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The AETL methodology as a potential solution to current challenges associated with the development and use of acute exposure levels in Seveso II applications.

This paper analyses current trends in the development and use of acute exposure levels in Europe for the implementation of the Seveso II Directive [Council Directive 96/82/EC of December 9, 1996 on the control of major-accident hazards involving dangerous substances. Official Journal of the European Communities, vol. L 10, January 14, 1997, Luxembourg, pp. 13-33]. It also describes a new initiative to develop a European methodology for deriving acute exposure threshold levels that responds to emerging needs in this area. The need for acute exposure values to predict human health effects of potential accidents on exposed populations has burgeoned in recent years. As the driving legislation for managing industrial hazards in Europe, the Seveso II Directive has particularly influenced this trend. Yet at this time it is questionable whether the availability and range of acute exposure values for toxic substances has kept apace with the growing need. Results of a survey of Seveso II competent authorities in the EU-15 revealed that a variety of different types of acute exposure values (AEGLs, EPRGs, etc.) are used for Seveso II applications. Moreover, a comparison of these values indicates gaps in coverage of substances as well as inconsistencies in terms of how health effects and exposure periods are defined for each type. These findings highlight an opportunity for greater collaboration on scientific inputs to application of the Directive in Europe. The ACUTEX project is an EU-funded research project aimed at furthering scientific exchange and collaboration in support of the development of acute exposure levels for toxic substances in Europe. Its goal is to develop a European methodology for deriving acute exposure threshold levels (AETLs). In particular, it provides the possibility for a common European platform for developing additional acute exposure values to meet emerging needs and cover more chemical substances. To maximise success, the work plan is designed to meet two very important challenges, the need to complement and add value to the existing array of acute exposure methodologies and the necessity of meeting requirements of a diverse range of European stakeholders. As such the project will draw on collaboration among European scientists and process of deliberation among stakeholders to deliver the following key results: (1) to facilitate wide acceptance of the methodology in Europe by both the scientific community and communities of different end-users; (2) to provide greater equivalence and transparency in implementation of the Seveso II Directive across the Member States, specifically through the development of common scientific bases for assessing risks and making risk management decisions related to toxic releases; (3) to produce a methodology that remains open to future collaboration on derivation of acute exposure levels on a European and a global basis.

Accident Prevention↗

Modeling ship transportation risk

This article presents results from the Commission of the European Communities (CEC) project "Safety of Shipping in Coastal Waters" (SAFECO). The project was performed by ten European partners during the period 1995-1998. The principal aim of the SAFECO project was to determine the influences that could increase the safety of shipping in coastal waters by analyzing the underlying factors contributing to the marine accident risk level. The work reported here focuses on the Marine Accident Risk Calculation System (MARCS) that was further developed during the SAFECO project. This paper presents the methods used by MARCS, as well as data and results from a "demonstration of concept" case study covering the North Sea area. The estimated accident frequencies (number of accidents per year) were compared with historical accident data, to demonstrate the validity of the modeling approach. Reasonable (within a factor of 5) to good (within a factor of 2) agreement between calculated accident frequencies and observed accident statistics was generally obtained. However, significant discrepancies were identified for some ship types and accident categories. The risk model has particular problems with estimating the accident frequency for drift grounding in general and powered grounding for ferries. It was concluded that these discrepancies are related to uncertainties in several areas, specifically in the risk model algorithms, the traffic data, the error and failure probability data, and the historical accident statistics.

Journal Article↗

A new era in the European marketplace.

While many American healthcare supply companies already do business in a global market, the European Community's impending switch to a single-market system and the radical changes in Eastern European countries in recent months should spell increased opportunities overseas. However, as European trade barriers come down, the level of competition is likely to go up, both at home and abroad.

Commerce↗

European School of Oncology Advisory report to the European Commission for the "Europe Against Cancer Programme" European Code Against Cancer.

A European School of Oncology Advisory Group has reviewed the European Code Against Cancer after its initial use over a 6-year period. With minor modifications, the original ten recommendations were found to be adequate, although it was agreed that an Annex was necessary to explain the scientific evidence supporting each point, and is presented herewith. Tobacco smoking clearly remains the most important cause of cancer, and now it can be quantified better than ever before. It is also clear that it is never too late to stop smoking: stopping even in middle age, prior to the onset of serious illness has a beneficial effect on life expectancy. Alcohol drinking is an important cause of cancer, and yet modest consumption levels protect against cardiovascular disease mortality. The optimal strategy seems to be a consumption not exceeding 2-3 drinks per day, although this limit may be lower for women. Increased consumption of fruits and vegetables, reduction in consumption of fatty foods, reduction of obesity and increased physical activity can all be recommended to reduce cancer risk. Exposure to excessive sunlight remains a problem which should be limited. Control of occupational cancer is a three-way partnership: legislation identifies and limits exposure to known carcinogens, employers enact the legislation and workers should respect the measures introduced. There are a number of signs and symptoms which may lead to cancer being diagnosed earlier, and patients with these should be referred to a doctor. For women, participation in organised programmes of cervical cancer and breast cancer (after 50 years of age) should lead to a reduction in mortality from these forms of cancer. The key element is organised programmes, where quality control and quality assurance are in force. These revised recommendations are the result of an agreement following advice, review and dialogue with cancer experts throughout Europe. They were approved by the European Community Cancer Experts at their meeting in Bonn on 28-29 November 1994. Their implementation by the European population should greatly reduce cancer incidence and mortality.

Alcohol Drinking↗

Recent activities of EC4 in the harmonization of clinical chemistry in the European Union.

This article describes the recent activities of the European Communities Confederation of Clinical Chemistry (EC4). Main goal of EC4 is harmonization of clinical chemistry in the European Union and Europe. EC4's actions connected to that are training and registration of professionals, and accreditation of laboratories. The 35000 professionals practising clinical chemistry in the EU have different backgrounds (medical, pharmaceutical, science-oriented, veterinary, or microbiological). Thus, for the harmonization of training of clinical chemists, EC4 has published a European Syllabus for Postgraduate Training, and instituted a European Union Register for Clinical Chemists. The Syllabus is an indication of the level of requirements in postgraduate training. The EC4 initiative to implement the European Register for Clinical Chemists is based on the 8 years vocational training necessary to obtain sufficient knowledge in clinical chemistry according to the European Syllabus. A guide to the EC4 Register has been published; registration leads to the title European Clinical Chemist (EurClinChem). The accreditation of laboratories must be based on a total quality management system. EC4 has described guidelines (essential criteria) which it judges appropriate for establishing the quality of medical laboratory service; it does not wish to fulfil the role of an accrediting body. Moreover, a working group has been set up to seek to harmonize the work of national accrediting bodies. Therefore, it is logical that EC4 monitors the activities of the different standardizing bodies that might influence the practice of clinical chemistry in the EU. Finally, some aspects concerning the future strategy of EC4 are brought forward.

Chemistry, Clinical↗

Vera Mia Beets-Proper v. F. van Lanschot Bankiers NV, 21 November 1986.

The Supreme Court of the Netherlands held that a provision of a contract stipulating that a female employee was entitled to a pension at age 60 and a male employee at age 65 was void and in violation of European Community Council Directive of 9 September 1976. It reached this decision following a similar decision by the European Court of Justice.

Developed Countries↗

Essential criteria for quality systems in medical laboratories.

The introduction of total quality systems in medical and clinical laboratories and accreditation of these laboratories is gaining more and more interest. In several countries laboratories have set up quality systems, and accrediation schemes are also operating. The standards of these schemes have much in common although several differences exist. There exists uncertainty in several countries on the choice of a system. Laboratory specialists are confronted with a new way of thinking concerning the management and daily practice of their laboratories. It is not clear, which standards should be used as a basis, and certainly not how to interpret such standards. Particulary in the European Union, harmonisation of criteria for quality systems is desirable. In the present paper, the document entitled "Essential Criteria for Quality Systems in Medical Laboratories" is presented. The document has been accepted in the general Assembly of the European Communities Confederation of Clinical Chemistry (EC4) and by the working group on Good Laboratory Services of the European Council on Laboratory Medicine (ECLM). The criteria in the document are focussed on the particular situation of medical laboratories, including pre- and post-analytical aspects. Reference is made, where applicable, to EN 45001, ISO 9001 and ISO guide 25 draft 3.

Chemistry, Clinical↗

Process indicators from ten centres in the Finnish breast cancer screening programme from 1991 to 2000.

The aim of this study was to evaluate the quality of the Finnish mammography programme by assessing process indicators from 10 screening centres using data from the first and subsequent screens. We compared these screen-specific indicators with European standards and results from countries with similar screening protocols. Ten Finnish centres invited approximately 1,000,000 women from 1991-2000. Women were mainly 50-64 years old. Mean compliance amongst this age group was 90% at the first and 93% at subsequent screens. The corresponding recall rates were 4.6% and 2.3%, respectively. The average breast cancer detection rates were 0.44% and 0.36%, respectively. The positive predictive values (PPVs) of mammography at the first and subsequent screens were 10% (range 7-20%) and 16% (range 12-31%), and the corresponding benign to malignant (B:M) biopsy ratios were 1:1 (range 0.5-1.8:1) and 0.4:1 (range 0.3-0.8:1). The PPV of mammography increased significantly during the study period, and the average process indicators fulfilled the criteria of the European community for the most part. However, the variation in PPVs was wide, as has been seen for other European mammography programmes, indicating meaningful differences in diagnostic criteria and potential adverse effects.

Adult↗

European Pharmacopoeia foot-and-mouth disease vaccine potency testing in cattle: between test variability and its consequences.

In the event of a foot-and-mouth (FMD) outbreak in a densely populated livestock area within the European Community, emergency vaccination will most likely be employed. The objective of the present study was to support the European FMD control policy by evaluating the between test variability of the European accepted method for assessing the potency, a major determinant in vaccine choice, of an FMD vaccine batch. The test system suffers from low in vivo repeatability and reproducibility (67.6 and 58.8%, respectively). Consequently, the results of 10 identical, individual vaccine potency tests using an FMD virus O1 Manisa vaccine batch indicate that the obtained potency of a vaccine with an overall 50% protective dose (PD(50)) value of 9.99 may vary from 4.59 to 24.25 PD(50).

Animals↗

Trans-European medical education: experience of the Faculty of Medicine of Oviedo.

The European Community has played a key role in organizing student mobility programmes and in emphasizing the need for a European medical culture. The need for a common core of medical principles and efforts to strengthen inter-European cooperation nurture the philosophy of these exchanges. The Faculty of Medicine of Oviedo has been working on student mobility programmes for the last 7 years. As a result of this activity, about four hundred medical students have participated in various exchanges. This experience is highly positive both for the students and for the institutions taking part in it. The students have the chance to become acquainted with a different country, language, culture and medical training system. Meanwhile, the institutions benefit from their students' experience as well as having the opportunity of starting further cooperative programmes.

Education, Medical, Undergraduate↗

A European comparative study of serological methods for the diagnosis of infectious bovine rhinotracheitis.

A comparison is made of serological diagnostic procedures used for infectious bovine rhinotracheitis in the European Community. A panel of 65 sera, including positive, doubtful, negative and diluted samples was dispatched to nine different European laboratories and tested by neutralisation, enzyme-linked immunosorbent assay (ELISA), indirect immunofluorescence and passive haemagglutination, according to the methods used in each laboratory. The results showed good agreement between the various tests for positive and negative sera. However, considerable variability between tests was noted in the "doubtful" category of sera. The highest test sensitivity, as judged by the detection limit for samples serially diluted in negative serum, was found with the blocking ELISAs. A need was identified for international standard reference sera to be made available.

Animals↗

Designing medical devices for conformance with harmonized standards: a case study of non-active implants.

The European Community's Medical Devices Directives represent an ambitious effort to streamline the regulation of medical devices within the European Economic Area, an area comprising more than 380 million people. In this, the second of two special reports, Jean A. Goggins uses a case study format to demonstrate the process that would be used to gain European approval for a hypothetical medical device. In the first report, appearing on page 284, Richard C. Fries and Mark D. Graber describe the Medical Devices Directives and their effect on the product-development process.

Biocompatible Materials↗

Decreased incidence of VanA-type vancomycin-resistant enterococci isolated from poultry meat and from fecal samples of humans in the community after discontinuation of avoparcin usage in animal husbandry.

The use of the glycopeptide antibiotic avoparcin (AVO) as a feed additive in animal husbandry of many European countries led in 1994-1995 to frequent isolation of VanA-type vancomycin-resistant enterococci (VRE) from commercially produced animal foodstuffs as well as from fecal samples of nonhospitalized persons in Germany (Saxony-Anhalt state). However, at the end of 1997, a decreasing number of such VRE was detected in frozen and fresh poultry meat (chickens and turkeys) from German producers. At this point in time, AVO had been discontinued in animal husbandry for more than 2 and one-half years in Denmark/Norway, nearly 2 years in Germany, and about 8-9 months in all countries of the European Community and Switzerland, respectively. VRE were then only detected in very low concentrations in one-quarter of the poultry meat samples (eight of 31, originating from 18 distinct German producers and bought in 12 different supermarkets). A decline of VRE prevalence was also observed in the gut flora of healthy persons (VRE carriers) in the same region (Saxony-Anhalt state, Germany), having fallen from 12% (12/100) in 1994 when AVO was being used to 6% (6/100) in 1996 and 3% (13/400) in 1997 after it was discontinued. These results likely indicate the importance of antibiotic selective pressure by glycopeptides such as AVO for the presence of VRE in animal meat products from commercial animal husbandry. Additionally, it underlines the role of animal products for the spread of resistant bacteria and transferable resistance genes to humans in the community.

Animal Husbandry↗

Smoking policy in the workplace and other public places.

In may 1989, the Council of Health Ministers of the European Community adopted a joint resolution which urges the 12 member states to adopt legislation restricting smoking in public places. European citizens support this action. A survey in March-April 1987 using a sample of 12,000 Europeans in the 12 member states concluded that 77% of European citizens want measures to ban smoking in public places. The conditions that are necessary to make a smoking policy successful in the workplace and other public places will be discussed. We want to stress that an information and awareness campaign before the enforcement of the smoking ban is the most important condition.

Europe↗

Results from the European multicenter study on lead neurotoxicity in children: implications for risk assessment.

In order to improve dose-response information on neurobehavioral effects of environmental lead exposure in children, the World Health Organization, Regional Office for Europe (WHO/EURO), in collaboration with the Commission of the European Communities, initiated this international study which was planned, executed and evaluated between 1984 and 1989. Eight groups from eight European countries (Bulgaria, Denmark, Greece, Hungary, Italy, Roumania, W. Germany and Yugoslavia) took part. A common study protocol with inherent quality assurance elements was developed to achieve comparability. Blood-lead concentrations (PbB) were the main markers of exposure. The WISC (4 subtests) for psychometric intelligence, the Bender Gestalt test (GFT version) and the Trail-Making test for visual-motor integration, the Vienna Reaction Device and a delayed RT task for reaction performance, and the Needleman scales for behavior ratings served as behavioral endpoints. All individual studies taken together represent a sample size of 1879 school-age children and cover a PbB range from below 5 to about 60 micrograms/100 ml. Overall statistical evaluation of outcome was done by multiple regression analysis using a uniform confounder model. The strongest and most consistent effects occurred for the Bender Gestalt test (GFT version) and for serial choice reaction performance (Vienna Device). The degree of association with PbB was significant for these variables, although the contribution of PbB to the observed variance never exceeded 0.8%. Psychometric intelligence was also negatively affected, although the consistency of outcome between studies was poor, and the association with PbB only borderline. An effort towards risk assessment was made by calculating the proportion of children at risk, using the observed regression coefficients as well as means and standard deviations.

Child↗

European perspectives on healthy aging in women.

Using data from the 1994 European Community Household Panel, we compare active life expectancy differentials at age 65 years between women and men in 12 European countries. We seek to explain the extent to which differences are a reflection of gender differentials in life expectancy at 65 years or reflect differences in active life expectancy earlier in life. Considerable variation in the gender differentials in both total and active life expectancies at age 65 years exist within Europe, with some countries experiencing 20% lower life expectancy at age 65 years for men compared to women. Some evidence was found to suggest that gender differentials in active life expectancy may continue from younger ages through to later life.

Activities of Daily Living↗

Migrant populations: the development of something to evaluate.

UNLABELLED: The setting up of the "migrants" of the European Community "Assessing AIDS Prevention" Concerted Action in 1989 practically coincided with the start of HIV/AIDS prevention activities for migrants in European countries. This article discusses the migration situation in Europe, why migrants may, or may not, be important for HIV/AIDS prevention, and the particular difficulties inherent in such prevention. Government-sponsored and NGO programmes for foreigners in 12 European countries are described. CONCLUSIONS: programmes need to be based on the right to know rather than on notions of risk group. The category "migrants" includes people with vastly different backgrounds and needs. Migrants or ethnic minority populations cannot be assumed to be reached by HIV/AIDS education messages directed towards the general population of that country, but specific programmes for them should follow the model developed for other general populations, with culturally adapted messages aimed at the entire population, followed by specific targeted interventions for particular sub-groups. For both aspects it is essential to work with the target community, in synergy between "top down" and "bottom up" programmes. The main needs in the field of HIV/AIDS prevention among migrants are for: adequately funded programmes; serious evaluation, both of baseline information and programme evaluation; international networking and cooperation concerning programmes, materials and methods, and research.

Acquired Immunodeficiency Syndrome↗