Scientific Opinion on good modelling practice in the context of mechanistic effect models for risk assessment of plant protection products

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Article
Panel on Plant Protection Products and their Residues
EFSA Journal
EFSA Journal 2014;12(3):3589 [92 pp.].
doi
10.2903/j.efsa.2014.3589
Panel Members
Alf Aagaard, Theo Brock, Ettore Capri, Sabine Duquesne, Metka Filipic, Antonio F. Hernandez-Jerez, Karen I. Hirsch-Ernst, Susanne Hougaard Bennekou, Michael Klein, Thomas Kuhl, Ryszard Laskowski, Matthias Liess, Alberto Mantovani, Colin Ockleford, Bernadette Ossendorp, Daniel Pickford, Robert Smith, Paulo Sousa, Ingvar Sundh, Aaldrik Tiktak, Ton Van Der Linden
Acknowledgements

: The Panel wishes to thank the members of the Working Group on good modelling practice: Virginie Ducrot, Sabine Duquesne, Mira Kattwinkel, Matthias Liess, Alberto Mantovani, Melissa Reed, Richard Sibly, Robert Smith, Aaldrik Tiktak, Christopher John Topping for the preparatory work on this scientific opinion and EFSA staff Franz Streissl for the support provided to this scientific opinion.

Type
Opinion of the Scientific Committee/Scientific Panel
On request from
EFSA
Question Number
EFSA-Q-2011-00989
Adopted
13 February 2014
Published in the EFSA Journal
7 March 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

The Panel has interpreted the Terms of Reference as a stepwise analysis of issues relevant to both the development and the evaluation of models to assess ecological effects of pesticides. The regulatory model should be selected or developed to address the relevant specific protection goal. The basis of good modelling practice must be the knowledge of relevant processes and the availability of data of sufficient quality. The opinion identifies several critical steps in order to set models within risk assessment, namely: problem formulation, considering the specific protection goals for the taxa or functional groups of concern; model domain of applicability, which drives the species and scenarios to model; species (and life stage) selection, considering relevant life history traits and toxicological/toxicokinetics characteristics of the pesticide; selection of the environmental scenario, which is defined by a combination of abiotic, biotic and agronomic parameters to provide a realistic worst-case situation. Model development should follow the modelling cycle, in which every step has to be fully documented: (i) problem definition; (ii) model formulation, i.e. design of a conceptual model; (iii) model formalisation, in which variables and parameters are linked together into mathematical equations or algorithms; (iv) model implementation, in which a computer code is produced and verified; (v) model setup, including sensitivity analysis, uncertainty analysis and comparison with observed data, that delivers the regulatory model; (vi) prior to actual use in risk assessment, the regulatory model should be evaluated for relevance to the specific protection goals; (vii) feedback from risk assessor with possible recommendations for model improvement. Model evaluation by regulatory authorities should consider each step of the modelling cycle: the opinion identifies points of particular attention for the use of mechanistic effect models in pesticide risk assessment. It is recommended that models be documented in a complete and transparent way, that a feedback platform be established involving risk assessors and model developers, and that a set of agreed models be made available.

Keywords
model evaluation, model documentation, effect modelling, environmental scenarios, environmental pesticide risk assessment
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Number of Pages
92