1. 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

2. 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

3. 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

4. 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

5. 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

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

7. 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

8. 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

9. 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

10. 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.

11. Life Cycle stages of a substance

12. 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

13. 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

14. 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

15. 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:

16. 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

17. 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

18. 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

19. 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

20. 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.

21. 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;

22. Description of Uses Tool for use collection:
Downstream Users Organisation DUCC UseR
Sources for use descriptors developed by industry
Sector groups have developed use descriptors typical for their sector:
This gives overview of links to different sectors with their use mappings
SPERCs and guidance and fact sheets:

23. 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

24. 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

25. 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

26. Exposure Estimation: Workers and Consumers
Models for Workers Exposure:
Inhalation:
Ecetoc TRA ( )
Stoffenmanager ( )
COSHH tool ( )
EASE ( )
ART ( )
Dermal:
Ecetoc TRA
RISKOFDERM ( )
Oral:
No models available yet }
Tier 1 }
Tier +
Tier 1
Tier +

27. Exposure Estimation: Workers and Consumers
Models for Consumers Exposure:
Inhalation
Ecetoc TRA
ConsExpo ( )
EUSES ( )
Dermal
Ecetoc TRA
ConsExpo
EUSES
Oral

28. 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

29. 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

30. 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

31. 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

32. 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.

33. Exposure Estimation: Environment
Environmental Release Estimation Models
EUSES ( )
Tier 1 estimation with default daily/annual uses
Higher Tier is possible with specific information on release
EU TGD ( )
Tier 1 estimation model
Developed by Cefic with Univerty of Nijmegen
Is used in Ecetoc TRA
Higher Tier models have been developed
Overview from: ( )

34. 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

35. 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:

36. 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:

37. 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

38. 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

39. 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

40. 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

41. Thank you