Page 3 - Volume 2, Issue 1, January 2009

Hellenic Plant Protection Journal

2:

1-9, 2009

REVIEW ARTICLE

Evaluating the risks of occupational pesticide exposure

C.R. Glass

1

and K. Machera

2

Summary

In the European Union (EU), the estimation and/or measurement of the operator expo-

sure 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 reflecting the Southern

European conditions. Several data, including outdoor and indoor trials in Greece, where hand-held ap-

plication 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 low-

er. 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 specific application scenario examined each time leads

to a systemic exposure level lower than the systemic Acceptable Operator Exposure Levels (AOEL) as

defined from the toxicological evaluation of each active substance.

Additional keywords

: operator exposure, pesticide safety, dermal, inhalation

market with PPPs. The authorization of PPPs

(i.e. pesticides) in the EUMember States (MS)

is essentially a two stage process. At present,

one MS acts as a Rapporteur on behalf of the

Commission (EC) and prepares the Draft As-

sessment Report (DAR) for each active sub-

stance of PPPs. In the DAR, the risk assess-

ment for the substance is provided which

includes hazard identification, setting of ref-

erence values, exposure assessment, and

risk characterisation. The DAR is then con-

sidered by the Pesticide Risk Assessment

Peer Review (PRAPeR) Unit of the European

Food Safety Authority (EFSA). A comprehen-

sive summary of the Risk Assessment is pro-

duced by EFSA and sent to the Commission,

where the final decision is made. Active sub-

stances that are demonstrated not to pres-

ent an unacceptable level of risk for human

health and the environment are then includ-

ed in Annex I to Directive 91/414/EEC.

The second stage of the process involves

and it is carried out at MS (granting the au-

Introduction

Plant Protection Products (PPPs) have be-

come a key part of many crop protection

programmes, allowing intensive produc-

tion techniques for a wide range of crops.

However, as a consequence, there are tasks

involved with PPP use that can result in ex-

posure of the user (operator) to the ac-

tive ingredient(s) of the PPPs and potential

risk for human health. The legislative basis

for the regulation of PPPs in the European

Union (EU) is the Directive 91/414/EEC, con-

cerning the placing of PPPs on the market.

This involves a harmonised approach to the

official evaluation of PPPs and data require-

ments for applicants seeking to supply the

1

Central Science Laboratory, Sand Hutton, York, YO41

1LZ, United Kingdom

2

Laboratory of Pesticides Toxicology, Department of

Pesticides Control and Phytopharmacy, Benaki Phy-

topathological Institute, 8 St. Delta str., GR-145 61 Ki-

fissia (Athens), Greece.