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:
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
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
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
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
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
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.
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.
Application – pre-pressure manual sprayer Downward – non cultivated permeable area Downward – low plants Upward – hedges, free shaped trees
Application – ready-to-use liquid and granules 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 exposure Inhalation exposure: (air filter). Step 2 - General methodology
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
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
Step 3 – Excel datasheet overview
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