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FEDERAL INSTITUTE FOR RISK ASSESSMENT New Developments in Operator Exposure The Greenhouse Agricultural Operator Exposure Model (Greenhouse AOEM) Sabine Martin Federal Institute for Risk Assessment

The Greenhouse Agricultural Operator Exposure …...greenhouse application types, particularly for: - Low crop applications (normal and dense scenario) - High crop applications (normal

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Page 1: The Greenhouse Agricultural Operator Exposure …...greenhouse application types, particularly for: - Low crop applications (normal and dense scenario) - High crop applications (normal

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The Greenhouse Agricultural Operator

Exposure Model (Greenhouse AOEM)

Sabine Martin

Federal Institute for Risk Assessment

Page 2: The Greenhouse Agricultural Operator Exposure …...greenhouse application types, particularly for: - Low crop applications (normal and dense scenario) - High crop applications (normal

Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 2

Introduction

Current situation:

· different models used in risk assessment for PPPs

· mainly based on data for outdated equipment and practices

Plant protection

product

� no harmonised risk assessment in EU-MS

Exposure

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 3

Development of a new, harmonised operator exposure model for greenhouse application types, particularly for:

- Low crop applications (normal and dense scenario)- High crop applications (normal and dense scenario)

→ data based on the Southern European Greenhouse Project,→ appropriate deterministic model for regular exposure estimations

in authorisation procedures, → based on values from valid exposure studies analysed according to the

present scientific knowledge,→ transparent evaluation – publication of a detailed project report.

Scope of the new model

Project group- ANSES (French Agency for Food, Environmental and Occupational Health & Safety)- BfR (Federal Institute for Risk Assessment)- BPI (Benaki Phytopathological Institute)- BVL (Federal Office of Consumer Protection and Food Safety)- HSE (Health and Safety Executive)- INSHT (National Institute of Safety and Hygiene at Work )- JKI (Federal Research Centre for Cultivated Plants) and- ECPA (European Crop Protection Association) observed by EFSA

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 4

Scope of the new model

Quality criteria for exposure studies

• Compliance with OECD Series No. 9

• Trained operators working in accordance with Good Agricultural Practice

• Data recording and observations according to current scientific knowledge

• Compliance with GLP

• Consistent field recovery

• Suitable data form

• Whole body dosimetry for dermal exposure

• Appropriate inhalation fraction samplers for inhalation exposure

• Representative application methods and application techniques

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 5

Database

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 6

Database

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 7

Database

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 8

Types of dosimeters

Head dosimeter (face/neck wipes)

Outer body dosimeter(work clothes, coveralls)

Inner hand exposure (hand rinse/wash)

Outer Hand exposure(protective gloves)

Inner body dosimeter (long underwear)

Personal air sampler

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 9

Database

Number of mixing/loading and application data available for model development

Inhalation Total handsProtected

handsTotal body

Protected body

Head

Mixing/Loading

Tank 1) 161 / 70 229 / 69 206 / 70 129 / - 129 / -129 (33) /30 (11) 5)

Knapsack 40 / - 49 / - 49 / - 40 / - 40 / - 40 (40) / -

Total 271 347 325 169 169 199 5)

Application

LCHH 10+29 2) 10+30 10+30 10+2010 +

30 (10) 2),4)

10 (10)+30 (12) 2),5)

HCHH 30+32 2) 28 (8)+19 (14) 3) 22+18 30+10

30 + 32 (22) 2),4)

29 (16)+31 (31) 2),5)

Total 101 87 80 70 102 1001) outdoor / indoor data 4) in brackets beneath rain clothes2) normal + dense scenario 5) in brackets with face shields/masks3) in brackets from unprotected hands

Page 10: The Greenhouse Agricultural Operator Exposure …...greenhouse application types, particularly for: - Low crop applications (normal and dense scenario) - High crop applications (normal

Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 10

Statistical evaluation

LCHH (normal scenario)

HCHH (normal scenario)

LCHH (dense scenario)

HCHH (dense scenario)

EO = DEOML(H) + DEOML(B) + DEOML(C) + IEOML + DEOA(H) + DEOA(B) + DEOA(C) + IEOA

Tank ML

LCHH A (normal scenario)

HCHH A (normal scenario)

LCHH A (dense scenario)

HCHH A (dense scenario)

+ =

ML scenario Application scenarios Model scenarios

log-linear model: log X = α · log A + Σ [Fi] (0 < α ≤ 1)

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 11

Statistical evaluation

Method: Quantile Regression (75. percentile)

Comparison of outdoor and greenhouse mixing/loading data for tank equipment

Red: outdoorGreen: greenhouseo: WG ∆: WP �: WP (sachets) +: liquid

(grey, outdoor only)

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 12

Statistical evaluation

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Statistical evaluation

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 14

Validation

• Robustness (Cross validation)

• Prediction

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 15

Validation

• Prediction

• Robustness (Cross validation)

black: normal culturered: dense culture green: dense culture with water repellent clothingempty circles: validation data filled circles: model prediction (75th; solid lines)

High crop application

Low crop application

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 16

Models

M/L - Exposure models predicting the 75th percentile [µg/person]

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 17

Models

Application - Exposure models predicting the 75th percentile [µg/person]

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 18

Limitations

� no liquid formulations

� no body exposure for ML

� different levels of PPE used

� no studies in the central or the northern zone

� limited range of active substance used in low crops

� no data for application using knapsacks

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Sabine Martin, Interzonal workshop on harmonisation of risk assessment in toxicology - Vienna, June 2015 Page 19

Conclusions

� New model for typical greenhouse scenarios

� Exposure factors selected by statistical analysis

� Log linear model (quantile regression, 75th and 95th percentile)

� Validation

� Tiered approach possible

� Model suitable for risk assessment for

zonal and national applications

� Draft report is provided to MS,

comments and remarks are appreciated by the end of August

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Thank you for your attention

Dr. Sabine Martin

Federal Institute for Risk Assessment

Max-Dohrn-Str. 8-10 � 10589 Berlin, GERMANY

Tel. +49 30 - 184 12 - 4589

[email protected] � www.bfr.bund.de