Aggregate Exposure: Acropolis and links to other projects
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1 Aggregate Exposure: Acropolis and links to other projects Andy Hart & Richard Glass Food and Environment Research Agency UK 1 Acropolis Stakeholder Conference
2 Aggregate exposure assessment A process for developing an estimate of the (exposure) of a defined population to a given chemical by all relevant routes and from all relevant sources (ILSI, US EPA) Potentially includes: Dietary, dermal, inhalation routes Occupational (operator/worker), residential, bystander activities 2 Acropolis Stakeholder Conference
3 Why assess aggregate exposure? Support measures relating to harmonised pesticide MRLs shall be established at Community level, including... methods of assessing aggregate, cumulative and synergistic effects (Reg. 396/2005, Article 36) the residues of the plant protection products, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use shall not have any harmful effects on human health (Reg. 1107/2009, Article 4.2) 3 Acropolis Stakeholder Conference
4 Potentially challenging! Real exposures result from a series of activities, with multiple routes 4 Acropolis Stakeholder Conference
5 Relevant European initiatives include: EFSA 2010 Opinion on Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Bystanders and Residents Acropolis project: aggregate & cumulative exposure Browse project: bystanders, residents, operators, workers EFSA project: survey of operator & worker practices BfR/ECPA project: operator exposure 5 Acropolis Stakeholder Conference
6 Acropolis WP3 Aggregate exposure assessment Objectives Improved methodology for aggregate exposure assessment allowing the possibility of calculating the exposure via more than one exposure route. Better understanding of the validity of s by comparison with measured intakes. 6 Acropolis Stakeholder Conference
7 Tasks Review data for non-dietary exposure to PPPs, biocides and veterinary medicines Conceptual for integrating dermal, inhalation and dietary exposure Test with case studies for specific scenarios Biomarker and duplicate diet study Validation of with biomarkers and duplicate diets Identification and evaluation of uncertainties affecting aggregate assessment 7 Acropolis Stakeholder Conference
8 Review of data Reasonable data sets for operator exposure to PPPs, less good for workers, bystanders and residents Still reliant on EUROPOEM data BREAM becoming available (bystanders) Biocides exposure for operators using BEAT Veterinary medicines has few data sets for exposure, so need to use appropriate scenarios, e.g. for biocides Consumer products relies on CONSEXPO Good usage data only for PPPs, in a few countries 8 Acropolis Stakeholder Conference
9 Conceptual POPULATION Individual Specified by user BROWSE/EFSA surveys or user-specified Food consumption Residues in food Activities MCRA Consumption Database MCRA Recipes Databas e MCRA MCRA Pesticide Residues Databas e Operator activities Pesticides: EUROPOE M database or BROWSE Biocides: BEAT/ART s Vet meds: case by case Operator exposure Worker activities Pesticides: EUROPOEM or BROWSE Biocides: BEAT/ART s Vet meds: case by case Worker exposure Resident activities Pesticides: BREAM or BROWSE Resident exposure Bystander activities Pesticides: EUROPOEM database BREAM or BROWSE Bystander exposure Consumer Product use Pesticides & biocides: CONSEXP O Consumer Product exposure Dietary exposure contribution (external) Absorption factors Non-dietary exposure contributions (internal and external) TOTAL AGGREGATE EXPOSURE (INTERNAL or EXTERNAL) Repeat calculation for large sample of individuals
10 Three case studies Triazoles UK: Operators, arable boom spraying Italy: Operators, broadcast air assisted spraying (vines) Netherlands: Users of consumer products Use EUROPOEM data and usage surveys for operators, CONSEXPO for consumers, MCRA for dietary Aggregate dietary and product use exposures 10 Acropolis Stakeholder Conference
11 Biomarker and duplicate diet study Tebuconazole Operators of vineyard sprayers in Italy Measurements: Potential dermal exposure (outer coverall dosimeter) Actual dermal exposure (inner dosimeter) Urine samples analysed for key metabolite and parent compound Duplicate diet samples before and after application, analysed for triazoles Pilot study 2011, full study 2012 Compare results with case study 11 Acropolis Stakeholder Conference
12 Browse project EU FP7 Project Objectives Improved exposure s for operators, workers and bystanders New for residents Involve stakeholders Take account of gender & regional factors 12 Acropolis Stakeholder Conference
13 New and improved s Focus on priority exposure scenarios Integrate all relevant & available data Take account of key factors and mechanisms Surveys of B, R, O, W practices and behaviour Take account of gender & regional differences Model volatilisation from treated areas Bayesian methods for calibration, uncertainty analysis and updating with additional data 13 Acropolis Stakeholder Conference
14 Personal enclosure FF surface zone Operators FF air zone Source enclosure Local control influence region (LCIR) NF surface zone* NF air zone Source NF bulk zone Respiratory protective equipment Outer clothing contaminant layer Inner clothing contaminant layer Respiratory tract Oral Skin contaminant layer (different body parts)
15 Project outputs Risk assessment: Model software Guidance & training Sustainable use: Training materials Risk indicators Example interface design options 15 Acropolis Stakeholder Conference
16 Timetable Review s & data Prioritise scenarios Model design Model implementation Software Guidance & training Initial workshop Software workshop Sustainable Use workshops Surveys: operators, workers, residents & bystanders User-testing of software & training materials Final versions released Final stakeholder workshop
17 EFSA PROJECT CFT/EFSA/PPR/2010/04 Non-dietary cumulative exposure of farmers, contract applicators, amateur users and workers Review existing data Design & conduct pilot surveys Develop conceptual 17 Acropolis Stakeholder Conference
18 Progress Review <30 published papers with data on operator/worker behaviour <5 data sets suitable for project inclusion Pilot surveys carried out in six countries: UK Belgium Spain Greece Poland Italy Arable Crops, Soft Fruit Crops Greenhouse ornamentals, Outdoor vegetables Greenhouse fruiting vegetables, Greenhouse fruiting vegetables, Arable (cotton/maize) Arable (wheat), Orchard (apple) Vineyards (wine grapes) 18 Acropolis Stakeholder Conference
19 Surveys Operators: use of pesticides by individuals Workers: re-entry tasks, related to treatment history Data entered locally via internet Working days per month/year Working day length Daily activities & pesticides used Use of personal protective equipment, etc. Data quality variable: relies on good farm record keeping Generally very good for operators, not so good for workers 19 Acropolis Stakeholder Conference
20 Survey database 20 Acropolis Stakeholder Conference
21 Conclusions (1) POPULATION Specified by user Assessment of aggregate exposure is challenging Food consumption MCRA Consumption Database MCRA Recipes Database MCRA Residues in food MCRA Pesticide Residues Database Individual Operator activities Pesticides: EUROPOEM database or BROWSE Biocides: BEAT/ART s Vet meds: case by case Operator exposure Worker activities Pesticides: EUROPOEM or BROWSE Biocides: BEAT/ART s Vet meds: case by case Worker exposure Activities Resident activities Pesticides: BREAM or BROWSE Resident exposure BROWSE/EFSA surveys or user-specified Bystander activities Pesticides: EUROPOEM database BREAM or BROWSE Bystander exposure Consumer Product use Pesticides & biocides: CONSEXPO Consumer Product exposure Dietary exposure contribution (external) Absorption factors Non-dietary exposure contributions (internal and external) TOTAL AGGREGATE EXPOSURE (INTERNAL or EXTERNAL) Repeat calculation for large sample of individuals 21 Acropolis Stakeholder Conference
22 Conclusions (2) Current projects will provide tools for basic aggregate assessments a first tier Models exist for some routes and activities Acropolis, Browse & BfR/ECPA improved s Browse and EFSA surveys of use and behaviour MCRA function for combining outputs Acropolis case studies of aggregate assessment Higher tier assessments of aggregate exposure will require further activity data and development 22 Acropolis Stakeholder Conference
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