REACH and the use of occupational exposure modelling<br />John Cherrie<br />
Summary…<br />The role of regulatory risk assessments and REACH<br />Substances of Very High Concern (SVHC)<br />The suppl...
REACH…<br />Single system to replace 40 existing sets of regulations<br />Applies to new and existing chemicals<br />Cover...
The role of regulatory risk assessment…<br />A workplace<br />Chemical Agents Directive<br />Requirement to assess risks i...
SVHC…<br />SVHC subject to Authorisation (Article 57 and Annex XIV)<br />Class 1 and 2 CMR substances (Directive 67/548)<b...
The supply chain…<br />Manufacturer – production or extraction of substances in the natural state<br />Importer – physical...
Example of a complex supply chain…<br />Marquart (2006) Exposure scenarios for REACH – why should the user care? NvVA Conf...
The CSA and CSRs<br />For chemicals > 10 tonnes/year manufacturers/importers:<br />Must predict the exposures in manufactu...
DNELs and DMELs<br />DNELs, derived no effect levels, or DMELs, derived minimal effect levels (for substances without thre...
Comparison DNELs and OELs<br />OELs and possible chronic inhalation DNEL in mg/m3<br />Roy et al, “The Use of Health-Based...
Risk characterisation…<br />For worker exposure, determine residual risk to workers (after RMM implemented) by comparing e...
Exposure scenarios…<br />An ES describes:<br />processes and tasks<br />frequency and duration<br />operational conditions...
The role of an ES…<br />Exposure scenarios have multiple functions in the REACH system<br />document manufacturer’s own ex...
PROCs…<br />Process category <br />Application techniques or process types defined from the occupational perspective<br />...
Generic ESs…<br />
Risk Management Measures…<br />Must cover workers, consumers, and general public<br />For workers, consider…<br />Hierarch...
CEFIC RMM Library<br />
RMM effectiveness…<br />Default and “max. achievable” values for RMM efficiencies in RMM Library<br />Evidence base is poo...
ECEL…<br />Fransman et al. Development and Evaluation of an Exposure Control Efficacy Library (ECEL). Annals of Occupation...
Conclusions concerning modelling…<br />REACH has the potential to stimulate continuous development of modelling and modell...
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1. REACH and modelling

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The fist lecture on modelling exposure for a course held in Norway 2011. Some of these slides are based on material presented by Andy Gillies - used with his permission (Thanks Andy).

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  • The first puzzle is created by the DNELs. They will usually be derived from animal experiments and the assessment will have to allow for uncertainties in both the data and the extrapolation to humans. This will be done by including in the calculation a series of Assessment Factors to take into account interspecies differences, intraspecies difference, differences in duration of exposure, issues related to dose-response, and the quality of the whole database. Default values are prescribed and reduce as further information becomes available. For chemicals with only basic testing information available, the safety margin incorporated could be a factor of 10-100 times, and therefore it is likely that DNELs will in general be much lower than traditional OELs.The situation is even more difficult for substances such as genotoxic carcinogens where no safe threshold can be defined. For these materials the manufacturer is expected to set a Derived Minimum-Effect Level, that corresponds to a “low, possibly theoretical, risk” (ECHA, 2008a). It is not clear how that will be defined – will it equate to the so-called Threshold of Toxicological Concern ie. a risk of one death in a million which equates to around 1 microgram per cubic metre? Will it use a linear extrapolation or a Margin of Error calculation? In such cases, the default Assessment Factor could be as high as 10,000.
  • Consider sub-populations of people who may be susceptible or who have particularly high exposure
  • One of the keys to simplification is the use of generic exposure scenarios. Generic scenarios group together substances with similar properties and scenarios with similar exposures so that there are fewer unique situations to deal with.
  • 1. REACH and modelling

    1. 1. REACH and the use of occupational exposure modelling<br />John Cherrie<br />
    2. 2. Summary…<br />The role of regulatory risk assessments and REACH<br />Substances of Very High Concern (SVHC)<br />The supply chain and its role<br />Chemical Safety Assessments (CSA) and Chemical Safety Reports (CSR) <br />Exposure Scenarios (ES) and Process Categories (PROC)<br />Exposure routes<br />Risk characterisation – DNELs and DMELs<br />Risk Management Measures (RMM)<br />
    3. 3. REACH…<br />Single system to replace 40 existing sets of regulations<br />Applies to new and existing chemicals<br />Covers worker, environmental, and consumer risks<br />Burden of proof on industry<br />Manufacturer/importer responsible for:<br />testing and assessment<br />safe downstream use and disposal<br />Registration,<br />Evaluation,<br />Authorisation and Restriction of <br />Chemicals<br />
    4. 4. The role of regulatory risk assessment…<br />A workplace<br />Chemical Agents Directive<br />Requirement to assess risks in that wokplace to ensure safe work<br />Responsibility on employer<br />All workplaces<br />REACH<br />Requirement to assess safety of products on the market <br />Responsibility of “society” as a whole (for REACH with industry providing leadership)<br />
    5. 5. SVHC…<br />SVHC subject to Authorisation (Article 57 and Annex XIV)<br />Class 1 and 2 CMR substances (Directive 67/548)<br />PBT and vPvB substances (Annex XIII criteria)<br />equivalent level of concern<br />First Authorisation List published by EChA in 2009<br />Priority given to PBT, vPvB, large quantities, or wide dispersive applications<br />Aim is to progressively replace SVHC by less harmful substances or technologies<br />
    6. 6. The supply chain…<br />Manufacturer – production or extraction of substances in the natural state<br />Importer – physical introduction into the customs territory of the Community<br />Downstream User – use of a substance, either on its own or in a preparation<br />Where USE means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation<br />
    7. 7. Example of a complex supply chain…<br />Marquart (2006) Exposure scenarios for REACH – why should the user care? NvVA Conference Presentation<br />
    8. 8. The CSA and CSRs<br />For chemicals > 10 tonnes/year manufacturers/importers:<br />Must predict the exposures in manufacture and use(s) <br />Identify the conditions that will ensure control of risks<br />Prepare a corresponding Exposure Scenario (ES) to be communicated to the users in an extended-Safety Data Sheet (e-SDS)<br />Document the assessment in a Chemical Safety Report (CSR)<br />Exposure Scenarios<br />Exposure estimates<br />Risk characterisation<br />Risk Management Measures <br />
    9. 9. DNELs and DMELs<br />DNELs, derived no effect levels, or DMELs, derived minimal effect levels (for substances without threshold)<br />Acute/Chronic, route specific<br />Tension between DNELs and Occupational Exposure Limits<br />
    10. 10. Comparison DNELs and OELs<br />OELs and possible chronic inhalation DNEL in mg/m3<br />Roy et al, “The Use of Health-Based Occupational Exposure Limits As REACH Derived No Effect Levels.” Poster presented at SOT Meeting, Seattle Wa 2008<br />
    11. 11. Risk characterisation…<br />For worker exposure, determine residual risk to workers (after RMM implemented) by comparing exposure with the relevant DNEL or DMEL<br />If ratio >1, additional RMMs required<br />Perform similar calculation for:<br />all routes of exposure (especially air and skin)<br />other groups of people at risk<br />environmental risks<br />
    12. 12. Exposure scenarios…<br />An ES describes:<br />processes and tasks<br />frequency and duration<br />operational conditions<br />measured exposure data or modelling data<br />risk management measures required<br />Covers manufacture and intended uses throughout substance life cycle, including disposal/recycling<br />For each population exposed (as workers, consumers, via the environment, or a combination)<br />
    13. 13. The role of an ES…<br />Exposure scenarios have multiple functions in the REACH system<br />document manufacturer’s own exposures <br />provide information to be fed into exposure assessment tools (to enable comparisons with DNELs)<br />form part of Chemical Safety Report to be submitted with the Registration package to the authorities <br />Included as an appendix to extended Safety Data Sheet<br />guidance on how to safely use the substance, for formulators, trade and industrial end users<br />Development of ES envisaged as an iterative process of communications between manufacturer and downstream user<br />
    14. 14. PROCs…<br />Process category <br />Application techniques or process types defined from the occupational perspective<br />29 codes describing most uses<br />Described in ECHA Guidance on information requirements and chemical safety assessment Chapter R.12: Use descriptor system. <br />Basis for the ECETOC TRA tool<br />
    15. 15.
    16. 16. Generic ESs…<br />
    17. 17. Risk Management Measures…<br />Must cover workers, consumers, and general public<br />For workers, consider…<br />Hierarchy of control<br />General principles of good control practice<br />All routes of exposure (inhalation, dermal, accidental ingestion)<br />Must be able to determine the residual risk after RMM implemented<br />
    18. 18. CEFIC RMM Library<br />
    19. 19. RMM effectiveness…<br />Default and “max. achievable” values for RMM efficiencies in RMM Library<br />Evidence base is poor for worker, environment and consumer control measures<br />CEFIC RMM task force working with national associations to produce consensus<br />Separate initiatives from industry, academia, professions (e.g. ECEL database)<br />
    20. 20. ECEL…<br />Fransman et al. Development and Evaluation of an Exposure Control Efficacy Library (ECEL). Annals of Occupational Hygiene (2008) vol. 52 (7) pp. 567-575<br />
    21. 21. Conclusions concerning modelling…<br />REACH has the potential to stimulate continuous development of modelling and modelling tools<br />The need to a cost-effective way of evaluating exposure is clear<br />It is a problem that the systems for risk assessment – toxicology and exposure assessment - are being developed independently<br />
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