Exposure Scenario Conference Oslo Exposure models in REACH

Transcription

1 Exposure Scenario Conference Oslo Exposure models in REACH 24 October 2014 Stefano Frattini Risk Management Identification D2

2 Overview Purpose of Chemical Safety Assessment (CSA) Worker exposure assessment Consumer exposure assessment Environmental exposure assessment Chemical Safety Assessment tool (Chesar) 2

3 Purpose of the Chemical safety Assessment (CSA)

4 When is a CSA required? If the substance manufactured or imported at 10 tonnes or more per year a CSA is required. The CSA includes exposure assessment and risk characterisation for all the identified hazards, if one of the criteria is met to classify the substance as hazardous the substance is to be treated as PBT/vPvB information requirements are adapted based on exposure considerations according to Annex XI (3) Identified hazards = adverse effects observed Annex I of REACH sets out the general provision for the assessment 4

5 Purpose of the CSA process Describe the conditions ensuring control of risks arising from manufacture and use(s) of a substance The set of information describing the operational conditions and risk management (if needed) for a use is called exposure scenario Identify where further information is needed (exposure data or testing the substance). Inform users of the substance on the conditions of safe use (via exposure scenario attached to the SDS) Document the assessment in a CSR for the companies own documentation. Submit CSR to the authorities (ECHA and MS) 5

6 Assessment workflow Fulfil information requirements for the various endpoints Derive hazard assessment conclusions (DNELs, PNECs, CnL); Describe the uses of the substance; compile information on the existing conditions of use Exposure scenario building, exposure estimation, risk characterisation CSR to authorities Communicate information on substance properties and conditions of safe use via extended SDS 6

7 Exposure estimation Role of exposure estimation Enable the calculation of Risk Characterization Ratio (RCR) when (semi)quantitative assessment is needed (DN(M)EL, PNEC) Can be used to support qualitative assessment as well Exposure estimation can be achieved by: Modelling tools Measured data Exposure estimation follows from conditions of use reported in the exposure scenario 7

8 Exposure estimation - Workers

9 Workers - Routes of exposure Inhalation Dust Gas Vapour Liquid aerosol On the skin and via the skin Inadvertent ingestion? 9

10 How to assess exposure Empirical models Tier 1 Supposed to be screening tools Often no access to original data May be issues over validity of data Generic but may be off the mark (domain of applicability) Process-based May be highly over-predictive or may be under-predictive Need very careful interpretation (context) 10

11 How to assess it Empirical models Tier 2 Generic Often linked to original data sources Better defined inputs and outputs Data specifically collected to address specific scenarios Multiple individual targeted models (inhalation, dermal) More refined for aerosols and dermal exposures Expertise needed to select correct models and defaults Can select appropriate values from the distributions of exposure (50%, 75% 90%, 95% values) to inform acute, short, medium, long term exposure scenarios 11

12 What models do we have? Inhalation ECETOC TRA Stoffenmanager ART (Tier 2) BEAT (Tier 2) EMKG MEASE SprayExpo Dermal ECETOC TRA Riskofderm BEAT (biocides) POEM/BROWSE (plant protection products) Ingestion? 12

13 ECETOC - TRA workers v2 ECHA guidance R14 the preferred model Standalone and simple to use Developed from EASE based on UK HSE exposure data from range of industrial workplaces Amended on the basis of industry professional judgement Developed to align with and influence structure of exposure assessment under REACH Not scientifically validated (Eteam project) but decent documentation Introduces exposure reduction factors as RMMs and operational conditions Introduced concept of Process Categories (PROCs) 13

14 ECETOC - TRA worker v2 user defined variables Fugacity (dustiness or volatility: 3 bands for each) Molecular weight, physical state Volatility (Pa) for liquids Process Category (30+) Industrial or public domain use (professional) Indoors/outdoors Local exhaust ventilation (yes/no) PROCs define effectiveness Duration of activity (4 bands) RPE used? (0%, 90%, 95% reduction in exposure) Preparation (yes/no) Concentration range (<1%, 1-5%, 5-25%, >25%) 14

15 ECETOC - TRA Boundaries of applicability Aerosols/mists X Fibrous materials X Inhalable v respirable X Process fumes X Solids in liquids X Gases X CMRs and Sensitisers - use caution? Mixtures - take care? UVCBs developed for mono-constituents? Elevated temperatures? 15

16 ECETOC TRA worker v2 issues Generally ok to accept point of departure of inhalation exposures but high exposure reduction through LEV is questionable Very wide volatility bands (same answer for all substances in band) Address long term and not short term inhalation exposure All estimates deemed to be 90th percentile values Personal protective equipment for dermal exposure is not included The dermal exposure for some situations (with local exhaust ventilation) is underestimated compared to measured data Artificially uses hands, forearms and face as target exposed area can lead to spurious conclusions on RMMs Model has limited scientific foundation for dermal exposure LEV modifier automatically applied for dermal if used for inhalation 16

17 ECETOC TRA worker v3 Similar to version 2 but with some new modifiers related to gloves, general ventilation and use of mixtures for dermal exposure, peak exposures. New very low volatility category for liquids Model default decouples LEV from dermal exposure Some changes to LEV effectiveness for some PROCs Changes to LEV effectiveness for dermal challenge Standalone version not user friendly and all TRA tools bundled together 17

18 ECETOC TRA worker v3 (input) Physical-chemical properties - minimum input for Human Health and Environmental Assessment Molecular weight 120 g.mol -1 -> HH and env Vapour pressure (Pa OR hpa) 2.20E+01 Pa conversion 2.20E+01 VP [Pa] at C 20 -> HH and env Water solubility mg.l -1 at C 20 -> Env Partition coefficient octanol-water ( - OR Log(Kow)) 1.10E+00 logkow conversion 1.26E+01 Kow [-] -> Env Biodegradability test result Chemical class for Koc-QSAR readily biodegradable mandatory if QSAR estimation of ksoil/water and Ksediment/water is required Koc (L.kg -1 ) OR Log(Koc)) Koc Koc L.kg -1 -> Env Partition coefficient k soil/water L.kg -1 optional - can be estimated by QSAR -> Env Partition coefficient k sediment/water L.kg -1 optional - can be estimated by QSAR -> Env Partition coefficient to suspended solids L.kg -1 optional -> Env -> Env -> Env comments: Additional physico-chemical parameter input for refined environmental assessment (TIER 2) Input of additional PC data: go to row 165 of datasheets Human Health Assessment - Workers No. Scenario name Process Category (PROC) Type of setting (PROC 7 and 22 always industrial, PROC 11 and 20 always professional) Is substance a solid? (yes/no) Dustiness of solids OR VP of volatiles (Pa) at process temperature (clear entries if you change column F to "No") Duration of activity [hours/day] Batch mixing PROC 5 industrial No >4 hours (default) 1 Use of ventilation? (addresses outdoor use, LEV and general ventilation) Indoors with LEV and good general ventilation Use of respiratory protection and, if so, minimum efficiency? Substance in preparation? (applies to inhalation and dermal for volatiles and solids) Dermal PPE / Gloves No 5-25% Gloves APF 5 No Consider LEV for dermal exposure? (conservative default is "No") Spaying PROC 7 industrial No >4 hours (default) Indoors with LEV and good general ventilation No 5-25% Gloves APF 10 No 2 3 Brushing PROC 10 industrial No >4 hours (default) Indoors with LEV and good general ventilation No 5-25% Gloves APF 10 No 4 Dipping PROC 13 industrial No >4 hours (default) Indoors with LEV and good general ventilation No 5-25% Gloves APF 10 No 18

19 ECETOC TRA worker v3 (output) Long-term Inhalative Exposure Estimate (ppm for volatiles) / (mg/m3 for solids) Long-term Inhalative Exposure Estimate (mg/m3) Long-term Dermal Exposure Estimate (mg/kg/day) Short-term Inhalative Exposure Estimate (mg/m3) 2.10E E E E E E E E E E E E E E E E E E E E+02 Local Dermal Exposure Estimate (µg/cm2) Notes/comments on exposure estimates: LEV efficiency inhalation [%]: 90, LEV efficiency demal [%]: 0, LEV efficiency inhalation [%]: 95, LEV efficiency demal [%]: 0, Note that the TRA predicts vapour phase exposure; exposure by aerosols is not taken into account; if aerosol formation is relevant, refer to other information or models. LEV efficiency inhalation [%]: 90, LEV efficiency demal [%]: 0, LEV efficiency inhalation [%]: 90, LEV efficiency demal [%]: 0, 19

20 Riskofderm Attempt to gather dermal exposure data specifically for REACH purposes Independent check of earlier work Extending dermal exposure into industrial chemicals Simple model 20

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22 ART Web-based expert tool Assessment of volatile components and aerosols for low volatility substances Multiple input fields Many variables and easily configured Provides outputs at a range of %ile values from distribution Requires experienced user to define scenarios 22

23 ECETOC TRA v ART (inhalation) Roller styrene resin: Directly in breathing zone (8 hour twa) PROC 10 roller application Room size: 300 m 3 (ART) ECETOC TRA estimate No LEV (ppm) ART estimate No LEV (ppm) ECETOC TRA estimate LEV (ppm) ART estimate LEV (ppm) m 3 (ART) Styrene (SVP 0.67 o C) major component 10-50% Boiling Point 145 o C ART 90% value Process temperature 30 o C ECETOC fugacity range SVP: kpa Typical worker 8-hour exposures to styrene from laminating ppm Short term exposures ppm 23

24 Exposure estimation - Consumers

25 Principles Set in R15 guidance Scope very broad (e.g. mixtures, articles, construction material) Covers reasonable worst case situation (combined exposure, phases of activities) Routes are inhalation, dermal and oral Targets can be adults and/or children Tools Tier I (ECETOC TRA v2, v3.0, v3.1) Tier II - Consexpo 4.1 Other tools (RIVM emission tool, EGRET, REACT) 25

26 Tier I models ECETOC TRA v.2 Very rigid Conservative (i.e. air exposure estimation = event exposure) Principles following R15 guidance Difficult to ensure safe use Documentation: Addendum to ECETOC Targeted Risk Assessment Report No. 93 Technical Report No. 107 Appendix E ( 26

27 Tier I models ECETOC TRA v3.0 More flexible but still conservative E.g. air concentration = event concentration Not possible to average dose/concentration over the year for infrequent uses What s new: Saturated vapour concentration Dilution in air due to standard room ventilation Dermal/oral transfer factor (default = 1) Possible to set a new subcategory with new input parameters 27

28 Tier I models ECETOC TRA v3.0 Shortcomings How to justify Dermal/oral transfer factor lower than 1 New subcategory parameter can be set by single registrant Documentation ECETOC TRA version 3: Background and Rationale for the Improvements Technical Report No. 114 ( Chapter 3, Appendix F-I. 28

29 DEFAULT VP (non-spray) CLASSES A B C D Vapour Pressure (Pa) A: Vapour pressure >= 10 Pa 1 COLOR CODES DISCLAIMER Default Vapour Pressure Band (non-spray) Default fraction released to air A: Vapour pressure >= 10 Pa 1 A B: Vapour pressure between 1 and 10 Pa 0.1 C: Vapour pressure between 0.1 and 1 Pa 0.01 D: Vapour pressure < 0.1 Pa E+01 Reference Value (Inhalation) 2.50E+01 mg/m 3 Mandatory entries Optional entries Automatically selected Please note that this tool is provided for your personal use only. It should not be copied or forwarded to third parties.the tool has been subjected to thorough testing. Despite this, ECETOC does not guarantee that the ECETOC TRA tool works errorfree. ECETOC is making this tool available for users to aid them in the risk assessment of their materials. ECETOC offers no warranty either to the reliability of the tool and of the provided information or to the conclusions or assumptions made by any user on the basis of the use of this tool or the use of such information. All usage is at the discretion of the user and ECETOC is not liable for any consequences resulting from such use. Reference Value (Inhalation) Reference Value (Dermal) Reference Value (Oral) 8.00E E+00 mg/kg/day mg/kg/day mg/kg/day Molecular weight 108 g/mol OPTIONAL (default values will be used if none entered) Saturated vapour concentration (SVC) Descriptor 9.59E+02 Use "x" only Select Use by Sentinel Product mg/m3 Product Subcategory Use "x" only Select Use by Product Subcategory Product is a spray Product Ingredient Fraction by Weight ADULT CHILD ADULT CHILD Skin Contact Area (cm 2 ) DERMAL Skin Contact Area (cm 2 ) Contact Area (cm 2 ) ORAL Contact Area (cm 2 ) INHALATION Amount Product used per Application (g/event) PRODUCT SUBCATEGORY Dermal Transfer Factor Oral Transfer Factor Default values of 1 (or 100%) are used unless noted otherwise PC1:Adhesives, sealants Glues, hobby use x 0.01 Glues DIY-use (carpet glue, tile glue, wood parquet glue) 0.01 Glue from spray x x 0.01 Sealants 0.01 Parameter: Product Ingredient (g/g) Contact Area (cm 2 ) Transfer Factor (unitless) FreQuency of use (events / day) Thickness of Layer (cm) Density (g/cm 3 ) Conversion Factor (mg/g) Body Weight (kg) Exposure (mg/kg/day) Algorithm: (PI x CA x TF x FQ x TL x D x 1000) / BW Descriptor Product Subcategory PC1:Adhesives, sealants Glues, hobby use E-02 Glues DIY-use (carpet glue, tile glue, wood parquet glue) Glue from spray E-02 29

30 Beyond Tier I? ECETOC TRA v3.1 What s new: Inhalation transfer factor included (by default 1) Reduction of long term exposure/dose by frequency over the year Bands of frequency are used to reduce dose/exposure: occasional uses (less than once/week), infrequent uses (less than once/month), very infrequent uses (less than once/6 months) Developed for SCEDs Now available on ECETOC website ( 30

31 SCEDs SCEDs (Specific Consumers Exposure Determinants) define specific new subcategories with related input parameters (to feed TRA v 3.1) with justification/source of info Developed by sector organizations (DUCC) AISE (PC 35, 31, 3), CEPE (PC 9), CONCAWE (PC 13, 24), FEICA (PC1) Available at: Boundaries Long term exposure only, no post application 31

32 SCEDs Areas which needs careful evaluation Justifications related to dermal/oral/inhalation transfer factors; not clear yet what are convincing reasons to justify a reduction of exposure (measured data for inhalation, viscosity for dermal, etc.) Justification to skip exposure routes (unless evident) Applicability domain of the SCED (e.g. only for non volatile substance) Possibility to average exposure/dose over the year subject to R15 Guidance update. 32

33 Tier II tools Consexpo 4.1 Complex tool which includes several models 4 for air exposure estimation (1 spray model) 5 for dermal and 4 for oral Boundaries / limitations Evaporation model not suitable for article (designed for mixture) Limited validation (evaporation and spray model only) Some boundary not expressed (spray model suited to non volatile substances only) 33

34 Tier II tools Consexpo 4.1 Outputs: Event, daily and yearly averaged concentration/dose Sensitivity analysis Montecarlo analysis Standard scenarios based on RIVM fact sheet Very useful, input parameter based on well established RIVM fact sheet Only few parameters to be entered by the user Covering PC 35, PC 31, some PC 9 and PC 1 sub products 34

35 Tier II tools Consexpo 4.1 Standard scenarios useful but High granularity of sub products: how to ensure representativeness in a reasonable limited number of scenarios (for PC 35 more then 30 RIVM factsheets covering different sub products) Pre application, application and post application considered for the same product (e.g. dishwashing). How to reflect it in the ES. Some input parameter not easy to understand Documentation/tool ownload_page_for_consexpo_software 35

36 Exposure estimation - Environment

37 Principles Principles set in R16 Guidance Different scale of the assessment Local scale Regional scale Environmental exposure assessment encompasses: Release estimation (release models) Exposure estimation for different targets (fate and transport model) Exposure estimation and risk characterization for different compartments Water (fresh/marine water, sediment/pelagic, food chain) STP Air Soil (agricultural soil, food chain) Man via environment (oral intake, inhalation) 37

38 Scale of the assessment At local scale, meaning in the vicinity of point sources of release to the environment: industrial facilities STP (standard town of 10,000 inhabitants) As a consequence of the short time between release and exposure, concentration at local scale is controlled by initial mixing and adsorption. Degradation mechanism are not (less) relevant at this level The output is the calculation of the Local Concentration At regional scale, for a larger area which includes all point sources and wide dispersive sources in that area: 200 x 200 km with 20 million inhabitants More time available for transport and degradation mechanism Regional concentration (PEC regional) serves as background for the local Predicted Environmental Concentration (PEC Local) PEC Local = Local Concentration + PEC regional 38

39 General scheme of the assessment Stage described with at minimum: - ERC -Tonnage for that stage: daily use at site annual use at site daily wide dispersive use Municipal STP Dilution in receiving water Conditions of use: OC/RMM Release estimates for -Water -Air -Soil Substance properties E U S E S Exposure estimates for all protection target: -Water fresh and marine : pelagic, sediment STP food chain -Air -Soil soil food chain Release model Fate and transport model 39

40 Releases vs transport/fate Local scenario 40

41 Release estimation Basic use conditions Amount related determinants Tonnage per use (used for regional assessment) Daily/annual use at a site (used for local assessment) Percentage of tonnage used at regional scale (used for regional assessment) Municipal sewage treatment plant (STP) related determinants: Availability of the STP (yes by default) Discharge rate of STP: 2000 m3/day by default as in EUSES Application of the STP sludge on agricultural soil (yes by default leading to soil exposure) Dilution related determinant Receiving surface water flow rate: set by default to m3/day as in EUSES 41

42 Release estimation - Methods ERC methods (default) release factor is given by ERC selection (conservative) Release factor release factor is provided by the registrant, generally derived from literature (e.g. OECD ESD). Measured releases Release rate measured at the site is provided by the registrant (e.g. from manufacturing site) SPERC Release factor together with related condition of use (either at the process level or as end of pipe RMMs) are provided by sector organization in standard format 42

43 CoU driving release factor / rate Unless default (conservative) ERC release method is used, the registrant should justify release factors / rate and report related Condition of Use At the process level: e.g. water contact (dry/wet process), equipment cleaning, efficient use of chemicals (water reuse), etc. RMM reducing releases to air (e.g. air scrubber) or water (e.g. WWTP like physical separator, chemical oxidation, etc.) 43

44 SPERCs SPERCs are developed by sector organisation (e.g. ESIG, Eurometaux, FEICA, AISE, CEPE, ACEA, etc.) SPERCs provide release factors, justifications, related CoU (OC/RMM) for different uses supported by sector organization Those elements are collected in standardised format called SPERC Factsheet Can be used by registrant for release estimation in their dossier Ongoing project held by ECHA (via contractor) in collaboration with industries: Define SPERC requisites Develop good examples of SPERCs Same principles above apply to SPERCs SPERCs documentation available at CEFIC and sector organisation website. 44

45 Fate and transport estimation The EUSES fate/transport estimation encompasses different mechanism/model: Partitioning and degradation behaviour (mainly driven by substance properties). Distribution and fate model at local scale Distribution and fate model at regional scale Modelling STP (% of inflow substance which biodegrades, adsorbs into sludge, volatilizes and will be finally released to surface water) 45

46 heat content 0 MW Air model: Local scale wind air gas phase degradation S TP SW model: Local scale v ola tilis ation 0 m 10 m 100 m C soil C air partitioning partitioning rainwater aerosol wet deposition dry deposition 1000 m Average deposition flux (regional) degrad ation (regional) d ilution pa rtitioning s edim en tatio n/ res us pens ion s us pend ed m atter Accumulation over 10 year REGIONAL MODEL: Overview 46

47 Chemical Safety assessment tool

48 Chesar tool Chemical Safety Assessment and Reporting Tool IT Tool developed by ECHA supports registrants to prepare their CSA used to carry out the exposure assessment and risk assessment TRA workers and consumers (v ) and EUSES (+release module) are embedded in Chesar facilitates the re-use of CSA elements imported from external sources (e.g. SPERC / SCED developed by industry organisations) enables automated generation of the Chemical Safety Report (CSR) and the Exposure Scenario (ES) for communication greater efficiency, harmonisation & consistency Available at: 48

49 Assessment workflow Fulfil information requirements for the various endpoints Derive hazard assessment conclusions (DNELs, PNECs, CnL) Describe the uses of the substance; compile information on the existing conditions of use Exposure scenario building, exposure estimation, risk characterisation CSR to authorities Communicate information on substance properties and conditions of safe use via extended SDS 10/27/

50 Exposure Scenario Conference Oslo Scaling 24 October 2014 Stefano Frattini Risk Management Identification D2

51 Overview Verification of the ES attached to SDS What the scaling is Option and limitation of scaling How to apply scaling Outcome of scaling Example of scaling 51

52 Verification of the ES attached to SDS The use and condition of use are covered by the ES No action! Only document conclusion of the verification It is not clear whether the use and use condition are covered by the ES Use might be included in more general use in the ES Scaling might be applicable The use and condition of use are not covered by the ES Actions are needed Modify use and/or use condition Request the supplier to include the use / use condition into a new ES Look for another supplier Do not use the substance Prepare DU CSR 52

53 What the scaling is It is a mathematical method to show that DU works under use condition described in the ES It is applicable to quantitative parameter only Is applicable if registrant has used an exposure model for the assessment Not applicable if the assessment is based on measured data Scaling is not a means for DU to justify his condition of use if the received ES is ultra conservative 53

54 Options and limitations Options for scaling Are included in section 4 of ES received by the supplier They include Method, i.e. formula or link to software or model Parameters that may be scaled and their limits of variability Limitation of scaling The RCR obtained by scaling should not be higher than the RCR obtained under the condition of use set in the ES Scaling does not impact on other elements of the assessment Qualitative assessment PEC regional for the environment (i.e. increasing release rate to water compensated by higher dilution factor) 54

55 How to apply scaling Compare your condition of use to those reported in the ES and identify what parameters do not correspond Verify if scaling is foreseen in the ES and if parameters previously identified can be scaled. If not, scaling is not applicable Use scalable parameter reflecting CoU at the site as input to a model (or formula) mentioned in section 4 of the ES Verify if scaling boundaries are fulfilled (e.g. RCR is not increased) Document the outcome of scaling 55

56 Outcome of the scaling Scaling shows that the use is covered Scaling does not fulfil boundaries (e.g. RCR SC > RCR ES or parameters are not scalable or scaling is not foreseen in section 4) The use is not covered 56

57 Example of scaling - Environment 4. Guidance to DU to evaluate whether he works inside the boundaries set by the ES Scaling method Environment Exposure estimation tool used: EUSES Scalable Parameters: Environment Daily quantity The effectiveness of the following RMM, if available at DU sites, can be included in the scaling parameters On site air emission abatement system On site waste water treatment Non scalable parameters Other parameters (different from those indicated under scalable parameters) have to be taken (with no change) from the Exposure Scenario provided Boundaries of Scaling RCR not to be exceeded are described in Section 3of the ES. Release Rate not to be exceeded as described in Section 3 of the ES Scaling instructions For Scaling instructions and scaling software please go to the following website: 57

58 Example of scaling - Environment Parameter ES DU Daily use of the substance (kg/d) Wastewater treatment plant flow (m 3 /d) Receiving water body flow rate (m 3 /d) Onsite Removal Efficiency - Wastewater - other than on-site STP (%) Municipal Sewage Treatment Plant used? On-site (industrial) Sewage treatment plant used? Municipal Sewage Sludge applied to soil? (yes/no) In line with ES In line with ES 0% (not foreseen) Yes Yes Yes 90% In line with ES In line with ES In line with ES Release rate Release route ES Scaling Tool (DU Conclusion conditions) Water 0.1 kg/day 0.05 Kg/Day OK RCR Protection target ES Scaling OK (DU) Freshwater OK Sediment OK (freshwater) Marine water OK Sediment (marine water) OK Sewage treatment plant OK Agricultural soil OK Man via Environment < 0.01 < 0.01 OK Inhalation Man via Environment Oral < 0.01 < 0.01 OK 58

59 Background slides

60 From hazard conclusions to exposure assessment Route Type of effect Type of risk characterisation Inhalation Dermal Hazard conclusion (see section 5.11) Systemic effect - Long-term Quantitative DNEL = 24.7 mg/m3 Systemic effects -Acute Not required No hazard identified Local effects - Long-term Qualitative Hazard unknown (no further information required) Local effects - Acute Qualitative Hazard unknown (no further information required)) Systemic effect - Long-term Quantitative DNEL = 7 mg/kg bw /day Systemic effects -Acute - Not required No hazard identified Local effects - Long-term Qualitative Low hazard Local effects - Acute Qualitative Low hazard Eyes Local effects Acute Qualitative Low hazard 60

61 spraying 61

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