agricultural operator exposure bundesinstitut …€¦ · bundesinstitut fÜr risikobewertung...
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Agricultural Operator Exposure Model (AOEM)
Claudia Großkopf
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP 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· mainly based on data for outdated equipment and practices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
exposure
Scope: · use of new exposure data
· statistical approach, fully transparent
· main outdoor application scenarios
· applicable for authorisation
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 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, 2014-06-18, European Conference on Safe Use of PPP Page 4
Database
grapevine
cereals
olives
citrus
pome
potatoes / sugarbeets
fallow land / stubble field
UK
FranceBelgium
NL
Italy
Portugal
Greece
Spain
Switzerland
Germany
884051761496010859147344280all
-134601460---9044HCHH
88-960-19--4849LCHH
-1336612-55555410979HCTM
-1384163-3449397108LCTM
knapsacktankSC/SLEC/EWWPWGnoyesAM/L
EquipmentFormulationCabinReplicates
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 5
LCHH (knapsack)
area (ha)
num
ber
of tr
ials
0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1
02
46
810
12
LCTM
area (ha)
num
ber
of tr
ials
0 50 100 150
020
40
60
80
HCHH (tank)
area (ha)
num
ber
of tr
ials
0 1 2 3 4 5 6 7
010
20
30
40
50
HCTM
area (ha)
num
ber
of tr
ials
5 10 15 20
010
20
30
Database
1 ha 50 ha
10 ha4 ha
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 6
Types of dosimeters
Head dosimeter (hat/cap, hood, face/neck wipe)
Outer body dosimeter(work clothes, coverall)
Inner hand exposure (absorbent gloves, hand rinse/wash)
Outer Hand exposure((absorbent) gloves)
Inner body dosimeter (long underwear)
Personal air sampler
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 7
909090909090323232444432HCHH
246247246276320278169170169278255201all
393939204839404040494940LCHH
717272929783404141776652HCTM
464645748566575756108
96
77LCTM
HeadBodyouterBody nnerGloveHandInhalat.HeadBody outerBodyinnerGloveHandInhalat.
ApplicationMixing/Loading
Exposure data
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 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
Inhalation exposure:amount collected by air sampling corrected for respiratory rate
Head exposure:deposit on the head dosimeter corrected for the whole head
Actual/protected hand exposure: deposits on protected hands (inner gloves, hand rinse/wash)
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 9
Model
log-linear model: log X = α·log A + Σ [Fi] 0 < α ≤ 1
X = Aα · Π ci
A
exp
osu
re
log A
log e
xposu
re
log X = α·log A
log X = α·log A + F1α > 1
0 < α < 1
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 10
P
R2
Analysis
n
AIC P
R2
Analysis
n
AIC
P
R2
Analysis
n
AIC P
R2
Analysis
n
AIC
AnalysisAnalysis
AnalysisAnalysis
Analysis Analysis AnalysisAnalysis
Statistical analysis
• formulation type
• total amount a.s. used per day
• number of containers handled
• number of M/L tasks
• concentration of a.s.
• equipment (induction hopper)
• duration of M/L
• formulation type
• total amount a.s. used per day
• concentration of a.s. in spray solution
• equipment (cabin)
• size of area treated
• spray droplet size
• cleaning
• duration of cleaning
M/L task Application task
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 11
Induction hopper
yes no
23
45
6
log
to
tal
ha
nd
s e
xp
os
ure
yes no
2.5
3.5
4.5
5.5
log
to
tal
bo
dy
ex
po
su
re
yes no
-2-1
01
23
4
log
he
ad
ex
po
su
re
yes no
-2-1
01
23
4
log
in
ha
lati
on
ex
po
su
re
→ no impact
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 12
Model
Method: Quantile Regression
0.2 0.5 1.0 2.0 5.0 10.0 50.0 200.0
100
1000
10000
100000
1000000
potential hands
TA
measure
d v
alu
e
LSQR
WGliquidWP
0.2 0.5 1.0 2.0 5.0 10.0 50.0 200.0
0.0
11.0
0100.0
010000.0
0
protected hands
TA
measure
d v
alu
e
LSQR
WGliquidWP
Potential Hands tank M/L Protected Hands tank M/L
log e
xposu
re (
measu
red v
alu
e)
log e
xposu
re (
measu
red v
alu
e)
log TA (kg a.s./day) log TA (kg a.s./day)
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 13
Validation
• Robustness (Cross validation)
3.0 3.5 4.0 4.5 5.0 5.5
2.5
3.0
3.5
4.0
4.5
5.0
5.5
Predicted (fit to all data)
observ
ed
ML tank, total body exposureQuantile regression, 75.percentileFold 1Fold 2
Fold 3Fold 4
Fold 5Fold 6
Fold 7Fold 8
Fold 9Fold 10
Fold 1Fold 2
Fold 3Fold 4
Fold 5Fold 6
Fold 7Fold 8
Fold 9Fold 10
Fold 1Fold 2
Fold 3Fold 4
Fold 5Fold 6
Fold 7Fold 8
Fold 9Fold 10
Fold 1Fold 2
Fold 3Fold 4
Fold 5Fold 6
Fold 7Fold 8
Fold 9Fold 10
Fold 1Fold 2
Fold 3Fold 4
Fold 5Fold 6
Fold 7Fold 8
Fold 9Fold 10
Fold 1Fold 2
Fold 3Fold 4
Fold 5Fold 6
Fold 7Fold 8
Fold 9Fold 10
Fold 1Fold 2
Fold 3Fold 4
Fold 5Fold 6
Fold 7Fold 8
Fold 9Fold 10
Fold 1Fold 2
Fold 3Fold 4
Fold 5Fold 6
Fold 7Fold 8
Fold 9Fold 10
Fold 1Fold 2
Fold 3Fold 4
Fold 5Fold 6
Fold 7Fold 8
Fold 9Fold 10
Fold 1Fold 2
Fold 3Fold 4
Fold 5Fold 6
Fold 7Fold 8
Fold 9Fold 10
• Prediction (MLA data)
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 14
Validation
• Prediction (MLA data)
-2
0
2
4
6HCTM
inner bodyLCTM
inner body
HCTMtotal body
-2
0
2
4
6LCTM
total body
-2
0
2
4
6HCTM
protected handLCTM
protected hand
HCTMtotal hand
1 2 3 4 5
-2
0
2
4
6LCTM
total hand• Robustness (Cross validation)
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 15
Model
Mixing/loading –tank
potential hands log DM(H) = 0.77 log TA + 0.57 [liquid] + 1.27 [WP] – 0.29 [glove wash] + 3.12
protected hands log DM(Hp) = 0.65 log TA + 0.32 [liquid] + 1.74 [WP] + 1.22
total body log DM(B) = 0.70 log TA + 0.46 [liquid] + 1.83 [WP] + 3.09
protected body log DM(Bp) = 0.89 log TA + 0.11 [liquid] + 1.76 [WP] + 1.27
head log DM(C) = log TA + 0.90 [liquid] + 1.28 [WP] + 1.79 [no face shield] - 0.98
inhalation log IM = 0.30 log TA - 1.00 [liquid] + 1.76 [WP] + 1.57
Mixing/loading -knapsack
potential hands
75th percentile (above 1.5 kg a.s. linear extrapolation)
protected hands
total body
protected body
head
inhalation
Downward spraying –vehicle mounted
potential hands log DA(H) = log TA + 0.37 [normal droplets] - 1.04 [normal equipment] + 2.84
protected hands log DA(Hp) = 0.54 log TA + 1.11 [normal droplets] + 0.29 [normal equipment] - 0.23
total body log DA(B) = log TA + 0.81 [normal droplets] - 1.43 [normal equipment] + 2.54
protected body log DA(Bp) = log TA + 0.70 [normal droplets] - 1.09 [normal equipment] + 0.74
head log DA(C) = log TA + 0.88 [normal droplets] - 0.53 [normal equipment] + 0.24
inhalation log IA = 0.50 log TA + 0.01 [normal droplets] - 0.71 [normal equipment] + 0.72
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 16
Upward spraying –vehicle mounted
potential hands log DA(H) = 0.89 log TA + 0.28 [no cabin] + 3.12
protected hands log DA(Hp) = log TA - 1.55
total body log DA(B) = log TA + 0.48 [no cabin] + 3.47
protected body log DA(Bp) = log TA + 0.23 [no cabin] + 1.83
head log DA(C) = log TA + 1.89 [no cabin] + 1.17
inhalation log IA = 0.57 log TA + 0.82 [no cabin] + 0.99
Downward spraying –hand-held
potential hands
75th percentile (above 1.5 kg a.s. linear extrapolation)
protected hands
total body
protected body
head
inhalation
Upward spraying –hand-held
potential hands log DA(H) = 0.84 log TA - 0.83 [normal culture] + 4.26
protected hands log (DA(Hp) = log TA - 0.88 [normal culture] + 2.26
total body log DA(B) = 0.16 log TA - 1.29 [normal culture] + 6.08
protected body log DA(Bp) = - 1.64 [normal culture] + 4.65
head log DA(C) = 0.32 log TA - 1.09 [normal culture] + 3.27
inhalation log IA = 0.83 log TA - 0.26 [normal culture] + 2.17
Model
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 17
0.150.03LCHH
0.070.01Knapsack
0.040.11HCTM
0.050.11LCTM
0.040.05Tank WP
0.020.02Tank liquid
0.040.03Tank WG
0.030.02HCHH
0.040.03all
A
0.040.02all
ML
75th percentile75th percentile
Work clothesProtective gloves
Protection factor
Actual hand Actual body
Mixing/Loading: Face shield
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 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 modelcoverall
UK POEMlong shirt + trousers
AOEM tankworkwear
AOEM knapsackworkwear
FCTM400 L/ha
liquid 130 343 183
WG 116 653 59
WP 232 1324 910
HCTM400 L/ha
liquid 160 556 103
WG 155 650 67
WP 201 852 314
LCHH200 L/ha15 L tank
liquid 921 71 33
WG 1137 53 33
WP 1139 176 33
HCHH200 L/ha2.5 L tank
liquid 351 1019 41 23
WG 88 905 24 23
WP 131 907 146 23
117 125
111 125
155 125
Claudia Großkopf, 2014-06-18, European Conference on Safe Use of PPP Page 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
http://www.bfr.bund.de/cm/350/joint-development-of-a-new-agricultural-operator-exposure-model.pdf
http://www.springerlink.com/openurl.asp?genre=article&id=doi:10.1007/s00003-013-0836-x
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Thank you for your attention
Claudia Großkopf
Federal Institute for Risk Assessment
Max-Dohrn-Str. 8-10 � 10589 Berlin, GERMANY
Tel. +49 30 - 184 12 - 3371 � Fax +49 30 - 184 12 - 47 41
[email protected] � www.bfr.bund.de