Transferring Knowledge to Enable Safe Working With Hazardous Chemicals in Small Firms : A Chemical Industry Perspective on What Really Matters Chris Money Cardiff, 6 th March 2008

Outline Core considerations for successful knowledge transfer Core considerations for successful knowledge transfer Supplier systems for knowledge development and transfer in the chemicals supply chain Supplier systems for knowledge development and transfer in the chemicals supply chain To what extent are existing systems working satisfactorily? To what extent are existing systems working satisfactorily? To what extent might REACH lead to improvements? To what extent might REACH lead to improvements?

Core Considerations For Successful Knowledge Transfer The chemical industry generally considers the following to be core to any process for successful knowledge transfer The chemical industry generally considers the following to be core to any process for successful knowledge transfer Relevance of the information for the user Relevance of the information for the user It should not be too generic/abstract e.g. wear gloves It should not be too generic/abstract e.g. wear gloves Correctness Correctness It needs to be seen as being trusted It needs to be seen as being trusted Understandability Understandability Practical, pragmatic, oriented to sector terminology, etc. Practical, pragmatic, oriented to sector terminology, etc. Any knowledge transferred without consideration being given to these considerations is unlikely to be wholly successful Any knowledge transferred without consideration being given to these considerations is unlikely to be wholly successful

What Characterises How Chemical Suppliers Communicate Risk? A series of considerations characterise the nature of information provided by chemical suppliers A series of considerations characterise the nature of information provided by chemical suppliers The nature of the products marketed The nature of the products marketed Are they generally perceived as being hazardous? Are they generally perceived as being hazardous? Product stewardship aspirations of the company Product stewardship aspirations of the company Available technical competences Available technical competences Both at the supplier and subsequent (formulator) levels Both at the supplier and subsequent (formulator) levels Liability Liability Effectiveness of the communications Effectiveness of the communications Complex communications inevitably lead to questions Complex communications inevitably lead to questions This leads to inconsistencies across the supply chain This leads to inconsistencies across the supply chain When seen against the complexity of the chemicals supply chain (substances and preparations) and When seen against the complexity of the chemicals supply chain (substances and preparations) and The number of suppliers/substances/preparations/uses The number of suppliers/substances/preparations/uses

Supplier Systems For Knowledge Development And Transfer Information on chemicals risks is communicated (by suppliers) through a number of different mechanisms Information on chemicals risks is communicated (by suppliers) through a number of different mechanisms Safety Data Sheets Safety Data Sheets Supply chain dialogue Supply chain dialogue Sales, technical support, technical applications notes Sales, technical support, technical applications notes Trade associations Trade associations At the regional and national level At the regional and national level National authorities National authorities (Joint initiatives) e.g. UK HSE IACs (Joint initiatives) e.g. UK HSE IACs

To What Extent Are Existing Systems Working Satisfactorily? The primary system through which industry communicates knowledge is based on the SDS The primary system through which industry communicates knowledge is based on the SDS Supported on an ad hoc basis by technical advice issued at the company, sector or national level Supported on an ad hoc basis by technical advice issued at the company, sector or national level Is there evidence that there is a failure of this system to properly work? Is there evidence that there is a failure of this system to properly work? Poor SDSs exist as well as good ones Poor SDSs exist as well as good ones Both types of SDS are supplied to SMEs Both types of SDS are supplied to SMEs Some SMEs respond positively to SDS (and other) information, while others do not Some SMEs respond positively to SDS (and other) information, while others do not The picture is complex The picture is complex

To What Extent May REACH Lead To Improvements? Fundamental concepts behind REACH are that Fundamental concepts behind REACH are that Every substance has to be registered for (safe) supported uses (throughout the life cycle) Every substance has to be registered for (safe) supported uses (throughout the life cycle) The safe uses must be communicated down the supply chain (via Exposure Scenarios [ESs] contained in the SDS) The safe uses must be communicated down the supply chain (via Exposure Scenarios [ESs] contained in the SDS) Although the supply of ESs is only applicable to some types of substance Although the supply of ESs is only applicable to some types of substance But as the primary responsibility rests with the M/I, will M/Is copperplate the ES in order to guarantee the substance's registration? But as the primary responsibility rests with the M/I, will M/Is copperplate the ES in order to guarantee the substance's registration? And as most SMEs handle chemicals as preparations, what requirements does REACH place on formulators? And as most SMEs handle chemicals as preparations, what requirements does REACH place on formulators? Formulators are obliged to pass on the information received from suppliers. Is such an obligation workable for complex preparations (i.e. multiple Exposure Scenarios) Formulators are obliged to pass on the information received from suppliers. Is such an obligation workable for complex preparations (i.e. multiple Exposure Scenarios)

Content of an Exposure Scenario (1) Short title: 1 Description of activities + processes 2 Duration and frequency of use, with adequate control of risk 3 Product specification (concentration or % of substance in preparation or article) 4 Physical form of product 5 Maximum amount per time or activity, with adequate control of risk 6 Other operational conditions of use (if relevant) temperature, pressure temperature, pressure emission or release factors determined by technology emission or release factors determined by technology capacity of receiving environment (e.g. room size x ventilation rate) capacity of receiving environment (e.g. room size x ventilation rate) other other

Short title: 7 Risk management measures for adequate control of risk: options to be phrased as instructions options to be phrased as instructions impact of single measure or combination of measures to be quantified impact of single measure or combination of measures to be quantified structure according to exposure routes often useful structure according to exposure routes often useful 8 Waste related measures (incl. substances in articles at the end of service life) 9 Prediction of exposure and reference to the source of prediction; Prediction of exposure and reference to the source of prediction; Risk control indicator/parameter if applicable (e.g. safe amount) Risk control indicator/parameter if applicable (e.g. safe amount) 10 Variables and algorithm for scaling at DU level (including underlying assumptions) Other methods to check compliance Other methods to check compliance Content of an Exposure Scenario (2)

Exposure Scenarios 1. Short title of Exposure Scenario Exposure to a solvent (hazard group A [1] ), solvents based products [PC35], coatings and paints, fillers, putties, thinners [PC9] in building and construction work [SU19] by professional spraying outside industry settings and/or applications [PROC11] using air dispersive techniques [OU9]. [1] 2. Description of activities/process(-es) covered in the Exposure Scenario Professional indoor spraying of paints containing PGME [ ]. The process also involves the mixing (homogenizing) of paint and filling of the spray gun before application and cleaning of the spray gun by rinsing with water, followed by wiping with a cloth afterwards. 3. Operational conditions 3.1. Duration and frequency of use for which the ES ensures adequate control of risk The full process can be done up to 300 days per year per professional company. Individual workers can perform this task daily (approximately 250 days/year). The work is done in situ, not at a fixed working place, actual spraying takes up to 8 hours Other operational conditions determining exposure The operations are carried out at room temperature and atmospheric pressure. Water is the preferential target compartment at equilibrium according to the predicted distribution (para 8a) 4. Physical form of product The product is a water based liquid paint. 5. Product specifications PGME in water based paints at a maximum concentration of 5%. The density of paint is Risk Management Measures that, in combination with the operational conditions of use, ensure adequate control of risk related to the different target groups

RMMs to ensure safe use (maximum amount of solvent used 5% of 20 liter paint = 1 liter, ref ESIG control strategy 1): Ventilation; keep windows and doors open during application. More extensive indoor spraying (medium scale > 1 litre solvent or 20 litres paint ): provide extraction booth large enough to contain all equipment. Spraying on site (e.g. construction sites) requires mechanical ventilation/ extraction fan and respiratory protective equipment, Air-purifying Half-Mask (with gas/vapour- cartridge, that can be combined with a particulate filter (APF = 10, W30.09) When extractor fan is used ensure sufficient uncontaminated make up air is provided. Visual check ventilation equipment at least weekly (e.g. using smoke) to ensure that it is working and has not been damaged. Get ventilation systems checked periodically against the performance specification and keep records of the tests. Clean spray gun regularly. Conduct periodic air monitoring to assess potential for exposure based on local operational conditions. Avoid contact with skin and eyes. Give worker information on the hazards or solvents; provide training on handling solvents safely. Check that control measures are in place and being followed. Exposure Scenarios

8a. Prediction of exposure resulting from the conditions described above (entries 3-6) and the substance properties 8b. Control thresholds derived from the exposure prediction, like e.g. maximum emission, safe to use amount (m safe ) or safe concentration in product (c safe ) 8a. Worker exposure resulting from the conditions described above (entries 3-6) and the substance properties is: Maximum inhalation exposure during application of paint ranges is 370 mg/m 3. Dermal exposure = 256 mg/day (homogenizing paint, filling the spray gun, cleaning the spray gun) (EASE) Combined internal exposure= 6.4 mg/kg bw/day The predicted distribution of PGME is as follows: 4,1% to air, < 0,1% to soil, 95,8% to water, << 0,1% to sediment, 0% to suspended sediment, 0% to biota (fish) Local PEC in surface water during emission episode (dissolved) <1 mg/L (0.281 mg/L) 8b. It was not necessary to calculate the safe to use amount (m safe ) nor the safe to use concentration in product (c safe ). This ES assumes a concentration of 5% in paint. 9. Where relevant: A set of variables and a suitable algorithm which together indicate safe use. Other methods to check compliance at DU level may be included here as well. This generic ES ensures safe use of low hazardous solvents within the boundaries described. [Product evaluated]: ESIG group A solvents; propylene glycol methyl ether [ ]. [Substance properties]: maximum vapour pressure = 1200 Pa (pure PGME). Partial vp used : 60 Pa TRA: [scenario] spraying of substance mg/m3 [fugacity] Low [LEV] No task = 374 mg/m3 Dermal exposure input parameters (EASE 2.0): task = spraying [Use pattern] Wide dispersive use [Aerosol formation] Yes [Tendency to become airborne] High [Process fully contained] No [Pattern of control, inhalation] Direct handling with dilution ventilation] [Pattern of control, dermal] direct handling [Level of contact, dermal] Intermittent (1-10 times/day)] [Area of skin exposed: Two hands = 840 cm2]. Task = 256 mg/day 100% absorption through inhalation, 30% dermal absorption. Workers 8 hours exposure, 70 kg bw. 10m3 inhalation EUSES 2.0 (Number of emission days per year = 300. Production volume in EU (tonnes.yr-1) 1,88E+05 Regional production volume = 7,73E+04. Fraction of tonnage for application = 0,077. Fraction of chemical in formulation = 0,2. Fraction of tonnage for application = Emission tables = A4.5 (specific uses), B4.5 (specific uses) IC = 14, UC = 48 (water based). LOCAL PEC = [INDUSTRIAL USE] Maximum Derived No Effect Level (DNEL) indicating safe use; Inhalation exposure (eye irritation) 374 mg/m 3 (8 hour average Occupational Exposure Limit value). Internal exposure, systemic effects (Adaptive liver changes): 20 mg/kg bw/day.The Predicted No Effect concentration (PNEC) for freshwater = 10 mg/L. Exposure Scenarios

REACH Exposure Scenarios DUs generally find the REACH Exposure Scenarios (ESs) to be helpful and much better than existing SDS guidance DUs generally find the REACH Exposure Scenarios (ESs) to be helpful and much better than existing SDS guidance But the REACH TGD description of the ESs is abstract for many DUs i.e. they find it difficult to identify those ESs of relevance for them But the REACH TGD description of the ESs is abstract for many DUs i.e. they find it difficult to identify those ESs of relevance for them DUs are also not clear how they are meant to respond to some portions of the ES e.g. compliance checking DUs are also not clear how they are meant to respond to some portions of the ES e.g. compliance checking Some DUs commented that the REACH ESs appear to contain more information than may be necessary to simply describe exposure Some DUs commented that the REACH ESs appear to contain more information than may be necessary to simply describe exposure They also commented that the duplication of information across the eSDS was unnecessary They also commented that the duplication of information across the eSDS was unnecessary Generic ESs have therefore been suggested as a better solution for SMEs to more easily identify those ESs of relevance to their activities/operations Generic ESs have therefore been suggested as a better solution for SMEs to more easily identify those ESs of relevance to their activities/operations Based in part upon the COSHH Essentials and ?? ideas Based in part upon the COSHH Essentials and ?? ideas

Generic Exposure Scenarios Rather than indicate which specific ESs are relevant for a particular area of application, it may be possible to consolidate the information from such ESs into a composite ES for the broad area of use/application (termed a Generic Exposure Scenario) Rather than indicate which specific ESs are relevant for a particular area of application, it may be possible to consolidate the information from such ESs into a composite ES for the broad area of use/application (termed a Generic Exposure Scenario) Can approaches such as the COSHH Essentials aid in the identification of suitable generic/composite ES for an use? Can approaches such as the COSHH Essentials aid in the identification of suitable generic/composite ES for an use? Provides opportunity for alignment of REACH with Chemicals Agents Directive etc Provides opportunity for alignment of REACH with Chemicals Agents Directive etc Many DUs are most supportive of this type of ES Many DUs are most supportive of this type of ES Composite ESs also have the potential to more efficiently deal with how information on complex preparations is communicated/ transmitted in the supply chain Composite ESs also have the potential to more efficiently deal with how information on complex preparations is communicated/ transmitted in the supply chain

Risk management measures Human health - Pouring from small containers : undertake in a well-ventilated area. Wear suitable gloves (type EN374, code FJ) if skin contact likely. - Spraying : carry out in a vented spray booth. If no dedicated facility available, then use a respirator conforming to EN140 (with Type A filter) or better standard and undertake in a well-ventilated area segregated away from other work activities. - Manual applications e.g. brushing, rolling, spreading : undertake in well- ventilated workplace. Use long handled brushes and rollers where possible. Wear gloves (type EN374, code FJ) if prolonged contact with coatings expected. - Equipment clean-down : Wear gloves (type EN374, code FJ) if prolonged contact expected. Transfer wash-downs in sealed containers. Use liquors as recycle solvent or send for disposal or recycle. Waste related measures Dispose of used containers according to local regulations. Prediction of exposure Estimated workplace exposures (using the ECETOC [ TRA model) during spraying are not expected to exceed 50ppm (when undertaken in a spray booth) and 500ppm (when not). Estimated workplace exposures for brushing and printing are not expected to exceed 20ppm (with extract ventilation) and 100ppm (without extract ventilation). EASE indicates that exposures to areas of unprotected skin can typically be in the order of 100μg/cm 2 /day and up to 1000μg/cm 2 /day during spraying activities. Generic Exposure Scenarios

Might REACH Have Any Other Shortfalls? Extent to which consistency will be forthcoming Extent to which consistency will be forthcoming Across suppliers/substances/uses/sectors/countries Across suppliers/substances/uses/sectors/countries And across time (phase-in periods) And across time (phase-in periods) Transparency Transparency Accessibility Accessibility M/I REACH obligations do not necessarily equate to usefulness for DUs M/I REACH obligations do not necessarily equate to usefulness for DUs The REACH Regulation and Guidance might be perceived as having been written by technocrats for technocrats The REACH Regulation and Guidance might be perceived as having been written by technocrats for technocrats Supporting information Supporting information REACH is not an end to Product Stewardship e.g. non- classified substances; phase-ins; non-SHE communications; etc. REACH is not an end to Product Stewardship e.g. non- classified substances; phase-ins; non-SHE communications; etc.

Summary System for the current provision of chemicals safe handling advice to SMEs is variable System for the current provision of chemicals safe handling advice to SMEs is variable The system could be improved through voluntary initiatives e.g. Responsible Care The system could be improved through voluntary initiatives e.g. Responsible Care REACH will formalise supplier duties concerning the provision of information REACH will formalise supplier duties concerning the provision of information But there will be a need to ensure that the information supplied remains useful to SMEs But there will be a need to ensure that the information supplied remains useful to SMEs Whilst also enabling EChA (and others) to oversee the integrity of the substance registrations Whilst also enabling EChA (and others) to oversee the integrity of the substance registrations REACH has paid no formal attention to the specific needs of SMEs or the role of social partnerships at the workplace REACH has paid no formal attention to the specific needs of SMEs or the role of social partnerships at the workplace