Umweltbundesamt Federal Environment Agency

Dessau, Germany

Umweltbundesamt Federal Environment Agency

Dessau, Germany
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Ashbolt N.J.,U.S. Environmental Protection Agency | Amezquita A.,Unilever | Backhaus T.,Gothenburg University | Brandt K.K.,Copenhagen University | And 15 more authors.
Environmental Health Perspectives | Year: 2013

Background: Only recently has the environment been clearly implicated in the risk of antibiotic resistance to clinical outcome, but to date there have been few documented approaches to formally assess these risks. Objective: We examined possible approaches and sought to identify research needs to enable human health risk assessments (HHRA) that focus on the role of the environment in the failure of antibiotic treatment caused by antibiotic-resistant pathogens. Methods: The authors participated in a workshop held 4-8 March 2012 in Québec, Canada, to define the scope and objectives of an environmental assessment of antibiotic-resistance risks to human health. We focused on key elements of environmental-resistance-development "hot spots," exposure assessment (unrelated to food), and dose response to characterize risks that may improve antibiotic-resistance management options. Discussion: Various novel aspects to traditional risk assessments were identified to enable an assessment of environmental antibiotic resistance. These include a) accounting for an added selective pressure on the environmental resistome that, over time, allows for development of antibiotic-resistant bacteria (ARB); b) identifying and describing rates of horizontal gene transfer (HGT) in the relevant environmental "hot spot" compartments; and c) modifying traditional dose-response approaches to address doses of ARB for various health outcomes and pathways. Conclusions: We propose that environmental aspects of antibiotic-resistance development be included in the processes of any HHRA addressing ARB. Because of limited available data, a multi-criteria decision analysis approach would be a useful way to undertake an HHRA of environmental antibiotic resistance that informs risk managers.


PubMed | Bayer AG, RWTH Aachen, Fraunhofer Institute for Molecular Biology and Applied Ecology, Ctgb and 5 more.
Type: Journal Article | Journal: Integrated environmental assessment and management | Year: 2016

This case study of the Society of Environmental Toxicology and Chemistry (SETAC) workshop MODELINK demonstrates the potential use of mechanistic effects models for macrophytes to extrapolate from effects of a plant protection product observed in laboratory tests to effects resulting from dynamic exposure on macrophyte populations in edge-of-field water bodies. A standard European Union (EU) risk assessment for an example herbicide based on macrophyte laboratory tests indicated risks for several exposure scenarios. Three of these scenarios are further analyzed using effect models for 2 aquatic macrophytes, the free-floating standard test species Lemna sp., and the sediment-rooted submerged additional standard test species Myriophyllum spicatum. Both models include a toxicokinetic (TK) part, describing uptake and elimination of the toxicant, a toxicodynamic (TD) part, describing the internal concentration-response function for growth inhibition, and a description of biomass growth as a function of environmental factors to allow simulating seasonal dynamics. The TK-TD models are calibrated and tested using laboratory tests, whereas the growth models were assumed to be fit for purpose based on comparisons of predictions with typical growth patterns observed in the field. For the risk assessment, biomass dynamics are predicted for the control situation and for several exposure levels. Based on specific protection goals for macrophytes, preliminary example decision criteria are suggested for evaluating the model outputs. The models refined the risk indicated by lower tier testing for 2 exposure scenarios, while confirming the risk associated for the third. Uncertainties related to the experimental and the modeling approaches and their application in the risk assessment are discussed. Based on this case study and the assumption that the models prove suitable for risk assessment once fully evaluated, we recommend that 1) ecological scenarios be developed that are also linked to the exposure scenarios, and 2) quantitative protection goals be set to facilitate the interpretation of model results for risk assessment.


Christensen K.L.Y.,U.S. Environmental Protection Agency | Lorber M.,U.S. Environmental Protection Agency | Koch H.M.,Ruhr University Bochum | Kolossa-Gehring M.,Umweltbundesamt Federal Environment Agency | Morgan M.K.,U.S. Environmental Protection Agency
Journal of Exposure Science and Environmental Epidemiology | Year: 2012

Human exposure to phthalates and bisphenol A (BPA) can be assessed through urinary biomonitoring, but methods to infer daily intakes assume that spot sample concentrations are comparable to daily average concentrations. We evaluate this assumption using human biomonitoring data from Germany and the United States (US). The German data comprised three regional studies with spot samples and one with full-day samples analyzed for phthalate metabolites. The US data included: a study on DEHP metabolites and BPA involving eight persons supplying all urine voids (from which 24-h samples were constructed) for seven consecutive days; NHANES spot sample data on DEHP metabolites and BPA; and a regional study of children with 48-h samples analyzed for BPA. In the German data, measures of central tendency differed, but spot and 24-h samples showed generally comparable variance including 95th percentiles and maxima equidistant from central tendency measures. In contrast, the US adult data from the eight-person study showed similar central tendencies for phthalate metabolites and BPA, but generally greater variability for the spot samples, including higher 95th percentiles and maxima. When comparing children's BPA concentrations in NHANES spot and 48-h samples, distributions showed similar central tendency and variability. Overall, spot urinary concentrations of DEHP metabolites and BPA have variability roughly comparable with corresponding 24-h average concentrations obtained from a comparable population, suggesting that spot samples can be used to characterize population distributions of intakes. However, the analysis also suggests that caution should be exercised when interpreting the high end of spot sample data sets. © 2012 Nature America, Inc. All rights reserved.


Rapp T.,Umweltbundesamt Federal Environment Agency | Gunther H.,Umweltbundesamt Federal Environment Agency
Water Research | Year: 2015

For a round robin test for EN 1420-1 (Odour assessment for organic materials in contact with drinking water) with 14 contributing laboratories from 10 European countries segments of a plastic pipe were sent to the laboratories which performed a migration test and an odour analysis of the migration waters (water that had contact with the organic material) according to the procedure described in the standard from 1999. In addition reference substances (Methyl tert-butyl ether, 1-butanol and hexanal) were investigated for their suitability to qualify the panels and the individual panellists. Methyl tert-butyl ether (MtBE) and 1-butanol proved to be suitable for this purpose, whereas hexanal showed a wide distribution of the individual odour threshold concentrations. Both possible testing options (unforced and forced choice) were performed and gave similar results. However, with respect to the qualification of the panellists and the data analysis the unforced choice procedure showed advantages. As human olfactory perception is used for the analysis, the reproducibility and the comparability between laboratories is of particular concern. For the pipe material the TON results of the different laboratories were in a range of ±1.5 dilutions based on a dilution factor of 2. This might be improved by taking the individual sensitivities of the panellists into account more strongly. Appropriate measures for the improvement of the test method appear to be the use of the proposed reference substances for the training of the panellists as well as the auditing and the selection of the panellists. The results of this round robin test are used in the revision process of the standard. © 2015 Elsevier Ltd.


Kuster A.,Umweltbundesamt Federal Environment Agency | Becker P.R.,U.S. National Institute of Standards and Technology | Kucklick J.R.,U.S. National Institute of Standards and Technology | Pugh R.S.,U.S. National Institute of Standards and Technology | Koschorreck J.,Umweltbundesamt Federal Environment Agency
Environmental Science and Pollution Research | Year: 2014

Environmental specimen banks (ESBs) are facilities that archive samples from the environment for future research and monitoring purposes. In addition, the long-term preservation of representative specimens is an important complement to environmental research and monitoring. Today, environmental specimen banking is experiencing a renaissance due to an increase in regulatory interest in ESB biota standards and trend data. The International Environmental Specimen Bank Group (IESB) promotes the worldwide development of techniques and strategies of environmental specimen banking and the international cooperation and collaboration among national ESBs. In order to provide a current and comprehensive overview on international environmental specimen banking activities, a questionnaire was sent to the national ESBs and asked for detailed information on the respective ESBs. The results show the rich diversity of national sampling programs, including more detailed information on archived samples, sampling strategies, and studies that have already been performed in the respective countries. All ESBs completing the survey expressed a strong interest in cooperating with other ESBs on a collaborative project. The collected information of national ESBs is intended to be made publicly available. © 2014 Springer-Verlag Berlin Heidelberg.


Kuster A.,Umweltbundesamt Federal Environment Agency | Adler N.,Umweltbundesamt Federal Environment Agency
Philosophical Transactions of the Royal Society B: Biological Sciences | Year: 2014

During the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for human and veterinary pharmaceutical products before they are marketed. The results show that approximately 10% of pharmaceutical products are of note regarding their potential environmental risk. For human medicinal products, hormones, antibiotics, analgesics, antidepressants and antineoplastics indicated an environmental risk. For veterinary products, hormones, antibiotics and parasiticides were most often discussed as being environmentally relevant. These results are in good correlation with the results within the open scientific literature of prioritization approaches for pharmaceuticals in the environment. UBA results revealed that prospective approaches, such as ERA of pharmaceuticals, play an important role in minimizing problems caused by pharmaceuticals in the environment. However, the regulatory ERA framework could be improved by (i) inclusion of the environment in the risk–benefit analysis for human pharmaceuticals, (ii) improvement of risk management options, (iii) generation of data on existing pharmaceuticals, and (iv) improving the availability of ERA data. In addition, more general and integrative steps of regulation, legislation and research have been developed and are presented in this article. In order to minimize the quantity of pharmaceuticals in the environment these should aim to (i) improve the existing legislation for pharmaceuticals, (ii) prioritize pharmaceuticals in the environment and (iii) improve the availability and collection of pharmaceutical data. © 2014 The Author(s) Published by the Royal Society. All rights reserved.


Fabris C.,Umweltbundesamt Federal Environment Agency
42nd International Congress and Exposition on Noise Control Engineering 2013, INTER-NOISE 2013: Noise Control for Quality of Life | Year: 2013

This summarizes the principle and main noise policy instruments in Germany from the point of view of the Federal Environment Agency. It shows a simple model of these instruments, embedded both in European and German federal state legislations. German legislation on noise is divided into several laws, ordinances and other regulations concerning the various sources of noise (traffic, industry, mobile machinery, sports grounds, etc.) Noise emissions are generally governed by European legislation. Examples are the so-called 'Outdoor Directive' and the 'Energy-using-Products Directive'. Other laws limit the noise exposure from noise sources. Another example is the implementation of the Environmental Noise Directive into German noise policy. This contains the principles to create feasible noise abatement plans considering public concerns. The planning of traffic routes as the most annoying noise source in Germany is regulated in particular laws and ordinances for the respective sources. Noise exposure of the most stationary noise sources is limited by a national instrument of legislation, the 'Technical Instructions on Noise Abatement - TA Laerm'. There are also some governmental economic development schemes which are related to noise criteria. Last but not least there is the environmental label 'Blue Angel', which awards several products that are outstanding quiet in their product family.


PubMed | Umweltbundesamt Federal Environment Agency
Type: Journal Article | Journal: Philosophical transactions of the Royal Society of London. Series B, Biological sciences | Year: 2014

During the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for human and veterinary pharmaceutical products before they are marketed. The results show that approximately 10% of pharmaceutical products are of note regarding their potential environmental risk. For human medicinal products, hormones, antibiotics, analgesics, antidepressants and antineoplastics indicated an environmental risk. For veterinary products, hormones, antibiotics and parasiticides were most often discussed as being environmentally relevant. These results are in good correlation with the results within the open scientific literature of prioritization approaches for pharmaceuticals in the environment. UBA results revealed that prospective approaches, such as ERA of pharmaceuticals, play an important role in minimizing problems caused by pharmaceuticals in the environment. However, the regulatory ERA framework could be improved by (i) inclusion of the environment in the risk-benefit analysis for human pharmaceuticals, (ii) improvement of risk management options, (iii) generation of data on existing pharmaceuticals, and (iv) improving the availability of ERA data. In addition, more general and integrative steps of regulation, legislation and research have been developed and are presented in this article. In order to minimize the quantity of pharmaceuticals in the environment these should aim to (i) improve the existing legislation for pharmaceuticals, (ii) prioritize pharmaceuticals in the environment and (iii) improve the availability and collection of pharmaceutical data.


PubMed | Umweltbundesamt Federal Environment Agency
Type: Journal Article | Journal: Environmental science and pollution research international | Year: 2015

Environmental specimen banks (ESBs) are facilities that archive samples from the environment for future research and monitoring purposes. In addition, the long-term preservation of representative specimens is an important complement to environmental research and monitoring. Today, environmental specimen banking is experiencing a renaissance due to an increase in regulatory interest in ESB biota standards and trend data. The International Environmental Specimen Bank Group (IESB) promotes the worldwide development of techniques and strategies of environmental specimen banking and the international cooperation and collaboration among national ESBs. In order to provide a current and comprehensive overview on international environmental specimen banking activities, a questionnaire was sent to the national ESBs and asked for detailed information on the respective ESBs. The results show the rich diversity of national sampling programs, including more detailed information on archived samples, sampling strategies, and studies that have already been performed in the respective countries. All ESBs completing the survey expressed a strong interest in cooperating with other ESBs on a collaborative project. The collected information of national ESBs is intended to be made publicly available.


PubMed | Umweltbundesamt Federal Environment Agency
Type: | Journal: Water research | Year: 2015

For a round robin test for EN 1420-1 (Odour assessment for organic materials in contact with drinking water) with 14 contributing laboratories from 10 European countries segments of a plastic pipe were sent to the laboratories which performed a migration test and an odour analysis of the migration waters (water that had contact with the organic material) according to the procedure described in the standard from 1999. In addition reference substances (Methyl tert-butyl ether, 1-butanol and hexanal) were investigated for their suitability to qualify the panels and the individual panellists. Methyl tert-butyl ether (MtBE) and 1-butanol proved to be suitable for this purpose, whereas hexanal showed a wide distribution of the individual odour threshold concentrations. Both possible testing options (unforced and forced choice) were performed and gave similar results. However, with respect to the qualification of the panellists and the data analysis the unforced choice procedure showed advantages. As human olfactory perception is used for the analysis, the reproducibility and the comparability between laboratories is of particular concern. For the pipe material the TON results of the different laboratories were in a range of 1.5 dilutions based on a dilution factor of 2. This might be improved by taking the individual sensitivities of the panellists into account more strongly. Appropriate measures for the improvement of the test method appear to be the use of the proposed reference substances for the training of the panellists as well as the auditing and the selection of the panellists. The results of this round robin test are used in the revision process of the standard.

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