MARINE RISK ASSESSMENT METHODOLOGY APPLIED IN THE CONTEXT OF ACCIDENTAL SPILLS An example with the CLARA Project
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1 TOXICITY and ENVIRONMENTAL IMPACT MARINE RISK ASSESSMENT METHODOLOGY APPLIED IN THE CONTEXT OF ACCIDENTAL SPILLS An example with the CLARA Project Alice JAMES Marine Risk Assessment Unit, Nantes 1
2 Joint IFREMER/INERIS ARC Unit Analyse des Risques Chimiques (ARC) en milieu marin = Marine Risk Assessment Unit 2 institutes : IFREMER / INERIS combination of two skills : Knowledge of the marine environment ARC Unit Knowledge of risk assessment methodology 2
3 INVOLVMENT OF ARC Unit IN THE CLARA PROJECT (1/2) In the second phase of the project : Collection of valid ecotoxicity data to derive... Predicted No Effect Concentrations (PNECs) for short term exposure for long term exposure 3
4 INVOLVMENT OF ARC Unit IN THE CLARA PROJECT (2/2) Derivation of PNECs : what for? Aim : definition of risk areas PNEC long term Long Term Risk Area High Risk Area S PNEC short term No Risk Area 4
5 RISK ASSESSMENT METHODOLOGY DERIVATION OF PNEC marine, long term TGD : Technical Guidance Document in support of Commission Directive 93/67/EEC on risk assessment for new notified substances and Commission Regulation EC No 1488/94 on risk assessment for existing substances and Commission Directive (EC) 98/8 on biocides. Chapter 3. Environmental Risk Assessment - Marine 5
6 DERIVATION OF PNEC long term 2 methods available for derivation Bioassays Effect Concentrations (LC 50, EC 50, NOEC) Assessment factors method Statistical extrapolation method Predicted No Effect Concentrations (PNEC long term ) 6
7 DERIVATION OF PNEC long term 2 methods available for derivation extrapolation factors method Bioassays Effect Concentrations (LC 50, EC 50, NOEC) Assessment factors method Statistical extrapolation method Predicted No Effect Concentrations (PNEC long term ) 7
8 DERIVATION OF PNEC long term extrapolation factors method Definition of extrapolation factors : they are divisor coefficients of effect concentrations PNEC = effect concentrations (EC(L) 50, NOEC) extrapolation factor 8
9 DERIVATION OF PNEC long term extrapolation factors method Why we apply extrapolation factor : to take account, if necessary, of Extrapolation of data : laboratory field acute toxicity chronic toxicity freshwater saltwater Uncertainties of data, due to intra- and inter-specific variations intra- and inter-laboratories variations. Lack of data (marine and estuarine waters) 9
10 DERIVATION OF PNEC freshwater, long term extrapolation factors method 10
11 DERIVATION OF PNEC marine, long term extrapolation factors method Marine environment Lack of ecotoxicity data on marine organisms 11
12 DERIVATION OF PNEC marine, long term extrapolation factors method Adaptation of the TGD to the marine environment When it seems that there are no significant differences between freshwater data (FW) and marine data (SW) Higher biodiversity and Specific taxa in the marine environment Use of the whole data set (FW and SW) to derive PNEC Precaution : application of an additional extrapolation factor of 10 (FW -> SW) 12
13 DERIVATION OF PNEC marine, long term extrapolation factors method 13
14 DERIVATION OF PNEC long term 2 methods available for derivation statistical extrapolation method Bioassays Effect Concentrations (LC 50, EC 50, NOEC) Assessment factors method Statistical extrapolation method Predicted No Effect Concentrations (PNEC long term ) 14
15 Assumptions : DERIVATION OF PNEC long term statistical extrapolation method the distribution of species sensitivities follows a theoretical distribution function the group of species tested in the laboratory is a random sample of this distribution Number of species Log NOEC (average) Log NOEC 15
16 DERIVATION OF PNEC long term statistical extrapolation method Chronic ecotoxicological data available : NOEC At least 10 NOEC (preferably more than 15) among 8 different taxa log-normal distribution, log-logistic distribution Number of species Log NOEC (average) Log NOEC 16
17 DERIVATION OF PNEC long term statistical extrapolation method SSD : «Species Sensitivity Distribution 1 Toxicité long terme du cadmium vis à vis des organismes d'eau douce Pourcentage Affected d'espèces species affectées (%) 0,9 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 0 Algues Algae Batraciens Amphibians Invertébrés Invertebrates Poissons Fish loi normal normale law -1-0,5 0 0,5 1 1,5 2 log NOEC (µg/l) 17
18 DERIVATION OF PNEC long term statistical extrapolation method Chronic ecotoxicological data available : NOEC At least 10 NOEC (preferably more than 15) among 8 different taxa log-normal distribution, log-logistic distribution HC5 estimation : 5 th percentile of SSD 1 Toxicité long terme du cadmium vis à vis des organismes d'eau douce 0,9 5% species affected Pourcentage d'espèces affectées 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 0 Algues Batraciens Invertébrés Poissons loi normale -1-0,5 0 0,5 1 1,5 2 log NOEC (µg/l) HC5 18
19 DERIVATION OF PNEC long term statistical extrapolation method Chronic ecotoxicological data available : NOEC At least 10 NOEC (preferably more than 15) among 8 different taxa log-normal distribution, log-logistic distribution HC5 estimation : 5 th percentile of SSD assessment factor (AF) = 1-5 PNEC = HC5 / AF 19
20 DERIVATION OF PNEC marine, short term hazard assessment for long term exposure : for saltwater : clear guidance in the TGD (Part 4.3.1) hazard assessment for intermittent release : for freshwater : guidance in the TGD (Part 3.3.2) for saltwater : no clear guidance in the TGD Methodology proposed by ARC Unit 20
21 DERIVATION OF PNEC marine, short term Acute toxicity data set Effect Concentrations (EC 50, LC 50 ) Assessment factor proposed for intermittent releases in freshwater (TGD) 100 Additional assessment factor for saltwater data set 10 PNEC short term 21
22 Short term Long term CAS Chemicals PNEC PNEC Number (µg.l -1 ) (µg.l -1 ) Methanol Ethylene glycol Dichloromethane ,2-Dichloroethane MTBE MDI Ethyl acetate ,1,2-Trichloroethane Benzene Acetic acid Phenol Toluene Ethyl benzene Ortho cresol Naphtalene Styrene Vinyl acetate Xylenes Biphenyl Nonylphenols RESULTS : PNECs To define risk areas PNEC long term PNEC short term Long Term Risk Area High Risk Area S No Risk Area 22
23 Thank you for your attention Contacts : Alice JAMES (INERIS) alice.james@ifremer.fr Websites : IFREMER INERIS 23
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