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Problem Formulation for EFSA Scientific Assessments

on the Wiley Online Library


Disclaimer: The present document has been produced and adopted by the bodies identified above as authors. This task has been carried out exclusively by the authors in the context of a contract between the European Food Safety Authority and the authors, awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.


This report addresses the problem formulation step of scientific assessments to support the European Food Safety Authority (EFSA) in the development of guidance. The current report is comprised of a review of published literature on approaches for problem formulation, an environmental scan of two years of scientific assessments published in the EFSA Journal, classification of each publication as to its questions and sub‐questions, and a proposed framework and drafted handbook of recommendations to guide problem formulation. Over 700 EFSA publications were reviewed to identify scientific assessment activities, questions, and sub‐questions. A framework was developed to: 1) translate the mandate into assessment questions; 2) define the sub‐questions of each assessment and their relationship, optionally including a conceptual model; and 3) select the approach to take in designing the methods of the protocol for the assessment. The framework and guidance for problem formulation describe the role of literature scans, question formulation, relationships among sub‐questions, and screening and prioritizing sub‐questions. The report includes proposed cross‐cutting language with a common set of terms to promote understanding and application across diverse EFSA domains. For question formulation, the acronym APRIO was proposed, referring to A(gent), P(athway), R(eceptor), I(ntervention), and O(utput) as variously essential elements of all EFSA questions and sub‐questions.

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