Hellenic Plant Protection Journal

Volume 2, Issue 1, January 2009 ISSN 1791-3691 Hellenic Plant Protection Journal A semiannual scientifi c publication of the BENAKIBEB PHYTOPATHOLOGICAL INSTITUTE The Hellenic Plant Protection Journal (ISSN 1791-3691) is the new scientifi c publication of the Benaki Phytopathological Institute replacing the Annals of the Benaki Phytopathologi- cal Institute (ISSN 1790-1480) which had been published since 1935. Starting from January 2008, the Benaki Phytopathological Institute is publishing the Hel- lenic Plant Protection Journal semiannually, in January and July each year, and accepts for publication any work related to plant protection in the Mediterranean region regardless of where it was conducted. All aspects of plant protection referring to plant pathogens, pests, weeds (identifi cation, biology, control), pesticides and relevant environmental issues are topics covered by the journal. Articles in the form of either a complete research paper or a short communication (including new records) may be submitted. Instructions on how to prepare the manuscript are provided at www.bpi.gr. Manuscripts should be submitted in electronic form either by e-mail at [email protected] or by post on a disk addressed to the Editorial Board, Benaki Phytopathological Institute, 8 St. Delta str., GR-145 61 Kifi ssia (Athens), Greece. Only origi- nal articles are considered and published after successful completion of a review proce- Hellenic Plant Protection Journal Hellenic Plant dure by two competent referees. EDITORIAL BOARD Editor: Dr C.N. Giannopolitis (Weed Science Department, B.P.I.) Associate editors: Dr K. Elena (Phytopathology Department, B.P.I.) Dr K. Machera (Pesticides Control & Phytopharmacy Department, BPI) Dr A.N. Michaelakis (Entomology & Agric. Zoology Department, B.P.I.) V. Papaconstantinou (Library Department, B.P.I.) Technical editor: Asteria Karadima (Information Technology Service, B.P.I.) Secretary: Emilia Pantazi (Information Technology Service, B.P.I.) For subscriptions, exchange agreements, back issues and other publications of the In- stitute contact the Library, Benaki Phytopathological Institute, 8 St. Delta str., GR-145 61 Kifi ssia (Athens), Greece, e-mail: [email protected]. This Journal is indexed by: CAB Abstracts-Plant Protection Database, INIST (Institute for Scientifi c and Technical Information) and SCOPUS. The olive tree of Plato in Athens is the emblem of the Benaki Phytopathological Institute Hellenic Plant Protection Journal also available at www.bpi.gr © Benaki Phytopathological Institute Hellenic Plant Protection Journal 2: 1-9, 2009 REVIEW ARTICLE Evaluating the risks of occupational pesticide exposure C.R. Glass1 and K. Machera2 Summary In the European Union (EU), the estimation and/or measurement of the operator exposure levels to a plant protection product (PPP) during its mixing/loading and application to the crops (outdoors or indoors) is a key issue in the registration process in accordance with Directive 91/414/EEC. The predictive models currently applied for regulatory purposes within the EU (UK POEM, German and Dutch models) have been based on data generated in Northern Europe, not refl ecting the Southern European conditions. Several data, including outdoor and indoor trials in Greece, where hand-held application techniques were used, have been generated recently in order to address this issue. The most important route of exposure to PPPs is dermal, while the contribution of inhalation exposure is lower. The selection of the method to measure the operator exposure in each study is a decisive step and many factors should be taken into account. On the other hand, there are a great number of factors to consider when using predictive operator exposure models in the risk assessment of a PPP. In any case, the operator is considered to be safe only if the specifi c application scenario examined each time leads to a systemic exposure level lower than the systemic Acceptable Operator Exposure Levels (AOEL) as defi ned from the toxicological evaluation of each active substance. Additional keywords: operator exposure, pesticide safety, dermal, inhalation Introduction market with PPPs. The authorization of PPPs (i.e. pesticides) in the EU Member States (MS) Plant Protection Products (PPPs) have be- is essentially a two stage process. At present, come a key part of many crop protection one MS acts as a Rapporteur on behalf of the programmes, allowing intensive produc- Commission (EC) and prepares the Draft As- tion techniques for a wide range of crops. sessment Report (DAR) for each active sub- However, as a consequence, there are tasks stance of PPPs. In the DAR, the risk assess- involved with PPP use that can result in ex- ment for the substance is provided which posure of the user (operator) to the ac- includes hazard identifi cation, setting of ref- tive ingredient(s) of the PPPs and potential erence values, exposure assessment, and risk for human health. The legislative basis risk characterisation. The DAR is then con- for the regulation of PPPs in the European sidered by the Pesticide Risk Assessment Union (EU) is the Directive 91/414/EEC, con- Peer Review (PRAPeR) Unit of the European cerning the placing of PPPs on the market. Food Safety Authority (EFSA). A comprehen- This involves a harmonised approach to the sive summary of the Risk Assessment is pro- offi cial evaluation of PPPs and data require- duced by EFSA and sent to the Commission, ments for applicants seeking to supply the where the fi nal decision is made. Active substances that are demonstrated not to present an unacceptable level of risk for human 1 Central Science Laboratory, Sand Hutton, York, YO41 1LZ, United Kingdom health and the environment are then includ- 2 Laboratory of Pesticides Toxicology, Department of ed in Annex I to Directive 91/414/EEC. Pesticides Control and Phytopharmacy, Benaki Phy- topathological Institute, 8 St. Delta str., GR-145 61 Ki- The second stage of the process involves fi ssia (Athens), Greece. and it is carried out at MS (granting the au- © Benaki Phytopathological Institute 2 Glass and Machera thorization of the product) which has the re- tends to be used in conjunction with exist- sponsibility of carrying out risk assessments ing models developed in the UK and Germa- for the examined PPPs which contain Annex ny. Data have been added since EUROPOEM I listed active substances. With the informa- was set up, with fi eld assessments carried tion from the hazard assessment for the ac- out, especially in southern Europe (Machera tive substance(s), as concluded during the et al., 2001; Glass et al., 2002) as part of the Annex I inclusion, the regulatory authori- project SMT4-CT96-2048. In North Ameri- ty for each individual MS decides wheth- ca, a Pesticides Handlers Exposure Database er the PPP can be used safely under nation- (PHED) provides generic mixer/loader/appli- al conditions. With decisions now made on cator exposure data (Krieger, 1995). Work is a European basis for the selection of active being done to combine PHED and EUROPO- substances for inclusion in the Annex I, it is EM datasets in a new North American mod- important that data and information used el, the Applicator and Handlers Exposure in the initial risk assessment (such as expo- Database (AHED). sure models) are valid for all MS, and not just The modelling of operator exposure still for those that have generated the most in- relies on a number of assumptions related formation. to the personal protective equipment (PPE) There are various tasks involved which worn by operators, the protection factor of- result in occupational exposure to pesti- fered by coveralls for example. The degree cides, but the greatest exposures are often of dermal absorption of the compound is a associated with the operator, during both substantial information for reliable human the handling of the concentrated pesticide risk assessment. This information is usually when mixing and loading, and the appli- derived from in vivo animal data and in vit- cation of the diluted pesticide in the fi eld. ro human and animal skin data. When there Studies to measure operator exposure have are no available data for a substance, default been carried out since the 1960’s using a values of dermal absorption are used. range of methodologies to determine po- The methods used to measure operator tential dermal and inhalation exposure. exposure, and the subsequent use of these More recent studies have measured dermal data together with toxicology data in risk as- exposure and the absorbed dose, and data sessments are discussed. is now available from a wide range of studies using diff erent application techniques. Routes of operator exposure The estimation or measurement of operator The most important route for exposure exposure is a key element of occupational to pesticides is dermal for the majority of health and a requirement of the risk assess- application techniques. The other routes ment in pesticide registration (van Hemmen are inhalation, particularly with fogging and and Brouwer, 1997), which is carried out ac- misting application techniques, and by acci- cording to the directive 91/414/EEC. dental ingestion (oral), for example by eat- Three predictive models are used for ing or smoking while working, or not wash- regulatory purposes within the EU: the UK ing adequately after work. model (Martin, 1990); the German model Potential dermal exposure is the total (Lundehn et al., 1992) and the Dutch mod- amount of pesticide landing on the body, el (van Hemmen, 1992). These models con- including amounts landing on clothing. The tain experimental data obtained from par- mass of pesticide available on the skin for ticular use scenarios and were incorporated absorption into the body is the actual der- into the European Predictive Operator Ex- mal exposure, which is the amount depos- posure Model (EUROPOEM) Expert Group ited directly on the skin plus any that pene- under concerted Action AIR3-CT93-1370.

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