[Approach of noise emission limit value sciences: on the topic of stress during the day and at night].
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Aircraft↗
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Threshold values in toxicology - useful or not?
In many fields of toxicology, numbers are used as threshold values, e.g. as "acceptable daily intake values" resulting in maximum permissible concentrations in food or in animal feed by using "safety factors"; maximal admissible concentrations of toxic substances in the air at the workplace; cut-off values in analytical toxicology; limit values for biological specimens in the case of driving under the influence of drugs, guidance values for environmental specimens, etc. The philosophy behind these values must be well understood and they should only be applied to real cases by persons with enough toxicological background. The bad use of these numbers in toxicology can have dramatic consequences. Especially in regulatory toxicology their use should be made with great care. Moreover, tremendous improvements in analytical methodology, e.g. the decreasing of the limits of detection for many potentially toxic substances in recent years, should not end up in an overestimation of risks to humans. To avoid these abuses careful interpretations of analytical findings by qualified toxicologists are of paramount importance. The use and abuse of some of these threshold values will be outlined in several applications from analytical toxicology, risk assessment issues, forensic toxicology in post-mortem cases, as well as from the drugs and driving cases. Generally, if threshold values are considered as guidance values and not as the "absolute truth" in toxicology, they may be very useful in the interpretation of toxicology data.
Food Inspection↗
Improvement of LDL-C laboratory values achieved by participation in a cardiac or diabetes disease management program.
Poor lipid control is a risk factor for cardiovascular diseases and diabetes complications. Frequently, however, patients with these diseases do not achieve blood lipid levels recommended by current standards of care. A retrospective study of 67,244 members eligible for disease management (DM) was initiated to evaluate the ability of interventions to promote improvement in low-density lipoprotein cholesterol (LDL-C) laboratory values for people with cardiovascular diseases or diabetes. The baseline trend in improving LDL-C values in the absence of DM was established. A two-year period prior to the start of the DM intervention was examined to measure the mean percent change in LDL-C values that was occurring in the population. The mean percent change observed for this pre-intervention group was then compared to the change in LDL-C values observed during the DM study period. A significant reduction in elevated LDL-C values (F-test; p < 0.0001) was observed for members who participated in the DM interventions, even when elevated LDL-C was defined as low as > or =70 mg/dL. Members with LDL-C values within threshold limits maintained these levels during the DM program. The significant reduction in elevated LDL-C values and maintenance of optimal values (< 100 mg/dL) was observed over the course of 3 years of participation in a DM program. A subset of the population also was examined to assess the impact of telephone intervention on reducing elevated LDL-C values. A significant relationship between receiving care calls and reduction in elevated LDL-C levels was observed; members who received calls achieved up to a 32.5% relative reduction in elevated LDL-C values compared to members who did not receive calls. In conclusion, these findings demonstrate the ability of DM interventions to assist a large, geographically diverse member population in reducing a clinical laboratory value.
Cardiovascular Diseases↗
[A "technically attainable" refernce value for exposure to wood dust in the light of Law 66/2000].
The question of appropriate exposure standards for wood dust is addressed by reference to the major health effects, especially sino-nasal cancer, that have been investigated. A review of several key papers on wood dust exposure permits some associations to be made between exposure data and effects, particularly impaired/suppressed nasal mucociliary clearance, according to which it may be suggested, based on available evidence, that a standard of 1.5-2 mg/m3 of total suspended wood dust could reasonably protect against the observed effects. Moreover, data from the literature show that reducing personal wood dust exposures to below 2 mg/m3 is accomplished relatively easily, whereas reducing exposures to below 1 mg/m3 is considerably more difficult and expensive. The exposure level of 1.5-2 mg/m3 is suggested for all wood dusts; it does not seem reasonable at the present time to distinguish between hardwood and softwood because many of the important mortality studies report results based on patients with mixed exposures. The threshold exposure value of 5 mg/m3 for hardwood proposed from 1/1/2003 by Law 66/2000 is deemed to be too high as a health-based occupational exposure limit.
Dust↗
Predicting residue solvent accessibility from protein sequence by considering the sequence environment.
The solvent accessibility of each residue is predicted on the basis of the protein sequence. A set of 338 monomeric, non-homologous and high-resolution protein crystal structures is used as a learning set and a jackknife procedure is applied to each entry. The prediction is based on the comparison of the observed and the average values of the solvent-accessible area. It appears that the prediction accuracy is significantly improved by considering the residue types preceding and/or following the residue whose accessibility must be predicted. In contrast, the separate treatment of different secondary structural types does not improve the quality of the prediction. It is furthermore shown that the residue accessibility is much better predicted in small than in larger proteins. Such a discrepancy must be carefully considered in any algorithm for predicting residue accessibility.
Amino Acid Sequence↗
Normal intersubject threshold variability and normal limits of the SITA SWAP and full threshold SWAP perimetric programs.
PURPOSE: To compare intersubject variability and normal limits of threshold values between the new Swedish interactive test algorithm short wavelength automated perimetry (SITA SWAP) and the older Full Threshold SWAP programs (Carl Zeiss Meditec, Dublin, CA). METHODS: Normal reduction of differential light sensitivity with age, age-corrected thresholds, intersubject variability, and normal limits of sensitivity were calculated from SITA SWAP and Full Threshold SWAP fields obtained in 53 normal subjects between 20 and 72 years of age. RESULTS: Age influence on threshold sensitivity was the same with the two SWAP programs. On average, sensitivity decreased by 0.13 dB per year of age. Age-corrected normal threshold sensitivity was significantly higher (P<0.0001) for SITA SWAP than for Full Threshold SWAP. The means for a subject 45.4 years of age were 28.8 dB with SITA SWAP and 24.4 dB with Full Threshold SWAP. Intersubject variance was 22% smaller with SITA SWAP than with Full Threshold SWAP. Normal limits at the P<5% significance level were, on average, 14% narrower with SITA SWAP than with Full Threshold SWAP using Total Deviations from age-corrected normal thresholds and 11% narrower when applying Pattern Deviation, which is intended to adjust for general depression or elevation of the field. CONCLUSIONS: SITA SWAP test results from normal eyes showed higher sensitivities than results from the older Full Threshold SWAP. This represents an increase of the dynamic range, which implies that more patients can be tested with SWAP. The smaller intersubject variability with SITA SWAP means narrower normal limits and may be associated with more sensitive probability maps.
Adult↗
Specific Contributions of Politics, Economics, and Toxicology in Setting Socially Consensual Limit Values
/ Limit values are legal limits for the concentrations of substances in the environment. They must be agreed upon in a consensual procedure between science, economics/technology, and political forces. This is a crucial political precondition for their social acceptance. The arguments put forward to justify their expediency and numerical level are based not only on risk-benefit considerations but also on the aspect of the technical avoidability of direct and indirect exposure. The critical assessment of the direct benefit of specified exposures falls within the responsibility of economics/technology, whereas criteria for their potential adverse effects (direct and indirect) are provided by medicine/biochemistry and/or ecology. Within this concept, the avoidance of nonbeneficial-even if not openly adverse-exposure is the essential aim of environmental hygiene and should be promoted by politics/science. In general, society or segments thereof reject adverse, accept beneficial, and tolerate unavoidable exposure. Conflicts of interest arise when different groups of society simultaneously define a given exposure as being adverse, beneficial, and unavoidable. Therefore, from the viewpoint of society as a whole, an optimal exposure lies as far as reasonably achievable at a level lower than known or plausible adverse effect thresholds (as defined by toxicology or ecology). This optimal level of exposure must be determined using a transparent and, hence, public procedure.KEY WORDS: Legal limit values; Benefit threshold; Social acceptance; Social tolerability; Adverse effect threshold; Avoidable exposure; Tolerance threshold; Environmental hygiene
Journal Article↗
Safeguarding crushing points by limitation of forces.
Limitation of forces can be a simple measure to safeguard crushing points at doors, machines, and vehicles. In this connection different standards define a threshold force value of 150 N. This widely accepted value refers to static forces only. The dynamic forces that arise from impact on a person are frequently ignored, although they are generally higher than the static forces. The article describes an instrument for the measurement of static and dynamic crushing forces. This instrument has a stiffness that approximates the average stiffness of human fingers as one of the most at-risk parts of the human body with regard to crushing injuries. Sensory tests were carried out to define dynamic forces considered admissible at crushing points.
Adult↗
[Assessment of health-risk groups by the german public health service and realisation of preventive measures].
Recognizing concealed health risks and pertaining high-risk groups is a cardinal task of the Public Health Services. As far as relevant environmental pollutions concerned protection of high-risk groups on the basis of appreciation of the average load and also of the 90th-percentile is insufficient. Public health strategies must be found which also include protection of the most highly exposed 10 % of the population. More than thousand years of mining and metallurgical engineering in the Harz mountains is the reason why heavy metal contamination in soil and air by arsenic, cadmium and lead is a problem in parts of the Harz region. Small children playing in soil with their "Pica-behaviour", hand to mouth contact, to the most endangered group. Therefore it was the duty of the District Community Physician to declare limit values for heavy metals and arsenic in the soil of child playgrounds. Experiences in Goslar/Harz region are reported.
Body Burden↗
Multi-lineage interrogation of the performance characteristics of a split-signal fluorescence in situ hybridization probe for anaplastic lymphoma kinase gene rearrangements: a study of 101 cases characterized by immunohistomorphology on fixed archival tissue.
BACKGROUND: Fluorescence in situ hybridization (FISH) can identify chromosomal translocations on fixed archival tissue, but studies cross-validating the utility of FISH on lesions of different cell lineages that harbor similar translocations (e.g. those involving anaplastic lymphoma kinase [ALK]) have not been published. AIM: Our objective was to define the diagnostic utility, performance characteristics, and limitations of a commercially available, split-signal, FISH probe for ALK gene rearrangements on fixed, archived tissue from lesions of diverse cell lineage. STUDY DESIGN: The sensitivity, specificity, and positive and negative predictive values of the Vysis ALK FISH probe were compared with those of the ALK-1 antibody (Dako) in a series of 101 cases, comprising 43 hematolymphoid neoplasms, 4 reactive lymphoid controls, 50 non-hematolymphoid (including neuroectodermal, epithelial, myofibroblastic, and germ cell) lesions, and 4 early-trimester aborted fetuses that served as neuroblastic controls. METHODS: The study involved a predominantly (72%) Singaporean Chinese population aged between 9 months and 88 years (excluding the aborted fetal controls). All cases were reviewed both histologically and immunohistochemically with a wide panel of antibodies using the standard protocols in order to diagnose them according to the latest WHO classification systems. A positive cut-off value was determined, both by comparison with diagnostic categories with and without ALK translocations, as well as with negative controls. RESULTS: The ALK FISH probe suffered a 33% non-informative rate, but in informative cases it showed 94% concordance with the ALK-1 immunostain. A minimum cut-off value of 5 in 200 informative cells was adopted to make a positive call in each case. Of the ALK-1 immunoreactive lesions, nine lymphomas were concordantly ALK translocation-positive but one vesical inflammatory myofibroblastic tumor was discordantly FISH-negative. Among the ALK-1-immunonegative lesions, one case each of anaplastic lymphoma and pulmonary mycobacterial spindle cell pseudotumor were discordantly ALK FISH-positive, while a case each of intestinal myeloblastic tumor and ganglioglioma showed initial--but not reproducible--positive FISH readings. The remaining cases were concordantly negative. DISCUSSION: The discrepancies between ALK FISH results and well-established immunomorphological parameters indicate that interpretation is not always straightforward. Notably, the derivation of threshold cut-off values for positive calls on FISH assays has seldom been addressed in the literature, and has raised issues in interpreting cases with borderline positivity in this study. The factors that may influence such cut-off values are extensively reviewed. CONCLUSIONS: We propose the term 'conditional threshold positivity' to encourage the adoption of different cut-off values for making positive calls in lesions of different origin.
Adolescent↗
A proposed methodology for setting occupational exposure limits for hydrocarbon solvents.
Occupational exposure limit (OEL) development for hydrocarbon solvents is complicated because most of these solvents have complex compositions and only a few representative constituents have been studied in detail. A proposed solution to this problem is to group constituents with similar physical, chemical, and toxicological properties and to assign "guidance values" to each group. A unique OEL can then be calculated for each solvent, using a reciprocal calculation procedure (RCP) based on the liquid composition. This procedure follows the American Conference of Governmental Industrial Hygienists' (ACGIH) generic advice for complex mixtures and is recommended by the U.K. Health and Safety Executive for OEL calculations by hydrocarbon solvent manufacturers. The RCP is justified, as the toxicological properties of the constituents are additive and the differences between the vapor and liquid compositions do not substantially affect the calculated exposure limits. The guidance values are based principally on acute central nervous system depression and eye and respiratory tract irritation, effects that are the most sensitive indicators of hydrocarbon solvent exposure. One benefit of this procedure is that it is a relatively simple but practical procedure that requires limited compositional information. Further, it provides OEL recommendations that are consistent with occupational experience and current regulatory advice. Groupings and guidance values are proposed, and sample calculations are provided.
Eye Diseases↗
A new method using a health index (HI) to screen low level toxic organic substances in consumer products.
To ensure selection of appropriate materials for industrial use in terms of toxicity, a procedure to estimate a health index (HI) that can be used for prioritizing less hazardous components of consumer products is described. The HI is based on the occupational exposure limits (OELs) of organic substances that compose the products. To calculate the HI of a product, it is often necessary to predict OEL values for the substances for which an OEL value has not yet been promulgated. We developed a method to estimate the OEL values from median lethal dose (LD50) data of rodent. A good correlation between known OEL values and the LD50 data was obtained by a multivariate regression analysis by introducing organic compensation coefficients, which were caluculated as 10 to the Bth power where B is the regression coefficient of dummy variables denoting the characteristics of the organic compounds such as functional groups, molecular structures, and so on. We believe that the use of the present method should be limited to predicting unknown OEL values for the HI and used for material prioritization. It should not be extended to determinations of regulatory OELs.
Consumer Product Safety↗
[Definition of low threshold volumes for quality assurance: conceptual and methodological issues involved in the definition and evaluation of thresholds for volume outcome relations in clinical care].
In a large number of mostly retrospective association studies, a statistical relationship between volume and quality of health care has been reported. However, the relevance of these results is frequently limited by methodological shortcomings. In this article, criteria for the evidence and definition of thresholds for volume-outcome relations are proposed, e.g. the specification of relevant outcomes for quality indicators, analysis of volume as a continuous variable with an adequate case-mix and risk adjustment, accounting for cluster effects and considering mathematical models for the derivation of cut-off values. Moreover, volume thresholds are regarded as surrogate parameters for the indirect classification of the quality of care, whose diagnostic validity and effectiveness in improving health care quality need to be evaluated in prospective studies.
Confounding Factors, Epidemiologic↗
Predictors of weaning outcome in chronic obstructive pulmonary disease patients.
Several threshold values for predicting weaning outcome from mechanical ventilation have been proposed. These values, however, have been obtained in nonhomogeneous patient populations. The aim of the present study was to determine the threshold values in chronic obstructive pulmonary disease (COPD) patients and compare them to those reported for nonhomogeneous patient populations. The initial weaning trial included 81 COPD patients. Fifty-three of them underwent a successful weaning trial, whereas 28 failed it. The latter were enrolled into the present investigation, and were restudied during a subsequent successful trial. The weaning indices used were those reported in the literature. The threshold values obtained were within 10% of those reported for a nonhomogeneous patients population only for tidal volume and effective compliance. The classification error was <20% for maximal inspiratory pressure (MIP), occluded inspiratory pressure swing (deltaPI)/MIP, rapid and shallow breathing (respiratory frequency/tidal volume), and compliance, rate, oxygenation, pressure index (CROP), whereas the area under the receiver operating characteristic curves was >0.9 only for deltaPI/MIP and CROP. In conclusion, the threshold values obtained in chronic obstructive pulmonary disease patients who failed the first weaning attempt differed from those previously reported. Although a gold standard weaning index is not available for chronic obstructive pulmonary disease patients, the occluded inspiratory pressure swing/ maximal inspiratory pressure and compliance, rate, oxygenation, pressure index may be candidates for such a role.
Acute Disease↗
[A proposed method for evaluating short-term exposure condition].
High short-term exposure to toxic chemicals can occur during a workday, even if the daily average exposure is lower than the permissible exposure limit, because the exposure concentration varies from minute to minute. To protect workers from acute health effects due to high short-term exposure, the Japan Society for Occupational Health recommends that the maximum value for 15-min time-weighted average (15-min TWA) exposure during a workday should not exceed 1.5 times the occupational exposure limit for 8-hr TWA, and the American Conference of Governmental Industrial Hygienists issues the threshold limit value-short-term exposure limit (TLV-STEL), that is a 15-min TWA exposure which should not be exceeded at any time during a workday. A workday (8 hr) consists of thirty two 15-min periods. If the thirty-two 15-min TWAs are measured, the short-term exposure situation can be appropriately evaluated by comparing the highest measured value with the standard value (e.g. TLV-STEL), but such continuous monitoring consumes a lot of cost and time. In this paper, we propose a method for evaluating short-term exposure by using three or more measured values. This evaluation method corresponds to two different types of selection of sampling periods. One is a random selection of three or more 15-min periods among the 32 periods. If this selection is adopted, a comparison between the 98.44 percentile of the within-day distribution of 15-min TWAs and the standard value can be made by using one-sided tolerance factors, KI, KII and KIII, and the exposure situation is classified into four exposure classes at 95% and 50% confidence levels. Another is a random selection among high exposure periods. If this selection is adopted, a comparison between the specific percentile of the distribution and the standard value can be made with modified one-sided tolerance factors, and the exposure class is determined similarly. This method can provide a precise evaluation of exposure, so that it is useful in the industrial hygiene field.
Chemical Industry↗
Color vision loss among styrene-exposed workers neurotoxicological threshold assessment.
Styrene represents nowadays one of the most used organic solvent. The current exposure limit proposed for this chemical differs significantly from country to country: the Threshold Limit Value-Time Weighted Average (TLV-TWA) proposed by the American Conference of Governmental Industrial Hygienists (ACGIH) is 50 ppm while the German, Finnish and Swedish occupational exposure limit is 20 ppm. Nevertheless, effects on the nervous system were recently reported in workers exposed at TWA styrene levels below the current TLV. Neuro-optic pathways have been shown to be particularly vulnerable to organic solvent exposure. Analysis and measurements of visual functions can provide important information on early neurotoxic effects. Previous studies support the hypothesis that styrene exposure can induce a dose-dependent color vision loss. The aim of this study is to assess a threshold level below which no detectable effect occurs for color vision. We applied a sub-application of the change point problem in two-phase regression considering one phase as a constant line. In accordance with this model the maximum-likelihood technique was used as a method to examine the dose- effect relationship between external styrene exposure and chromatic discrimination. The present article presents a joint analysis of data from two previously published studies, one carried out in Canada and the other in Italy. The age and seniority of the workers from both countries were remarkably similar, as were the process type, the chemicals used and the work-tasks of exposed subjects. The mathematical method presented here shows the existence of a statistically significant threshold. This finding shows that, in fiberglass-reinforced plastics industry, visual color impairment could be significantly detected above 4 ppm (upper limit of the confidence interval at 5% = 26 ppm). The exact clinical meaning of this effect, and also the progress of the impairment in exposed workers, is still to be assessed in further studies. The results of our study support the need of a reduction of the occupational limits for styrene in workplaces to values close to or lower than German, Finnish or Swedish exposure limits.
Adult↗
[Toxicologically determined indoor air guidelines values].
At the Austrian Ministry for Environment (now: Federal Ministry for agriculture and forestry, environment and water management) a working group was established to propose indoor air guideline values. This consists of representatives of different disciplines, such as physicians, toxicologists, engineers and lawyers. Already in the constituent meeting it was decided to employ a set pattern for establishing toxicologically sound guideline values. It was then agreed to use the pattern proposed by the German ad-hoc-working team. The interdisciplinary discussions, however, demonstrated the need for additional clarification, since representatives of different disciplines obviously interpret the various terms and principles differently. In particular, there is a need for discussing in detail the relation between the guideline values for indoor air to other air quality standards (outdoor air and workplace) and to specify their scope and application, especially the need to describe in greater detail what should be done in case either guideline value I or II was exceeded.
Air Pollution, Indoor↗
Differences in national legislation for the implementation of lead regulations included in the European directive for the protection of the health and safety of workers with occupational exposure to chemical agents (98/24/EC).
BACKGROUND: The European Council Directive 98/24 on the protection of the health and safety of workers exposed to chemical agents sets out provisions for environmental and biological monitoring, making specific reference to binding limit values and health surveillance measures for those with exposure to lead OBJECTIVES: To compare how the Directive has been implemented at a national level in EU countries and to determine whether workers receive equivalent protection. METHODS: Information on selected key issues was collected from 14 EU countries by means of a structured questionnaire. RESULTS: National occupational exposure limit values generally reflect that set by the Directive (0.15 mg/m(3)), but in five cases lower limits are set. National binding biological limit values range from 20 microg/100 ml blood in one country up to 80 microg/100 ml blood in others. The risk to the unborn child is generally recognised with specific measures for women of child-bearing potential or those that are pregnant or breast feeding. In only three countries are special arrangements included for young workers. Limits at which medical surveillance is put into effect are more consistent at 40 microg/100 ml in most countries. The Directive also refers to guidelines for health surveillance but none have been issued with respect to lead. Thus monitoring strategies and requirements for analytical performance vary considerably. CONCLUSIONS: The results of this survey suggest that protection of workers against the risk of exposure to lead at work is far from uniform across the European Union. Such disparity may also have implications on the requirements set at national level for laboratories measuring lead in blood and/or air. In the interest of harmonisation within the EU, further consideration should be given to the Annex II of the EC Directive 98/24, taking into account the suggestions for lower binding limit values for lead; this should include full guidelines for medical surveillance and requirements for laboratories should be issued.
Environmental Monitoring↗