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Recycled paperboard contains hundreds of non-evaluated or even unidentified substances that could endanger human health if they turn out to be highly toxic. It seems as unrealistic to evaluate each of them as it is to phase out the use of the problematic ones or sort out the papers and boards introducing them into the recyclate. Therefore, measures should be taken that generally reduce migration into food, such as functional barriers or functional sorbents. A general approach is used for the recycling of plastics, particularly poly(ethylene terephthalate), PET: as not every potential contaminant can be regulated, a pragmatic approach is applied, for PET mainly on the required decontamination efficiency. Criteria are required on the required efficacy of the measures to be taken. Recycled paperboard is used for various types of food contact: mostly contact is through the gas phase (evaporation and recondensation), often indirect through other layers (e.g. internal bags or for transport boxes), seldom in wetting contact. Numerous factors have to be considered. For typical folding boxes and at least strongly dominating gas phase contact, it was proposed that no more than 1% of each contaminant in the recycled paperboard should enter the food. The efficiency of the measures required to comply with this criterion depends on the application. The three main measures are reviewed with regard to this criterion: (i) internal bags with an incorporated functional barrier (successfully used for some time), (ii) a barrier layer on the internal wall of the box (for which the design of the closures might be most critical) and (iii) functional sorbents added to the paperboard (for which the sorbent capacity is critical). For transport boxes, commonly of corrugated board (quantitatively the most important use of recycled paperboard in food contact), an adjusted or different criterion is needed.

Since 2012, the European Radiation Dosimetry Group (EURADOS) has developed its Strategic Research Agenda (SRA), which contributes to the identification of future research needs in radiation dosimetry in Europe. Continued scientific developments in this field necessitate regular updates and, consequently, this paper summarises the latest revision of the SRA, with input regarding the state of the art and vision for the future contributed by EURADOS Working Groups and through a stakeholder workshop. Five visions define key issues in dosimetry research that are considered important over at least the next decade. They include scientific objectives and developments in (i) updated fundamental dose concepts and quantities, (ii) improved radiation risk estimates deduced from epidemiological cohorts, (iii) efficient dose assessment for radiological emergencies, (iv) integrated personalised dosimetry in medical applications and (v) improved radiation protection of workers and the public. This SRA will be used as a guideline for future activities of EURADOS Working Groups but can also be used as guidance for research in radiation dosimetry by the wider community. It will also be used as input for a general European research roadmap for radiation protection, following similar previous contributions to the European Joint Programme for the Integration of Radiation Protection Research, under the Horizon 2020 programme (CONCERT). The full version of the SRA is available as a EURADOS report (www.eurados.org).

Objectives The emergence of the 2019 novel coronavirus (SARS-CoV-2) has necessitated evaluation of the potential for SARS-CoV-2 infection in dogs and cats. Using a large data set, we evaluated the frequency of SARS-CoV-2 and other respiratory pathogens in samples submitted for respiratory testing from mid-February to mid-April 2020. Materials and methods A SARS-CoV-2 real-time PCR was developed and validated. A subset of canine and feline samples submitted for respiratory pathogen panel testing to reference laboratories in Asia, Europe, and North America were also tested for SARS-CoV-2. The frequency of respiratory pathogens was compared for the February-April period of 2020 and 2019. Results Samples from 4616 patients were included in the study and 44% of canine and 69% of feline samples were PCR positive with Mycoplasma cynos and Bordetella bronchiseptica and Mycoplasma felis and feline calicivirus, respectively. No SARS-CoV-2 infections were identified. Positive results for respiratory samples were similar between years. Clinical significance The data in this study suggest that during the emergence of the SARS-CoV-2 pandemic in early 2020, respiratory diseases in tested pet cats and dogs were caused by common veterinary pathogens and that SARS-CoV-2 infections in dogs and cats are rare.

Following the fast spread of the coronavirus (Covid-19) across Europe and North America in March 2020, many people started stockpiling commodities like toilet paper. Despite the high relevance for public authorities to adequately address stockpiling behavior, empirical studies on the psychological underpinnings of toilet paper stockpiling are still scarce. In this study, we investigated the relation between personality traits, perceived threat of Covid-19, and stockpiling of toilet paper in an online survey (N = 996) across 22 countries. Results suggest that people who felt more threatened by Covid-19 stockpiled more toilet paper. Further, a predisposition towards Emotionality predicted the perceived threat of Covid-19 and affected stockpiling behavior indirectly. Finally, Conscientiousness was related to toilet paper stockpiling, such that individuals higher in Conscientiousness tended to stockpile more toilet paper. These results emphasize the importance of clear communication by public authorities acknowledging anxiety and, at the same time, transmitting a sense of control.

OBJECTIVE: Even when medical treatments are limited, supporting patients' coping strategies could improve their quality of life. Greater understanding of patients' coping strategies, and influencing factors, can aid developing such support. We examined the prevalence of coping strategies and associated variables.METHODS: We used sociodemographic and baseline data from the ACTION trial, including measures of Denial, Acceptance, and Problem-focused coping (COPE; Brief COPE inventory), of patients with advanced cancer from six European countries. Clinicians provided clinical information. Linear mixed models with clustering at hospital level were used.RESULTS: Data from 675 patients with stage III/IV lung (342, 51%) or stage IV colorectal (333, 49%) cancer were used; mean age 66 (10 SD) years. Overall, patients scored low on Denial and high on Acceptance and Problem-focused coping. Older age was associated with higher scores on Denial than younger age (β = 0.05; CI[0.023; 0.074]), and patients from Italy (β = 1.57 CI[0.760; 2.388]) and Denmark (β = 1.82 CI[0.881; 2.750]) scored higher on Denial than patients in other countries.CONCLUSIONS: Patients with advanced cancer predominantly used Acceptance and Problem-focused coping, and Denial to a lesser extent. Since the studied coping strategies of patients with advanced cancer vary between subpopulations, we recommend taking these factors into account when developing tailored interventions to support patients' coping strategies.

International audience

Environmental radiation monitoring networks have been established in Europe and world-wide for the purpose of protecting population and environment against ionizing radiation. Some of these networks had been established during the cold war period and were improved after the Chernobyl accident in 1986. Today, the German Federal Office for Radiation Protection (BfS) operates an early warning network with roughly 1800 ambient dose equivalent rate (ADER) stations equally distributed over the German territory. The hardware and software of all network components are developed in-house allowing the continuous optimization of all relevant components. A probe characterization and quality assurance and control program are in place. Operational and technical aspects of the network and data harmonization techniques are described. The latter allows for calculating of the terrestrial and net ADER combined with uncertainties mainly from site specific effects. Harmonized data are finally used as input to the German emergency management system and the European radiological data exchange platform.

Introduction: Specific food allergy quality of life questionnaires have been developed within the context of the EuroPrevall project. We aimed to adapt and validate the Food Allergy Quality of Life Questionnaire-Adult Form (FAQLQ-AF) in the Spanish language.Methods: The original English questionnaire was translated and culturally adapted into Spanish following World Health Organization guidelines. The final Spanish version of the FAQLQ-AF (S-FAQLQ-AF) was approved by the original authors. Consecutive patients (>= 18 years old) who fulfilled the following criteria were recruited: 1) diagnosis of food allergy defined as immediate allergic symptoms and a positive prick test or IgE against the culprit food(s) and 2) physician-assessed ability to complete the questionnaires. Patients completed the S-FAQLQ-AF and a Spanish version of the SF-12 questionnaire. Reliability was assessed 10 to 14 days after completion of the first questionnaire.Results: Eighty-two consecutive outpatients were recruited and cross-sectional validity was assessed based on the correlation between the S-FAQLQ-AF and the Food Allergy Independent Measure (FAIM) in this population (rho=0.83, PConclusion: The S-FAQLQ-AF is a valid, short, easy-to-use, and reliable instrument that discriminates between patients with different atopic phenotypes and is suitable for assessing the impact of IgE-mediated food allergy on patient quality of life.

Introduction: Specific food allergy quality of life questionnaires have been developed within the context of the EuroPrevall project. We aimed to adapt and validate the Food Allergy Quality of Life Questionnaire-Adult Form (FAQLQ-AF) in the Spanish language. Methods: The original English questionnaire was translated and culturally adapted into Spanish following World Health Organization guidelines. The final Spanish version of the FAQLQ-AF (S-FAQLQ-AF) was approved by the original authors. Consecutive patients (>= 18 years old) who fulfilled the following criteria were recruited: 1) diagnosis of food allergy defined as immediate allergic symptoms and a positive prick test or IgE against the culprit food(s) and 2) physician-assessed ability to complete the questionnaires. Patients completed the S-FAQLQ-AF and a Spanish version of the SF-12 questionnaire. Reliability was assessed 10 to 14 days after completion of the first questionnaire. Results: Eighty-two consecutive outpatients were recruited and cross-sectional validity was assessed based on the correlation between the S-FAQLQ-AF and the Food Allergy Independent Measure (FAIM) in this population (rho=0.83, P Conclusion: The S-FAQLQ-AF is a valid, short, easy-to-use, and reliable instrument that discriminates between patients with different atopic phenotypes and is suitable for assessing the impact of IgE-mediated food allergy on patient quality of life.

This study provides a systematic approach for assessment of contaminants in materials for recycling. Paper recycling is used as an illustrative example. Three selected chemicals, bisphenol A (BPA), diethylhexyl phthalate (DEHP) and mineral oil hydrocarbons (MOHs), are evaluated within the paper cycle. The approach combines static material flow analysis (MFA) with dynamic material and substance flow modeling. The results indicate that phasing out of chemicals is the most effective measure for reducing chemical contamination. However, this scenario was also associated with a considerable lag phase (between approximately one and three decades) before the presence of chemicals in paper products could be considered insignificant. While improved decontamination may appear to be an effective way of minimizing chemicals in products, this may also result in lower production yields. Optimized waste material source-segregation and collection was the least effective strategy for reducing chemical contamination, if the overall recycling rates should be maintained at the current level (approximately 70% for Europe). The study provides a consistent approach for evaluating contaminant levels in material cycles. The results clearly indicate that mass-based recycling targets are not sufficient to ensure high quality material recycling.

Anaerobic digestion of organic waste generated by households, businesses, agriculture, and industry is an important approach as method of waste treatment - especially with regard to its potential as an alternative energy source and its cost-effectiveness. Separate collection of biowaste from households or vegetal waste from public green spaces is already established in some EU-27 countries. The material recovery in composting plants is common for biowaste and vegetal waste. Brewery waste fractions generated by beer production are often used for animal feeding after a suitable preparation. Waste streams from paper industry generated by pulp and paper production such as black liquor or paper sludge are often highly contaminated with toxic substances. Recovery of chemicals and the use in thermal processes like incineration, pyrolysis, and gasification are typical utilization paths. The current utilization of organic waste from households and institutions (without agricultural waste) was investigated for EU-27 countries with Germany as an in-depth example. Besides of biowaste little is known about the suitability of waste streams from brewery and paper industry for anaerobic digestion. Therefore, an evaluation of the most important biogas process parameters for different substrates was carried out, in order to calculate the biogas utilization potential of these waste quantities. Furthermore, a calculation of biogas energy potentials was carried out for defined waste fractions which are most suitable for anaerobic digestion. Up to 1% of the primary energy demand can be covered by the calculated total biogas energy potential. By using a "best-practice-scenario" for separately collected biowaste, the coverage of primary energy demand may be increased above 2% for several countries. By using sector-specific waste streams, for example the German paper industry could cover up to 4.7% and the German brewery industry up to 71.2% of its total energy demand.

WOS: 000380137500017 PubMed: 27146949 The aim of this study was the optimisation of a multi-analyte method for the analysis of primary aromatic amines ( PAAs) from napkins in order to support official controls and food safety. We developed a UHPLC- MS/ MS method for the simultaneous determination of 36 toxicologically relevant PAAs for paper and board. Good regression coefficients of the calibration curves in a range of 0.992- 0.999 and reproducibilities in a range of 2.3- 15% were obtained. Limits of detections ( LODs) were in the range of 0.03-1.4 mu g l(-1) and recoveries were in a range of 21-110% for all the amines. A total of 93 coloured paper napkin samples from different European countries were bought and extracted with water to determine the PAAs. The results showed that 42 of 93 samples contained at least one PAA. More than half of the detected PAAs are considered as toxic, carcinogenic or probably carcinogenic to humans by the International Agency for Research on Cancer ( IARC), or are classified as such in the European Union legislation on chemicals. Summed concentrations of PAAs in seven samples were higher than 10 mu g l(-1), the limit of summed PAA in the European Union plastic food contact material regulation. Also, eight PAAs, classified as Category 1A and 1B carcinogen in the European Union legislation of chemicals, were detected at concentrations higher than 2 mu g l(-1), exceeding the limit proposed by the Federal Institute for Risk Assessment in Germany. Aniline ( n = 14) was most frequently present in higher concentrations followed by o-toluidine, o-anisidine, 2,4-dimethylaniline and 4-aminoazobenzene. Red, orange, yellow and multicoloured paper napkins contained the highest concentrations of total PAAs (> 10 mu g l(-1)). Although the European Union has not harmonised the legislation of paper and board materials and, thus, there is no specific migration limit for PAAs from paper napkins, the present study showed that coloured paper napkins can contain toxic and carcinogenic PAAs at concentrations that are relevant for monitoring.

Modern veterinary medicine offers numerous options for treatment and clinicians must decide on the best one to use. Interventions causing short-term harm but ultimately benefitting the animal are often justified as being in the animal's best interest. Highly invasive clinical veterinary procedures with high morbidity and low success rates may not be in the animal's best interest. A working party was set up by the European College of Veterinary Anaesthesia and Analgesia to discuss the ethics of clinical veterinary practice and improve the approach to ethically challenging clinical cases. Relevant literature was reviewed. The 'best interest principle' was translated into norms immanent to the clinic by means of the 'open question argument'. Clinical interventions with potential to cause harm need ethical justification, and suggest a comparable structure of ethical reflection to that used in the context ofin vivoresearch should be applied to the clinical setting. To structure the ethical debate, pertinent questions for ethical decision-making were identified. These were incorporated into a prototype ethical tool developed to facilitate clinical ethical decision-making. The ethical question 'Where should the line on treatment be drawn' should be replaced by 'How should the line be drawn?'

Specific food allergy quality of life questionnaires have been developed within the context of the EuroPrevall project. We aimed to adapt and validate the Food Allergy Quality of Life Questionnaire-Adult Form (FAQLQ-AF) in the Spanish language.The original English questionnaire was translated and culturally adapted into Spanish following World Health Organization guidelines. The final Spanish version of the FAQLQ-AF (S-FAQLQ-AF) was approved by the original authors. Consecutive patients ( 18 years old) who fulfilled the following criteria were recruited: 1) diagnosis of food allergy defined as immediate allergic symptoms and a positive prick test or IgE against the culprit food(s) and 2) physician-assessed ability to complete the questionnaires. Patients completed the S-FAQLQ-AF and a Spanish version of the SF-12 questionnaire. Reliability was assessed 10 to 14 days after completion of the first questionnaire.Eighty-two consecutive outpatients were recruited and cross-sectional validity was.assessed based on the correlation between the S-FAQLQ-AF and the Food Allergy Independent Measure (FAIM) in this population (rho = 0.83, P.0001). The S-FAQLQ-AF showed excellent internal consistency (Cronbach α, 0.95). S-FAQLQ-AF domains also had excellent internal consistency: α = 0.93 for allergen avoidance-dietary restrictions; α = 0.83 for emotional impact; α = 0.85 for risk of accidental exposure, and α = 0.66 for food allergy related health. Limited correlation was found between the S-FAQLQ-AF and the SF-12.The S-FAQLQ-AF is a valid, short, easy-to-use, and reliable instrument that discriminates between patients with different atopic phenotypes and is suitable for assessing the impact of IgE-mediated food allergy on patient quality of life.

As part of an International Agency for Research on Cancer (IARC) international epidemiological study of workers in the pulp and paper industry, previously unpublished exposure measurements were assembled in a database. This article summarizes the results of 3,873 measurements carried out in the production departments of paper and paperboard mills and recycling plants in 12 countries. In the paper and paperboard mills, most of the agents were measured in the pulping and refining departments and in on-machine coating and winding of paper/paperboard. Exposures to asbestos, carbon monoxide, formaldehyde, fungal spores, bacteria, nitrogen dioxide, minerals dusts, paper dust, sulphuric acid and different solvents sometimes exceeded exposure limit values. In the re-pulping and de-inking departments of recycling plants high exposures to formaldehyde, fungal spores, bacteria and paper dust were observed. High exposures to asbestos, bioaerosols, carbon monoxide and paper dust were found in many departments; ammonia, formaldehyde, mineral and paper dust and solvents were found in coating machines; and diphenyl and polychlorobiphenyls (PCBs) were found in some special circumstances. Measurements in the newsprint and uncoated paper machine departments revealed only a few elevated exposures. In nearly all departments, measurements of epichlorohydrin, PCBs, sulphur dioxide, hydrogen sulphide and mercaptans tended to be low, often even below their detection limits. In spite of some uncertainties in the measurement data, the study provides new insights into the level and variation of occupational exposures of production workers in the paper and paperboard industry. © Springer-Verlag 2004.

A field study was developed in a new landfill for refuse from construction and demolition (C&D) material recovery plants of small size (4 Ha.) in Europe, with the aim of evaluating the liquid and gas emissions in this type of facility at a large scale. It included characterization of the materials, monitoring leachate and gas quantity and composition. Besides thermometers, piezometers and sampling ports were placed in several points within the waste. This paper presents the data obtained for five years of the landfill life. The materials disposed were mainly made up of wood and concrete, similar to other C&D debris sites, but the amount of gypsum drywall (below 3% of the waste) was significantly smaller than other available studies, where percentages above 20% had been reported. Leachate contained typical C&D pollutants, such as different inorganic ions and metals, some of which exceeded other values reported in the literature (conductivity, ammonium, lead and arsenic). The small net precipitation in the area and the leachate recirculation into the landfill surface help explain these higher concentrations, thus highlighting the impact of liquid to solid (L/S) ratio on leachate characteristics. In contrast to previous studies, neither odor nuisances nor significant landfill gas over the surface were detected. However, gas samples taken from the landfill inside revealed sulfate reducing and methanogenic activity.

The manufacture of paper generates significant quantities of wastewater; as high as 60 m3/tonne of paper produced. The raw wastewaters from paper and board mills can be potentially very polluting. Indeed, a recent survey within the UK industry has found that their chemical oxygen demands can be as high as 11000 mg/l. This paper reviews the processes involved in paper making and examines the effects which they could have on the environment. It also evaluates the treatment processes which are used to minimise these effects. In line with the majority of UK practice, it focuses mainly on aerobic biological treatment and, in particular, on the activated sludge process. This means that there is an in-depth discussion about the problems associated with filamentous bacteria and sludge "bulking". The paper also discusses the way in which anaerobic digestion can be applied to the treatment of liquid wastes from the manufacture of paper.

In this work, a detailed technical-economic analysis of a fluidized bed based waste-to-energy system for disposal of paper manufacturing sludges has been carried out. Specific reference is made to a case study represented by the largest plant in Italy producing recycled paper, with a daily sludge output of about 52 t. The adopted plant has been sized for a nominal capacity of 140 t per day also allowing the progressive elimination of sludges accumulated in a previously utilized landfill, giving a nominal electrical power output of 3.5 MW. The main plant sections have been described and the adopted technical solutions have been outlined. A detailed process and equipment characterization has been carried out leading to a thorough evaluation of capital investment, operating costs and revenues. A differential analysis has been performed with respect to the alternative solution represented by the disposal of untreated sludges in an external landfill in order to highlight the savings obtainable. The economic profitability of the investment has been evaluated regarding several performance indices. The economic evaluation has been completed by a sensitivity and risk analysis in order to assess the effects of uncertainties in the economically significant parameters. Adopting most probable values, the savings obtained with the considered waste-to-energy system are evaluated in the 15–20 million Euro range during the estimated plant life of 15 years with a foreseen pay back time of 4 years. Moreover, many environmental benefits result such as the remediation of existing landfill, the avoidance of new landfills opening and very low air pollutants emissions.

Although coastal eutrophication is generally recognised as a recent phenomenon related to the well-documented increase in riverine nutrient delivery during the last 30 or 40 years, a few historical records paradoxically show that, in some places like the Southern Bight of the North Sea, or the Northern Adriatic, algal proliferation as intense as presently observed was already regularly occurring at the end of the 19th century. Estimated riverine nutrient loads from diffuse sources or from domestic point sources of waste water at that time are too low to account for these observations. We attempted a retrospective evaluation of the possible contribution of industrial activity to nutrient river loading. The figures indicate that, by the end of the last century, large scale use of traditional processes in textile and paper industries, in tanneries, candles factories and others was responsible for a dominant part of the nutrient load carried by rivers in Western Europe and could have caused nutrient inputs to coastal zones similar to the present ones.

Nicotine is recognized to be the major inducer of tobacco dependence. The smoking of cigarettes as an advantageous delivery system for nicotine, accelerates and aggravates cardiovascular disease, and is causally associated with increased risks for chronic obstructive lung disease, cancer of the lung and of the upper aerodigestive system, and cancer of the pancreas, renal pelvis, and urinary bladder. It is also associated with cancer of the liver, cancer of the uterine cervix, cancer of the nasal cavity, and myeloid leukemia. In 1950, the first large-scale epidemiological studies documented that cigarette smoking induces lung cancer and described a dose-response relationship between number of cigarettes smoked and the risk for developing lung cancer. In the following decades these observations were not only confirmed by several hundreds of prospective and case-control studies but the plausibility of this causal association was also supported by bioassays and by the identification of carcinogens in cigarette smoke. Whole smoke induces lung tumors in mice and tumors in the upper respiratory tract of hamsters. The particulate matter of the smoke elicits benign and malignant tumors on the skin of mice and rabbits, sarcoma in the connective tissue of rats, and carcinoma in the lungs of rats upon intratracheal instillation. More than 50 carcinogens have been identified, including the following classes of compounds: polynuclear aromatic hydrocarbons (PAH), aromatic amines, and N-nitrosamines. Among the latter, the tobacco-specific N-nitrosamines (TSNA) have been shown to be of special significance. Since 1950, the makeup of cigarettes and the composition of cigarette smoke have gradually changed. In the United States, the sales-weighted average "tar" and nicotine yields have declined from a high of 38 mg "tar" and 2.7 mg nicotine in 1954 to 12 mg and 0.95 mg in 1992, respectively. In the United Kingdom, the decline was from about 32 mg "tar" and 2.2 mg nicotine to less than 12 mg "tar" and 1.0 mg nicotine per cigarette. During the same time, other smoke constituents changed correspondingly. These reductions of smoke yields were primarily achieved by the introduction of filter tips, with and without perforation, selection of tobacco types and varieties, utilization of highly porous cigarette paper, and incorporation into the tobacco blend of reconstituted tobacco, opened and cut ribs, and "expanded tobacco." In most countries where tobacco blends with air-cured (burley) tobacco are used, the nitrate content of the cigarette tobacco increased. In the United States nitrate levels in cigarette tobacco rose from 0.3-0.5% to 0.6-1.35%, thereby enhancing the combustion of the tobacco. More complete combustion decreases the carcinogenic PAH, yet the increased generation of nitrogen oxides enhances the formation of the carcinogenic N-nitrosamines, especially the TSNA in the smoke. However, all analytical measures of the smoke components have been established on the basis of standardized machine smoking conditions, such as those introduced by the Federal Trade Commission, that call for 1 puff to be taken once a minute over a 2-s period with a volume of 35 ml. These smoking parameters may have simulated the way in which people used to smoke the high-yield cigarettes; however, they no longer reflect the parameters applicable to contemporary smokers, and especially not those applicable to the smoking of low- and ultra-low-yield filter cigarettes. Recent smoking assays have demonstrated that most smokers of cigarettes with low nicotine yield take between 2 and 4 puffs per minute with volumes up to 55 ml to satisfy their demands for nicotine. The overview also discusses further needs for reducing the toxicity and carcinogenicity of cigarette smoke. From a public health perspective, nicotine in the smoke needs to be lowered to a level at which there is no induction of dependence on tobacco.

The first Open Access (OA) peer reviewed online journals in aerospace were all established after 2007. Still today more and more OA aerospace journals get started. Many publishers are located in less developed countries. The benefits of OA publishing are undisputed in the academic community, but there is disagreement if the new publishers can work to required standards. The current situation is evaluated based on an Internet review. OA journals in aerospace are listed with their major characteristics. Well known OA publishers charge high publication fees, whereas less known OA publishers tend to charge relatively low fees. All publishers need to be carefully checked for their level of rigor in peer review and their offered service in the scholarly publication process. Authors should evaluate OA journals and publishers against provided lists of criteria before submitting their work.

The newly updated FDA Guidance for Industry on Process Validation: General Principles and Practices ushers in a life cycle approach to process validation. While the guidance no longer considers the use of traditional three-batch validation appropriate, it does not prescribe the number of validation batches for a prospective validation protocol, nor does it provide specific methods to determine it. This potentially could leave manufacturers in a quandary. In this paper, I develop a Bayesian method to address the issue. By combining process knowledge gained from Stage 1 Process Design (PD) with expected outcomes of Stage 2 Process Performance Qualification (PPQ), the number of validation batches for PPQ is determined to provide a high level of assurance that the process will consistently produce future batches meeting quality standards. Several examples based on simulated data are presented to illustrate the use of the Bayesian method in helping manufacturers make risk-based decisions for Stage 2 PPQ, and they highlight the advantages of the method over traditional Frequentist approaches. The discussions in the paper lend support for a life cycle and risk-based approach to process validation recommended in the new FDA guidance. LAY ABSTRACT: The newly updated FDA Guidance for Industry on Process Validation: General Principles and Practices ushers in a life cycle approach to process validation. While the guidance no longer considers the use of traditional three-batch validation appropriate, it does not prescribe the number of validation batches for a prospective validation protocol, nor does it provide specific methods to determine it. This potentially could leave manufacturers in a quandary. In this paper, I develop a Bayesian method to address the issue. By combining process knowledge gained from Stage 1 Process Design (PD) with expected outcomes of Stage 2 Process Performance Qualification (PPQ), the number of validation batches for PPQ is determined to provide a high level of assurance that the process will consistently produce future batches meeting quality standards. Several examples based on simulated data are presented to illustrate the use of the Bayesian method in helping manufacturers make risk-based decisions for Stage 2 PPQ, and THEY highlight the advantages of the method over traditional Frequentist approaches. The discussions in the paper lend support for a life cycle and risk-based approach to process validation recommended in the new FDA guidance.

With the development of modern waste management systems in Western Europe, a remarkable increase in the distances for waste transportation has been observed. The question thus arises whether recycling with longer transport distances is ecologically advantageous or whether disposal without recycling is to be preferred. This situation was analysed using selected product and waste streams. This included refrigerators, paper, polyethylene films and expanded polystyrene. For each of these streams, a life cycle analysis was conducted with an emphasis on waste transport. The system boundaries were set in terms of the generation of waste to recycling or landfilling. The comparison included several scenarios with recycling and different transport distances. Landfilling was used as the reference scenario. The results obtained demonstrated how transport distances influence the ecological benefit of recycling. In the case of expanded polystyrene, the ecological boundaries are reached in practical situations, while with other materials these boundaries are far from being attained. In these cases, more complex and elaborate collection schemes, such as kerbside collection, which is economically convenient and shows the highest collection rates, can also be recommended.

Background: Previous studies have shown an inverse gradient in socioeconomic status for disability after stroke. However, no distinction has been made between the period in the stroke rehabilitation unit (SRU) and the period after discharge. The purpose of this study was to examine the impact of education and equivalent income on motor and functional recovery for both periods. Methods: 419 consecutive patients were recruited from six SRUs across Europe. The Barthel Index (BI) and Rivermead Motor Assessment (RMA) were measured on admission, at discharge and 6 months after stroke. Ordinal logistic regression models were used, adjusting for case mix. Cumulative odds ratios (OR) were calculated to measure differences in recovery between educational levels and income groups with adjustments for case mix. Results: Patients with a low educational level were less likely to improve on the BI (OR 0.53; 95% CI 0.32 to 0.87) and the RMA arm during inpatient stay (OR 0.54; 95% CI 0.31 to 0.94). For this period, no differences in recovery were found between income groups. After discharge, patients with a low equivalent income were less likely to improve on all three sections of the RMA: gross function (OR 0.20; 95% CI 0.06 to 0.66), leg and trunk (OR 0.22; 95% CI 0.09 to 0.55) and arm (OR 0.30; 95% CI 0.10 to 0.87). No differences were found for education. Conclusions: During inpatient rehabilitation, educational level was a determinant of recovery, while after discharge, equivalent income played an important role. This study suggests that it is important to develop a better understanding of how socioeconomic factors affect the recovery of stroke patients.

To assess overall resource consumption, work capacity and quality of life of patients with multiple sclerosis in nine European countries.Information on resource consumption related to multiple sclerosis, informal care by relatives, productivity losses and overall quality of life (utility) was collected with a standardised pre-tested questionnaire from 13,186 patients enrolled in national multiple sclerosis societies or followed up in neurology clinics. Information on disease included disease duration, self-assessed disease severity and relapses. Mean annual costs per patient (Euro, 2005) were estimated from the societal perspective.The mean age ranged from 45.1 to 53.4 years, and all levels of disease severity were represented. Between 16% and 29% of patients reported experiencing a relapse in the 3 months preceding data collection. The proportion of patients in early retirement because of multiple sclerosis ranged from 33% to 45%. The use of direct medical resources (eg, hospitalisation, consultations and drugs) varied considerably across countries, whereas the use of non-medical resources (eg, walking sticks, wheel chairs, modifications to house and car) and services (eg, home care and transportation) was comparable. Informal care use was highly correlated with disease severity, but was further influenced by healthcare systems and family structure. All types of costs increased with worsening disease. The total mean annual costs per patient (adjusted for gross domestic product purchasing power) were estimated at Euro 18,000 for mild disease (Expanded Disability Status Scale (EDSS)4.0), Euro 36,500 for moderate disease (EDSS 4.0-6.5) and Euro 62,000 for severe disease (EDSS7.0). Utility was similar across countries at around 0.70 for a patient with an EDSS of 2.0 and around 0.45 for a patient with an EDSS of 6.5. Intangible costs were estimated at around Euro 13,000 per patient.

The studies reported here examined differences in user behaviour when presented with a low-fidelity paper prototype compared to fully operational product, and evaluated the effectiveness of different types of enhanced labelling of controls. In the first study with a paper prototype, 30 users of high-pressure washers were asked to choose the settings of the temperature control for different cleaning objects, comparing standard with information-enriched control labelling. In the second study, 34 users operated a real high-pressure washer with different forms of control labelling. The results of both studies provided evidence for some benefits of an information-enriched control labelling over traditional temperature-centred controls labelling. Furthermore, a comparative analysis of the data of the two studies suggested that low-fidelity paper prototypes may have to be used with caution. Therefore, designers need to be aware that the behavioural effects induced by different design modifications may be overestimated when using paper prototypes. The implications of the findings are discussed within the framework of an enlarged concept of fidelity.

Background: The medical care of patients with acute stroke varies considerably between countries. This could lead to measurable differences in mortality and functional outcome. Objective: To compare case mix, clinical management, and functional outcome in stroke between 11 countries. Methods: All 1484 patients from 11 countries who were enrolled into the tinzaparin in acute ischaemic stroke trial (TAIST) were included in this substudy. Information collected prospectively on demographics, risk factors, clinical features, measures of service quality (for example, admission to a stroke unit), and outcome were assessed. Outcomes were adjusted for treatment assignment, case mix, and service relative to the British Isles. Results: Differences in case mix (mostly minor) and clinical service (many of prognostic relevance) were present between the countries. Significant differences in outcome were present between the countries. When assessed by geographical region, death or dependency were lower in North America (odds ratio (OR) adjusted for treatment group only = 0.52 (95% confidence interval, 0.39 to 0.71) and north west Europe (OR = 0.54 (0.37 to 0.78)) relative to the British Isles; similar reductions were found when adjustments were made for 11 case mix variables and five service quality measures. Similarly, case fatality rates were lower in North America (OR = 0.44 (0.30 to 0.66)) and Scandinavia (OR = 0.50 (0.33 to 0.74)) relative to the British Isles, whether crude or adjusted for case mix and service quality. Conclusions: Both functional outcome and case fatality vary considerably between countries, even when adjusted for prognostic case mix variables and measures of good stroke care. Differing health care systems and the management of patients with acute stroke may contribute to these findings.

Background: There are significant variations in the short term patterns of care and outcome after a first stroke in Europe. Objective: To estimate the variation in stroke care and outcome up to 1 year after a stroke in selected European centres. Methods: Hospital based stroke registers were established in 11 hospitals in seven western and central European countries to collect demographic, clinical, and resource use data at the time of first ever stroke during 1993–4. At 3 and 12 months, details of survival, activities of daily living score, and use of services were recorded. Univariate comparisons between centres were made using the χ2 test and stepwise regression was used to identify associations between centre, case mix, therapy provision, and outcomes. Results: Of the 4048 patients registered, 23% were lost to follow up and 38% had died at 1 year. The proportions of survivors who felt they needed assistance at 12 months ranged from 35% in Italy to 77% in UK2. There were comparatively high amounts of therapy provided up to 1 year in UK3, France and Germany 1, mainly at home. At 1 year, social services were still providing support in UK1, UK5 and France, with some support in Germany 1 and family support was provided in France. In multivariate analysis, after adjustment for case mix and receipt of rehabilitation, non-UK centres had improved activities of daily living (p

This paper discusses the relationship between environmental and economic performance and the influence of corporate strategies with regard to sustainability and the environment. After formulating a theoretical model, results are reported from an empirical analysis of the European paper manufacturing industry. New data are used to test hypotheses derived from the theoretical model, using environmental performance indices representing different corporate environmental strategy orientations. In particular, an emissions-based index largely reflecting end-of-pipe strategies and an inputs-based index reflecting integrated pollution prevention are distinguished. For the emissions-based index, a predominantly negative relationship between environmental and economic performance is found, whereas for the inputs-based index no significant link is found. This is consistent with the theoretical model, which predicts the possibility of different relationships. The results also show that for firms with pollution prevention-oriented corporate environmental strategies, the relationship between environmental and economic performance is more positive, thus making improvements in corporate sustainability more likely. Based on this last insight, managerial implications of this are discussed with regard to strategy choices, investment decisions and operations management.

Soluble silicates, commercially known as waterglass, are among the largest volume synthetic chemicals in the world. Silicon from waterglass is rapidly transformed to the biologically active orthosilicic acid (referred to as dissolved silicate). This paper aims to assess the impact of waterglass on the aquatic environment in Western Europe. The emission to surface waters from the four most relevant application areas, household detergents, pulp and paper production, water and wastewater treatment, and soil stabilization, is estimated to be ca. 88-121 kton of SiO2 per year. This is a small fraction (

Objective: To survey the current clinical treatment of refractory status epilepticus and to identify steps in its management which may need further investigation. Methods: Epileptologists and critical care neurologists were surveyed using a standardised postal questionnaire. Results: Sixty three of 91 participants (69%) returned the questionnaires. Two thirds of the respondents applied another non-anaesthetising anticonvulsant after failure of first line drugs. General anaesthesia for ongoing complex partial status epilepticus (CPSE) was part of the therapeutic regimen of 75% of the interviewees. A non-barbiturate as general anaesthetic of first choice was used by 42%. Up to 70% titrated the anaesthetic to achieve a burst suppression pattern in the electroencephalogram, indicating deep sedation, and 94% reduce anaesthesia within 48 hours. Conclusions: The management of refractory status epilepticus is heterogeneous in many aspects, even among clinicians who are most familiar with this severe condition. Randomised trials are needed to compare the efficacy, side effects, optimal duration, and depth of general anaesthesia.

Current methodology used for studying the microflora of pulps and boards was assessed and some improvements are recommended. Microbiological quality of 37 samples including recycled fibre pulps, boards, kitchen rolls, virgin fibre sheets and circulating process water were investigated. The papermaking process had drastically reduced the total microbial counts. The dominant microflora in all the samples were aerobic bacteria. The amounts in boards were only 103–106 cfu g−1 d.w., whereas the untreated pulps contained 108–1010 cfu g−1 d.w. Aerobic, anaerobic and facultatively anaerobic spore‐forming bacteria formed a large group in the bacterial flora of pulp samples (103–106 and 102–104 cfu g−1 d.w., respectively). In the boards the maximum numbers of aerobic spore‐forming bacteria were about 104 cfu g−1 d.w. and the numbers of anaerobic and facultatively anaerobic spore formers were negligible. Moulds were common in the untreated pulp samples at 102–106 cfu g−1 d.w., but their occurrence in boards was close to the detection limit. Yeasts were common only in the pulps of one mill, and were found to be present in the circulating process water. Both mesophilic and thermophilic actinomycetes were detected in pulps at levels up to 102–105 cfu g 1 d.w. However, no mesophilic actinomycetes were detected in boards, although some boards contained up to 102 cfu g−1 d.w. of thermophilic actinomycetes. The virgin fibre sheets were practically free of microbes. Only a few bacterial colonies were detected from the kitchen rolls.

The history of the urinary test papers does not being in the post-war period. As early as the 1880's some practitioners and pharmacists tried to replace the complicated wet-chemical procedures and apparatus by "dry chemistry." The first popular test paper for sugar and albumin originated in England in 1883. Dry reagents for proving hematuria have been available since the beginning of this century. Until the 1930s a wide palette of commercial urine tests with "modern" brand names was established. A methodological breakthrough was created by the spot test chemistry inaugurated by the Austrian, Fritz Feigl, about 1920. Using the capillary properties of filter paper in enhancing color reactions he founded a new area of analytical chemistry. Many of the pioneers were recruited from Jewish scientists. In this lecture is proposed that their emigration and banishment as well as the Second World War have stopped the development of urinary diagnostics on the European continent. In the post-war period the American industry succeeded to the leading position in the researching and marketing of test papers. In 1956, the triumphal progress of the "stick tests" began with the "Clinistix" (Ames Company, today Bayer Diagnostic).

Papers used for food packing were studied for formaldehyde migration from them by the colorimetric method with acetylacetone. The studied material comprised 14 samples of paper of Polish or foreign production: pergamenous paper, offset and sulphite papers and one sample from waste paper imported from Germany. Formaldehyde migration from these samples differed but never exceeded 1 mg/dm2, with the exception of the recycled paper from which it was 1.77 mg/dm2.

In the past 20 years, there have been numerous reports of skin and mucous membrane disorders allegedly caused by the use of carbonless copy paper, to such an extent that some people in Europe were refusing to work with it and concern was expressed in the European Parliament. In view of its undoubted convenience and superiority over carbon paper, the author was asked by the Commission of the European Communities for a report. Based on visits to manufacturers and users and the investigation of complaints, the conclusion is that, as exposure to the constituents of the paper during its manufacture is considerably greater than in its use and no cases have arisen in his experience in the industry, the complaints are more likely to be attributable to "sick building syndrome" than to the specific effect of any component of the paper.

Summary: Within the quality control scheme of the Deutsche Gesellschaft fur Klinische Chemie, seven quali-ty control surveys of thyrotropin (TSH) determinations in blood dried on filter paper have been carried outsince 1980. Ninety-six screening laboratories from 12 European countries took part in these surveys. In asingle survey each participant usually analysed four different samples; each of these consisted of three spots ofdried blood spiked with defined amounts of thyrotropin. For the evaluations of the surveys the participantswere asked to give Information about their analytical results, and from these, their diagnostic classifications.The medians of the analytical results correlated well with the given thyrotropin concentrations, but the indi-vidual estimations from different laboratories varied greatly. Major discrepancies of classification were alsoapparent, both in the given thyrotropin concentrations and in the individual estimations.Two special coHaborative studies with nine selected laboratories showed on the one band that analysis of thelafgest possible part of the dried blood sample can help to optimize the precision of the results; on the otherband, considerable drawbacks related to the reagents and the methods were sometimes observed.