Pharmaceutical Residues in Freshwater by OECD

Author:OECD
Language: eng
Format: epub
Tags: agriculture/science/socialissues/environment
Publisher: OECD Publishing
Published: 2019-11-13T00:00:00+00:00

Passive sampling, together with effect-based approaches, are being considered as potentially suitable tools that could be employed for monitoring of European water bodies in the implementation strategy of the EU Water Framework Directive (European Commission, 2015). While both approaches are often employed independently, their use in combination has been demonstrated previously in studies focusing on WWTP effluents and affected rivers (Creusot et al., 2013; Jalova et al., 2013; Jarosova et al., 2012).

While the ideal environmental monitoring system would routinely include all three components (chemical analysis, bioassays, ecosystem/effect-based monitoring), resource limitations and other practical constraints generally dictate where they are employed on a case-by case basis (Ekman et al., 2013[29]). For example, some sites have limited prior knowledge and information about the pollution burden and possible effects, other sites have low ecological health status, and others have known effects and exposure where the major sources needs to be identified. Ekman et al. (2013[29]) suggest a stepwise process to design and implement a strategic and integrated monitoring approach. The first step is to start with a problem formulation considering the existing information about the site, management goals and particular regulatory motivators. Once these basics are understood, strategic decisions about which specific monitoring tools should be employed are possible, which then allows for informed decision-making on what actions may (or may not) be required.

One of the challenges using alternative tools and data types is the interpretation of endpoints in the context of biological effects. Biological activity (e.g. measured in vitro or in biomarkers) does not necessarily constitute a hazard. The Adverse Outcome Pathways (AOP) concept (OECD, 2018[45]) was developed to address this issue and to make it possible to relate endpoints from in vitro bioassays and biomarkers to endpoints useful for risk assessment (e.g. of survival, reproduction, development, and growth) (Ankley et al., 2010[67]) (Ankley and Edwards, 2018[68]). It is a conceptual chain that links the exposure of contaminants to their cellular concentrations and molecular initiating events, via pathway disturbance and key events, to response at the cellular, organism and population or community levels. The framework can be used for different purposes, including to predict the effects of mixtures (Carusi et al., 2018[69]). AOPs increase the efficiency of chemical safety assessments, reduce the need for animal testing, and has received significant attention and use in the regulatory toxicology community (Carusi et al., 2018[69]). Recently, the AOP has been moving from a linear concept to a pathway network considering the idea of multiple causes for adverse effects (Escher et al., 2017[70]) (Knapen et al., 2015[71]).

Another alternative method to predict the toxicity of pharmaceuticals, is to group APIs that are structurally similar and may therefore cause similar adverse environmental effects. The OECD has developed the Integrated Approaches to Testing and Assessment (IATA, which can include AOPs), providing a framework and tools for data gathering to maximise the amount of information about risks of chemicals. For example, the OECD Quantitative Structure-Activity Relationships (QSAR) Toolbox (OECD, 2018[72]) is a software application intended to be used by governments,

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