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Implementation of PROMETHEUS 4‐step approach for evidence use in EFSA scientific assessments: benefits, issues, needs and solutions

2018; European Food Safety Authority; Volume: 15; Issue: 4 Linguagem: Inglês

10.2903/sp.efsa.2018.en-1395

2397-8325

Elisa Aiassa, Laura Martino, Fulvio Barizzone, Laura Ciccolallo, Ana Caroline Falcão Garcia, Marios Georgiadis, Irene Muñoz Guajardo, Daniela Tomčíková, Jan Alexander, Paolo Calistri, Ursula Gundert‐Remy, Andrew Hart, L.A.P. Hoogenboom, Antoine Messéan, Androniki Naska, María Navajas Navarro, Birgit Noerrung, Colin Ockleford, Robert John Wallace, Maged Younes, Blaize Abuntori, Fernando Álvarez, Monica Aryeetey, Francesca Baldinelli, Federica Barrucci, Andrea Baù, Marco Binaglia, Alessandro Broglia, Anna Federica Castoldi, Eugen H. Christoph, Agnès de Sesmaisons‐Lecarré, Nikolaos Georgiadis, Andrea Gervelmeyer, Frédérique Istace, Gloria López‐Gálvez, Paola Manini, Daniela Maurici, Caroline Merten, Winy Messens, Olaf Mosbach‐Schulz, Claudio Putzu, Luisa Ramos Bordajandi, Camilla Smeraldi, Manuela Tiramani, Silvia Valtueña Martínez, Vos Sybren, Amy Hardy, Marta Hugas, Juliane Kleiner, Guilhem De Seze, Hans Verhagen, Didier Verloo,

Pesticide Residue Analysis and Safety

In 2014, the European Food Safety Authority (EFSA) started the PROMETHEUS (PROmoting METHods for Evidence Use in Scientific assessments) project to improve further and increase the consistency of the methods it uses in its scientific assessments. The project defined a set of principles for the scientific assessment process and a 4-step approach (plan/carry out/verify/report) for their fulfilment, which was tested in ten case studies, one from each EFSA panel. The present report describes the benefits, issues, needs and solutions related to the implementation of the 4-step approach in EFSA, identified in a dedicated workshop in October 2017. The key benefits of the approach, which was deemed applicable to all types of EFSA scientific assessment including assessments of regulated products, are: 1) increased ‘scientific value’ of EFSA outputs, i.e. the extent of impartiality, methodological rigour, transparency and engagement; 2) guarantee of fitness-for-purpose, as it implies tailoring the methods to the specificities of each assessment; 3) efficiency gain, since preparing a protocol for the assessment upfront helps more streamlined processes throughout the implementation phase; 4) innovation, as the approach promotes the pioneering practice of ‘planning before doing’ (well established in primary research) for broad scientific assessments in regulatory science; and 5) increased harmonisation and consistency of EFSA assessments. The 4-step approach was also considered an effective system for detecting additional methodological and/or expertise needs and a useful basis for further defining a quality management system for EFSA's scientific processes. The identified issues and solutions related to the implementation of the approach are: a) lack of engagement and need for effective communication on benefits and added value; b) need for further advances especially in the field of problem formulation/protocol development, evidence appraisal and evidence integration; c) need for specialised expertise in the previous aspects; and specific needs for d) assessments of regulated products and e) outsourced projects.