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

MR arthrography: pharmacology, efficacy and safety in clinical trials

International Nuclear Information System (INIS)

Schulte-Altedorneburg, G.; Gebhard, M.; Wohlgemuth, W.A.; Fischer, W.; Zentner, J.; Bohndorf, K.; Wegener, R.; Balzer, T.

2003-01-01

A meta-analysis was carried out of clinical trials published between 1987 and 2001 in respect of the clinical pharmacology and safety as well as the diagnostic efficacy of gadolinium-DTPA (Gd-DTPA) for direct intra-articular injection before MRI examination.Design. Scientific papers (clinical, postmortem and experimental studies) and information from the manufacturer regarding intra-articular injection of Gd-DTPA that addressed questions of mode of action, optimal concentration and dose, elimination and safety were reviewed. Clinical studies were classified according to their study design. The sensitivity, specificity and accuracy of MR arthrography (MRA) were compared with a ''gold standard'' (arthroscopy, arthrotomy) and other radiological evidence for different joints.Results. Fifty-two clinical studies of the overall 112 studies addressed aspects of diagnostic efficacy of MRA in patients or in healthy volunteers. The shoulder was the most assessed joint (29 of 52 studies). Good (>80%) or even excellent (90-100%) sensitivity, specificity and accuracy were found for MRA in most indications, especially for the shoulder and knee joints and induced extension of rotator cuff lesions, labrum abnormalities and postoperative meniscal tears. Two millimoles per liter has proven to be the best concentration for intra-articular administration of Gd-DTPA. After passive complete diffusion from the joint within 6-24 h, complete and rapid renal elimination takes place after intra-articular injection. Local safety proved to be excellent after intra-articular administration of Gd-DTPA. Regarding systemic tolerance almost no side effects have been reported, but the same safety considerations apply for intra-articular administration of Gd-DTPA as for intravenous injection.Conclusions. The diagnostic efficacy of intra-articular MRA in most clinical conditions affecting major joints is greater than that of plain MRI. In some diagnostic problems MRA achieves almost the same

Double pharmacological challenge on repolarization opens new avenues for drug safety research

DEFF Research Database (Denmark)

Thomsen, Morten Bækgaard

2007-01-01

pointes (TdP) arrhythmia. Both the pharmaceutical industry and the regulatory bodies are neglecting the available proarrhythmia models. In vitro studies have suggested that combined pharmacological hits on repolarization will produce a superior substrate for in vivo proarrhythmia, compared to the single......-drug assessment. By using consecutive pharmacological challenges, a simple model is proposed, in which combinatorial pharmacology is employed to provoke TdP in the conscious dog. The pharmaceutical industry interested in evaluating the proarrhythmic potential of their present and future drugs now has a simple...

Pharmacological stress agents in nuclear cardiology

International Nuclear Information System (INIS)

Buscombe, J.R.

2004-01-01

Treadmill test combined with myocardial perfusion scintigraphy (MPS) is a commonly used technique in the assessment of coronary artery disease. However there are a group of patients who may not be able to undergo treadmill tests. Patients with underlying conditions like neuromuscular disease, musculoskeletal disorder, heart failure and end-stage renal disease (ESRD) on renal dialysis would find it difficult to perform exercise on a treadmill or bicycle ergometer. These conditions prevent them from performing adequate exercise. Such patients would benefit from pharmacological stress procedures combined with MPS. Nuclear medicine departments use various pharmacological agents while performing stress tests on cardiac patients. The most commonly used pharmacological agents for cardiac stress are coronary vasodilators and catecholamines. In addition to these agents, adjuvant use of nitrates and atropine is also a common practice in nuclear cardiology. This review addresses various physiological and pharmacological properties of the commonly used pharmacological stress agents in MPS and critically analyses their advantages and disadvantages, as well as their safety and efficacy. (author)

Renal studies in safety pharmacology and toxicology: A survey conducted in the top 15 pharmaceutical companies.

Science.gov (United States)

Benjamin, Amanda; Gallacher, David J; Greiter-Wilke, Andrea; Guillon, Jean-Michel; Kasai, Cheiko; Ledieu, David; Levesque, Paul; Prelle, Katja; Ratcliffe, Sian; Sannajust, Frederick; Valentin, Jean-Pierre

2015-01-01

With the recent development of more sensitive biomarkers to assess kidney injury preclinically, a survey was designed i) to investigate what strategies are used to investigate renal toxicity in both ICH S7A compliant Safety Pharmacology (SP) studies after a single dose of a compound and within repeat-dose toxicity studies by large pharmaceutical companies today; ii) to understand whether renal SP studies have impact or utility in drug development and/or if it may be more appropriate to assess renal effects after multiple doses of compounds; iii) to ascertain how much mechanistic work is performed by the top 15 largest pharmaceutical companies (as determined by R&D revenue size); iv) to gain an insight into the impact of the validation of DIKI biomarkers and their introduction in the safety evaluation paradigm; and v) to understand the impact of renal/urinary safety study data on progression of projects. Two short anonymous surveys were submitted to SP leaders of the top 15 pharmaceutical companies, as defined by 2012 R&D portfolio size. Fourteen multiple choice questions were designed to explore the strategies used to investigate renal effects in both ICH S7A compliant SP studies and within toxicology studies. A 67% and 60% response rate was obtained in the first and second surveys, respectively. Nine out of ten respondent companies conduct renal excretory measurements (eg. urine analysis) in toxicology studies whereas only five out of ten conduct specific renal SP studies; and all of those 5 also conduct the renal excretory measurements in toxicology studies. These companies measure and/or calculate a variety of parameters as part of these studies, and also on a case by case basis include regulatory qualified and non-qualified DIKI biomarkers. Finally, only one company has used renal/urinary functional data alone to stop a project, whereas the majority of respondents combine renal data with other target organ assessments to form an integrated decision-making set

Pharmacologic treatment in pediatric functional abdominal pain disorders: a systematic review

NARCIS (Netherlands)

Korterink, Judith J.; Rutten, Juliette M. T. M.; Venmans, Leonie; Benninga, Marc A.; Tabbers, Merit M.

2015-01-01

To systematically review literature assessing efficacy and safety of pharmacologic treatments in children with abdominal pain-related functional gastrointestinal disorders (AP-FGIDs). MEDLINE and Cochrane Database were searched for systematic reviews and randomized controlled trials investigating

Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacological Effect of Orally Administered CORT125134: An Adaptive, Double-Blind, Randomized, Placebo-Controlled Phase 1 Clinical Study.

Science.gov (United States)

Hunt, Hazel; Donaldson, Kirsteen; Strem, Mark; Zann, Vanessa; Leung, Pui; Sweet, Suzanne; Connor, Alyson; Combs, Dan; Belanoff, Joseph

2018-05-01

CORT125134 is an orally active, high-affinity, selective antagonist of the glucocorticoid receptor that is being developed for indications that may benefit from the modulation of cortisol activity. This first-in-human study was conducted to evaluate the dose-related safety, tolerability, pharmacokinetics and pharmacological effects of CORT125134 and its active metabolite CORT125201. Eighty-one healthy male or female subjects received a single dose of 5 to 500 mg CORT125134 or matching placebo across 9 cohorts; 1 cohort received 150 mg CORT125134 after a high-fat breakfast; and 46 subjects received 50 to 500 mg CORT125134 or matching placebo once daily for up to 14 days across 4 cohorts. CORT125134 was well tolerated at doses up to 250 mg per day for 14 days. CORT125134 was absorbed rapidly and eliminated with a mean half-life ranging from 11 to 19 hours. Steady state was achieved by day 7. Exposure increased in a greater than proportional manner, particularly at lower doses. Exposure to CORT125201 at steady state was less than 5% that of parent CORT125134. Evidence for the desired pharmacological effect (glucocorticoid receptor antagonism) was demonstrated by the ability of CORT125134 to prevent several effects of the glucocorticoid receptor agonist prednisone. © 2018 The Authors. Clinical Pharmacology in Drug Development Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

Pharmacology and safety of glycerol phenylbutyrate in healthy adults and adults with cirrhosis.

Science.gov (United States)

McGuire, Brendan M; Zupanets, Igor A; Lowe, Mark E; Xiao, Xunjun; Syplyviy, Vasyliy A; Monteleone, Jon; Gargosky, Sharron; Dickinson, Klara; Martinez, Antonia; Mokhtarani, Masoud; Scharschmidt, Bruce F

2010-06-01

Phenylbutyric acid (PBA), which is approved for treatment of urea cycle disorders (UCDs) as sodium phenylbutyrate (NaPBA), mediates waste nitrogen excretion via combination of PBA-derived phenylacetic acid with glutamine to form phenylactylglutamine (PAGN) that is excreted in urine. Glycerol phenylbutyrate (GPB), a liquid triglyceride pro-drug of PBA, containing no sodium and having favorable palatability, is being studied for treatment of hepatic encephalopathy (HE). In vitro and clinical studies have been performed to assess GPB digestion, safety, and pharmacology in healthy adults and individuals with cirrhosis. GPB hydrolysis was measured in vitro by way of pH titration. Twenty-four healthy adults underwent single-dose administration of GPB and NaPBA and eight healthy adults and 24 cirrhotic subjects underwent single-day and multiple-day dosing of GPB, with metabolites measured in blood and urine. Simulations were performed to assess GPB dosing at higher levels. GPB was hydrolyzed by human pancreatic triglyceride lipase, pancreatic lipase-related protein 2, and carboxyl-ester lipase. Clinical safety was satisfactory. Compared with NaPBA, peak metabolite blood levels with GPB occurred later and were lower; urinary PAGN excretion was similar but took longer. Steady state was achieved within 4 days for both NaPBA and GPB; intact GPB was not detected in blood or urine. Cirrhotic subjects converted GPB to PAGN similarly to healthy adults. Simulations suggest that GPB can be administered safely to cirrhotic subjects at levels equivalent to the highest approved NaPBA dose for UCDs. GPB exhibits delayed release characteristics, presumably reflecting gradual PBA release by pancreatic lipases, and is well tolerated in adults with cirrhosis, suggesting that further clinical testing for HE is warranted.

Applications of Dynamic Clamp to Cardiac Arrhythmia Research: Role in Drug Target Discovery and Safety Pharmacology Testing

Directory of Open Access Journals (Sweden)

Francis A. Ortega

2018-01-01

Full Text Available Dynamic clamp, a hybrid-computational-experimental technique that has been used to elucidate ionic mechanisms underlying cardiac electrophysiology, is emerging as a promising tool in the discovery of potential anti-arrhythmic targets and in pharmacological safety testing. Through the injection of computationally simulated conductances into isolated cardiomyocytes in a real-time continuous loop, dynamic clamp has greatly expanded the capabilities of patch clamp outside traditional static voltage and current protocols. Recent applications include fine manipulation of injected artificial conductances to identify promising drug targets in the prevention of arrhythmia and the direct testing of model-based hypotheses. Furthermore, dynamic clamp has been used to enhance existing experimental models by addressing their intrinsic limitations, which increased predictive power in identifying pro-arrhythmic pharmacological compounds. Here, we review the recent advances of the dynamic clamp technique in cardiac electrophysiology with a focus on its future role in the development of safety testing and discovery of anti-arrhythmic drugs.

Overview of clinical efficacy and safety of pharmacologic strategies for blood conservation.

Science.gov (United States)

Levy, Jerrold H

2005-09-15

The pharmacologic management of hemostasis in patients undergoing surgery with cardiopulmonary bypass is discussed. Nearly 45 studies involving 7,000 patients have reported efficacy of aprotinin in blood conservation. Both in primary coronary artery bypass graft (CABG) surgeries and in repeat surgeries, aprotinin treatment significantly reduces the incidence of blood transfusions and the number of units of blood transfused. These effects have been observed for red blood cell, platelet, and other blood products. The safety of aprotinin treatment has been extensively evaluated in randomized clinical trials, in postmarketing databases, and in systematic reviews of the literature. Overall, data do not indicate that aprotinin treatment increases mortality, myocardial infarction, or renal failure. These findings are supported by the results of a recent meta-analysis of 35 studies in patients undergoing CABG surgery. In addition, the meta-analysis suggests that aprotinin treatment was associated with a reduced incidence of stroke and a trend toward a reduced incidence of atrial fibrillation. Although lysine analogs, desmopressin, and recombinant factor VIIa are sometimes used to reduce bleeding, only aprotinin is indicated for use during CABG surgery. The future of cardiac surgery will be marked by an increasingly complex, high-risk group of patients and a greater need for multiple pharmacologic options for reducing bleeding. Pharmacologic approaches that attenuate the activation of the hemostatic system and inflammation need to be employed to decrease coagulopathies and the need for allogeneic blood administration.

Safety Assessment for Decommissioning

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-06-15

In the past few decades, international guidance has been developed on methods for assessing the safety of predisposal and disposal facilities for radioactive waste. More recently, it has been recognized that there is also a need for specific guidance on safety assessment in the context of decommissioning nuclear facilities. The importance of safety during decommissioning was highlighted at the International Conference on Safe Decommissioning for Nuclear Activities held in Berlin in 2002 and at the First Review Meeting of the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management in 2003. At its June 2004 meeting, the Board of Governors of the IAEA approved the International Action Plan on Decommissioning of Nuclear Facilities (GOV/2004/40), which called on the IAEA to: ''establish a forum for the sharing and exchange of national information and experience on the application of safety assessment in the context of decommissioning and provide a means to convey this information to other interested parties, also drawing on the work of other international organizations in this area''. In response, in November 2004, the IAEA launched the international project Evaluation and Demonstration of Safety for Decommissioning of Facilities Using Radioactive Material (DeSa) with the following objectives: -To develop a harmonized approach to safety assessment and to define the elements of safety assessment for decommissioning, including the application of a graded approach; -To investigate the practical applicability of the methodology and performance of safety assessments for the decommissioning of various types of facility through a selected number of test cases; -To investigate approaches for the review of safety assessments for decommissioning activities and the development of a regulatory approach for reviewing safety assessments for decommissioning activities and as a basis for regulatory decision making; -To provide a forum

Drug discrimination: A versatile tool for characterization of CNS safety pharmacology and potential for drug abuse.

Science.gov (United States)

Swedberg, Michael D B

2016-01-01

Drug discrimination studies for assessment of psychoactive properties of drugs in safety pharmacology and drug abuse and drug dependence potential evaluation have traditionally been focused on testing novel compounds against standard drugs for which drug abuse has been documented, e.g. opioids, CNS stimulants, cannabinoids etc. (e.g. Swedberg & Giarola, 2015), and results are interpreted such that the extent to which the test drug causes discriminative effects similar to those of the standard training drug, the test drug would be further characterized as a potential drug of abuse. Regulatory guidance for preclinical assessment of abuse liability by the European Medicines Agency (EMA, 2006), the U.S. Food and Drug Administration (FDA, 2010), the International Conference of Harmonization (ICH, 2009), and the Japanese Ministry of Health Education and Welfare (MHLW, 1994) detail that compounds with central nervous system (CNS) activity, whether by design or not, need abuse and dependence liability assessment. Therefore, drugs with peripheral targets and a potential to enter the CNS, as parent or metabolite, are also within scope (see Swedberg, 2013, for a recent review and strategy). Compounds with novel mechanisms of action present a special challenge due to unknown abuse potential, and should be carefully assessed against defined risk criteria. Apart from compounds sharing mechanisms of action with known drugs of abuse, compounds intended for indications currently treated with drugs with potential for abuse and or dependence are also within scope, regardless of mechanism of action. Examples of such compounds are analgesics, anxiolytics, cognition enhancers, appetite control drugs, sleep control drugs and drugs for psychiatric indications. Recent results (Swedberg et al., 2014; Swedberg & Raboisson, 2014; Swedberg, 2015) on the metabotropic glutamate receptor type 5 (mGluR5) antagonists demonstrate that compounds causing hallucinatory effects in humans did not exhibit

Foeniculum vulgare: A comprehensive review of its traditional use, phytochemistry, pharmacology, and safety

Directory of Open Access Journals (Sweden)

Manzoor A. Rather

2016-11-01

Full Text Available Foeniculum vulgare (Apiaceae commonly known as fennel is a well known and important medicinal and aromatic plant widely used as carminative, digestive, lactogogue and diuretic and in treating respiratory and gastrointestinal disorders. Its seeds are used as flavourings in baked goods, meat and fish dishes, ice cream, alcoholic beverages and herb mixtures. Phenols, phenolic glycosides and volatile aroma compounds such as trans-anethole, estragole and fenchone have been reported as the major phytoconstituents of this species. Different pharmacological experiments in a number of in vitro and in vivo models have convincingly demonstrated the ability of F. vulgare to exhibit antifungal, antibacterial, antioxidant, antithrombotic and hepatoprotective activities, lending support to the rationale behind several of its therapeutic uses. Phenolic compounds isolated from F. vulgare are considered to be responsible for its antioxidant activity while the volatile aroma compounds make it an excellent flavouring agent. The present review is an up-to-date and comprehensive analysis of the chemistry, pharmacology, traditional uses and safety of F. vulgare.

Have the Findings from Clinical Risk Prediction and Trials Any Key Messages for Safety Pharmacology?

Directory of Open Access Journals (Sweden)

Jem D. Lane

2017-11-01

Full Text Available Anti-arrhythmic drugs are a mainstay in the management of symptoms related to arrhythmias, and are adjuncts in prevention and treatment of life-threatening ventricular arrhythmias. However, they also have the potential for pro-arrhythmia and thus the prediction of arrhythmia predisposition and drug response are critical issues. Clinical trials are the latter stages in the safety testing and efficacy process prior to market release, and as such serve as a critical safeguard. In this review, we look at some of the lessons to be learned from approaches to arrhythmia prediction in patients, clinical trials of drugs used in the treatment of arrhythmias, and the implications for the design of pre-clinical safety pharmacology testing.

Safety pharmacology of acute MDMA administration in healthy subjects.

Science.gov (United States)

Vizeli, Patrick; Liechti, Matthias E

2017-05-01

3,4-Methylenedioxymethamphetamine (MDMA; ecstasy) is being investigated in MDMA-assisted psychotherapy. The present study characterized the safety pharmacology of single-dose administrations of MDMA (75 or 125 mg) using data from nine double-blind, placebo-controlled, crossover studies performed in the same laboratory in a total of 166 healthy subjects. The duration of the subjective effects was 4.2 ± 1.3 h (range: 1.4-8.2 h). The 125 mg dose of MDMA produced greater 'good drug effect' ratings than 75 mg. MDMA produced moderate and transient 'bad drug effect' ratings, which were greater in women than in men. MDMA increased systolic blood pressure to >160 mmHg, heart rate >100 beats/min, and body temperature >38°C in 33%, 29% and 19% of the subjects, respectively. These proportions of subjects with hypertension (>160 mmHg), tachycardia, and body temperature >38°C were all significantly greater after 125 mg MDMA compared with the 75 mg dose. Acute and subacute adverse effects of MDMA as assessed by the List of Complaints were dose-dependent and more frequent in females. MDMA did not affect liver or kidney function at EOS 29 ± 22 days after use. No serious adverse events occurred. In conclusion, MDMA produced predominantly acute positive subjective drug effects. Bad subjective drug effects and other adverse effects were significantly more common in women. MDMA administration was overall safe in physically and psychiatrically healthy subjects and in a medical setting. However, the risks of MDMA are likely higher in patients with cardiovascular disease and remain to be investigated in patients with psychiatric disorders.

Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment.

Science.gov (United States)

Brennan, Frank R; Cavagnaro, Joy; McKeever, Kathleen; Ryan, Patricia C; Schutten, Melissa M; Vahle, John; Weinbauer, Gerhard F; Marrer-Berger, Estelle; Black, Lauren E

2018-01-01

Monoclonal antibodies (mAbs) are improving the quality of life for patients suffering from serious diseases due to their high specificity for their target and low potential for off-target toxicity. The toxicity of mAbs is primarily driven by their pharmacological activity, and therefore safety testing of these drugs prior to clinical testing is performed in species in which the mAb binds and engages the target to a similar extent to that anticipated in humans. For highly human-specific mAbs, this testing often requires the use of non-human primates (NHPs) as relevant species. It has been argued that the value of these NHP studies is limited because most of the adverse events can be predicted from the knowledge of the target, data from transgenic rodents or target-deficient humans, and other sources. However, many of the mAbs currently in development target novel pathways and may comprise novel scaffolds with multi-functional domains; hence, the pharmacological effects and potential safety risks are less predictable. Here, we present a total of 18 case studies, including some of these novel mAbs, with the aim of interrogating the value of NHP safety studies in human risk assessment. These studies have identified mAb candidate molecules and pharmacological pathways with severe safety risks, leading to candidate or target program termination, as well as highlighting that some pathways with theoretical safety concerns are amenable to safe modulation by mAbs. NHP studies have also informed the rational design of safer drug candidates suitable for human testing and informed human clinical trial design (route, dose and regimen, patient inclusion and exclusion criteria and safety monitoring), further protecting the safety of clinical trial participants.

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)

An overview of the safety pharmacology career of Dr. C.R. Hassler.

Science.gov (United States)

Hawk, M A; Pugsley, M K; Vinci, T; Wallery, J; Hassler, C R; Hamlin, R L

2017-09-01

Each year the Safety Pharmacology Society (SPS) recognizes an investigator who has had a marked impact upon the discipline. The 2016 recipient of the SPS Distinguished Service Award (DSA) was Dr. Craig R. Hassler. Dr. Hassler is one of the founding members of the SPS and has been actively engaged in physiological research for over 46years. Dr. Hassler delivered a talk entitled "My 43Years at Battelle Memorial Institute" to meeting attendees. In this article an overview is provided of the illustrious career of Dr. Hassler along with an account of the numerous animal models that were developed at Battelle under his guidance over the years. Copyright © 2017 Elsevier Inc. All rights reserved.

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

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.

The role of risk assessment and safety analysis in integrated safety assessments

International Nuclear Information System (INIS)

Niall, R.; Hunt, M.; Wierman, T.E.

1990-01-01

To ensure that the design and operation of both nuclear and non- nuclear hazardous facilities is acceptable, and meets all societal safety expectations, a rigorous deterministic and probabilistic assessment is necessary. An approach is introduced, founded on the concept of an ''Integrated Safety Assessment.'' It merges the commonly performed safety and risk analyses and uses them in concert to provide decision makers with the necessary depth of understanding to achieve ''adequacy.'' 3 refs., 1 fig

Systematic review of pharmacological treatments in fragile X syndrome

Directory of Open Access Journals (Sweden)

Tejada Maria-Isabel

2009-10-01

Full Text Available Abstract Background Fragile X syndrome (FXS is considered the most common cause of inherited mental retardation. Affected people have mental impairment that can include Attention Deficit and/or Hyperactivity Disorder (ADHD, autism disorder, and speech and behavioural disorders. Several pharmacological interventions have been proposed to treat those impairments. Methods Systematic review of the literature and summary of the evidence from clinical controlled trials that compared at least one pharmacological treatment with placebo or other treatment in individuals with diagnosis of FXS syndrome and assessed the efficacy and/or safety of the treatments. Studies were identified by a search of PubMed, EMBASE and the Cochrane Databases using the terms fragile X and treatment. Risk of bias of the studies was assessed by using the Cochrane Collaboration criteria. Results The search identified 276 potential articles and 14 studies satisfied inclusion criteria. Of these, 10 studies on folic acid (9 with crossover design, only 1 of them with good methodological quality and low risk of bias did not find in general significant improvements. A small sample size trial assessed dextroamphetamine and methylphenidate in patients with an additional diagnosis of ADHD and found some improvements in those taking methylphenidate, but the length of follow-up was too short. Two studies on L-acetylcarnitine, showed positive effects and no side effects in patients with an additional diagnosis of ADHD. Finally, one study on patients with an additional diagnosis of autism assessed ampakine compound CX516 and found no significant differences between treatment and placebo. Regarding safety, none of the studies that assessed that area found relevant side effects, but the number of patients included was too small to detect side effects with low incidence. Conclusion Currently there is no robust evidence to support recommendations on pharmacological treatments in patients with

Telemetry video-electroencephalography (EEG) in rats, dogs and non-human primates: methods in follow-up safety pharmacology seizure liability assessments.

Science.gov (United States)

Bassett, Leanne; Troncy, Eric; Pouliot, Mylene; Paquette, Dominique; Ascah, Alexis; Authier, Simon

2014-01-01

Non-clinical seizure liability studies typically aim to: 1) confirm the nature of EEG activity during abnormal clinical signs, 2) identify premonitory clinical signs, 3) measure plasma levels at seizure onset, 4) demonstrate that drug-induced seizures are self-limiting, 5) confirm that conventional drugs (e.g. diazepam) can treat drug-induced seizures and 6) confirm the no observed adverse effect level (NOAEL) at EEG. Our aim was to originally characterize several of these items in a three species comparative study. Cynomolgus monkey, Beagle dog and Sprague-Dawley rat with EEG telemetry transmitters were used to obtain EEG using the 10-20 system. Pentylenetetrazol (PTZ) was used to determine seizure threshold or as a positive seizurogenic agent. Clinical signs were recorded and premonitory signs were evaluated. In complement, other pharmacological agents were used to illustrate various safety testing strategies. Intravenous PTZ doses required to induce clonic convulsions were 36.1 (3.8), 56.1 (12.7) and 49.4 (11.7) mg/kg, in Beagle dogs, cynomolgus monkeys and Sprague-Dawley rats, respectively. Premonitory clinical signs typically included decreased physical activity, enhanced physiological tremors, hypersalivation, ataxia, emesis (except in rats) and myoclonus. In Sprague-Dawley rats, amphetamine (PO) increased high (approximately 40-120Hz), and decreased low (1-14Hz) frequencies. In cynomolgus monkeys, caffeine (IM) increased power in high (14-127Hz), and attenuated power in low (1-13Hz) frequencies. In the rat PTZ infusion seizure threshold model, yohimbine (SC and IV) and phenobarbital (IP) confirmed to be reliable positive controls as pro- and anticonvulsants, respectively. Telemetry video-EEG for seizure liability investigations was characterized in three species. Rats represent a first-line model in seizure liability assessments. Beagle dogs are often associated with overt susceptibility to seizure and are typically used in seizure liability studies only if

Current trends and future development in pharmacologic stress testing

International Nuclear Information System (INIS)

Bae, Jin Ho; Lee, Jae Tae

2005-01-01

Pharmacologic stress testing for myocardial perfusion imaging is a widely used noninvasive method for the evaluation of known or suspected coronary artery disease. The use of exercise for cardiac stress has been practiced for over 60 years and clinicians are familiar with its using. However, there are inevitable situations in which exercise stress is inappropriate. A large number of patients with cardiac problems are unable to exercise to their full potential due to comorbidity such as osteoarthritis, vascular disease and pulmonary disease and a standard exercise stress test for myocardial perfusion imaging is suboptimal means for assessment of coronary artery disease. This problem has led to the development of the pharmacologic stress test and to a great increase in its popularity. All of the currently used pharmacologic agents have well-documented diagnostic value. This review deals the physiological actions, clinical protocols, safety, nuclear imaging applications of currently available stress agents and future development of new vasodilating agents

Assessment of Safety Culture

International Nuclear Information System (INIS)

Bilic Zabric, T.; Kavsek, D.

2006-01-01

A strong safety culture leads to more effective conduct of work and a sense of accountability among managers and employees, who should be given the opportunity to expand skills by training. The resources expended would thus result in tangible improvements in working practices and skills, which encourage further improvement of safety culture. In promoting an improved safety culture, NEK has emphasized both national and organizational culture with an appropriate balance of behavioural sciences and quality management systems approaches. In recent years there has been particular emphasis put on an increasing awareness of the contribution that human behavioural sciences can make to develop good safety practices. The purpose of an assessment of safety culture is to increase the awareness of the present culture, to serve as a basis for improvement and to keep track of the effects of change or improvement over a longer period of time. There is, however, no single approach that is suitable for all purposes and which can measure, simultaneously, all the intangible aspects of safety culture, i.e. the norms, values, beliefs, attitudes or the behaviours reflecting the culture. Various methods have their strengths and weaknesses. To prevent significant performance problems, self-assessment is used. Self-assessment is the process of identifying opportunities for improvement actively or, in some cases, weaknesses that could cause more serious errors or events. Self-assessments are an important input to the corrective action programme. NEK has developed questionnaires for safety culture self-assessment to obtain information that is representative of the whole organization. Questionnaires ensure a greater degree of anonymity, and create a less stressful situation for the respondent. Answers to questions represent the more apparent and conscious values and attitudes of the respondent. NEK proactively co-operates with WANO, INPO, IAEA in the areas of Safety Culture and Human

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)

IAEA safety requirements for safety assessment of fuel cycle facilities and activities

International Nuclear Information System (INIS)

Jones, G.

2013-01-01

The IAEA's Statute authorises the Agency to establish standards of safety for protection of health and minimisation of danger to life and property. In that respect, the IAEA has established a Safety Fundamentals publication which contains ten safety principles for ensuring the protection of workers, the public and the environment from the harmful effects of ionising radiation. A number of these principles require safety assessments to be carried out as a means of evaluating compliance with safety requirements for all nuclear facilities and activities and to determine the measures that need to be taken to ensure safety. The safety assessments are required to be carried out and documented by the organisation responsible for operating the facility or conducting the activity, are to be independently verified and are to be submitted to the regulatory body as part of the licensing or authorisation process. In addition to the principles of the Safety Fundamentals, the IAEA establishes requirements that must be met to ensure the protection of people and the environment and which are governed by the principles in the Safety Fundamentals. The IAEA's Safety Requirements publication 'Safety Assessment for Facilities and Activities', establishes the safety requirements that need to be fulfilled in conducting and maintaining safety assessments for the lifetime of facilities and activities, with specific attention to defence in depth and the requirement for a graded approach to the application of these safety requirements across the wide range of fuel cycle facilities and activities. Requirements for independent verification of the safety assessment that needs to be carried out by the operating organisation, including the requirement for the safety assessment to be periodically reviewed and updated are also covered. For many fuel cycle facilities and activities, environmental impact assessments and non-radiological risk assessments will be required. The

Experiences in assessing safety culture

International Nuclear Information System (INIS)

Spitalnik, J.

2002-01-01

Based on several Safety Culture self-assessment applications in nuclear organisations, the paper stresses relevant aspects to be considered when programming an assessment of this type. Reasons for assessing Safety Culture, basic principles to take into account, necessary resources, the importance of proper statistical analyses, the feed-back of results, and the setting up of action plans to enhance Safety Culture are discussed. (author)

OSART Independent Safety Culture Assessment (ISCA) Guidelines

International Nuclear Information System (INIS)

2016-01-01

Safety culture is understood as an important part of nuclear safety performance. This has been demonstrated by the analysis of significant events such as Chernobyl, Davis Besse, Vandellos II, Asco, Paks, Mihamma and Forsmark, among others. In order to enhance safety culture, one essential activity is to perform assessments. IAEA Safety Standard Series No. GS-R-3, The Management System for Facilitites and Activities, states requirements for continuous improvement of safety culture, of which self, peer and independent safety culture assessments constitute an essential part. In line with this requirement, the Independent Safety Culture Assessment (ISCA) module is offered as an add-on module to the IAEA Operational Safety Review Team (OSART) programme. The OSART programme provides advice and assistance to Member States to enhance the safety of nuclear power plants during commissioning and operation. By including the ISCA module in an OSART mission, the receiving organization benefits from the synergy between the technical and the safety culture aspects of the safety review. The joint operational safety and safety culture assessment provides the organization with the opportunity to better understand the interactions between technical, human, organizational and cultural aspects, helping the organization to take a systemic approach to safety through identifying actions that fully address the root causes of any identified issue. Safety culture assessments provide insight into the fundamental drivers that shape organizational patterns of behaviour, safety consciousness and safety performance. The complex nature of safety culture means that the analysis of the results of such assessments is not as straightforward as for other types of assessment. The benefits of the results of nuclear safety culture assessments are maximized only if appropriate tools and guidance for these assessments is used; hence, this comprehensive guideline has been developed. The methodology explained

Assessing pharmacologic and nonpharmacologic risks in candidates for kidney transplantation.

Science.gov (United States)

Maldonado, Angela Q; Tichy, Eric M; Rogers, Christin C; Campara, Maya; Ensor, Christopher; Doligalski, Christina T; Gabardi, Steven; Descourouez, Jillian L; Doyle, Ian C; Trofe-Clark, Jennifer

2015-05-15

Pharmacotherapy concerns and other factors with a bearing on patient selection for kidney transplantation are discussed. The process of selecting appropriate candidates for kidney transplantation involves multidisciplinary assessment to evaluate a patient's mental, social, physical, financial, and medical readiness for successful surgery and good posttransplantation outcomes. Transplantation pharmacists can play important roles in the recognition and stratification of pharmacologic and nonpharmacologic risks in prospective kidney transplant recipients and the identification of issues that require a mitigation strategy. Key pharmacotherapy-related issues and considerations during the risk assessment process include (1) anticoagulation concerns, (2) cytochrome P-450 isoenzyme-mediated drug interactions, (3) mental health-related medication use, (4) chronic pain-related medication use, (5) medication allergies, (6) use of hormonal contraception and replacement therapy, (7) prior or current use of immunosuppressants, (8) issues with drug absorption, (9) alcohol use, (10) tobacco use, (11) active use of illicit substances, and (12) use of herbal supplements. Important areas of nonpharmacologic risk include vaccine delivery, infection prophylaxis and treatment, and socially related factors such as nonadherent behavior, communication barriers, and financial, insurance, or transportation challenges that can compromise posttransplantation outcomes. Consensus opinions of practitioners in transplantation pharmacy regarding the pharmacologic and nonpharmacologic factors that should be considered in assessing candidates for kidney transplantation are presented. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Metrics design for safety assessment

NARCIS (Netherlands)

Luo, Yaping; van den Brand, M.G.J.

2016-01-01

Context:In the safety domain, safety assessment is used to show that safety-critical systems meet the required safety objectives. This process is also referred to as safety assurance and certification. During this procedure, safety standards are used as development guidelines to keep the risk at an

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.

Safety assessment principles for nuclear plants

International Nuclear Information System (INIS)

1992-01-01

The present Safety Assessment Principles result from the revision of those which were drawn up following a recommendation arising from the Sizewell-B enquiry. The principles presented here relate only to nuclear safety; there is a section on risks from normal operation and accident conditions and the standards against which those risks are assessed. A major part of the document deals with the principles that cover the design of nuclear plants. The revised Safety assessment principles are aimed primarily at the safety assessment of new nuclear plants but they will also be used in assessing existing plants. (UK)

Development of safety related technology and infrastructure for safety assessment

International Nuclear Information System (INIS)

Venkat Raj, V.

1997-01-01

Development and optimum utilisation of any technology calls for the building up of the necessary infrastructure and backup facilities. This is particularly true for a developing country like India and more so for an advanced technology like nuclear technology. Right from the inception of its nuclear power programme, the Indian approach has been to develop adequate infrastructure in various areas such as design, construction, manufacture, installation, commissioning and safety assessment of nuclear plants. This paper deals with the development of safety related technology and the relevant infrastructure for safety assessment. A number of computer codes for safety assessment have been developed or adapted in the areas of thermal hydraulics, structural dynamics etc. These codes have undergone extensive validation through data generated in the experimental facilities set up in India as well as participation in international standard problem exercises. Side by side with the development of the tools for safety assessment, the development of safety related technology was also given equal importance. Many of the technologies required for the inspection, ageing assessment and estimation of the residual life of various components and equipment, particularly those having a bearing on safety, were developed. This paper highlights, briefly, the work carried out in some of the areas mentioned above. (author)

Thinking of the safety assessment of HLW disposal

International Nuclear Information System (INIS)

Li Honghui; Zhao Shuaiwei; Liu Jianqin; Liu Wei; Wan Lei; Yang Zhongtian; An Hongxiang; Sun Qinghong

2014-01-01

The function and the research methods of safety assessment are discussed. Two methods about safety assessment and the requirement of safety assessment are introduced. The key parameters and influence factors in nuclide transport of safety assessment are specialized. The works will be done on safety assessment is discussed which will give some suggests for the development of safety assessment. (authors)

ALARP considerations in criticality safety assessments

International Nuclear Information System (INIS)

Bowden, Russell L.; Barnes, Andrew; Thorne, Peter R.; Venner, Jack

2003-01-01

Demonstrating that the risk to the public and workers is As Low As Reasonably Practicable (ALARP) is a fundamental requirement of safety cases for nuclear facilities in the United Kingdom. This is embodied in the Safety Assessment Principles (SAPs) published by the Regulator, the essence of which is incorporated within the safety assessment processes of the various nuclear site licensees. The concept of ALARP within criticality safety assessments has taken some time to establish in the United Kingdom. In principle, the licensee is obliged to search for a deterministic criticality safety solution, such as safe geometry vessels and passive control features, rather than placing reliance on active measurement devices and plant administrative controls. This paper presents a consideration of some ALARP issues in relation to the development of criticality safety cases. The paper utilises some idealised examples covering a range of issues facing the criticality safety assessor, including new plant design, operational plant and decommissioning activities. These examples are used to outline the elements of the criticality safety cases and present a discussion of ALARP in the context of criticality safety assessments. (author)

Safety culture assessment developed by JANTI

International Nuclear Information System (INIS)

Hamada, Jun

2009-01-01

Japan's JCO accident in September 1999 provided a real-life example of what can happen when insufficient attention is paid to safety culture. This accident brought to light the importance of safety culture and reinforced the movement to foster a safety culture. Despite this, accidents and inappropriate conduct have continued to occur. Therefore, there is a strong demand to instill a safety culture throughout the nuclear power industry. In this context, Japan's nuclear power regulator, the Nuclear and Industrial Safety Agency (NISA), decided to include in its safety inspections assessments of the safety culture found in power utilities' routine safety operations to get signs of deterioration in the organizational climate. In 2007, NISA constructed guidelines for their inspectors to carry out these assessments. At the same time, utilities have embarked on their own independent safety culture initiatives, such as revising their technical specifications and building effective PDCA cycle to promote safety culture. In concert with these developments, JANTI has also instituted safety culture assessments. (author)

Rad waste disposal safety analysis / Integrated safety assessment of a waste repository

International Nuclear Information System (INIS)

Jeong, Jongtae; Choi, Jongwon; Kang, Chulhyung

2012-04-01

We developed CYPRUS+and adopted PID and RES method for the development of scenario. Safety performance assessment program was developed using GoldSim for the safety assessment of disposal system for the disposal of spnet fuels and wastes resulting from the pyrpoprocessing. Biosphere model was developed and verified in cooperation with JAEA. The capability to evaluate post-closure performance and safety was added to the previously developed program. And, nuclide migration and release to the biosphere considering site characteristics was evaluated by using deterministic and probabilistic approach. Operational safety assessment for drop, fire, and earthquake was also statistically evaluated considering well-established input parameter distribution. Conservative assessment showed that dose rate is below the limit value of low- and intermediate-level repository. Gas generation mechanism within engineered barrier was defined and its influence on safety was evaluated. We made probabilistic safety assessment by obtaining the probability distribution functions of important input variables and also made a sensitivity analysis. The maximum annual dose rate was shown to be below the safety limit value of 10 mSv/yr. The structure and element of safety case was developed to increase reliability of safety assessment methodology for a deep geological repository. Finally, milestone for safety case development and implementation strategy for each safety case element was also proposed

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.

Safety assessment for facilities and activities. General safety requirements. Pt. 4

International Nuclear Information System (INIS)

2009-01-01

The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation. The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF 6 ; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are installed; (i

Safety Assessment for Facilities and Activities. General Safety Requirements. Pt. 4

International Nuclear Information System (INIS)

2009-01-01

The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation. The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF6; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are installed; (i

Safety Assessment for Facilities and Activities. General Safety Requirements. Pt. 4

International Nuclear Information System (INIS)

2010-01-01

The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation. The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF6; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are installed; (i

Safety Assessment for Facilities and Activities. General Safety Requirements. Pt. 4

International Nuclear Information System (INIS)

2009-01-01

The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation.? read more The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF6; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are

Safety Culture Monitoring: How to Assess Safety Culture in Real Time?

International Nuclear Information System (INIS)

Zronek, B.; Maryska, J.; Treslova, L.

2016-01-01

Do you know what is current level of safety culture in your company? Are you able to follow trend changes? Do you know what your recent issues are? Since safety culture is understood as vital part of nuclear industry daily life, it is crucial to know what the current level is. It is common to perform safety culture survey or ad hoc assessment. This contribution shares Temelin NPP, CEZ approach how to assess safety culture level permanently. Using behavioral related outputs of gap solving system, observation program, dedicated surveys, regulatory assessment, etc., allows creating real time safety culture monitoring without the need to perform any other activities. (author)

Regulatory review of safety cases and safety assessments - associated challenges

International Nuclear Information System (INIS)

Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

2006-01-01

Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

Intermediate probabilistic safety assessment approach for safety critical digital systems

International Nuclear Information System (INIS)

Taeyong, Sung; Hyun Gook, Kang

2001-01-01

Even though the conventional probabilistic safety assessment methods are immature for applying to microprocessor-based digital systems, practical needs force to apply it. In the Korea, UCN 5 and 6 units are being constructed and Korean Next Generation Reactor is being designed using the digital instrumentation and control equipment for the safety related functions. Korean regulatory body requires probabilistic safety assessment. This paper analyzes the difficulties on the assessment of digital systems and suggests an intermediate framework for evaluating their safety using fault tree models. The framework deals with several important characteristics of digital systems including software modules and fault-tolerant features. We expect that the analysis result will provide valuable design feedback. (authors)

Safety assessments for potential exposures

International Nuclear Information System (INIS)

Dunn, D.I.

2012-04-01

Safety Assessment of potential exposures have been carried out in major practices, namely: industrial radiography, gamma irradiators and electron accelerators used in industry and research, and radiotherapy. This paper focuses on reviewing safety assessment methodologies and using developed software to analyse radiological accidents, also review, and discuss these past accidents.The primary objective of the assessment is to assess the adequacy of planned or existing measures for protection and safety and to identify any additional measures that should be put in place. As such, both routine use of the source and the probability and magnitude of potential exposures arising from accidents or incidents should be considered. Where the assessment indicates that there is a realistic possibility of an accident affecting workers or members of the public or having consequences for the environment, the registrant or licensee should prepare a suitable emergency plan. A safety assessment for normal operation addresses all the conditions under which the radiation source operates as expected, including all phases of the lifetime of the source. Due account needs to be taken of the different factors and conditions that will apply during non-operational phases, such as installation, commissioning and maintenance. (author)

Development of a Safety Assessment Information System for the Management of Periodic Safety Assessment Activities

International Nuclear Information System (INIS)

Song, Tae Young

2007-01-01

At present, the 10-year Periodic Safety Review(PSR) has been performing to confirm all the aspects of safety issues for all the operating plants in compliance with domestic nuclear law of article 23, subarticle 3. For each plant, in addition, Probabilistic Safety Assessment(PSA) and Severe Accident Management Guideline(SAMG) are being implemented and revised periodically to reflect the latest safety level according to principle fulfillment of severe accident policy statement. The assessment reports, as one of outcomes from these activities, are submitted into and reviewed by domestic regulatory body. During reviewing (in-office duty) and licensing (regulatory duty) process, a large number of outcomes of which most are the formal technical reports and licensing materials, are inevitably produced. Moreover, repeated review process over the plants can make them accumulated and produce a variety of documents additionally. This circumstance motivates to develop effective tool or system for the management of these reports and related technical documents for the future use in licensing process and for subsequent plant assessments. This paper presents the development status of Safety Assessment Information System(SAIS) which manages safety-related documents of PSR, PSA and SAMG for practical use for experienced engineers in charge of these areas

Development of a Safety Assessment Information System for the Management of Periodic Safety Assessment Activities

Energy Technology Data Exchange (ETDEWEB)

Song, Tae Young [Nuclear Engineering and Technology Institute, Daejeon (Korea, Republic of)

2007-07-01

At present, the 10-year Periodic Safety Review(PSR) has been performing to confirm all the aspects of safety issues for all the operating plants in compliance with domestic nuclear law of article 23, subarticle 3. For each plant, in addition, Probabilistic Safety Assessment(PSA) and Severe Accident Management Guideline(SAMG) are being implemented and revised periodically to reflect the latest safety level according to principle fulfillment of severe accident policy statement. The assessment reports, as one of outcomes from these activities, are submitted into and reviewed by domestic regulatory body. During reviewing (in-office duty) and licensing (regulatory duty) process, a large number of outcomes of which most are the formal technical reports and licensing materials, are inevitably produced. Moreover, repeated review process over the plants can make them accumulated and produce a variety of documents additionally. This circumstance motivates to develop effective tool or system for the management of these reports and related technical documents for the future use in licensing process and for subsequent plant assessments. This paper presents the development status of Safety Assessment Information System(SAIS) which manages safety-related documents of PSR, PSA and SAMG for practical use for experienced engineers in charge of these areas.

A Review of Botanical Characteristics, Traditional Usage, Chemical Components, Pharmacological Activities, and Safety of Pereskia bleo (Kunth DC

Directory of Open Access Journals (Sweden)

Sogand Zareisedehizadeh

2014-01-01

Full Text Available Pereskia bleo, a leafy cactus, is a medicinal plant native to West and South America and distributed in tropical and subtropical areas. It is traditionally used as a dietary vegetable, barrier hedge, water purifier, and insect repellant and for maintaining health, detoxification, prevention of cancer, and/or treatment of cancer, hypertension, diabetes, stomach ache, muscle pain, and inflammatory diseases such as dermatitis and rheumatism. The aim of this paper was to provide an up-to-date and comprehensive review of the botanical characteristics, traditional usage, phytochemistry, pharmacological activities, and safety of P. bleo. A literature search using MEDLINE (via PubMed, Science direct, Scopus and Google scholar and China Academic Journals Full-Text Database (CNKI and available eBooks and books in the National University of Singapore libraries in English and Chinese was conducted. The following keywords were used: Pereskia bleo, Pereskia panamensis, Pereskia corrugata, Rhodocacus corrugatus, Rhodocacus bleo, Cactus panamensis, Cactus bleo, Spinach cactus, wax rose, Perescia, and Chinese rose. This review revealed the association between the traditional usage of P. bleo and reported pharmacological properties in the literature. Further investigation on the pharmacological properties and phytoconstituents of P. bleo is warranted to further exploit its potentials as a source of novel therapeutic agents or lead compounds.

A Review of Botanical Characteristics, Traditional Usage, Chemical Components, Pharmacological Activities, and Safety of Pereskia bleo (Kunth) DC.

Science.gov (United States)

Zareisedehizadeh, Sogand; Tan, Chay-Hoon; Koh, Hwee-Ling

2014-01-01

Pereskia bleo, a leafy cactus, is a medicinal plant native to West and South America and distributed in tropical and subtropical areas. It is traditionally used as a dietary vegetable, barrier hedge, water purifier, and insect repellant and for maintaining health, detoxification, prevention of cancer, and/or treatment of cancer, hypertension, diabetes, stomach ache, muscle pain, and inflammatory diseases such as dermatitis and rheumatism. The aim of this paper was to provide an up-to-date and comprehensive review of the botanical characteristics, traditional usage, phytochemistry, pharmacological activities, and safety of P. bleo. A literature search using MEDLINE (via PubMed), Science direct, Scopus and Google scholar and China Academic Journals Full-Text Database (CNKI) and available eBooks and books in the National University of Singapore libraries in English and Chinese was conducted. The following keywords were used: Pereskia bleo, Pereskia panamensis, Pereskia corrugata, Rhodocacus corrugatus, Rhodocacus bleo, Cactus panamensis, Cactus bleo, Spinach cactus, wax rose, Perescia, and Chinese rose. This review revealed the association between the traditional usage of P. bleo and reported pharmacological properties in the literature. Further investigation on the pharmacological properties and phytoconstituents of P. bleo is warranted to further exploit its potentials as a source of novel therapeutic agents or lead compounds.

Safety assessment for spent fuel storage facilities

International Nuclear Information System (INIS)

1994-01-01

This Safety Practice has been prepared as part of the IAEA's programme on the safety assessment of interim spent fuel storage facilities which are not an integral part of an operating nuclear power plant. This report provides general guidance on the safety assessment process, discussing both deterministic and probabilistic assessment methods. It describes the safety assessment process for normal operation and anticipated operational occurrences and also related to accident conditions. 10 refs, 2 tabs

Consideration of aging in probabilistic safety assessment

International Nuclear Information System (INIS)

Titina, B.; Cepin, M.

2007-01-01

Probabilistic safety assessment is a standardised tool for assessment of safety of nuclear power plants. It is a complement to the safety analyses. Standard probabilistic models of safety equipment assume component failure rate as a constant. Ageing of systems, structures and components can theoretically be included in new age-dependent probabilistic safety assessment, which generally causes the failure rate to be a function of age. New age-dependent probabilistic safety assessment models, which offer explicit calculation of the ageing effects, are developed. Several groups of components are considered which require their unique models: e.g. operating components e.g. stand-by components. The developed models on the component level are inserted into the models of the probabilistic safety assessment in order that the ageing effects are evaluated for complete systems. The preliminary results show that the lack of necessary data for consideration of ageing causes highly uncertain models and consequently the results. (author)

A Methodology for Safety Culture Impact Assessment

Energy Technology Data Exchange (ETDEWEB)

Han, Kiyoon; Jae, Moosung [Hanyang Univ., Seoul (Korea, Republic of)

2014-05-15

The purpose of this study is to develop methodology for assessing safety culture impact on nuclear power plants. A new methodology for assessing safety culture impact index has been developed and applied for the reference nuclear power plants. The developed SCII model might contribute to comparing the level of safety culture among nuclear power plants as well as to improving the safety of nuclear power plants. Safety culture is defined to be fundamental attitudes and behaviors of the plant staff which demonstrate that nuclear safety is the most important consideration in all activities conducted in nuclear power operation. Through several accidents of nuclear power plant including the Fukusima Daiichi in 2011 and Chernovyl accidents in 1986, the safety of nuclear power plant is emerging into a matter of interest. From the accident review report, it can be easily found out that safety culture is important and one of dominant contributors to accidents. However, the impact methodology for assessing safety culture has not been established analytically yet. It is difficult to develop the methodology for assessing safety culture impact quantitatively.

A Methodology for Safety Culture Impact Assessment

International Nuclear Information System (INIS)

Han, Kiyoon; Jae, Moosung

2014-01-01

The purpose of this study is to develop methodology for assessing safety culture impact on nuclear power plants. A new methodology for assessing safety culture impact index has been developed and applied for the reference nuclear power plants. The developed SCII model might contribute to comparing the level of safety culture among nuclear power plants as well as to improving the safety of nuclear power plants. Safety culture is defined to be fundamental attitudes and behaviors of the plant staff which demonstrate that nuclear safety is the most important consideration in all activities conducted in nuclear power operation. Through several accidents of nuclear power plant including the Fukusima Daiichi in 2011 and Chernovyl accidents in 1986, the safety of nuclear power plant is emerging into a matter of interest. From the accident review report, it can be easily found out that safety culture is important and one of dominant contributors to accidents. However, the impact methodology for assessing safety culture has not been established analytically yet. It is difficult to develop the methodology for assessing safety culture impact quantitatively

Criminal investigations: pupil pharmacological reactivity as method for assessing time since death is fallacious.

Science.gov (United States)

Orrico, Marco; Melotti, Roberto; Mantovani, Anna; Avesani, Barbara; De Marco, Roberto; De Leo, Domenico

2008-12-01

Determination of the time since death in the early postmortem period is one of the most critical issues to be faced by criminal investigators. One of the techniques is the evaluation of the pupil pharmacological reactivity. In the present work, we aim at identifying whether an objective and single method, based on pharmacological pupil reaction, is feasible or not. Between 2002 and 2003 calendar years, we observed 309 bodies, whose eyes have been each instilled apart, within 26 hours since death, with either a myotic substance or a mydriatic solution. Our results show that the real effectiveness of pupil pharmacological reactivity as method for assessing the time since death in early postmortem period is not only questionable but even highly misleading if not replaced by alternative objective physiological tests and appropriate professional judgments by the investigators.

Regulatory review of safety cases and safety assessments for near surface

International Nuclear Information System (INIS)

Nys, V.

2003-01-01

The activities of the ASAM Regulatory Review Working Group are presented. Regulatory review of the safety assessment is made. It includes the regulatory review of post-closure safety assessment; safety case development and confidence building. The ISAM methodology is reviewed and SA system description is presented. Recommendations on the review process management are given

Safety Auditing and Assessments

Science.gov (United States)

Goodin, James Ronald (Ronnie)

2005-01-01

Safety professionals typically do not engage in audits and independent assessments with the vigor as do our quality brethren. Taking advantage of industry and government experience conducting value added Independent Assessments or Audits benefits a safety program. Most other organizations simply call this process "internal audits." Sources of audit training are presented and compared. A relation of logic between audit techniques and mishap investigation is discussed. An example of an audit process is offered. Shortcomings and pitfalls of auditing are covered.

Confidence building in safety assessments

International Nuclear Information System (INIS)

Grundfelt, Bertil

1999-01-01

Future generations should be adequately protected from damage caused by the present disposal of radioactive waste. This presentation discusses the core of safety and performance assessment: The demonstration and building of confidence that the disposal system meets the safety requirements stipulated by society. The major difficulty is to deal with risks in the very long time perspective of the thousands of years during which the waste is hazardous. Concern about these problems has stimulated the development of the safety assessment discipline. The presentation concentrates on two of the elements of safety assessment: (1) Uncertainty and sensitivity analysis, and (2) validation and review. Uncertainty is associated both with respect to what is the proper conceptual model and with respect to parameter values for a given model. A special kind of uncertainty derives from the variation of a property in space. Geostatistics is one approach to handling spatial variability. The simplest way of doing a sensitivity analysis is to offset the model parameters one by one and observe how the model output changes. The validity of the models and data used to make predictions is central to the credibility of safety assessments for radioactive waste repositories. There are several definitions of model validation. The presentation discusses it as a process and highlights some aspects of validation methodologies

Safety Management and Safety Culture Self Assessment of Kartini Research Reactor

Energy Technology Data Exchange (ETDEWEB)

Syarip, S., E-mail: syarip@batan.go.id [Centre for Accelerator and Material Process Technology, National Nuclear Energy Agency (BATAN), Yogyakarta (Indonesia)

2014-10-15

The self-assessment of safety culture and safety management status of Kartini research reactor is a step to foster safety culture and management by identifying good practices and areas for improvement, and also to improve reactor safety in a whole. The method used in this assessment is based on questionnaires provided by the Forum for Nuclear Cooperation in Asia (FNCA), then reviewed by experts. Based on the assessment and evaluation results, it can be concluded that there were several good practices in maintaining the safety status of Kartini reactor such as: reactor operators and radiation protection workers were aware and knowledgeable of the safety standards and policies that apply to their operation, readily accept constructive criticism from their management and from the inspectors of regulatory body that address safety performance. As a proof, for the last four years the number of inspection/audit findings from Regulatory Body (BAPETEN) tended to decrease while the reactor utilization and its operating hour increased. On the other hands there were also some comments and recommendations for improvement of reactor safety culture, such as that there should be more frequent open dialogues between employees and managers, to grow and attain a mutual support to achieve safety goals. (author)

Determination of Safety Performance Grade of NPP Using Integrated Safety Performance Assessment (ISPA) Program

International Nuclear Information System (INIS)

Chung, Dae Wook

2011-01-01

Since the beginning of 2000, the safety regulation of nuclear power plant (NPP) has been challenged to be conducted more reasonable, effective and efficient way using risk and performance information. In the United States, USNRC established Reactor Oversight Process (ROP) in 2000 for improving the effectiveness of safety regulation of operating NPPs. The main idea of ROP is to classify the NPPs into 5 categories based on the results of safety performance assessment and to conduct graded regulatory programs according to categorization, which might be interpreted as 'Graded Regulation'. However, the classification of safety performance categories is highly comprehensive and sensitive process so that safety performance assessment program should be prepared in integrated, objective and quantitative manner. Furthermore, the results of assessment should characterize and categorize the actual level of safety performance of specific NPP, integrating all the substantial elements for assessing the safety performance. In consideration of particular regulatory environment in Korea, the integrated safety performance assessment (ISPA) program is being under development for the use in the determination of safety performance grade (SPG) of a NPP. The ISPA program consists of 6 individual assessment programs (4 quantitative and 2 qualitative) which cover the overall safety performance of NPP. Some of the assessment programs which are already implemented are used directly or modified for incorporating risk aspects. The others which are not existing regulatory programs are newly developed. Eventually, all the assessment results from individual assessment programs are produced and integrated to determine the safety performance grade of a specific NPP

Applications of stable isotopes in clinical pharmacology

NARCIS (Netherlands)

Schellekens, Reinout C A; Stellaard, Frans; Woerdenbag, Herman J; Frijlink, Henderik W; Kosterink, Jos G W

2011-01-01

This review aims to present an overview of the application of stable isotope technology in clinical pharmacology. Three main categories of stable isotope technology can be distinguished in clinical pharmacology. Firstly, it is applied in the assessment of drug pharmacology to determine the

Safety assessment in plant layout design using indexing approach: Implementing inherent safety perspective

International Nuclear Information System (INIS)

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-01-01

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design

Provision and assessment of pharmacology and pharmacotherapy education across an integrated medical school curriculum

NARCIS (Netherlands)

Franson, Kari Lanette

2008-01-01

The papers presented here detail the approach to provide pharmacology and pharmacotherapy education at the Leiden University Medical Center. First it was decided to use the ability-based education model as the educational method and to have consistent outcomes and assessments throughout the

''In-house'' pharmacological management for computed tomography coronary angiography: heart rate reduction, timing and safety of different drugs used during patient preparation

International Nuclear Information System (INIS)

Maffei, Erica; Tedeschi, Carlo; Seitun, Sara; Ruffini, Livia; Aldrovandi, Annachiara; Palumbo, Alessandro A.; Martini, Chiara; Tarantini, Giuseppe; Weustink, Annick C.; Meijboom, Willem B.; Mollet, Nico R.; Krestin, Gabriel P.; Feyter, Pim J. de; Cademartiri, Filippo

2009-01-01

We retrospectively evaluated the effect, timing and safety of different pharmacological strategies during 64-slice CT coronary angiography (CT-CA). From the institutional database of CT-CA we enrolled 560 consecutive patients with suspected coronary artery disease. The type of drug preparation (group 1 = no treatment; group 2 = oral metoprolol; group 3 = other; group 4 = intravenous (IV) atenolol; group 5 = IV atenolol + nitrates; NR = non-responders), timing, and adverse effects were recorded. Heart rate (HR) during different preparation phases was recorded. Four adverse effects were recorded, none of which was attributable to pharmacological treatment. In all groups, except group 1, the HR on arrival was significantly reduced by the pharmacological treatment (p < 0.01). Group 4 showed the best (-16 ± 8 bpm) HR reduction. There was no significant effect on HR due to nitrates (p = 0.49), while a slight increase due to contrast material was noted (p < 0.05). Average time required for preparation was 44 ± 25 min. Groups 4 and 5 showed the most effective timing (8 ± 9 min and 8 ± 8 min, respectively; p < 0.01). Pharmacological preparation in patients undergoing CT-CA is safe and effective. Best results in terms of HR reduction and fast preparation are obtained with IV administration of beta-blockers. (orig.)

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

Reactor Safety Assessment System

International Nuclear Information System (INIS)

Sebo, D.E.; Bray, M.A.; King, M.A.

1987-01-01

The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (USNRC). RSAS is designed for use at the USNRC Operations Center in the event of a serious incident at a licensed nuclear power plant. RSAS is a situation assessment expert system which uses plant parametric data to generate conclusions for use by the NRC Reactor Safety Team. RSAS uses multiple rule bases and plant specific setpoint files to be applicable to all licensed nuclear power plants in the United States. RSAS currently covers several generic reactor categories and multiple plants within each category

Reactor safety assessment system

International Nuclear Information System (INIS)

Sebo, D.E.; Bray, M.A.; King, M.A.

1987-01-01

The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (USNRC). RSA is designed for use at the USNRC Operations Center in the event of a serious incident at a licensed nuclear power plant. RSAS is a situation assessment expert system which uses plant parametric data to generate conclusions for use by the NRC Reactor Safety Team. RSAS uses multiple rule bases and plant specific setpoint files to be applicable to all licensed nuclear power plants in the United States. RSAS currently covers several generic reactor categories and multiple plants within each category

Independent assessment for new nuclear reactor safety

Directory of Open Access Journals (Sweden)

D'Auria Francesco

2017-01-01

Full Text Available A rigorous framework for safety assessment is established in all countries where nuclear technology is used for the production of electricity. On the one side, industry, i.e. reactor designers, vendors and utilities perform safety analysis and demonstrate consistency between results of safety analyses and requirements. On the other side, regulatory authorities perform independent assessment of safety and confirm the acceptability of safety of individual reactor units. The process of comparing results from analyses by reactor utilities and regulators is very complex. The process is also highly dependent upon mandatory approaches pursued for the analysis and from very many details which required the knowledge of sensitive proprietary data (e.g. spacer designs. Furthermore, all data available for the design, construction and operation of reactors produced by the nuclear industry are available to regulators. Two areas for improving the process of safety assessment for individual Nuclear Power Plant Units are identified: New details introduced by industry are not always and systematically requested by regulators for the independent assessment; New analytical techniques and capabilities are not necessarily used in the analyses by regulators (and by the industry. The established concept of independent assessment constitutes the way for improving the process of safety assessment. This is possible, or is largely facilitated, by the recent availability of the so-called Best Estimate Plus Uncertainty approach.

Independent assessment for new nuclear reactor safety

International Nuclear Information System (INIS)

D'Auria, F.; Glaeser, H.; Debrecin, N.

2017-01-01

A rigorous framework for safety assessment is established in all countries where nuclear technology is used for the production of electricity. On one side, industry, i.e. reactor designers, vendors and utilities perform safety analysis and demonstrate consistency between results of safety analyses and requirements. On the other side, regulatory authorities perform independent assessment of safety and confirm the acceptability of safety of individual reactor units. The process of comparing results from analyses by reactor utilities and regulators is very complex. The process is also highly dependent upon mandatory approaches pursued for the analysis and from very many details which required the knowledge of sensitive proprietary data (e.g. spacer designs). Furthermore, all data available for the design, construction and operation of reactors produced by the nuclear industry are available to regulators. Two areas for improving the process of safety assessment for individual Nuclear Power Plant Units are identified: New details introduced by industry are not always and systematically requested by regulators for the independent assessment; New analytical techniques and capabilities are not necessarily used in the analyses by regulators (and by the industry). The established concept of independent assessment constitutes the way for improving the process of safety assessment. This is possible, or is largely facilitated, by the recent availability of the so-called Best Estimate Plus Uncertainty (BEPU) approach. (authors)

AGR core safety assessment methodologies

International Nuclear Information System (INIS)

McLachlan, N.; Reed, J.; Metcalfe, M.P.

1996-01-01

To demonstrate the safety of its gas-cooled graphite-moderated AGR reactors, nuclear safety assessments of the cores are based upon a methodology which demonstrates no component failures, geometrical stability of the structure and material properties bounded by a database. All AGRs continue to meet these three criteria. However, predictions of future core behaviour indicate that the safety case methodology will eventually need to be modified to deal with new phenomena. A new approach to the safety assessment of the cores is currently under development, which can take account of these factors while at the same time providing the same level of protection for the cores. This approach will be based on the functionality of the core: unhindered movement of control rods, continued adequate cooling of the fuel and the core, continued ability to charge and discharge fuel. (author). 5 figs

A new assessment method for demonstrating the sufficiency of the safety assessment and the safety margins of the geological disposal system

International Nuclear Information System (INIS)

Ohi, Takao; Kawasaki, Daisuke; Chiba, Tamotsu; Takase, Toshio; Hane, Koji

2013-01-01

A new method for demonstrating the sufficiency of the safety assessment and safety margins of the geological disposal system has been developed. The method is based on an existing comprehensive sensitivity analysis method and can systematically identify the successful conditions, under which the dose rate does not exceed specified safety criteria, using analytical solutions for nuclide migration and the results of a statistical analysis. The successful conditions were identified using three major variables. Furthermore, the successful conditions at the level of factors or parameters were obtained using relational equations between the variables and the factors or parameters making up these variables. In this study, the method was applied to the safety assessment of the geological disposal of transuranic waste in Japan. Based on the system response characteristics obtained from analytical solutions and on the successful conditions, the classification of the analytical conditions, the sufficiency of the safety assessment and the safety margins of the disposal system were then demonstrated. A new assessment procedure incorporating this method into the existing safety assessment approach is proposed in this study. Using this procedure, it is possible to conduct a series of safety assessment activities in a logical manner. (author)

Procedures for self-assessment of operational safety

International Nuclear Information System (INIS)

1997-08-01

Self-assessment processes have been continuously developed by nuclear organizations, including nuclear power plants. Currently, the nuclear industry and governmental organizations are showing an increasing interest in the implementation of this process as an effective way for improving safety performance. Self-assessment involves the use of different types of tools and mechanisms to assist the organizations in assessing their own safety performance against given standards. This helps to enhance the understanding of the need for improvements, the feeling of ownership in achieving them and and the safety culture as a whole. The concepts developed in this report present the basic approach to self-assessment taking into consideration experience gained during Operational Safety Review Team (OSART) missions, from organizations and utilities which have successfully implemented parts of a self-assessment programme and from meetings organized to discuss the subject

Botany, traditional uses, phytochemistry and pharmacology of Apocynum venetum L. (Luobuma): A review.

Science.gov (United States)

Xie, Wenyan; Zhang, Xiaoying; Wang, Tian; Hu, Jianjun

2012-05-07

Apocynum venetum L. (Apocynaceae, Luobuma ) has a long history as a Chinese traditional medicine with uses to calm the liver, soothe the nerves, dissipate heat, and promote diuresis. Recently, Luobuma tea has been commercialized as a sedative and anti-aging supplement that has become increasingly popular in North American and East Asian health food markets. The aim of this review is to provide an up-to-date and comprehensive overview of the botany, chemical constituents, traditional uses, pharmacological activities and safety aspects of Apocynum venetum in order to assess its ethnopharmacological use and to explore its therapeutic potentials and future opportunities for research. The accessible literature on Apocynum venetum written in English, Chinese and Japanese were collected and analyzed. The literatures included ancient Chinese herbal classics, pharmacopoeias and articles that included in Pubmed, Web of Science, Google Scholar and Wanfang. Modern pharmacological studies demonstrated that Apocynum venetum possess wide pharmacological activities that include antihypertensive, cardiotonic, hepatoprotective, antioxidant, lipid-lowering, antidepressant and anxiolytic effects, which can be explained by the presence of various flavonoid compounds in this plant. The traditional (Lop Nor region) use of Apocynum venetum with tobacco as an agent to detoxify nicotine may receive interest as a possible therapeutic option to detoxify the body from smoking. Based on animal studies and clinical trials, Apocynum venetum causes no severe side effects, even in a stable daily dosage (50mg/person/day) for more than three years. Apocynum venetum potentially has therapeutic potential in the prevention and treatment for the cardiovascular and neurological diseases, especially for high blood pressure, high cholesterol, neurasthenia, depression and anxiety. Further investigations are needed to explore individual bioactive compounds responsible for these in vitro and in vivo

Delirium in the elderly: A systematic review of pharmacological and non-pharmacological treatments

Directory of Open Access Journals (Sweden)

Cecília Carboni Tardelli Cerveira

Full Text Available ABSTRACT Delirium is a common disorder associated with poor prognosis, especially in the elderly. The impact of different treatment approaches for delirium on morbimortality and long-term welfare is not completely understood. OBJECTIVE: To determine the efficacy of pharmacological and non-pharmacological treatments in elderly patients with delirium. METHODS: This systematic review compared pharmacological and non-pharmacological treatments in patients over 60 years old with delirium. Databases used were: MEDLINE (PubMed, EMBASE, Cochrane CENTRAL and LILACS from inception to January 6th, 2016. RESULTS: A total of ten articles were selected. The six non-pharmacological intervention studies showed no impact on duration of delirium, mortality or institutionalization, but a decrease in severity of delirium and improvement in medium-term cognitive function were observed. The most commonly used interventions were temporal-spatial orientation, orientation to self and others, early mobilization and sleep hygiene. The four studies with pharmacological interventions found that rivastigmine reduced the duration of delirium, improved cognitive function and reduced caregiver burden; olanzapine and haloperidol decreased the severity of delirium; droperidol reduced length of hospitalization and improved delirium remission rate. CONCLUSION: Although the pharmacological approach has been used in the treatment of delirium among elderly, there have been few studies assessing its efficacy, involving a small number of patients. However, the improvements in delirium duration and severity suggest these drugs are effective in treating the condition. Once delirium has developed, non-pharmacological treatment seems less effective in controlling symptoms, and there is a lack of studies describing different non-pharmacological interventions.

Uncertainty analysis in safety assessment

International Nuclear Information System (INIS)

Lemos, Francisco Luiz de; Sullivan, Terry

1997-01-01

Nuclear waste disposal is a very complex subject which requires the study of many different fields of science, like hydro geology, meteorology, geochemistry, etc. In addition, the waste disposal facilities are designed to last for a very long period of time. Both of these conditions make safety assessment projections filled with uncertainty. This paper addresses approaches for treatment of uncertainties in the safety assessment modeling due to the variability of data and some current approaches used to deal with this problem. (author)

NUMO's approach for long-term safety assessment - 59404

International Nuclear Information System (INIS)

Ebashi, Takeshi; Kaku, Kenichi; Ishiguro, Katsuhiko

2012-01-01

One of NUMO's policies for ensuring safety is staged and flexible project implementation and decision-making based on iterative confirmation of safety. The safety assessment takes the central role in multiple lines of reasoning and argumentation by providing a quantitative evaluation of long-term safety; a key aspect is uncertainty management. This paper presents NUMO's basic strategies for long-term safety assessment based on the above policy. NUMO's approach considering Japanese boundary conditions is demonstrated as a starting-point for evaluating the long-term safety of an actual site. In Japan, the Act on Final Disposal of Specified Radioactive Waste states that the siting process shall consist of three stages. The Nuclear Waste Management Organization of Japan (NUMO) is responsible for geological disposal of vitrified high-level waste and some types of TRU waste. NUMO has chosen to implement a volunteer approach to siting. NUMO decided to prepare the so-called 2010 technical report, which sets out three safety policies, one of which is staged project implementation and decision-making based on iterative confirmation of safety. Based on this policy, NUMO will gradually integrate relevant interdisciplinary knowledge to build a safety case when a formal volunteer application is received that would allow site investigations to be initiated. The safety assessment takes the central role in multiple lines of reasoning and argumentation by providing a quantitative evaluation of long-term safety; one of a key aspect is uncertainty management. This paper presents the basic strategies for NUMO's long-term safety assessment based on the above policy. In concrete terms, the common procedures involved in safety assessment are applied in a stepwise manner, based on integration of knowledge obtained from site investigations/evaluations and engineered measures. The results of the safety assessment are then reflected in the planning of site investigations and engineered

Probabilistic safety assessment

International Nuclear Information System (INIS)

Hoertner, H.; Schuetz, B.

1982-09-01

For the purpose of assessing applicability and informativeness on risk-analysis methods in licencing procedures under atomic law, the choice of instruments for probabilistic analysis, the problems in and experience gained in their application, and the discussion of safety goals with respect to such instruments are of paramount significance. Naturally, such a complex field can only be dealt with step by step, making contribution relative to specific problems. The report on hand shows the essentials of a 'stocktaking' of systems relability studies in the licencing procedure under atomic law and of an American report (NUREG-0739) on 'Quantitative Safety Goals'. (orig.) [de

Breastfeeding information in pharmacology textbooks: a content analysis.

Science.gov (United States)

Amir, Lisa H; Raval, Manjri; Hussainy, Safeera Y

2013-07-01

Women often need to take medicines while breastfeeding and pharmacists need to provide accurate information in order to avoid undue caution about the compatibility of medicines and breastfeeding. The objective of this study was to review information provided about breastfeeding in commonly used pharmacology textbooks. We asked 15 Australian universities teaching pharmacy courses to provide a list of recommended pharmacology textbooks in 2011. Ten universities responded, generating a list of 11 textbooks that we analysed for content relating to breastfeeding. Pharmacology textbooks outline the mechanisms of actions of medicines and their use: however, only a small emphasis is placed on the safety/compatibility of medicines for women during breastfeeding. Current pharmacology textbooks recommended by Australian universities have significant gaps in their coverage of medicine use in breastfeeding. Authors of textbooks should address this gap, so academic staff can recommend texts with the best lactation content.

A Methodology To Incorporate The Safety Culture Into Probabilistic Safety Assessments

Energy Technology Data Exchange (ETDEWEB)

Park, Sunghyun; Kim, Namyeong; Jae, Moosung [Hanyang University, Seoul (Korea, Republic of)

2015-10-15

In order to incorporate organizational factors into PSA, a methodology needs to be developed. Using the AHP to weigh organizational factors as well as the SLIM to rate those factors, a methodology is introduced in this study. The safety issues related to nuclear safety culture have occurred increasingly. The quantification tool has to be developed in order to include the organizational factor into Probabilistic Safety Assessments. In this study, the state-of-the-art for the organizational evaluation methodologies has been surveyed. This study includes the research for organizational factors, maintenance process, maintenance process analysis models, a quantitative methodology using Analytic Hierarchy Process, Success Likelihood Index Methodology. The purpose of this study is to develop a methodology to incorporate the safety culture into PSA for obtaining more objective risk than before. The organizational factor considered in nuclear safety culture might affect the potential risk of human error and hardware-failure. The safety culture impact index to monitor the plant safety culture can be assessed by applying the developed methodology into a nuclear power plant.

A Methodology To Incorporate The Safety Culture Into Probabilistic Safety Assessments

International Nuclear Information System (INIS)

Park, Sunghyun; Kim, Namyeong; Jae, Moosung

2015-01-01

In order to incorporate organizational factors into PSA, a methodology needs to be developed. Using the AHP to weigh organizational factors as well as the SLIM to rate those factors, a methodology is introduced in this study. The safety issues related to nuclear safety culture have occurred increasingly. The quantification tool has to be developed in order to include the organizational factor into Probabilistic Safety Assessments. In this study, the state-of-the-art for the organizational evaluation methodologies has been surveyed. This study includes the research for organizational factors, maintenance process, maintenance process analysis models, a quantitative methodology using Analytic Hierarchy Process, Success Likelihood Index Methodology. The purpose of this study is to develop a methodology to incorporate the safety culture into PSA for obtaining more objective risk than before. The organizational factor considered in nuclear safety culture might affect the potential risk of human error and hardware-failure. The safety culture impact index to monitor the plant safety culture can be assessed by applying the developed methodology into a nuclear power plant

Regulatory Forum Review*: Utility of in Vitro Secondary Pharmacology Data to Assess Risk of Drug-induced Valvular Heart Disease in Humans: Regulatory Considerations.

Science.gov (United States)

Papoian, Thomas; Jagadeesh, Gowraganahalli; Saulnier, Muriel; Simpson, Natalie; Ravindran, Arippa; Yang, Baichun; Laniyonu, Adebayo A; Khan, Imran; Szarfman, Ana

2017-04-01

Drug-induced valvular heart disease (VHD) is a serious side effect linked to long-term treatment with 5-hydroxytryptamine (serotonin) receptor 2B (5-HT 2B ) agonists. Safety assessment for off-target pharmacodynamic activity is a common approach used to screen drugs for this undesired property. Such studies include in vitro assays to determine whether the drug is a 5-HT 2B agonist, a necessary pharmacological property for development of VHD. Measures of in vitro binding affinity (IC 50 , K i ) or cellular functional activity (EC 50 ) are often compared to maximum therapeutic free plasma drug levels ( fC max ) from which safety margins (SMs) can be derived. However, there is no clear consensus on what constitutes an appropriate SM under various therapeutic conditions of use. The strengths and limitations of SM determinations and current risk assessment methodology are reviewed and evaluated. It is concluded that the use of SMs based on K i values, or those relative to serotonin (5-HT), appears to be a better predictor than the use of EC 50 or EC 50 /human fC max values for determining whether known 5-HT 2B agonists have resulted in VHD. It is hoped that such a discussion will improve efforts to reduce this preventable serious drug-induced toxicity from occurring and lead to more informed risk assessment strategies.

Complementary safety assessments - Report by the French Nuclear Safety Authority

International Nuclear Information System (INIS)

2011-12-01

As an immediate consequence of the Fukushima accident, the French Authority of Nuclear Safety (ASN) launched a campaign of on-site inspections and asked operators (mainly EDF, AREVA and CEA) to make complementary assessments of the safety of the nuclear facilities they manage. The approach defined by ASN for the complementary safety assessments (CSA) is to study the behaviour of nuclear facilities in severe accidents situations caused by an off-site natural hazard according to accident scenarios exceeding the current baseline safety requirements. This approach can be broken into 2 phases: first conformity to current design and secondly an approach to the beyond design-basis scenarios built around the principle of defence in depth. 38 inspections were performed on issues linked to the causes of the Fukushima crisis. It appears that some sites have to reinforce the robustness of the heat sink. The CSA confirmed that the processes put into place at EDF to detect non-conformities were satisfactory. The complementary safety assessments demonstrated that the current seismic margins on the EDF nuclear reactors are satisfactory. With regard to flooding, the complementary safety assessments show that the complete reassessment carried out following the flooding of the Le Blayais nuclear power plant in 1999 offers the installations a high level of protection against the risk of flooding. Concerning the loss of electrical power supplies and the loss of cooling systems, the analysis of EDF's CSA reports showed that certain heat sink and electrical power supply loss scenarios can, if nothing is done, lead to core melt in just a few hours in the most unfavourable circumstances. As for nuclear facilities that are not power or experimental reactors, some difficulties have appeared to implement the CSA approach that was initially devised for reactors. Generally speaking, ASN considers that the safety of nuclear facilities must be made more robust to improbable risks which are not

Integrated Assessment of Pharmacological and Nutritional Cardiovascular Risk Management : Blood Pressure Control in the DIAbetes and LifEstyle Cohort Twente (DIALECT)

NARCIS (Netherlands)

Gant, Christina M.; Binnenmars, S. Heleen; van den Berg, Else; Bakker, Stephan J. L.; Navis, Gerjan; Laverman, Gozewijn D.

2017-01-01

Cardiovascular risk management is an integral part of treatment in Type 2 Diabetes Mellitus (T2DM), and requires pharmacological as well as nutritional management. We hypothesize that a systematic assessment of both pharmacological and nutritional management can identify targets for the improvement

Development and applications of a safety assessment system for promoting safety culture in nuclear power plants

International Nuclear Information System (INIS)

Takano, Ken-ichi; Hasegawa, Naoko; Hirose, Ayako; Hayase, Ken-ichi

2004-01-01

For past five years, CRIEPI has been continuing efforts to develop and make applications of a 'safety assessment system' which enable to measure the safety level of organization. This report describe about frame of the system, assessment results and its reliability, and relation between labor accident rate in the site and total safety index (TSI), which can be obtained by the principal factors analysis. The safety assessment in this report is based on questionnaire survey of employee. The format and concrete questionnaires were developed using existing literatures including organizational assessment tools. The tailored questionnaire format involved 124 questionnaire items. The assessment results could be considered as a well indicator of the safety level of organization, safety management, and safety awareness of employee. (author)

Safety culture' is integrating 'human' into risk assessment

International Nuclear Information System (INIS)

Sugimoto, Taiji

2014-01-01

Significance of Fukushima nuclear power accident requested reconsideration of safety standards, of which we had usually no doubt. Risk assessment standard (JIS B 9702), Which was used for repetition of database preparation and cumulative assessment, defined allowable risk and residual risk. However, work site and immediate assessment was indispensable beside such assessment so as to ensure safety. Risk of casualties was absolutely not acceptable in principle and judgments to approve allowable risk needed accountability, which was reminded by safety culture proposed by IAEA and also identified by investigation of organizational cause of Columbia accident. Actor of safety culture would be organization and individual, and mainly individual. Realization of safety culture was conducted by personnel having moral consciousness and firm sense of mission in the course of jobs and working daily with sweat pouring. Safety engineering/technology should have framework integrating human as such totality. (T. Tanaka)

Trials of Pharmacological Interventions for Tourette Syndrome: A Systematic Review

Directory of Open Access Journals (Sweden)

Karen Waldon

2013-01-01

Full Text Available Introduction: Gilles de la Tourette Syndrome (GTS is a childhood-onset hyperkinetic movement disorder defined by the chronic presence of multiple motor tics and at least one vocal tic and often complicated by co-morbid behavioural problems. The pharmacological treatment of GTS focuses on the modulation of monoaminergic pathways within the cortico-striato-thalamo-cortical circuitry. This paper aims to evaluate the efficacy and safety profiles of pharmacological agents used in the treatment of tics in patients with GTS, in order to provide clinicians with an evidence-based rationale for the pharmacological treatment in GTS.

Uncertainty analysis in safety assessment

Energy Technology Data Exchange (ETDEWEB)

Lemos, Francisco Luiz de [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN), Belo Horizonte, MG (Brazil); Sullivan, Terry [Brookhaven National Lab., Upton, NY (United States)

1997-12-31

Nuclear waste disposal is a very complex subject which requires the study of many different fields of science, like hydro geology, meteorology, geochemistry, etc. In addition, the waste disposal facilities are designed to last for a very long period of time. Both of these conditions make safety assessment projections filled with uncertainty. This paper addresses approaches for treatment of uncertainties in the safety assessment modeling due to the variability of data and some current approaches used to deal with this problem. (author) 13 refs.; e-mail: lemos at bnl.gov; sulliva1 at bnl.gov

Safety assessment of foods derived from genetically modified crops

NARCIS (Netherlands)

Kleter, G.A.; Kuiper, H.A.

2003-01-01

The pre-market safety assessment of foods derived from genetically modified crops is carried out according to the consensus approach of "substantial equivalence", in other words: the comparative safety assessment. Currently, the safety assessment of genetically modified foods is harmonized at the

National Waste Repository Novi Han operational safety analysis report. Safety assessment methodology

International Nuclear Information System (INIS)

2003-01-01

The scope of the safety assessment (SA), presented includes: waste management functions (acceptance, conditioning, storage, disposal), inventory (current and expected in the future), hazards (radiological and non-radiological) and normal and accidental modes. The stages in the development of the SA are: criteria selection, information collection, safety analysis and safety assessment documentation. After the review the facilities functions and the national and international requirements, the criteria for safety level assessment are set. As a result from the 2nd stage actual parameters of the facility, necessary for safety analysis are obtained.The methodology is selected on the base of the comparability of the results with the results of previous safety assessments and existing standards and requirements. The procedure and requirements for scenarios selection are described. A radiological hazard categorisation of the facilities is presented. Qualitative hazards and operability analysis is applied. The resulting list of events are subjected to procedure for prioritization by method of 'criticality analysis', so the estimation of the risk is given for each event. The events that fall into category of risk on the boundary of acceptability or are unacceptable are subjected to the next steps of the analysis. As a result the lists with scenarios for PSA and possible design scenarios are established. PSA logical modeling and quantitative calculations of accident sequences are presented

Assessment of safety culture: Changing regulatory approach in Hungary

International Nuclear Information System (INIS)

Ronaky, Jozsef; Toth, Andras

2002-01-01

Hungarian Atomic Energy Authority (HAEA) is changing its inspection practice and assessment methods of safety performance and safety culture in operating nuclear facilities. The new approach emphasises integrated team inspection of safety cornerstones and systematic assessment of safety performance of operators. (author)

Tolerability of risk, safety assessment principles and their implications for probabilistic safety analysis

International Nuclear Information System (INIS)

Ewing, D.J.F.; Campbell, J.F.

1994-01-01

This paper gives a regulatory view of probabilistic safety assessment as seen by the Nuclear Installations Inspectorate (NII) and in the light of the general regulatory risk aims set out in the Health and Safety Executive's (HSE) The tolerability of risk from nuclear power stations (TOR) and in Safety assessment principles for nuclear plants (SAPs), prepared by NII on behalf of the HSE. Both of these publications were revised and republished in 1992. This paper describes the SAPs, together with the historical background, the motivation for review, the effects of the Sizewell and Hinkley Point C public inquiries, changes since the original versions, comparison with international standards and use in assessment. For new plant, probabilistic safety analysis (PSA) is seen as an essential tool in balancing the safety of the design and in demonstrating compliance with TOR and the SAPs. (Author)

The radiation safety self-assessment program of Ontario Hydro

International Nuclear Information System (INIS)

Armitage, G.; Chase, W.J.

1987-01-01

Ontario Hydro has developed a self-assessment program to ensure that high quality in its radiation safety program is maintained. The self-assessment program has three major components: routine ongoing assessment, accident/incident investigation, and detailed assessments of particular radiation safety subsystems or of the total radiation safety program. The operation of each of these components is described

Probabilistic safety assessment for seismic events

International Nuclear Information System (INIS)

1993-10-01

This Technical Document on Probabilistic Safety Assessment for Seismic Events is mainly associated with the Safety Practice on Treatment of External Hazards in PSA and discusses in detail one specific external hazard, i.e. earthquakes

Safety analysis and risk assessment handbook

International Nuclear Information System (INIS)

Peterson, V.L.; Colwell, R.G.; Dickey, R.L.

1997-01-01

This Safety Analysis and Risk Assessment Handbook (SARAH) provides guidance to the safety analyst at the Rocky Flats Environmental Technology Site (RFETS) in the preparation of safety analyses and risk assessments. Although the older guidance (the Rocky Flats Risk Assessment Guide) continues to be used for updating the Final Safety Analysis Reports developed in the mid-1980s, this new guidance is used with all new authorization basis documents. With the mission change at RFETS came the need to establish new authorization basis documents for its facilities, whose functions had changed. The methodology and databases for performing the evaluations that support the new authorization basis documents had to be standardized, to avoid the use of different approaches and/or databases for similar accidents in different facilities. This handbook presents this new standardized approach. The handbook begins with a discussion of the requirements of the different types of authorization basis documents and how to choose the one appropriate for the facility to be evaluated. It then walks the analyst through the process of identifying all the potential hazards in the facility, classifying them, and choosing the ones that need to be analyzed further. It then discusses the methods for evaluating accident initiation and progression and covers the basic steps in a safety analysis, including consequence and frequency binning and risk ranking. The handbook lays out standardized approaches for determining the source terms of the various accidents (including airborne release fractions, leakpath factors, etc.), the atmospheric dispersion factors appropriate for Rocky Flats, and the methods for radiological and chemical consequence assessments. The radiological assessments use a radiological open-quotes templateclose quotes, a spreadsheet that incorporates the standard values of parameters, whereas the chemical assessments use the standard codes ARCHIE and ALOHA

Living probabilistic safety assessment (LPSA)

International Nuclear Information System (INIS)

1999-08-01

Over the past few years many nuclear power plant organizations have performed probabilistic safety assessments (PSAs) to identify and understand key plant vulnerabilities. As a result of the availability of these PSA studies, there is a desire to use them to enhance plant safety and to operate the nuclear stations in the most efficient manner. PSA is an effective tool for this purpose as it assists plant management to target resources where the largest benefit to plant safety can be obtained. However, any PSA which is to be used in this way must have a credible and defensible basis. Thus, it is very important to have a high quality 'living PSA' accepted by the plant and the regulator. With this background in mind, the IAEA has prepared this report on Living Probabilistic Safety Assessment (LPSA) which addresses the updating, documentation, quality assurance, and management and organizational requirements for LPSA. Deficiencies in the areas addressed in this report would seriously reduce the adequacy of the LPSA as a tool to support decision making at NPPs. This report was reviewed by a working group during a Technical Committee Meeting on PSA Applications to Improve NPP Safety held in Madrid, Spain, from 23 to 27 February 1998

Probabilistic safety assessment in nuclear power plant management

International Nuclear Information System (INIS)

Holloway, N.J.

1989-06-01

Probabilistic Safety Assessment (PSA) techniques have been widely used over the past few years to assist in understanding how engineered systems respond to abnormal conditions, particularly during a severe accident. The use of PSAs in the design and operation of such systems thus contributes to the safety of nuclear power plants. Probabilistic safety assessments can be maintained to provide a continuous up-to-date assessment (Living PSA), supporting the management of plant operations and modifications

Types of safety assessments of near surface repository for radioactive waste

International Nuclear Information System (INIS)

Mateeva, M.

2004-01-01

The purpose of this article is to presents the classification of different types safety assessments of near surface repository for low and intermediate level radioactive waste substantiated with results of safety assessments generated in Bulgaria. The different approach of safety assessments applied for old existing repository as well as for site selection for construction new repository is outlined. The regulatory requirements in Bulgaria define three main types of assessments: Safety assessment; Technical substation of repository safety; Assessment of repository influence on environment that is in form of report prepared from the Ministry of environment and waters on the base of results obtained in two first types of assessments. Additionally first type is subdivided in three categories - preliminary safety assessment, safety assessment and post closure safety assessment, which are generated using deterministic approach. The technical substation of repository safety is generated using probabilistic approach. Safety assessment results that are presented here are based on evaluation of existing old repository type 'Radon' in Novi Han and real site selection procedure for new near surface repository for low and intermediate level radioactive waste from nuclear power station in Kozloduy. The important role of safety assessment for improvement the repository safety as well as for repository licensing, correct site selection and right choice of engineer barriers and repository design is discussed using generated results. (author)

Data used for safety assessment of reprocessing facilities

International Nuclear Information System (INIS)

Nomura, Yasushi; Suzuki, Atsuyuki; Kanagawa, Akira

1990-08-01

For safety assessment of a reprocessing facility, it is important to know performance of radioactive materials in their accidental release and transfer. Accordingly, it is necessary to collect and prepare data for use in analyses for their performance. In JAERI, experiments such as for data acquisition, for source-term evaluation and for radioactive material transfer, are now planned to be performed. Prior to these experiments, it is decided to investigate data in use for accidental safety assessment of reprocessing plants and their based experimental data, thus to make it possible to recommend reasonable values for safety analysis parameters by evaluating the investigated results, to select the experimental items, to edit a safety assessment handbook and so on. In this line of objectives, JAERI rewarded a two-year contract of investigation to Nuclear Safety Research Association, to make a working group under a special committee on data investigation for reprocessing facility safety assessment. This report is a collection of results reviewed and checked by the working group. The contents consist of two parts, one for investigation and review of data used for safety assessment of domestic or oversea reprocessing facilities, and the other for investigation, review and evaluation of ANSI recommended American standard data reported by E. Walker together with their based experimental data resorting to the original referred reports. (author)

Safety functions and safety function indicators - key elements in SKB'S methodology for assessing long-term safety of a KBS-3 repository

International Nuclear Information System (INIS)

Hedin, A.

2008-01-01

The application of so called safety function indicators in SKB safety assessment of a KBS-3 repository for spent nuclear fuel is presented. Isolation and retardation are the two main safety functions of the KBS-3 concept. In order to quantitatively evaluate safety on a sub-system level, these functions need to be differentiated, associated with quantitative measures and, where possible, with quantitative criteria relating to the fulfillment of the safety functions. A safety function is defined as a role through which a repository component contributes to safety. A safety function indicator is a measurable or calculable property of a repository component that allows quantitative evaluation of a safety function. A safety function indicator criterion is a quantitative limit such that if the criterion is fulfilled, the corresponding safety function is upheld. The safety functions and their associated indicators and criteria developed for the KBS-3 repository are primarily related to the isolating potential and to physical states of the canister and the clay buffer surrounding the canister. They are thus not directly related to release rates of radionuclides. The paper also describes how the concepts introduced i) aid in focussing the assessment on critical, safety related issues, ii) provide a framework for the accounting of safety throughout the different time frames of the assessment and iii) provide key information in the selection of scenarios for the safety assessment. (author)

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

Safety assessment as basis for the decision making process

International Nuclear Information System (INIS)

Ilie, P.; Didita, L.; Danchiv, A.

2005-01-01

This paper deals with the safety assessment for a new near surface repository, particularly for the early stage of repository development using ISAM (Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities) safety assessment methodology. In this stage of the repository life cycle the main purpose of the safety assessment is to demonstrate that the plant is capable to be constructed and operated safely. The paper is based on development of the ASAM (Application of the Safety Assessment Methodologies for Near-Surface Disposal Facilities) Decision Support Subgroup of the Common Aspects Working Group. The implications of decision making for the application of the ISAM methodology on post-closure safety assessment are analysed. Some important elements of the decision-making process with impact on key components of the ISAM process are described. Following the development of Decision Support Subgroup of the ASAM Common Aspects Working Group the proposed change of ISAM methodology is analysed. This approach puts all activities in a decision context where the first iteration of the safety assessment is based on the existing state of knowledge and the initial engineering design. Confidence in the process is accomplished through the direct inclusion of all decision makers and stakeholders in the formulation of decisions, the definition of the state of knowledge, and decision making activities. The decision process is developed in context of undertaking assessments with little site-specific information, this situation is specifically for new planned repository. Limited site-specific information can result in a high degree of uncertainty, therefore it is important first of all to identify the sources of uncertainty arising from the limited nature of the site-specific information and then to apply appropriate approaches to manage the uncertainties and to determine whether the uncertainties are important to the overall safety of the disposal facility

Assessment of safety culture at INPP

International Nuclear Information System (INIS)

Lesin, S.

2002-01-01

Safety Culture covers all main directions of plant activities and the plant departments involved through integration into the INPP Quality Assurance System. Safety Culture is represented by three components. The first is the clear INPP Safety and Quality Assurance Policy. Based on the Policy INPP is safely operated and managers' actions firstly aim at safety assurance. The second component is based on personal responsibility for safety and attitude of each employee of the plant. The third component is based on commitment to safety and competence of managers and employees of the plant. This component links the first two to ensure efficient management of safety at the plant. The above mentioned components including the elements which may significantly affect Safety Culture are also presented in the attachment. The concept of such model implies understanding of effect of different factors on the level of Safety Culture in the organization. In order to continuously correct safety problems, self-assessment of the Safety Culture level is performed at regular intervals. (author)

Safety assessment for radioactive waste disposal facility

International Nuclear Information System (INIS)

Thanaletchumy Karuppiah; Mohd Abdul Wahab Yusof; Nik Marzuki Nik Ibrahim; Nurul Wahida Ahmad Khairuddin

2008-08-01

Safety assessments are used to evaluate the performance of a radioactive waste disposal facility and its impact on human health and the environment. This paper presents the overall information and methodology to carry out the safety assessment for a long term performance of a disposal system. A case study was also conducted to gain hands-on experience in the development and justification of scenarios, the formulation and implementation of models and the analysis of results. AMBER code using compartmental modeling approach was used to represent the migration and fate of contaminants in this training. This safety assessment is purely illustrative and it serves as a starting point for each development stage of a disposal facility. This assessment ultimately becomes more detail and specific as the facility evolves. (Author)

Preliminary safety assessment of the WIPP facility

International Nuclear Information System (INIS)

Balestri, R.J.; Torres, B.W.; Pahwa, S.B.; Brannen, J.P.

1979-01-01

This paper summarizes the efforts to perform a safety assessment of the Waste Isolation Pilot Plant (WIPP) facility being proposed for southeastern New Mexico. This preliminary safety assessment is limited to a consequence assessment in terms of the dose to a maximally exposed individual as a result of introducing the radionuclides into the biosphere. The extremely low doses to the organs as a result of the liquid breach scenarios are contrasted with the background radiation

LNG Safety Assessment Evaluation Methods

Energy Technology Data Exchange (ETDEWEB)

Muna, Alice Baca [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); LaFleur, Angela Christine [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

2015-05-01

Sandia National Laboratories evaluated published safety assessment methods across a variety of industries including Liquefied Natural Gas (LNG), hydrogen, land and marine transportation, as well as the US Department of Defense (DOD). All the methods were evaluated for their potential applicability for use in the LNG railroad application. After reviewing the documents included in this report, as well as others not included because of repetition, the Department of Energy (DOE) Hydrogen Safety Plan Checklist is most suitable to be adapted to the LNG railroad application. This report was developed to survey industries related to rail transportation for methodologies and tools that can be used by the FRA to review and evaluate safety assessments submitted by the railroad industry as a part of their implementation plans for liquefied or compressed natural gas storage ( on-board or tender) and engine fueling delivery systems. The main sections of this report provide an overview of various methods found during this survey. In most cases, the reference document is quoted directly. The final section provides discussion and a recommendation for the most appropriate methodology that will allow efficient and consistent evaluations to be made. The DOE Hydrogen Safety Plan Checklist was then revised to adapt it as a methodology for the Federal Railroad Administration’s use in evaluating safety plans submitted by the railroad industry.

Promoting and assessment of safety culture within regulatory body

International Nuclear Information System (INIS)

Awasthi, Sumit; Bhattacharya, D.; Koley, J.; Krishnamurthy, P.R.

2015-01-01

Regulators have an important role to play in assisting organizations under their jurisdiction to develop positive safety cultures. It is therefore essential for the regulator to have a robust safety culture as an inherent strategy and communication of this strategy to the organizations it supervises. Atomic Energy Regulatory Board (AERB) emphasizes every utility to institute a good safety culture during various stages of a NPP. The regulatory requirement for establishing organisational safety culture within utility at different stages are delineated in the various AERB safety codes which are presented in the paper. Although the review and assessment of the safety culture is a part of AERB’s continual safety supervision through existing review mechanism, AERB do not use any specific indicators for safety culture assessment. However, establishing and nurturing a good safety culture within AERB helps in encouraging the utility to institute the same. At the induction level AERB provides training to its staffs for regulatory orientation which include a specific course on safety culture. Subsequently, the junior staffs are mentored by seniors while involving them in various regulatory processes and putting them as observers during regulatory decision making process. Further, AERB established a formal procedure for assessing and improving safety culture within its staff as a management system process. The paper describes as a case study the above safety culture assessment process established within AERB

Probabilistic safety assessment for research reactors

International Nuclear Information System (INIS)

1986-12-01

Increasing interest in using Probabilistic Safety Assessment (PSA) methods for research reactor safety is being observed in many countries throughout the world. This is mainly because of the great ability of this approach in achieving safe and reliable operation of research reactors. There is also a need to assist developing countries to apply Probabilistic Safety Assessment to existing nuclear facilities which are simpler and therefore less complicated to analyse than a large Nuclear Power Plant. It may be important, therefore, to develop PSA for research reactors. This might also help to better understand the safety characteristics of the reactor and to base any backfitting on a cost-benefit analysis which would ensure that only necessary changes are made. This document touches on all the key aspects of PSA but placed greater emphasis on so-called systems analysis aspects rather than the in-plant or ex-plant consequences

Safety assessment of radioactive wastes storage 'Mironova Gora'

International Nuclear Information System (INIS)

Serbryakov, B.; Karamushka, V.; Ostroborodov, V.

2000-01-01

A project of transforming the radioactive wastes storage 'Mironova Gora' is under development. A safety assessment of this storage facility was performed to gain assurance on the design decision. The assessment, which was based on the safety assessment methods developed for radioactive wastes repositories, is presented in this paper. (author)

Safety studies on Korean fusion DEMO plant using integrated safety assessment methodology

International Nuclear Information System (INIS)

Oh, Kyemin; Kang, Myoung-suk; Heo, Gyunyoung; Kim, Hyoung-chan

2014-01-01

Highlights: •The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant. •The concepts of integrated safety assessment methodology (ISAM) that can be applied in addressing regulatory requirements and recognizing safety issues for K-DEMO were emphasized. •Phenomena identification and ranking table (PIRT) was proposed. It can recognize vulnerabilities of systems and identify the gaps in technical areas requiring additional researches. •This work is expected to contribute on the conceptual design of safety features for K-DEMO to design engineers and the guidance for regulatory requirements to licensers. -- Abstract: The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant (K-DEMO) as a part of R and D program through the National Fusion Research Institute of Korea. Even though nuclear regulation and licensing framework is well setup due to the operating and design experience of Pressurized Water Reactors (PWRs) since 1970s, the regulatory authority of South Korea has concerns on the challenge of facing new nuclear facilities including K-DEMO due to the differences in systems, materials, and inherent safety feature from conventional PWRs. Even though the follow-up of the ITER license process facilitates to deal with significant safety issues of fusion facilities, a licensee as well as a licenser should identify the gaps between ITER and DEMO in terms of safety issues. First we reviewed the methods of conducting safety analysis for unprecedented nuclear facilities such as Generation IV reactors, particularly very high temperature reactor (VHTR), which is called as integrated safety assessment methodology (ISAM). Second, the analysis for the conceptual design of K-DEMO on the basis of ISAM was conducted. The ISAM consists of five analytical tools to develop the safety requirements from licensee

Safety studies on Korean fusion DEMO plant using integrated safety assessment methodology

Energy Technology Data Exchange (ETDEWEB)

Oh, Kyemin; Kang, Myoung-suk [Kyung Hee University, Youngin-si, Gyeonggi-do 446-701 (Korea, Republic of); Heo, Gyunyoung, E-mail: gheo@khu.ac.kr [Kyung Hee University, Youngin-si, Gyeonggi-do 446-701 (Korea, Republic of); Kim, Hyoung-chan [National Fusion Research Institute, Daejeon-si 305-333 (Korea, Republic of)

2014-10-15

Highlights: •The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant. •The concepts of integrated safety assessment methodology (ISAM) that can be applied in addressing regulatory requirements and recognizing safety issues for K-DEMO were emphasized. •Phenomena identification and ranking table (PIRT) was proposed. It can recognize vulnerabilities of systems and identify the gaps in technical areas requiring additional researches. •This work is expected to contribute on the conceptual design of safety features for K-DEMO to design engineers and the guidance for regulatory requirements to licensers. -- Abstract: The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant (K-DEMO) as a part of R and D program through the National Fusion Research Institute of Korea. Even though nuclear regulation and licensing framework is well setup due to the operating and design experience of Pressurized Water Reactors (PWRs) since 1970s, the regulatory authority of South Korea has concerns on the challenge of facing new nuclear facilities including K-DEMO due to the differences in systems, materials, and inherent safety feature from conventional PWRs. Even though the follow-up of the ITER license process facilitates to deal with significant safety issues of fusion facilities, a licensee as well as a licenser should identify the gaps between ITER and DEMO in terms of safety issues. First we reviewed the methods of conducting safety analysis for unprecedented nuclear facilities such as Generation IV reactors, particularly very high temperature reactor (VHTR), which is called as integrated safety assessment methodology (ISAM). Second, the analysis for the conceptual design of K-DEMO on the basis of ISAM was conducted. The ISAM consists of five analytical tools to develop the safety requirements from licensee

Self-assessment of operational safety for nuclear power plants

International Nuclear Information System (INIS)

1999-12-01

Self-assessment processes have been continuously developed by nuclear organizations, including nuclear power plants. Currently, the nuclear industry and governmental organizations are showing an increasing interest in the implementation of this process as an effective way for improving safety performance. Self-assessment involves the use of different types of tools and mechanisms to assist the organizations in assessing their own safety performance against given standards. This helps to enhance the understanding of the need for improvements, the feeling of ownership in achieving them and the safety culture as a whole. Although the primary beneficiaries of the self-assessment process are the plant and operating organization, the results of the self-assessments are also used, for example, to increase the confidence of the regulator in the safe operation of an installation, and could be used to assist in meeting obligations under the Convention on Nuclear Safety. Such considerations influence the form of assessment, as well as the type and detail of the results. The concepts developed in this report present the basic approach to self-assessment, taking into consideration experience gained during Operational Safety Review Team (OSART) missions, from organizations and utilities which have successfully implemented parts of a self-assessment programme and from meetings organized to discuss the subject. This report will be used in IAEA sponsored workshops and seminars on operational safety that include the topic of self-assessment

Male enhancement Nutraceuticals in the Middle East market: Claim, pharmaceutical quality and safety assessments.

Science.gov (United States)

ElAgouri, Ghada; ElAmrawy, Fatema; ElYazbi, Ahmed; Eshra, Ahmed; Nounou, Mohamed I

2015-08-15

The global market is invaded by male enhancement nutraceuticals claimed to be of natural origin sold with a major therapeutic claim. Most of these products have been reported by international systems like the Food and Drug Administration (FDA). We hypothesize that these products could represent a major threat to the health of the consumers. In this paper, pharmaceutical evaluation of some of these nutraceutical products sold in Egypt under the therapeutic claim of treating erectile dysfunction, are discussed along with pharmacological evaluation to investigate their safety and efficacy parameters. Samples were analyzed utterly using conventional methods, i.e.: HPLC, HPTLC, NIR, content uniformity and weight variation and friability. The SeDeM system was used for quality assessment. On the basis of the results of this research, the sampled products are adulterated and totally heterogeneous in their adulterant drug content and pharmaceutical quality. These products represent a major safety threat for the consumers in Egypt and the Middle East, especially; the target audience is mostly affected with heart and blood pressure problems seeking natural and safe alternatives to the well-established Phosphodiesterase 5 Inhibitors (PDE-5Is). Copyright © 2015 Elsevier B.V. All rights reserved.

Analysis of truncation limit in probabilistic safety assessment

International Nuclear Information System (INIS)

Cepin, Marko

2005-01-01

A truncation limit defines the boundaries of what is considered in the probabilistic safety assessment and what is neglected. The truncation limit that is the focus here is the truncation limit on the size of the minimal cut set contribution at which to cut off. A new method was developed, which defines truncation limit in probabilistic safety assessment. The method specifies truncation limits with more stringency than presenting existing documents dealing with truncation criteria in probabilistic safety assessment do. The results of this paper indicate that the truncation limits for more complex probabilistic safety assessments, which consist of larger number of basic events, should be more severe than presently recommended in existing documents if more accuracy is desired. The truncation limits defined by the new method reduce the relative errors of importance measures and produce more accurate results for probabilistic safety assessment applications. The reduced relative errors of importance measures can prevent situations, where the acceptability of change of equipment under investigation according to RG 1.174 would be shifted from region, where changes can be accepted, to region, where changes cannot be accepted, if the results would be calculated with smaller truncation limit

Risk assessment of safety violations for coal mines

Energy Technology Data Exchange (ETDEWEB)

Megan Orsulaka; Vladislav Kecojevicb; Larry Graysona; Antonio Nietoa [Pennsylvania State University, University Park, PA (United States). Dept of Energy and Mineral Engineering

2010-09-15

This article presents an application of a risk assessment approach in characterising the risks associated with safety violations in underground bituminous mines in Pennsylvania using the Mine Safety and Health Administration (MSHA) citation database. The MSHA database on citations provides an opportunity to assess risks in mines through scrutiny of violations of mandatory safety standards. In this study, quantitative risk assessment is performed, which allows determination of the frequency of occurrence of safety violations (through associated citations) as well as the consequences of them in terms of penalty assessments. Focus is on establishing risk matrices on citation experiences of mines, which can give early indication of emerging potentially serious problems. The resulting frequency, consequence and risk rankings present valuable tools for prioritising resource allocations, determining control strategies, and could potentially contribute to more proactive prevention of incidents and injuries.

Healthcare professionals’ views of feedback on patient safety culture assessment.

OpenAIRE

Zwijnenberg, N.C.; Hendriks, M.; Hoogervorst-Schilp, J.; Wagner, C.

2016-01-01

Background: By assessing patient safety culture, healthcare providers can identify areas for improvement in patient safety culture. To achieve this, these assessment outcomes have to be relevant and presented clearly. The aim of our study was to explore healthcare professionals’ views on the feedback of a patient safety culture assessment. Methods: Twenty four hospitals participated in a patient safety culture assessment in 2012. Hospital departments received feedback in a report and on a web...

Safety assessment of research reactors and preparation of the safety analysis report

International Nuclear Information System (INIS)

1994-01-01

This Safety Guide presents guidelines, approved by international consensus, for the preparation, review and assessment of safety documentation for research reactors such as the Safety Analysis Report. While the Guide is most applicable to research reactors in the design and construction stage, it is also recommended for use during relicensing or reassessment of existing reactors

Pharmacological treatment for memory disorder in multiple sclerosis.

Science.gov (United States)

He, Dian; Zhang, Yun; Dong, Shuai; Wang, Dongfeng; Gao, Xiangdong; Zhou, Hongyu

2013-12-17

This is an update of the Cochrane review "Pharmacologic treatment for memory disorder in multiple sclerosis" (first published in The Cochrane Library 2011, Issue 10).Multiple sclerosis (MS) is a chronic immune-mediated, inflammatory, demyelinating, neurodegenerative disorder of the central nervous system (CNS) and can cause both neurological and neuropsychological disability. Both demyelination and axonal and neuronal loss are believed to contribute to MS-related cognitive impairment. Memory disorder is one of the most frequent cognitive dysfunctions and presents a considerable burden to people with MS and to society due to the negative impact on function. A number of pharmacological agents have been evaluated in many existing randomised controlled trials for their efficacy on memory disorder in people with MS but the results were not consistent. To assess the absolute and comparative efficacy, tolerability and safety of pharmacological treatments for memory disorder in adults with MS. We searched the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group Trials Register (24 July 2013), PsycINFO (January 1980 to 26 June 2013) and CBMdisc (1978 to 24 June 2013), and checked reference lists of identified articles, searched some relevant journals manually, registers of clinical trials and published abstracts of conference proceedings. All double-blind, randomised controlled parallel trials on pharmacological treatment versus placebo or one or more pharmacological treatments in adults with MS who had at least mild memory impairment (at 0.5 standard deviations below age- and sex-based normative data on a validated memory scale). We placed no restrictions regarding dose, route of administration and frequency; however, we only included trials with an administration duration of 12 weeks or greater. Two review authors independently assessed trial quality and extracted data. We discussed disagreements and resolved them by consensus among review

Safety Assessment of Polyether Lanolins as Used in Cosmetics.

Science.gov (United States)

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan; Heldreth, Bart

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 39 polyether lanolin ingredients as used in cosmetics. These ingredients function mostly as hair conditioning agents, skin conditioning agent-emollients, and surfactant-emulsifying agents. The Panel reviewed available animal and clinical data, from previous CIR safety assessments of related ingredients and components. The similar structure, properties, functions, and uses of these ingredients enabled grouping them and using the available toxicological data to assess the safety of the entire group. The Panel concluded that these polyether lanolin ingredients are safe in the practices of use and concentration as given in this safety assessment.

Probabilistic safety assessment as a standpoint for decision making

International Nuclear Information System (INIS)

Cepin, M.

2001-01-01

This paper focuses on the role of probabilistic safety assessment in decision-making. The prerequisites for use of the results of probabilistic safety assessment and the criteria for the decision-making based on probabilistic safety assessment are discussed. The decision-making process is described. It provides a risk evaluation of impact of the issue under investigation. Selected examples are discussed, which highlight the described process. (authors)

The Safety Assessment Framework Tool (SAFRAN) - Description, Overview and Applicability

International Nuclear Information System (INIS)

Alujevic, Luka

2014-01-01

The SAFRAN tool (Safety Assessment Framework) is a user-friendly software application that incorporates the methodologies developed in the SADRWMS (Safety Assessment Driven Radioactive Waste Management Solutions) project. The International Atomic Energy Agency (IAEA) organized the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) to examine international approaches to safety assessment for predisposal management of all types of radioactive waste, including disused sources, small volumes, legacy and decommissioning waste, operational waste, and large volume naturally occurring radioactive material residues. SAFRAN provides aid in: Describing the predisposal RW management activities in a systematic way, Conducting the SA (safety assessment) with clear documentation of the methodology, assumptions, input data and models, Establishing a traceable and transparent record of the safety basis for decisions on the proposed RW management solutions, Demonstrating clear consideration of and compliance with national and international safety standards and recommendations. The SAFRAN tool allows the user to visibly, systematically and logically address predisposal radioactive waste management and decommissioning challenges in a structured way. It also records the decisions taken in such a way that it constitutes a justifiable safety assessment of the proposed management solutions. The objective of this paper is to describe the SAFRAN architecture and features, properly define the terms safety case and safety assessment, and to predict the future development of the SAFRAN tool and assess its applicability to the construction of a future LILW (Low and Intermediate Level Waste) storage facility and repository in Croatia, taking into account all the capabilities and modelling features of the SAFRAN tool. (author)

Safety factors for neutron fluences in NPP safety assessment

International Nuclear Information System (INIS)

Demekhin, V.L.; Bukanov, V.N.; Il'kovich, V.V.; Pugach, A.M.

2016-01-01

In accordance with global practice and a number of existing regulations, the use of conservative approach is required for the calculations related to nuclear safety assessment of NPP. It implies the need to consider the determination of neutron fluence errors that is rather complicated. It is proposed to carry out the consideration by the way of multiplying the neutron fluences obtained with transport calculations by safety factors. The safety factor values are calculated by the developed technique based on the theory of errors, features of the neutron transport calculation code and the results obtained with the code. It is shown that the safety factor value is equal 1.18 with the confidence level of not less than 0.95 for the majority of VVER-1000 reactor places where neutron fluences are determined by MCPV code, and its maximum value is 1.25

Pharmacological Profile of Quinoxalinone

Directory of Open Access Journals (Sweden)

Youssef Ramli

2014-01-01

Full Text Available Quinoxalinone and its derivatives are used in organic synthesis for building natural and designed synthetic compounds and they have been frequently utilized as suitable skeletons for the design of biologically active compound. This review covers updated information on the most active quinoxalinone derivatives that have been reported to show considerable pharmacological actions such as antimicrobial, anti-inflammatory, antidiabetic, antiviral, antitumor, and antitubercular activity. It can act as an important tool for chemists to develop newer quinoxalinone derivatives that may prove to be better agents in terms of efficacy and safety.

Need for an "integrated safety assessment" of GMOs, linking food safety and environmental considerations.

Science.gov (United States)

Haslberger, Alexander G

2006-05-03

Evidence for substantial environmental influences on health and food safety comes from work with environmental health indicators which show that agroenvironmental practices have direct and indirect effects on human health, concluding that "the quality of the environment influences the quality and safety of foods" [Fennema, O. Environ. Health Perspect. 1990, 86, 229-232). In the field of genetically modified organisms (GMOs), Codex principles have been established for the assessment of GM food safety and the Cartagena Protocol on Biosafety outlines international principles for an environmental assessment of living modified organisms. Both concepts also contain starting points for an assessment of health/food safety effects of GMOs in cases when the environment is involved in the chain of events that could lead to hazards. The environment can act as a route of unintentional entry of GMOs into the food supply, such as in the case of gene flow via pollen or seeds from GM crops, but the environment can also be involved in changes of GMO-induced agricultural practices with relevance for health/food safety. Examples for this include potential regional changes of pesticide uses and reduction in pesticide poisonings resulting from the use of Bt crops or influences on immune responses via cross-reactivity. Clearly, modern methods of biotechnology in breeding are involved in the reasons behind the rapid reduction of local varieties in agrodiversity, which constitute an identified hazard for food safety and food security. The health/food safety assessment of GM foods in cases when the environment is involved needs to be informed by data from environmental assessment. Such data might be especially important for hazard identification and exposure assessment. International organizations working in these areas will very likely be needed to initiate and enable cooperation between those institutions responsible for the different assessments, as well as for exchange and analysis of

Ensuring the quality of occupational safety risk assessment.

Science.gov (United States)

Pinto, Abel; Ribeiro, Rita A; Nunes, Isabel L

2013-03-01

In work environments, the main aim of occupational safety risk assessment (OSRA) is to improve the safety level of an installation or site by either preventing accidents and injuries or minimizing their consequences. To this end, it is of paramount importance to identify all sources of hazards and assess their potential to cause problems in the respective context. If the OSRA process is inadequate and/or not applied effectively, it results in an ineffective safety prevention program and inefficient use of resources. An appropriate OSRA is an essential component of the occupational safety risk management process in industries. In this article, we performed a survey to elicit the relative importance for identified OSRA tasks to enable an in-depth evaluation of the quality of risk assessments related to occupational safety aspects on industrial sites. The survey involved defining a questionnaire with the most important elements (tasks) for OSRA quality assessment, which was then presented to safety experts in the mining, electrical power production, transportation, and petrochemical industries. With this work, we expect to contribute to the main question of OSRA in industries: "What constitutes a good occupational safety risk assessment?" The results obtained from the questionnaire showed that experts agree with the proposed OSRA process decomposition in steps and tasks (taxonomy) and also with the importance of assigning weights to obtain knowledge about OSRA task relevance. The knowledge gained will enable us, in the near future, to build a framework to evaluate OSRA quality for industrial sites. © 2012 Society for Risk Analysis.

Safety assessment in plant layout design using indexing approach: Implementing inherent safety perspective

International Nuclear Information System (INIS)

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-01-01

The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design

Exploiting data from safety investigations and processes to assess performance of safety management aspects

NARCIS (Netherlands)

Karanikas, Nektarios

2016-01-01

This paper presents an alternative way to use records from safety investigations as a means to support the evaluation of safety management (SM) aspects. Datasets from safety investigation reports and progress records of an aviation organization were analyzed with the scope of assessing safety

NPP Krsko periodic safety review. Safety assessment and analyses

International Nuclear Information System (INIS)

Basic, I.; Spiler, J.; Thaulez, F.

2002-01-01

Definition of a PSR (Periodic Safety Review) project is a comprehensive safety review of a plant after ten years of operation. The objective is a verification by means of a comprehensive review using current methods that the plant remains safe when judged against current safety objectives and practices and that adequate arrangements are in place to maintain plant safety. The overall goals of the NEK PSR Program are defined in compliance with the basic role of a PSR and the current practice typical for most of the countries in EU. This practice is described in the related guides and good practice documents issued by international organizations. The overall goals of the NEK PSR are formulated as follows: to demonstrate that the plant is as safe as originally intended; to evaluate the actual plant status with respect to aging and wear-out identifying any structures, systems or components that could limit the life of the plant in the foreseeable future, and to identify appropriate corrective actions, where needed; to compare current level of safety in the light of modern standards and knowledge, and to identify where improvements would be beneficial for minimizing deviations at justifiable costs. The Krsko PSR will address the following safety factors: Operational Experience, Safety Assessment, EQ and Aging Management, Safety Culture, Emergency Planning, Environmental Impact and Radioactive Waste.(author)

Safety assessment of a lithium target

International Nuclear Information System (INIS)

Burgazzi, Luciano; Roberta, Ferri; Barbara, Giannone

2006-01-01

This paper addresses the safety assessment of the lithium target of the International Fusion Materials Irradiation Facility (IFMIF) through evaluating the most important risk factors related to system operation and verifying the fulfillment of the safety criteria. The hazard assessment is based on using a well-structured Failure Mode and Effect Analysis (FMEA) procedure by detailing on a component-by-component basis all the possible failure modes and identifying their effects on the plant. Additionally, a systems analysis, applying the fault tree technique, is performed in order to evaluate, from a probabilistic standpoint, all the relevant and possible failures of each component required for safe system operation and assessing the unavailability of the lithium target system. The last task includes the thermal-hydraulic transient analysis of the target lithium loop, including operational and accident transients. A lithium target loop model is developed, using the RELAP5/Mod3.2 thermal-hydraulic code, which has been modified to include specific features of IFMIF itself. The main conclusions are that target safety is fulfilled, the hazards associated with lithium operation are confined within the IFMIF security boundaries, the environmental impact is negligible, and the plant responds to the simulated transients by being able to reach steady conditions in a safety situation

Systematic review of clinical trials assessing pharmacological properties of Salvia species on memory, cognitive impairment and Alzheimer's disease.

Science.gov (United States)

Miroddi, Marco; Navarra, Michele; Quattropani, Maria C; Calapai, Fabrizio; Gangemi, Sebastiano; Calapai, Gioacchino

2014-06-01

Salvia officinalis L. and Salvia lavandulaefolia L. have a longstanding use as traditional herbal remedies that can enhance memory and improve cognitive functions. Pharmacological actions of S. officinalis and S. lavandulaefolia on healthy subjects and on patients suffering of cognitive decline have been investigated. Aim of this review was to summarize published clinical trials assessing effectiveness and safety of S. officinalis and S. lavandulaefolia in the enhancement of cognitive performance in healthy subjects and neurodegenerative illnesses. Furthermore, to purchase a more complete view on safety of S. officinalis and S. lavandulaefolia, we collected and discussed articles regarding toxicity and adverse reactions. Eight clinical studies investigating on acute effects of S. officinalis on healthy subjects were included in the review. Six studies investigated on the effects of S. officinalis and S. lavandaeluaefolia on cognitive performance in healthy subjects. The two remaining were carried out to study the effects of sage on Azheimer's disease. Our review shows that S. officinalis and S. lavandulaefolia exert beneficial effects by enhancing cognitive performance both in healthy subjects and patients with dementia or cognitive impairment and is safe for this indication. Unfortunately, promising beneficial effects are debased by methodological issues, use of different herbal preparations (extracts, essential oil, use of raw material), lack of details on herbal products used. We believe that sage promising effects need further higher methodological standard clinical trials. © 2014 John Wiley & Sons Ltd.

Environment, safety and health progress assessment manual

International Nuclear Information System (INIS)

1992-12-01

On June 27, 1989, the Secretary of Energy announced a 1O-Point Initiative to strengthen environment,safety, and health (ES ampersand H) programs, and waste management activities at involved conducting DOE production, research, and testing facilities. One of the points independent Tiger Team Assessments of DOE operating facilities. The Office of Special Projects (OSP), EH-5, in the Office of the Assistant Secretary for Environment, Safety and Health, EH-1, was assigned the responsibility to conduct the Tiger Team Assessments. Through June 1992, a total of 35 Tiger Team Assessments were completed. The Secretary directed that Corrective Action Plans be developed and implemented to address the concerns identified by the Tiger Teams. In March 1991, the Secretary approved a plan for assessments that are ''more focused, concentrating on ES ampersand H management, ES ampersand H corrective actions, self-assessment programs, and root-cause related issues.'' In July 1991, the Secretary approved the initiation of ES ampersand H Progress Assessments, as a followup to the Tiger Team Assessments, and in the continuing effort to institutionalize the self-assessment process and line management accountability in the ES ampersand H areas. This volume contains appendices to the Environment, Safety and Health Progress Assessment Manual

The role of natural analogues in safety assessment and acceptability

International Nuclear Information System (INIS)

Papp, Toenis

1987-01-01

The safety assessment must evaluate the level of safety for a repository, the confidence that can be placed on the assessment and how well the repository can meet the acceptance criteria of the society. Many of the processes and phenomena that govern the long term performance of a deep geologic repository for radioactive waste also take place in nature. To investigate these natural analogues and try to validate the models on which the safety assessment are based is a main task in the effort to build of confidence in the safety assessments. The assessment of the safety of a repository can, however, not only be based on good models. The possible role of natural analogues or natural evidence in other parts of the safety assessment is discussed. Specially with regard to - the need to demonstrate that all relevant processes have been taken into account, and that the important ones have been validated to an acceptable level for relevant parameters spans, -the definition and analysis of external scenarios for the safety assessment and for the claim that all reasonable scenarios have been addressed, - the public confidence in the long-term relevance of the acceptance criteria. (author)

Safety assessment of HLW geological disposal system

International Nuclear Information System (INIS)

Naito, Morimasa

2006-01-01

In accordance with the Japanese nuclear program, the liquid waste with a high level of radioactivity arising from reprocessing is solidified in a stable glass matrix (vitrification) in stainless steel fabrication containers. The vitrified waste is referred to as high-level radioactive waste (HLW), and is characterized by very high initial radioactivity which, even though it decreases with time, presents a potential long-term risk. It is therefore necessary to thoroughly manage HLW from human and his environment. After vitrification, HLW is stored for a period of 30 to 50 years to allow cooling, and finally disposed of in a stable geological environment at depths greater than 300 m below surface. The deep underground environment, in general, is considered to be stable over geological timescales compared with surface environment. By selecting an appropriate disposal site, therefore, it is considered to be feasible to isolate the waste in the repository from man and his environment until such time as radioactivity levels have decayed to insignificance. The concept of geological disposal in Japan is similar to that in other countries, being based on a multibarrier system which combines the natural geological environment with engineered barriers. It should be noted that geological disposal concept is based on a passive safety system that does not require any institutional control for assuring long term environmental safety. To demonstrate feasibility of safe HLW repository concept in Japan, following technical steps are essential. Selection of a geological environment which is sufficiently stable for disposal (site selection). Design and installation of the engineered barrier system in a stable geological environment (engineering measures). Confirmation of the safety of the constructed geological disposal system (safety assessment). For site selection, particular consideration is given to the long-term stability of the geological environment taking into account the fact

Environmental Restoration Disposal Facility (Project W-296) Safety Assessment

International Nuclear Information System (INIS)

Armstrong, D.L.

1994-08-01

This Safety Assessment is based on information derived from the Conceptual Design Report for the Environmental Restoration Disposal Facility (DOE/RL 1994) and ancillary documentation developed during the conceptual design phase of Project W-296. The Safety Assessment has been prepared to support the Solid Waste Burial Ground Interim Safety Basis document. The purpose of the Safety Assessment is to provide an evaluation of the design to determine if the process, as proposed, will comply with US Department of Energy (DOE) Limits for radioactive and hazardous material exposures and be acceptable from an overall health and safety standpoint. The evaluation considered affects on the worker, onsite personnel, the public, and the environment

Environmental Restoration Disposal Facility (Project W-296) Safety Assessment

Energy Technology Data Exchange (ETDEWEB)

Armstrong, D.L.

1994-08-01

This Safety Assessment is based on information derived from the Conceptual Design Report for the Environmental Restoration Disposal Facility (DOE/RL 1994) and ancillary documentation developed during the conceptual design phase of Project W-296. The Safety Assessment has been prepared to support the Solid Waste Burial Ground Interim Safety Basis document. The purpose of the Safety Assessment is to provide an evaluation of the design to determine if the process, as proposed, will comply with US Department of Energy (DOE) Limits for radioactive and hazardous material exposures and be acceptable from an overall health and safety standpoint. The evaluation considered affects on the worker, onsite personnel, the public, and the environment.

RSAS: a Reactor Safety Assessment System

International Nuclear Information System (INIS)

Sebo, D.E.; Dixon, B.W.; Bray, M.A.

1985-01-01

The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (NRC). RSAS is being developed for use at the NRC's Operations Center in the event of a serious incident at a licensed nuclear power plant. The system generates situation assessments for the NRC Reactor Safety Team based on a limited number of plant parameters, known operator actions, and plant status data. The RSAS rule base currently covers one reactor type. The extension of the rule base to other reactor types is also discussed

''In-house'' pharmacological management for computed tomography coronary angiography: heart rate reduction, timing and safety of different drugs used during patient preparation

Energy Technology Data Exchange (ETDEWEB)

Maffei, Erica; Tedeschi, Carlo; Seitun, Sara; Ruffini, Livia; Aldrovandi, Annachiara [Azienda Ospedaliero - Universitaria di Parma, Department of Radiology and Cardiology, Parma (Italy); Palumbo, Alessandro A.; Martini, Chiara [Azienda Ospedaliero - Universitaria di Parma, Department of Radiology and Cardiology, Parma (Italy); Erasmus Medical Center, Department of Radiology and Cardiology, Rotterdam (Netherlands); Tarantini, Giuseppe [Azienda Ospedaliero - Universitaria di Parma, Department of Radiology and Cardiology, Parma (Italy); University of Padua, Department of Cardiology, Padua (Italy); Weustink, Annick C.; Meijboom, Willem B.; Mollet, Nico R.; Krestin, Gabriel P.; Feyter, Pim J. de [Erasmus Medical Center, Department of Radiology and Cardiology, Rotterdam (Netherlands); Cademartiri, Filippo [Azienda Ospedaliero - Universitaria di Parma, Department of Radiology and Cardiology, Parma (Italy); Erasmus Medical Center, Department of Radiology and Cardiology, Rotterdam (Netherlands); Azienda Ospedaliero-Universitaria - Parma, Department of Radiology c/o Piastra Tecnica - Piano 0, Parma (Italy)

2009-12-15

We retrospectively evaluated the effect, timing and safety of different pharmacological strategies during 64-slice CT coronary angiography (CT-CA). From the institutional database of CT-CA we enrolled 560 consecutive patients with suspected coronary artery disease. The type of drug preparation (group 1 = no treatment; group 2 = oral metoprolol; group 3 = other; group 4 = intravenous (IV) atenolol; group 5 = IV atenolol + nitrates; NR = non-responders), timing, and adverse effects were recorded. Heart rate (HR) during different preparation phases was recorded. Four adverse effects were recorded, none of which was attributable to pharmacological treatment. In all groups, except group 1, the HR on arrival was significantly reduced by the pharmacological treatment (p < 0.01). Group 4 showed the best (-16 {+-} 8 bpm) HR reduction. There was no significant effect on HR due to nitrates (p = 0.49), while a slight increase due to contrast material was noted (p < 0.05). Average time required for preparation was 44 {+-} 25 min. Groups 4 and 5 showed the most effective timing (8 {+-} 9 min and 8 {+-} 8 min, respectively; p < 0.01). Pharmacological preparation in patients undergoing CT-CA is safe and effective. Best results in terms of HR reduction and fast preparation are obtained with IV administration of beta-blockers. (orig.)

Measuring the effectiveness of pharmacology teaching in undergraduate medical students.

Science.gov (United States)

Urrutia-Aguilar, Maria Esther; Martinez-Gonzalez, Adrian; Rodriguez, Rodolfo

2012-03-01

Information overload and recent curricular changes are viewed as important contributory factors to insufficient pharmacological education of medical students. This study was designed to assess the effectiveness of pharmacology teaching in our medical school. The study subjects were 455 second-year medical students, class of 2010, and 26 pharmacology teachers at the National University of Mexico Medical School. To assess pharmacological knowledge, students were required to take 3 multiple-choice exams (70 questions each) as part of their evaluation in the pharmacology course. A 30-item questionnaire was used to explore the students' opinion on teaching. Pharmacology professors evaluated themselves using a similar questionnaire. Students and teachers rated each statement on a 5-point Likert scale. The groups' exam scores ranged from 54.5% to 90.0% of correct responses, with a mean score of 77.3%. Only 73 (16%) of 455 students obtained an exam score of 90% and higher. Students' evaluations of faculty and professor self-ratings were very high (90% and 96.2%, of the maximal response, respectively). Student and professor ratings were not correlated with exam scores (r = 0.291). Our study shows that knowledge on pharmacology is incomplete in a large proportion of second-year medical students and indicates that there is an urgent need to review undergraduate training in pharmacology. The lack of relationship between the subjective ratings of teacher effectiveness and objective exam scores suggests the use of more demanding measures to assess the effectiveness of teaching.

Safety assessment and detection methods of genetically modified organisms.

Science.gov (United States)

Xu, Rong; Zheng, Zhe; Jiao, Guanglian

2014-01-01

Genetically modified organisms (GMOs), are gaining importance in agriculture as well as the production of food and feed. Along with the development of GMOs, health and food safety concerns have been raised. These concerns for these new GMOs make it necessary to set up strict system on food safety assessment of GMOs. The food safety assessment of GMOs, current development status of safety and precise transgenic technologies and GMOs detection have been discussed in this review. The recent patents about GMOs and their detection methods are also reviewed. This review can provide elementary introduction on how to assess and detect GMOs.

Guidelines for Self-assessment of Research Reactor Safety

International Nuclear Information System (INIS)

2018-01-01

Self-assessment is an organization’s internal process to review its current status, processes and performance against predefined criteria and thereby to provide key elements for the organization’s continual development and improvement. Self-assessment helps the organization to think through what it is expected to do, how it is performing in relation to these expectations, and what it needs to do to improve performance, fulfil the expectations and achieve better compliance with the predefined criteria. This publication provides guidelines for a research reactor operating organization to perform a self-assessment of the safety management and the safety of the facility and to identify gaps between the current situation and the IAEA safety requirements for research reactors. These guidelines also provide a methodology for Member States, regulatory bodies and operating organizations to perform a self-assessment of their application of the provisions of the Code of Conduct on the Safety of Research Reactors. This publication also addresses planning, implementation and follow-up of actions to enhance safety and strengthen application of the Code. The guidelines are applicable to all types of research reactor and critical and subcritical assemblies, at all stages in their lifetimes, and to States, regulatory bodies and operating organizations throughout all phases of research reactor programmes. Research reactor operating organizations can use these guidelines at any time to support self-assessments conducted in accordance with the organization’s integrated management system. These guidelines also serve as a tool for an organization to prepare to receive an IAEA Integrated Safety Assessment of Research Reactors (INSARR) mission. An important result of this is the opportunity for an operating organization to identify focus areas and make safety improvements in advance of an INSARR mission, thereby increasing the effectiveness of the mission and efficiency of the

Safety Culture Assessment at Regulatory Body - PNRA Experience of Implementing IAEA Methodology for Safety Culture Self Assessment

International Nuclear Information System (INIS)

Bhatti, S.A.N.; Arshad, N.

2016-01-01

The prevalence of a good safety culture is equally important for all kind of organizations involved in nuclear business including operating organizations, designers, regulator, etc., and this should be reflected through all the processes and activities of these organizations. The need for inculcating safety culture into regulatory processes and practices is gradually increasing since the major accident at Fukushima. Accordingly, several international fora in last few years repeatedly highlighted the importance of prevalence of safety culture in regulatory bodies as well. The utilisation of concept of safety culture always remained applicable in regulatory activities of PNRA in the form of core values. After the Fukushima accident, PNRA considered it important to check the extent of utilisation of safety culture concept in organizational activities and decided to conduct its “Safety Culture Self-Assessment (SCSA)” for presenting itself as a role model in-order to endorse the fact that safety culture at regulatory authority plays an important role to influence safety culture at licenced facilities.

ASCOT guidelines revised 1996 edition. Guidelines for organizational self-assessment of safety culture and for reviews by the assessment of safety culture in organizations team

International Nuclear Information System (INIS)

1996-01-01

In order to properly assess safety culture, it is necessary to consider the contribution of all organizations which have an impact on it. Therefore, while assessing the safety culture in an operating organization it is necessary to address at least its interfaces with the local regulatory agency, utility corporate headquarters and supporting organizations. These guidelines are primarily intended for use by any organization wishing to conduct a self-assessment of safety culture. They should also serve as a basis for conducting an international peer review of the organization's self-assessment carried out by an ASCOT (Assessment of Safety Culture in Organizations Team) mission

Application of fuzzy set theory for safety culture and safety management assessment of Kartini research reactor

International Nuclear Information System (INIS)

Syarip; Hauptmanns, U.

2000-01-01

The safety culture status of nuclear power plant is usually assessed through interview and/or discussions with personnel and management in plant, and an assessment of the pertinent documentation. The approach for safety culture assessment described in IAEA Safety Series, make uses of a questionnaire composed of questions which require 'Yes' or 'No' as an answer. Hence, it is basically a check-list approach which is quite common for safety assessments in industry. Such a procedure ignores the fact that the expert answering the question usually has knowledge which goes far beyond a mere binary answer. Additionally, many situations cannot readily be described in such restricted terms. Therefore, it was developed a checklist consisting of questions which are formulated such that they require more than a simple 'yes' or 'no' as an answer. This allows one to exploit the expert knowledge of the analyst appropriately by asking him to qualify the degree of compliance of each of the topics examined. The method presented has proved useful in assessing the safety culture and quality of safety management of the research reactor. The safety culture status and the quality of safety management of Kartini research reactor is rated as 'average'. The method is also flexible and allows one to add questions to existing areas or to introduce new areas covering related topics

Criticality safety evaluations - a open-quotes stalking horseclose quotes for integrated safety assessment

International Nuclear Information System (INIS)

Williams, R.A.

1995-01-01

The Columbia Fuel Fabrication Facility of the Westinghouse Commercial Nuclear Fuel Division manufactures low-enriched uranium fuel and associated components for use in commercial pressurized water power reactors. To support development of a comprehensive integrated safety assessment (ISA) for the facility, as well as to address increasing U.S. Nuclear Regulatory Commission (NRC) expectations regarding such a facility's criticality safety assessments, a project is under way to complete criticality safety evaluations (CSEs) of all plant systems used in processing nuclear materials. Each CSE is made up of seven sections, prepared by a multidisciplinary team of process engineers, systems engineers, safety engineers, maintenance representatives, and operators. This paper provides a cursory outline of the type of information presented in a CSE

Systems Pharmacology in Small Molecular Drug Discovery

Directory of Open Access Journals (Sweden)

Wei Zhou

2016-02-01

Full Text Available Drug discovery is a risky, costly and time-consuming process depending on multidisciplinary methods to create safe and effective medicines. Although considerable progress has been made by high-throughput screening methods in drug design, the cost of developing contemporary approved drugs did not match that in the past decade. The major reason is the late-stage clinical failures in Phases II and III because of the complicated interactions between drug-specific, human body and environmental aspects affecting the safety and efficacy of a drug. There is a growing hope that systems-level consideration may provide a new perspective to overcome such current difficulties of drug discovery and development. The systems pharmacology method emerged as a holistic approach and has attracted more and more attention recently. The applications of systems pharmacology not only provide the pharmacodynamic evaluation and target identification of drug molecules, but also give a systems-level of understanding the interaction mechanism between drugs and complex disease. Therefore, the present review is an attempt to introduce how holistic systems pharmacology that integrated in silico ADME/T (i.e., absorption, distribution, metabolism, excretion and toxicity, target fishing and network pharmacology facilitates the discovery of small molecular drugs at the system level.

IRSN-ANCCLI partnership. Work session on Complementary safety assessments - November 2011

International Nuclear Information System (INIS)

Lachaume, Jean-Luc; Lheureux, Yves; Sene, Monique; Sene, Raymond; Jorel, Martial; Lavarenne, Caroline; Rousseau, Jean-Marie; Rebour, Vincent; Baumont, David; Dupuy, Patricia

2011-11-01

After an overview by the ASN of complementary safety assessments and an assessment of 'post-Fukushima' inspections of basic nuclear installations, the contributions (Power Point presentations) of this seminar proposed: the opinion of the Gravelines CLI (local information commission) on the Gravelines complementary safety assessment report, an analysis and discussion by the GSIEN on reports of complementary assessment of safety of nuclear installations with respect to the Fukushima accident, an analysis by the IRSN of complementary safety assessments performed by operators, the IRSN approach to analyze complementary safety assessments, reports on installation conditions, external flooding and seismic hazard, 'meltdown prevention' aspects in the management of accidental situations in EDF reactors

Neuropathic pain in people with cancer (part 2): pharmacological and non-pharmacological management.

Science.gov (United States)

Taverner, Tarnia

2015-08-01

The aim of this paper is to provide an overview of the management of neuropathic pain associated with cancer and to provide helpful clinical advice for nurses working with patients who may have neuropathic pain. While cancer pain is a mixed-mechanism pain, this article will focus only on neuropathic pain management. The impact of neuropathic pain on patients' quality of life is great and while many patients recover from their cancer, a significant number continue to suffer from a neuropathic pain syndrome. Management of neuropathic pain is significantly different from management of nociceptive pain with respect to pharmacological and non-pharmacological strategies. Neuropathic pain is complex, and as such requires complex management using pharmacological as well as non-pharmacological approaches. Specific drugs for neuropathic pain may be effective for some patients, but not all; therefore, ongoing and comprehensive assessment and management are required. Furthermore, these patients may require trials of several drugs before they find one that works for them. It is important for nurses to understand neuropathic pain, its manifestation, impact on quality of life and management when nursing patients with neuropathic pain associated with cancer.

Student Perceptions of Social Learning Space: Designing and Implementing a Co-Operative Assessment Task in Pharmacology

Science.gov (United States)

Moni, Roger W.; Depaz, Iris; Lluka, Lesley J.

2008-01-01

We report findings from a case study of co-operative, group-based assessment in Pharmacology for second-year undergraduates at The University of Queensland, Australia. Students enrolled in the 2005 Bachelor of Science and 2006 Bachelor of Pharmacy degree programs, were early users of the university's new Collaborative Teaching and Learning Centre…

Initial development of a practical safety audit tool to assess fleet safety management practices.

Science.gov (United States)

Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

2012-07-01

Work-related vehicle crashes are a common cause of occupational injury. Yet, there are few studies that investigate management practices used for light vehicle fleets (i.e. vehicles less than 4.5 tonnes). One of the impediments to obtaining and sharing information on effective fleet safety management is the lack of an evidence-based, standardised measurement tool. This article describes the initial development of an audit tool to assess fleet safety management practices in light vehicle fleets. The audit tool was developed by triangulating information from a review of the literature on fleet safety management practices and from semi-structured interviews with 15 fleet managers and 21 fleet drivers. A preliminary useability assessment was conducted with 5 organisations. The audit tool assesses the management of fleet safety against five core categories: (1) management, systems and processes; (2) monitoring and assessment; (3) employee recruitment, training and education; (4) vehicle technology, selection and maintenance; and (5) vehicle journeys. Each of these core categories has between 1 and 3 sub-categories. Organisations are rated at one of 4 levels on each sub-category. The fleet safety management audit tool is designed to identify the extent to which fleet safety is managed in an organisation against best practice. It is intended that the audit tool be used to conduct audits within an organisation to provide an indicator of progress in managing fleet safety and to consistently benchmark performance against other organisations. Application of the tool by fleet safety researchers is now needed to inform its further development and refinement and to permit psychometric evaluation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Animal-Free Chemical Safety Assessment

Directory of Open Access Journals (Sweden)

George D Loizou

2016-07-01

Full Text Available The exponential growth of the Internet of Things and the global popularity and remarkable decline in cost of the mobile phone is driving the digital transformation of medical practice. The rapidly maturing digital, nonmedical world of mobile (wireless devices, cloud computing and social networking is coalescing with the emerging digital medical world of omics data, biosensors and advanced imaging which offers the increasingly realistic prospect of personalized medicine. Described as a potential seismic shift from the current healthcare model to a wellness paradigm that is predictive, preventative, personalized and participatory, this change is based on the development of increasingly sophisticated biosensors which can track and measure key biochemical variables in people. Additional key drivers in this shift are metabolomic and proteomic signatures, which are increasingly being reported as pre-symptomatic, diagnostic and prognostic of toxicity and disease. These advancements also have profound implications for toxicological evaluation and safety assessment of pharmaceuticals and environmental chemicals. An approach based primarily on human in vivo and high-throughput in vitro human cell-line data is a distinct possibility. This would transform current chemical safety assessment practise which operates in a human data poor to a human data rich environment. This could also lead to a seismic shift from the current animal-based to an animal-free chemical safety assessment paradigm.

Additional safety assessments. Report by the Nuclear Safety Authority - December 2011

International Nuclear Information System (INIS)

2011-12-01

The first part of this voluminous report proposes an assessment of targeted audits performed in French nuclear installations (water pressurized reactors on the one hand, laboratories, factories and waste and dismantling installations on the other hand) on issues related to the Fukushima accident. The examined issues were the protection against flooding and against earthquake, and the loss of electricity supplies and of cooling sources. The second part addresses the additional safety assessments of the reactors and the European resistance tests: presentation of the French electronuclear stock, earthquake, flooding and natural hazards (installation sizing, safety margin assessment), loss of electricity supplies and cooling systems, management of severe accidents, subcontracting conditions. The third part addresses the same issues for nuclear installations other than nuclear power reactors

Preliminary investigation on reliability assessment of passive safety system

International Nuclear Information System (INIS)

Huang Changfan; Kuang Bo

2012-01-01

The reliability evaluation of passive safety system plays an important part in probabilistic safety assessment (PSA) of nuclear power plant applying passive safety design, which depends quantitatively on reliabilities of passive safety system. According to the object of reliability assessment of passive safety system, relevant parameters are identified. Then passive system behavior during accident scenarios are studied. A practical example of this method is given for the case of reliability assessment of AP1000 passive heat removal system in loss of normal feedwater accident. Key and design parameters of PRHRS are identified and functional failure criteria are established. Parameter combinations acquired by Latin hyper~ cube sampling (LHS) in possible parametric ranges are input and calculations of uncertainty propagation through RELAP5/MOD3 code are carried out. Based on the calculations, sensitivity assessment on PRHRS functional criteria and reliability evaluation of the system are presented, which might provide further PSA with PRHR system reliability. (authors)

Probabilistic safety assessment of the Fugen NPS

International Nuclear Information System (INIS)

Sotsu, Masutake; Iguchi, Yukihiro; Mizuno, Kouichi; Sato, Shinichirou; Shimizu, Miwako

1999-01-01

We performed a probabilistic safety assessment (PSA) on the Fugen NPS. The main topic of assessment was internal factors. We assessment core damage frequency (level 1 PSA) and containment damage frequency (level 2 PSA) during rated operation, and core damage frequency during shutdown (PSA during shutdowns). Our assessment showed that the core damage frequency of Fugen is well below the IAEA criteria for existing plants, that the conditional containment damage during shutdown is almost the target value of 0.1, and that the core damage frequency during shutdown is almost the same as that assessed during operation. These results confirm that the Fugen plant maintains a sufficient safety margin during shutdowns for regular inspections and for refueling. We developed and verified the effectiveness of an accident management plan incorporating the results of the assessment. (author)

Local Anesthetics: Review of Pharmacological Considerations

Science.gov (United States)

Becker, Daniel E; Reed, Kenneth L

2012-01-01

Local anesthetics have an impressive history of efficacy and safety in medical and dental practice. Their use is so routine, and adverse effects are so infrequent, that providers may understandably overlook many of their pharmacotherapeutic principles. The purpose of this continuing education article is to provide a review and update of essential pharmacology for the various local anesthetic formulations in current use. Technical considerations will be addressed in a subsequent article. PMID:22822998

Safety standards for near surface disposal and the safety case and supporting safety assessment for demonstrating compliance with the standards

International Nuclear Information System (INIS)

Metcalf, P.

2003-01-01

The report presents the safety standards for near surface disposal (ICRP guidance and IAEA standards) and the safety case and supporting safety assessment for demonstrating compliance with the standards. Special attention is paid to the recommendations for disposal of long-lived solid radioactive waste. The requirements are based on the principle for the same level of protection of future individuals as for the current generation. Two types of exposure are considered: human intrusion and natural processes and protection measures are discussed. Safety requirements for near surface disposal are discussed including requirements for protection of human health and environment, requirements or safety assessments, waste acceptance and requirements etc

Failure rate data for fusion safety and risk assessment

International Nuclear Information System (INIS)

Cadwallader, L.C.

1993-01-01

The Fusion Safety Program (FSP) at the Idaho National Engineering Laboratory (INEL) conducts safety research in materials, chemical reactions, safety analysis, risk assessment, and in component research and development to support existing magnetic fusion experiments and also to promote safety in the design of future experiments. One of the areas of safety research is applying probabilistic risk assessment (PRA) methods to fusion experiments. To apply PRA, we need a fusion-relevant radiological dose code and a component failure rate data base. This paper describes the FSP effort to develop a failure rate data base for fusion-specific components

Fusion blanket inherent safety assessment

International Nuclear Information System (INIS)

Sze, D.K.; Jung, J.; Cheng, E.T.

1986-01-01

Fusion has significant potential safety advantages. There is a strong incentive for designing fusion plants to ensure that inherent safety will be achieved. Accordingly, both the Tokamak Power Systems Studies and MINIMARS have identified inherent safety as a design goal. A necessary condition is for the blanket to maintain its configuration and integrity under all credible accident conditions. A main problem is caused by afterheat removal in an accident condition. In this regard, it is highly desirable to achieve the required level of protection of the plant capital investment and limitation of radioactivity release by systems that rely only on inherent properties of matter (e.g., thermal conductivity, specific heat, etc.) and without the use of active safety equipment. This paper assesses the conditions under which inherent safety is feasible. Three types of accident conditions are evaluated for two blankets. The blankets evaluated are a self cooled vanadium/lithium blanket and a self-cooled vanadium/Flibe blanket. The accident conditions evaluated are: (1) loss-of-flow accident; (2) loss-of-coolant accident (LOCA); and (3) partial loss-of-coolant accident

Mathematical Safety Assessment Approaches for Thermal Power Plants

Directory of Open Access Journals (Sweden)

Zong-Xiao Yang

2014-01-01

Full Text Available How to use system analysis methods to identify the hazards in the industrialized process, working environment, and production management for complex industrial processes, such as thermal power plants, is one of the challenges in the systems engineering. A mathematical system safety assessment model is proposed for thermal power plants in this paper by integrating fuzzy analytical hierarchy process, set pair analysis, and system functionality analysis. In the basis of those, the key factors influencing the thermal power plant safety are analyzed. The influence factors are determined based on fuzzy analytical hierarchy process. The connection degree among the factors is obtained by set pair analysis. The system safety preponderant function is constructed through system functionality analysis for inherence properties and nonlinear influence. The decision analysis system is developed by using active server page technology, web resource integration, and cross-platform capabilities for applications to the industrialized process. The availability of proposed safety assessment approach is verified by using an actual thermal power plant, which has improved the enforceability and predictability in enterprise safety assessment.

Buffer and backfill process report for the safety assessment SR-Can

Energy Technology Data Exchange (ETDEWEB)

Sellin, Patrik (comp.)

2006-09-15

This document compiles information on processes in the buffer and deposition tunnel backfill relevant for long-term safety of a KBS-repository. It supports the safety assessment SR-Can, which is a preparatory step for a safety assessment that will support the licence application for a final repository in Sweden. The purpose of the process reports is to document the scientific knowledge of the processes to a level required for an adequate treatment of the processes in the safety assessment. The documentation is not exhaustive from a scientific point of view, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. However, it must be sufficiently detailed to motivate, by arguments founded on scientific understanding, the treatment of each process in the safety assessment. The purpose is further to determine how to handle each process in the safety assessment at an appropriate degree of detail, and to demonstrate how uncertainties are taken care of, given the suggested handling.

Buffer and backfill process report for the safety assessment SR-Can

International Nuclear Information System (INIS)

Sellin, Patrik

2006-09-01

This document compiles information on processes in the buffer and deposition tunnel backfill relevant for long-term safety of a KBS-repository. It supports the safety assessment SR-Can, which is a preparatory step for a safety assessment that will support the licence application for a final repository in Sweden. The purpose of the process reports is to document the scientific knowledge of the processes to a level required for an adequate treatment of the processes in the safety assessment. The documentation is not exhaustive from a scientific point of view, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. However, it must be sufficiently detailed to motivate, by arguments founded on scientific understanding, the treatment of each process in the safety assessment. The purpose is further to determine how to handle each process in the safety assessment at an appropriate degree of detail, and to demonstrate how uncertainties are taken care of, given the suggested handling

A Computer Program for Assessing Nuclear Safety Culture Impact

Energy Technology Data Exchange (ETDEWEB)

Han, Kiyoon; Jae, Moosung [Hanyang Univ., Seoul (Korea, Republic of)

2014-10-15

Through several accidents of NPP including the Fukushima Daiichi in 2011 and Chernobyl accidents in 1986, a lack of safety culture was pointed out as one of the root cause of these accidents. Due to its latent influences on safety performance, safety culture has become an important issue in safety researches. Most of the researches describe how to evaluate the state of the safety culture of the organization. However, they did not include a possibility that the accident occurs due to the lack of safety culture. Because of that, a methodology for evaluating the impact of the safety culture on NPP's safety is required. In this study, the methodology for assessing safety culture impact is suggested and a computer program is developed for its application. SCII model which is the new methodology for assessing safety culture impact quantitatively by using PSA model. The computer program is developed for its application. This program visualizes the SCIs and the SCIIs. It might contribute to comparing the level of the safety culture among NPPs as well as improving the management safety of NPP.

Healthcare professionals? views on feedback of a patient safety culture assessment

OpenAIRE

Zwijnenberg, Nicolien C.; Hendriks, Michelle; Hoogervorst-Schilp, Janneke; Wagner, Cordula

2016-01-01

Background By assessing patient safety culture, healthcare providers can identify areas for improvement in patient safety culture. To achieve this, these assessment outcomes have to be relevant and presented clearly. The aim of our study was to explore healthcare professionals? views on the feedback of a patient safety culture assessment. Methods Twenty four hospitals participated in a patient safety culture assessment in 2012. Hospital departments received feedback in a report and on a websi...

Safety assessment of the liquid-fed ceramic melter process

International Nuclear Information System (INIS)

Buelt, J.L.; Partain, W.L.

1980-08-01

As part of its development program for the solidification of high-level nuclear waste, Pacific Northwest Laboratory assessed the safety issues for a complete liquid-fed ceramic melter (LFCM) process. The LFCM process, an adaption of commercial glass-making technology, is being developed to convert high-level liquid waste from the nuclear fuel cycle into glass. This safety assessment uncovered no unresolved or significant safety problems with the LFCM process. Although in this assessment the LFCM process was not directly compared with other solidification processes, the safety hazards of the LFCM process are comparable to those of other processes. The high processing temperatures of the glass in the LFCM pose no additional significant safety concerns, and the dispersible inventory of dried waste (calcine) is small. This safety assessment was based on the nuclear power waste flowsheet, since power waste is more radioactive than defense waste at the time of solidification, and all accident conditions for the power waste would have greater radiological consequences than those for defense waste. An exhaustive list of possible off-standard conditions and equipment failures was compiled. These accidents were then classified according to severity of consequence and type of accident. Radionuclide releases to the stack were calculated for each group of accidents using conservative assumptions regarding the retention and decontamination features of the process and facility. Two recommendations that should be considered by process designers are given in the safety assessment

Safety assessment of novel foods and strategies to determine their safety in use

International Nuclear Information System (INIS)

Edwards, Gareth

2005-01-01

Safety assessment of novel foods requires a different approach to that traditionally used for the assessment of food chemicals. A case-by-case approach is needed which must be adapted to take account of the characteristics of the individual novel food. A thorough appraisal is required of the origin, production, compositional analysis, nutritional characteristics, any previous human exposure and the anticipated use of the food. The information should be compared with a traditional counterpart of the food if this is available. In some cases, a conclusion about the safety of the food may be reached on the basis of this information alone, whereas in other cases, it will help to identify any nutritional or toxicological testing that may be required to further investigate the safety of the food. The importance of nutritional evaluation cannot be over-emphasised. This is essential for the conduct of toxicological studies in order to avoid dietary imbalances, etc., that might lead to interpretation difficulties, but also in the context of its use as food and to assess the potential impact of the novel food on the human diet. The traditional approach used for chemicals, whereby an acceptable daily intake (ADI) is established with a large safety margin relative to the expected exposure, cannot be applied to foods. The assessment of safety in use should be based upon a thorough knowledge of the composition of the food, evidence from nutritional, toxicological and human studies, expected use of the food and its expected consumption. Safety equates to a reasonable certainty that no harm will result from intended uses under the anticipated conditions of consumption

LANL Safety Conscious Work Environment (SCWE) Self-Assessment

Energy Technology Data Exchange (ETDEWEB)

Hargis, Barbara C. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

2014-01-29

On December 21, 2012 Secretary of Energy Chu transmitted to the Defense Nuclear Facilities Safety Board (DNFSB) revised commitments on the implementation plan for Safety Culture at the Waste Treatment and Immobilization Plant. Action 2-5 was revised to require contractors and federal organizations to complete Safety Conscious Work Environment (SCWE) selfassessments and provide reports to the appropriate U.S. Department of Energy (DOE) - Headquarters Program Office by September 2013. Los Alamos National Laboratory (LANL) planned and conducted a Safety Conscious Work Environment (SCWE) Self-Assessment over the time period July through August, 2013 in accordance with the SCWE Self-Assessment Guidance provided by DOE. Significant field work was conducted over the 2-week period August 5-16, 2013. The purpose of the self-assessment was to evaluate whether programs and processes associated with a SCWE are in place and whether they are effective in supporting and promoting a SCWE.

Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review.

Directory of Open Access Journals (Sweden)

Isabelle Boutron

2006-10-01

Full Text Available BACKGROUND: Blinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments. METHODS AND FINDINGS: We undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1 established blinding of patients or health care providers, (2 maintained the blinding of patients or health care providers, and (3 obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58% describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage, or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or

Quantitative risk assessment of digitalized safety systems

Energy Technology Data Exchange (ETDEWEB)

Shin, Sung Min; Lee, Sang Hun; Kang, Hym Gook [KAIST, Daejeon (Korea, Republic of); Lee, Seung Jun [UNIST, Ulasn (Korea, Republic of)

2016-05-15

A report published by the U.S. National Research Council indicates that appropriate methods for assessing reliability are key to establishing the acceptability of digital instrumentation and control (I and C) systems in safety-critical plants such as NPPs. Since the release of this issue, the methodology for the probabilistic safety assessment (PSA) of digital I and C systems has been studied. However, there is still no widely accepted method. Kang and Sung found three critical factors for safety assessment of digital systems: detection coverage of fault-tolerant techniques, software reliability quantification, and network communication risk. In reality the various factors composing digitalized I and C systems are not independent of each other but rather closely connected. Thus, from a macro point of view, a method that can integrate risk factors with different characteristics needs to be considered together with the micro approaches to address the challenges facing each factor.

Safety assessment of high consequence robotics system

International Nuclear Information System (INIS)

Robinson, D.G.; Atcitty, C.B.

1996-01-01

This paper outlines the use of a failure modes and effects analysis for the safety assessment of a robotic system being developed at Sandia National Laboratories. The robotic system, the weigh and leak check system, is to replace a manual process for weight and leakage of nuclear materials at the DOE Pantex facility. Failure modes and effects analyses were completed for the robotics process to ensure that safety goals for the systems have been met. Due to the flexible nature of the robot configuration, traditional failure modes and effects analysis (FMEA) were not applicable. In addition, the primary focus of safety assessments of robotics systems has been the protection of personnel in the immediate area. In this application, the safety analysis must account for the sensitivities of the payload as well as traditional issues. A unique variation on the classical FMEA was developed that permits an organized and quite effective tool to be used to assure that safety was adequately considered during the development of the robotic system. The fundamental aspects of the approach are outlined in the paper

Noninvasive Assessment of Gastric Emptying by Near-Infrared Fluorescence Reflectance Imaging in Mice: Pharmacological Validation with Tegaserod, Cisapride, and Clonidine

Directory of Open Access Journals (Sweden)

Hans-Ulrich Gremlich

2004-10-01

Full Text Available Noninvasive near-infrared fluorescence reflectance imaging (FRI is an in vivo technique to assess physiological and molecular processes in the intact organism. Here we describe a method to assess gastric emptying in mice. TentaGel™ beads with covalently bound cyanine dye (Cy5.5 conjugates as fluorescent probe were administered by oral gavage. The amount of intragastric beads/label was derived from the fluorescence signal intensity measured in a region of interest corresponding to the mouse stomach. The FRI signal intensity decreased as a function of time reflecting gastric emptying. In control mice, the gastric half-emptying time was in agreement with literature data. Pharmacological modulation of gastric motility allowed the evaluation of the sensitivity of the FRI-based method. Gastric emptying was either stimulated or inhibited by treatment with the 5-HT4 receptor agonists tegaserod (Zelnorm® and cisapride or the α2-receptor agonist clonidine, respectively. Tegaserod and cisapride dose-dependently accelerated gastric emptying. In contrast, clonidine dose-dependently delayed gastric emptying. In conclusion, FRI using fluorescently labeled beads allows the reliable determination of gastric emptying as well as the assessment of pharmacological interventions. The technique thus offers the potential to characterize molecular targets and pathways involved in physiological regulation and pharmacological modulation of gastric emptying.

Research on fuzzy comprehensive assessment method of nuclear power plant safety culture

International Nuclear Information System (INIS)

Xiang Yuanyuan; Chen Xukun; Xu Rongbin

2012-01-01

Considering the traits of safety culture in nuclear plant, 38 safety culture assessment indexes are established from 4 aspects such as safety values, safety institution, safety behavior and safety sub- stances. Based on it, a comprehensive assessment method for nuclear power plant safety culture is constructed by using AHP (Analytic Hierarchy Process) approach and fuzzy mathematics. The comprehensive assessment method has the quality of high precision and high operability, which can support the decision making of safety culture development. (authors)

Safety/security interface assessments at commercial nuclear power plants

International Nuclear Information System (INIS)

Byers, K.R.; Brown, P.J.; Norderhaug, L.R.

1985-01-01

The findings of the Haynes Task Force Committee (NUREG-0992) are used as the basis for defining safety/security assessment team activities at commercial nuclear power plants in NRC Region V. A safety/security interface assessment outline and the approach used for making the assessments are presented along with the composition of team members. As a result of observing simulated plant emergency conditions during scheduled emergency preparedness exercises, examining security and operational response procedures, and interviewing plant personnel, the team has identified instances where safety/security conflicts can occur

Safety/security interface assessments at commercial nuclear power plants

International Nuclear Information System (INIS)

Byers, K.R.; Brown, P.J.; Norderhaug, L.R.

1985-07-01

The findings of the Haynes Task Force Committee (NUREG-0992) are used as the basis for defining safety/security assessment team activities at commercial nuclear power plants in NRC Region V. A safety/security interface assessment outline and the approach used for making the assessments are presented along with the composition of team members. As a result of observing simulated plant emergency conditions during scheduled emergency preparedness exercises, examining security and operational response procedures, and interviewing plant personnel, the team has identified instances where safety/security conflicts can occur. 2 refs

Safety assessment for Generation IV nuclear systems

International Nuclear Information System (INIS)

Leahy, T.J.

2012-01-01

The Generation IV International Forum (GIF) Risk and Safety Working Group (RSWG) was created to develop an effective approach for the safety of Generation IV advanced nuclear energy systems. Recent RSWG work has focused on the definition of an integrated safety assessment methodology (ISAM) for evaluating the safety of Generation IV systems. ISAM is an integrated 'tool-kit' consisting of 5 analytical techniques that are available and matched to appropriate stages of Generation IV system concept development: 1) qualitative safety features review - QSR, 2) phenomena identification and ranking table - PIRT, 3) objective provision tree - OPT, 4) deterministic and phenomenological analyses - DPA, and 5) probabilistic safety analysis - PSA. The integrated methodology is intended to yield safety-related insights that help actively drive the evolving design throughout the technology development cycle, potentially resulting in enhanced safety, reduced costs, and shortened development time

Nirex safety assessment research programme: 1987/88

International Nuclear Information System (INIS)

George, D.; Hodgkinson, D.P.

1987-01-01

The Nirex Safety Assessment Research programme's objective is to provide information for the radiological safety case for disposing low-level and intermediate-level radioactive wastes in underground repositories. The programme covers a wide range of experimental studies and mathematical modelling for the near and far field. It attempts to develop a quantitative understanding of events and processes which have an impact on the safety of radioactive waste disposal. (U.K.)

Safety assessment requirements for onsite transfers of radioactive material

International Nuclear Information System (INIS)

Opperman, E.K.; Jackson, E.J.; Eggers, A.G.

1992-05-01

This document contains the requirements for developing a safety assessment document for an onsite package containing radioactive material. It also provides format and content guidance to establish uniformity in the safety assessment documentation and to ensure completeness of the information provided

Geosphere process report for the safety assessment SR-Site

International Nuclear Information System (INIS)

Skagius, Kristina

2010-11-01

This report documents geosphere processes identified as relevant to the long-term safety of a KBS-3 repository, and forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

Geosphere process report for the safety assessment SR-Site

Energy Technology Data Exchange (ETDEWEB)

Skagius, Kristina (ed.) (Kemakta Konsult AB, Stockholm (Sweden))

2010-11-15

This report documents geosphere processes identified as relevant to the long-term safety of a KBS-3 repository, and forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

Research on advanced system safety assessment procedures (4)

International Nuclear Information System (INIS)

Suzuki, Kazuhiko; Shimada, Yukiyasu

2001-03-01

The past research reports in the area of safety engineering proposed the Computer-aided HAZOP system to be applied to Nuclear Reprocessing Facilities. Automated HAZOP system has great advantage compared with human analysts in terms of accuracy of the results, and time required to conduct HAZOP studies. This report surveys the literature on risk assessment and safety design based on the concept of independent protection layers (IPLs). Furthermore, to improve HAZOP System, tool is proposed to construct the basic model and the internal state model. Such HAZOP system is applied to analyze two kinds of processes, where the ability of the proposed system is verified. In addition, risk assessment support system is proposed to integrate safety design environment and assessment result to be used by other plants as well as to enable the underline plant to use other plants' information. This technique can be implemented using web-based safety information systems. (author)

Audit of data and code use in the SR-Can safety assessment

Energy Technology Data Exchange (ETDEWEB)

Hicks, T.W.; Baldwin, T.D. [Galson Sciences Ltd, 5 Grosvenor House, Melton R oad, Oakham, Rutland LE15 6AX (United Kingdom)

2008-03-15

Building on the findings of previous studies on data and code quality assurance (QA) in safety assessments, this report provides a review of data and code QA in the SR-Can safety assessment. The data quality audit aimed to check that the selection and use of data in the SR-Can safety assessment was appropriate, focusing on the data that underpin representations of and assumptions about canister, insert, buffer, and backfill behaviour. The SR-Can Data Report provided the initial focus for examining the traceability and reliability of data used in the safety assessment; the Data Report is one of the series of SR-Can safety assessment reports and, in this review, it was anticipated that it would provide the primary source of data on the canister, insert, buffer, and backfill. However, other safety assessment reports (the SR-Can Main Report, the Initial State Report, the Fuel and Canister Process Report, and the Buffer and Backfill Process Report) were found to provide key information on data used in the safety assessment. The quality audit of codes aimed to check that code use in the SR-Can safety assessment has been justified through a transparent and traceable process of code development and selection. The Model Summary Report provided the focus for reviewing the QA status of the codes used in the safety assessment. As well as highlighting a number of concerns regarding QA aspects of specific data sets, parameter values, and codes used in the SR-Can safety assessment (which are presented in the report), the review has led to several general observations on data and code QA that should be considered by SKB in the development and implementation of a QA system for the SR-Site safety assessment: - The SR-Site safety assessment and associated QA records should include information that demonstrates that a full QA system has been implemented in order to build confidence in the validity of the assessment. - The data and parameter values used directly in the safety

Assessing safety culture using RADAR matrix

International Nuclear Information System (INIS)

Mariscal-Saldana, M. a.; Garcia-Herrero, S.; Toca-Otero, A.

2009-01-01

Santa Maria de Garona nuclear power plant, in collaboration with Burgos University, has proceeded to conduct a pilot project aimed at seeing the possibilities for the RADAR (Results, Approach, Development, Assessment and review) logic of EFQM model, as a tool for self evaluation of Safety Culture in a nuclear power plant. In the work it has sought evidences of Safety culture implanted in the plant, and identify strengths and areas for improvement regarding this Culture. the score obtained by analyzing these strengths and areas for improvements has served to prioritize actions implemented. The nuclear power plant has been submitted voluntarily to the mission SCART (Safety Culture Assessment Review Team), an international review being done for the first time in the world at a plant in operation and the team of experts led by International Agency of Atomic Energy (IAEA) has identified this project as a good practice, an innovative process implemented in the plant, that must be transmitted to other plants. (Author) 10 refs

Developing IAM for Life Cycle Safety Assessment

NARCIS (Netherlands)

Toxopeus, Marten E.; Lutters, Diederick; Nee, Andrew Y.C.; Song, Bin; Ong, Soh-Khim

2013-01-01

This publication discusses aspects of the development of an impact assessment method (IAM) for safety. Compared to the many existing IAM’s for environmentally oriented LCA, this method should translate the impact of a product life cycle on the subject of safety. Moreover, the method should be

Safety assessment of smoke flavouring primary products by the European Food Safety Authority

NARCIS (Netherlands)

Theobald, A.; Arcella, D.; Carere, A.; Croera, C.; Engel, K.H.; Gott, D.; Gurtler, R.; Meier, D.; Pratt, I.; Rietjens, I.M.C.M.; Simon, R.; Walker, R.

2012-01-01

This paper summarises the safety assessments of eleven smoke flavouring primary products evaluated by the European Food Safety Authority (EFSA). Data on chemical composition, content of polyaromatic hydrocarbons and results of genotoxicity tests and subchronic toxicity studies are presented and

Fire safety assessment of tunnel structures

DEFF Research Database (Denmark)

Gkoumas, Konstantinos; Giuliani, Luisa; Petrini, Francesco

2011-01-01

.g. structural and non structural, organizational, human behavior). This is even more truth for the fire safety design of such structures. Fire safety in tunnels is challenging because of the particular environment, bearing in mind also that a fire can occur in different phases of the tunnel’s lifecycle. Plans...... for upgrading fire safety provisions and tunnel management are also important for existing tunnels. In this study, following a brief introduction of issues regarding the above mentioned aspects, the structural performance of a steel rib for a tunnel infrastructure subject to fire is assessed by means...

Safety management system needs assessment.

Science.gov (United States)

2016-04-01

The safety of the traveling public is critical as each year there are approximately 200 highway fatalities in Nebraska and numerous crash injuries. The objective of this research was to conduct a needs assessment to identify the requirements of a sta...

Criticality safety evaluations - a {open_quotes}stalking horse{close_quotes} for integrated safety assessment

Energy Technology Data Exchange (ETDEWEB)

Williams, R.A. [Westinghouse Electric Corp., Columbia, SC (United States)

1995-12-31

The Columbia Fuel Fabrication Facility of the Westinghouse Commercial Nuclear Fuel Division manufactures low-enriched uranium fuel and associated components for use in commercial pressurized water power reactors. To support development of a comprehensive integrated safety assessment (ISA) for the facility, as well as to address increasing U.S. Nuclear Regulatory Commission (NRC) expectations regarding such a facility`s criticality safety assessments, a project is under way to complete criticality safety evaluations (CSEs) of all plant systems used in processing nuclear materials. Each CSE is made up of seven sections, prepared by a multidisciplinary team of process engineers, systems engineers, safety engineers, maintenance representatives, and operators. This paper provides a cursory outline of the type of information presented in a CSE.

Safety and security risk assessments--now demystified!

Science.gov (United States)

White, Donald E

2011-01-01

Safety/security risk assessments no longer need to spook nor baffle healthcare safety/security managers. This grid template provides at-at-glance quick lookup of the possible threats, the affected people and things, a priority ranking of these risks, and a workable solution for each risk. Using the standard document, spreadsheet, or graphics software already available on your computer, you can easily use a scientific method to produce professional looking risk assessments that get quickly understood by both senior managers and first responders alike!

Visualization of Safety Assessment Result Using GIS in SITES

International Nuclear Information System (INIS)

Yun, Bong-Yo; Park, Joo Wan; Park, Se-Moon; Kim, Chang-Lak

2006-01-01

Site Information and Total Environmental database management System (SITES) is an integrated program for overall data analysis, environmental monitoring, and safety analysis that are produced from the site investigation and environmental assessment of the relevant nuclear facility. SITES is composed of three main modules such as Site Environment Characterization database for Unified and Reliable Evaluation system (SECURE), Safety Assessment INTegration system (SAINT) and Site Useful Data Analysis and ALarm system (SUDAL). The visualization function of safety assessment and environmental monitoring results is designed. This paper is to introduce the visualization design method using Geographic Information System (GIS) for SITES

Additional safety assessment of ITER - Addition safety investigation of the INB ITER

International Nuclear Information System (INIS)

2012-01-01

This assessment aims at re-assessing safety margins in the light of events which occurred in Fukushima Daiichi, i.e. extreme natural events challenging the safety of installations. After a presentation of some characteristics of the ITER installation (location, activities, buildings, premise detritiation systems, electric supply, handling means, radioactive materials, chemical products, nuclear risks, specific risks), the report addresses the installation robustness by identifying cliff-edge effect risks which can be related to a loss of confinement of radioactive materials, explosions, a significant increase of exposure level, a possible effect on water sheets, and so on. The next part addresses the various aspects related to a seismic risk: installation sizing (assessment methodology, seismic risk characterization in Cadarache), sizing protection measures, installation compliance, and margin assessment. External flooding is the next addressed risk: installation sizing with respect to this specific risk, protection measures, installation compliance, margin assessment, and studied additional measures. Other extreme natural phenomena are considered (meteorological conditions, earthquake and flood) which may have effects on other installations (dam, canal). Then, the report addresses technical risks like the loss of electric supplies and cooling systems, the way a crisis is managed in terms of technical and human means and organization in different typical accidental cases. Subcontracting practices are also discussed. A synthesis proposes an overview of this additional safety assessment and discusses the impact which could have additional measures which could be implemented

[Non-Pharmacological Interventions for Pregnancy-Related Sleep Disturbances].

Science.gov (United States)

Hung, Hsuan-Man; Chiang, Hsiao-Ching

2017-02-01

Most women experience the worse sleep quality of their life during pregnancy and the early postpartum period. Although pregnancy typically accounts for a relatively short part of a woman's life, the related sleep disturbances may have a significant and negative impact on her long-term health. Approximately 78-80% of pregnant women experience sleep disturbances, including interruptions in deep sleep, decreased total sleep time, poor subjective sleep quality, frequent night waking, and reduced sleep efficacy. Sleep disturbances during pregnancy start during the first trimester and become prevalent during the third trimester. Related factors include physiological and psychosocial changes and an unhealthy lifestyle. As non-pharmacological interventions have the potential to improve sleep quality in 70% to 80% of patients with insomnia, this is the main approached that is currently used to treat pregnancy-related sleep disturbances. Examples of these non-pharmacological interventions include music therapy, aerobic exercise, massage, progressive muscle relaxation, multi-modal interventions, and the use of a maternity support belt. The efficacy and safety of other related non-pharmacological interventions such as auricular acupressure, cognitive therapy, tai chi, and aromatherapy remain uncertain, with more empirical research required. Additionally, non-pharmacological interventions do not effectively treat sleep disturbances in all pregnant women.

Swedish REGULATORY APPROACH TO SAFETY Assessment AND SEVERE ACCIDENT MANAGEMENT

International Nuclear Information System (INIS)

Frid, W.; Sandervaag, O.

1997-01-01

The Swedish regulatory approach to safety assessment and severe accident management is briefly described. The safety assessment program, which focuses on prevention of incidents and accidents, has three main components: periodic safety reviews, probabilistic safety analysis, and analysis of postulated disturbances and accident progression sequences. Management and man-technology-organisation issues, as well as inspections, play a key role in safety assessment. Basis for severe accident management were established by the Government decisions in 1981 and 1986. By the end of 1988, the severe accident mitigation systems and emergency operating procedures were implemented at all Swedish reactors. The severe accident research has continued after 1988 for further verification of the protection provided by the systems and reduction of remaining uncertainties in risk dominant phenomena

Complementary assessment of the safety of French nuclear power plants

International Nuclear Information System (INIS)

Camarcat, N.; Pouget-Abadie, X.

2011-01-01

As an immediate consequence of the Fukushima accident the French nuclear safety Authority (ASN) asked EDF to perform a complementary safety assessment for each nuclear power plant dealing with 3 points: 1) the consequences of exceptional natural disasters, 2) the consequences of total loss of electrical power, and 3) the management of emergency situations. The safety margin has to be assessed considering 3 main points: first a review of the conformity to the initial safety requirements, secondly the resistance to events overdoing what the facility was designed to stand for, and the feasibility of any modification susceptible to improve the safety of the facility. This article details the specifications of such assessment, the methodology followed by EDF, the task organization and the time schedule. (A.C.)

The use of monoamine pharmacological agents in the treatment of sexual dysfunction: evidence in the literature.

Science.gov (United States)

Moll, Jennifer L; Brown, Candace S

2011-04-01

The monoamine neurotransmitters serotonin, dopamine, and norepinephrine play an important role in many medical and psychological conditions, including sexual responsiveness and behavior. Pharmacological agents that modulate monoamines may help alleviate sexual dysfunction. To provide an overview of pharmacological agents that modulate monoamines and their use in the treatment of sexual dysfunction. EMBASE and PubMed search for articles published between 1950 and 2010 using key words "sexual dysfunction,"monoamines,"monoaminergic receptors," and "generic names for pharmacological agents." To assess the literature evaluating the efficacy of monoamine pharmacologic agents used in the treatment of sexual dysfunction. The literature primarily cites the use of monoaminergic agents to treat sexual side effects from serotonergic reuptake inhibitors (SSRIs), with bupropion, buspirone and ropinirole providing the most convincing evidence. Controlled trials have shown that bupropion improves overall sexual dysfunction, but not frequency of sexual activity in depressed and nondepressed patients. Nefazodone and apomorphine have been used to treat sexual dysfunction, but their use is limited by significant side effect and safety profiles. New research on pharmacologic agents with subtype selectivity at dopaminergic and serotonergic receptors and those that possess dual mechanisms of action are being investigated. There has been tremendous progress over the past 50 years in understanding the role of monoamines in sexual function and the effect of pharmacologic agents which stimulate or antagonize monoaminergic receptors on sexual dysfunction. Nevertheless, large, double-blind, placebo-controlled studies evaluating the efficacy of currently available agents in populations without comorbid disorders are limited, preventing adequate interpretation of data. Continued research on sexual function and specific receptor subtypes will result in the development of more selective

Assessment of safety regulation using an artificial society

International Nuclear Information System (INIS)

Furuta, Kazuo; Nagase, Masaya

2005-01-01

This study proposes using an artificial society to assess impacts of safety regulation on the society. The artificial society used in this study is a multi-agent system, which consists of many agents representing companies. The agents cannot survive unless they get profits by producing some products. Safety regulation functions as the business environment, which the agents will evolve to fit to. We modeled this process of survival and adaptation by the genetic algorithm. Using the proposed model, case simulations were performed to compare various regulation styles, and some interesting insights were obtained how regulation style influences behavior of the agents and then productivity and safety level of the industry. In conclusion, an effective method for assessment of safety regulation has been developed, and then several insights were shown in this study

Integrated Deterministic-Probabilistic Safety Assessment Methodologies

Energy Technology Data Exchange (ETDEWEB)

Kudinov, P.; Vorobyev, Y.; Sanchez-Perea, M.; Queral, C.; Jimenez Varas, G.; Rebollo, M. J.; Mena, L.; Gomez-Magin, J.

2014-02-01

IDPSA (Integrated Deterministic-Probabilistic Safety Assessment) is a family of methods which use tightly coupled probabilistic and deterministic approaches to address respective sources of uncertainties, enabling Risk informed decision making in a consistent manner. The starting point of the IDPSA framework is that safety justification must be based on the coupling of deterministic (consequences) and probabilistic (frequency) considerations to address the mutual interactions between stochastic disturbances (e.g. failures of the equipment, human actions, stochastic physical phenomena) and deterministic response of the plant (i.e. transients). This paper gives a general overview of some IDPSA methods as well as some possible applications to PWR safety analyses. (Author)

Human reliability in probabilistic safety assessments

International Nuclear Information System (INIS)

Nunez Mendez, J.

1989-01-01

Nowadays a growing interest in medioambiental aspects is detected in our country. It implies an assessment of the risk involved in the industrial processess and installations in order to determine if those are into the acceptable limits. In these safety assessments, among which PSA (Probabilistic Safety Assessments), can be pointed out the role played by the human being in the system is one of the more relevant subjects. (This relevance has been demostrated in the accidents happenned). However in Spain there aren't manuals specifically dedicated to asses the human contribution to risk in the frame of PSAs. This report aims to improve this situation providing: a) a theoretical background to help the reader in the understanding of the nature of the human error, b) a guide to carry out a Human Reliability Analysis and c) a selected overwiev of the techniques and methodologies currently applied in this area. (Author)

Probabilistic assessment of NPP safety under aircraft impact

International Nuclear Information System (INIS)

Birbraer, A.N.; Roleder, A.J.; Arhipov, S.B.

1999-01-01

Methodology of probabilistic assessment of NPP safety under aircraft impact is described below. The assessment is made taking into account not only the fact of aircraft fall onto the NPP building, but another casual parameters too, namely an aircraft class, velocity and mass, as well as point and angle of its impact with the building structure. This analysis can permit to justify the decrease of the required structure strength and dynamic loads on the NPP equipment. It can also be especially useful when assessing the safety of existing NPP. (author)

Nirex Safety Assessment Research Programme bibliography, 1990

International Nuclear Information System (INIS)

Cooper, M.J.

1990-10-01

This bibliography lists reports and papers written as part of the Nirex Safety Assessment Research Programme, which is concerned with disposal of low-level and intermediate-level waste (LLW and ILW) and associated radiological assessments. (author)

Understanding and assessing safety culture

International Nuclear Information System (INIS)

Dalling, Ian

1997-01-01

The 'Dalling' integrated model of organisational performance is introduced and described. A principal element of this model is culture, which is dynamically contrasted with the five other interacting critical elements, which comprise: the management system, the knowledge base, corporate leadership, stakeholders and consciousness. All six of these principal driving elements significantly influence health, safety, environmental, security, or any other aspect of organisational performance. It is asserted that the elements of organisational performance must be clearly defined and understood if meaningful measurements are to be carried out and sustained progress made in improving the knowledge of organisational performance. AEA Technology's safety culture research programme is then described together with the application of a safety culture assessment tool to organisations in the nuclear, electricity, transport, and oil and gas industries, both within and outside of the United Kingdom. (author)

The use of probabilistic safety assessments for improving nuclear safety in Europe

International Nuclear Information System (INIS)

Birkhofer, A.

1992-01-01

The political changes in Europe broadened the scope of international nuclear safety matters considerably. The Western world started to receive reliable and increasingly detailed information on Eastern European nuclear technology and took note of a broad range of technical and administrative problems relevant for nuclear safety in these countries. Reunification made Germany a focus of information exchange on these matters. Here, cooperation with the former German Democratic Republic and with other Eastern European countries as well as safety analyses of Soviet-built nuclear power plants started rather early. Meanwhile, these activities are progressing toward all-European cooperation in the nuclear safety sector. This cooperation includes the use of probabilistic safety assessments (PSAs) addressing applications in both Western and Eastern Europe as well as the further development of this methodology in a converging Europe

Risk assessment of safety data link and network communication in digital safety feature control system of nuclear power plant

International Nuclear Information System (INIS)

Lee, Sang Hun; Son, Kwang Seop; Jung, Wondea; Kang, Hyun Gook

2017-01-01

Highlights: • Safety data communication risk assessment framework and quantitative scheme were proposed. • Fault-tree model of ESFAS unavailability due to safety data communication failure was developed. • Safety data link and network risk were assessed based on various ESF-CCS design specifications. • The effect of fault-tolerant algorithm reliability of safety data network on ESFAS unavailability was assessed. - Abstract: As one of the safety-critical systems in nuclear power plants (NPPs), the Engineered Safety Feature-Component Control System (ESF-CCS) employs safety data link and network communication for the transmission of safety component actuation signals from the group controllers to loop controllers to effectively accommodate various safety-critical field controllers. Since data communication failure risk in the ESF-CCS has yet to be fully quantified, the ESF-CCS employing data communication systems have not been applied in NPPs. This study therefore developed a fault tree model to assess the data link and data network failure-induced unavailability of a system function used to generate an automated control signal for accident mitigation equipment. The current aim is to provide risk information regarding data communication failure in a digital safety feature control system in consideration of interconnection between controllers and the fault-tolerant algorithm implemented in the target system. Based on the developed fault tree model, case studies were performed to quantitatively assess the unavailability of ESF-CCS signal generation due to data link and network failure and its risk effect on safety signal generation failure. This study is expected to provide insight into the risk assessment of safety-critical data communication in a digitalized NPP instrumentation and control system.

Savannah River Site K-Reactor Probabilistic Safety Assessment

International Nuclear Information System (INIS)

Brandyberry, M.D.; Bailey, R.T.; Baker, W.H.; Kearnaghan, D.P.; O'Kula, K.R.; Wittman, R.S.; Woody, N.D.; Amos, C.N.; Weingardt, J.J.

1992-12-01

This report gives the results of a Savannah River Site (SRS) K-Reactor Probabilistic Safety Assessment (PSA). Measures of adverse consequences to health and safety resulting from representations of severe accidents in SRS reactors are presented. In addition, the report gives a summary of the methods employed to represent these accidents and to assess the resultant consequences. The report is issued to provide useful information to the U. S. Department of Energy (DOE) on the risk of operation of SRS reactors, for insights into severe accident phenomena that contribute to this risk, and in support of improved bases for other DOE programs in Heavy Water Reactor safety

A novel safety assessment strategy applied to non-selective extracts.

Science.gov (United States)

Koster, Sander; Leeman, Winfried; Verheij, Elwin; Dutman, Ellen; van Stee, Leo; Nielsen, Lene Munch; Ronsmans, Stefan; Noteborn, Hub; Krul, Lisette

2015-06-01

A main challenge in food safety research is to demonstrate that processing of foodstuffs does not lead to the formation of substances for which the safety upon consumption might be questioned. This is especially so since food is a complex matrix in which the analytical detection of substances, and consequent risk assessment thereof, is difficult to determine. Here, a pragmatic novel safety assessment strategy is applied to the production of non-selective extracts (NSEs), used for different purposes in food such as for colouring purposes, which are complex food mixtures prepared from reference juices. The Complex Mixture Safety Assessment Strategy (CoMSAS) is an exposure driven approach enabling to efficiently assess the safety of the NSE by focussing on newly formed substances or substances that may increase in exposure during the processing of the NSE. CoMSAS enables to distinguish toxicologically relevant from toxicologically less relevant substances, when related to their respective levels of exposure. This will reduce the amount of work needed for identification, characterisation and safety assessment of unknown substances detected at low concentration, without the need for toxicity testing using animal studies. In this paper, the CoMSAS approach has been applied for elderberry and pumpkin NSEs used for food colouring purposes. Copyright © 2015 Elsevier Ltd. All rights reserved.

Suggestions on the Development of Safety Culture Assessment Method

International Nuclear Information System (INIS)

Choi, Young Sung; Choi, Kwang Sik; Kim, Woong Sik

2006-01-01

Several efforts have been made to assess safety culture of organization that operates nuclear power plants in Korea. The MOST and KINS played a major role to develop assessment methods and KHNP applied them to its NPPs. This paper explains the two methods developed by KINS briefly and presents the insights obtained from the two different applications. It concludes with some suggestions for safety culture assessment based on the insights

Traumatic brain injury pharmacological treatment: recommendations

Directory of Open Access Journals (Sweden)

Renato Anghinah

Full Text Available ABSTRACT This article presents the recommendations on the pharmacological treatment employed in traumatic brain injury (TBI at the outpatient clinic of the Cognitive Rehabilitation after TBI Service of the Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil. A systematic assessment of the consensus reached in other countries, and of articles on TBI available in the PUBMED and LILACS medical databases, was carried out. We offer recommendations of pharmacological treatments in patients after TBI with different symptoms.

Safety assessment of primary system components at the USNRC

Energy Technology Data Exchange (ETDEWEB)

Serpan, C Z; Chen, C Y; Taboada, A

1988-12-31

This document deals with the safety assessment in nuclear reactor components at the USNRC. The USNRC regulations and requirements concerning nuclear reactor design and operations are presented, together with guides and standards which describe how the actions should be implemented. The safety assessment relies on fracture analysis and Non Destructive Examination (NDE). (TEC).

Safety assessment for a KBS-3H spent nuclear fuel repository at Olkiluoto. Complementary evaluations of safety

International Nuclear Information System (INIS)

Neall, Fiona; Pastina, Barbara; Snellman, Margit; Smith, Paul; Gribi, P.; Johnson, Lawrence

2008-12-01

The KBS-3H design is a variant of the more general KBS-3 method for the geological disposal of spent nuclear fuel in Finland and Sweden. In the KBS-3H design, multiple assemblies containing spent fuel are emplaced horizontally in parallel, approximately 300 m long, slightly inclined deposition drifts. The copper canisters, each with a surrounding layer of bentonite clay, are placed in perforated steel shells prior to deposition in the drifts; the assembly is called the 'supercontainer'. The other KBS-3 variant is the KBS-3V design, in which the copper canisters are emplaced vertically in individual deposition holes surrounded by bentonite clay but without steel supercontainer shells. SKB and Posiva have conducted a Research, Development and Demonstration programme over the period 2002-2007 with the overall aim of establishing whether KBS-3H represents a feasible alternative to KBS-3V. As part of this programme, the long-term safety of a KBS-3H repository has been assessed in the KBS-3H safety studies. In order to focus the safety studies, the Olkiluoto site in the municipality of Eurajoki, which is the proposed site for a spent fuel repository in Finland, was used as a hypothetical site for a KBS-3H repository. The present report is part of a portfolio of reports discussing the long-term safety of the KBS-3H repository. The overall outcome of the KBS-3H safety studies is documented in the summary report, 'Safety assessment for a KBS-3H repository for spent nuclear fuel at Olkiluoto'. The purpose and scope of the KBS-3H complementary evaluations of safety report is provided in Posiva's Safety Case Plan, which is based on Regulatory Guide YVL 8.4 and on international guidelines on complementary lines of argument to long-term safety that are considered an important element of a post-closure safety case for geological repositories. Complementary evaluations of safety require the use of evaluations, evidence and qualitative supporting arguments that lie outside the

Operational safety review programmes for nuclear power plants. Guidelines for assessment

International Nuclear Information System (INIS)

2002-01-01

The IAEA has been offering the Operational Safety Review Team (OSART) programme to provide advice and assistance to Member States in enhancing the operational safety of nuclear power plants (NPPs). Simultaneously, the IAEA has encouraged self-assessment and review by Member States of their own nuclear power plants to continuously improve nuclear safety. Currently, some utilities have been implementing safety review programmes to independently review their own plants. Corporate or national operational safety review programmes may be compliance or performance based. Successful utilities have found that both techniques are necessary to provide assurance that (i) as a minimum the NPP meets specific corporate and legal requirements and (ii) management at the NPP is encouraged to pursue continuous improvement principles. These programmes can bring nuclear safety benefits to the plants and utilities. The IAEA has conducted two pilot missions to assess the effectiveness of the operational review programme. Based on these missions and on the experience gained during OSART missions, this document has been developed to provide guidance on and broaden national/corporate safety review programmes in Member States, and to assist in maximizing their benefits. These guidelines are intended primarily for the IAEA team to conduct assessment of a national/corporate safety review programme. However, this report may also be used by a country or utility to establish its own national/corporate safety review programme. The guidelines may likewise be used for self-assessment or for establishing a baseline when benchmarking other safety review programmes. This report consists of four parts. Section 2 addresses the planning and preparation of an IAEA assessment mission and Sections 3 and 4 deal with specific guidelines for conducting the assessment mission itself

Flamanville 3 EPR, Safety Assessment and On-site Inspections

International Nuclear Information System (INIS)

Piedagnel, Corinne; Tarallo, Francois; Monnot, Bernard

2011-01-01

As a Technical Support Organisation of the French Safety Authority (ASN), the IRSN carries out the safety assessment of EPR project design and participates in the ASN inspections performed at the construction site and in factories. The design assessment consists in defining the safety functions which should be ensured by civil structures, evaluating the EPR Technical Code for Civil works (ETC-C) in which EdF has defined design criteria and construction rules, and carrying out a detailed assessment of a selection of safety-related structures. Those detailed assessments do not consist of a technical control but of an analysis whose objectives are to ensure that design and demonstrations are robust, in accordance with safety and regulatory rules. Most assessments led IRSN to ask EdF to provide additional justification sometimes involving significant modifications. In the light of those complementary justifications and modifications, IRSN concluded that assessments carried out on design studies were globally satisfactory. The participation of IRSN to the on-site inspections led by ASN is a part of the global control of the compliance of the reactor with its safety objectives. For that purpose IRSN has defined a methodology and an inspection program intended to ASN: based on safety functions associated with civil works (confinement and resistance to aggressions), the corresponding behaviour requirements are identified and linked to a list of main civil works elements. During the inspections, deviations to the project's technical specifications or to the rules of the art were pointed out by IRSN. Those deviations cover various items, such as concrete fabrication, concrete pouring methodology, lack of reinforcement in some structures, unadapted welding procedures of the containment leak-tight steel liner and unsatisfactory treatment of concreting joints. The analysis of those problems has revealed flaws in the organisation of the contractors teams together with an

Prospects for probabilistic safety assessment

International Nuclear Information System (INIS)

Hirschberg, S.

1992-01-01

This article provides some reflections on future developments of Probabilistic Safety Assessment (PSA) in view of the present state of the art and evaluates current trends in the use of PSA for safety management. The main emphasis is on Level 1 PSA, although Level 2 aspects are also highlighted to some extent. As a starting point, the role of PSA is outlined from a historical perspective, demonstrating the rapid expansion of the uses of PSA. In this context the wide spectrum of PSA applications and the associated benefits to the users are in focus. It should be kept in mind, however, that PSA, in spite of its merits, is not a self-standing safety tool. It complements deterministic analysis and thus improves understanding and facilitating prioritization of safety issues. Significant progress in handling PSA limitations - such as reliability data, common-cause failures, human interactions, external events, accident progression, containment performance, and source-term issues - is described. This forms a background for expected future developments of PSA. Among the most important issues on the agenda for the future are PSA scope extensions, methodological improvements and computer code advancements, and full exploitation of the potential benefits of applications to operational safety management. Many PSA uses, if properly exercised, lead to safety improvements as well as major burden reductions. The article provides, in addition, International Atomic Energy Agency (IAEA) perspective on the topics covered, as reflected in the current PSA programs of the agency. 74 refs., 6 figs., 1 tab

The practice of pre-marketing safety assessment in drug development.

Science.gov (United States)

Chuang-Stein, Christy; Xia, H Amy

2013-01-01

The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

Training courses on integrated safety assessment modelling for waste repositories

International Nuclear Information System (INIS)

Mallants, D.

2007-01-01

Near-surface or deep repositories of radioactive waste are being developed and evaluated all over the world. Also, existing repositories for low- and intermediate-level waste often need to be re-evaluated to extend their license or to obtain permission for final closure. The evaluation encompasses both a technical feasibility as well as a safety analysis. The long term safety is usually demonstrated by means of performance or safety assessment. For this purpose computer models are used that calculate the migration of radionuclides from the conditioned radioactive waste, through engineered barriers to the environment (groundwater, surface water, and biosphere). Integrated safety assessment modelling addresses all relevant radionuclide pathways from source to receptor (man), using in combination various computer codes in which the most relevant physical, chemical, mechanical, or even microbiological processes are mathematically described. SCK-CEN organizes training courses in Integrated safety assessment modelling that are intended for individuals who have either a controlling or supervising role within the national radwaste agencies or regulating authorities, or for technical experts that carry out the actual post-closure safety assessment for an existing or new repository. Courses are organised by the Department of Waste and Disposal

Human Reliability in Probabilistic Safety Assessments

International Nuclear Information System (INIS)

Nunez Mendez, J.

1989-01-01

Nowadays a growing interest in environmental aspects is detected in our country. It implies an assessment of the risk involved in the industrial processes and installations in order to determine if those are into the acceptable limits. In these safety assessments, among which PSA (Probabilistic Safety Assessments), can be pointed out the role played by the human being in the system is one of the more relevant subjects (This relevance has been demonstrated in the accidents happened) . However, in Spain there aren't manuals specifically dedicated to asses the human contribution to risk in the frame of PSAs. This report aims to improve this situation providing: a) a theoretical background to help the reader in the understanding of the nature of the human error, b) a quid to carry out a Human Reliability Analysis and c) a selected overview of the techniques and methodologies currently applied in this area. (Author) 20 refs

Interim process report for the safety assessment SR-Can

International Nuclear Information System (INIS)

Sellin, Patrick

2004-08-01

This report is a documentation of buffer processes identified as relevant to the long-term safety of a KBS-3 repository. The report is part of the interim reporting of the safety assessment SR-Can, see further the Interim main report. The final SR-Can reporting will support SKB's application to build an Encapsulation plant for spent nuclear fuel and is to be produced in 2006. The purpose of this report is to document the scientific knowledge of the processes to a level required for an adequate treatment in the safety assessment. The documentation is thus from a scientific point of not exhaustive since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. The purpose is further to determine the handling of each process in the safety assessment and to demonstrate how uncertainties are taken care of, given the suggested handling. The process documentation in the SR 97 version of the Process report is a starting point for this SR-Can interim version. As further described in the Interim main report, the list of relevant processes has been reviewed and slightly extended by comparison to other databases. Furthermore, the backfill has been included as a system part of its own, rather than being described together with the buffer as in SR 97. Apart from giving an interim account of the documentation and handling of buffer processes in SR-Can, this report is meant to serve as a template for the forthcoming documentation of processes occurring in other parts of the repository system. A complete list of processes can be found in the Interim FEP report for the safety assessment SR-Can. All material presented in this document is preliminary in nature and will possibly be updated as the SR-Can project progresses

Interim process report for the safety assessment SR-Can

Energy Technology Data Exchange (ETDEWEB)

Sellin, Patrick (ed.)

2004-08-01

This report is a documentation of buffer processes identified as relevant to the long-term safety of a KBS-3 repository. The report is part of the interim reporting of the safety assessment SR-Can, see further the Interim main report. The final SR-Can reporting will support SKB's application to build an Encapsulation plant for spent nuclear fuel and is to be produced in 2006. The purpose of this report is to document the scientific knowledge of the processes to a level required for an adequate treatment in the safety assessment. The documentation is thus from a scientific point of not exhaustive since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of an assessment. The purpose is further to determine the handling of each process in the safety assessment and to demonstrate how uncertainties are taken care of, given the suggested handling. The process documentation in the SR 97 version of the Process report is a starting point for this SR-Can interim version. As further described in the Interim main report, the list of relevant processes has been reviewed and slightly extended by comparison to other databases. Furthermore, the backfill has been included as a system part of its own, rather than being described together with the buffer as in SR 97. Apart from giving an interim account of the documentation and handling of buffer processes in SR-Can, this report is meant to serve as a template for the forthcoming documentation of processes occurring in other parts of the repository system. A complete list of processes can be found in the Interim FEP report for the safety assessment SR-Can. All material presented in this document is preliminary in nature and will possibly be updated as the SR-Can project progresses.

Probabilistic safety assessment goals in Canada

International Nuclear Information System (INIS)

Snell, V.G.

1986-01-01

CANDU safety philosphy, both in design and in licensing, has always had a strong bias towards quantitative probabilistically-based goals derived from comparative safety. Formal probabilistic safety assessment began in Canada as a design tool. The influence of this carried over later on into the definition of the deterministic safety guidelines used in CANDU licensing. Design goals were further developed which extended the consequence/frequency spectrum of 'acceptable' events, from the two points defined by the deterministic single/dual failure analysis, to a line passing through lower and higher frequencies. Since these were design tools, a complete risk summation was not necessary, allowing a cutoff at low event frequencies while preserving the identification of the most significant safety-related events. These goals gave a logical framework for making decisions on implementing design changes proposed as a result of the Probabilistic Safety Analysis. Performing this analysis became a regulatory requirement, and the design goals remained the framework under which this was submitted. Recently, there have been initiatives to incorporate more detailed probabilistic safety goals into the regulatory process in Canada. These range from far-reaching safety optimization across society, to initiatives aimed at the nuclear industry only. The effectiveness of the latter is minor at very low and very high event frequencies; at medium frequencies, a justification against expenditures per life saved in other industries should be part of the goal setting

Probabilistic Safety Assessment of Waste from PyroGreen Processes

International Nuclear Information System (INIS)

Ju, Hee Jae; Ham, In hye; Hwang, Il Soon

2016-01-01

The main object of PyroGreen processes is decontaminating SNFs into intermediate level waste meeting U.S. WIPP contact-handled (CH) waste characteristics to achieve long-term radiological safety of waste disposal. In this paper, radiological impact of PyroGreen waste disposal is probabilistically assessed using domestic input parameters for safety assessment of disposal. PyroGreen processes is decontamination technology using pyro-chemical process developed by Seoul National University in collaboration with KAERI, Chungnam University, Korea Hydro-Nuclear Power and Yonsei University. Advanced Korean Reference Disposal System (A-KRS) design for vitrified waste is applied to develop safety assessment model using GoldSim software. The simulation result shows that PyroGreen vitrified waste is expected to satisfy the regulatory dose limit criteria, 0.1 mSv/yr. With small probability, however, radiological impact to public can be higher than the expected value after 2E5-year. Although the result implies 100 times safety margin even in that case, further study will be needed to assess the sensitivity of other input parameters which can affect the radiological impact for long-term.

Probabilistic Safety Assessment of Waste from PyroGreen Processes

Energy Technology Data Exchange (ETDEWEB)

Ju, Hee Jae; Ham, In hye; Hwang, Il Soon [Seoul National University, Seoul (Korea, Republic of)

2016-05-15

The main object of PyroGreen processes is decontaminating SNFs into intermediate level waste meeting U.S. WIPP contact-handled (CH) waste characteristics to achieve long-term radiological safety of waste disposal. In this paper, radiological impact of PyroGreen waste disposal is probabilistically assessed using domestic input parameters for safety assessment of disposal. PyroGreen processes is decontamination technology using pyro-chemical process developed by Seoul National University in collaboration with KAERI, Chungnam University, Korea Hydro-Nuclear Power and Yonsei University. Advanced Korean Reference Disposal System (A-KRS) design for vitrified waste is applied to develop safety assessment model using GoldSim software. The simulation result shows that PyroGreen vitrified waste is expected to satisfy the regulatory dose limit criteria, 0.1 mSv/yr. With small probability, however, radiological impact to public can be higher than the expected value after 2E5-year. Although the result implies 100 times safety margin even in that case, further study will be needed to assess the sensitivity of other input parameters which can affect the radiological impact for long-term.

Electronuclear's safety culture assessment and enhancement program

International Nuclear Information System (INIS)

Selvatici, E.; Diaz-Francisco, J.M.; Diniz de Souza, V.

2002-01-01

The present paper describes the Eletronuclear's safety culture assessment and enhancement program. The program was launched by the company's top management one year after the creation of Eletronuclear in 1997, from the merging of two companies with different organizational cultures, the design and engineering company Nuclen and the nuclear directorate of the Utility Furnas, Operator of the Angra1 NPP. The program consisted of an assessment performed internally in 1999 with the support and advice of the IAEA. This assessment, performed with the help of a survey, pooled about 80% of the company's employees. The overall result of the assessment was that a satisfactory level of safety culture existed; however, a number of points with a considerable margin for improvement were also identified. These points were mostly related with behavioural matters such as motivation, stress in the workplace, view of mistakes, handling of conflicts, and last but not least a view by a considerable number of employees that a conflict between safety and production might exist. An Action Plan was established by the company managers to tackle these weak points. This Plan was issued as company guideline by the company's Directorate. The subsequent step was to detail and implement the different actions of the Plan, which is the phase that we are at present. In the detailing of the Action Plan, special care was taken to sum up efforts, avoiding duplication of work or competition with already existing programs. In this process it was identified that the company had a considerable number of initiatives directly related to organizational and safety culture improvement, already operational. These initiatives have been integrated in the detailed Action Plan. A new assessment, for checking the effectiveness of the undertaken actions, is planned for 2003. (author)

Efficacy of Neurofeedback Versus Pharmacological Support in Subjects with ADHD.

Science.gov (United States)

González-Castro, Paloma; Cueli, Marisol; Rodríguez, Celestino; García, Trinidad; Álvarez, Luis

2016-03-01

Behavioral training in neurofeedback has proven to be an essential complement to generalize the effects of pharmacological support in subjects who have attention deficit with hyperactivity disorder (ADHD). Therefore, this investigation attempts to analyze the efficacy of neurofeedback compared with pharmacological support and the combination of both. Participants were 131 students, classified into four groups: control (did not receive neurofeedback or pharmacological support), neurofeedback group, pharmacological support group, and combined group (neurofeedback + pharmacological support). Participants' executive control and cortical activation were assessed before and after treatment. Results indicate that the combined group obtained more benefits and that the neurofeedback group improved to a greater extent in executive control than the pharmacological support group. It is concluded that this kind of training may be an alternative to stimulate activation in subjects with ADHD.

In Silico Systems Pharmacology to Assess Drug's Therapeutic and Toxic Effects

DEFF Research Database (Denmark)

Orozco, Alejandro Aguayo; Audouze, Karine; Brunak, Soren

2016-01-01

For many years, the "one target, one drug" paradigm has been the driving force behind developments in pharmaceutical research. With the recent advances in molecular biology and genomics technologies, the focus is shifting toward "drug-holistic" systems based approaches (i.e. systems pharmacology......). The integration of large and diverse amount of data from chemistry and biology coupled with the development and the application of network-based approaches to cope with these data is the next paradigm of drug discovery. Systems pharmacology offers a novel way of approaching drug discovery by developing models...

Development of a quality assurance safety assessment database for near surface radioactive waste disposal

International Nuclear Information System (INIS)

Park, J. W.; Kim, C. L.; Park, J. B.; Lee, E. Y.; Lee, Y. M.; Kang, C. H.; Zhou, W.; Kozak, M. W.

2003-01-01

A quality assurance safety assessment database, called QUARK (QUality Assurance program for Radioactive waste management in Korea), has been developed to manage both analysis information and parameter database for safety assessment of Low- and Intermediate-Level radioactive Waste (LILW) disposal facility in Korea. QUARK is such a tool that serves QA purposes for managing safety assessment information properly and securely. In QUARK, the information is organized and linked to maximize the integrity of information and traceability. QUARK provides guidance to conduct safety assessment analysis, from scenario generation to result analysis, and provides a window to inspect and trace previous safety assessment analysis and parameter values. QUARK also provides default database for safety assessment staff who construct input data files using SAGE(Safety Assessment Groundwater Evaluation), a safety assessment computer code

Safety assessments for deep geological disposal of radioactive wastes

International Nuclear Information System (INIS)

Lyon, R.B.

1984-01-01

The objective of safety assessment for deep geological disposal of radioactive wastes is to evaluate how well the engineered barriers and geological setting inhibit radionuclide migration and prevent radiation dose to man. Safety assessment is influenced through interaction with the regulatory agencies, research groups, the public and the various levels of government. Under the auspices of the IAEA, a generic disposal system description has been developed to facilitate international exchange and comparison of data and results, and to enable development and comparison of performance for all components of the disposal system. It is generally accepted that a systems modelling approach is required and that safety assessment can be considered on two levels. At the systems level, all components of the system are taken into account to evaluate the risk to man. At the systems level, critical review and quality assurance on software provide the major validation techniques. Risk is a combination of dose estimate and probability of that dose. For analysis of the total system to be practical, the components are usually represented by simplified models. Recently, assessments have been taking uncertainties in the input data into account. At the detailed level, large-scale, complex computer programs model components of the system in sufficient detail that validation by comparison with field and laboratory measurements is possible. For example, three-dimensional fluid-flow, heat-transport and solute-transport computer programs have been used. Approaches to safety assessment are described, with illustrations from safety assessments performed in a number of countries. (author)

New safety performance indicators for safety assessment of radioactive waste disposal facilities. Cuban experience

International Nuclear Information System (INIS)

Peralta Vital, J.L.; Castillo, R.G.; Olivera, J.

2002-01-01

The paper shows the Cuban experience on implementing geological disposal of radioactive waste and the necessity for identifying new safety performance indicators for the safety assessment (SA) of radioactive waste disposal facilities. The selected indicator was the concentration of natural radioactive elements (U, Ra, Th, K) in the Cuban geologic environment. We have carried out a group of investigations, which have allowed characterising the concentration for the whole Country, creating a wide database where this indicator is associated with the lithology. The main lithologies in Cuba are: the sedimentary rocks (70 percent of national occurrence), which are present in the three regions (limestone and lutite), and finally the igneous and metamorphic rocks. The results show the concentrations ranges of the natural radionuclides associated fundamentally to the variation in the lithology and geographical area of the Country. In Cuba, the higher concentration (ppm) of Uranium and Radium are referenced to the Central region associated to Skarn, while for Thorium (ppm) and Potassium (%), in the East region the concentration peaks in Tuffs have been found. The concentrations ranges obtained are preliminary, they characterise the behaviour of this parameter for the Cuban geology, but they do not represent limits for safety assessment purposes yet. Also other factors should be taken into account as the assessment context, time scales and others assumptions before establishing the final concentration limits for the natural radionuclides as a radiological and nuclear safety performance indicator complementary to dose and risk for safety assessment for radiological and nuclear facilities. (author)

EFFICIENT QUANTITATIVE RISK ASSESSMENT OF JUMP PROCESSES: IMPLICATIONS FOR FOOD SAFETY

OpenAIRE

Nganje, William E.

1999-01-01

This paper develops a dynamic framework for efficient quantitative risk assessment from the simplest general risk, combining three parameters (contamination, exposure, and dose response) in a Kataoka safety-first model and a Poisson probability representing the uncertainty effect or jump processes associated with food safety. Analysis indicates that incorporating jump processes in food safety risk assessment provides more efficient cost/risk tradeoffs. Nevertheless, increased margin of safety...

Safety re-assessment of AECL test and research reactors

International Nuclear Information System (INIS)

Winfield, D.J.

1990-01-01

Atomic Energy of Canada Limited currently has four operating engineering test/research reactors of various sizes and ages; a new isotope-production reactor Maple-X10, under construction at Chalk River Nuclear Laboratories (CRNL), and a heating demonstration reactor, SDR, undergoing high-power commissioning at Whiteshell Nuclear Research Establishment (WNRE). The company is also performing design studies of small reactors for hot water and electricity production. The older reactors are ZED-2, PTR, NRX, and NRU; these range in age from 42 years (NRX) to 29 years (ZED-2). Since 1984, limited-scope safety re-assessments have been underway on three of these reactors (ZED-2, NRX AND NRU). ZED-2 and PTR are operated by the Reactor Physics Branch; all other reactors are operated by the respective site Reactor Operations Branches. For the older reactors the original safety reports produced were entirely deterministic in nature and based on the design-basis accident concept. The limited scope safety re-assessments for these older reactors, carried out over the past 5 years, have comprised both quantitative probabilistic safety-assessment techniques, such as event tree and fault analysis, and/or qualitative techniques, such as failure mode and effect analysis. The technique used for an individual assessment was dependent upon the specific scope required. This paper discusses the types of analyses carried out, specific insights/recommendations resulting from the analysis, and the plan for future analysis. In addition, during the last four years safety assessments have been carried out on the new isotope-, heat-, and electricity-producing reactors, as part of the safety design review, commissioning and licensing activities

Value-impact assessment of safety-related modifications

International Nuclear Information System (INIS)

Knowles, W.M.C.; Dinnie, K.S.; Gordon, C.W.

1992-01-01

Like other nuclear utilities, Ontario Hydro, as part of its risk management activities, continually assesses the safety of its nuclear operations. In addition, new regulatory requirements are being applied to the older nuclear power plants. Both of these result in proposed plant modifications designed to reduce the risk to the public. However, modifications to an operating plant can have serious economic effects, and the resources, both financial and personnel, required for the implementation of these modifications are limited. Thus, all potential benefits and effects of a proposed modification must be thoroughly investigated to judge whether the modification is beneficial. Ontario Hydro has begun to use comprehensive value-impact assessments, utilizing plant-specific probabilistic risk assessments (PRAs), as tools to provide an informed basis for judgments on the benefit of safety-related modifications. The results from value-impact assessments can also be used to prioritize the implementation of these modifications

Use of the Home Safety Self-Assessment Tool (HSSAT) within Community Health Education to Improve Home Safety.

Science.gov (United States)

Horowitz, Beverly P; Almonte, Tiffany; Vasil, Andrea

2016-10-01

This exploratory research examined the benefits of a health education program utilizing the Home Safety Self-Assessment Tool (HSSAT) to increase perceived knowledge of home safety, recognition of unsafe activities, ability to safely perform activities, and develop home safety plans of 47 older adults. Focus groups in two senior centers explored social workers' perspectives on use of the HSSAT in community practice. Results for the health education program found significant differences between reported knowledge of home safety (p = .02), ability to recognize unsafe activities (p = .01), safely perform activities (p = .04), and develop a safety plan (p = .002). Social workers identified home safety as a major concern and the HSSAT a promising assessment tool. Research has implications for reducing environmental fall risks.

Formal safety assessment based on relative risks model in ship navigation

Energy Technology Data Exchange (ETDEWEB)

Hu Shenping [Merchant Marine College, Shanghai Maritime University, 1550, Pudong Dadao, Shanghai 200135 (China)]. E-mail: sphu@mmc.shmtu.edu.cn; Fang Quangen [Merchant Marine College, Shanghai Maritime University, 1550, Pudong Dadao, Shanghai 200135 (China)]. E-mail: qgfang@mmc.shmtu.edu.cn; Xia Haibo [Merchant Marine College, Shanghai Maritime University, 1550, Pudong Dadao, Shanghai 200135 (China)]. E-mail: hbxia@mmc.shmtu.edu.cn; Xi Yongtao [Merchant Marine College, Shanghai Maritime University, 1550, Pudong Dadao, Shanghai 200135 (China)]. E-mail: xiyt@mmc.shmtu.edu.cn

2007-03-15

Formal safety assessment (FSA) is a structured and systematic methodology aiming at enhancing maritime safety. It has been gradually and broadly used in the shipping industry nowadays around the world. On the basis of analysis and conclusion of FSA approach, this paper discusses quantitative risk assessment and generic risk model in FSA, especially frequency and severity criteria in ship navigation. Then it puts forward a new model based on relative risk assessment (MRRA). The model presents a risk-assessment approach based on fuzzy functions and takes five factors into account, including detailed information about accident characteristics. It has already been used for the assessment of pilotage safety in Shanghai harbor, China. Consequently, it can be proved that MRRA is a useful method to solve the problems in the risk assessment of ship navigation safety in practice.

Formal safety assessment based on relative risks model in ship navigation

International Nuclear Information System (INIS)

Hu Shenping; Fang Quangen; Xia Haibo; Xi Yongtao

2007-01-01

Formal safety assessment (FSA) is a structured and systematic methodology aiming at enhancing maritime safety. It has been gradually and broadly used in the shipping industry nowadays around the world. On the basis of analysis and conclusion of FSA approach, this paper discusses quantitative risk assessment and generic risk model in FSA, especially frequency and severity criteria in ship navigation. Then it puts forward a new model based on relative risk assessment (MRRA). The model presents a risk-assessment approach based on fuzzy functions and takes five factors into account, including detailed information about accident characteristics. It has already been used for the assessment of pilotage safety in Shanghai harbor, China. Consequently, it can be proved that MRRA is a useful method to solve the problems in the risk assessment of ship navigation safety in practice

Integrated safety assessment report: Integrated Safety Assessment Program: Millstone Nuclear Power Station, Unit 1 (Docket No. 50-245): Draft report

International Nuclear Information System (INIS)

1987-04-01

The Integrated Safety Assessment Program (ISAP) was initiated in November 1984, by the US Nuclear Regulatory Commission to conduct integrated assessments for operating nuclear power reactors. The integrated assessment is conducted in a plant-specific basis to evaluate all licensing actions, licensee initiated plant improvements and selected unresolved generic/safety issues to establish implementation schedules for each item. In addition, procedures will be established to allow for a periodic updating of the schedules to account for licensing issues that arise in the future. This report documents the review of Millstone Nuclear Power Station, Unit No. 1, operated by Northeast Nuclear Energy Company (located in Waterford, Connecticut). Millstone Nuclear Power Station, Unit No. 1, is one of two plants being reviewed under the pilot program for ISAP. This report indicates how 85 topics selected for review were addressed. This report presents the staff's recommendations regarding the corrective actions to resolve the 85 topics and other actions to enhance plant safety. The report is being issued in draft form to obtain comments from the licensee, nuclear safety experts, and the Advisory Committee for Reactor Safeguards (ACRS). Once those comments have been resolved, the staff will present its positions, along with a long-term implementation schedule from the licensee, in the final version of this report

Assessing progress in the development of safety culture

International Nuclear Information System (INIS)

Rotaru, Ioan; Ghita, Sorin

1999-01-01

The concept of safety culture was introduced by the International Nuclear Safety Advisory Group (INSAG) in the Summary Report on the Post-Accident Meeting on the Chernobyl Accident in 1986. The concept was further expanded in the 1988 INSAG-3 report, Basic Safety Principles for Nuclear Power Plants, and again in 1991 in the INSAG-4 report. Recognizing the increasing role that safety culture is expected to play in nuclear installations worldwide, the Convention on Nuclear Safety states the Contracting Parties' desire 'to promote an effective nuclear safety culture'. The concept of safety culture is defined in INSAG-4 as follows: Safety culture is that assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, nuclear plant safety issues receive the attention warranted by their significance. Safety culture is also an amalgamation of values, standards, morals and norms of acceptable behaviour. These are aimed at maintaining a self disciplined approach to the enhancement of safety beyond legislative and regulatory requirements. Therefore, the safety culture has to be inherent in the thoughts and actions of all the individuals at every level in an organization. The leadership provided by top management is crucial. Safety culture applies to conventional and personal safety as well as nuclear safety. All safety consideration are affected by common points of beliefs, attitudes, behaviour, and cultural differences, closely linked to a shared system of values and standards. The paper poses questions and tries to find answers relative to issues like: - how to assess progress; - specific organizational indicators of a progressive safety culture; - detection of incipient weaknesses in safety culture (organizational issues, employee issues, technology issues); - revitalizing a weakened safety culture; - overall assesment of safety culture; - general evaluation model. In conclusion, there is no consistent and

Traditional uses, phytochemistry, pharmacology and toxicology of Codonopsis: A review.

Science.gov (United States)

Gao, Shi-Man; Liu, Jiu-Shi; Wang, Min; Cao, Ting-Ting; Qi, Yao-Dong; Zhang, Ben-Gang; Sun, Xiao-Bo; Liu, Hai-Tao; Xiao, Pei-Gen

2018-06-12

Species of the genus Codonopsis are perennial herbs mainly distributed throughout East, Southeast and Central Asia. As recorded, they have been used as traditional Chinese medicines since the Qing Dynasty, where they were claimed for strengthening the spleen and tonifying the lung, as well as nourishing blood and engendering liquid. Some species are also used as food materials in southern China and Southeast Asia, such as tea, wine, soup, plaster, and porridge. The review aims to assess the ethnopharmacological uses, explicit the material basis and pharmacological action, promote the safety of medical use, and suggest the future research potentials of Codonopsis. Information on the studies of Codonopsis was collected from scientific journals, books, and reports via library and electronic data search (PubMed, Elsevier, Scopus, Google Scholar, Springer, Science Direct, Wiley, Researchgate, ACS, EMBASE, Web of Science and CNKI). Meanwhile, it was also obtained from published works of material medica, folk records, ethnopharmacological literatures, Ph.D. and Masters Dissertation. Plant taxonomy was confirmed to the database "The Plant List" (www.theplantlist.org). Codonopsis has been used for medicinal purposes all around the world. Some species are also used as food materials in southern China and Southeast Asia. The chemical constituents of Codonopsis mainly are polyacetylenes, polyenes, flavonoids, lignans, alkaloids, coumarins, terpenoids, steroids, organic acids, saccharides, and so on. Extract of Codonopsis exhibit extensive pharmacological activities, including immune function regulation, hematopoiesis improvement, cardiovascular protection, neuroprotection, gastrointestinal function regulation, endocrine function regulation, cytotoxic and antibacterial effects, anti-aging and anti-oxidation, etc. Almost no obvious toxicity or side effect are observed and recorded for Codonopsis. The traditional uses, phytochemistry, pharmacology and toxicology of Codonopsis are

Safety assessment for a KBS-3H spent nuclear fuel repository at Olkiluoto. Complementary evaluations of safety

Energy Technology Data Exchange (ETDEWEB)

Neall, Fiona; Pastina, Barbara; Snellman, Margit; Smith, Paul; Gribi, P.; Johnson, Lawrence

2008-12-15

The KBS-3H design is a variant of the more general KBS-3 method for the geological disposal of spent nuclear fuel in Finland and Sweden. In the KBS-3H design, multiple assemblies containing spent fuel are emplaced horizontally in parallel, approximately 300 m long, slightly inclined deposition drifts. The copper canisters, each with a surrounding layer of bentonite clay, are placed in perforated steel shells prior to deposition in the drifts; the assembly is called the 'supercontainer'. The other KBS-3 variant is the KBS-3V design, in which the copper canisters are emplaced vertically in individual deposition holes surrounded by bentonite clay but without steel supercontainer shells. SKB and Posiva have conducted a Research, Development and Demonstration programme over the period 2002-2007 with the overall aim of establishing whether KBS-3H represents a feasible alternative to KBS-3V. As part of this programme, the long-term safety of a KBS-3H repository has been assessed in the KBS-3H safety studies. In order to focus the safety studies, the Olkiluoto site in the municipality of Eurajoki, which is the proposed site for a spent fuel repository in Finland, was used as a hypothetical site for a KBS-3H repository. The present report is part of a portfolio of reports discussing the long-term safety of the KBS-3H repository. The overall outcome of the KBS-3H safety studies is documented in the summary report, 'Safety assessment for a KBS-3H repository for spent nuclear fuel at Olkiluoto'. The purpose and scope of the KBS-3H complementary evaluations of safety report is provided in Posiva's Safety Case Plan, which is based on Regulatory Guide YVL 8.4 and on international guidelines on complementary lines of argument to long-term safety that are considered an important element of a post-closure safety case for geological repositories. Complementary evaluations of safety require the use of evaluations, evidence and qualitative supporting arguments

Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities

International Nuclear Information System (INIS)

Batandjieva, B.; Torres-Vidal, C.

2002-01-01

The International Atomic Energy Agency (IAEA) Coordinated research program ''Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities'' (ISAM) has developed improved safety assessment methodology for near surface disposal facilities. The program has been underway for three years and has included around 75 active participants from 40 countries. It has also provided examples for application to three safety cases--vault, Radon type and borehole radioactive waste disposal facilities. The program has served as an excellent forum for exchange of information and good practices on safety assessment approaches and methodologies used worldwide. It also provided an opportunity for reaching broad consensus on the safety assessment methodologies to be applied to near surface low and intermediate level waste repositories. The methodology has found widespread acceptance and the need for its application on real waste disposal facilities has been clearly identified. The ISAM was finalized by the end of 2000, working material documents are available and an IAEA report will be published in 2002 summarizing the work performed during the three years of the program. The outcome of the ISAM program provides a sound basis for moving forward to a new IAEA program, which will focus on practical application of the safety assessment methodologies to different purposes, such as licensing radioactive waste repositories, development of design concepts, upgrading existing facilities, reassessment of operating repositories, etc. The new program will also provide an opportunity for development of guidance on application of the methodology that will be of assistance to both safety assessors and regulators

Pharmacological Aspects of Neuro-Immune Interactions.

Science.gov (United States)

Tarasov, Vadim V; Kudryashov, Nikita V; Chubarev, Vladimir N; Kalinina, Tatiana S; Barreto, George E; Ashraf, Ghulam Md; Aliev, Gjumrakch

2018-01-01

The use of systematic approach for the analysis of mechanism of action of drugs at different levels of biological organization of organisms is an important task in experimental and clinical pharmacology for drug designing and increasing the efficacy and safety of drugs. The analysis of published data on pharmacological effects of psychotropic drugs possessing immunomodulatory and/or antiviral properties have shown a correlation between central effects of examined drugs associated with the impact on the processes of neurogenesis of adult brain and survival of neurons, and their ability to alter levels of key proinflammatory cytokines. The changes that occur as a result of the influence of pharmacological agents at one of the systems should inevitably lead to the functional reorganization at another. Integrative mechanisms underlying the neuro-immune interactions may explain the "pleiotropic" pharmacological effects of some antiviral and immunomodulatory drugs. Amantadine, which was originally considered as an antiviral agent, was approved as anti-parkinsonic drug after its wide medical use. The prolonged administration of interferon alpha caused depression in 30-45% of patients, thus limiting its clinical use. The antiviral drug "Oseltamivir" may provoke the development of central side effects, including abnormal behavior, delirium, impaired perception and suicides. Anti-herpethetical drug "Panavir" shows pronounced neuroprotective properties. The purpose of this review is to analyze the experimental and clinical data related to central effects of drugs with antiviral or/and immunotropic activity, and to discover the relationship of these effects with changes in reactivity of immune system and proinflammatory response. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Exploring new pharmacology and toxicological screening and safety evaluation of one widely used formulation of Nidrakar Bati from South Asia region.

Science.gov (United States)

Zaman, Afria; Khan, Md Shamsuddin Sultan; Akter, Lucky; Syeed, Sharif Hossain; Akter, Jakia; Al Mamun, Abdullah; Alam, Md Ershad; Habib, Md Ahsan; Jalil, Md Abdul

2015-04-16

Nidrakar Bati (NKB) is an herbal remedy consisted with seven medicinal herbs widely used to cure Somnifacient (sleeping aid) in South Asia as Ayurvedic medicinal system. In the present study, pharmacological and toxicological effects of this medicine was investigated in mice to validate the safety and efficacy of the herb. Organic solvent extracts NKB were prepared using maceration method. Effect of extracts on the central nervous system was evaluated using hypnotic activity assay. Effect of the extracts on metabolic activity, assessing involvement of thyroid was conducted using hypoxia test. analgesic and anti-inflammatory activities were assessed in mice using acetic acid induced writhing, formalin induced paw edema, xylene induced ear edema assays. Anxiolytic activity was performed using plus maze, climbing out and forced swimming tests. Effect of the extracts on psychopharmacological effect was carried out using locomotor activity tests (open field, Hole-board and Hole-cross tests). Neuropharmacological effect of the extracts was performed using motor coordination (rotarod test). Toxicological potential of the extract was evaluated using gastro-intestinal activity (gastric emptying and gastrointestinal motility tests). The studied formulation reduced the CNS stimulant effects dose independently. In the hypoxia test, only a dose of 100 mg/kg of NKB decreased the survival time. Orally administration of the NKB (200 and 400 mg/kg) produced significant inhibition (P acetic acid-induced writhing in mice and suppressed xylene induced ear edema and formalin-induced licking response of animals in both phases of the test. NKB showed locomotor activity (p < 0.05) both in higher and lower doses (100 and 400 mg/kg). NKB increased the total ambulation dose dependently (p < 0.05). NKB, at all tested doses (100, 200 and 400 mg/kg) increased some locomotion activity parameters (ambulation, head dipping and emotional defecation) in hole board test. At higher doses (200 and 400

[Agricultural biotechnology safety assessment].

Science.gov (United States)

McClain, Scott; Jones, Wendelyn; He, Xiaoyun; Ladics, Gregory; Bartholomaeus, Andrew; Raybould, Alan; Lutter, Petra; Xu, Haibin; Wang, Xue

2015-01-01

Genetically modified (GM) crops were first introduced to farmers in 1995 with the intent to provide better crop yield and meet the increasing demand for food and feed. GM crops have evolved to include a thorough safety evaluation for their use in human food and animal feed. Safety considerations begin at the level of DNA whereby the inserted GM DNA is evaluated for its content, position and stability once placed into the crop genome. The safety of the proteins coded by the inserted DNA and potential effects on the crop are considered, and the purpose is to ensure that the transgenic novel proteins are safe from a toxicity, allergy, and environmental perspective. In addition, the grain that provides the processed food or animal feed is also tested to evaluate its nutritional content and identify unintended effects to the plant composition when warranted. To provide a platform for the safety assessment, the GM crop is compared to non-GM comparators in what is typically referred to as composition equivalence testing. New technologies, such as mass spectrometry and well-designed antibody-based methods, allow better analytical measurements of crop composition, including endogenous allergens. Many of the analytical methods and their intended uses are based on regulatory guidance documents, some of which are outlined in globally recognized documents such as Codex Alimentarius. In certain cases, animal models are recommended by some regulatory agencies in specific countries, but there is typically no hypothesis or justification of their use in testing the safety of GM crops. The quality and standardization of testing methods can be supported, in some cases, by employing good laboratory practices (GLP) and is recognized in China as important to ensure quality data. Although the number of recommended, in some cases, required methods for safety testing are increasing in some regulatory agencies, it should be noted that GM crops registered to date have been shown to be

Assessing propensity to learn from safety-related events

NARCIS (Netherlands)

Drupsteen, L.; Wybo, J.L.

2015-01-01

Most organisations aim to use experience from the past to improve safety, for instance through learning from safety-related incidents and accidents. Whether an organisation is able to learn successfully can however only be determined afterwards. So far, there are no proactive measures to assess

Healthcare professionals’ views of feedback on patient safety culture assessment.

NARCIS (Netherlands)

Zwijnenberg, N.C.; Hendriks, M.; Hoogervorst-Schilp, J.; Wagner, C.

2016-01-01

Background: By assessing patient safety culture, healthcare providers can identify areas for improvement in patient safety culture. To achieve this, these assessment outcomes have to be relevant and presented clearly. The aim of our study was to explore healthcare professionals’ views on the

Application of the Integrated Safety Assessment methodology to safety margins. Dynamic Event Trees, Damage Domains and Risk Assessment

International Nuclear Information System (INIS)

Ibánez, L.; Hortal, J.; Queral, C.; Gómez-Magán, J.; Sánchez-Perea, M.; Fernández, I.; Meléndez, E.; Expósito, A.; Izquierdo, J.M.; Gil, J.; Marrao, H.; Villalba-Jabonero, E.

2016-01-01

The Integrated Safety Assessment (ISA) methodology, developed by the Consejo de Seguridad Nuclear, has been applied to an analysis of Zion NPP for sequences with Loss of the Component Cooling Water System (CCWS). The ISA methodology proposal starts from the unfolding of the Dynamic Event Tree (DET). Results from this first step allow assessing the sequence delineation of standard Probabilistic Safety Analysis results. For some sequences of interest of the outlined DET, ISA then identifies the Damage Domain (DD). This is the region of uncertain times and/or parameters where a safety limit is exceeded, which indicates the occurrence of certain damage situation. This paper illustrates application of this concept obtained simulating sequences with MAAP and with TRACE. From information of simulation results of sequence transients belonging to the DD and the time-density probability distributions of the manual actions and of occurrence of stochastic phenomena, ISA integrates the dynamic reliability equations proposed to obtain the sequence contribution to the global Damage Exceedance Frequency (DEF). Reported results show a slight increase in the DEF for sequences investigated following a power uprate from 100% to 110%. This demonstrates the potential use of the method to help in the assessment of design modifications. - Highlights: • This paper illustrates an application of the ISA methodology to safety margins. • Dynamic Event Trees are useful tool for verifying the standard PSA Event Trees. • The ISA methodology takes into account the uncertainties in human action times. • The ISA methodology shows the Damage Exceedance Frequency increase in power uprates.

Guidance on the safety assessment methodology for storage of radioactive waste

International Nuclear Information System (INIS)

Kinyanjui, M.N.

2014-04-01

This project on safety assessment on storage was carried out with the main objective of ensuring safety of human life and our environment. This is the fundamental principle of radiation protection. Safety assessment has been evaluated as a tool in the safety case in the pre-construction, operational and the post closure phase of storage. In particular the iterative process of evaluating and predicting safety scenarios at each stage of the process has proved to be prudent. It is important that this concept be adopted for this type of facility to ensure safety of mankind and the environment now and in the future.

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

Science.gov (United States)

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-12-15

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design.

MAPLE-X10 reactor safety assessment

International Nuclear Information System (INIS)

Cotnam, K.D.; Lounsbury, R.I.; Gillespie, G.E.

1990-01-01

This paper reports on the safety assessment of the 10 MW MAPLE-X10 reactor which has involved a substantial component of PSA analysis to supplement deterministic analysis. Initiating events are identified through the use of a master logic diagram. The events are then examined through event sequence diagrams, at the concept design stage, followed by a set of reliability analyses that are coordinated with the event sequence diagrams. Improvements identified through the reliability analyses are incorporated into the design to ensure that safety objectives are attained

Medicinal Uses, Phytochemistry, and Pharmacology of Origanum onites (L.): A Review.

Science.gov (United States)

Tepe, Bektas; Cakir, Ahmet; Sihoglu Tepe, Arzuhan

2016-05-01

Origanum onites L., known as Turkish oregano, has great traditional, medicinal, preservative, and commercial importance. It is used for the treatment of several kinds of ailments, such as gastrointestinal disorders, diabetes, high cholesterol, leukemia, bronchitis, etc. In this review, traditional use, phytochemistry, and pharmacology of O. onites reported between 1988 and 2014 were discussed. This review was prepared based on literature survey on scientific journals and books from libraries and electronic sources, such as Web of Science, PubMed, Scopus, Google Scholar, etc. All databases were searched up to June 2014. Several different classes of terpenoids, triterpene acids, phenolic acids, hydroquinones, flavonoids, hydrocarbons, sterols, pigments, fatty acids, tocopherols, and inorganic compounds were detected mainly in the aerial parts of this plant. Pharmacological studies revealed that extracts obtained from several solvents and individual compounds exhibited antimicrobial, antiviral, antioxidant, insecticidal, anticancer, hepatoprotective, genotoxic, antidiabetic, cholinesterase inhibitory, anti-inflammatory, analgesic activities, etc. O. onites, in general, exhibited remarkable activity potential in almost all test systems. The results of toxicity studies indicated that O. onites did not show any significant toxicity and mutagenicity on Drosophila and Salmonella. Toxicity of the extracts/essential oils and also individual compounds should be evaluated on mammalian cells to ensure their safety. The bioactivity of individual compounds aside from terpenoids should also be assessed in detail. Additionally, mode of action for the bioactive compounds should be evaluated to understand the complex pharmacological effects of these phytochemicals. © 2016 Verlag Helvetica Chimica Acta AG, Zürich.

Alternative pharmacological treatment options for agitation in Alzheimer’s disease

Directory of Open Access Journals (Sweden)

Francesco Panza

2015-11-01

Full Text Available In patients with dementia and Alzheimer’s disease (AD, treatment of neuropsychiatric symptoms (NPS is a major concern in the management of these devastating diseases. Among NPS in AD, agitation and aggression are common with earlier institutionalization, increased morbidity and mortality, and greater caregiver burden. Pharmacological treatments for AD-related agitation, specifically off-label use of atypical antipsychotics, showed only modest improvements, with increased side-effect burden and risk of mortality. Non-pharmacological treatment approaches have become the preferred firstline option. However, when such treatments fail, pharmacological options are often used. Therefore, there is an urgent need to identify effective and safe pharmacological treatments for agitation/aggression in AD and dementia. Unfortunately, progresses have been slow, with a small number of methodologically heterogeneous randomized controlled trials (RCTs, with disappointing results. However, evidence coming from recently completed RCTs on novel or repositioned drugs (mibampator, dextromethorphan/ quinidine, cannabinoids, and citalopram showed some promise in treating agitation in AD, but still with safety concerns. Further evidence will come from ongoing Phase II and III trials on promising novel drugs for treating these distressing symptoms in patients with AD and dementia.

Intrusion resistant underground structure (IRUS) - safety assessment and licensing

International Nuclear Information System (INIS)

Lange, B. A.

1997-01-01

This paper describes the safety goals, human exposure scenarios and critical groups, the syvac-nsure performance assessment code, groundwater pathway safety results, and inadvertent human intrusion of the IRUS. 2 tabs

Subchronic and Genetic Safety Assessment of a New Medicinal Dendrobium Species: Dendrobium Taiseed Tosnobile in Rats

Directory of Open Access Journals (Sweden)

Li-Chan Yang

2018-01-01

Full Text Available Dendrobium Taiseed Tosnobile is a new species of herba dendrobii (Shi-Hu that was developed by crossbreeding D. tosaense and D. nobile. Its pharmacological activity and active component have been reported, but its subchronic toxicity and genetic safety have not yet been investigated. This study assessed the 90-day oral toxicity and genetic safety of the aqueous extracts of D. Taiseed Tosnobile (DTTE in male and female Sprague-Dawley (SD rats. Eighty rats were divided into four groups, each consisting of ten male and ten female rats. DTTE was given orally to rats at 800, 1600, or 2400 mg/kg for 90 consecutive days, and distilled water was used for the control group. Genotoxicity studies were performed using a bacterial reverse mutation assay and in vivo mammalian cell micronucleus test in ICR mice and analyzed using flow cytometry. Throughout the study period, no abnormal changes were observed in clinical signs and body weight or on ophthalmological examinations. Additionally, no significant differences were found in urinalysis, hematology, and serum biochemistry parameters between the treatment and control groups. Necropsy and histopathological examination indicated no treatment-related changes. Based on results, the no-observed-adverse-effect level of DTTE is greater than 2400 mg/kg in SD rats.

Safety assessment of complex engineered and natural systems: radioactive waste disposal

International Nuclear Information System (INIS)

McNeish, J.A.; Vallikat, V.; Atkins, J.; Balady, M.A.

1997-01-01

Evaluation of deep, geologic disposal of nuclear waste requires the probabilistic safety assessment of a complex system from the coupling of various processes and sub-systems, parameter and model uncertainties, spatial and temporal variabilities, and the multiplicity of designs and scenarios. Both the engineered and natural system are included in the evaluation. Each system has aspects with considerable uncertainty both in important parameters and in overall conceptual models. The study represented herein provides a probabilistic safety assessment of a potential respository system for multiple engineered barrier system (EBS) design and conceptual model configurations (CRWMS M and O, 1996a) and considers the effects of uncertainty on the overall results. The assessment is based on data and process models available at the time of the study and doesnt necessarily represent the current safety evaluation. In fact, the percolation flux through the repository system is now expected to be higher than the estimate used for this study. The potential effects of higher percolation fluxes are currently under study. The safety of the system was assessed for both 10,000 and 1,000,000 years. Use of alternative conceptual models also produced major improvement in safety. For example, use of a more realistic engineered system release model produced improvement of over an order of magnitude in safety. Alternative measurement locations for the safety assessment produced substantial increases in safety, through the results are based on uncertain dilution factors in the transporting groundwater. (Author)

Safety Culture Perceptions in a Collegiate Aviation Program: A Systematic Assessment

OpenAIRE

Adjekum, Daniel Kwasi

2014-01-01

An assessment of the perceptions of respondents on the safety culture at an accredited Part 141 four year collegiate aviation program was conducted as part of the implementation of a safety management system (SMS). The Collegiate Aviation Program Safety Culture Assessment Survey (CAPSCAS), which was modified and revalidated from the existing Commercial Aviation Safety Survey (CASS), was used. Participants were drawn from flight students and certified flight instructors in the program. The sur...

Role and meaning of safety assessment from the point of view of IAEA

International Nuclear Information System (INIS)

Lyubarskiy, A.

2012-01-01

In 2006, the IAEA published its revised Safety Fundamentals. This states that the ''fundamental safety objective is to protect people and the environment from harmful effects of ionizing radiation''. This objective has to be achieved for all facilities and activities and for all stages over the lifetime of a facility by adherence to ten fundamental principles. This leads, inter alia, to the requirement for a safety assessment to be carried out. In particular, the text accompanying Principle 3 on leadership and management for safety states that: ''3.15. Safety has to be assessed for all facilities and activities, consistent with a graded approach. Safety assessment involves the systematic analysis of normal operation and its effects, of the ways in which failures might occur and of the consequences of such failures. Safety assessments cover the safety measures necessary to control the hazard, and the design and engineered safety features are assessed to demonstrate that they fulfill the safety functions required of them. Where control measures or operator actions are called on to maintain safety, an initial safety assessment has to be carried out to demonstrate that the arrangements made are robust and that they can be relied on. A facility may only be constructed and commissioned or an activity may only be commenced once it has been demonstrated to the satisfaction of the regulatory body that the proposed safety measures are adequate.'' Principle 3 further states that the process of safety assessment for facilities and activities is repeated in the conduct of operations in order to take into account changed circumstances (such as the application of new standards or scientific and technological developments), the feedback of operating experience, modifications and the effects of ageing. Continuation of operations over long periods of time requires reassessments demonstrating that the safety measures remain adequate. (orig.)

Methodology for Safety Assessment Applied to Predisposal Waste Management. Report of the Results of the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) 2004–2010)

International Nuclear Information System (INIS)

2015-12-01

Report of the Results of the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) (2004–2010) The IAEA’s progamme on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) focused on approaches and mechanisms for application of safety assessment methodologies for the predisposal management of radioactive waste. The initial outcome of the SADRWMS Project was achieved through the development of flowcharts, which have since been incorporated into IAEA Safety Standards Series No. GSG-3, Safety Case and Safety Assessment for Predisposal Management of Radioactive Waste. In 2005, an initial specification was developed for the Safety Assessment Framework (SAFRAN) software tool to apply the SADRWMS flowcharts. In 2008, an in-depth application of the SAFRAN tool and the SADRWMS methodology was carried out on the predisposal management facilities of the Thailand Institute of Nuclear Technology Radioactive Waste Management Centre (TINT Facility). This publication summarizes the content and outcomes of the SADRWMS programme. The Chairman’s Report of the SADRWMS Project and the Report of the TINT test case are provided on the CD-ROM which accompanies this report

Safety assessment of human and organizational factors in French fuel cycle facilities

International Nuclear Information System (INIS)

Menuet, Lise; Beauquier, Sophie

2013-01-01

According to the French law, each nuclear facility has to provide a safety demonstration every ten years. The assessment of this demonstration supports the decision of the French Safety Authority regarding the authorisation of operating for the ten years to come. In addition, transversal topics, which are linked with safety performance, such as safety management, management of competencies, maintenance's policy are periodically evaluated. One aspect of these assessments relates to Human and Organizational Factors (HOF) and their contribution to safety. Our communication will describe the assessment of the HOF-related part, performed by the Institute for Radioprotection and Nuclear Safety Institute (IRSN) the Technical Support Organisation of the French Safety Authority). It will focus on the methodological framework, the tools which are developed and used for assessing the integration of HOF in safety demonstration, and the main difficulties of this kind of assessment. Each situation will be illustrated by concrete examples coming from safety assessments concerning fuel cycle's plants: Areva's plants dedicated to uranium conversion, uranium enrichment, fuel manufacturing, spent fuel reprocessing, treatment facilities and CEA's laboratories dedicated to research and development and to interim spent fuel storage. The methodological framework for assessing HOF currently implements three main steps which will be precisely described: - checking that the nuclear plant has made an exhaustive analysis of the risks linked with HOF. Regarding to HOF, the Licensee safety demonstration is based on the description of the main human activities which are considered as hazardous regarding safety. These activities are accomplished with a human contribution and they require a safe realisation. - assessing the human, organisational and technical barriers that the nuclear plant have planed in order to make the operations safe, to avoid, prevent or detect an

Low prevalence of hypertension with pharmacological treatments and associated factors

Directory of Open Access Journals (Sweden)

Helena Gama

2013-06-01

Full Text Available OBJECTIVE: To assess the determinants of the lack of pharmacological treatment for hypertension. METHODS: In 2005, 3,323 Mozambicans aged 25-64 years old were evaluated. Blood pressure, weight, height and smoking status were assessed following the Stepwise Approach to Chronic Disease Risk Factor Surveillance. Hypertensives (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg and/or antihypertensive drug therapy were evaluated for awareness of their condition, pharmacological and non-pharmacological management, as well as use of herbal or traditional remedies. Prevalence ratios (PR were calculated, adjusted for sociodemographic characteristics, cardiovascular risk factors and non-pharmacological treatment. RESULTS: Most of the hypertensive subjects (92.3%, and nearly half of those aware of their condition were not treated pharmacologically. Among the aware, the prevalence of untreated hypertension was higher in men {PR = 1.61; 95% confidence interval (95%CI 1.10;2.36} and was lower in subjects under non-pharmacological treatment (PR = 0.58; 95%CI 0.42;0.79; there was no significant association with traditional treatments (PR = 0.75; 95%CI 0.44;1.26. CONCLUSIONS: The lack of pharmacological treatment for hypertension was more frequent in men, and was not influenced by the presence of other cardiovascular risk factors; it could not be explained by the use of alternative treatments as herbal/traditional medicines or non-pharmacological management. It is important to understand the reasons behind the lack of management of diagnosed hypertension and to implement appropriate corrective actions to reduce the gap in the access to healthcare between developed and developing countries.

Taiwan consensus of pharmacological treatment for bipolar disorder

Directory of Open Access Journals (Sweden)

Ya-Mei Bai

2013-10-01

Full Text Available Bipolar disorder is an important psychiatric disorder with different disease phases. The pharmacological treatment is complicated, and is updated frequently as new research evidence emerges. For the purpose of international collaboration, research, and education, the Taiwan consensus of pharmacological treatment for bipolar disorders was initiated by the Taiwanese Society of Biological Psychiatry and Neuropsychopharmacology (TSBPN – the Bipolar Chapter, which was established in August 2010 and approved as a member of International Society of Bipolar Disorder. TSBPN is the country member of the World Federation of Societies of Biological Psychiatry (WFSBP. The development of the Taiwan consensus for bipolar disorder was mainly based on the template of WFSBP Guidelines, with references to other international guidelines including the Canadian Network for Mood and Anxiety Treatments, and British Association for Psychopharmacology. We have also added Taiwanese experts’ experience, Taiwan national health insurance data, and the indications for the pharmacological treatment of bipolar disorder given by the Taiwan Department of Health, to emphasize the balance between efficacy and safety, and to make this consensus a concise, empirical, and important reference for clinical psychiatric practice.

Economic aspects of risk assessment in chemical safety

Energy Technology Data Exchange (ETDEWEB)

Drummond, M F; Shannon, H S

1986-05-01

This paper considers how the economic aspects of risk assessment in chemical safety can be strengthened. Its main focus is on how economic appraisal techniques, such as cost-benefit and cost-effectiveness analysis, can be adapted to the requirements of the risk-assessment process. Following a discussion of the main methodological issues raised by the use of economic appraisal, illustrated by examples from the health and safety field, a number of practical issues are discussed. These include the consideration of the distribution of costs, effects and benefits, taking account of uncertainty, risk probabilities and public perception, making the appraisal techniques useful to the early stages of the risk-assessment process and structuring the appraisal to permit continuous feedback to the participants in the risk-assessment process. It is concluded that while the way of thinking embodied in economic appraisal is highly relevant to the consideration of choices in chemical safety, the application of these principles in formal analysis of risk reduction procedures presents a more mixed picture. The main suggestions for improvement in the analyses performed are the undertaking of sensitivity analyses of study results to changes in the key assumptions, the presentation of the distribution of costs and benefits by viewpoint, the comparison of health and safety measures in terms of their incremental cost per life-year (or quality-adjusted life-year) gained and the more frequent retrospective review and revision of the economic analyses that are undertaken.

The role of probabilistic safety assessment in the design

International Nuclear Information System (INIS)

Green, A.; Ingham, E.L.

1989-01-01

The use of probabilistic safety assessment (PSA) for Heysham 2 and Torness marked a major change in the design approach to nuclear safety within the U.K. Design Safety Guidelines incorporating probabilistic safety targets required that design justification would necessitate explicit consideration of the consequence of accidents in relation to their frequency. The paper discusses these safety targets and their implications, the integration of PSA into the design process and an outline of the methodology. The influence of PSA on the design is discussed together with its role in the overall demonstration of reactor safety. (author)

Procedures for conducting probabilistic safety assessment for non-reactor nuclear facilities

International Nuclear Information System (INIS)

2002-01-01

A well performed and adequately documented safety assessment of a nuclear facility will serve as a basis to determine whether the facility complies with the safety objectives, principles and criteria as stipulated by the national regulatory body of the country where the facility is in operation. International experience shows that the practices and methodologies used to perform safety assessments and periodic safety re-assessment for non-reactor nuclear facilities differ significantly from county to country. Most developing countries do not have methods and guidance for safety assessment that are prescribed by the regulatory body. Typically the safety evaluation for the facility is based on a case by case assessment. Whilst conservative deterministic analyses are predominantly used as a licensing basis in many countries, recently probabilistic safety assessment (PSA) techniques have been applied as a useful complementary tool to support safety decision making. The main benefit of PSA is to provide insights into the safety aspects of facility design and operation. PSA points up the potential environmental impacts of postulated accidents, including the dominant risk contributors, and enables safety analysts to compare options for reducing risk. In order to advise on how to apply PSA methodology for the safety assessment of non-reactor nuclear facilities, the IAEA organized several consultants meetings, which led to the preparation of this TECDOC. This document is intended as guidance for the conduct of PSA in non-nuclear facilities. The main emphasis here is on the general procedural steps of a PSA that is specific for a non-reactor nuclear facility, rather than the details of the specific methods. The report is directed at technical staff managing or performing such probabilistic assessments and to promote a standardized framework, terminology and form of documentation for these PSAs. It is understood that the level of detail implied in the tasks presented in this

Selected component failure rate values from fusion safety assessment tasks

Energy Technology Data Exchange (ETDEWEB)

Cadwallader, L.C.

1998-09-01

This report is a compilation of component failure rate and repair rate values that can be used in magnetic fusion safety assessment tasks. Several safety systems are examined, such as gas cleanup systems and plasma shutdown systems. Vacuum system component reliability values, including large vacuum chambers, have been reviewed. Values for water cooling system components have also been reported here. The report concludes with the examination of some equipment important to personnel safety, atmospheres, combustible gases, and airborne releases of radioactivity. These data should be useful to system designers to calculate scoping values for the availability and repair intervals for their systems, and for probabilistic safety or risk analysts to assess fusion systems for safety of the public and the workers.

Selected Component Failure Rate Values from Fusion Safety Assessment Tasks

Energy Technology Data Exchange (ETDEWEB)

Cadwallader, Lee Charles

1998-09-01

This report is a compilation of component failure rate and repair rate values that can be used in magnetic fusion safety assessment tasks. Several safety systems are examined, such as gas cleanup systems and plasma shutdown systems. Vacuum system component reliability values, including large vacuum chambers, have been reviewed. Values for water cooling system components have also been reported here. The report concludes with the examination of some equipment important to personnel safety, atmospheres, combustible gases, and airborne releases of radioactivity. These data should be useful to system designers to calculate scoping values for the availability and repair intervals for their systems, and for probabilistic safety or risk analysts to assess fusion systems for safety of the public and the workers.

Selected component failure rate values from fusion safety assessment tasks

International Nuclear Information System (INIS)

Cadwallader, L.C.

1998-01-01

This report is a compilation of component failure rate and repair rate values that can be used in magnetic fusion safety assessment tasks. Several safety systems are examined, such as gas cleanup systems and plasma shutdown systems. Vacuum system component reliability values, including large vacuum chambers, have been reviewed. Values for water cooling system components have also been reported here. The report concludes with the examination of some equipment important to personnel safety, atmospheres, combustible gases, and airborne releases of radioactivity. These data should be useful to system designers to calculate scoping values for the availability and repair intervals for their systems, and for probabilistic safety or risk analysts to assess fusion systems for safety of the public and the workers

Traditional uses, phytochemistry, pharmacology and toxicology of the genus Cimicifuga: A review.

Science.gov (United States)

Guo, Yaqing; Yin, Tong; Wang, Xiaoming; Zhang, Fan; Pan, Guixiang; Lv, Hong; Wang, Xianrui; Owoicho Orgah, John; Zhu, Yan; Wu, Honghua

2017-09-14

Plants of the genus Cimicifuga have long been used as an ethnomedicine in China, Europe, and North America for its high medicinal value and health benefits. Their dried rhizomes are widely used for treating wind-heat headache, toothache, aphtha, sore throat, measles, spot poison, archoptosis, and uterine prolapse. In addition, it is used as a dietary supplement for preventing women menopausal symptoms and osteoporosis. This paper aims to provide up-to-date information on the genus Cimicifuga, including botanical characterization, medicinal resources, traditional medicinal uses, phytochemistry, quality control, pharmacological research as well as the toxicology. The possible structural-activity relationships and molecular mechanisms of the bioactive constituents are discussed in ways that contribute to the structural optimization and preclinical safety assessment for further drug design. The relevant information on Cimicifuga was collected from scientific databases (such as Google Scholar, PubMed, SciFinder Scholar, Science Direct, CNKI, Baidu Scholar, Web of Science, China Knowledge Resource Integrated Database), Chinese herbal classics, ethnobotanical books, PhD and MSc dissertations, Chinese Pharmacopoeia, published articles in peer-reviewed journals, local magazines, and unpublished materials. In addition, the Plant List (TPL, www.theplantlist.org) was also used to validate the scientific names and synonyms of this plant. The literature cited in this review dated from 1953 to 2017. The majority of chemical constituents of this plant include triterpenoid glycosides, phenylpropanoids, nitrogenous compounds, chromones, flavonoids and 4α-methyl steroid. Among them, the primary bioactive constituents are believed to be present in the triterpene glycoside fraction. To date, investigation of seven Cimicifuga spp. plants led to the identification of more than 457 compounds. Years of pharmacological research proved that the crude extracts and certain pure compounds

Safety Assessment of Talc as Used in Cosmetics.

Science.gov (United States)

Fiume, Monice M; Boyer, Ivan; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of talc for use in cosmetics. The safety of talc has been the subject of much debate through the years, partly because the relationship between talc and asbestos is commonly misunderstood. Industry specifications state that cosmetic-grade talc must contain no detectable fibrous, asbestos minerals. Therefore, the large amount of available animal and clinical data the Panel relied on in assessing the safety of talc only included those studies on talc that did not contain asbestos. The Panel concluded that talc is safe for use in cosmetics in the present practices of use and concentration (some cosmetic products are entirely composed of talc). Talc should not be applied to the skin when the epidermal barrier is missing or significantly disrupted. © The Author(s) 2015.

Environment, safety and health progress assessment manual

International Nuclear Information System (INIS)

1992-12-01

On June 27, 1989, the Secretary of Energy announced a 10-Point Initiative to strengthen environment, safety, and health (ES ampersand H) programs, and waste management activities at DOE production, research, and testing facilities. One of the points involved conducting dent Tiger Team Assessments of DOE operating facilities. The Office of Special independent Projects (OSP), EH-5, in the Office of the Assistant Secretary for Environment, Safety and Health, EH-1, was assigned the responsibility to conduct the Tiger Team Assessments. Through June 1992, a total of 35 Tiger Team Assessments were completed. The Secretary directed that Corrective Action Plans be developed and implemented to address the concerns identified by the Tiger Teams. In March 1991, the Secretary approved a plan for assessments that are ''more focused, concentrating on ES ampersand H management, ES ampersand H corrective actions, self-assessment programs, and root-cause related issues.'' In July 1991, the Secretary approved the initiation of ES ampersand H Progress Assessments, as a followup to the Tiger Team Assessments, and in the continuing effort to institutionalize the self-assessment process and line management accountability in the ES ampersand H areas. This manual documents the processes to be used to perform the ES ampersand H Progress Assessments. It was developed based upon the lessons learned from Tiger Team Assessments, the two pilot Progress Assessments, and Progress Assessments that have been completed. The manual will be updated periodically to reflect lessons learned or changes in policy

Assessing the effects of pharmacological agents on respiratory dynamics using time-series modeling.

Science.gov (United States)

Wong, Kin Foon Kevin; Gong, Jen J; Cotten, Joseph F; Solt, Ken; Brown, Emery N

2013-04-01

Developing quantitative descriptions of how stimulant and depressant drugs affect the respiratory system is an important focus in medical research. Respiratory variables-respiratory rate, tidal volume, and end tidal carbon dioxide-have prominent temporal dynamics that make it inappropriate to use standard hypothesis-testing methods that assume independent observations to assess the effects of these pharmacological agents. We present a polynomial signal plus autoregressive noise model for analysis of continuously recorded respiratory variables. We use a cyclic descent algorithm to maximize the conditional log likelihood of the parameters and the corrected Akaike's information criterion to choose simultaneously the orders of the polynomial and the autoregressive models. In an analysis of respiratory rates recorded from anesthetized rats before and after administration of the respiratory stimulant methylphenidate, we use the model to construct within-animal z-tests of the drug effect that take account of the time-varying nature of the mean respiratory rate and the serial dependence in rate measurements. We correct for the effect of model lack-of-fit on our inferences by also computing bootstrap confidence intervals for the average difference in respiratory rate pre- and postmethylphenidate treatment. Our time-series modeling quantifies within each animal the substantial increase in mean respiratory rate and respiratory dynamics following methylphenidate administration. This paradigm can be readily adapted to analyze the dynamics of other respiratory variables before and after pharmacologic treatments.

On the fundamentals of nuclear reactor safety assessment. Inherent threats and their implications

Energy Technology Data Exchange (ETDEWEB)

Hyvaerinen, J. [Finnish Centre for Radiation and Nuclear Safety, Helsinki (Finland). Nuclear Safety Dept.

1996-12-01

The thesis addresses some fundamental questions related to implementation and assessment of nuclear safety. The safety principles and assessment methods are described, followed by descriptions of selected novel technical challenges to nuclear safety. The novel challenges encompass a wide variety of technical issues, thus providing insights on the limitations of conventional safety assessment methods. Study of the limitations suggests means to improve nuclear reactor design criteria and safety assessment practices. The novel safety challenges discussed are (1) inherent boron dilution in PWRs, (2) metallic insulation performance with respect to total loss of emergency cooling systems in a loss-of-coolant accident, and (3) horizontal steam generator heat transfer performance at natural circulation conditions. (50 refs.).

On the fundamentals of nuclear reactor safety assessment. Inherent threats and their implications

International Nuclear Information System (INIS)

Hyvaerinen, J.

1996-12-01

The thesis addresses some fundamental questions related to implementation and assessment of nuclear safety. The safety principles and assessment methods are described, followed by descriptions of selected novel technical challenges to nuclear safety. The novel challenges encompass a wide variety of technical issues, thus providing insights on the limitations of conventional safety assessment methods. Study of the limitations suggests means to improve nuclear reactor design criteria and safety assessment practices. The novel safety challenges discussed are (1) inherent boron dilution in PWRs, (2) metallic insulation performance with respect to total loss of emergency cooling systems in a loss-of-coolant accident, and (3) horizontal steam generator heat transfer performance at natural circulation conditions. (50 refs.)

Assessment of Safety Standards for Automotive Electronic Control Systems

Science.gov (United States)

2016-06-01

This report summarizes the results of a study that assessed and compared six industry and government safety standards relevant to the safety and reliability of automotive electronic control systems. These standards include ISO 26262 (Road Vehicles - ...

Plasma-safety assessment model and safety analyses of ITER

International Nuclear Information System (INIS)

Honda, T.; Okazaki, T.; Bartels, H.-H.; Uckan, N.A.; Sugihara, M.; Seki, Y.

2001-01-01

A plasma-safety assessment model has been provided on the basis of the plasma physics database of the International Thermonuclear Experimental Reactor (ITER) to analyze events including plasma behavior. The model was implemented in a safety analysis code (SAFALY), which consists of a 0-D dynamic plasma model and a 1-D thermal behavior model of the in-vessel components. Unusual plasma events of ITER, e.g., overfueling, were calculated using the code and plasma burning is found to be self-bounded by operation limits or passively shut down due to impurity ingress from overheated divertor targets. Sudden transition of divertor plasma might lead to failure of the divertor target because of a sharp increase of the heat flux. However, the effects of the aggravating failure can be safely handled by the confinement boundaries. (author)

Safety assessment for the above ground storage of Cadmium Safety and Control Rods at the Solid Waste Management Facility

International Nuclear Information System (INIS)

Shaw, K.W.

1993-11-01

The mission of the Savannah River Site is changing from radioisotope production to waste management and environmental restoration. As such, Reactor Engineering has recently developed a plan to transfer the safety and control rods from the C, K, L, and P reactor disassembly basin areas to the Transuranic (TRU) Waste Storage Pads for long-term, retrievable storage. The TRU pads are located within the Solid Waste Management Facilities at the Savannah River Site. An Unreviewed Safety Question (USQ) Safety Evaluation has been performed for the proposed disassembly basin operations phase of the Cadmium Safety and Control Rod Project. The USQ screening identified a required change to the authorization basis; however, the Proposed Activity does not involve a positive USQ Safety Evaluation. A Hazard Assessment for the Cadmium Safety and Control Rod Project determined that the above-ground storage of the cadmium rods results in no change in hazard level at the TRU pads. A Safety Assessment that specifically addresses the storage (at the TRU pads) phase of the Cadmium Safety and Control Rod Project has been performed. Results of the Safety Assessment support the conclusion that a positive USQ is not involved as a result of the Proposed Activity

Review and assessment of nuclear facilities by the regulatory body. Safety guide

International Nuclear Information System (INIS)

2004-01-01

The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

Review and assessment of nuclear facilities by the regulatory body. Safety guide

International Nuclear Information System (INIS)

2005-01-01

The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

Safety assessment guidance in the International Atomic Energy Agency RADWASS Program

Energy Technology Data Exchange (ETDEWEB)

Vovk, I.F.; Seitz, R.R.

1995-12-31

The IAEA RADWASS programme is aimed at establishing a coherent and comprehensive set of principles and standards for the safe management of waste and formulating the guidelines necessary for their application. A large portion of this programme has been devoted to safety assessments for various waste management activities. Five Safety Guides are planned to be developed to provide general guidance to enable operators and regulators to develop necessary framework for safety assessment process in accordance with international recommendations. They cover predisposal, near surface disposal, geological disposal, uranium/thorium mining and milling waste, and decommissioning and environmental restoration. The Guide on safety assessment for near surface disposal is at the most advanced stage of preparation. This draft Safety Guide contains guidance on description of the disposal system, development of a conceptual model, identification and description of relevant scenarios and pathways, consequence analysis, presentation of results and confidence building. The set of RADWASS publications is currently undergoing in-depth review to ensure a harmonized approach throughout the Safety Series.

Uncertainty in safety : new techniques for the assessment and optimisation of safety in process industry

NARCIS (Netherlands)

Rouvroye, J.L.; Nieuwenhuizen, J.K.; Brombacher, A.C.; Stavrianidis, P.; Spiker, R.Th.E.; Pyatt, D.W.

1995-01-01

At this moment there is no standardised method for the assessment for safety in the process industry. Many companies and institutes use qualitative techniques for safety analysis while other companies and institutes use quantitative techniques. The authors of this paper will compare different

Nuclear utility self-assessment as viewed by the corporate nuclear safety committee

International Nuclear Information System (INIS)

Corcoran, W.R.

1992-01-01

This paper discusses how corporate nuclear safety committees use the principles of self-assessment to enhance nuclear power plant safety performance. Corporate nuclear safety committees function to advise the senior nuclear power executive on matters affecting nuclear safety. These committees are required by the administrative controls section of the plant technical specifications which are part of the final safety analysis report and the operating license. Committee membership includes senior utility executives, executives from sister utilities, utility senior technical experts, and outside consultants. Current corporate nuclear safety committees often have a finely tuned intuitive feel for self-assessment that they use to probe the underlying opportunities for quality and safety enhancements. The questions prompted by the self-assessment orientation enable the utility line organization members to gain better perspectives on the characteristics of the organizational systems that they manage and work in

Quantitative reliability assessment for safety critical system software

International Nuclear Information System (INIS)

Chung, Dae Won; Kwon, Soon Man

2005-01-01

An essential issue in the replacement of the old analogue I and C to computer-based digital systems in nuclear power plants is the quantitative software reliability assessment. Software reliability models have been successfully applied to many industrial applications, but have the unfortunate drawback of requiring data from which one can formulate a model. Software which is developed for safety critical applications is frequently unable to produce such data for at least two reasons. First, the software is frequently one-of-a-kind, and second, it rarely fails. Safety critical software is normally expected to pass every unit test producing precious little failure data. The basic premise of the rare events approach is that well-tested software does not fail under normal routine and input signals, which means that failures must be triggered by unusual input data and computer states. The failure data found under the reasonable testing cases and testing time for these conditions should be considered for the quantitative reliability assessment. We will present the quantitative reliability assessment methodology of safety critical software for rare failure cases in this paper

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

Science.gov (United States)

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

2010-02-01

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

Measuring Best Practices for Workplace Safety, Health, and Well-Being: The Workplace Integrated Safety and Health Assessment.

Science.gov (United States)

Sorensen, Glorian; Sparer, Emily; Williams, Jessica A R; Gundersen, Daniel; Boden, Leslie I; Dennerlein, Jack T; Hashimoto, Dean; Katz, Jeffrey N; McLellan, Deborah L; Okechukwu, Cassandra A; Pronk, Nicolaas P; Revette, Anna; Wagner, Gregory R

2018-05-01

To present a measure of effective workplace organizational policies, programs, and practices that focuses on working conditions and organizational facilitators of worker safety, health and well-being: the workplace integrated safety and health (WISH) assessment. Development of this assessment used an iterative process involving a modified Delphi method, extensive literature reviews, and systematic cognitive testing. The assessment measures six core constructs identified as central to best practices for protecting and promoting worker safety, health and well-being: leadership commitment; participation; policies, programs, and practices that foster supportive working conditions; comprehensive and collaborative strategies; adherence to federal and state regulations and ethical norms; and data-driven change. The WISH Assessment holds promise as a tool that may inform organizational priority setting and guide research around causal pathways influencing implementation and outcomes related to these approaches.

NASA Aviation Safety Program Systems Analysis/Program Assessment Metrics Review

Science.gov (United States)

Louis, Garrick E.; Anderson, Katherine; Ahmad, Tisan; Bouabid, Ali; Siriwardana, Maya; Guilbaud, Patrick

2003-01-01

The goal of this project is to evaluate the metrics and processes used by NASA's Aviation Safety Program in assessing technologies that contribute to NASA's aviation safety goals. There were three objectives for reaching this goal. First, NASA's main objectives for aviation safety were documented and their consistency was checked against the main objectives of the Aviation Safety Program. Next, the metrics used for technology investment by the Program Assessment function of AvSP were evaluated. Finally, other metrics that could be used by the Program Assessment Team (PAT) were identified and evaluated. This investigation revealed that the objectives are in fact consistent across organizational levels at NASA and with the FAA. Some of the major issues discussed in this study which should be further investigated, are the removal of the Cost and Return-on-Investment metrics, the lack of the metrics to measure the balance of investment and technology, the interdependencies between some of the metric risk driver categories, and the conflict between 'fatal accident rate' and 'accident rate' in the language of the Aviation Safety goal as stated in different sources.

Development of Safety Culture Assessment Strategy for Korean NPP

International Nuclear Information System (INIS)

Park, Jung Hwan; Kim, Jong Hyun

2014-01-01

This paper aims at developing the requirements for a method to evaluate the operational safety culture, evaluating currently available methods based on the requirements, and suggesting a method to evaluate and improve the operational safety culture for Korean nuclear power plants. This paper reviews the widely-used methods to assess safety culture for NPPs and their basis. Then, this paper develops the requirements for the method to evaluate operational safety culture for Korean NPPs. Based on these requirements, Korean Safety Culture Indicators (KSCI) and evaluation measures are also suggested. Finally this paper proposes the guidelines to develop improvements to safety culture from the evaluation results

Development of Safety Culture Assessment Strategy for Korean NPP

Energy Technology Data Exchange (ETDEWEB)

Park, Jung Hwan; Kim, Jong Hyun [KEPCO, Ulsan (Korea, Republic of)

2014-08-15

This paper aims at developing the requirements for a method to evaluate the operational safety culture, evaluating currently available methods based on the requirements, and suggesting a method to evaluate and improve the operational safety culture for Korean nuclear power plants. This paper reviews the widely-used methods to assess safety culture for NPPs and their basis. Then, this paper develops the requirements for the method to evaluate operational safety culture for Korean NPPs. Based on these requirements, Korean Safety Culture Indicators (KSCI) and evaluation measures are also suggested. Finally this paper proposes the guidelines to develop improvements to safety culture from the evaluation results.

Institutionalization of safety re-assessment system for operating nuclear power plants

International Nuclear Information System (INIS)

Kim, H. J.; Cho, J. C.; Min, B. K.; Park, J. S.; Jung, H. D.; Oh, K. M.; Kim, W. K.; Lim, J. H.

1999-01-01

In this study, in-depth reviews of the foreign countries' experiences and practices in applications of the periodic safety review (PSR), backfitting and license renewal systems as well as the current status of nuclear power safety assurance programs and activities in Korea have been performed to investigate the necessity and feasibility of the application of the systems for the domestic operating nuclear power plants and to establish effective strategy and methodology for the institutionalization of a periodic safety re-assessment system appropriate to both the domestic and international nuclear power environments by incorporating the PSR with the backfitting and license renewal systems. For these purposes, the regulatory policy, fundamental principles and detailed requirements for the institutionalization of the safety re-assessment system and the effective measures for active implementation of the backfitting program have been developed and then a comparative study of benefits and shortcomings has been conducted for the three different models of the periodic safety re-assessment system incorporated with either the license renewal or life extension process, which have been considered as practicable ones in the domestic situation. The model chosen in this study as the most appropriate safety re-assessment system is the one that the re-assessments are performed at the interval of ten years throughout the service life of nuclear power plant and the ten-year license renewal or life extension after the expiration of design life can be permitted based on the regulatory review of the re-assessment results and follow-up measures. Finally, this paper has discussed on the details of the requirements, approach and procedures established for the institutionalization of the periodic safety re-assessment system chosen as the most appropriate one for domestic applications

Comparative assessment of safety indicators for vehicle trajectories on the highway

NARCIS (Netherlands)

Mullakkal Babu, F.A.; Wang, M.; Farah, H.; van Arem, B.; Happee, R.

2017-01-01

Safety measurement and analysis have been a challenging and well-researched topic in transportation. Conventionally, surrogate safety measures have been used as safety indicators in simulation models for safety assessment, in control formulations for driver assistance systems, and in data analysis

Safety assessment of Novi Han radioactive waste repository - features, problems, results and perspectives

International Nuclear Information System (INIS)

Mateeva, M.

2000-01-01

This paper summarizes the work done and the achievements reached in the Novi Han radioactive waste repository safety assessment within the IAEA Model Project 'Increasing the safety of Novi Han radioactive waste repository BUL 4/005'. The overall safety assessment has a wide context, but the work reported here relates only to some details and results concerning the development and implementation of the appropriate methodology approach, model and computer code used for the calculations. Different steps and procedures are included for a better practical understanding of the obtained results during the safety assessment performance. The methodology approach is widely based on an international experience in safety analysis and implemented for evaluation computer code AMBER, which is one of the recommended from the safety assessments experts. (author)

76 FR 74723 - New Car Assessment Program (NCAP); Safety Labeling

Science.gov (United States)

2011-12-01

... [Docket No. NHTSA 2010-0025] RIN 2127-AK51 New Car Assessment Program (NCAP); Safety Labeling AGENCY... NHTSA's regulation on vehicle labeling of safety rating information to reflect the enhanced NCAP ratings... Traffic Safety Administration under the enhanced NCAP testing and rating program. * * * * * (e) * * * (4...

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 standards are also applied by regulatory bodies and operators around the world to enhance safety in nuclear power generation and in nuclear applications in medicine, industry, agriculture and research. Safety is not an end in itself but a prerequisite for the purpose of the protection of people in all States and of the environment - now and in the future. The risks associated with ionizing radiation must be assessed and controlled without unduly limiting the contribution of nuclear energy to equitable and sustainable development. Governments, regulatory bodies and operators everywhere must ensure that nuclear material and radiation sources are used beneficially, safely and ethically. The IAEA safety standards are designed to facilitate this, and I encourage all Member States to make use of them.

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

International Nuclear Information System (INIS)

2011-01-01

. The standards are also applied by regulatory bodies and operators around the world to enhance safety in nuclear power generation and in nuclear applications in medicine, industry, agriculture and research. Safety is not an end in itself but a prerequisite for the purpose of the protection of people in all States and of the environment - now and in the future. The risks associated with ionizing radiation must be assessed and controlled without unduly limiting the contribution of nuclear energy to equitable and sustainable development. Governments, regulatory bodies and operators everywhere must ensure that nuclear material and radiation sources are used beneficially, safely and ethically. The IAEA safety standards are designed to facilitate this, and I encourage all Member States to make use of them.

Guidelines for the review research reactor safety. Reference document for IAEA Integrated Safety Assessment of Research Reactors (INSARR)

International Nuclear Information System (INIS)

1997-01-01

In 1992, the IAEA published new safety standards for research reactors as part of the set of publications considered by its Research Reactor Safety Programme (RRSP). This set also includes publications giving guidance for all safety aspects related to the lifetime of a research reactor. In addition, the IAEA has also revised the Safety Standards for radiation protection. Consequently, it was considered advisable to revise the Integrated Safety Assessment of Research Reactors (INSARR) procedures to incorporate the new requirements and guidance as well as to extend the scope of the safety reviews to currently operating research reactors. The present report is the result of this revision. The purpose of this report is to give guidance on the preparation, execution, reporting and follow-up of safety review mission to research reactors as conducted by the IAEA under its INSARR missions safety service. However, it will also be of assistance to operators and regulators in conducting: (a) ad hoc safety assessments of research reactors to address individual issues such as ageing or safety culture; and (b) other types of safety reviews such as internal and peer reviews and regulatory inspections

Data report for the safety assessment SR-Site

International Nuclear Information System (INIS)

2010-12-01

This report compiles, documents, and qualifies input data identified as essential for the long-term safety assessment of a KBS-3 repository, and forms an important part of the reporting of the safety assessment project SR-Site. The input data concern the repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock, and the biosphere in the proximity of the repository. The input data also concern external influences acting on the system, in terms of climate related data. Data are provided for a selection of relevant conditions and are qualified through traceable standardised procedures

Data report for the safety assessment SR-Site

Energy Technology Data Exchange (ETDEWEB)

2010-12-15

This report compiles, documents, and qualifies input data identified as essential for the long-term safety assessment of a KBS-3 repository, and forms an important part of the reporting of the safety assessment project SR-Site. The input data concern the repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock, and the biosphere in the proximity of the repository. The input data also concern external influences acting on the system, in terms of climate related data. Data are provided for a selection of relevant conditions and are qualified through traceable standardised procedures

Psychometric model for safety culture assessment in nuclear research facilities

Energy Technology Data Exchange (ETDEWEB)

Nascimento, C.S. do, E-mail: claudio.souza@ctmsp.mar.mil.br [Centro Tecnológico da Marinha em São Paulo (CTMSP), Av. Professor Lineu Prestes 2468, 05508-000 São Paulo, SP (Brazil); Andrade, D.A., E-mail: delvonei@ipen.br [Instituto de Pesquisas Energéticas e Nucleares (IPEN/CNEN – SP), Av. Professor Lineu Prestes 2242, 05508-000 São Paulo, SP (Brazil); Mesquita, R.N. de, E-mail: rnavarro@ipen.br [Instituto de Pesquisas Energéticas e Nucleares (IPEN/CNEN – SP), Av. Professor Lineu Prestes 2242, 05508-000 São Paulo, SP (Brazil)

2017-04-01

Highlights: • A psychometric model to evaluate ‘safety climate’ at nuclear research facilities. • The model presented evidences of good psychometric qualities. • The model was applied to nuclear research facilities in Brazil. • Some ‘safety culture’ weaknesses were detected in the assessed organization. • A potential tool to develop safety management programs in nuclear facilities. - Abstract: A safe and reliable operation of nuclear power plants depends not only on technical performance, but also on the people and on the organization. Organizational factors have been recognized as the main causal mechanisms of accidents by research organizations through USA, Europe and Japan. Deficiencies related with these factors reveal weaknesses in the organization’s safety culture. A significant number of instruments to assess the safety culture based on psychometric models that evaluate safety climate through questionnaires, and which are based on reliability and validity evidences, have been published in health and ‘safety at work’ areas. However, there are few safety culture assessment instruments with these characteristics (reliability and validity) available on nuclear literature. Therefore, this work proposes an instrument to evaluate, with valid and reliable measures, the safety climate of nuclear research facilities. The instrument was developed based on methodological principles applied to research modeling and its psychometric properties were evaluated by a reliability analysis and validation of content, face and construct. The instrument was applied to an important nuclear research organization in Brazil. This organization comprises 4 research reactors and many nuclear laboratories. The survey results made possible a demographic characterization and the identification of some possible safety culture weaknesses and pointing out potential areas to be improved in the assessed organization. Good evidence of reliability with Cronbach's alpha

Psychometric model for safety culture assessment in nuclear research facilities

International Nuclear Information System (INIS)

Nascimento, C.S. do; Andrade, D.A.; Mesquita, R.N. de

2017-01-01

Highlights: • A psychometric model to evaluate ‘safety climate’ at nuclear research facilities. • The model presented evidences of good psychometric qualities. • The model was applied to nuclear research facilities in Brazil. • Some ‘safety culture’ weaknesses were detected in the assessed organization. • A potential tool to develop safety management programs in nuclear facilities. - Abstract: A safe and reliable operation of nuclear power plants depends not only on technical performance, but also on the people and on the organization. Organizational factors have been recognized as the main causal mechanisms of accidents by research organizations through USA, Europe and Japan. Deficiencies related with these factors reveal weaknesses in the organization’s safety culture. A significant number of instruments to assess the safety culture based on psychometric models that evaluate safety climate through questionnaires, and which are based on reliability and validity evidences, have been published in health and ‘safety at work’ areas. However, there are few safety culture assessment instruments with these characteristics (reliability and validity) available on nuclear literature. Therefore, this work proposes an instrument to evaluate, with valid and reliable measures, the safety climate of nuclear research facilities. The instrument was developed based on methodological principles applied to research modeling and its psychometric properties were evaluated by a reliability analysis and validation of content, face and construct. The instrument was applied to an important nuclear research organization in Brazil. This organization comprises 4 research reactors and many nuclear laboratories. The survey results made possible a demographic characterization and the identification of some possible safety culture weaknesses and pointing out potential areas to be improved in the assessed organization. Good evidence of reliability with Cronbach's alpha

78 FR 14912 - International Aviation Safety Assessment (IASA) Program Change

Science.gov (United States)

2013-03-08

... Aviation Safety Assessment (IASA) Program Change AGENCY: Federal Aviation Administration (FAA), DOT. ACTION..., into the U.S., or codeshare with a U.S. air carrier, complies with international aviation safety... subject to that country's aviation safety oversight can serve the United States using its own aircraft or...

Fuel and canister process report for the safety assessment SR-Site

International Nuclear Information System (INIS)

Werme, Lars; Lilja, Christina

2010-12-01

This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

Fuel and canister process report for the safety assessment SR-Site

Energy Technology Data Exchange (ETDEWEB)

Werme, Lars; Lilja, Christina (eds.)

2010-12-15

This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

Probabilistic safety assessment in radioactive waste disposal

International Nuclear Information System (INIS)

Robinson, P.C.

1987-07-01

Probabilistic safety assessment codes are now widely used in radioactive waste disposal assessments. This report gives an overview of the current state of the field. The relationship between the codes and the regulations covering radioactive waste disposal is discussed and the characteristics of current codes is described. The problems of verification and validation are considered. (author)

Assessment of Electrical Safety Beliefs and Practices: A Case Study

Directory of Open Access Journals (Sweden)

S. Boubaker

2017-12-01

Full Text Available In this paper, the electrical safety beliefs and practices in Hail region, Saudi Arabia, have been assessed. Based on legislative recommendations and rules applied in Saudi Arabia, on official statistics regarding the electricity-caused accidents and on the analysis of more than 200 photos captured in Hail (related to electrical safety, a questionnaire composed of 36 questions (10 for the respondents information, 16 for the home safety culture and 10 for the electrical devices purchasing culture has been devised and distributed to residents. 228 responses have been collected and analyzed. Using a scale similar to the one adopted for a university student GPA calculation, the electrical safety level (ESL in Hail region has been found to be 0.76 (in a scale of 4 points which is a very low score and indicates a poor electrical safety culture. Several recommendations involving different competent authorities have been proposed. Future work will concern the assessment of safety in industrial companies in Hail region.

Edible safety requirements and assessment standards for agricultural genetically modified organisms.

Science.gov (United States)

Deng, Pingjian; Zhou, Xiangyang; Zhou, Peng; Du, Zhong; Hou, Hongli; Yang, Dongyan; Tan, Jianjun; Wu, Xiaojin; Zhang, Jinzhou; Yang, Yongcun; Liu, Jin; Liu, Guihua; Li, Yonghong; Liu, Jianjun; Yu, Lei; Fang, Shisong; Yang, Xiaoke

2008-05-01

This paper describes the background, principles, concepts and methods of framing the technical regulation for edible safety requirement and assessment of agricultural genetically modified organisms (agri-GMOs) for Shenzhen Special Economic Zone in the People's Republic of China. It provides a set of systematic criteria for edible safety requirements and the assessment process for agri-GMOs. First, focusing on the degree of risk and impact of different agri-GMOs, we developed hazard grades for toxicity, allergenicity, anti-nutrition effects, and unintended effects and standards for the impact type of genetic manipulation. Second, for assessing edible safety, we developed indexes and standards for different hazard grades of recipient organisms, for the influence of types of genetic manipulation and hazard grades of agri-GMOs. To evaluate the applicability of these criteria and their congruency with other safety assessment systems for GMOs applied by related organizations all over the world, we selected some agri-GMOs (soybean, maize, potato, capsicum and yeast) as cases to put through our new assessment system, and compared our results with the previous assessments. It turned out that the result of each of the cases was congruent with the original assessment.

Safety assessment of emergency power systems for nuclear power plants

International Nuclear Information System (INIS)

1992-01-01

This publication is intended to assist the safety assessor within a regulatory body, or one working as a consultant, in assessing the safety of a given design of the emergency power systems (EPS) for a nuclear power plant. The present publication refers closely to the NUSS Safety Guide 50-SG-D7 (Rev. 1), Emergency Power Systems at Nuclear Power Plants. It covers therefore exactly the same technical subject as that Safety Guide. In view of its objective, however, it attempts to help in the evaluation of possible technical solutions which are intended to fulfill the safety requirements. Section 2 clarifies the scope further by giving an outline of the assessment steps in the licensing process. After a general outline of the assessment process in relation to the licensing of a nuclear power plant, the publication is divided into two parts. First, all safety issues are presented in the form of questions that have to be answered in order for the assessor to be confident of a safe design. The second part presents the same topics in tabulated form, listing the required documentation which the assessor has to consult and those international and national technical standards pertinent to the topics. An extensive reference list provides information on standards. 1 tab

Reactor Safety Assessment System--A situation assessment aid for USNRC emergency response

International Nuclear Information System (INIS)

Bray, M.A.; Sebo, D.E.; Dixon, B.W.

1985-01-01

The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (USNRC). RSAS is intended for use at the NRC's Operations Center in the event of a serious incident at a licensed nuclear power plant. The system uses plant parameter data and status information from the power plant. It has a rule base that uses the parametric values, the known operator actions, and the time sequence information in the data to generate situation assessment conclusions for use by the NRC Reactor Safety Team. RSAS rules currently cover one specific reactor type and use setpoints specific to one power plant

Reactor Safety Assessment System: a situation assessment aid for USNRC emergency response

International Nuclear Information System (INIS)

Bray, M.A.; Sebo, D.E.; Dixon, B.W.

1985-04-01

The Reactor Safety Assessment System is an expert system under development for the United States Nuclear Regulatory Commission (NRC). RSAS is intended for use at the NRC's Operations Center in the event of a serious incident at a licensed nuclear power plant. The system uses plant parameter data and status information from the power plant. It has a rule base which uses the parametric values, the known operator actions and the time sequence information in the data to generate situation assessment conclusions for use by the NRC Reactor Safety Team. RSAS rules currently cover one specific reactor type and use setpoints specific to one power plant. 5 figs

Russian guidelines for the management of COPD: algorithm of pharmacologic treatment

Directory of Open Access Journals (Sweden)

Aisanov Z

2018-01-01

nonpharmacologic measures for all patients, and the decision not to use the letters A–D for simplicity and clarity. At all stages of the treatment algorithm, efficacy and safety have to be carefully assessed. Escalation and de-escalation is possible in the case of lack of or insufficient efficacy or safety issues. Bronchodilators should not be discontinued except in the case of significant side effects. At the same time, inhaled corticosteroid (ICS withdrawal is not represented in the algorithm, because it was agreed that there is insufficient evidence to establish clear criteria for ICSs discontinuation. Finally, based on the Global Initiative for Obstructive Lung Disease statement, the proposed algorithm reflects and summarizes different approaches to the pharmacological treatment of COPD taking into account the reality of health care in the Russian Federation. Keywords: COPD, clinical guidelines, Russia, treatment algorithm

[Safety assessment of foods derived from genetically modified plants].

Science.gov (United States)

Pöting, A; Schauzu, M

2010-06-01

The placing of genetically modified plants and derived food on the market falls under Regulation (EC) No. 1829/2003. According to this regulation, applicants need to perform a safety assessment according to the Guidance Document of the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA), which is based on internationally agreed recommendations. This article gives an overview of the underlying legislation as well as the strategy and scientific criteria for the safety assessment, which should generally be based on the concept of substantial equivalence and carried out in relation to an unmodified conventional counterpart. Besides the intended genetic modification, potential unintended changes also have to be assessed with regard to potential adverse effects for the consumer. All genetically modified plants and derived food products, which have been evaluated by EFSA so far, were considered to be as safe as products derived from the respective conventional plants.

The Fukushima Daiichi Accident. Technical Volume 2/5. Safety Assessment

International Nuclear Information System (INIS)

2015-08-01

Technical Volume 1 of this report has described what happened during the accident at the Fukushima Daiichi nuclear power plant (NPP). This volume begins (Section 2.1) with a review of how the design basis of the site for external events was assessed initially and then reassessed over the life of the NPP. The section also describes the physical changes that were made to the units as a result. The remainder of the volume describes the treatment of beyond design basis events in the safety assessment of the site, the accident management provisions, the effectiveness of regulatory programmes, human and organizational factors and the safety culture, and the role of operating experience. Further background information is contained in three annexes included on the CD-ROM of this Technical Volume which describe analytical investigations of the accident along with information on topics such as system performance, defence in depth and severe accident phenomena. Section 2.2 provides an assessment of the systems that failed, resulting in a failure to maintain the fundamental safety functions in Units 1–3, which were in operation at the time of the tsunami and in which the reactor pressure vessels (RPV) and containment vessels failed. The section also describes Units 4-6, which were shut down at the time of the tsunami, and the site’s central spent fuel storage facility. Section 2.3 discusses the probabilistic and deterministic safety assessments of beyond design basis accidents (BDBAs) that had been performed for the plant and the insights from these assessments that had led to changes in the plant’s design. The section pays particular attention to the assessment of extreme natural hazards, such as the one which led to the total loss of AC power supply on the site. The additional loss of DC power supply in Units 1 and 2 played a key role in the progression of the accident because it impeded the diagnosis of plant conditions and made the operators unaware of the status of

Pharmacologic therapy for acute pancreatitis

Science.gov (United States)

Kambhampati, Swetha; Park, Walter; Habtezion, Aida

2014-01-01

While conservative management such as fluid, bowel rest, and antibiotics is the mainstay of current acute pancreatitis management, there is a lot of promise in pharmacologic therapies that target various aspects of the pathogenesis of pancreatitis. Extensive review of preclinical studies, which include assessment of therapies such as anti-secretory agents, protease inhibitors, anti-inflammatory agents, and anti-oxidants are discussed. Many of these studies have shown therapeutic benefit and improved survival in experimental models. Based on available preclinical studies, we discuss potential novel targeted pharmacologic approaches that may offer promise in the treatment of acute pancreatitis. To date a variety of clinical studies have assessed the translational potential of animal model effective experimental therapies and have shown either failure or mixed results in human studies. Despite these discouraging clinical studies, there is a great clinical need and there exist several preclinical effective therapies that await investigation in patients. Better understanding of acute pancreatitis pathophysiology and lessons learned from past clinical studies are likely to offer a great foundation upon which to expand future therapies in acute pancreatitis. PMID:25493000

Safety assessment of Vitis vinifera (grape)-derived ingredients as used in cosmetics.

Science.gov (United States)

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

2014-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 24 Vitis vinifera (grape)-derived ingredients and found them safe in the present practices of use and concentration in cosmetics. These ingredients function in cosmetics mostly as skin-conditioning agents, but some function as antioxidants, flavoring agents, and/or colorants. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients. Additionally, some constituents of grapes have been assessed previously for safety as cosmetic ingredients by the Panel, and others are compounds that have been discussed in previous Panel safety assessments. © The Author(s) 2014.

Self-assessment of safety culture in nuclear installations. Highlights and good practices

International Nuclear Information System (INIS)

2002-11-01

This report summarizes the findings of two IAEA Technical Committee Meetings on Safety Culture Self-Assessment Highlights and Good Practices. The meetings took place on 3-5 June 1998 and 23-25 October 2000 in Vienna, and involved an international cross-section of representatives who participated both in plenary discussions and working groups. The purpose of the meetings was to discuss the practical implications of evolutionary changes in the development of safety culture, and to share international experience, particularly on the methods used for the assessment of safety culture and good practices for its enhancement in an organization. The working groups were allocated specific topics for discussion, which included the following: organizational factors influencing the implementation of actions to improve safety culture; how to measure, effectively, progress in implementing solutions to safety culture problems; the symptoms of a weakening safety culture; the suitability of different methods for assessing safety culture; the achievement of sustainable improvements in safety culture using the results of assessment; the potential threats to the continuation of a strong safety culture in an organization from the many challenges facing the nuclear industry. The working groups, when appropriate, considered issues from both the utility's and the regulator's perspectives. This report will be of interest to all organizations who wish to assess and achieve a strong and sustainable safety culture. This includes not only nuclear power plants, but also other sectors of the nuclear industry such as uranium mines and mills, nuclear fuel fabrication facilities, nuclear waste repositories, research reactors, accelerators, radiography facilities, etc. The report specifically supplements other IAEA publications on this subject

A 2-year study of patient safety competency assessment in 29 clinical laboratories.

Science.gov (United States)

Reed, Robyn C; Kim, Sara; Farquharson, Kara; Astion, Michael L

2008-06-01

Competency assessment is critical for laboratory operations and is mandated by the Clinical Laboratory Improvement Amendments of 1988. However, no previous reports describe methods for assessing competency in patient safety. We developed and implemented a Web-based tool to assess performance of 875 laboratory staff from 29 laboratories in patient safety. Question categories included workplace culture, categorizing error, prioritization of patient safety interventions, strength of specific interventions, and general patient safety concepts. The mean score was 85.0%, with individual scores ranging from 56% to 100% and scores by category from 81.3% to 88.6%. Of the most difficult questions (laboratory technologists. Computer-based competency assessments help laboratories identify topics for continuing education in patient safety.

South African safety assessment framework for the pebble bed modular reactor - HTR2008-58192

International Nuclear Information System (INIS)

Joubert, J.; Kohtz, N.; Coe, I.

2008-01-01

It is planned to construct a first of a kind Pebble Bed Modular Reactor (PBMR) in South Africa. A need has been recognized to accompany the licensing process for the PBMR with independent safety assessments to ensure that the safety case submitted by the applicant complies with the licensing requirements of the NNR. At the HTR 2006 Conference, the framework and major challenges on safety assessment that the South African National Nuclear Regulator (NNR) faces in developing and applying appropriate strategies and tools were presented. This paper discusses the current status of the various NNR assessment activities and describes how this will be considered in the NNR Final Report on the PBMR Safety Case. The traditional safety assessment process has been adapted to take into account the developmental nature of the project. By performing safety assessments, the designer and applicant must ensure that the design as proposed for construction and as-built meets the safety requirements defined by the regulatory framework. The regulator performs independent safety assessments, including independent analyses in areas deemed safety significant and potentially safety significant. The developmental nature of the project also led to the identification of a series of regulatory assessment activities preceding the formal assessment of the safety case. Besides an assessment of the resolution of Key Licensing Issues which have been defined in an early stage of the project and are discussed in /l/, these activities comprise the participation in an SAR Early Intervention Process, the execution of a regulatory HAZOP and the development of a regulatory assessment specification for the formal assessment of the safety case. This paper briefly describes these activities and their current status. During the last two years, significant progress was made with the development or adjustment of tools for the independent analysis by the regulator of the steady state core design, of the transient

Recent Trends In The Methods Of Safety Assessment Of Rad Waste Treatment And Disposal

International Nuclear Information System (INIS)

Mahmoud, N.S.

2012-01-01

Radioactive waste management system involves a huge variety of processes and activities. This includes; collection and segregation, pretreatment, treatment, conditioning, storage and finally disposal. To assure the safety of the different facility of each step in the waste management system, the operator should prepare a safety analysis report to be assessed by the national regulatory body. The content of the safety analysis report must include all data about the site, facility design, operational phase, waste materials, and safety assessment methodologies. Safety assessment methodologies are iterative processes involving site-specific, prospective modeling evaluations of the pre-operational, operational, and post-closure time in case of disposal facilities. The safety assessment focuses primarily on a decision about compliance with performance objectives, rather than the much more difficult problem of predicting actual radiological impacts on the public at far future times. The recent organization processes of the safety assessment are improved by the ISAM working group from IAEA for waste disposal site. These safety assessment methodologies have been modified within SADRWMS IAEA project for the establishment of safety methodologies for the pre-disposal facilities (treatment and storage facilities) and the disposal site.

Safety assessment of genetically modified foods

NARCIS (Netherlands)

Kleter, G.A.; Noordam, M.Y.

2016-01-01

The cultivation of genetically modified (GM) crops has steadily increased since their introduction to the market in the mid-1990s. Before these crops can be grown and sold they have to obtain regulatory approval in many countries, the process of which includes a pre-market safety assessment. The

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...

The pharmacologic and clinical effects of medical cannabis.

Science.gov (United States)

Borgelt, Laura M; Franson, Kari L; Nussbaum, Abraham M; Wang, George S

2013-02-01

Cannabis, or marijuana, has been used for medicinal purposes for many years. Several types of cannabinoid medicines are available in the United States and Canada. Dronabinol (schedule III), nabilone (schedule II), and nabiximols (not U.S. Food and Drug Administration approved) are cannabis-derived pharmaceuticals. Medical cannabis or medical marijuana, a leafy plant cultivated for the production of its leaves and flowering tops, is a schedule I drug, but patients obtain it through cannabis dispensaries and statewide programs. The effect that cannabinoid compounds have on the cannabinoid receptors (CB(1) and CB(2) ) found in the brain can create varying pharmacologic responses based on formulation and patient characteristics. The cannabinoid Δ(9) -tetrahydrocannabinol has been determined to have the primary psychoactive effects; the effects of several other key cannabinoid compounds have yet to be fully elucidated. Dronabinol and nabilone are indicated for the treatment of nausea and vomiting associated with cancer chemotherapy and of anorexia associated with weight loss in patients with acquired immune deficiency syndrome. However, pain and muscle spasms are the most common reasons that medical cannabis is being recommended. Studies of medical cannabis show significant improvement in various types of pain and muscle spasticity. Reported adverse effects are typically not serious, with the most common being dizziness. Safety concerns regarding cannabis include the increased risk of developing schizophrenia with adolescent use, impairments in memory and cognition, accidental pediatric ingestions, and lack of safety packaging for medical cannabis formulations. This article will describe the pharmacology of cannabis, effects of various dosage formulations, therapeutics benefits and risks of cannabis for pain and muscle spasm, and safety concerns of medical cannabis use. © 2013 Pharmacotherapy Publications, Inc.

Quantitative safety assessment of air traffic control systems through system control capacity

Science.gov (United States)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the

Safety assessment of discharge chute isolation barrier preparation and installation

International Nuclear Information System (INIS)

Meichle, R.H.

1994-01-01

This analysis examines activities associated with the installation of isolation barriers in the K Basins at the Hanford Reservation. This revision adds evaluation of barrier drops on stored fuel and basin floor, identifies fuel which will be moved and addresses criticality issues with sludge. The safety assessment is made for the activities for the preparation and installation of the discharge chute isolation barriers. The safety assessment includes a hazard assessment and comparisons of potential accidents/events to those addressed by the current safety basis documentation. No significant hazards were identified. An evaluation against the USQ evaluation questions was made and the determination made that the activities do not represent a USQ. Hazard categorization techniques were used to provide a basis for readiness review classifications

HANFORD SAFETY ANALYSIS & RISK ASSESSMENT HANDBOOK (SARAH)

Energy Technology Data Exchange (ETDEWEB)

EVANS, C B

2004-12-21

The purpose of the Hanford Safety Analysis and Risk Assessment Handbook (SARAH) is to support the development of safety basis documentation for Hazard Category 2 and 3 (HC-2 and 3) U.S. Department of Energy (DOE) nuclear facilities to meet the requirements of 10 CFR 830, ''Nuclear Safety Management''. Subpart B, ''Safety Basis Requirements.'' Consistent with DOE-STD-3009-94, Change Notice 2, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses'' (STD-3009), and DOE-STD-3011-2002, ''Guidance for Preparation of Basis for Interim Operation (BIO) Documents'' (STD-3011), the Hanford SARAH describes methodology for performing a safety analysis leading to development of a Documented Safety Analysis (DSA) and derivation of Technical Safety Requirements (TSR), and provides the information necessary to ensure a consistently rigorous approach that meets DOE expectations. The DSA and TSR documents, together with the DOE-issued Safety Evaluation Report (SER), are the basic components of facility safety basis documentation. For HC-2 or 3 nuclear facilities in long-term surveillance and maintenance (S&M), for decommissioning activities, where source term has been eliminated to the point that only low-level, residual fixed contamination is present, or for environmental remediation activities outside of a facility structure, DOE-STD-1120-98, ''Integration of Environment, Safety, and Health into Facility Disposition Activities'' (STD-1120), may serve as the basis for the DSA. HC-2 and 3 environmental remediation sites also are subject to the hazard analysis methodologies of this standard.

Evaluation of safety assessment methodologies in Rocky Flats Risk Assessment Guide (1985) and Building 707 Final Safety Analysis Report (1987)

International Nuclear Information System (INIS)

Walsh, B.; Fisher, C.; Zigler, G.; Clark, R.A.

1990-01-01

FSARs. Rockwell International, as operating contractor at the Rocky Flats plant, conducted a safety analysis program during the 1980s. That effort resulted in Final Safety Analysis Reports (FSARs) for several buildings, one of them being the Building 707 Final Safety Analysis Report, June 87 (707FSAR) and a Plant Safety Analysis Report. Rocky Flats Risk Assessment Guide, March 1985 (RFRAG85) documents the methodologies that were used for those FSARs. Resources available for preparation of those Rocky Flats FSARs were very limited. After addressing the more pressing safety issues, some of which are described below, the present contractor (EG ampersand G) intends to conduct a program of upgrading the FSARs. This report presents the results of a review of the methodologies described in RFRAG85 and 707FSAR and contains suggestions that might be incorporated into the methodology for the FSAR upgrade effort

Pharmacologic interventions for the prevention and treatment of retinopathy of prematurity.

Science.gov (United States)

Beharry, Kay D; Valencia, Gloria B; Lazzaro, Douglas R; Aranda, Jacob V

2016-04-01

Retinopathy of prematurity (ROP), a significant morbidity in prematurely born infants, is the most common cause of visual impairment and blindness in children and persists till adulthood. Strict control of oxygen therapy and prevention of intermittent hypoxia are the keys in the prevention of ROP, but pharmacologic interventions have decreased risk of ROP. Various drug classes such as methylxanthines (caffeine), VEGF inhibitors, antioxidants, and others have decreased ROP occurrence. The timing of pharmacologic intervention remains unsettled, but early prevention rather than controlling disease progression may be preferred. These drugs act through different mechanisms, and synergistic approaches should be considered to maximize efficacy and safety. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Validity of instruments to assess students' travel and pedestrian safety

Directory of Open Access Journals (Sweden)

Baranowski Tom

2010-05-01

Full Text Available Abstract Background Safe Routes to School (SRTS programs are designed to make walking and bicycling to school safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research validated the SRTS school travel survey and a pedestrian safety behavior checklist. Methods Fourth grade students completed a brief written survey on how they got to school that day with set responses. Test-retest reliability was obtained 3-4 hours apart. Convergent validity of the SRTS travel survey was assessed by comparison to parents' report. For the measure of pedestrian safety behavior, 10 research assistants observed 29 students at a school intersection for completion of 8 selected pedestrian safety behaviors. Reliability was determined in two ways: correlations between the research assistants' ratings to that of the Principal Investigator (PI and intraclass correlations (ICC across research assistant ratings. Results The SRTS travel survey had high test-retest reliability (κ = 0.97, n = 96, p Conclusions These validated instruments can be used to assess SRTS programs. The pedestrian safety behavior checklist may benefit from further formative work.

Efficacy and safety of pharmacological and psychological interventions for the treatment of psychosis and schizophrenia in children, adolescents and young adults: a systematic review and meta-analysis.

Directory of Open Access Journals (Sweden)

Megan R Stafford

Full Text Available Studies report contrasting results regarding the efficacy and safety of pharmacological, psychological, and combined interventions in psychosis and schizophrenia in children, adolescents and young adults.Systematic review and meta-analysis. Embase, Medline, PreMedline, PsycINFO, and CENTRAL were searched to July 2013 without restriction to publication status. Randomised trials comparing any pharmacological, psychological, or combined intervention for psychosis and schizophrenia in children, adolescents and young adults were included. Studies were assessed for bias, and GRADE criteria were used to describe the quality of the results.Twenty-seven trials including 3067 participants were identified. Meta-analyses were performed for 12 comparisons: symptoms, relapse, global state, psychosocial functioning, depression, weight and discontinuation. Low quality evidence demonstrated that antipsychotics have small beneficial effects on psychotic symptoms (SMD = -0.42, 95% CI -0.58 to -0.26, and a medium adverse effect on weight gain (WMD = 1.61, 95% CI 0.61 to 2.60 and discontinuation due to side effects (RR = 2.44, 95% CI, 1.12 to 5.31. There were no trials of psychological treatments in under-18 year olds. There was no evidence of an effect of psychological interventions on psychotic symptoms in an acute episode, or relapse rate, but low quality evidence of a large effect for family plus individual CBT on the number of days to relapse (WMD = 32.25, 95% CI -36.52 to -27.98.For children, adolescents and young adults, the balance of risk and benefit of antipsychotics appears less favourable than in adults. Research is needed to establish the potential for psychological treatments, alone and in combination with antipsychotics, in this population.

Assessment of safety of the nuclear installations of the world

International Nuclear Information System (INIS)

Thomas, B.A.; Pozniakov, N.; Banga, U.

1992-01-01

Incidents and accidents periodically remind us that preventive measures at nuclear installations are not fully reliable. Although sound design is widely recognized to be prerequisite for safe operation, it is not sufficient. An active management that compensates for the weak aspects of the installations design by redundant operational provisions, is the key factor to ensure safe operation. Safety of nuclear installations cannot be assessed on an emotional basis. Since 1986, accurate safety assessment techniques based on an integrated approach to operational safety have been made available by the ASSET services and are applicable to any industrial process dealing with nuclear materials. The ASSET methodology enables to eliminate in advance the Root Causes of the future accidents by introducing practical safety culture principles in the current managerial practices

Safety assessment driving radioactive waste management solutions (SADRWMS Methodology) implemented in a software tool (SAFRAN)

Energy Technology Data Exchange (ETDEWEB)

Kinker, M., E-mail: M.Kinker@iaea.org [International Atomic Energy Agency (IAEA), Vienna (Austria); Avila, R.; Hofman, D., E-mail: rodolfo@facilia.se [FACILIA AB, Stockholm (Sweden); Jova Sed, L., E-mail: jovaluis@gmail.com [Centro Nacional de Seguridad Nuclear (CNSN), La Habana (Cuba); Ledroit, F., E-mail: frederic.ledroit@irsn.fr [IRSN PSN-EXP/SSRD/BTE, (France)

2013-07-01

In 2004, the International Atomic Energy Agency (IAEA) organized the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) to examine international approaches to safety assessment for predisposal management of radioactive waste. The initial outcome of the SADRWMS Project was achieved through the development of flowcharts which could be used to improve the mechanisms for applying safety assessment methodologies to predisposal management of radioactive waste. These flowcharts have since been incorporated into DS284 (General Safety Guide on the Safety Case and Safety Assessment for Predisposal Management of Radioactive Waste), and were also considered during the early development stages of the Safety Assessment Framework (SAFRAN) Tool. In 2009 the IAEA presented DS284 to the IAEA Waste Safety Standards Committee, during which it was proposed that the graded approach to safety case and safety assessment be illustrated through the development of Safety Reports for representative predisposal radioactive waste management facilities and activities. To oversee the development of these reports, it was agreed to establish the International Project on Complementary Safety Reports: Development and Application to Waste Management Facilities (CRAFT). The goal of the CRAFT project is to develop complementary reports by 2014, which the IAEA could then publish as IAEA Safety Reports. The present work describes how the DS284 methodology and SAFRAN Tool can be applied in the development and review of the safety case and safety assessment to a range of predisposal waste management facilities or activities within the Region. (author)

Safety assessment driving radioactive waste management solutions (SADRWMS Methodology) implemented in a software tool (SAFRAN)

International Nuclear Information System (INIS)

Kinker, M.; Avila, R.; Hofman, D.; Jova Sed, L.; Ledroit, F.

2013-01-01

In 2004, the International Atomic Energy Agency (IAEA) organized the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) to examine international approaches to safety assessment for predisposal management of radioactive waste. The initial outcome of the SADRWMS Project was achieved through the development of flowcharts which could be used to improve the mechanisms for applying safety assessment methodologies to predisposal management of radioactive waste. These flowcharts have since been incorporated into DS284 (General Safety Guide on the Safety Case and Safety Assessment for Predisposal Management of Radioactive Waste), and were also considered during the early development stages of the Safety Assessment Framework (SAFRAN) Tool. In 2009 the IAEA presented DS284 to the IAEA Waste Safety Standards Committee, during which it was proposed that the graded approach to safety case and safety assessment be illustrated through the development of Safety Reports for representative predisposal radioactive waste management facilities and activities. To oversee the development of these reports, it was agreed to establish the International Project on Complementary Safety Reports: Development and Application to Waste Management Facilities (CRAFT). The goal of the CRAFT project is to develop complementary reports by 2014, which the IAEA could then publish as IAEA Safety Reports. The present work describes how the DS284 methodology and SAFRAN Tool can be applied in the development and review of the safety case and safety assessment to a range of predisposal waste management facilities or activities within the Region. (author)

Safety assessment of genetically modified crops

International Nuclear Information System (INIS)

Atherton, Keith T.

2002-01-01

The development of genetically modified (GM) crops has prompted widespread debate regarding both human safety and environmental issues. Food crops produced by modern biotechnology using recombinant techniques usually differ from their conventional counterparts only in respect of one or a few desirable genes, as opposed to the use of traditional breeding methods which mix thousands of genes and require considerable efforts to select acceptable and robust hybrid offspring. The difficulties of applying traditional toxicological testing and risk assessment procedures to whole foods are discussed along with the evaluation strategies that are used for these new food products to ensure the safety of these products for the consumer

Assessing progress in the development of safety culture

International Nuclear Information System (INIS)

Rotaru, I.; Ghita, S.; Biro, L.

2002-01-01

This paper is focussed on the organizational culture and learning processes required for the implementation of all aspects of safety culture. There is no prescriptive formula for improving safety culture. However, some common characteristics and practices are emerging that can be adopted by organizations in order to make progress. The paper refers to some approaches that have been successful in a number of countries. The experience of the international nuclear industry in the development and improvement of safety culture could be extended and found useful in other nuclear activities, irrespective of scale. The examples given of specific practice cover a wide range of activities including analysis of events, the regulatory approach on safety culture, employee participation and safety performance measures. Many of these practices may be relevant to smaller organizations and could contribute to improving safety culture, whatever the size of the organization. The most effective approach is to pursue a range of practices that can be mutually supportive in the development of a progressive safety culture, supported by professional standards, organizational and management commitment. Some guidance is also given on the assessment of safety culture and on the detection of a weakening safety culture. Few suggestions for accelerating the safety culture development and improvement process are also provided. (author)

Crane Safety Assessment Method Based on Entropy and Cumulative Prospect Theory

Directory of Open Access Journals (Sweden)

Aihua Li

2017-01-01

Full Text Available Assessing the safety status of cranes is an important problem. To overcome the inaccuracies and misjudgments in such assessments, this work describes a safety assessment method for cranes that combines entropy and cumulative prospect theory. Firstly, the proposed method transforms the set of evaluation indices into an evaluation vector. Secondly, a decision matrix is then constructed from the evaluation vectors and evaluation standards, and an entropy-based technique is applied to calculate the index weights. Thirdly, positive and negative prospect value matrices are established from reference points based on the positive and negative ideal solutions. Thus, this enables the crane safety grade to be determined according to the ranked comprehensive prospect values. Finally, the safety status of four general overhead traveling crane samples is evaluated to verify the rationality and feasibility of the proposed method. The results demonstrate that the method described in this paper can precisely and reasonably reflect the safety status of a crane.

An approach for risk informed safety culture assessment for Canadian nuclear power stations

International Nuclear Information System (INIS)

Nelson, W.R.

2010-01-01

One of the most important components of effective safety and risk management for nuclear power stations is a healthy safety culture. DNV has developed an approach for risk informed safety culture assessment that combines two complementary paradigms for safety and risk management: loss prevention - for preventing and intervening in accidents; and critical function management - for achieving safety and performance goals. Combining these two paradigms makes it possible to provide more robust systems for safety management and to support a healthy safety culture. This approach is being applied to safety culture assessment in partnership with a Canadian nuclear utility. (author)

Safety assessment of existing highway bridges and viaducts

NARCIS (Netherlands)

Maljaars, J.; Steenbergen, R.; Abspoel, L.; Kolstein, M.H.

2012-01-01

The assessment of the structural safety of existing br idges and viaducts becomes increasingly important in many countries owing to an increase in traffic loads. Most existing standards, however, are developed for the design of new structures. For this reason, an assessment method for determining

Development of a New Safety Culture Assessment Method for Nuclear Power Plants (NPPs) (A study to suggest a new safety culture assessment method in nuclear power plants)

International Nuclear Information System (INIS)

Han, Sang Min; Seong, Poong Hyun

2014-01-01

This study is conducted to suggest a new safety culture assessment method in nuclear power plants. Criteria with various existing safety culture analysis methods are united, and reliability analysis methods are applied. The concept of the most representative methods, Fault Tree Analysis (FTA) and Failure Mode and Effect Analysis (FMEA), are adopted to assess safety culture. Through this application, it is expected that the suggested method will bring results with convenience and objectiveness

Development of a New Safety Culture Assessment Method for Nuclear Power Plants (NPPs) (A study to suggest a new safety culture assessment method in nuclear power plants)

Energy Technology Data Exchange (ETDEWEB)

Han, Sang Min; Seong, Poong Hyun [KAIST, Daejeon (Korea, Republic of)

2014-08-15

This study is conducted to suggest a new safety culture assessment method in nuclear power plants. Criteria with various existing safety culture analysis methods are united, and reliability analysis methods are applied. The concept of the most representative methods, Fault Tree Analysis (FTA) and Failure Mode and Effect Analysis (FMEA), are adopted to assess safety culture. Through this application, it is expected that the suggested method will bring results with convenience and objectiveness.

Overview of the ISAM safety assessment methodology

International Nuclear Information System (INIS)

Simeonov, G.

2003-01-01

The ISAM safety assessment methodology consists of the following key components: specification of the assessment context description of the disposal system development and justification of scenarios formulation and implementation of models running of computer codes and analysis and presentation of results. Common issues run through two or more of these assessment components, including: use of methodological and computer tools, collation and use of data, need to address various sources of uncertainty, building of confidence in the individual components, as well as the overall assessment. The importance of the iterative nature of the assessment should be recognised

Building quality into performance and safety assessment software

International Nuclear Information System (INIS)

Wojciechowski, L.C.

2011-01-01

Quality assurance is integrated throughout the development lifecycle for performance and safety assessment software. The software used in the performance and safety assessment of a Canadian deep geological repository (DGR) follows the CSA quality assurance standard CSA-N286.7 [1], Quality Assurance of Analytical, Scientific and Design Computer Programs for Nuclear Power Plants. Quality assurance activities in this standard include tasks such as verification and inspection; however, much more is involved in producing a quality software computer program. The types of errors found with different verification methods are described. The integrated quality process ensures that defects are found and corrected as early as possible. (author)

Safety assessment input for site selection - the Swedish example - 59031

International Nuclear Information System (INIS)

Andersson, Johan

2012-01-01

Svensk Kaernbraenslehantering AB (SKB) has performed comprehensive investigations of two candidate sites for a final repository for Sweden's spent nuclear fuel. In March 2011 SKB decided to submit licence applications for a final repository at Forsmark. Before selection, SKB stated that the site that offers the best prospects for achieving long-term safety in practice would be selected. Based on experiences previous safety assessments, a number of issues related to long-term safety need to be considered in the context of site comparison. The factors include sensitivity to climate change such as periods of permafrost and glaciations, rock mechanics evolution including the potential for thermally induced spalling and sensitivity to potential future earthquakes, current and future groundwater flow, evolution of groundwater composition and proximity to mineral resources. Each of these factors related to long-term safety for the two candidate sites is assessed in a comparative analysis of site characteristics. The assessment also considers differences in biosphere conditions and in the confidence of the site descriptions. The comparison is concluded by an assessment on how the identified differences would affect the estimated radiological risk from a repository located at either of the sites. The assessment concludes that there are a number of safety related site characteristics for which the analyses do not show any decisive differences in terms of implications on safety, between the sites Forsmark and Laxemar. However, the frequency of water conducting fractures at repository depth is much smaller at Forsmark than at Laxemar. This difference, in turn, affects the future stability of the current favourable groundwater composition, which combined with the much higher flows at Laxemar would, for the current repository design, lead to a breach in the safety functions for the buffer and the canister for many more deposition positions at Laxemar than at Forsmark. Thereby

Project SAFE. Update of the SFR-1 safety assessment. Phase 1

International Nuclear Information System (INIS)

Andersson, Johan; Riggare, P.; Skagius, K.

1998-10-01

SFR-1 is a facility for disposal of low-level radioactive operational waste from the nuclear power plants in Sweden. Low-level radioactive waste from industry, medicine, and research is also disposed in SFR-1. The facility is situated in bedrock beneath the Baltic Sea, 1 km off the coast near the Forsmark nuclear power plant. SFR-1 was built between the years 1983 and 1988. An assessment of the long-term performance of the facility was included in the vast documentation that was a part of the application for an operational license. The assessment was presented in the form of a final safety report. In the operational licence for SFR-1 it is stated that renewed safety assessments should be carried out at least each ten years. In order to meet this demand SKB has launched a special project, SAFE (Safety Assessment of Final Disposal of Operational Radioactive Waste). The aim of the project is to update the safety analysis and to prepare a safety report that will be presented to the Swedish authorities not later than year 2000. Project SAFE is divided into three phases. The first phase is a prestudy, and the results of the prestudy are given in this report. The aim of the prestudy is to identify issues where additional studies would improve the basis for the updated safety analysis as well as to suggest how these studies should be carried out. The work has been divided into six different topics, namely the inventory, the near field, the far field, the biosphere, radionuclide transport calculations and scenarios. For each topic the former safety reports and regulatory reviews are scrutinised and needs for additional work is identified. The evaluations are given in appendices covering the respective topics. The main report is a summary of the appendices with a more stringent description of the repository system and the processes that are of interest and therefore should be addressed in an updated safety assessment. However, it should be pointed out that one of the

Human reliability analysis methods for probabilistic safety assessment

International Nuclear Information System (INIS)

Pyy, P.

2000-11-01

Human reliability analysis (HRA) of a probabilistic safety assessment (PSA) includes identifying human actions from safety point of view, modelling the most important of them in PSA models, and assessing their probabilities. As manifested by many incidents and studies, human actions may have both positive and negative effect on safety and economy. Human reliability analysis is one of the areas of probabilistic safety assessment (PSA) that has direct applications outside the nuclear industry. The thesis focuses upon developments in human reliability analysis methods and data. The aim is to support PSA by extending the applicability of HRA. The thesis consists of six publications and a summary. The summary includes general considerations and a discussion about human actions in the nuclear power plant (NPP) environment. A condensed discussion about the results of the attached publications is then given, including new development in methods and data. At the end of the summary part, the contribution of the publications to good practice in HRA is presented. In the publications, studies based on the collection of data on maintenance-related failures, simulator runs and expert judgement are presented in order to extend the human reliability analysis database. Furthermore, methodological frameworks are presented to perform a comprehensive HRA, including shutdown conditions, to study reliability of decision making, and to study the effects of wrong human actions. In the last publication, an interdisciplinary approach to analysing human decision making is presented. The publications also include practical applications of the presented methodological frameworks. (orig.)

A review on indole alkaloids isolated from Uncaria rhynchophylla and their pharmacological studies.

Science.gov (United States)

Ndagijimana, Andre; Wang, Xiaoming; Pan, Guixiang; Zhang, Fan; Feng, Hong; Olaleye, Olajide

2013-04-01

Uncaria rhynchophylla (Miq.) Jacks, Rubiaceae, is one of the original plants of the important Chinese crude drug, Gou-teng, mainly used for the treatment of convulsion, hypertension, epilepsy, eclampsia, and cerebral diseases. The pharmacological activities of this plant are related to the presence of active compounds predominantly indole alkaloids. In this article, we have reviewed some reports about the pharmacological activities of the main indole alkaloids isolated from U. rhynchophylla. This review paper will contribute to the studies on the chemistry, safety and quality control of medicinal preparations containing Uncaria species. Copyright © 2013 Elsevier B.V. All rights reserved.

Initialization of Safety Assessment Process for the Croatian Radioactive Waste repository on Trgovska gora

International Nuclear Information System (INIS)

Lokner, V.; Levanat, I.; Subasic, D.

2000-01-01

An iterative process of safety assessment, presently focusing on the site-specific evaluation of the post-closure phase for the prospective LILW repository on Trgovska gora in Croatia, has recently been initiated. The primary aim of the first assessment iterations is to provide the experts involved, the regulators and the general public with a reasonable assurance that the applicable long term performance and safety objectives can be met. Another goal is to develop a sufficient understanding of the system behavior to support decisions about the site investigation, the facility design, the waste acceptance criteria and the closure conditions. In this initial phase, the safety assessment is structured in a manner following closely methodology of the ISAM. The International Programme for Improving Long Term Safety Assessment Methodologies for Near Surface Radioactive Waste Disposal Facilities the IAEA coordinated research program started in 1997. Results of the safety assessment first iteration will be organized and presented in the form of a preliminary safety analysis report (PSAR), expected to be completed in the second part of the year 2000. As the first report on the initiated safety assessment activities, the PSAR will describe the concept and aims of the assessment process. Particular emphasis will be placed on description of the key elements of a safety assessment approach by: a) defining the assessment context; b) providing description of the disposal system; c) developing and justifying assessment scenarios; d) formulating and implementing models; and e) interpreting the scoping calculations. (author)

Development of the KINS Safety Culture Maturity Model for Self and Independent Assessment

International Nuclear Information System (INIS)

Sheen, C.; Choi, Y.S.

2016-01-01

Safety culture of an organization is cultivated and affected not only by societal and regulatory environment of the organization, but by its philosophies, policies, events and activities experienced in the process of accomplishing its mission. The safety culture would be continuously changed by the interactions between its members along with time as an organic entity. In order to perform a systematic self- or independent assessment of safety culture, a safety culture assessment model (SCAM) properly reflecting cultural characteristics should be necessary. In addition, a SCAM should be helpful not only to establish correct directions, goals, and strategies for safety culture development, but should anticipating obstacles against safety culture development in the implementation process derived from the assessment. In practical terms, a SCAM should be useful for deriving effective guidelines and implementing of corrective action programs for the evaluated organization. Korea Institute of Nuclear Safety (KINS) performed a research project for six years to develop a SCAM satisfying the above prerequisites for self- and independent assessment. The KINS SCAM was developed based on the five stage safety culture maturity model proposed by Professor Patrick Hudson and was modified into four stages to reflect existing safety culture assessment experiences at Korean nuclear power plants. In order to define the change mechanism of safety culture for development and reversion, the change model proposed by Prochaska and DiClemente was introduced into KINS SCAM and developed into the Spiral Change Model.

Climate and climate-related issues for the safety assessment SR-Can

International Nuclear Information System (INIS)

Naeslund, Jens-Ove

2006-11-01

The purpose of this report is to document current scientific knowledge of the climate-related conditions and processes relevant to the long-term safety of a KBS-3 repository to a level required for an adequate treatment in the safety assessment SR-Can. The report also includes a concise background description of the climate system. The report includes three main chapters: A description of the climate system (Chapter 2); Identification and discussion of climate-related issues (Chapter 3); and, A description of the evolution of climate-related conditions for the safety assessment (Chapter 4). Chapter 2 includes an overview of present knowledge of the Earth climate system and the climate conditions that can be expected to occur in Sweden on a 100,000 year time perspective. Based on this, climate-related issues relevant for the long-term safety of a KBS-3 repository are identified. These are documented in Chapter 3 'Climate-related issues' to a level required for an adequate treatment in the safety assessment. Finally, in Chapter 4, 'Evolution of climate-related conditions for the safety assessment' an evolution for a 120,000 year period is presented, including discussions of identified climate-related issues of importance for repository safety. The documentation is from a scientific point of view not exhaustive, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of a safety assessment. As further described in the SR-Can Main Report and in the Features Events and Processes report, the content of the present report has been audited by comparison with FEP databases compiled in other assessment projects. This report follows as far as possible the template for documentation of processes regarded as internal to the repository system. However, the term processes is not used in this report, instead the term issue has been used. Each issue includes a set of processes together resulting in the behaviour of a

Climate and climate-related issues for the safety assessment SR-Can

Energy Technology Data Exchange (ETDEWEB)

Naeslund, Jens-Ove (comp.)

2006-11-15

The purpose of this report is to document current scientific knowledge of the climate-related conditions and processes relevant to the long-term safety of a KBS-3 repository to a level required for an adequate treatment in the safety assessment SR-Can. The report also includes a concise background description of the climate system. The report includes three main chapters: A description of the climate system (Chapter 2); Identification and discussion of climate-related issues (Chapter 3); and, A description of the evolution of climate-related conditions for the safety assessment (Chapter 4). Chapter 2 includes an overview of present knowledge of the Earth climate system and the climate conditions that can be expected to occur in Sweden on a 100,000 year time perspective. Based on this, climate-related issues relevant for the long-term safety of a KBS-3 repository are identified. These are documented in Chapter 3 'Climate-related issues' to a level required for an adequate treatment in the safety assessment. Finally, in Chapter 4, 'Evolution of climate-related conditions for the safety assessment' an evolution for a 120,000 year period is presented, including discussions of identified climate-related issues of importance for repository safety. The documentation is from a scientific point of view not exhaustive, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of a safety assessment. As further described in the SR-Can Main Report and in the Features Events and Processes report, the content of the present report has been audited by comparison with FEP databases compiled in other assessment projects. This report follows as far as possible the template for documentation of processes regarded as internal to the repository system. However, the term processes is not used in this report, instead the term issue has been used. Each issue includes a set of processes together resulting in the

Ultrasound-guided stellate ganglion blocks combined with pharmacological and occupational therapy in Complex Regional Pain Syndrome (CRPS): a pilot case series ad interim.

Science.gov (United States)

Wei, Karin; Feldmann, Robert E; Brascher, Anne-Kathrin; Benrath, Justus

2014-12-01

This preliminary and retrospective pilot case series examines a treatment concept consisting of ultrasound-guided stellate ganglion blocks (SGBs) combined with pharmacological and occupational therapy in patients with complex regional pain syndrome (CRPS) of the hand. Efficacy of combined treatment concepts and safety of ultrasound-guided SGB have not been sufficiently investigated yet. A total number of 156 blocks were evaluated in 16 patients with CRPS in a retrospective analysis. All patients received pharmacotherapy and a standard regimen of occupational therapy offered simultaneously to the SGBs. Changes in both spontaneous and evoked pain levels were assessed by numerical pain rating score before and after the last blockade of a series. Side effects were documented. The overall mean pain reduction was 63.2% regarding spontaneous and 45.3% regarding evoked pain. Mild complications, such as hoarseness or dysphagia, occurred in 13.5% of the blocks (21 SGBs). Serious complications, such as plexus paresis or accidental puncture of vessels or other structures, did not occur. Time between symptom onset and start of treatment did not affect the extent of pain reduction. The combination of ultrasound-guided SGB and simultaneous pharmacological and occupational therapy showed encouraging treatment results under conditions of this pilot case series. Assessment of efficacy of this combined treatment concept and safety of ultrasound-guided SGB require further prospective clinical studies with larger number of participants. Wiley Periodicals, Inc.

Integrated safety assessment report, Haddam Neck Plant (Docket No. 50-213): Integrated Safety Assessment Program: Draft report

International Nuclear Information System (INIS)

1987-07-01

The integrated assessment is conducted on a plant-specific basis to evaluate all licensing actions, licensee initiated plant improvements and selected unresolved generic/safety issues to establish implementation schedules for each item. Procedures allow for a periodic updating of the schedules to account for licensing issues that arise in the future. The Haddam Neck Plant is one of two plants being reviewed under the pilot program. This report indicates how 82 topics selected for review were addressed, and presents the staff's recommendations regarding the corrective actions to resolve the 82 topics and other actions to enhance plant safety. 135 refs., 4 figs., 5 tabs

Safety Assessment Methodologies and Their Application in Development of Near Surface Waste Disposal Facilities--ASAM Project

International Nuclear Information System (INIS)

Batandjieva, B.; Metcalf, P.

2003-01-01

Safety of near surface disposal facilities is a primary focus and objective of stakeholders involved in radioactive waste management of low and intermediate level waste and safety assessment is an important tool contributing to the evaluation and demonstration of the overall safety of these facilities. It plays significant role in different stages of development of these facilities (site characterization, design, operation, closure) and especially for those facilities for which safety assessment has not been performed or safety has not been demonstrated yet and the future has not been decided. Safety assessments also create the basis for the safety arguments presented to nuclear regulators, public and other interested parties in respect of the safety of existing facilities, the measures to upgrade existing facilities and development of new facilities. The International Atomic Energy Agency (IAEA) has initiated a number of research coordinated projects in the field of development and improvement of approaches to safety assessment and methodologies for safety assessment of near surface disposal facilities, such as NSARS (Near Surface Radioactive Waste Disposal Safety Assessment Reliability Study) and ISAM (Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities) projects. These projects were very successful and showed that there is a need to promote the consistent application of the safety assessment methodologies and to explore approaches to regulatory review of safety assessments and safety cases in order to make safety related decisions. These objectives have been the basis of the IAEA follow up coordinated research project--ASAM (Application of Safety Assessment Methodologies for Near Surface Disposal Facilities), which will commence in November 2002 and continue for a period of three years

Operational safety assessment of underground test facilities for mined geologic waste disposal

International Nuclear Information System (INIS)

Elder, H.K.

1993-01-01

This paper describes the operational safety assessment for the underground facilities for the exploratory studies facility (ESF) at the Yucca Mountain Project. The systematic identification and evaluation of hazards related to the ESF is an integral part of the systems engineering process; whereby safety is considered during planning, design, testing, and construction. A largely qualitative approach based on the analysis of potential accidents was used since radiological safety analysis was not required. The risk assessment summarized credible accident scenarios and the design provides mitigation of the risks to a level that the facility can be constructed and operated with an adequate level of safety. The risk assessment also provides reasonable assurance that all identifiable major accident scenarios have been reviewed and design mitigation features provided to ensure an adequate level of safety

Radionuclide transport report for the safety assessment SR-Site

Energy Technology Data Exchange (ETDEWEB)

2010-12-15

This document compiles radionuclide transport calculations of a KBS-3 repository for the safety assessment SR-Site. The SR-Site assessment supports the licence application for a final repository at Forsmark, Sweden

The probability safety assessment impact on the BR2 refurbishment

International Nuclear Information System (INIS)

Pouleur, Yvan

1995-01-01

The probabilistic safety assessment (PSA) study has proven its worth by establishing a sensitive safety screening of the reactor. It has focused engineering forces to technically improve safety systems and to measure the influence of functional modifications. In the future, the project will be developed in a living way, to reinforce the present structure along with continuous safety monitoring of the reactor and to develop engineers and operators safety skills. This paper presents the PSA impact on the BR2 (Belgian Reactor Two) refurbishment. (author)

IAEA Issues Report on Mission to Review Japan's Nuclear Power Plant Safety Assessment Process

International Nuclear Information System (INIS)

2012-01-01

Full text: A team of international nuclear safety experts has delivered its report on a mission it conducted from 21-31 January 2012 to review Japan's process for assessing nuclear safety at the nation's nuclear power plants. International Atomic Energy Agency (IAEA) officials delivered the IAEA Mission Report to Japanese officials yesterday and made it publicly available today. Following the 11 March 2011 accident at TEPCO's Fukushima Daiichi Nuclear Power Station, Japan's Nuclear and Industrial Safety Agency (NISA) announced the development of a revised safety assessment process for the nation's nuclear power reactors. At the request of the Government of Japan, the IAEA organized a team of five IAEA and three international nuclear safety experts and visited Japan to review NISA's approach to the Comprehensive Assessments for the Safety of Existing Power Reactor Facilities and how NISA examines the results submitted by nuclear operators. A Preliminary Summary Report was issued on 31 January. 'The mission report provides additional information regarding the team's recommendations and overall finding that NISA's instructions to power plants and its review process for the Comprehensive Safety Assessments are generally consistent with IAEA Safety Standards', said team leader James Lyons, Director of the IAEA's Nuclear Installation Safety Division. National safety assessments and their peer review by the IAEA are a key component of the IAEA Action Plan on Nuclear Safety, which was approved by the Agency's Member States following last year's nuclear accident at Fukushima Daiichi Nuclear Power Station. The IAEA safety review mission held meetings in Tokyo with officials from NISA, the Japanese Nuclear Energy Safety Organization (JNES), and the Kansai Electric Power Company (KEPCO), and the team visited the Ohi Nuclear Power Station to see an example of how Japan's Comprehensive Safety Assessment is being implemented by nuclear operators. In its report delivered today

Safety assessment of geologic repositories for nuclear waste

International Nuclear Information System (INIS)

Bartlett, J.W.; Burkholder, H.C.; Winegardner, W.K.

1977-01-01

Consideration of geologic isolation for final disposition of radioactive wastes has led to the need for evaluation of the safety of the concept. Such evaluations require consideration of factors not encountered in conventional risk analysis: consequences at times and places far removed from the repository site; indirect, complex, and alternative pathways between the waste and the point of potential consequences; a highly limited data base; and limited opportunity for experimental verification of results. R and D programs to provide technical safety evaluations are under way. Three methods are being considered for the probabilistic aspects of the evaluations: fault tree analysis, repository simulation analysis, and system stability analysis. Nuclide transport models, currently in a relatively advanced state of development, are used to evaluate consequences of postulated loss of geologic isolation. This paper outlines the safety assessment methods, unique features of the assessment problem that affect selection of methods and reliability of results, and available results. It also discusses potential directions for future work

Safety Assessment in the AREVA Group: Operating Experience from a Self-Assessment Tool

International Nuclear Information System (INIS)

Coye de Brunélis, T.; Mignot, E.; Sidaner, J.-F.

2016-01-01

The expression “safety culture” first appeared following analysis of the Chernobyl accident in 1986. It was first defined in INSAG-4 (International Nuclear Safety Advisory Group safety series) in 1991. Other events have occurred in nuclear facilities and during transportation since Chernobyl: Tokai Mura in 1999, Roissy Transport in 2002, Davis Besse in 2002, Thorp in 2005. These events show that the initial approach was too simplistic. Based on this observation, the definition of safety culture was supplemented by including concepts of cultural value (associated with the country and the company) and human and organizational factors, and was integrated in that form with the emergence and implementation of integrated management systems (IMS). Today, the concept of nuclear safety culture covers a wide set of factors such as safety, quality, corporate culture, defined processes and policies, organizations and related resources. Any assessment of people’s safety culture, particularly people directly involved in facility operations, is thus part of a comprehensive policy and contributes to a de facto demonstration of the priority which management assigns to safety.