Potential application of ecological models in the European environmental risk assessment of chemicals I: Review of protection goals in EU directives and regulations

Abstract

Several European directives and regulations address the environmental risk assessment of chemicals. We used the protection of freshwater ecosystems against plant protection products, biocidal products, human and veterinary pharmaceuticals, and other chemicals and priority substances under the Water Framework Directive as examples to explore the potential of ecological effect models for a refined risk assessment. Our analysis of the directives, regulations, and related guidance documents lead us to distinguish the following 5 areas for the application of ecological models in chemical risk assessment: 1) Extrapolation of organism-level effects to the population level: The protection goals are formulated in general terms, e.g., avoiding "unacceptable effects" or "adverse impact" on the environment or the "viability of exposed species." In contrast, most of the standard ecotoxicological tests provide data only on organism-level endpoints and are thus not directly linked to the protection goals which focus on populations and communities. 2) Extrapolation of effects between different exposure profiles: Especially for plant protection products, exposure profiles can be very variable and impossible to cover in toxicological tests. 3) Extrapolation of recovery processes: As a consequence of the often short-term exposures to plant protection products, the risk assessment is based on the community recovery principle. On the other hand, assessments under the other directives assume a more or less constant exposure and are based on the ecosystem threshold principle. 4) Analysis and prediction of indirect effects: Because effects on 1 or a few taxa might have consequences on other taxa that are not directly affected by the chemical, such indirect effects on communities have to be considered. 5) Prediction of bioaccumulation within food chains: All directives take the possibility of bioaccumulation, and thus secondary poisoning within the food chain, into account.

Development of a framework based on an ecosystem services approach for deriving specific protection goals for environmental risk assessment of pesticides

“…For the majority of key drivers, SPGs can be defined at the level of the population or higher which is in accordance with US-EPA (2003), Delorme et al (2005), and Hommen et al (2010), which state that most ecological protection goals aim to preserve populations of non-target organisms rather than individuals. In these reports, however, the ecosystem services concept was not explicitly used to derive SPGs.…”

“…Directive 98/8/EC of the European Parliament and of the council of 16 February, 1998, Regulation (EC), 2006, Council Directive 92/43/EEC of 21 May, 1992and Directive, 2000, see also Hommen et al (2010) for a review). In Regulation (EC) No 1107/2009, a high level of protection is required (e.g.…”

Outcome of a public consultation on the draft scientific opinion of the EFSA Scientific Committee on recovery in environmental risk assessments at EFSA

“…EFSA answer: Rubach et al (2011) are cited for the definition of population sustainability in a population context. The references should be Hommen et al, 2010;EFSA PPR, 2010. Line 1759 onward Table 1 specifically mentions that laboratory test "Cannot assess external recovery". This is incorrect in regulation 283/2013 it is actually a requirement when refining the non-target arthropod risk assessment for PPPs.…”

Ecotoxicology: The Challenges for the 21st Century

“…Anyway, it is questionable if most commonly used endpoints are suitable for covering this objective. Current procedures required by chemical regulations only achieve a small part of these goals [29]. We must be aware that the complexity of the problem is two-fold:…”