0494 A regulatory perspective on the need for improving exposure assessment for epidemiological studies on pesticides

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Manufacturers intending to market pesticides are required to perform and submit extensive toxicology studies in animals to support risk assessments which demonstrate an absence of harm to human health in order to gain authorisation to supply their products. While such data provides necessary reassurance it is acknowledged that there are uncertainties in extrapolating from animal models to humans and in addition some human diseases lack appropriate models.Epidemiological studies therefore are regarded as an important alternative source of information that may either support animal data based risk assessments or indicate potential concerns not previously identified. For this reason within the UK the epidemiological literature has for some time been routinely considered with the aim of identifying any emerging concerns. More recently EU data requirements for pesticides have been amended to require applicants to conduct literature searches and to formally evaluate relevant epidemiology data. An additional recent action by the EFSA has been the commissioning of a systematic review of pesticide epidemiology published 2006–2012.A large and growing database of epidemiology relating to pesticides exists. However, despite the regulatory efforts mentioned above the impact of such data on regulatory outcomes is negligible. Identification of specific pesticides and levels of exposure are often cited as significant limitations of studies. The regulatory requirements, limitations in the existing data, and suggestions for potential improvements will be discussed.

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