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Development of criteria to establish health-based occupational exposure limits for pesticides

Contract nr: FAIR-CT98-3663
Project nr: 3663
Project type: SE
Starting date: 01/06/1998
Duration: 24 months
Total cost: 600,000 EUR
EC Contribution: 300,000 EUR
Scientific Officer: Maurizio SALVI
Research topic: Plant health

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market provides a framework for the control of pesticide composition, marketing and use, to protect human health and the environment. In accordance with Directive 91/414/EEC, no authorisation for an active substance (a.s.) or a plant protection product (PPP) should be granted if the estimated operator exposure, according to the proposed conditions of use, exceeds the acceptable operator exposure level (AOEL), defined as "the maximum amount of a.s. to which the operator may be exposed without any adverse health effect". An AOEL applies, not only to pesticide operators, but also to re-entry workers and bystanders. Active substances meeting certain requirements with regard to human health and the environment are included in a Positive Community list of a.s. (Annex I of Directive 91/414/EEC). The information required from applicants seeking authorisation of an a.s. and a particular preparation is listed in Annex II and Annex III of Directive 91/414/EEC respectively. Member States are responsible for authorising Plant Protection Products (PPPs) which contain one or more of the a.s. included in Annex I. Criteria for the evaluation and the decision process are laid down in the Uniform Principles (Annex VI to the Directive), so as to ensure harmonisation throughout European Member States (MS). Harmonised guidance on specific criteria and procedures to establish AOELs for pesticides in the EU has not yet been officially agreed. A European Commission Working Document (CEC, 1997b) is currently used by some MS and industry as a draft reference guidance, but this document is not legally binding and does not represent the views of individual MS.

The scope of the project is to develop scientific guidance on how to establish health-based occupational exposure limits for pesticide workers, with particular reference to agricultural operators and pesticide applicators in public health. The final purpose is not to set limits for individual substances, but to propose a uniform and agreed scientific framework and discuss the general criteria and specific procedures through which AOELs for pesticides can be established. The ultimate goal is to achieve scientific consensus within European Member States on a harmonised procedure to establish AOELs for pesticides.

The main product of the project will be a `Guidance Document' discussing the scientific issues involved in the establishment of AOELs for pesticides, and providing recommendations for a harmonised approach to be used in Europe. Such an approach may be followed by the Commission and the individual European Member States for the authorisation of plant protection products on the market, as well as by industry, when preparing their dossiers for registration of pesticides. The project will be carried out by a group of partners from five European countries in three separate Phases of action, over two-years. During the first six months, a literature search will be carried out to review and critically evaluate the different approaches developed to set AOELs in various countries, and the contents of the Guidance Document will be defined. A six-month period will be devoted to the preparation of specific contributions by identified experts (who will be chosen among professionals from the participating institutes), and to editing of a Draft Guidance Document. During the second year, contacts will be developed with reference organisations and experts at European and non-European level, in order to raise comments and critiques on the proposed approach. A Workshop will eventually be organised, to discuss the Guidance Document, with participants chosen among reference world organisations, as well as from the agrochemical industry, academia and governmental or non-governmental bodies. After the workshop, the Guidance Document will be prepared and sent to the Commission.

Some of the important issues relevant to the project which will be discussed relate to:

a) the contents and specific requirements of the toxicological database needed for establishing oels for pesticides,;
b) the nature and type of the exposure limits to be set;
c) the procedures for inter and intraspecies extrapolation, for route to route extrapolation or for extrapolation from high to low doses;
d) the criteria to address the problem of multiple exposure to formulations containing more than one active substance, or multiple exposure over time.

Current situation/results:
The Workshop was organised in Orta (Italy), on March 1-3. The final Guidance Document is in preparation.


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  • Joop J. VAN HEMMEN
    TNO Nutrition and Food Research Institute
    Utrechtseweg 48
    NL-3700 AJ Zeist
    Tel.: +31 306 94 49 13
    Fax: +31 306 94 49 26

  • Leonard Stephen LEVY
    Medical Research Council
    Park Crescent 20
    UK-W1N 4AL London
    Tel.: +44 1162 23 16 30
    Fax: +44 1162 23 16 01

  • Helmut GREIM
    GSF - Forschungzentrum fuer Umwelt und Gesundheit (Gmbh)
    Postfach 1129
    D-85758 Oberschleissheim
    Tel.: +49 893 187 24 46
    Fax: +49 893 187 34 49
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