Operator Exposure (OPEX) trials – SynTech Spain
Lidón Avinent, Managing Director and Vicente Corts, National Coordinator & Study Director, SynTech Spain
To register new agrochemical products in the EU (under Regulation (EC) No 1107/2009), an assessment is needed of the extent of exposure to the active substance(s) and/or toxicologically relevant compounds likely to occur under the proposed conditions of use. Inhalation and dermal absorption studies are required for estimating non-dietary exposure. The information generated also allows specification of protective measures (including personal protective equipment – PPE) to be used by operators.
Spain is a high risk country for pesticides use, particularly in protected conditions, because of the large number of greenhouses, the intensive crop cycles and the high temperatures. Products need a risk assessment in real-life field conditions, since mathematical models may not reflect reality. Trials need to be done to GLP, in different situations, both open air and in protected conditions, for spray and fumigant applications.
SynTech Research Spain obtained its GLP certificate for Operator Exposure Trials (OPEX) in Spain, in 2000, and is the only Spanish company to hold a certificate. We have a close relationship with Ministry of Health and with AEPLA (Asociación Empresarial para la Protección de las Plantas) for training and delivery of national programs. The OPEX Team, trained by a GLP recognized analytical laboratory, uses our field stations around Spain (including the Canary Islands). SynTech has all the necessary equipment including pumps and meters needed to perform the inhalation trials; as well as OPEX trials, we also perform worker/bystander and re-entry exposure trials (Dislodgeable Foliar Residues – DFR).
SynTech Spain’s 2012 inhalation monitoring trials, working with more than 40 operators/workers are being to be completed in the next few months ….
For more information download SynTech’s Environmental chemistry (GLP) services brochure, or contact Daniel Mourad email: firstname.lastname@example.org and for SynTech Research Spain’s services contact Lidón Avinent email: email@example.com