AbstractInformation on transformation and persistence of chemical substances in the environment is important for hazard and risk assessment within a regulatory context or as a decision criterion in a safe and sustainable by design framework. Half-lives for human and veterinary medicinal products available from marketing authorization applications were compared between soil (OECD 307) and aquatic water/sediment systems (OECD 308). The comparison shows, that there is no obvious correlation between the total system half-lives in the two different compartments and that surpassing persistence criteria is compartment-specific in 45% of the cases.
AbstractAdvanced materials, and nanomaterials, are promising for healthcare applications and are in particular in the spotlight of medical innovation since rapidly developed nano-formulated vaccines provide relief in the SARS-CoV-2 pandemic. Further increased rapid growth is to be expected as more and more products are in development and reach the market, beneficial for human health. However, the human body is not a dead end and these products are likely to enter the environment, whereas their fate and effects in the environment are unknown. This part of the life-cycle of advanced medicinal products tends to be overlooked, if the perspective is human-centered and excludes the connectedness of human activity with, and consequences for our environment. Gaps are reviewed that exist in awareness, perspective taking, inclusion of environmental concerns into research and product development and also in available methodologies and regulatory guidance. To bridge these gaps, possible ways forward start to emerge, that could help to find a more integrative way of assessing human and environmental safety for advanced material medicinal products and nanomedicines.
Advanced materials promise technical solutions to support sustainable transformation. They play an important role for a variety of environmental topics worked on at UBA, such as energy transition, circular economy and chemical safety. Various sectors can benefit from the use of advanced materials, but they can also face challenges. The UBA position paper describes the area of tension between the promising use and possible challenges for environmental and health protection and other sustainability dimensions, illustrates this with various examples and derives corner stones for a safe and sustainable life cycle of advanced materials.
Neuartige Materialen versprechen technische Lösungen zur Unterstützung der nachhaltigen Transformation. Sie spielen eine wichtige Rolle für eine Vielzahl der am UBA bearbeiteten Umweltthemen wie beispielsweise die Energiewende, Kreislaufwirtschaft und Chemikaliensicherheit. Dabei können die verschiedenen Bereiche durch den Einsatz neuartiger Materialien profitieren, aber auch vor Herausforderungen gestellt werden. Das UBA-Positionspapier beschreibt das Spannungsfeld zwischen dem vielversprechenden Einsatz und möglichen Herausforderungen für den Umwelt- und Gesundheitsschutz und anderen Nachhaltigkeitsdimensionen, verdeutlicht dies an verschiedenen Beispielen und leitet Eckpunkte für ein sicheren und nachhaltigen Lebenszyklus von neuartigen Materialien ab.
Abstract Background Spreading of manure on agricultural soils represents an important pathway by which veterinary medicinal and biocidal products enter the environment. To assess their environmental impact in the context of authorization processes, experimental testing of transformation of these compounds in manure is considered in regulatory guidance documents. However, there is no standardized experimental test method available so far. To fill this gap, an experimental test method was developed to examine transformation in liquid cattle and pig manure.
Results To account for manure specifics and for a possible influence of manure parameters on transformation rates, a comprehensive data acquisition and statistical analysis were performed. To address the variability of liquid manure of different type and origin, 30 manures were sampled and characterized. Thereof, three cattle and three pig manures were selected to perform anaerobic transformation studies with two radiolabeled veterinary medicinal active substances (14C-salicylic acid and 14C-paracetamol) and a confidential radiolabeled "14C-biocide B" serving as test compounds. Spatial and seasonal variability of manure parameters was quantified, and a sampling technique to obtain homogenous manure samples was developed. Transformation studies with six replicates per sampling point were conducted to examine the influence of test setup, of manure storage conditions, and of parameter variations between manure of the same species and of different species on half-lives, formation of extractable and non-extractable residues and mineralization rates. Finally, a test design was established that yields reproducible results for transformation studies in liquid cattle and pig manure under anaerobic conditions.
Conclusions Results give a reliable basis for an experimental test method to perform anaerobic transformation studies in liquid cattle and pig manure. The developed test method comprises detailed guidance on selection of sampling date and site, collection from manure tank, storage duration and temperature in the laboratory, duration of manure acclimation period, and the incubation system design. It proved to give reproducible results in a validation ring test performed in a follow-up project and is planned to be submitted as draft test guideline for approval by the OECD.
