Environmental risk assessment ERA

Table 3 describes the main parts of an environmental risk assessment (ERA) that are based on the two major elements characterisation of exposure and characterisation of effects [27, 51]. ERA uses a combination of exposure and effects data as a basis for assessing the likelihood and severity of adverse effects (risks) and feeds this into the decision-making process for managing risks. The process of assessing risk ranges from the simple calculation of hazard ratios to complex utilisation of probabilistic methods based on models and/or measured data sets. Setting of thresholds such as EQS and quality norms (QN) [27] relies primarily on... 

In broad terms risk assessments are carried out to examine the effects of an agent on humans (Health Risk Assessment) and ecosystems (Ecological Risk Assessment). Environmental Risk Assessment (ERA) is the examination of risks resulting from technology that threaten ecosystems, animals and people. It includes human health risk assessments, ecological or ecotoxicological risk assessments, and specific industrial applications of risk assessment that examine end-points in people, biota or ecosystems. 

Under both national and international agreements, the process of quantitatively predicting the probability of an adverse response in ecosystem health due to exposure to one or more pollutants is collectively known as Environmental Risk Assessment, ERA (US EPA, 1992). 

The principal scheme of environmental risk assessment, ERA, is shown in Figure 1. 

Abstract Active pharmaceutical ingredients (APIs) represent a group of emerging environmental contaminants. Albeit in trace amounts, they are of great concern since given their continuous introduction into the environment, their impact on ecosystems and human health is of great importance. As a result, the environmental risk assessment (ERA) of medicinal products has to be evaluated and appropriate legislation has been issued in the European Union (EU). 

Keywords Active pharmaceutical ingredients Environmental risk assessment (ERA)... 

Over the last 10 years a lot of efforts have been made to implement probabilistic methods for environmental risk assessments (ERA) into regulatory decisionmaking schemes. ECOFRAME in the US (www.epa.gov/oppefedl/ecorisk) was the first and largest project in this area, the EU-project EUFRAM (vww.eufram. com) is a comparable initiative. Whereas on the effect side, several examples exist where species sensitivity distributions (SSDs) were used for regulatory decisionmaking, comparable cases on the exposure side are rare. 

Environmental Risk assessments (ERA), Directive 2001/83/EC — Community code relating to medicinal products for human use and Guideline on the ERA... 

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