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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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).

Introduction

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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”.

Sustainable use of pesticides

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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 »).  

Background

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Step 1Step 1: survey on surface distribution in French gardens

to confirm assumptions – 2003

Step 2Step 2: set up of a study involving non-professional users

to generate real exposure data - 2003

Step 3Step 3: use of the data from step 2 to build a generic datasheet

to be able to calculate exposure to any product - 2005

Steps of the action

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Step 1 – Survey on surfaces in gardens

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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.

Step 2 – Exposure measurement

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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.

Mixing/loading

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Liquid product (EW) Powder product (WP)

Application – pre-pressure manual sprayer

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Downward – non cultivated permeable

area

Downward – low plants

Upward – hedges, free shaped trees

Application – ready-to-use liquid and granules

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Ready-to-use product (AL) Granules (GR) - hand

Substance used as analytical tracer. According to Good Laboratory Practices (GLP). Dermal exposure: Dermal exposure: cotton coverall; nitrile gloves;

hand washes; (cotton cap; face/neck wash). Inhalation exposureInhalation exposure: (air filter).

Step 2 - General methodology

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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.

Step 2 - Results

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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

Step 3 - Modelling

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Step 3 – Excel datasheet overview

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Formulation

Name of active substance: XXX Type:

0.020 mg/kg bw /daya.s. concentration in formulation:

30 g/kg

1.2 mg/day Dose rate: 750 g/10 m²

Volume (minimum) of spray applied by area:

10 L/m²

a.s. concentration in spray: 0.225 g/litre

Mixing/loading and application data

Diluted formulation (spray or AL):

Exposure (µg)Absorbed dose

(µg)% AOEL Exposure (µg) Absorbed dose (µg) % AOEL Exposure (µg)

Absorbed dose (µg)

% AOEL

Inhalation exposure: 0.939 0.939 0.939 0.939 0.939 0.939

Dermal exposure: 925.3 46.75 432.56 41.82No gloves during

application on clumps

No gloves during application on

clumps

Total exposure (inhalation + dermal):

926.2 47.68 3.97% 433.50 42.76 3.56%No gloves during

application on clumps

No gloves during application on

clumps

flow er bed, vegetable crop (<60 cm)

Risk assessment (according to

recommendations of the Commission d'Etude de la

Toxicité)

Crop type:

Toxicological data

Dermal penetration

Equipment used:

AOEL (Acceptable Operator Exposure Level or Tolerated dose):

Concentrate formulation (liquid or solid):

pre-pressure sprayer

Scenario 1: WITHOUT GLOVESScenario 2: WITH GLOVES (during mixing/loading)

Scenario 3: WITH GLOVES (during mixing/loading and application)

WP/SP

1.00%

10.00%

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).

Registration in France

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Questions

Comments

Thank you for attentionThank you for attention

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