Exposure Assessment and Risk Management of Hazardous Chemicals in the Workplace. Webinar 1 March 2016

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1 Exposure Assessment and Risk Management of Hazardous Chemicals in the Workplace Webinar 1 March 2016

2 Pete Walters (Chair) REACHReady Ltd Technical Advisor at REACHReady, Chemical Industries Association MSci in Chemistry, University of Nottingham Housekeeping Audio Q&As Recording

3 Parent company: Chemical Industries Association Began before REACH, helped numerous companies from the start Also advise on Classification, Labelling and Packaging Helping businesses help themselves Helpdesk (Gold Subscribers): ideal for building knowledge, checking for peace of mind and requesting a second opinion Training, both on-site bespoke and planned events: quickly get up to speed and stay on top of recent developments and compliance

4 REACHReady and Prefusion Matchmaker Outline Geoff Le Grys, Prefusion LLP outlining safety in the workplace, facilitated by procedures and software Herni Heussen, Cosanta BV demonstration on Stoffenmanager

5 Biographies Professor Geoff Le Grys Prefusion LLP, UK Founding partner of Prefusion LLP Professor Emeritus: Sheffield Hallam University Honorary Professor: University of Galaţi, Romania Formerly Senior Scientist with RHM Research Ltd. BA in Physics from Oxford University Dr Henri Heussen Cosanta BV, Netherlands CTO - Cosanta BV Formerly Senior Consultant: Arbo Unie Registered Occupational Hygienist Registered Toxicologist

6 Occupational Health (HSE Annual Report 2014/15) Respiratory 12,000 deaths from industry related lung disease 33,000 report lung conditions made worse by work 464,000 working days lost due to work-related breathing or lung problems Skin 1,320 new cases of skin disease 80% of which were contact dermatitis

7 REACH & Chemical Agents Directive (CAD) REACH Primarily concerned the manufacturers and distributors of hazardous materials to identify risk to human health and the environment. Development of extended SDS, exposure scenarios and PROCs Requires quantitative risk assessments Single substances for registration but informed of use by DUs CAD/COSHH Primarily concerned with downstream users of hazardous materials to ensure that they are handled safely in the WORKPLACE Single substances and mixtures BOTH REQUIRE CHEMICAL RISK ASSESSMENT

8 REACH Exposure Scenario and Communication in Supply Chain Use maps Registrants Roadmap activity 3 Exposure Scenario Comm. Ecetoc TRA Extended SDS to downstream users Roadmap activity 2 SUMI SCEDs SpERCs SWED Information on uses to registrants Supply chain Communication Downstream Users Formulators End users eguide Short titles Roadmap activity 4 Exposure Scenario for communication Adapted from ENES Nov 2014

9 Risk Assessment the Drivers Substances Mixtures

10 Risk Assessment the Tools

11 eteam Project: Evaluation Tier I Exposure Assessment Models under REACH Funded by BAuA Collaboration between IOM and Fraunhofer-ITEM Advisory Board, consisting of Model developers (CEFIC, TNO/Arbo Unie, Cosanta, BAuA, EBRC) Major data providers (IFA, NIOSH, HSE, SECO, Lund Univ.) ECHA

12 Five models identified in REACH R14 and evaluated by eteam. ECETOC TRA V2 & V3 STOFFENMANAGER v4.5 RISKOFDERM MEASE EMKG-Expo-Tool (EASE)

13 eteam: Evaluation Principles Validated against measured data Degree of conservatism A range of scenarios identified through REACH PROCs A variety of materials including Volatile and non-volatile liquids Dusts and Powders Dermal and inhalation Other sources of error Between user reliability Ease of use Uncertainty

14 Validation of the Models Critical how well do the models predict measured data? Selection (and exclusion) of data from 11 agencies Resulting in 2089 individual measured points for non-volatile and volatile liquids, metal abrasion and metal processing, powder handling and wood processing In addition 60 aggregated data sets derived from 1357 points 18 PROCs 146 assessors

15 Exemplar Results ECETOC TRA. v3 Measured data vs. prediction for volatile liquids Measured data vs. prediction for powder handling

16 Comparison of Three Tools for Volatile Liquids

17 Conservatism

18 eteam - Quotations eteam Summary Report abstract STOFFENMANAGER appeared to provide the most balanced performance with regard to the level of conservatism and predictive power for volatile liquids and powders eteam Uncertainty Report discussion ECETOC TRA, MEASE and STOFFENMANAGER use conservative modifiers which are expected to show a higher tendency to overestimate exposure than to produce underestimations.

19 Sensitivity analysis, dominant factors, and robustness of the ECETOC TRA v3, Stoffenmanager 4.5, and ART 1.5 occupational exposure models - Riedmann, Gasic & Vernez, 2015, practitioners should consider using Stoffenmanager as their default occupational exposure model since: (1) it provides mean exposure estimates and various CIs in a reasonable range, and (2) it is the most robust model.

20 Comparison and Evaluation of Multiple Users Usage of the Exposure and Risk Tool: Stoffenmanager Landberg et al., 2015 Hence, the variability between users was large but the model performed well

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22 STOFFENMANAGER Applicability Domain Moving & Stirring Gas Volatile liquids Non-volatile liquids Powders Fibres Objects n.a. Gravitational transfer n.a. Spreading & Immersion Air dispersion methods n.a. n.a. Hot working methods n.a. Abrasion & Impact wood/stone Abrasion & Impact other activities: plastic, glass or metal n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a. n.a.

23 Exposure algorithms for each class of material Inhalation (mg/m3) Powders Abrasive Liquids Wood Volatile Stone (inhalable & respirable) Low-volatile

24 STOFFENMANAGER Information Logic Manage/Set up Locations Activities Components Products Information: MSDS GESTIS Risk assessment (Control Banding) Dermal (local and systemic) Inhalation Risk assessment (Quantitative) Worker Exposure (OELV) REACH Control Band (I,II,III) Exposure (mg/m 3 ) Modify task, ventilation, materials, protective equipment, exposure times Workplace Instruction Card Safe? NO Action Plan Yes User management LOG RAs, Archive changes, etc

25 Live Demonstration by Henri Heussen

26 Sources of Information eteam Report is at: All 6 volumes can be downloaded as PDFs: Summary Background and gathering information External validation User friendliness Between user reliability Model uncertainty

27 Chemical Regulation and Strategy Consulting March 2010: Established in the UK : Dr. Liu appointed as an UK ACHS member by Defra Minister 2009-Date: Dr. Liu appointed as an advisor in the pool for DG SANCO committees 2010: Prof. Le Grys served as 3 rd party auditor for BRC Global Food Standards March 2015: Chemical Watch Service Provider 2015 April 2015: Exclusive representative of Stoffenmanager in the UK May 2015: Beijing office established in China July 2015: REACHReady Approved Service Provider Info@prefusion.co.uk

28 What can offer you Silver subscription Provides basic information for free Q&A session Gold subscription (Only 400 a year!) Seminars, conferences & training courses Specialist-staffed Helpdesk to answer your questions Exclusive website content, regular alerts, and much more! With significant savings at our events for gold subscribers REACH & CLP Consultancy Bespoke consultancy for your REACH and CLP compliance REACHMatchmaker Finds you approved REACH and CLP service providers