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Federal Institute for Risk Assessment1 Exposure Data Tools - Current Situation in Europe Gerhard Heinemeyer Federal Institute for Risk Assessment Berlin,

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Presentation on theme: "Federal Institute for Risk Assessment1 Exposure Data Tools - Current Situation in Europe Gerhard Heinemeyer Federal Institute for Risk Assessment Berlin,"— Presentation transcript:


2 Federal Institute for Risk Assessment1 Exposure Data Tools - Current Situation in Europe Gerhard Heinemeyer Federal Institute for Risk Assessment Berlin, Germany 2003 ISEA Annual Meeting, Stresa Italy

3 Federal Institute for Risk Assessment2 What is RISK? Level of Exposure (Theoretical) Level of Hazard margin of safety 0 0,02 0,04 0,06 0,08 0,1 0,12 0,14 0,16 0,18 0,2 -972,51001200230034004500560067007800890010000 Concentration/Level/Dose frequency distribution

4 Federal Institute for Risk Assessment3 Exposure Factors Source Distribution Release Deposition Disappearance Behaviour Anthropometrics Substance People Steps in Exposure evaluation Scenario ModelModel variables Descriptions/ Characterizations transformation of Scenario to formula Data to feed the model Measurements

5 Federal Institute for Risk Assessment4 Claims for Exposure Assessments §Scientific state l Evaluation of scenarios, models & exp. factors? l do they and the tools resemble reality? l New developments? §Regulatory requirements l Agreement upon certain approaches (incl. Models and data to be taken)

6 Federal Institute for Risk Assessment5 I. Scenario descriptions

7 Federal Institute for Risk Assessment6 Scenario Descriptions (first step of exposure analysis) §Can be characterized from use instructions l Use of categories of use is recommended (e.g. use of textile as carpet, cloth, furniture) §Models can be defined according to scenarios §The exposure factors needed can clearly be described §Harmonization is needed

8 Federal Institute for Risk Assessment7 Where can scenario descriptions be found? §EU Technical Guidance Document §EPA Exposure factors handbook §Food consumption surveys (image scenarios for food uptake) §ETAD reports (Textile emissions) §RIVM monographs (paints, toys, biocides) §Biocide TGD-draft §Literature §other publications (example Germany)other publications (example Germany)

9 Federal Institute for Risk Assessment8 II. Model evaluations

10 Federal Institute for Risk Assessment9 Needs for Consumer Exposure Estimation §Source: Amounts of substances in products, re Ieases, uses §Disposition of substance: Identification of release, distribution, ad- and desorption, disappearance §Contact: Behaviour of exposed person, contact times, frequencies, durations

11 Federal Institute for Risk Assessment10 Models §A number of models have been developed based on published literature §OECD has prepared an inventory of models §A limited number of tools are regularly used for exposure evaluation e.g.: l EU: EUSES, CONSEXPO, EASE l US: SCIES; CEM, MCCEM, THERdBASE §Validation remains a problem

12 Federal Institute for Risk Assessment11 Comparison of models §Comparative evaluation of models do not exist §Which model for which exposure? Different concepts for the same problem §Computer tools as black boxes §Recalculation of models with other tools is practically not possible, complete algorithms have not been published

13 Federal Institute for Risk Assessment12 III. Source Data

14 Federal Institute for Risk Assessment13 Needs for Consumer Exposure Estimation §Source data Weight fraction (amount) of substance in the product Releases Amount of residual monomers Use data Frequencies Durations

15 Federal Institute for Risk Assessment14 Datapools for sources of exposure Product information §Why is product information important? §The extent of exposure is direct proportional to the amount of substance in the product. §Frequencies and durations of use can modulate the emissions of the substances from the products

16 Federal Institute for Risk Assessment15 Datapools for sources of exposure Information about preparations §Product registers l Switzerland, the nordic countries, Italy, Germany l Poison Information Centres have product information §Safety Data Sheets, Information brochures from industry §Literature §Rules for gathering data are not harmonised l different regulations l no common formats

17 Federal Institute for Risk Assessment16 Datapools for sources of exposure Information about articles §Furniture, clothings, carpets, buildings, cars, toys etc. §The extent of exposure is direct proportional to the amount of substance that is released by the product but §Knowledge about substances in articles is limited (downstream users are not aware on the compositions) §Knowledge about release is also very limited §Measurements in air or dust sometimes give hints for releases from articles for certain substances (e.g. Flame retardants, PAH, heavy metals, pesticides) §No common data pool

18 Federal Institute for Risk Assessment17 Substances in food §We have national surveillance programs for controlling substances (as contaminants) in food by institutions publishing these data §National food consumption studies §Data need to be updated §Studies should be harmonised

19 Federal Institute for Risk Assessment18 Food Monitoring surveillance programme in Germany §National programme measuring substances in food according to a prefixed schedule l contamination of 282 chemicals l 137 different categories of food, focus on heavy metals chlorinated hydrocarbons pesticides l over a period of 12 years

20 Federal Institute for Risk Assessment19 IV. Peoples behaviour and Anthromopetrics

21 Federal Institute for Risk Assessment20 Needs for Consumer Exposure Estimation §Antropometric data l total population l subpopulations Behaviour data (e.g.) staying inhouse staying outside staying at workplace certain behaviours of subpopulations (focus on children, e.g. playing with toys, sucking)

22 Federal Institute for Risk Assessment21 Behaviour data §People do influence their own exposure by behaviour l variations in product uses frequencies, durations l variations in contacts with chemicals time pattern, staying home etc. l Age dependent behaviours hand to mouth contacts –Children –eating at the workplace –hygiene during preparation of food

23 Federal Institute for Risk Assessment22 Anthropometric Data §Lots of compilations about body weights, heights, and surfaces exist §Regional differences to be mentioned §North to South to West to East Europe §Scientific and regulation aspects may deviate considerably

24 Federal Institute for Risk Assessment23 Anthropometric data (cont.) §Body masses l weight l height l body surface l partial surfaces l breathing rates l lung surface §Uptake rates l food l drinking water l soil l retention, deposition and resorption of soil in lung l dermal absorption

25 Federal Institute for Risk Assessment24 Anthropometric data (cont.) §Body masses l weight l height l body surface l partial surfaces l breathing rates l lung surface §Data quality? l Good quality l can be modelled l sufficient, but limited l sufficient l limited

26 Federal Institute for Risk Assessment25 Anthropometric data (cont.) §Uptake rates l food and drinking water l soil l retention, deposition and resorption of soil in lung l dermal absorption Data quality? Sufficient, but limited limited model approaches, limited validation

27 Federal Institute for Risk Assessment26 Compilations that provide anthropometric data §EPA exposure monographs incl. Handbooks §AIHC exposure factors handbook §ECETOC Exposure factors sourcebooks §RIVM monographs (national data) §Standards zur Expositionsabschätzung (national data) §EU Technical Guidance Document §Annals of the ICRP (Intern. Comm. On Radiological Protection) §many data have been written out from other secondary sources...

28 Federal Institute for Risk Assessment27 What about secondary literature - body weight §Albania61,07 §Bosnia-Herzegovina61,70 §Croatia61,70 §Macedonia61,07 §Malta61,07 §Portugal61,07 §Slovenia61,07 §Italy73,23 §Spain73,23 §Yugoslavia75,28 §Greece76,13 Source: WHO, cited in ECETOC Technical Report

29 Federal Institute for Risk Assessment28 Children represent a special group of exposed persons §Physiological differences (children are no little adults) §Development (qualitative changes of toxicity during childhood) §Mouthing behaviour §Quantification is difficult

30 Federal Institute for Risk Assessment29 Information about children §Scientific literature §US-EPA §Danish EPA §some publications from RIVM §workshops §hundreds of publications covering childrens exposures and dealing with specific questions, but comprehensive collections of high quality information is scarce

31 Federal Institute for Risk Assessment30 Data sources for exposure assessments in children Cohen Hubal et al, Env. Health Persp. 2003 §insufficient data on children's exposures and activities §multimedia exposures to environmental contaminants cannot be assessed §default assumptions are taken for exposure assessments §reduction of uncertainty in the assumptions and exposure estimates is needed

32 Federal Institute for Risk Assessment31 V. Quality aspects

33 Federal Institute for Risk Assessment32 Measurements vs. Modelling? Is there a contradiction? §Modelling exposure normally describes the whole estimation process, but a model can be calculated with hypothetical values, not reflecting reality §Frequently measurements are performed to describe specific exposure situations e.g. controlling workplace levels. §Measurements can be done for everything in the model e.g. model results, exposure factors, they make the model realistic §Measurements should reflect the scenario characterization, otherwise they may not be representative

34 Federal Institute for Risk Assessment33 Very conservative and hypothetical values High degree of uncertainty Default Worst case 50 th percentile Whole distribution Level of quality Single point estimates Distribution based 99 th percentile 50 th percentile 99 th percentile High quality data are representative, they characterize the range and variability

35 Federal Institute for Risk Assessment34 Data quality? ValidationRepresentativeness Transparency

36 Federal Institute for Risk Assessment35 RIVM quality factors 9Not questionable 8good value, discussion possible 7enough space 6useful, improvement needed 5doubtful, can be used as a default 4doubtful, can not be completely used a default 3bad value, not useful as a default 2useless, but nearer conceivabilities 1useless, no conceivabilities 1 2 4 7 2 3 0 0 0

37 Federal Institute for Risk Assessment36 Body weights of women 45505560657075 NL (25th, RIVM) D (25th, AUH) NL (50th, RIVM) D (50th, AUH) US Western Europe min max Southern Europe min max Northern Europe min max Eastern Europe min max WHO, cited in ECETOC

38 Federal Institute for Risk Assessment37 Data quality of some exposure factors Body weight and height formulations physiologic data use descriptions food consumption time patterns house and room characteristics room ventilation dermal uptake data dust and soil uptake hand to mouth emission rates migration of substances in material etc. Level of quality

39 Federal Institute for Risk Assessment38 Future aspects (under the aspects of regulation) §Exposure factors and exposure data compilations with the objective for l Standardization l Harmonization l Completeness l Representativeness l Ranges l Uncertainty and Variability §Compile a network for continous update §Data mining (inventory of exposure data)

40 Federal Institute for Risk Assessment39 The needs we have for exposure assessments only partly meet the tools Lots of data have been evaluated but they are not available unless they are published in a regular way or otherwise widely available (e.g. per internet)

41 Federal Institute for Risk Assessment40 Thank you for attention

42 Federal Institute for Risk Assessment41 Transparent presentation §Criteria for data compilations are transparent and well understood l source, method of analysis §Standardized methodology has been used §Original literature, secondary to be avoided §The procedure can be repeated easily by other people than the authors l e.g a model can by easily be recalculated (many of the computer tools for exposure analysis are black boxes) l overinterpretation of data from literature which does not meet the intention of the paper

43 Federal Institute for Risk Assessment42 Representativeness §Data have been evaluated using standard epidemiologic and statistical methodology §The selection of the study population has been performed by a transparent procedure §Confounders have been considered §Correlation of compared data is checked

44 Federal Institute for Risk Assessment43 Validation §The result obtained by modelling will be similar to measurements obtained under comparable conditions (same scenario) §Sensitivity analysis The influence of variables that have great or low influence in the model that is used is analysed and well described

45 Federal Institute for Risk Assessment44 Institutes and Organisations Publishing Data about Exposure in Germany §Superior federal institutions l UBA, BfR, BAM etc. §Institutions of Federal states §Federal state scientific institutions (e.g. universities) §Public foundations §Industry and manufacture §Private associations and foundations §Non governmental organisations §Private laboratories

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