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GENERAL INTRODUCTION 1.2 GENERAL PRINCIPLES OF ASSESSING ENVIRONMENTAL RISKS The environmental risk assessment approach outlined in this chapter attempts to address the concern for the potential impact of individual substances on the environment by examining both exposures resulting from discharges and/or releases of chemicals and the effects of such emissions on the structure and function of the ecosystem. Three approaches are used for this examination: • quantitative PEC/PNEC estimation for environmental risk assessment of a substance comparing compartmental concentrations (PEC) with the concentration below which unacceptable effects on organisms will most likely not occur (predicted no effect concentration (PNEC)). This includes also an assessment of food chain accumulation and secondary poisoning; • the qualitative procedure for the environmental risk assessment of a substance for those cases where a quantitative assessment of the exposure and/or effects is not possible; • the PBT assessment of a substance consisting of an identification of the potential of a substance to persist in the environment, accumulate in biota and be toxic combined with an evaluation of sources and major emissions. In principle, human beings as well as ecosystems in the aquatic, terrestrial and air compartment are to be protected. At present, the environmental risk assessment methodology has been developed for the following compartments: For inland risk assessment: • aquatic ecosystem (including sediment); • terrestrial ecosystem; • top predators; • microorganisms in sewage treatment systems; • atmosphere. For marine risk assessment: • aquatic ecosystem (including sediment); • top predators. In addition to the three primary environmental compartments, effects relevant to the food chain (secondary poisoning) are considered. Also effects on the microbiological activity of sewage treatment systems are considered. The latter is evaluated because proper functioning of sewage treatment plants (STPs) is important for the protection of the aquatic environment. The methodologies implemented have as aim the identification of acceptable or unacceptable risks. This identification provides the basis for the regulatory decisions, which follow from the risk assessment. In some cases the uncertainties in carrying out the standard assessment become unacceptably high. The methodologies implemented in these cases are based on identifying the emission sources in order to identify where exposures should be minimised. The PECs can be derived from available measured data and/or model calculations. The PNEC values are usually determined on the basis of results from single species laboratory tests or, in a few cases, established effect and/or no-effect concentrations from model ecosystem tests, taking into account adequate assessment factors. The PNEC can be derived using an assessment factor approach or, when sufficient data is available, using the statistical extrapolation methods. A 10
GENERAL INTRODUCTION PNEC is regarded as a concentration below which an unacceptable effect will most likely not occur. Dependent on the PEC/PNEC ratio the decision whether a substance presents a risk to organisms in the environment is taken. If it is not possible to conduct a quantitative risk assessment, either because the PEC or the PNEC or both cannot be derived, a qualitative evaluation is carried out of the risk that an adverse effect may occur. As will be explained in more detail in the section on exposure assessment, PEC values are derived for local as well as regional situations, each of them based on a number of specific emission characteristics with respect to time and scale. As a consequence, the comparison of PNEC values for the different compartments with different PEC values for different exposure scenarios can lead to a number of PEC/PNEC ratios. In some cases, the current quantitative risk assessment approach does not provide sufficient confidence that the environmental compartment or targets considered are sufficiently protected. The PBT assessment, given in Section 4.4, has been developed with the aim of identifying these cases. Table 1 shows a summary of the different targets of the risk characterisation and the exposure scenarios to which they apply for inland risk assessment and Table 2 summarises those used for the marine environment. In addition to the PECs mentioned in Tables 1 and 2, several other exposure levels are derived in Section 2. These are used for the assessment of indirect human exposure through the environment, which is described in Chapter 2 on Risk Assessment for Human Health. The PECs that are specifically derived for this indirect exposure assessment are summarised in Table 3. Table 1 Relationship between different targets of the risk characterisation for different inland compartments Target Medium of exposure (PEClocal / PECregional) Aquatic organisms Surface water 2.3.8.3 2.3.8.7 Benthic organisms Sediment 2.3.8.4 2.3.8.7 Terrestrial Organisms Fish-eating Predators Worm-eating Predators Agricultural soil 2.3.8.5 2.3.8.7 Section PNEC Section Fish 3.8 PNECoral from PNECwater 3.3 PNECsed 3.5 PNECsoil 3.6 NOAELavian/mammalian Earthworms 3.8 PNECoral from NOAELavian/mammalian Microorganisms STP aeration tank 2.3.7 PNECmicroorganisms 3.4 3.8 3.8 11
Page 1: Institute for Health and Consumer P
Page 4 and 5: LEGAL NOTICE Neither the European C
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Primary Settler Aeration Tank 2 5 3
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Explanation of symbols ENVIRONMENTA
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ENVIRONMENTAL EXPOSURE ASSESSMENT I
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ENVIRONMENTAL EXPOSURE ASSESSMENT d
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ENVIRONMENTAL EXPOSURE ASSESSMENT e
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Table 10 Overview of different expo
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ENVIRONMENTAL EXPOSURE ASSESSMENT -
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2.3.8.3 Calculation of PEClocal for
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ENVIRONMENTAL EXPOSURE ASSESSMENT W
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Guidance for calculating PEClocal i
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Concentration (% of initial) 160 14
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Explanation of symbols ENVIRONMENTA
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Calculation of PEClocalsoil For soi
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ENVIRONMENTAL EXPOSURE ASSESSMENT
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ENVIRONMENTAL EXPOSURE ASSESSMENT T
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Output ENVIRONMENTAL EXPOSURE ASSES
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3 EFFECTS ASSESSMENT 3.1 INTRODUCTI
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3.2.1.1 Completeness of data New su
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EFFECTS ASSESSMENT • it is clearl
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EFFECTS ASSESSMENT 3.3 EFFECTS ASSE
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Table 16 Assessment factors to deri
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Input data EFFECTS ASSESSMENT The m
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Estimation of the PNEC The PNEC is
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EFFECTS ASSESSMENT biodegradability
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Table 17 Test systems for derivatio
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EFFECTS ASSESSMENT representative o
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In the partitioning method, it is a
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EFFECTS ASSESSMENT As mentioned in
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3.6.2.1 Calculation of PNEC using t
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3.7 EFFECTS ASSESSMENT FOR THE AIR
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EFFECTS ASSESSMENT procedure availa
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EFFECTS ASSESSMENT bioaccumulation
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EFFECTS ASSESSMENT For some chemica
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EFFECTS ASSESSMENT i.e. without enh
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Conversion factors for laboratory a
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EFFECTS ASSESSMENT • relative sen
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EFFECTS ASSESSMENT Earthworms are a
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MARINE RISK ASSESSMENT environment
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MARINE RISK ASSESSMENT of equal rel
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4.2.3.3 Marine biodegradation simul
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MARINE RISK ASSESSMENT In addition
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Explanation of symbols MARINE RISK
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MARINE RISK ASSESSMENT evaluate the
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MARINE RISK ASSESSMENT marine water
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MARINE RISK ASSESSMENT The addition
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MARINE RISK ASSESSMENT Statistical
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MARINE RISK ASSESSMENT sediment, fo
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Table 27 Assessment factors for der
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Table 28 continued Acute and chroni
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MARINE RISK ASSESSMENT of different
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MARINE RISK ASSESSMENT • a measur
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MARINE RISK ASSESSMENT b. the conce
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MARINE RISK ASSESSMENT mechanisms s
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MARINE RISK ASSESSMENT The use of t
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4.4.4.2 Assessment of measured BCF
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MARINE RISK ASSESSMENT required to
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Table 33 Overview of PEC/PNEC ratio
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RISK CHARACTERISATION If a refineme
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Classified dangerous to the Environ
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RISK CHARACTERISATION eaters. This
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6 TESTING STRATEGIES 6.1 INTRODUCTI
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TESTING STRATEGIES Performance of a
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TESTING STRATEGIES Care must be tak
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Algal testing Algae toxicity test (
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TESTING STRATEGIES • long-term te
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Microbial assays TESTING STRATEGIES
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TESTING STRATEGIES A soil bioassay
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REFERENCES Brandes LJ, den Hollande
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REFERENCES IPCS (2000). Framework f
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REFERENCES OECD (1984f). Activated
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REFERENCES Pack S. (1993). A review
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REFERENCES US EPA (1996). Whole Sed
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APPENDIX I volume imported in the E
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APPENDIX I MC IV “Wide dispersive
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APPENDIX I 210 Stage Main category
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APPENDIX I the number of days over
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APPENDIX I Stage Main category Ia I
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APPENDIX I manufacturing of motor c
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APPENDIX I 1. extension of the tabl
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APPENDIX I 220 A-tables Estimates f
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APPENDIX I PRIVATE USE Not applicab
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APPENDIX I IC = 3: CHEMICAL INDUSTR
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APPENDIX I IC = 5: PERSONAL /DOMEST
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APPENDIX I Table A4.1 continued Com
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APPENDIX I IC = 7: LEATHER PROCESSI
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APPENDIX I IC = 9: MINERAL OIL AND
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APPENDIX I WASTE TREATMENT Table A5
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APPENDIX I For the emission factors
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APPENDIX I INDUSTRIAL USE Table A3.
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APPENDIX I INDUSTRIAL USE Table A3.
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APPENDIX I PRIVATE USE Table A4.5 C
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APPENDIX I PRIVATE USE Table A3.16
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APPENDIX I 246 B-tables Estimates f
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APPENDIX I FORMULATION Table B2.2 f
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APPENDIX I IC = 3: CHEMICAL INDUSTR
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APPENDIX I IC = 5: PERSONAL/DOMESTI
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APPENDIX I IC = 7: LEATHER PROCESSI
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APPENDIX I IC = 9: MINERAL OIL AND
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APPENDIX I IC = 11: POLYMERS INDUST
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APPENDIX I IC =13: TEXTILE PROCESSI
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APPENDIX I IC = 16: ENGINEERING IND
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APPENDIX I Appendix I-a: List of sy
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APPENDIX I No. Use Category No. Fun
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APPENDIX I Appendix I-b: List of sy
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APPENDIX I 290 Organic intermediate
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APPENDIX I Other IC/UC combinations
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APPENDIX II Appendix II Fate of che
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APPENDIX II b) Inherent biodegradab
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APPENDIX II log H % removal -4 -3 -
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APPENDIX III Appendix III Evaluatio
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APPENDIX III Field studies In gener
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APPENDIX IV together the mentioned
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290 Table 1 Selected soil test meth
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292 Table 1 continued Selected soil
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298 Table 1 Selected freshwater sed
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APPENDIX VII Appendix VII Toxicity
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APPENDIX VIII collection), and that
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APPENDIX VIII chemicals (see Sectio
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APPENDIX VIII Multimedia fate model
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APPENDIX VIII Monitoring data Metal
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APPENDIX VIII homeostatic regulatio
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APPENDIX IX based on the proportion
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APPENDIX IX Definition of “blocks
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APPENDIX IX these “blocks” will
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APPENDIX IX and PNECs for the “bl
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APPENDIX XI Appendix XI Environment
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APPENDIX XII Appendix XII Connectio
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APPENDIX XII +40% compared to 1992.
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APPENDIX XIII other substance is be
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APPENDIX XIV Taxonomic group No. of
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