Examples of specific protection goals
For reasons already discussed, specific environmental protection goals are generally lacking in legislation and guidance concerning the prospective and retrospective ERA of chemicals (Table C1.1), including the following specific industry sectors:
- the plant protection products regulation (EC 1107/2009), which specifies the goal of “no unacceptable effects on the environment”,
- the pharmaceuticals industry (Directive 2001/83/EC), which aims to prevent “any risk of undesirable effects on the environment”,
- and the maritime transport industry (Directive 2012/33/EU), which aims to achieve “levels of air quality that do not give rise to significant negative impacts on and risks to human health and the environment”.
Conversely, it may be argued that some environmental protection goals are too specific, such as the environmental protection goals for bees in the EFSA guidance for plant protection products (EFSA, 2013), which require measuring and linking PPP exposure to colony-relevant population changes (despite the potential influence of other causal factors). This apparent ‘gulf’ between the general and specific protection goals is also apparent for other groups of organisms / species that are covered in the prospective environmental risk assessment of plant protection and other chemical products. However, there are several examples of specific protection goals associated with environmental monitoring in retrospective ERA (Tables C1.2 and C1.3), and these generally fall into two categories. The first category contains population-level goals for indicator species, identified using a reductionist approach typified by OSPAR’s Ecological Quality Objectives (e.g. focusing on priority chemicals and individual biomarkers or population trends for indicator species, Table C1.3). The second category contains more holistic community or ecosystem-level goals (e.g. protection of ecological communities reflecting biological quality status defined under the Water Framework Directive, or entire habitat features under the Habitats Directive, Table C1.3). These specific protection goals provide valuable working examples for guiding prospective ERA, helping to justify the selection of ecological entities (e.g. population, functional group or community) and their key attributes (e.g. biomass or function) as reliable indicators of ecosystem health. Quantifiable changes in these attributes, versus acceptable limits or reference values, should ideally be defined in terms of magnitude of change, spatial scale and temporal scale (EFSA, 2010). All three dimensions are considered in the setting of specific protection goals under OSPAR (e.g. “ecological quality objective” of <10% decline in recruitment (5 year rolling average) for defined sub-populations of 5 species of North Sea seals [OSPAR, 2010]), the Water Framework Directive (“biological water quality classification” based on species diversity, abundance, distribution and trends) and the Habitats Directive (“favourable conservation status” based on species population dynamics, long-term viability and natural range; habitat species richness, structure and function, extent and trends, necessary for their long-term maintenance [EC, 2011c; EC, 2012]). Critically, in each of these cases, the main focus is on magnitude of change, while spatial and temporal dimensions are constrained by pre-defined monitoring regions, water bodies or habitats and reporting cycles.