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ENVIRONMENTAL EXPOSURE ASSESSMENT PEClocal The concentrations of substances released from point sources are assessed for a generic local environment. This is not an actual site, but a hypothetical site with predefined, agreed environmental characteristics, the so-called “standard environment”. These environmental conditions can be average values, or reasonable worst-case values, depending on the parameter in question. The scale is usually small and it is assumed that the targets are exposed in, or at the border of, the area. In general, concentrations during an emission episode are measured or calculated. This means that PEClocal is calculated on the basis of a daily release rate, regardless of whether the discharge is intermittent or continuous. It represents the concentration expected at a certain distance from the source on a day when discharge occurs. Only for the soil compartment (being a less dynamic environment than air or surface water) longer-term averages apply. However, in some cases time related concentrations may be obtained, for instance in situations where intermittent releases occur. In principle, degradation and distribution processes are taken into consideration for the PEClocal. However, because of the relatively small spatial scale, only one or two key processes typically govern the ultimate concentration in a compartment. PECregional The concentrations of substances released from point and diffuse sources over a wider area are assessed for a generic regional environment. The PECregional takes into account the further distribution and fate of the chemical upon release. It also provides a background concentration to be incorporated in the calculation of the PEClocal. As with the local models, a generic standard environment is defined. The PECregional is assumed to be a steady-state concentration of the substance. Concentrations in air and water are also estimated at a continental scale (Europe) to provide inflow concentrations for the regional environment. These concentrations are not used as endpoints for exposure in the risk characterisation. Figure 1 illustrates the relationships between the three spatial scales. The local scale receives the background concentration from the regional scale; the regional scale receives the inflowing air and water from the continental scale. This implies that the continental, regional, and local calculations must be done sequentially. It should be noted that the use of regional data as background for the local situation may not always be appropriate. If there is only one source of the substance, this emission is counted twice at the local scale: not only due to the local emission, but the same emission is also responsible for the background concentration of the region. 16 CONTINENT inflow concentrations REGION background concentrations LOCAL ENVIRONMENT Figure 1 The relationship between the continental, regional, and local scale exposure assessments
2.2 MEASURED DATA ENVIRONMENTAL EXPOSURE ASSESSMENT For a number of existing substances measured data are available for air, fresh or saline water, sediment, biota and/or soil. These data have to be carefully evaluated for their adequacy and representativeness according to the criteria below. They are used together with calculated environmental concentrations in the interpretation of exposure data. The evaluation should follow a stepwise procedure: • reliable and representative data should be selected by evaluation of the sampling and analytical methods employed and the geographic and time scales of the measurement campaigns (Section 2.2.1); • the data should be assigned to local or regional scenarios by taking into account the sources of exposure and the environmental fate of the substance (Section 2.2.2); • the measured data should be compared to the corresponding calculated PEC. For naturally occurring substances background concentrations have to be taken into account. For risk characterisation, a representative PEC should be decided upon based on measured data and a calculated PEC (Section 2.5). 2.2.1 Selection of adequate measured data The available measured environmental concentrations have to be assessed first. The following aspects could be considered in order to decide if the data are adequate for use in the exposure assessment and how much importance should be attached to them: Quality of the applied measuring techniques The applied techniques of sampling, sample shipping and storage, sample preparation for analysis and analysis must consider the physico-chemical properties of the substance. Measured concentrations that are not representative as indicated by an adequate sampling programme or are of insufficient quality should not be used in the exposure assessment. The limit of quantitation (LOQ) of the analytical method, which is normally defined by the analytical technique being used, should be suitable for the risk assessment and the comparability of the measured data should be carefully evaluated. For example, the concentrations in water may either reflect total concentrations or dissolved concentrations according to the sampling and preparation procedures used. The concentrations in sediment may significantly depend on the content of organic carbon and particle size of the sampled sediment. The soil and sediment concentrations should preferably be based on concentrations normalised for the particle size (i.e. coarsest particles taken out by sieving). All measurements below the LOQ constitute a special problem and should be considered on a case-by-case basis. One approach that could be considered would be to use a value corresponding to LOQ/2 before estimating a mean or standard deviation (EC, 1999). As this method could heavily influence the mean and standard deviation, other methods may also be considered (e.g. assuming same distribution of data below and above the LOQ). The aim is to obtain as much useful information on exposure from a data set as possible, but there is inherent danger for inappropriate use of the data for risk assessment purposes. To address this problem, two quality levels for existing data are given in Table 4 (taken from OECD, 2000k). In recommending this table the OECD stressed “…these criteria should be applied in a flexible manner. For example, data should not always be discounted because they do not meet the criteria. Risk assessors should make a decision to use the data or not, on a case-by- 17
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Page 4 and 5: LEGAL NOTICE Neither the European C
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Page 35 and 36: Production ENVIRONMENTAL EXPOSURE A
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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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