Leo Heezen Cefic 30 – 31 May 2011, KIEV UKRAINE Exposure Assessment Workshop GPS Risk Assessment and REACH/GHS implementation in practice Leo Heezen Cefic 30 – 31 May 2011, KIEV UKRAINE

STEP 1: Select Substances for Risk Assessment STEP 2: Gather information STEP 3: Allocate Substances into Tiers STEP 4: Complete Tier-relevant Information STEP 5: Characterise Hazard STEP 6: Assess Exposure STEP 7: Conduct Risk Characterization STEP 8: Document outcome and Communicate to the public

Content Process of Exposure Assessment Basic information required for Exposure Assessment Description of uses Exposure estimation Workers and Consumers Exposure estimation Environment Exposure Assessment Exposure estimating tools: Ecetoc TRA

Process of Exposure Assessment Main goal of the Exposure Assessment: To prove that the uses identified for your substance in combination with the Operational Conditions (OC) and Risk Management Measures (RMM), it is safe for the Workers, Consumers and the Environment Basic concept Perform stepwise assessment, start with “conservative” normal conditions Take existing RMM and OC into account Examine entire product life cycle Consider exposure the Workers, Consumers and Environment

Process of Exposure Assessment How to do the Exposure Assessment? Collect information on properties Collect information on the uses and the typical OC/RMM applied Set up an Exposure Scenario Estimate Exposure for that scenario, using estimating tools or measured data Check if the Estimated Exposure is below hazard level If not refine assessment If yes, communicate safe conditions of use

Simplified flow diagram for Exposure Assessment process Identification of Uses Description of Uses Estimation of Exposures Characterisation of Risks Hazard Assessment Communication of Risks

Basic Information Required for EA The extent of basic information for Exposure Assessment depends on the Assessment Result and additional info might be required to conclude an Assessment Base set of information Product information Product Characteristics Operational Conditions Risk Management Measures Environmental Characteristics Other relevant information

Basic Information Requirements for EA Tier models for exposure TIER 1 Estimation Simple models Limited info required Very conservative Covers majority of cases TIER 2 More advanced models Increased level of information Increased level of knowledge Higher TIER models Very sophisticated and specific models Expert knowledge required Measured data Most accurate Still careful in using

Basic Information Requirements for EA Base set of information The exposure estimating tools require base information as input. The level of information required increases with more advanced tools For a Tier 1 estimation the minimal requirements are: Molecular Weight Inhalation, Dermal, Oral Vapor Pressure Biodegrability Volatility Partition coefficient Vapor/Liquid/Solid Dustiness Solubility

Basic Information Requirements for EA Product information Life Cycle information What are the different steps until the waste stage of the substance Manufacturing Formulation Use Service life Waste stage Could mean that when substance is captured in a matrix, but released later, this should be included as well Recycling etc is normally not included Could be characterised by Sector of Use, Product and Article category Information come from: Marketing/Sales, Customers, Sector branches In several cases Sectors have published typical life cycle information.

Life Cycle stages of a substance

Basic Information Requirements for EA Product Characteristics Volume used in different sectors Composition Shape Packaging Could be characterised by Product Category, Article Category, NACE code

Basic Information Requirements for EA Operational Conditions and Risk Management Measures Process conditions Protective equipment Ventilation Effluent treatment Typical handling Ventilation Spraying Local exhaust Operational conditions and Risk Management Measures are closely related and are normally communicated in combination. Typical OC/RMM defined by specific sectors (business as usual). Overview available on Cefic web site

Basic Information Requirements for EA Environmental Characteristics Surrounding environment Sewage Water Treatment (STP) Municipal Waste Water Treatment (WWT) Vent system, scrubber, incinerator etc Spatial dimensions Treatment of waste Sludge disposal Typical sector info from ERC or SPERCs

Basic Information Requirements for EA Other relevant information MSDS Information from other relevant regulations like IPPC, GHS, etc Measured exposure data Waste Management Measures Standard info sheets like OECD Emission Scenario Documents (ESD), EMKG sheets, BAT etc A template with drop down menus for collection of Tier 1 information for Ecetoc TRA can be downloaded from Cefic website: http://cefic.org/templates/shwPublications.asp?HID=750&T=806&P=2

Description of Uses Transported isolated intermediates Normally workplace legislation in place and well controlled by law Chemicals included into or onto a matrix Normally low exposure, but wider use and therefore increased HH and Env exposure possible Non-disperse use – Professional use Controlled and non-controlled use possible Wide disperse use – consumers Potential high number of persons exposed High level of emission to Env

Description of Uses Use categories Describes the function and application of a substance May differ from region to region Use descriptors are used as input for Exposure Estimating models and for communication through the supply chain Different use descriptor systems in place: EU NACE codes for sectors of use OECD Use patterns (Main Pattern, Industrial and Use Category) Updated IUCLID use descriptor system (Sector of Use, Product Category, Process Category, Article Category and Environmental Release Class) Harmonised codes for US and CND 36 Industrial functions and 40 Consumer and Product codes

Description of Uses Updated IUCLID 5.2 Use Descriptor system Is used as input for several exposure estimation tools Sector of Use (SU) Main user groups (Industrial, Consumer, Professional) for TRA Sector of industry indication for higher Tier estimations To be specific in case of use against Product Category (PC) Use of substance by end use To structure the market by end use Consumer exposure for TRA Process category (PROC) Nature of the process steps Defined from occupational perspective Workers Exposure for TRA

Description of Uses Article Category (AC) Updated IUCLID 5.2 Use Descriptor system (cont’d) Article Category (AC) To cover the subsequent life cycle stages in an article Relevant for Consumers, Workers and Environmental Exp. Consumers exposure in TRA Environmental Release Categories (ERC) Conditions of use from Env perspective Relevant for all uses and service life of articles Environmental Exposure TRA Sector Specific ERC: SPERC, more realistic default values, developed by industry ± 150 available Including fact sheets to support assumptions

Example Process Categories and Release classes Examples for process/activity Process category (PROC) and Environmental Release Class (ERC) Pattern of exposure “encoded” in the process category and the environmental release category. Spraying of paints, cleaners, lubricants, adhesives Air dispersive techniques, like e.g. Spraying (PROC 7 or PROC 11) Industrial use or wide dispersive professional use of substance intended to become part of an article (ERC 5/ ERC 8c) or not ERC 4/ ERC 8a). Substances can be inhaled as vapour and aerosols. The energy of the aerosol particles may require particular exposure controls; in case of coating, overspray may lead to waste water and waste solvent may be emitted to air. Dying and finishing of textiles, leather or paper; Immersion operations such as dipping and pouring (PROC 13) Industrial use of substances intended to become part of an article or not (ERC 4 or 5) Substance is applied to a surface by dipping the article into a bath and is intended to become part of the article. Formation of dust and aerosols usually low, releases can be easily controlled. Discharge or waste disposal of waste water and/or exhausted baths may be relevant. Coating of floors, painting walls by brushing or rolling, cleaning/polishing of surfaces by wiping Low energy spreading such as rolling, brushing (PROC 10) Wide dispersive professional use (ERC 8a or 8c,) Exposure during spreading of the substance is mainly driven by the substance properties (e.g. vapour pressure) or direct skin contact. Formation of dust and aerosols unlikely; cleaning of devices and machinery may lead to waste water and/or waste. Solvents may be emitted to air. Mechanical cutting, grinding drilling or sanding of articles High mechanical work up of massive metals, substances bound in materials or articles (PROC 24). Industrial or dispersive processing of articles by workers under release promoting conditions (ERC 11b or 12). Substantial thermal or kinetic energy applied to substance by grinding, mechanical cutting, drilling or sanding. Release of solids (dust) or fumes to be expected. Fall-out to be disposed of as waste. Mixing of solids and liquids in batch formulation of coatings, cleaners, plastic compounds, textile dyes Use in closed batch process (PROC 3) or mixing and blending in batch process (multistage and/or significant contact) (PROC 5); related transfers of substances (PROC 8a, 8b and 9). Formulation of/into preparations (ERC2 or ERC 3) Predominant handling in contained manner (e.g. through enclosed transfers), but some opportunity of contact (e.g. during sampling) Solid or liquid materials can be released as vapour or dust, significant contact possible Waste or waste water from equipment cleaning to be expected.

Example Use Descriptor pigment Questions for briefly describing a use in general terms Category Exemplification for a pigment Which sectors of the formulating industry buy the substance? In which categories of chemical products is it used? PC 9a Paints and coatings Which processes are applied during mixing/formulation of substance? PROC 3, 8b, 9 ERC 2 Mixing of liquid preparation in closed batch process, incl. transfers of substance Is the substance as such or in preparations used by industrial workers, professionals or consumers? SU 3, 21, 22 Industrial workers, professionals outside industrial sites, and consumers In which type of processes is the substance applied on end-use (worker perspective)? What are the broad environmental characteristics of these uses: indoor/outdoor use; use at industrial site or wide dispersive use; substance intended to become part of an article matrix or intended to serve as a processing aid or intended to react on use? PROC 7 , 10, 11, 13 ERC 5 ERC 8c/f Spraying, brushing, dipping Industrial sites and wide disperse use, in- door and outdoor uses. Substance becomes part of articles. In which consumer products is the substance used? What are the broad environmental characteristics of these uses? Paints and coatings for consumer use If substance becomes part of an article: In which articles is it contained during service life (and subsequent waste life stage)? AC 11 Wooden articles If substance becomes part of an article: What are the broad environmental characteristics of the substance during service life: indoor/outdoor use of the article; low or high release of substance from the article? ERC 10a/11a Indoor and outdoor use, low release of substance from article; If the substance becomes part of an article: Are there foreseeable activities with the article that lead to removal of substances from the surface on processing or maintenance by abrasive techniques (e.g. paint stripping) ERC 10b/11b Indoor and outdoor use, high release of substance from article;

Description of Uses Tool for use collection: Downstream Users Organisation DUCC UseR http://cefic.org/templates/shwPublications.asp?HID=750&T=806 Sources for use descriptors developed by industry Sector groups have developed use descriptors typical for their sector: http://cefic.org/en/reach-for-industries-libraries.html This gives overview of links to different sectors with their use mappings SPERCs and guidance and fact sheets: http://www.cefic.org/Industry-support/Implementing-reach/Documents-and-Tools1/

Exposure Estimation: Workers Workplace exposure Identify relevant uses (PROCs) Compile all available exposure data, linked to OC and RMM When no exposure data available, use Ecetoc TRA for first (conservative) exposure estimate Check if exposure level is below threshold value. If not refine assessment. If yes, document safe use conditions

Exposure Estimation: Consumers Consumers exposure: Identify all relevant uses (AC, PC etc) Compile all available exposure data ( use level surveys etc) In case no exposure data, use Ecetoc TRA for first (conservative) exposure estimate Check if exposure level is below threshold value. If not refine assessment. If yes, document safe use conditions

Exposure Estimation: Workers and Consumers Three exposure route for workers and consumer exposure: Inhalation Dermal Oral Determination of exposure through these route: Measured data Extensive guidance available on how to get workers exposure data Normally (conservative) predictive models are preferred, but measured data might be necessary Predictive Estimation Models Wide variety of predictive models Simple (conservative) Tier 1 to complex more accurate higher Tier models Need to confirm applicability of the model

Exposure Estimation: Workers and Consumers Models for Workers Exposure: Inhalation: Ecetoc TRA (http://www.ecetoc.org/tra ) Stoffenmanager (www.stoffenmanager.nl ) COSHH tool ( http://www.coshh-essentials.org.uk/ ) EASE (http://www.hse.gov.uk/index.htm ) ART (http://www.advancedreachtool.com/ ) Dermal: Ecetoc TRA RISKOFDERM (http://www.tno.nl/content.cfm?context=markten&content=product&laag1=177&laag2=333&item_id=1155&Taal=2 ) Oral: No models available yet } Tier 1 } Tier + Tier 1 Tier +

Exposure Estimation: Workers and Consumers Models for Consumers Exposure: Inhalation Ecetoc TRA ConsExpo (http://www.rivm.nl/en/healthanddisease/productsafety/ConsExpo.jsp ) EUSES (http://ecb.jrc.ec.europa.eu/euses/ ) Dermal Ecetoc TRA ConsExpo EUSES Oral

Exposure Estimation: Environment Environmental Exposure: Collect all relevant uses (ERC and SPERCs) together with typical OC/RMM Compile all available exposure data (environmental level surveys) Calculate exposure level with (conservative) estimation tools like Ecetoc TRA or EUSES Check if exposure level is below threshold value. If not refine assessment. If yes, document safe use conditions

Exposure Estimation: Environment Environmental exposure estimation is very complex and needs expertise to come to solid conclusions Environmental Exposure should include local and regional effects Environmental Exposure should include Inland and Marine risks Can be based on measured or modeled data Adequate assessment factors are used to compensate for uncertainties

Exposure Estimation: Environment Environment Exposure Assessment required for: Aquatic Ecosystem (Marine and Fresh water) Terrestrial Ecosystem (Soil) Top predators (End of food chain: whales, polar bears, wolves etc) Micro organisms in STP (Municipal waste water treatment) Atmosphere (Direct or indirect release) Not all input in base set. Triggered by concern of substance All life cycle stages of the substance should be considered Supplied tonnage to each life cycle stage Release factors depending of type of use and stage in the life cycle

Exposure Estimation: Environment Required information for environmental release estimation Tonnage to each compartment Life cycle stage and type of use Distribution of tonnage in market Emission pattern – distribution in time and space Multiple emissions Emission factors RMM to reduce emissions

Exposure Estimation: Environment Workprocess Environmental assessment: Select appropriate and validated release estimation model Compile relevant substance properties Determine volume applied Carry out exposure estimation at local and regional level Compare derived exposure level with thresholds and refine if required.

Exposure Estimation: Environment Environmental Release Estimation Models EUSES ( http://ecb.jrc.it/euses ) Tier 1 estimation with default daily/annual uses Higher Tier is possible with specific information on release EU TGD ( http://www.envsci.science.ru.nl/cem-nl/products.html ) Tier 1 estimation model Developed by Cefic with Univerty of Nijmegen Is used in Ecetoc TRA Higher Tier models have been developed Overview from: (http://focus.jrc.ec.europa.eu/ )

Assessment of Exposure Based on the use information and life cycle stage, exposure scenario to be developed These scenarios should feed into the different exposure estimating calculation models If exposure levels derived from estimation models lead to conclusion that risk to workers, consumers or environment, is not controlled, the exposure estimation needs more refinement: Change operational conditions Change Risk Management Measures Go to higher tier estimation model Use measured data Expert judgment required

Assessment of Exposure: helpful tools Industry sectors have developed tools to help in the assessment: Generic Exposure Scenarios (GES) GESs describe exposure assessments for (groups of) substances for an area of operation within industry and are developed by M/Is in partnership with DU Associations describes Risk Management Measures & Operational Conditions relevant for safe use of a group of substances with a similar risk profile M/I selects relevant GES to support his assessment most advanced for workers exposure Overview of GES from: http://cefic.org/en/reach-for-industries-libraries.html

Assessment of Exposure: helpful tools Specific Environmental Release Classes (SPERCs) Developed by different industry sectors to make ERCs more specific. Describe the typical operations in their sectors including (conservative) release factors and efficiencies of RMM/OC. Fact sheets to justify specific factors under preparation Are used in the Ecetoc TRA and Chesar Overview of SPERCs and fact sheets from: http://cefic.org/templates/shwPublications.asp?HID=750&T=806

Assessment of Exposure: helpful tools Chemical Safety Assessment and Reporting Tool (Chesar) Developed by EU Chemicals Agency Release 1.2 in June 2011 Use descriptor system Uses Ecetoc TRA for workers/consumers and EUSES for environment as default Results of other estimating tools can be processed Helps in the assessment process Generates some reporting

Assessment of Exposure: helpful tools Standard phrases for communication Standard phrase library available for MSDS and offered by EHS providers Standard phrases for safe use of chemicals are developed by industry and are available in English, free of charge XML standard for harmonised communication available Translation into local language via EHS providers http://reach.bdi.info/380.htm

Assessment of Exposure: assessment factors DNEL = NOAEL or NOAEC = NOAEL or NOAEC AF1 x AF2 x ... x AFn Overall Assessment Factor  PNEC = L(E)C50 AF’s Assessment factors gives margins of safety and depending on endpoint they can give high dilutions When comparing estimated exposure levels with DNEL or PNEC, realize that exposure estimate is conservative as well as the DNEL/PNEC

Tiering tools on Exposure estimates Workers Consumers Environment TIER 1 Ecetoc TRA COSHH BAuA ConsExpo EUSES PetroRisk “TIER 1.5” GES UseR SPERCs TIER 2 and higher Stoffenmanager ART HERA GEXframe BAMA GE-eater GEMCO AS-treat Measurement

Thank you lhe@cefic.be