety management system in a more structured way and according to very strict and specific criteria will have a better insight in their actual microbiological food safety performance, because food safety problems will be more systematically detected. The diagnosis can be a useful tool to have a first indication about the microbiological performance of a food safety management system present in a food business. Moreover, the diagnosis can be used in quantitative studies to get insight in the effect of interventions on sector or governmental level. Copyright 2010 Elsevier B.V. All rights reserved.

Biological cellular response to carbon nanoparticle toxicity

International Nuclear Information System (INIS)

Panessa-Warren, B J; Warren, J B; Wong, S S; Misewich, J A

2006-01-01

Recent advances in nanotechnology have increased the development and production of many new nanomaterials with unique characteristics for industrial and biomedical uses. The size of these new nanoparticles (<100 nm) with their high surface area and unusual surface chemistry and reactivity poses unique problems for biological cells and the environment. This paper reviews the current research on the reactivity and interactions of carbon nanoparticles with biological cells in vivo and in vitro, with ultrastructural images demonstrating evidence of human cell cytotoxicity to carbon nanoparticles characteristic of lipid membrane peroxidation, gene down regulation of adhesive proteins, and increased cell death (necrosis, apoptosis), as well as images of nontoxic carbon nanoparticle interactions with human cells. Although it is imperative that nanomaterials be systematically tested for their biocompatibility and safety for industrial and biomedical use, there are now ways to develop and redesign these materials to be less cytotoxic, and even benign to cell systems. With this new opportunity to utilize the unique properties of nanoparticles for research, industry and medicine, there is a responsibility to test and optimize these new nanomaterials early during the development process, to eliminate or ameliorate identified toxic characteristics

Safety first. Status reports on the IAEA's safety standards

International Nuclear Information System (INIS)

Webb, G.; Karbassioun, A.; Linsley, G.; Rawl, R.

1998-01-01

Documents in the IAEA's Safety Standards Series known as RASS (Radiation Safety Standards) are produced to develop an internally consistent set of regulatory-style publications that reflects an international consensus on the principles of radiation protection and safety and their application through regulation. In this article are briefly presented the Agency's programmes on Nuclear Safety Standards (NUSS), Radioactive Waste Safety Standards (RADWASS), and Safe Transport of Radioactive Materials

Safety analysis SFR 1. Long-term safety

Energy Technology Data Exchange (ETDEWEB)

2008-12-15

An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the regulatory

Safety analysis SFR 1. Long-term safety

International Nuclear Information System (INIS)

2008-12-01

An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the regulatory

Safety analysis SFR 1. Long-term safety

Energy Technology Data Exchange (ETDEWEB)

2008-12-15

An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the

IAEA safety standards and approach to safety of advanced reactors

International Nuclear Information System (INIS)

Gasparini, M.

2004-01-01

The paper presents an overview of the IAEA safety standards including their overall structure and purpose. A detailed presentation is devoted to the general approach to safety that is embodied in the current safety requirements for the design of nuclear power plants. A safety approach is proposed for the future. This approach can be used as reference for a safe design, for safety assessment and for the preparation of the safety requirements. The method proposes an integration of deterministic and risk informed concepts in the general frame of a generalized concept of safety goals and defence in depth. This methodology may provide a useful tool for the preparation of safety requirements for the design and operation of any kind of reactor including small and medium sized reactors with innovative safety features.(author)

Is road safety management linked to road safety performance?

Science.gov (United States)

Papadimitriou, Eleonora; Yannis, George

2013-10-01

This research aims to explore the relationship between road safety management and road safety performance at country level. For that purpose, an appropriate theoretical framework is selected, namely the 'SUNflower' pyramid, which describes road safety management systems in terms of a five-level hierarchy: (i) structure and culture, (ii) programmes and measures, (iii) 'intermediate' outcomes'--safety performance indicators (SPIs), (iv) final outcomes--fatalities and injuries, and (v) social costs. For each layer of the pyramid, a composite indicator is implemented, on the basis of data for 30 European countries. Especially as regards road safety management indicators, these are estimated on the basis of Categorical Principal Component Analysis upon the responses of a dedicated road safety management questionnaire, jointly created and dispatched by the ETSC/PIN group and the 'DaCoTA' research project. Then, quasi-Poisson models and Beta regression models are developed for linking road safety management indicators and other indicators (i.e. background characteristics, SPIs) with road safety performance. In this context, different indicators of road safety performance are explored: mortality and fatality rates, percentage reduction in fatalities over a given period, a composite indicator of road safety final outcomes, and a composite indicator of 'intermediate' outcomes (SPIs). The results of the analyses suggest that road safety management can be described on the basis of three composite indicators: "vision and strategy", "budget, evaluation and reporting", and "measurement of road user attitudes and behaviours". Moreover, no direct statistical relationship could be established between road safety management indicators and final outcomes. However, a statistical relationship was found between road safety management and 'intermediate' outcomes, which were in turn found to affect 'final' outcomes, confirming the SUNflower approach on the consecutive effect of each layer

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.

Reactor safety

International Nuclear Information System (INIS)

Butz, H.P.; Heuser, F.W.; May, H.

1985-01-01

The paper comprises an introduction into nuclear physics bases, the safety concept generally speaking, safety devices of pwr type reactors, accident analysis, external influences, probabilistic safety assessment and risk studies. It further describes operational experience, licensing procedures under the Atomic Energy Law, research in reactor safety and the nuclear fuel cycle. (DG) [de

MPACT OF GENETIC BIOTECHNOLOGIES ON BIOSECURITY AND FOOD SAFETY

Directory of Open Access Journals (Sweden)

NICA-BADEA DELIA

2014-05-01

Full Text Available Biosecurity is a relatively new area global, being promoted by the significant results, particularly in the last 20 years, fundamental and applied research. Biotechnology is a collection of techniques that can be used in the agro-food, medical and industrial. The paper examines the potential impact of transgenic biotechnology, vulnerabilities, implications, benefits and risks, quality of life and health. Introduction into the environment, cross-border trade and use of GMOs resulting from modern biotechnology can untoward effects on the conservation and sustainable use of biological diversity, food security and safety. It is openly acknowledged that modern biotechnology has great potential to promote human welfare, in particular, to overcome the critical needs in food, agriculture and human health. Establish appropriate safety measures when using genetically modified organisms (biosecurity policy, regulatory regime, scientific and technical measures is a highly sensitive process, aiming both to maximize the benefits of modern biotechnology and to minimize potential risk

Safety indicators: an efficient tool for a better safety

International Nuclear Information System (INIS)

Aufort, P.; Lars, R.

1993-01-01

Safety indicators based on the examination of the Operating Technical Specifications have been defined with the aim of following the in-operation safety level of French nuclear power plants. These safety indicators are operation feedback tools which permit the a posteriori justification and the adjustment of actual procedures. They would allow detection of an abnormal unavailability occurrence rate or a situation revealing a potential safety problem. So, data acquisition, processing, analysis and display software allowing trend analysis of these indicators has been developed so far as: a reflexion tool for the power plant operators about the safety instructions and the adjustment of preventive maintenance, and a help for decision making at a national level for the examination and the improvement of Operating Technical Specifications. This paper presents the objectives of these safety indicators, the processing tool associated, the preliminary results obtained and more elaborate processing of these indicators. These safety indicators may be very useful in framing probabilistic safety assessments. (author)

Safety culture: modern slogan or effective contribution to safety?

International Nuclear Information System (INIS)

Salm, M.

1994-01-01

Safety culture is defined and its impact on nuclear power plants is documented using the words of the INSAG of IAEA. Two examples from the field of aviation and space flight testify, that the upper management, by its sheer image, may considerably influence actions of the lower levels of the hierarchy. Management therefore can do a lot more for safety than is commonly assumed. Two examples, although separated by 57 years, show that the mentioned influence remains unchanged inspire of progress in management- and organisation-methods as well as in safety-engineering. Safety culture is an overriding element of safety, acting at all levels of a hierarchy. Its action is most important on those levels, for which precise reglementation is hardly possible. The chain of technical and organisational measures guarantees safety only under the condition, that it is embedded in 'safety culture'. Safety culture therefore merits our full attention. (author) 1 fig

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.)

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

In question: the scientific value of preclinical safety pharmacology and toxicology studies with cell-based therapies

Directory of Open Access Journals (Sweden)

Christiane Broichhausen

2014-01-01

Full Text Available A new cell-based medicinal product containing human regulatory macrophages, known as Mreg_UKR, has been developed and conforms to expectations of a therapeutic drug. Here, Mreg_UKR was subjected to pharmacokinetic, safety pharmacology, and toxicological testing, which identified no adverse reactions. These results would normally be interpreted as evidence of the probable clinical safety of Mreg_UKR; however, we contend that, owing to their uncertain biological relevance, our data do not fully support this conclusion. This leads us to question whether there is adequate scientific justification for preclinical safety testing of similar novel cell-based medicinal products using animal models. In earlier work, two patients were treated with regulatory macrophages prior to kidney transplantation. In our opinion, the absence of acute or chronic adverse effects in these cases is the most convincing available evidence of the likely safety of Mreg_UKR in future recipients. On this basis, we consider that safety information from previous clinical investigations of related cell products should carry greater weight than preclinical data when evaluating the safety profile of novel cell-based medicinal products. By extension, we argue that omitting extensive preclinical safety studies before conducting small-scale exploratory clinical investigations of novel cell-based medicinal products data may be justifiable in some instances.

Organization and Nuclear Safety: Safety culture

International Nuclear Information System (INIS)

Martin Marquinez, A.

1998-01-01

This book presents the experience in nuclear safety and its influence in the exploitation on nuclear power plants. The safety organization and quality management before and after Chernobylsk and three mile island accidents

High Risk Behaviors in Marine Mammals: Linking Behavioral Responses to Anthropogenic Disturbance to Biological Consequences

Science.gov (United States)

2015-09-30

1 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. High Risk Behaviors in Marine Mammals : Linking...comprehensive evaluation of biological safety zones for diving marine mammals . In this way we intend to identify those marine mammal species or specific...improving the protection of marine mammals during naval operations. OBJECTIVES We are testing the hypothesis that extreme behaviors requiring

Safety assessment and verification for nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2004-01-01

This Safety Guide was prepared under the IAEA programme for safety standards for nuclear power plants. The present publication is a revision of the IAEA Safety Guide on Management of Nuclear Power Plants for Safe Operation issued in 1984. It supplements Section 2 of the Safety Requirements publication on Safety of Nuclear Power Plants: Operation. Nuclear power technology is different from the customary technology of power generation from fossil fuel and by hydroelectric means. One major difference between the management of nuclear power plants and that of conventional generating plants is the emphasis that should be placed on nuclear safety, quality assurance, the management of radioactive waste and radiological protection, and the accompanying national regulatory requirements. This Safety Guide highlights the important elements of effective management in relation to these aspects of safety. The attention to be paid to safety requires that the management recognize that personnel involved in the nuclear power programme should understand, respond effectively to, and continuously search for ways to enhance safety in the light of any additional requirements socially and legally demanded of nuclear energy. This will help to ensure that safety policies that result in the safe operation of nuclear power plants are implemented and that margins of safety are always maintained. The structure of the organization, management standards and administrative controls should be such that there is a high degree of assurance that safety policies and decisions are implemented, safety is continuously enhanced and a strong safety culture is promoted and supported. The objective of this publication is to guide Member States in setting up an operating organization which facilitates the safe operation of nuclear power plants to a high level internationally. The second objective is to provide guidance on the most important organizational elements in order to contribute to a strong safety

Safety assessment and verification for nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2005-01-01

This Safety Guide was prepared under the IAEA programme for safety standards for nuclear power plants. The present publication is a revision of the IAEA Safety Guide on Management of Nuclear Power Plants for Safe Operation issued in 1984. It supplements Section 2 of the Safety Requirements publication on Safety of Nuclear Power Plants: Operation. Nuclear power technology is different from the customary technology of power generation from fossil fuel and by hydroelectric means. One major difference between the management of nuclear power plants and that of conventional generating plants is the emphasis that should be placed on nuclear safety, quality assurance, the management of radioactive waste and radiological protection, and the accompanying national regulatory requirements. This Safety Guide highlights the important elements of effective management in relation to these aspects of safety. The attention to be paid to safety requires that the management recognize that personnel involved in the nuclear power programme should understand, respond effectively to, and continuously search for ways to enhance safety in the light of any additional requirements socially and legally demanded of nuclear energy. This will help to ensure that safety policies that result in the safe operation of nuclear power plants are implemented and that margins of safety are always maintained. The structure of the organization, management standards and administrative controls should be such that there is a high degree of assurance that safety policies and decisions are implemented, safety is continuously enhanced and a strong safety culture is promoted and supported. The objective of this publication is to guide Member States in setting up an operating organization which facilitates the safe operation of nuclear power plants to a high level internationally. The second objective is to provide guidance on the most important organizational elements in order to contribute to a strong safety

Safety and security profiles of industry networks used in safety- critical applications

Directory of Open Access Journals (Sweden)

Mária FRANEKOVÁ

2008-01-01

Full Text Available The author describes the mechanisms of safety and security profiles of industry and communication networks used within safety – related applications in technological and information levels of process control recommended according to standards IEC 61784-3,4. Nowadays the number of vendors of the safety – related communication technologies who guarantees besides the standard communication, the communication amongst the safety – related equipment according to IEC 61508 is increasing. Also the number of safety – related products is increasing, e. g. safety Fieldbus, safety PLC, safety curtains, safety laser scanners, safety buttons, safety relays and other. According to world survey the safety Fieldbus denoted the highest growth from all manufactured safety products.The main part of this paper is the description of the safety-related Fieldbus communication system, which has to guaranty Safety Integrity Level.

Hospital safety climate and safety behavior: A social exchange perspective.

Science.gov (United States)

Ancarani, Alessandro; Di Mauro, Carmela; Giammanco, Maria D

Safety climate is considered beneficial to the improvement of hospital safety outcomes. Nevertheless, the relations between two of its key constituents, namely those stemming from leader-subordinate relations and coworker support for safety, are still to be fully ascertained. This article uses the theoretical lens of Social Exchange Theory to study the joint impact of leader-member exchange in the safety sphere and coworker support for safety on safety-related behavior at the hospital ward level. Social exchange constructs are further related to the existence of a shame-/blame-free environment, seen as a potential antecedent of safety behavior. A cross-sectional study including 166 inpatients in hospital wards belonging to 10 public hospitals in Italy was undertaken to test the hypotheses developed. Hypothesized relations have been analyzed through a fully mediated multilevel structural equation model. This methodology allows studying behavior at the individual level, while keeping into account the heterogeneity among hospital specialties. Results suggest that the linkage between leader support for safety and individual safety behavior is mediated by coworker support on safety issues and by the creation of a shame-free environment. These findings call for the creation of a safety climate in which managerial efforts should be directed not only to the provision of new safety resources and the enforcement of safety rules but also to the encouragement of teamwork and freedom to report errors as ways to foster the capacity of the staff to communicate, share, and learn from each other.

Safety assessment, safety performance indicators at the Paks Nuclear Power Plant

International Nuclear Information System (INIS)

Baji, C.; Vamos, G.; Toth, J.

2001-01-01

The Paks Nuclear Power Plant has been using different methods of safety assessment (event analysis, self-assessment, probabilistic safety analysis), including performance indicators characterizing both operational and safety performance since the early years of operation of the plant. Regarding the safety performance, the indicators include safety system performance, number of scrams, release of radioactive materials, number of safety significant events, industrial safety indicator, etc. The Paks NPP also reports a set of ten indicators to WANO Performance Indicator Programme which, among others, include safety related indicators as well. However, a more systematic approach to structuring and trending safety indicators is needed so that they can contribute to the enhancement of the operational safety. A more comprehensive set of indicators and a systematic evaluation process was introduced in 1996. The performance indicators framework proposed by the IAEA was adapted to Paks in this year to further improve the process. Safety culture assessment and characterizing safety culture is part of the assessment process. (author)

Management of safety and safety culture at the NPPs of Ukraine

International Nuclear Information System (INIS)

Koltakov, Vladimir

2002-01-01

The report contains general aspects of safety and safety culture. The brief description of operational characteristics and basic indexes of atomic power plants at the Ukraine are represented. The information referring to structure of NPPs of Operation organization license-holder, safety responsibility of both Regulatory and Utility Bodies also is given. The main part of the report include seven sections: 1. Practical application of safety management models; 2. erspective on the relationship between safety management and safety culture; 3. The role of leadership in achieving high standards of safety; 4. Current and future challengers that impact on safety culture and safety management (e.g. the impact of competition, changing, economic and political circumstances, workforce demographics, etc.); 5. Key lessons learned from major events; 6. Practical applications of safety culture concepts (e.g. learning organizations, training staff communications, etc.); 7. dvance in human performance. Some of the main pending safety and safety culture problems that are necessary to achieve in the near future are mentioned

Feasibility of disposal of high-level radioactive waste into the seabed. Volume 6: Deep-sea biology, biological processes and radiobiology

International Nuclear Information System (INIS)

Pentreath, R.J.; Hargrave, B.T.; Roe, H.S.J.; Sibuet, M.

1988-01-01

One of the options suggested for disposal of high-level radioactive waste resulting from the generation of nuclear power is burial beneath the deep ocean floor in geologically stable sediment formations which have no economic value. The 8-volume series provides an assessment of the technical feasibility and radiological safety of this disposal concept based on the results obtained by ten years of co-operation and information exchange among the Member countries participating in the NEA Seabed Working Group. This report summarizes the biological description of selected sites, the means by which radionuclides could result in human exposure via seafood pathways, and the doses likely to be received by, and effects on, the deep-sea fauna

The Safety Case and Safety Assessment for the Disposal of Radioactive Waste

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-09-15

This Safety Guide provides guidance and recommendations on meeting the safety requirements in respect of the safety case and supporting safety assessment for the disposal of radioactive waste. The safety case and supporting safety assessment provide the basis for demonstration of safety and for licensing of radioactive waste disposal facilities and assist and guide decisions on siting, design and operations. The safety case is also the main basis on which dialogue with interested parties is conducted and on which confidence in the safety of the disposal facility is developed. This Safety Guide is relevant for operating organizations preparing the safety case as well as for the regulatory body responsible for developing the regulations and regulatory guidance that determine the basis and scope of the safety case. Contents: 1. Introduction; 2. Demonstrating the safety of radioactive waste disposal; 3. Safety principles and safety requirements; 4. The safety case for disposal of radioactive waste; 5. Radiological impact assessment for the period after closure; 6. Specific issues; 7. Documentation and use of the safety case; 8. Regulatory review process.

7th Annual Systems Biology Symposium: Systems Biology and Engineering

Energy Technology Data Exchange (ETDEWEB)

Galitski, Timothy P.

2008-04-01

Systems biology recognizes the complex multi-scale organization of biological systems, from molecules to ecosystems. The International Symposium on Systems Biology has been hosted by the Institute for Systems Biology in Seattle, Washington, since 2002. The annual two-day event gathers the most influential researchers transforming biology into an integrative discipline investingating complex systems. Engineering and application of new technology is a central element of systems biology. Genome-scale, or very small-scale, biological questions drive the enigneering of new technologies, which enable new modes of experimentation and computational analysis, leading to new biological insights and questions. Concepts and analytical methods in engineering are now finding direct applications in biology. Therefore, the 2008 Symposium, funded in partnership with the Department of Energy, featured global leaders in "Systems Biology and Engineering."

Design for safety: theoretical framework of the safety aspect of BIM system to determine the safety index

Directory of Open Access Journals (Sweden)

Ai Lin Evelyn Teo

2016-12-01

Full Text Available Despite the safety improvement drive that has been implemented in the construction industry in Singapore for many years, the industry continues to report the highest number of workplace fatalities, compared to other industries. The purpose of this paper is to discuss the theoretical framework of the safety aspect of a proposed BIM System to determine a Safety Index. An online questionnaire survey was conducted to ascertain the current workplace safety and health situation in the construction industry and explore how BIM can be used to improve safety performance in the industry. A safety hazard library was developed based on the main contributors to fatal accidents in the construction industry, determined from the formal records and existing literature, and a series of discussions with representatives from the Workplace Safety and Health Institute (WSH Institute in Singapore. The results from the survey suggested that the majority of the firms have implemented the necessary policies, programmes and procedures on Workplace Safety and Health (WSH practices. However, BIM is still not widely applied or explored beyond the mandatory requirement that building plans should be submitted to the authorities for approval in BIM format. This paper presents a discussion of the safety aspect of the Intelligent Productivity and Safety System (IPASS developed in the study. IPASS is an intelligent system incorporating the buildable design concept, theory on the detection, prevention and control of hazards, and the Construction Safety Audit Scoring System (ConSASS. The system is based on the premise that safety should be considered at the design stage, and BIM can be an effective tool to facilitate the efforts to enhance safety performance. IPASS allows users to analyse and monitor key aspects of the safety performance of the project before the project starts and as the project progresses.

The Promises of Biology and the Biology of Promises

DEFF Research Database (Denmark)

Lee, Jieun

2015-01-01

commitments with differently imagined futures. I argue that promises are constitutive of the stem cell biology, rather than being derivative of it. Since the biological concept of stem cells is predicated on the future that they promise, the biological life of stem cells is inextricably intertwined...... patients’ bodies in anticipation of materializing the promises of stem cell biology, they are produced as a new form of biovaluable. The promises of biology move beyond the closed circuit of scientific knowledge production, and proliferate in the speculative marketplaces of promises. Part II looks at how...... of technologized biology and biological time can appear promising with the backdrop of the imagined intransigence of social, political, and economic order in the Korean society....

A field survey of chemicals and biological products used in shrimp farming

International Nuclear Information System (INIS)

Graeslund, S.; Holmstroem, K.; Wahlstroem, A.

2003-01-01

This study documented the use of chemicals and biological products in marine and brackish water shrimp farming in Thailand, the world's top producer of farmed shrimp. Interviews were conducted with 76 shrimp farmers in three major shrimp producing regions, the eastern Gulf coast, the southern Gulf coast and the Andaman coast area. Farmers in the study used on average 13 different chemicals and biological products. The most commonly used products were soil and water treatment products, pesticides and disinfectants. Farmers in the southern Gulf coast area used a larger number of products than farmers in the other two areas. In the study, the use of more than 290 different chemicals and biological products was documented. Many of the pesticides, disinfectants and antibiotics used by the farmers could have negative effects on the cultured shrimps, cause a risk for food safety, occupational health, and/or have negative effects on adjacent ecosystems. Manufacturers and retailers of the products often neglected to provide farmers with necessary information regarding active ingredient and relevant instructions for safe and efficient use

Periodic safety review of the HTR-10 safety analysis

International Nuclear Information System (INIS)

Chen Fubing; Zheng Yanhua; Shi Lei; Li Fu

2015-01-01

Designed by the Institute of Nuclear and New Energy Technology (INET) of Tsinghua University, the 10 MW High Temperature Gas-cooled Reactor-Test Module (HTR-10) is the first modular High Temperature Gas-cooled Reactor (HTGR) in China. According to the nuclear safety regulations of China, the periodic safety review (PSR) of the HTR-10 was initiated by INET after approved by the National Nuclear Safety Administration (NNSA) of China. Safety analysis of the HTR-10 is one of the key safety factors of the PSR. In this paper, the main contents in the review of safety analysis are summarized; meanwhile, the internal evaluation on the review results is presented by INET. (authors)

Safety-barrier diagrams as a safety management tool

DEFF Research Database (Denmark)

Duijm, Nijs Jan

2009-01-01

Safety-barrier diagrams and “bow-tie” diagrams have become popular methods in risk analysis and safety management. This paper describes the syntax and principles for constructing consistent and valid safety-barrier diagrams. The latter's relation to other methods such as fault trees and Bayesian...

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

Patient safety climate and worker safety behaviours in acute hospitals in Scotland.

Science.gov (United States)

Agnew, Cakil; Flin, Rhona; Mearns, Kathryn

2013-06-01

To obtain a measure of hospital safety climate from a sample of National Health Service (NHS) acute hospitals in Scotland and to test whether these scores were associated with worker safety behaviors, and patient and worker injuries. Data were from 1,866 NHS clinical staff in six Scottish acute hospitals. A Scottish Hospital Safety Questionnaire measured hospital safety climate (Hospital Survey on Patient Safety Culture), worker safety behaviors, and worker and patient injuries. The associations between the hospital safety climate scores and the outcome measures (safety behaviors, worker and patient injury rates) were examined. Hospital safety climate scores were significantly correlated with clinical workers' safety behavior and patient and worker injury measures, although the effect sizes were smaller for the latter. Regression analyses revealed that perceptions of staffing levels and managerial commitment were significant predictors for all the safety outcome measures. Both patient-specific and more generic safety climate items were found to have significant impacts on safety outcome measures. This study demonstrated the influences of different aspects of hospital safety climate on both patient and worker safety outcomes. Moreover, it has been shown that in a hospital setting, a safety climate supporting safer patient care would also help to ensure worker safety. The Scottish Hospital Safety Questionnaire has proved to be a usable method of measuring both hospital safety climate as well as patient and worker safety outcomes. Copyright © 2013 National Safety Council and Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.

Building biological foundries for next-generation synthetic biology.

Science.gov (United States)

Chao, Ran; Yuan, YongBo; Zhao, HuiMin

2015-07-01

Synthetic biology is an interdisciplinary field that takes top-down approaches to understand and engineer biological systems through design-build-test cycles. A number of advances in this relatively young field have greatly accelerated such engineering cycles. Specifically, various innovative tools were developed for in silico biosystems design, DNA de novo synthesis and assembly, construct verification, as well as metabolite analysis, which have laid a solid foundation for building biological foundries for rapid prototyping of improved or novel biosystems. This review summarizes the state-of-the-art technologies for synthetic biology and discusses the challenges to establish such biological foundries.

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.

Marine molecular biology: an emerging field of biological sciences.

Science.gov (United States)

Thakur, Narsinh L; Jain, Roopesh; Natalio, Filipe; Hamer, Bojan; Thakur, Archana N; Müller, Werner E G

2008-01-01

An appreciation of the potential applications of molecular biology is of growing importance in many areas of life sciences, including marine biology. During the past two decades, the development of sophisticated molecular technologies and instruments for biomedical research has resulted in significant advances in the biological sciences. However, the value of molecular techniques for addressing problems in marine biology has only recently begun to be cherished. It has been proven that the exploitation of molecular biological techniques will allow difficult research questions about marine organisms and ocean processes to be addressed. Marine molecular biology is a discipline, which strives to define and solve the problems regarding the sustainable exploration of marine life for human health and welfare, through the cooperation between scientists working in marine biology, molecular biology, microbiology and chemistry disciplines. Several success stories of the applications of molecular techniques in the field of marine biology are guiding further research in this area. In this review different molecular techniques are discussed, which have application in marine microbiology, marine invertebrate biology, marine ecology, marine natural products, material sciences, fisheries, conservation and bio-invasion etc. In summary, if marine biologists and molecular biologists continue to work towards strong partnership during the next decade and recognize intellectual and technological advantages and benefits of such partnership, an exciting new frontier of marine molecular biology will emerge in the future.

Safety Evakuation Of Triga-2000 Reactor Operation Viewed From Safety Culture

International Nuclear Information System (INIS)

Karliana, Itjeu

2001-01-01

The safety evaluation activities of TRIGA-2000 operation viewed from safety culture performed by questioners data collected from the operators and supervisor site of TRIGA-2000 P3TN, Bandung. There are 9 activity aspects surveyed, for instant to avail the policy of safety from their chairman, safety management, education and training, emergency aids planning, safety consultancy, accident information, safety analysis, safety devices, safety and occupational health. The surveying undertaken by filling the questioner that containing of 9 activity aspects and 20 samples of employees. The safety evaluation results' of the operation personnel in TRIGA-2000 P3TN are good implemented by both the operators and supervisors should be improve and attention need to provide the equipment's. The education and training especially for safety refreshment must be performing

Product Safety Culture: A New Variant of Safety Culture?

International Nuclear Information System (INIS)

Suhanyiova, L.; Flin, R.; Irwin, A.

2016-01-01

Product safety culture is a new research area which concerns user safety rather than worker or process safety. The concept appears to have emerged after the investigation into the Nimrod aircraft accident (Haddon-Cave, 2009) which echoed aspects of NASA’s Challenger and Columbia crashes. In these cases, through a blend of human and organizational failures, the culture deteriorated to the extent of damaging product integrity, resulting in user fatalities. Haddon-Cave noted that it was due to a failure in leadership and organizational safety culture that accidents such as the Nimrod happened, where the aircraft exploded due to several serious technical failures, preceded by deficiencies in the safety case. Now some organizations are starting to measure product safety culture. This is important in day-to-day life as well, where a product failure as a result of poor organizational safety culture, can cause user harm or death, as in the case of Takata airbags scandal in 2015. Eight people have lost their lives and many were injured. According to investigation reports this was due to the company’s safety malpractices of fixing faulty airbags and proceeding to install them in vehicles, as well as secretly conducting tests to assess the integrity of their product and then deleting the data and denying safety issues as a result of the company’s cost-cutting policies. As such, organizational culture, specifically the applications of safety culture, can have far-reaching consequences beyond the workplace of an organization.

Safety culture in nuclear installations. Management of safety and safety culture in Indian NPPs

International Nuclear Information System (INIS)

Rawal, S.C.

2002-01-01

Nuclear Power Corporation Of India Ltd. (NPCIL) is a company owned by Government of India and is responsible for Design, Construction, Commissioning, Operation and Decommissioning of Nuclear Power plants in India. Presently, a total of 13 Nuclear power Stations are in operation with an installed capacity of 2620 MWe and 2 VVR type PWR Units of 1000 MWe capacity each, 2 PHWR type units of 500 MWe capacity each and 4 PHWR type 220 MWe capacity each are under construction. NPPs generation capacity has been increased from 70% to 85% in the span Of last 7 years with high level of safety standards. This could be achieved through Management commitment towards building a strong Safety Culture. Safety culture is that assembly of characteristics and attitudes in organisation and individuals which establishes that as an overriding priority nuclear plant safety issues receives the attention warranted by their significance. This definition of safety culture brings out two major components in its manifestation. The framework within which individuals within the organisation works.The attitude and response of individual towards the safety issues over productivity and economics in the organisational work practices. The two attributes of safety culture are built in and upgraded in each individuals through special training at the time of entry in the organisation and later through in built procedures in the work practices, motivation and encouragement for free participation of each individuals. Individuals are encouraged to participate in Quality circle teams at the sectional level and review of safety proposal originated by individuals in Station operation Review Committee at Station level, in addition to this to continuously enhance the safety culture, refresher training courses are being organised at regular intervals. The safety related proposals are categorised in to two namely: Proposals from Operating Plants, and Proposals from projects and Design. The concept of safety

Plant Metabolomics: An Indispensable System Biology Tool for Plant Science

Directory of Open Access Journals (Sweden)

Jun Hong

2016-06-01

Full Text Available As genomes of many plant species have been sequenced, demand for functional genomics has dramatically accelerated the improvement of other omics including metabolomics. Despite a large amount of metabolites still remaining to be identified, metabolomics has contributed significantly not only to the understanding of plant physiology and biology from the view of small chemical molecules that reflect the end point of biological activities, but also in past decades to the attempts to improve plant behavior under both normal and stressed conditions. Hereby, we summarize the current knowledge on the genetic and biochemical mechanisms underlying plant growth, development, and stress responses, focusing further on the contributions of metabolomics to practical applications in crop quality improvement and food safety assessment, as well as plant metabolic engineering. We also highlight the current challenges and future perspectives in this inspiring area, with the aim to stimulate further studies leading to better crop improvement of yield and quality.

Plant Metabolomics: An Indispensable System Biology Tool for Plant Science

Science.gov (United States)

Hong, Jun; Yang, Litao; Zhang, Dabing; Shi, Jianxin

2016-01-01

As genomes of many plant species have been sequenced, demand for functional genomics has dramatically accelerated the improvement of other omics including metabolomics. Despite a large amount of metabolites still remaining to be identified, metabolomics has contributed significantly not only to the understanding of plant physiology and biology from the view of small chemical molecules that reflect the end point of biological activities, but also in past decades to the attempts to improve plant behavior under both normal and stressed conditions. Hereby, we summarize the current knowledge on the genetic and biochemical mechanisms underlying plant growth, development, and stress responses, focusing further on the contributions of metabolomics to practical applications in crop quality improvement and food safety assessment, as well as plant metabolic engineering. We also highlight the current challenges and future perspectives in this inspiring area, with the aim to stimulate further studies leading to better crop improvement of yield and quality. PMID:27258266

Correlation between safety climate and contractor safety assessment programs in construction.

Science.gov (United States)

Sparer, Emily H; Murphy, Lauren A; Taylor, Kathryn M; Dennerlein, Jack T

2013-12-01

Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Four hundred and one construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers' safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. Am. J. Ind. Med. 56:1463-1472, 2013. © 2013 Wiley Periodicals, Inc. © 2013 Wiley Periodicals, Inc.

Current Activities on Nuclear Safety Culture in Korea. How to meet the challenges for Safety and Safety Culture?

Energy Technology Data Exchange (ETDEWEB)

Oh, Chaewoon [International Policy Department Policy and Standard Division, Korea Institute of Nuclear Safety, 19 Gusung-Dong Yuseong-Ku, 305-338 DAEJEON (Korea, Republic of)

2008-07-01

'Statement of Nuclear Safety Policy' declared by the Korean Government elucidates adherence to the principle of 'priority to safety'. The 3. Comprehensive Nuclear Energy Promotion Plan (2007-2011) more specifically addressed the necessity to develop and apply 'safety culture evaluation criteria' and to strengthen safety management of concerned organizations in an autonomous way. Putting these policies as a backdrop, Korean Government has taken diverse safety culture initiatives and has encouraged the relevant organizations to develop safety culture practices of their own accord. Accordingly, KHNP, the operating organization in Korea, developed a 'safety culture performance indicator', which has been used to evaluate safety mind of employees and the evaluation results have been continuously reflected in operational management and training programs. Furthermore, KHNP inserted 'nuclear safety culture subject' into every course of more than two week length, and provided employees with special lectures on safety culture. KINS, the regulatory organization, developed indicators for the safety culture evaluation based on the IAEA Guidelines. Also, KINS has hosted an annual Nuclear Safety Technology Information Meeting to share information between regulatory organizations and industries. Furthermore, KINS provided a nuclear safety culture class to the new employees and they are given a chance to participate in performance of a role-reversal socio-drama. Additionally, KINS developed a safety culture training program, published training materials and conducted a 'Nuclear Safety Culture Basic Course' in October 2007, 4 times of which are planed this year. In conclusion, from Government to relevant organizations, 'nuclear safety culture' concept is embraced as important and has been put into practice on a variety of forms. Specifically, 'education and training' is a starting line and sharing

Report 5: Guidance document. Implementation of biological infestation hazards in extended PSA

International Nuclear Information System (INIS)

Hasnaoui, C.; Georgescu, G.; Joel, P.; Sperbeck, S.; Kollasko, H.; Kumar, M.

2016-01-01

This report covers the assessment of biological hazards with PSA. It provides an overview of the available data and available practices in modelling this type of hazard. First researches in the national and international literature regarding PSA for external and internal hazards shows that probabilistic analyses were very rarely carried out in order to quantify the risk induced by biological hazards. Nevertheless, Section 3 provides some data from some countries. History has shown that this hazard can happened and can be highly safety significant. Screening out this event must be done with great care. The overall analysis approach for Level 1 PSA for internal events can be used for the biological hazards with some care to take into impact the nature of the hazard as it impacts many systems at different times and duration. A proposed detailed methodology is described in Section 4. Still some open issues remain: the methodology must also consider event combination of biological infestation with other external hazards wind or flooding or rainfall and multi-units impact. These aspects present still a lot of challenges to PSA developers. The ASAMPSA-E report recommends that further emphasis shall be put on these two aspects of PSA modelling: multi-units site impact and hazards combinations. (authors)

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.)

Safety aspects of MR imaging

International Nuclear Information System (INIS)

Abart, J.; Ganssen, A.

1995-01-01

With the growing number of Magnetic Resonance Systems in operation in clinical practice, safety aspects gain increasing importance. Therefore, it is necessary to evaluate possible risks and effects on human health. After an introduction to the basic principles and techniques involved, the various effects on human health. After an introduction to the basic principles and techniques involved, the various effects on biological systems and especially the human organism caused by the static magnetic field, the alternating magnetic fields and the high frequency fields required are described on the basis of current literature and partially also on our own experience. Basic information for the safe operation of diagnostic Magnetic Resonance Systems is presented. Limits for exposure to magnetic fields and time-dependent changes of electromagnetic fields for patients and employees as suggested by health authorities are given. (orig.) [de

Patient participation in patient safety still missing: Patient safety experts' views.

Science.gov (United States)

Sahlström, Merja; Partanen, Pirjo; Rathert, Cheryl; Turunen, Hannele

2016-10-01

The aim of this study was to elicit patient safety experts' views of patient participation in promoting patient safety. Data were collected between September and December in 2014 via an electronic semi-structured questionnaire and interviews with Finnish patient safety experts (n = 21), then analysed using inductive content analysis. Patient safety experts regarded patients as having a crucial role in promoting patient safety. They generally deemed the level of patient safety as 'acceptable' in their organizations, but reported that patient participation in their own safety varied, and did not always meet national standards. Management of patient safety incidents differed between organizations. Experts also suggested that patient safety training should be increased in both basic and continuing education programmes for healthcare professionals. Patient participation in patient safety is still lacking in clinical practice and systematic actions are needed to create a safety culture in which patients are seen as equal partners in the promotion of high-quality and safe care. © 2016 John Wiley & Sons Australia, Ltd.

Dust control products at Hagerman National Wildlife Refuge, Texas: environmental safety and performance

Science.gov (United States)

Kunz, Bethany K.; Little, Edward E.

2015-01-01

Controlling fugitive dust while protecting natural resources is a challenge faced by all managers of unpaved roads. Unfortunately, road managers choosing between dust control products often have little objective environmental information to aid their decisions. To address this information gap, the U.S. Geological Survey and the U.S. Fish and Wildlife Service collaborated on a field test of three dust control products with the objectives of (a) evaluating product performance under real-world conditions, (b) verifying the environmental safety of products identified as practically nontoxic in laboratory tests, and (c) testing the feasibility of several environmental monitoring techniques for use in dust control tests. In cooperation with refuge staff and product vendors, three products (one magnesium chloride plus binder, one cellulose, and one synthetic fluid plus binder) were applied in July 2012 to replicated road sections at the Hagerman National Wildlife Refuge in Texas. These sections were monitored periodically for 12 months after application. Product performance was assessed by mobile-mounted particulate-matter meters measuring production of fugitive dust and by observations of road conditions. Environmental safety was evaluated through on-site biological observations and leaching tests with samples of treated aggregate. All products reduced dust and improved surface condition during those 12 months. Planned environmental measurements were not always compatible with day-to-day refuge management actions; this incompatibility highlighted the need for flexible biological monitoring plans. As one of the first field tests of dust suppressants that explicitly incorporated biological endpoints, this effort provides valuable information for improving field tests and for developing laboratory or semifield alternatives.

Drug Safety

Science.gov (United States)

... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

Safety - Multiple Languages

Science.gov (United States)

... bosanski (Bosnian) PDF Fire Safety at Home - English MP3 Fire Safety at Home - bosanski (Bosnian) MP3 Fire Safety at Home - English MP4 Fire Safety ... Burmese) PDF Home Safety Checklist - myanma bhasa (Burmese) MP3 Minnesota Department of Health Chinese, Simplified (Mandarin dialect) ( ...

How could intelligent safety transport systems enhance safety ?

NARCIS (Netherlands)

Wiethoff, M. Heijer, T. & Bekiaris, E.

2017-01-01

In Europe, many deaths and injured each years are the cost of today's road traffic. Therefore, it is wise to look for possible solutions for enhancing traffic safety. Some Advanced Driver Assistance Systems (ADAS) are expected to increase safety, but they may also evoke new safety hazards. Only

Safety design guide for safety related systems for CANDU 9

International Nuclear Information System (INIS)

Lee, Duk Su; Chang, Woo Hyun; Lee, Nam Young; A. C. D. Wright

1996-03-01

In general, two types of safety related systems and structures exist in the nuclear plant; The one is a systems and structures which perform safety functions during the normal operation of the plant, and the other is a systems and structures which perform safety functions to mitigate events caused by failure of the normally operating systems or by naturally occurring phenomena. In this safety design guide, these systems are identified in detail, and the major events for which the safety functions are required and the major safety requirements are identified in the list. As the probabilistic safety assessments are completed during the course of the project, additions or deletions to the list may be justified. 3 tabs. (Author) .new

Safety design guide for safety related systems for CANDU 9

Energy Technology Data Exchange (ETDEWEB)

Lee, Duk Su; Chang, Woo Hyun; Lee, Nam Young [Korea Atomic Energy Research Institute, Daeduk (Korea, Republic of); Wright, A.C.D. [Atomic Energy of Canada Ltd., Toronto (Canada)

1996-03-01

In general, two types of safety related systems and structures exist in the nuclear plant; The one is a systems and structures which perform safety functions during the normal operation of the plant, and the other is a systems and structures which perform safety functions to mitigate events caused by failure of the normally operating systems or by naturally occurring phenomena. In this safety design guide, these systems are identified in detail, and the major events for which the safety functions are required and the major safety requirements are identified in the list. As the probabilistic safety assessments are completed during the course of the project, additions or deletions to the list may be justified. 3 tabs. (Author) .new.

Occupational safety motivation

DEFF Research Database (Denmark)

Pedersen, Louise; Kines, Pete

2010-01-01

Background: Motivation is one of the most important factors for safety behaviour and for implementing change in general. However, theoretical and psychometric studies of safety performance have traditionally treated safety motivation, safety compliance and safety participation unidimensionally....... At the same time many motivation questionnaire items are seldom founded on theory and/or do not account for the theories’ ontological and epistemological differences, e.g. of how knowledge, attitude and action are related. Present questionnaire items tap into occupational safety motivation in asking whether...... or not respondents ‘are’ motivated and whether they feel that safety is important or worthwhile. Another important aspect is ‘what’ motivates workers to comply to and participate in safety. The aim of this article is to introduce a new theory-based occupational safety motivation scale which is validated...

Disentangling the roles of safety climate and safety culture: Multi-level effects on the relationship between supervisor enforcement and safety compliance.

Science.gov (United States)

Petitta, Laura; Probst, Tahira M; Barbaranelli, Claudio; Ghezzi, Valerio

2017-02-01

Despite increasing attention to contextual effects on the relationship between supervisor enforcement and employee safety compliance, no study has yet explored the conjoint influence exerted simultaneously by organizational safety climate and safety culture. The present study seeks to address this literature shortcoming. We first begin by briefly discussing the theoretical distinctions between safety climate and culture and the rationale for examining these together. Next, using survey data collected from 1342 employees in 32 Italian organizations, we found that employee-level supervisor enforcement, organizational-level safety climate, and autocratic, bureaucratic, and technocratic safety culture dimensions all predicted individual-level safety compliance behaviors. However, the cross-level moderating effect of safety climate was bounded by certain safety culture dimensions, such that safety climate moderated the supervisor enforcement-compliance relationship only under the clan-patronage culture dimension. Additionally, the autocratic and bureaucratic culture dimensions attenuated the relationship between supervisor enforcement and compliance. Finally, when testing the effects of technocratic safety culture and cooperative safety culture, neither safety culture nor climate moderated the relationship between supervisor enforcement and safety compliance. The results suggest a complex relationship between organizational safety culture and safety climate, indicating that organizations with particular safety cultures may be more likely to develop more (or less) positive safety climates. Moreover, employee safety compliance is a function of supervisor safety leadership, as well as the safety climate and safety culture dimensions prevalent within the organization. Copyright © 2016 Elsevier Ltd. All rights reserved.

Introducing Mammalian Cell Culture and Cell Viability Techniques in the Undergraduate Biology Laboratory.

Science.gov (United States)

Bowey-Dellinger, Kristen; Dixon, Luke; Ackerman, Kristin; Vigueira, Cynthia; Suh, Yewseok K; Lyda, Todd; Sapp, Kelli; Grider, Michael; Crater, Dinene; Russell, Travis; Elias, Michael; Coffield, V McNeil; Segarra, Verónica A

2017-01-01

Undergraduate students learn about mammalian cell culture applications in introductory biology courses. However, laboratory modules are rarely designed to provide hands-on experience with mammalian cells or teach cell culture techniques, such as trypsinization and cell counting. Students are more likely to learn about cell culture using bacteria or yeast, as they are typically easier to grow, culture, and manipulate given the equipment, tools, and environment of most undergraduate biology laboratories. In contrast, the utilization of mammalian cells requires a dedicated biological safety cabinet and rigorous antiseptic techniques. For this reason, we have devised a laboratory module and method herein that familiarizes students with common cell culture procedures, without the use of a sterile hood or large cell culture facility. Students design and perform a time-efficient inquiry-based cell viability experiment using HeLa cells and tools that are readily available in an undergraduate biology laboratory. Students will become familiar with common techniques such as trypsinizing cells, cell counting with a hemocytometer, performing serial dilutions, and determining cell viability using trypan blue dye. Additionally, students will work with graphing software to analyze their data and think critically about the mechanism of death on a cellular level. Two different adaptations of this inquiry-based lab are presented-one for non-biology majors and one for biology majors. Overall, these laboratories aim to expose students to mammalian cell culture and basic techniques and help them to conceptualize their application in scientific research.

Predicting safety culture: the roles of employer, operations manager and safety professional.

Science.gov (United States)

Wu, Tsung-Chih; Lin, Chia-Hung; Shiau, Sen-Yu

2010-10-01

This study explores predictive factors in safety culture. In 2008, a sample 939 employees was drawn from 22 departments of a telecoms firm in five regions in central Taiwan. The sample completed a questionnaire containing four scales: the employer safety leadership scale, the operations manager safety leadership scale, the safety professional safety leadership scale, and the safety culture scale. The sample was then randomly split into two subsamples. One subsample was used for measures development, one for the empirical study. A stepwise regression analysis found four factors with a significant impact on safety culture (R²=0.337): safety informing by operations managers; safety caring by employers; and safety coordination and safety regulation by safety professionals. Safety informing by operations managers (ß=0.213) was by far the most significant predictive factor. The findings of this study provide a framework for promoting a positive safety culture at the group level. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

Improving construction site safety through leader-based verbal safety communication.

Science.gov (United States)

Kines, Pete; Andersen, Lars P S; Spangenberg, Soren; Mikkelsen, Kim L; Dyreborg, Johnny; Zohar, Dov

2010-10-01

The construction industry is one of the most injury-prone industries, in which production is usually prioritized over safety in daily on-site communication. Workers have an informal and oral culture of risk, in which safety is rarely openly expressed. This paper tests the effect of increasing leader-based on-site verbal safety communication on the level of safety and safety climate at construction sites. A pre-post intervention-control design with five construction work gangs is carried out. Foremen in two intervention groups are coached and given bi-weekly feedback about their daily verbal safety communications with their workers. Foremen-worker verbal safety exchanges (experience sampling method, n=1,693 interviews), construction site safety level (correct vs. incorrect, n=22,077 single observations), and safety climate (seven dimensions, n=105 questionnaires) are measured over a period of up to 42 weeks. Baseline measurements in the two intervention and three control groups reveal that foremen speak with their workers several times a day. Workers perceive safety as part of their verbal communication with their foremen in only 6-16% of exchanges, and the levels of safety at the sites range from 70-87% (correct observations). Measurements from baseline to follow-up in the two intervention groups reveal that safety communication between foremen and workers increases significantly in one of the groups (factor 7.1 increase), and a significant yet smaller increase is found when the two intervention groups are combined (factor 4.6). Significant increases in the level of safety are seen in both intervention groups (7% and 12% increases, respectively), particularly in regards to 'access ways' and 'railings and coverings' (39% and 84% increases, respectively). Increases in safety climate are seen in only one of the intervention groups with respect to their 'attention to safety.' No significant trend changes are seen in the three control groups on any of the three measures

Human Factors and Safety Culture in Maritime Safety (revised

Directory of Open Access Journals (Sweden)

Heinz Peter Berg

2013-09-01

Full Text Available As in every industry at risk, the human and organizational factors constitute the main stakes for maritime safety. Furthermore, several events at sea have been used to develop appropriate risk models. The investigation on maritime accidents is, nowadays, a very important tool to identify the problems related to human factor and can support accident prevention and the improvement of maritime safety. Part of this investigation should in future also be near misses. Operation of ships is full of regulations, instructions and guidelines also addressing human factors and safety culture to enhance safety. However, even though the roots of a safety culture have been established, there are still serious barriers to the breakthrough of the safety management. One of the most common deficiencies in the case of maritime transport is the respective monitoring and documentation usually lacking of adequacy and excellence. Nonetheless, the maritime area can be exemplified from other industries where activities are ongoing to foster and enhance safety culture.

SafetyAnalyst : software tools for safety management of specific highway sites

Science.gov (United States)

2010-07-01

SafetyAnalyst provides a set of software tools for use by state and local highway agencies for highway safety management. SafetyAnalyst can be used by highway agencies to improve their programming of site-specific highway safety improvements. SafetyA...

76 FR 53086 - Pipeline Safety: Safety of Gas Transmission Pipelines

Science.gov (United States)

2011-08-25

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part 192 [Docket No. PHMSA-2011-0023] RIN 2137-AE72 Pipeline Safety: Safety of Gas Transmission Pipelines AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT...

Survey and evaluation of inherent safety characteristics and passive safety systems for use in probabilistic safety analyses

International Nuclear Information System (INIS)

Wetzel, N.; Scharfe, A.

1998-01-01

The present report examines the possibilities and limits of a probabilistic safety analysis to evaluate passive safety systems and inherent safety characteristics. The inherent safety characteristics are based on physical principles, that together with the safety system lead to no damage. A probabilistic evaluation of the inherent safety characteristic is not made. An inventory of passive safety systems of accomplished nuclear power plant types in the Federal Republic of Germany was drawn up. The evaluation of the passive safety system in the analysis of the accomplished nuclear power plant types was examined. The analysis showed that the passive manner of working was always assumed to be successful. A probabilistic evaluation was not performed. The unavailability of the passive safety system was determined by the failure of active components which are necessary in order to activate the passive safety system. To evaluate the passive safety features in new concepts of nuclear power plants the AP600 from Westinghouse, the SBWR from General Electric and the SWR 600 from Siemens, were selected. Under these three reactor concepts, the SWR 600 is specially attractive because the safety features need no energy sources and instrumentation in this concept. First approaches for the assessment of the reliability of passively operating systems are summarized. Generally it can be established that the core melt frequency for the passive concepts AP600 and SBWR is advantageous in comparison to the probabilistic objectives from the European Pressurized Water Reactor (EPR). Under the passive concepts is the SWR 600 particularly interesting. In this concept the passive systems need no energy sources and instrumentation, and has active operational systems and active safety equipment. Siemens argues that with this concept the frequency of a core melt will be two orders of magnitude lower than for the conventional reactors. (orig.) [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 assessment of biotechnology-derived pharmaceuticals: ICH and beyond.

Science.gov (United States)

Serabian, M A; Pilaro, A M

1999-01-01

Many scientific discussions, especially in the past 8 yr, have focused on definition of criteria for the optimal assessment of the preclinical toxicity of pharmaceuticals. With the current overlap of responsibility among centers within the Food and Drug Administration (FDA), uniformity of testing standards, when appropriate, would be desirable. These discussions have extended beyond the boundaries of the FDA and have culminated in the acceptance of formalized, internationally recognized guidances. The work of the International Committee on Harmonisation (ICH) and the initiatives developed by the FDA are important because they (a) represent a consensus scientific opinion, (b) promote consistency, (c) improve the quality of the studies performed, (d) assist the public sector in determining what may be generally acceptable to prepare product development plans, and (e) provide guidance for the sponsors in the design of preclinical toxicity studies. Disadvantages associated with such initiatives include (a) the establishment of a historical database that is difficult to relinquish, (b) the promotion of a check-the-box approach, i.e., a tendancy to perform only the minimum evaluation required by the guidelines, (c) the creation of a disincentive for industry to develop and validate new models, and (d) the creation of state-of-the-art guidances that may not allow for appropriate evaluation of novel therapies. The introduction of biotechnology-derived pharmaceuticals for clinical use has often required the application of unique approaches to assessing their safety in preclinical studies. There is much diversity among these products, which include the gene and cellular therapies, monoclonal antibodies, human-derived recombinant regulatory proteins, blood products, and vaccines. For many of the biological therapies, there will be unique product issues that may require specific modifications to protocol design and may raise additional safety concerns (e.g., immunogenicity

Computerized based training in nuclear safety in the nuclear research center Negev

International Nuclear Information System (INIS)

Ben-Shachar, B.; Krubain, H.; Sberlo, E.

2002-01-01

The Department of Human Resources and Training in the Nuclear Research Center, Negev, in collaboration with the Department of Radiation Protection and Safety used to organize different kinds of training and refresher courses for different aspects of safety in nuclear centers (radiation safety, biological effects of ionizing radiation, industrial safety, fire fighting, emergency procedures, etc.). All radiation workers received a training program of several days in all these subjects, each year. The administrative employees received a shorter training, each second year. The training included only frontal lectures and no quiz or exams were done. No feedback of the employees was received after the training, as well. Recently, a new training program was developed by the NRC-Negev and the CET (Center for Educational Technology), in order to perform the refresher courses. The training includes CBT-s (Computer Based Training), e.g. tutorials and quiz. The tutorial is an interactive course in one subject, including animations, video films and photo stills. The employee gets a simple and clear explanation (including pictures). After each tutorial there is a quiz which includes 7 American style questions. In the following lecture different parts from two of the tutorials used for the refresher courses, will be presented

Effect of the use of a safety intravenous catheters to prevent needle stick injuries

Directory of Open Access Journals (Sweden)

Fuladvandi M

2016-07-01

Full Text Available The damage caused by sharp objects is one of the most important biological hazards among health care workers. Due to the importance of occupational injury, this study aimed to investigate the efficiency of using safety intravenous catheters with the safety Chamber features in reducing the damage caused by the needle during veni puncture in Afzali pour hospital wards in Kerman. This was a Quasi-experimental study. The sample was consisted of all nurses who worked at Kerman Afzali pour Training hospital during the course of the study.After training was provided to the staff, the available intravenous catheters were distributed among them by hospital medical equipment units. The data were gathered six months before and after the use of safety intravenous catheters, and were analyzed by using SPSS and descriptive statistics tests.The average age at the time of NSI (4.7 ± was 30. People who were in the range of 25-29years oldhad40%injuries.There was a significant correlation between the NSI in the second half of2011 and first half of2012before and after the use of safety angicuts. (p<0.001Considering the results, the use of safety needles is recommended to reduce injury.

Low cost biological lung volume reduction therapy for advanced emphysema

Directory of Open Access Journals (Sweden)

Bakeer M

2016-08-01

Full Text Available Mostafa Bakeer,1 Taha Taha Abdelgawad,1 Raed El-Metwaly,1 Ahmed El-Morsi,1 Mohammad Khairy El-Badrawy,1 Solafa El-Sharawy2 1Chest Medicine Department, 2Clinical Pathology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt Background: Bronchoscopic lung volume reduction (BLVR, using biological agents, is one of the new alternatives to lung volume reduction surgery.Objectives: To evaluate efficacy and safety of biological BLVR using low cost agents including autologous blood and fibrin glue.Methods: Enrolled patients were divided into two groups: group A (seven patients in which autologous blood was used and group B (eight patients in which fibrin glue was used. The agents were injected through a triple lumen balloon catheter via fiberoptic bronchoscope. Changes in high resolution computerized tomography (HRCT volumetry, pulmonary function tests, symptoms, and exercise capacity were evaluated at 12 weeks postprocedure as well as for complications.Results: In group A, at 12 weeks postprocedure, there was significant improvement in the mean value of HRCT volumetry and residual volume/total lung capacity (% predicted (P-value: <0.001 and 0.038, respectively. In group B, there was significant improvement in the mean value of HRCT volumetry and (residual volume/total lung capacity % predicted (P-value: 0.005 and 0.004, respectively. All patients tolerated the procedure with no mortality.Conclusion: BLVR using autologous blood and locally prepared fibrin glue is a promising method for therapy of advanced emphysema in term of efficacy, safety as well as cost effectiveness. Keywords: BLVR, bronchoscopy, COPD, interventional pulmonology

Advancing sustainable safety : National Road Safety Outlook for 2005-2020.

NARCIS (Netherlands)

Wegman, F.C.M. & Aarts, L.T. (eds.)

2006-01-01

Advancing Sustainable Safety: National Road Safety Outlook for 2005-2020 is the follow-up to Naar een duurzaam veilig wegverkeer [Towards sustainably safe road traffic] (Koornstra et al., 1992). Advancing Sustainable Safety is a critique of Sustainable Safety. In this advanced version, adaptations

76 FR 70953 - Pipeline Safety: Safety of Gas Transmission Pipelines

Science.gov (United States)

2011-11-16

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part 192 [Docket ID PHMSA-2011-0023] RIN 2137-AE72 Pipeline Safety: Safety of Gas Transmission Pipelines AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA); DOT. ACTION: Advance notice of...

Safety of Nuclear Power Plants: Design. Specific Safety Requirements (Chinese Ed.)

International Nuclear Information System (INIS)

2012-01-01

On the basis of the principles included in the Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, this Safety Requirements publication establishes requirements applicable to the design of nuclear power plants. It covers the design phase and provides input for the safe operation of the power plant. It elaborates on the safety objective, safety principles and concepts that provide the basis for deriving the safety requirements that must be met for the design of a nuclear power plant. Contents: 1. Introduction; 2. Applying the safety principles and concepts; 3. Management of safety in design; 4. Principal technical requirements; 5. General plant design; 6. Design of specific plant systems.

Safety of Nuclear Power Plants: Design. Specific Safety Requirements (French Ed.)

International Nuclear Information System (INIS)

2012-01-01

On the basis of the principles included in the Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, this Safety Requirements publication establishes requirements applicable to the design of nuclear power plants. It covers the design phase and provides input for the safe operation of the power plant. It elaborates on the safety objective, safety principles and concepts that provide the basis for deriving the safety requirements that must be met for the design of a nuclear power plant. Contents: 1. Introduction; 2. Applying the safety principles and concepts; 3. Management of safety in design; 4. Principal technical requirements; 5. General plant design; 6. Design of specific plant systems.

Safety of Nuclear Power Plants: Design. Specific Safety Requirements (Arabic Ed.)

International Nuclear Information System (INIS)

2012-01-01

On the basis of the principles included in the Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, this Safety Requirements publication establishes requirements applicable to the design of nuclear power plants. It covers the design phase and provides input for the safe operation of the power plant. It elaborates on the safety objective, safety principles and concepts that provide the basis for deriving the safety requirements that must be met for the design of a nuclear power plant. Contents: 1. Introduction; 2. Applying the safety principles and concepts; 3. Management of safety in design; 4. Principal technical requirements; 5. General plant design; 6. Design of specific plant systems.

Safety climate and attitude as evaluation measures of organizational safety.

Science.gov (United States)

Isla Díaz, R; Díaz Cabrera, D

1997-09-01

The main aim of this research is to develop a set of evaluation measures for safety attitudes and safety climate. Specifically it is intended: (a) to test the instruments; (b) to identify the essential dimensions of the safety climate in the airport ground handling companies; (c) to assess the quality of the differences in the safety climate for each company and its relation to the accident rate; (d) to analyse the relationship between attitudes and safety climate; and (e) to evaluate the influences of situational and personal factors on both safety climate and attitude. The study sample consisted of 166 subjects from three airport companies. Specifically, this research was centered on ground handling departments. The factor analysis of the safety climate instrument resulted in six factors which explained 69.8% of the total variance. We found significant differences in safety attitudes and climate in relation to type of enterprise.

Academic Preparation in Biology and Advocacy for Teaching Evolution: Biology versus Non-Biology Teachers

Science.gov (United States)

Nehm, Ross H.; Kim, Sun Young; Sheppard, Keith

2009-01-01

Despite considerable focus on evolution knowledge-belief relationships, little research has targeted populations with strong content backgrounds, such as undergraduate degrees in biology. This study (1) measured precertified biology and non-biology teachers' (n = 167) knowledge of evolution and the nature of science; (2) quantified teacher…

Safety significance of ATR passive safety response attributes

International Nuclear Information System (INIS)

Atkinson, S.A.

1990-01-01

The Advanced Test Reactor (ATR) at the Idaho National Engineering Laboratory was designed with some passive safety response attributes which contribute to the safety of the facility. The three passive safety attributes being evaluated in the paper are: 1) In-core and in-vessel natural convection cooling, 2) a passive heat sink capability of the ATR primary coolant system (PCS) for the transfer of decay power from the uninsulated piping to the confinement, and 3) gravity feed of emergency coolant makeup. The safety significance of the ATR passive safety response attributes is that the reactor can passively respond to most transients, given a reactor scram, to provide adequate decay power removal and a significant time for operator action should the normal active heat removal systems and their backup systems both fail. The ATR Interim Level 1 Probabilistic Risk Assessment (PRA) models and results were used to evaluate the significance to ATR fuel damage frequency (or probability) of the above three passive response attributes. The results of the evaluation indicate that the first attribute is a major safety characteristic of the ATR. The second attribute has a noticeable but only minor safety significance. The third attribute has no significant influence on the ATR firewater injection system (emergency coolant system)