Health Healthand andSafety Safety Executive Executive A regulatory

Health Healthand andSafety Safety Executive Executive A regulatory

Health Healthand andSafety Safety Executive Executive A regulatory perspective on the need for improved exposure assessment for epidemiological studies on pesticides Paul Y Hamey Chemicals Regulation Division 30/08/2017 EPICOH 2017 1 Pesticides are regulated!

EU Regulation 1107/2009 - presumption harmful to health & environment Extensive data package to support proposed introduction Use only allowed where evidence predicts no risk of harm to health, or unacceptable risk to wildlife/environment 30/08/2017 EPICOH 2017

2 Health risk assessment Genotoxicity Toxicokinetics (ADME) Acute (3 routes) + irritancy/sensitisation Repeat dose (>2 species) [+dermal &/or inhalation] Chronic / carcinogenicity (2 species) Developmental (2 species) & Reproduction (2 generation) Special studies (mechanisms, neurotoxicity, metabolites, impurities, endocrine effects)

30/08/2017 EPICOH 2017 3 Hazard identification & health based exposure limits HUMAN VARIABILITY SPECIES DIFFERENCES 10 10

30/08/2017 EPICOH 2017 4 Exposure during and after use 30/08/2017 EPICOH 2017 5 Residues in food and feed 30/08/2017 EPICOH 2017

6 Uncertainties Extrapolation from animal models No models for some human diseases Complexity of real exposures Epidemiology important alternative source of information Where available must be submitted 25/08/2017 EPICOH 2017 7 Developing regulatory approach EFSA Guidance on submission of peer-reviewed

literature (EFSA 2011) EFSA External report: review of pesticide epidemiology studies 2006-2012 (Ntzani et al, 2013) Large number of articles & analysis Some associations that merit further investigation No firm conclusions for majority of outcomes 25/08/2017 EPICOH 2017 8 EFSA External report

Stated limitations Lack of direct exposure assessment Lack of appropriate biomarkers Use of questionnaires (not validated) Recall bias in retrospective studies No specific exposure information Use of generic pesticide definitions (~10% studies DDT & metabolites) 25/08/2017 EPICOH 2017 9 Best observed approach

Agricultural Health Study Prospective approach, specific a.s. (cost, power, time?) Biological monitoring to calibrate exposure models (incl. PPE modifiers) (Thomas et al, 2010, Coble et al, 2011, Hines et al, 2011) (cost, specificity, short -lives, temporal variation?) 25/08/2017 EPICOH 2017 10 Seasonal use (French example) 350

Spray/seed area ha 300 250 200 150 100 50 0 1 2 3 4 5

6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Week 30/08/2017 EPICOH 2017 11 Seasonal use remainder of year Spray/seed area ha 40 35

30 25 20 15 10 5 0 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 Week 30/08/2017 EPICOH 2017 12 Requirements

Regulatory approach requires specific pesticide descriptions Method of use may modify exposure User and other worker behaviours including use of PPE - may modify exposure 30/08/2017 EPICOH 2017 13 Possible approaches

Personal exposure monitors Personal biomonitoring Population level use of farmers mandatory pesticide use records Cropping patterns and use surveys (e.g. The Environment & Health Atlas for England & Wales, Hansell et al, 2003) Future - exposome EPICOH and2017metabolomics? 25/08/2017 14

Thank you 30/08/2017 EPICOH 2017 15

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