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Environmental Risk Assessment of Pharmaceuticals

Project structure

ERAPharm covers fate and exposure assessment, effects assessment and environmental risk assessment of pharmaceuticals. The project is organised in interdependent work packages (WPs):

WP 1.1: Environmental fate processes

Within WP 1.1, the effect of environmental variables on the fate of pharmaceuticals in water, sediment, soil and manure is studied in laboratory, semi-field and field experiments. A focus will be laid on the identification of transformation products and on the input of pharmaceuticals from pasture animals and through the application of manure and sewage sludge to soils.

WP-leader: Thomas Ternes (BfG)

Partners involved: BfG, UoY, AstraZeneca, DFU, Eawag

WP 1.2: Modelling fate and exposure

WP 1.2 develops a scenario-based exposure assessment system for predicting the concentrations of pharmaceuticals in soils, surface waters and sediments. This system will consist of standard scenarios for exposure of the terrestrial and aquatic environment to pharmaceuticals and process-based fate and transport models for soil, surface water and leaching/runoff.

WP-leader: Kathrin Fenner (Eawag)

Partners involved: Eawag, UoY, GI AG

WP 2.1: Bioanalytical assays for an initial hazard screening and mode of action classifi­cation

In WP 2.1, pharmaceuticals and selected transformation products are screened using in vitro and low complexity bioassays. These tests are based on the initial interactions of the pharmaceuticals with their targets and on the onset of defence and repair mechanisms in the cells. It will be explored to what extent these tests can be used to provide a first hazard characterisation and to inform higher tier testing.

WP-leader: Beate Escher (Eawag)

Partners involved: Eawag

WP 2.2: Impact of antibiotics on environmental microorganisms and development of antimicrobial resistance

WP 2.2 studies the effects of antibiotics on structure and function of microbial communities for the terrestrial and the aquatic environment. A main focus is on the potential of antibiotics to increase the level of genetically encoded resistance. The suitability of different test systems for inclusion in the environmental risk assessment procedures for pharmaceuticals will be evaluated.

WP-leader: Heike Schmitt (UU)

Partners involved: UU, AstraZeneca

WP 2.3: Impact of pharmaceuticals on terrestrial invertebrates

WP 2.3 investigates the effects of pharmaceuticals on terrestrial invertebrates on the laboratory, semi-field and field scale. The semi-field and field studies are carried out in close co-operation with fate studies (WP 1.1) considering environmental conditions in North and South European regions. Both structural and functional endpoints are evaluated. Special emphasis is placed on the systematic analysis of the effects of parasiticides on dung organisms.

WP-leader: Jörg Römbke (ECT)

Partners involved: ECT, INIA, NERI

WP 2.4: Impact of pharmaceuticals on aquatic invertebrates

In WP 2.4, effects of human and veterinary pharmaceuticals on aquatic invertebrates are studied at the single-species and microcosm level. Test organisms are exposed via water or via sediment. A main focus of the work package is to detect long-term effects of low levels of pharmaceuticals using life-cycle and multi-generation tests. Energy-based models are used for predicting effects at the population level.

WP-leader: Jeanne Garric (Cemagref)

Partners involved: Cemagref, INIA, ECT, BfG

WP 2.5: Impact of pharmaceuticals on fish: transfer of knowledge from toxicology to ecotoxicology

WP 2.5 studies chronic effects of human pharmaceuticals on fish. Information from molecular biological studies is used to supplement fish tests with additional specific endpoints. Moreover, it is evaluated how data on pharmacokinetics and -dynamics in mammals can be used to guide the evaluation of potential sub-lethal effects of human pharmaceuticals in fish.

WP-leader: Thomas Hutchinson (AstraZeneca)

Partners involved: AstraZeneca, UBRUN

WP 3: Environmental risk assessment

On the basis of the results of fate and effect studies, WP 3 will evaluate action limits and trigger values of current environmental risk assessment procedures. Recommendations on how to improve current European environmental risk assessment procedures for human and veterinary pharmaceuticals will be provided and made available to regulators, industry and the scientific community.

WP-leader: Alistair Boxall (UoY)

Partners involved: UoY, UBA, INIA, ECT, CWN, Cemagref, Eawag, UU, NERI, BfG, DFU, UBRUN, AstraZeneca