Agricultural Operator Exposure Model (AOEM)

Transcription

1 Agricultural Operator Exposure Model (AOEM) Claudia Großkopf BUNDESINSTITUT FÜR RISIKOBEWERTUNG

2 Introduction Current situation: different models used in risk assessment for PPPs mainly based on data for outdated equipment and practices plant protection product exposure Scope: use of new exposure data statistical approach, fully transparent main outdoor application scenarios applicable for authorisation Claudia Großkopf, , European Conference on Safe Use of PPP Page 2

3 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 Claudia Großkopf, , European Conference on Safe Use of PPP Page 3

4 Database Replicates Cabin Formulation Equipment M/L A yes no WG WP EC/EW SC/SL tank knapsack LCTM HCTM LCHH HCHH all potatoes / sugarbeets pome grapevine Greece Spain Germany UK citrus Portugal Switzerland olives cereals fallow land / stubble field Italy NL Belgium France Claudia Großkopf, , European Conference on Safe Use of PPP Page 4

5 Database LCHH (knapsack) LCTM number of trials number of trials ha 50 ha area (ha) area (ha) HCHH (tank) HCTM number of trials ha number of trials ha area (ha) area (ha) Claudia Großkopf, , European Conference on Safe Use of PPP Page 5

6 Types of dosimeters Head dosimeter (hat/cap, hood, face/neck wipe) Outer body dosimeter (work clothes, coverall) Personal air sampler Inner body dosimeter (long underwear) Outer Hand exposure ((absorbent) gloves) Inner hand exposure (absorbent gloves, hand rinse/wash) Claudia Großkopf, , European Conference on Safe Use of PPP Page 6

7 Exposure data Mixing/Loading Application Inhalat. Hand Glove Body inner Body outer Head Inhalat. Hand Glove Body nner Body outer Head LCTM HCTM LCHH HCHH all Claudia Großkopf, , European Conference on Safe Use of PPP Page 7

8 Exposure variables Potential body exposure: sum of deposits on outer and inner body dosimeters Actual body exposure: deposits on inner body dosimeters (below one layer of clothing) Potential hand exposure: sum of deposits on protective gloves and hands Actual/protected hand exposure: deposits on protected hands (inner gloves, hand rinse/wash) Head exposure: deposit on the head dosimeter corrected for the whole head Inhalation exposure: amount collected by air sampling corrected for respiratory rate Claudia Großkopf, , European Conference on Safe Use of PPP Page 8

9 Model loglinear model: log X = α log A + Σ [Fi] 0 < α 1 X = A α Π ci α > 1 log X = α log A + F 1 exposure 0 < α < 1 log exposure log X = α log A A log A Claudia Großkopf, , European Conference on Safe Use of PPP Page 9

10 Statistical analysis AIC n M/L task formulation type AIC Analysis P Analysis R 2 P Analysis Analysis AIC n Analysis total amount a.s. used per day total amount a.s. used per day number of containers handled number of M/L tasks Analysis concentration of a.s. equipment (induction hopper) duration of M/L Application task formulation type AIC Analysis P Analysis R 2 concentration of a.s. in spray solution equipment (cabin) Analysis Analysis Analysis size of area treated spray droplet size cleaning duration of cleaning P Analysis n R 2 n R 2 Claudia Großkopf, , European Conference on Safe Use of PPP Page 10

11 Induction hopper log total hands exposure log total body exposure yes no yes no no impact log head exposure log inhalation expos ure yes no yes no Claudia Großkopf, , European Conference on Safe Use of PPP Page 11

12 Model Method: Quantile Regression Potential Hands tank M/L potential hands Protected protected Hands handstank M/L log exposure measured (measured value value) LS QR WG liquid WP log exposure measured (measured value value) LS QR WG liquid WP log TA (kg TAa.s./day) log TA (kg TA a.s./day) Claudia Großkopf, , European Conference on Safe Use of PPP Page 12

13 Validation Robustness (Cross validation) Prediction (MLA data) observed ML tank, total body exposure Quantile regression, 75.percentile Fold 1 Fold 2 Fold 3 Fold 4 Fold 5 Fold 6 Fold 7 Fold 8 Fold 9 Fold Predicted (fit to all data) Claudia Großkopf, , European Conference on Safe Use of PPP Page 13

14 Validation Robustness (Cross validation) total hand HCTM total hand LCTM 6 Prediction (MLA data) protected hand HCTM protected hand LCTM total body HCTM total body LCTM inner body HCTM inner body LCTM Claudia Großkopf, , European Conference on Safe Use of PPP Page 14

15 Model Mixing/loading tank potential hands log D M(H) = 0.77 log TA [liquid] [WP] 0.29 [glove wash] protected hands log D M(Hp) = 0.65 log TA [liquid] [WP] total body log D M(B) = 0.70 log TA [liquid] [WP] protected body log D M(Bp) = 0.89 log TA [liquid] [WP] head log D M(C) = log TA [liquid] [WP] [no face shield] 0.98 inhalation log I M = 0.30 log TA 1.00 [liquid] [WP] Mixing/loading knapsack potential hands protected hands total body protected body 75 th percentile (above 1.5 kg a.s. linear extrapolation) head inhalation Downward spraying vehicle mounted potential hands log D A(H) = log TA [normal droplets] 1.04 [normal equipment] protected hands log D A(Hp) = 0.54 log TA [normal droplets] [normal equipment] 0.23 total body log D A(B) = log TA [normal droplets] 1.43 [normal equipment] protected body log D A(Bp) = log TA [normal droplets] 1.09 [normal equipment] head log D A(C) = log TA [normal droplets] 0.53 [normal equipment] inhalation log I A = 0.50 log TA [normal droplets] 0.71 [normal equipment] Claudia Großkopf, , European Conference on Safe Use of PPP Page 15

16 Model Upward spraying vehicle mounted potential hands log D A(H) = 0.89 log TA [no cabin] protected hands log D A(Hp) = log TA 1.55 total body log D A(B) = log TA [no cabin] protected body log D A(Bp) = log TA [no cabin] head log D A(C) = log TA [no cabin] inhalation log I A = 0.57 log TA [no cabin] Downward spraying handheld potential hands protected hands total body protected body 75 th percentile (above 1.5 kg a.s. linear extrapolation) head inhalation Upward spraying handheld potential hands log D A(H) = 0.84 log TA 0.83 [normal culture] protected hands log (D A(Hp) = log TA 0.88 [normal culture] total body log D A(B) = 0.16 log TA 1.29 [normal culture] protected body log D A(Bp) = 1.64 [normal culture] head log D A(C) = 0.32 log TA 1.09 [normal culture] inhalation log I A = 0.83 log TA 0.26 [normal culture] Claudia Großkopf, , European Conference on Safe Use of PPP Page 16

17 Protection factor Actual hand Actual body Protective gloves Work clothes 75 th percentile 75 th percentile ML Tank WG Tank WP Tank liquid Knapsack all A LCTM HCTM HCHH LCHH all Mixing/Loading: Face shield Claudia Großkopf, , European Conference on Safe Use of PPP Page 17

18 AOEM in risk assessment Comparison with German model and UK POEM Example: 300 g a.s./l; 5 L container (45 or 63 mm); 1 kg a.s./ha; 100 % dermal absorption; AOEL: 1 mg/kg bw German model coverall UK POEM long shirt + trousers AOEM tank workwear AOEM knapsack workwear FCTM 400 L/ha HCTM 400 L/ha LCHH 200 L/ha 15 L tank HCHH 200 L/ha 2.5 L tank liquid WG WP liquid WG WP liquid WG WP liquid WG WP Claudia Großkopf, , European Conference on Safe Use of PPP Page 18

19 Conclusions new model for typical outdoor scenarios exposure factors selected by statistical analysis log linear model (Quantile Regression) validation tiered approach possible updating of the model if new data become available Claudia Großkopf, , European Conference on Safe Use of PPP Page 19

20 BUNDESINSTITUT FÜR RISIKOBEWERTUNG Thank you for your attention Claudia Großkopf Federal Institute for Risk Assessment MaxDohrnStr Berlin, GERMANY Tel Fax