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Integration of epidemiological findings with mechanistic evidence in regulatory pesticide risk assessment: EFSA experiences

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Abstract

Toxicological risk assessment of plant protection products (PPP) is currently carried out with the principal input from regulatory toxicology studies following OECD test guidelines, with little input from epidemiological data. An EFSA-commissioned systematic review of pesticide epidemiological studies (Ntzani et al. in Literature review on epidemiological studies linking exposure to pesticides and health effects. EFSA supporting publication 2013:EN-497, 2013) revealed statistically significant associations, among others, between pesticide exposures, and Parkinson’s disease and childhood leukemia. Thereafter, EFSA launched a project with a mandate for the plant protection products and their residues (PPR) Panel to set the ground for the use of epidemiological data in the risk assessment of pesticides, as requested by Regulation (EC) 1107/2009. The project culminated with the publication of two EFSA’s scientific opinions on the potential contribution of experimental investigations and epidemiological studies in PPP risk assessment and with the scientific conference held on 20 November 2017, in Parma, Italy. The application of modern methodologies in exposure assessment, toxicology and epidemiology would improve the pesticide risk assessment process and support a mechanistic shift for the integration of these three disciplines under a novel paradigm in risk assessment. The application of the adverse outcome pathway (AOP) conceptual framework to this approach would contribute to gain insight into the biological plausibility of a hazard identified in epidemiological or experimental studies and would inform an Integrated Approach to Testing and Assessment (IATA) within a regulatory context.

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Notes

  1. 1.

    https://www.aghealth.nih.gov.

  2. 2.

    https://agricoh.iarc.fr.

  3. 3.

    Adverse outcome pathway knowledge base (AOP-KB): http://aopkb.org/ and AOP-wiki: https://aopwiki.org/.

  4. 4.

    https://echa.europa.eu/documents/10162/23715527/msc-57_minutes_en.pdf/11f11007-1814-48fc-5818-775f9e12e8ec.

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Correspondence to Olavi Pelkonen.

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Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

This report is based on plenary talks and extensive discussions at the EFSA Scientific conference on the use of epidemiological findings in regulatory pesticide risk assessment on 21 November, 2017, in Parma, Italy. The speakers were Federica Crivellente (EFSA), Susanne Hougaard Bennekou (Danish EPA, EFSA PPR Panel), Bette Meek (University of Ottawa), Antonio Hernandez Jerez (University of Granada, EFSA PPR Panel), David Miller (US-EPA), Karin Angeli (ANSES), Laura Beane Freeman (US NCI), Judy Lakind (LaKind Associates), Marie-Odile Rambourg (ANSES), Manolis Kogevinas (ISGlobal), Carol Burns (ECPA), and Martin Dermine (PAN Europe). The speakers and discussants are thanked for their contributions during the meeting; however, report authors are responsible for views and recommendations expressed in this report (see the EFSA site: https://www.efsa.europa.eu/en/events/event/171121-0).

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Pelkonen, O., Bennekou, S.H., Crivellente, F. et al. Integration of epidemiological findings with mechanistic evidence in regulatory pesticide risk assessment: EFSA experiences. Arch Toxicol 93, 1779–1788 (2019). https://doi.org/10.1007/s00204-019-02467-w

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Keywords

  • Plant protection products
  • Pesticides
  • Risk assessment
  • Epidemiology
  • Adverse outcome pathway (AOP)
  • Exposure
  • Integrated Approach to Testing and Assessment (IATA)