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Exposure model for risk assessment and registration of amateur products in France 2013 Conference on Safe and Sustainable Use of Pesticides Bratislava–

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Presentation on theme: "Exposure model for risk assessment and registration of amateur products in France 2013 Conference on Safe and Sustainable Use of Pesticides Bratislava–"— Presentation transcript:

1 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

2  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

3  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

4  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

5  Step 1  Step 1: survey on surface distribution in French gardens to confirm assumptions – 2003  Step 2  Step 2: set up of a study involving non-professional users to generate real exposure data  Step 3  Step 3: use of the data from step 2 to build a generic datasheet to be able to calculate exposure to any product Steps of the action

6 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 75 th and the 90 th percentile of the surfaces measured in the survey.

7 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.

8 Mixing/loading Liquid product (EW) Powder product (WP)

9 Application – pre-pressure manual sprayer Downward – non cultivated permeable area Downward – low plants Upward – hedges, free shaped trees

10 Application – ready-to-use liquid and granules Ready-to-use product (AL) Granules (GR) - hand

11  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 exposure  Inhalation exposure: (air filter). Step 2 - General methodology

12  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

13  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

14 Step 3 – Excel datasheet overview

15  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

16 Questions Comments Thank you for attention


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