L'esperienza dell'igiene Occupazionale nella definizione degli scenari espositivi previsti dal regolamento

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Aniella Lelli
8 anni fa
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Giornate di studio del Laboratorio di Approfondimento Rischio Chimico L'esperienza dell'igiene Occupazionale nella definizione degli scenari espositivi previsti dal regolamento

1 Giornate di studio del Laboratorio di Approfondimento Rischio Chimico L'esperienza dell'igiene Occupazionale nella definizione degli scenari espositivi previsti dal regolamento Domenico Maria Cavallo Università degli Studi dell Insubria Dipartimento di Scienze Chimiche ed Ambientali Associazione Italiana Degli Igienisti Industriali 17 marzo 2009 University of Insubria

2 REACH è una opportunità: riduzione delle malattie professionali riduzione dell impatto sull ambiente REACH e le normative Salute e Sicurezza sul Lavoro/Ambiente Nuovi ruoli di figure professionali Organizzazione nazionale (sia per la componente istruttoria che per la vigilanza) Formazione per le Professioni e per l Igiene Occupazionale? 2

3 Gli strumenti: Valutazione di Sicurezza Chimica (CSA Chemical Safety Assessment) Rapporto di Sicurezza Chimica (CSR - Chemical Safety Report) Le Schede di Sicurezza Chimica (SDS) per: determinare documentare comunicare Condizioni d uso (per sufficiente protezione salute umana e dell ambiente): Misure di gestione del rischio Condizioni operative Scenario di Esposizione (ES) 3

4 Exposure Scenarious: Scenario di esposizione l'insieme delle condizioni, comprese le condizioni operative e le misure di gestione dei rischi, che descrivono il modo in cui la sostanza è fabbricata o utilizzata durante il suo ciclo di vita e il modo in cui il fabbricante o l'importatore controlla o raccomanda agli utilizzatori a valle di controllare l'esposizione delle persone e dell'ambiente. Questi scenari d'esposizione possono coprire un processo o un uso specifico o più processi o usi specifici, se del caso Categoria d'uso e d'esposizione: uno scenario d'esposizione che copre una vasta gamma di processi o usi, in cui i processi o gli usi sono comunicati quanto meno in termini di breve descrizione generale dell'uso

5 Risk Assessment Hazard (Index Chemical s PoD for Group) Exposure (Index Chemical Exposure Equivalents) = Risk

6 Use patterns and exposure Exposure is strongly related to a task but there are exceptions There are many different tasks Duration of the task (and/or amount handled) Frequency of the task occurring

7 OCCUPATIONAL HYGIENE OELs PEL TLV STEL Ceiling Limit WEEL Exposure Profile Acceptable Risk = 10-3 ENVIRONMENTAL RISK ASSESSMENT RfD SLOPE Chronic/Subchronic Oral/Inhalation/Dermal CDI - LCR/NHQ Lifetime Cancer Risk/Noncancer Hazard Quotient Acceptable Risk = 10-6

8 OCCUPATIONAL HYGIENE Adult, healthy 30 years Trained 8 hrs/day 5 days/wk Inhalation, Skin, Ingest Physical Agents Averaging Times ENVIRONMENTAL RISK ASSESSMENT Young, Old, Infirmed Lifetime Unaware/Uneducated 24 hrs/day 7 days/wk Pathways - water, soil, air Chronic

9 Exposure Scenario under REACH An exposure scenario (ES) sets out, for a given use, how the substance can be used in a way that risks are adequately controlled by describing the conditions for use: Process descriptions (incl. quantity used) Operational conditions (incl. frequency and duration of specified operations) Risk management measures (process and emission control, personal protective equipment, good hygiene, etc.) An ES is part of the Chemical Safety Assessment (CSA)

10 Integrated Exposure Scenarios An exposure scenario is related to a USE of a substance The ES shall secure that risks associated with that use are controlled (NB! Reducing one risk may increase another) If for example an exhaust ventilation is implemented to protect the workers, this should not result in risks for the environment Similarly, use of a consumer product shall at the same time be safe for the consumer being directly exposed as well as for the environment to which the substance may be released during use of the consumer product

11 Exposure Emission Environmental distribution Exposure: man Effects

12 Exposure pathways of humans Occupational environment Consumer products oral inhalation dermal Environment air water food soil

13 Definitions Concentration Contact external internal Actual exposure Uptake Kinetics

14 Direct and Indirect Approaches to Measuring Exposure Exposure Analysis Assessment Direct Methods Indirect Methods Personal Monitoring Biological Markers Models Environmental Monitoring Questionnaires/ Diaries Surrogate Measures Pharmacokinetic and Pharmacodynamic Models Exposure Models

15 Modelling is used in exposure assessment as a means of forecasting human or other exposures in the absences of complete monitoring or other data (WHO, 1999). Modelling provides a mathematical expression representing a simplification of the essential elements of exposure processes (ibid). Point estimates and probability distributions are used in exposure modelling.

16 Modelling Exposure Modelling is Estimation of exposure as an alternative to measurement Personal Exposure can estimated using mathematical formulae based on data and a knowledge of other measurements Surrogate measures of exposure imply the use of a model of exposure

17 Human exposure: basics Potential exposure E(x,t) Actual exposure E(x p (t),t) x p (t) is position of person For oral and inhalatory routes: Potential uptake rate U(E,t) = I(t) x F(E,t) x E(x,t) I is intake rate of medium F is fraction absorbed

18 Human exposure: Inputs and results PECs (mg/l or mg/kg) physico-chemical properties TGD / EUSES exposure module standard exposure scenario dose (mg/kg BW/d) conc. in food (mg/kg)

19 Source Receptor model (Cherrie) The potential exposure pathways from source to workplace to worker (sourcereceptor model) are evaluated in compartments, i.e. the source, breathing zone air, respiratory tract, room air, outside air, surfaces, clothing and skin contaminant layer

23 Description of Exposure Model Formulation Indicative Exposures Uncertainty Professional pouring formulation from a container into a portable receiving vessel e.g. knapsack sprayer. The models are derived from data relating to mixing and loading of agricultural pesticides and cover relatively large volumes. The exposures are expressed as mg a.s./kg a.s. per operation and dermal exposure is limited to the hands. 1 EUROPOEM II database 2 Mixing and loading model 5 TNsG part 2, p 137 Granule 2 Powder 2 Liquid 1 Hands 171 mg/kg a.s. Inhalation mg/kg a.s. Inhalation 1.5 mg/kg a.s. Hands 464 mg/kg a.s. Body 48.3 mg/kg a.s. Inhalation mg/kg a.s. Uncertainty for hands is high indicative value based on highest of 8 data. Inhalation uncertainty is moderate; 90% C.I. for 75 th Uncertainty is moderate. 90% C.I. for 75 th mg/kg a.s. Uncertainty is moderate. 90% C.I. for the 75 th (hands); (body); (inhalation). Professional pouring formulation from a container into a fixed receiving vessel e.g. reservoir tank on tractor. The models are derived from data relating to loading of agricultural pesticides and cover relatively large volumes. The exposures are expressed as mg a.s./kg a.s. per operation and dermal exposure is limited to the hands only. 1 EUROPOEM II database 2 Mixing and loading model 5 TNsG part 2, p 137 Granule 2 Powder 2 Hands 3.3 mg/kg a.s. Inhalation 0.24 mg/kg a.s. Hands 10.2 mg/kg a.s. Inhalation 0.66 mg/kg a.s. Hand exposure uncertainty is moderate. 90% C.I. for 75 th Inhalation uncertainty is high, Indicative value is highest of 13 data. Hand exposure uncertainty is moderate. 90% C.I. for 75 th percentiles Inhalation uncertainty is high, Indicative value is highest of 8 data. Liquid 1 Hands 8.0 mg/kg a.s. Body 1.95 mg/kg a.s. Inhalation mg/kg a.s. Uncertainty is moderate. 90% C.I. for the 75 th percentiles are (hands); (body); (inhalation). Professional pouring liquid agricultural pesticides from various size containers into a receiving vessel. Exposure is limited to the hands and expressed as ml of in-use product per operation. Mixing and loading model 4 TNsG part 2, p 136 Liquid 1 litre 5 litre 10&20 litre 0.01 ml (hands) 0.2 ml (hands) 0.5 ml (hands) Indicative values currently based upon 75 th.

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