Exposure model for risk
assessment and registration of
amateur products in France
2013 Conference on
Safe and Sustainable Use of Pesticides
Bratislava– June 11, 2013
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Introduction
 Isabelle THOUVENIN – HumExpo company
 Consultant on human exposure assessment, especially to
pesticides.
 Study Director of field exposure studies, in collaboration with a
GLP test facility.
 Has been working with UPJ on operator exposure in gardens
(non-professional users) and amenities (professional users).
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Sustainable use of pesticides
 Directive 2009/118/EC – (11):
“Research programmes aimed at determining the impacts of
pesticide use on human health and the environment, including
studies on high-risk groups, should be promoted at European and
national level”.
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Background
 In France, until 2005, use of models from the professional
agricultural world to assess risk of operators to pesticides, as
in other member states.
 Discussion with the regulatory agency (now ANSES) started
more than 10 years ago, to take the amateur population into
better consideration.
 Final objective: to provide an adequate support to French
authorities for registration of products which are dedicated to
non-professional gardeners (specific label = « EAJ »).
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Steps of the action
 Step 1: survey on surface distribution in French gardens
to confirm assumptions – 2003
 Step 2: set up of a study involving non-professional users
to generate real exposure data - 2003
 Step 3: use of the data from step 2 to build a generic datasheet
to be able to calculate exposure to any product - 2005
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Step 1 – Survey on surfaces in gardens
 Among 750 investigated gardens, the data from 660 gardens
could finally be kept.
 The mean total surface is 751 m², with kitchen garden on 21 m²,
permeable non cultivated areas on 71 m², 10 fruit trees,
11 rosebushes,…
 For step 2 the areas planned to be treated were between the
75th and the 90th percentile of the surfaces measured in the
survey.
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Step 2 – Exposure measurement
 OPEX study design mainly based on the garden survey results
and on the application equipment used by non-professional
gardeners.
 Field phase in fall 2003 in the South-East region of France.
 Tasks studied not covered by professional exposure data (e.g.,
no knapsack sprayer).
 Mixing/loading and application.
 Liquid and solid products.
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Mixing/loading
Liquid product (EW)
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Powder product (WP)
Application – pre-pressure manual sprayer
Downward – non cultivated
permeable area
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Downward – low plants
Upward – hedges, free
shaped trees
Application – ready-to-use liquid
and granules
Ready-to-use product (AL)
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Granules (GR) - hand
Step 2 - General methodology
 Substance used as analytical tracer.
 According to Good Laboratory Practices (GLP).
 Dermal exposure: cotton coverall; nitrile gloves; hand washes;
(cotton cap; face/neck wash).
 Inhalation exposure: (air filter).
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Step 2 - Results
 Use conditions as close as possible to actual conditions
(treated surface, application duration, equipment,…).
 Generally, no inhalation exposure was detected.
 The exposure measured on the coverall was used for body
exposure assessment, considering the person was wearing a
short-sleeved T-shirt and a pair of shorts.
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Step 3 - Modelling
 Data from the step 2 study.
 Exposure values normalised as:
 µL formulation (or spray) per task (liquids) or as
 mg formulation per task (solids).
 Three exposure scenarios to determine the operator exposure
and risk:
 1 = no gloves during M/L and application
 2 = gloves during M/L
 3 = gloves during M/L and application
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Step 3 – Excel datasheet overview
Toxicological data
Form ulation
Name of active substance:
AOEL
(Acceptable Operator
Exposure Level or
Tolerated dose):
Type:
a.s. concentration in
formulation:
XXX
mg/kg bw /day
0.020
Dose rate:
mg/day
1.2
Volume (minimum) of spray
applied by area:
a.s. concentration in spray:
Derm al penetration
1.00%
Diluted formulation
(spray or AL):
10.00%
g/kg
750
g/10 m²
10
L/m²
0.225
g/litre
pre-pressure sprayer
Equipment used:
flow er bed, vegetable crop (<60
cm)
Crop type:
Absorbed dose
(µg)
Inhalation exposure:
0.939
Dermal exposure:
Total exposure
(inhalation + derm al):
Scenario 3: WITH GLOVES
(during m ixing/loading and application)
Scenario 2: WITH GLOVES
(during m ixing/loading)
Scenario 1: WITHOUT GLOVES
Exposure (µg)
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30
Mixing/loading and application data
Concentrate formulation
(liquid or solid):
Risk assessm ent
(according to
recom m endations of the
Com m ission d'Etude de la
Toxicité)
WP/SP
Exposure (µg)
Absorbed dose
(µg)
0.939
0.939
0.939
432.56
41.82
No gloves during
application on
clumps
No gloves during
application on
clumps
433.50
42.76
No gloves during
application on
clumps
No gloves during
application on
clumps
Exposure (µg)
Absorbed dose (µg)
0.939
0.939
925.3
46.75
926.2
47.68
% AOEL
3.97%
% AOEL
3.56%
% AOEL
Registration in France
 The UPJ amateur exposure model was accepted by French
authorities late in 2005 and has been used since then.
 Recommendations: use without gloves; packages allowing
exposure reduction.
 Most, but not all, companies marketing products for amateur
use in France have access to this model.
 Among member states, Belgium and Poland have already
requested an access to UPJ.
 Contact in UPJ: Jacques My (General Manager).
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Thank you for attention
Questions
Comments
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