EFSA cross-cutting guidance lifecycle. European Food Safety Authority (EFSA), Daniela Maurici, Raquel Garcia Matas, Andrea Gervelmeyer

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1 TECHNICAL REPORT APPROVED: 29 June 2018 doi: /sp.efsa.2018.en-1446 Abstract EFSA cross-cutting guidance lifecycle European Food Safety Authority (EFSA), Daniela Maurici, Raquel Garcia Matas, Andrea Gervelmeyer This document describes the lifecycle of cross-cutting guidance documents in EFSA. Cross-cutting guidance documents deal with matters of a horizontal nature in fields that affect scientific areas covered by more than one Panel. The main objective of developing cross-cutting guidance documents is to harmonise food and feed safety risk assessment in EFSA. The document outlines the procedures for the identification of needs for cross-cutting guidance documents, their development, implementation, their review and revision. European Food Safety Authority, 2018 Key words: cross-cutting, guidance, public consultation, implementation Requestor: EFSA Question number: EFSA-Q Correspondence: sc.secretariat@efsa.europa.eu EFSA Supporting publication 2018:EN-1446

2 Acknowledgements: EFSA wishes to thank the Scientific Committee for the comments provided on the draft document. Suggested citation: EFSA (European Food Safety Authority), Maurici D, Garcia Matas R and Gervelmeyer A, EFSA cross-cutting guidance lifecycle. EFSA supporting publication 2018:EN pp. doi: /sp.efsa.2018.en-1446 ISSN: European Food Safety Authority, 2018 Reproduction is authorised provided the source is acknowledged. 2 EFSA Supporting publication 2018:EN-1446

3 Table of contents Abstract Introduction Identification of guidance needs Developing a guidance document Implementation of a guidance document Activities for implementing the guidance Dissemination and Communication Capacity building Post-adoption monitoring of the implementation of guidance documents Review and possible revision of guidance documents Conclusions and recommendations... 8 References EFSA Supporting publication 2018:EN-1446

4 1. Introduction EFSA publishes guidance documents which explain the principles behind EFSA s procedures and approaches to scientific assessments to risk assessors, risk managers and/or applicants of dossiers submitted for evaluation. This includes risk assessment methodologies. Guidance documents may also specify the information and data which industry must provide when submitting applications for preauthorisation evaluation by EFSA. Others explain the scientific guiding principles on best practices for the monitoring, reporting and analysis of data related to food and feed safety and animal or plant health to Member States. The current document describes the lifecycle of guidance documents in EFSA. It outlines the procedures for the identification of needs for guidance documents, their development, implementation, their review and revision (Figure 1). The scope of this document is limited to cross-cutting guidance documents. These guidance documents deal with matters of a horizontal and cross-cutting nature in fields where European Union (EU)-wide approaches are not already defined and affecting scientific areas covered by more than one Panel. The main objective of developing cross-cutting guidance documents is to harmonise food and feed safety risk assessment in EFSA. They are developed mainly by EFSA Scientific Committee (SC) and by EFSA s Assessment and Methodological Support Unit, occasionally also by the Evidence Management Unit Sectoral guidance documents explain the principles and approaches to scientific assessments applying to scientific areas covered by specific Panels and are developed by them. The lifecycle of a sectoral guidance document is similar to that of cross-cutting guidance, but differs in as far as their development is mostly triggered by requests from the European Commission. Sectoral guidance documents are not subject of this document. However, they can benefit from the principles set forth in this report for the implementation and review phases. There are also cases, where a guidance developed by one Panel can be endorsed by other Panels, if the approach is also applicable to their scientific area. Guidance documents addressing complex issues that span the sectors covered by different EU agencies require a multi-competence approach. For these, inter-institutional guidance documents are developed jointly by the concerned EU agencies. Their development is mostly triggered by requests from the European Commission. Inter-institutional guidance documents are not subject of this document. 4 EFSA Supporting publication 2018:EN-1446

5 Figure 1: The phases of the guidance lifecycle 2. Identification of guidance needs Several mechanisms are in place to map the needs of the Scientific Panels/SC and EFSA in terms of guidance documents. In particular, for horizontal guidance related to methodologies for risk assessment, the SC has a role in identifying priority areas for cross-cutting guidance development. The EFSA Founding Regulation 178/2002 defines the scope and responsibility of the Scientific Committee, whose role is the general coordination for consistency of working procedures and harmonisation of working methodologies. It is therefore its task to identify gaps and needs for crosscutting guidance development based on their expertise and the presented information and analysis. After the identification of the gaps and the needs of cross-cutting guidance, a tentative prioritisation is done on the basis of the criteria that are defined in the SC guidance on the review, revision and development of cross-cutting guidance document (EFSA, 2015). Prioritisation criteria for guidance development include, but are not limited to: the degree of impact of the proposed guidance on the scientific assessments; improving the consistency in the way scientific assessment is carried out by the EFSA Panels; the number of EFSA Panels for which the guidance is relevant. Additional mechanisms are in place, such as consulting EFSA units and governance structures on the needs for new cross-cutting guidance. Also the Advisory Forum and the Stakeholder Forum provide strategic input to future priorities for guidance development. 3. Developing a guidance document Once the need for a guidance document has been identified and included in the work programme, a scoping document is developed by EFSA, usually with the assistance of some Scientific Committee members. That document explains the motivation for developing the guidance by providing a highlevel description of the current situation and how it impacts on EFSA. Further, it describes the 5 EFSA Supporting publication 2018:EN-1446

6 intended deliverables, their implementation, the resulting outcomes, and an analysis of the risks that could jeopardize their achievement, including mitigation actions. The strategic alignment, potential efficiency gains and how the guidance will impact the work of the different Panels and of EFSA, as well as its connections with other EFSA guidance documents are outlined. It also considers which Panels would be concerned. The draft scoping document is submitted to relevant stakeholders (e.g. DG SANTE) for collecting inputs. When dealing with complex or emerging scientific issues, a public consultation of the draft scoping document may be launched. In doing this, EFSA strives to engage with its stakeholders and capture societal needs and expectations at an early stage of the development of the guidance, and tries to ensure that relevant knowledge on different types of approaches and information existing outside EFSA is identified for developing the guidance. Based on the outcome of the consultation of the draft scoping document, EFSA with the assistance of some experts, will either revise the terms of reference (where relevant) and proceed with the development of the guidance, or decide not to continue with the guidance development. In case the guidance development is postponed or stopped, the reasoned decision is recorded in a central project repository, together with the draft scoping document. Where appropriate, the explanation as to why a scoping document does not progress to final guidance will also be made public (EFSA, 2018b). The terms of reference (ToR) and a detailed action plan for the development of a guidance document, including milestones and estimated resources as well as the expected benefits, are described in a charter document. Guidance development follows the rules and procedures outlined in the relevant EFSA Standard Operating Procedures and considering the relevant existing cross-cutting guidance documents. It is important to carefully consider and clearly state in the guidance document the obligation for the target audience, i.e. EFSA Panels or other relevant bodies, to apply the guidance (EFSA, 2015). The expertise available in the Scientific Committee/Panels and in EFSA can be augmented with additional experts through the establishment of an ad-hoc Working Group (WG). It is important that the expertise gathered in the WG covers the areas of all Panels that will be concerned by the guidance, and that throughout the development phase, regular updates on the progress made are provided to these Panels by their Chairs to assure that the final deliverable suits their needs and adequately supports their scientific assessments. In developing the guidance, the WG considers the need for case studies illustrating how it could be applied in the different areas concerned. Before its finalisation, comments on the draft guidance are gathered from EFSA Panels and staff. Further, the draft guidance document is subjected to a public or targeted consultation to collect external input on its clarity, completeness and applicability (EFSA, 2018b). In addition, for guidance documents on complex methodologies/approaches a piloting phase should be considered before adoption of the guidance. During this piloting phase, the endorsed guidance is tested by concerned Panels in their risk assessments and their feedback is gathered and considered when finalising the guidance after the piloting phase. The document is then submitted to the EFSA Scientific Committee for adoption or endorsement as applicable. The implementation is agreed with EFSA management. 4. Implementation of a guidance document For each Guidance document, an implementation plan is agreed with EFSA management, where needed in consultation with the EC. Unless specified otherwise in the implementation plan, a cross-cutting guidance document has to be applied to all new risk assessment projects that start 6 months after its publication and the completion of the dissemination, communication and capacity building activities. 6 EFSA Supporting publication 2018:EN-1446

7 In cases where the new guidance is very complex and/or has a high impact on risk assessment procedures, the implementation plan can foresee a gradual application of the guidance by the Scientific Panels over a certain period, but not exceeding one year. Guidance documents should be implemented in a harmonised manner across EFSA Panels. Where appropriate, this could lead to relevant approaches being incorporated in area-specific guidance documents. EFSA Panels and Units must ensure that their existing approaches are in line with the unconditional requirements of the new guidance document. Member States and applicants submitting dossiers should also take into account the guidance document. Consequent to an analysis of how much support Panels need to implement the new approach in the all relevant EFSA outputs, the implementation plan also describes the targeted activities to be executed for each guidance document. These activities as well as the necessary resources have to be reflected in the charter document Activities for implementing the guidance EFSA aims at fostering the harmonised implementation of new risk assessment methodologies through a range of activities. These focus on dissemination, communication and on the development of new capabilities in the EFSA risk assessment community Dissemination and Communication After its adoption by the SC or endorsement by EFSA, as part of the normal out roll procedure, the guidance document, usually accompanied by brief news, is published on EFSA s web page. EFSA disseminates the web link to the cross-cutting guidance documents directly to all Panels and EFSA scientific staff. EFSA also ensures that the guidance documents are included in the organisation s document management system, accessible on a dedicated space on EFSA s website, and efficiently retrievable from a central EFSA repository. This is enabled by clearly classifying cross-cutting guidance documents as such. The guidance documents are effectively managed throughout their entire life cycle by controlling their status and versioning. Information sessions are organised for EFSA Panel members and for EFSA staff to create awareness and understanding of the approaches of the new guidance document. Tailor-made presentations of the guidance at Panel plenary meeting are carried out upon request in order to improve the understanding of the applicability of the guidance in the specific area covered by the respective Panel. The EFSA Stakeholder Engagement Approach 1 clarifies the tools available to interact with key stakeholders, and at which moment of the guidance development. These tools include technical meetings and/or webinars for institutional and civil stakeholders (e.g. applicants) that may be organised by EFSA as an opportunity to introduce the new guidance and also to discuss a number of issues on which further clarification may be needed Capacity building Depending on the guidance document, specific capacity building activities are organised for Panel members, Working Group members and EFSA staff to improve their understanding and application of the guidance document. (i) Training sessions Short training sessions are developed by the EFSA staff and/or external experts involved in the drafting of the guidance. EFSA also organises advanced trainings on specific approaches to risk assessment. These are be organised as training sessions applicable to all EFSA Panels and scientific staff or as Panel-specific training sessions EFSA Supporting publication 2018:EN-1446

8 Other training modalities, such as webinars and E-learning, can also be used. (ii) Support For new approaches that require in-depths support, a standing working group can be established to support Panels and Working Groups in applying the approaches of the guidance documents in their scientific outputs, and to develop Panel-specific explanations in how to apply the guidance in their area. Selected EFSA staff is trained to support Panels in applying the approaches of the guidance documents in their scientific outputs Post-adoption monitoring of the implementation of guidance documents In accordance with its policy on quality and as part of its quality management system, EFSA monitors, with a range of different activities and tools (e.g. surveys), the implementation of guidance documents with the aim of identifying any issue regarding their use. In circumstances where a guidance document has not been applied in an EFSA scientific assessment, the appropriate justification needs to be provided. The outcome of this monitoring is used to improve the implementation activities and to inform the review process. Regular feedback on the impact of applying the guidance needs to be collected and lessons learnt during the implementation are gathered in this process. This is in line with the EFSA Scientific Committee recommendation to implement its cross-cutting guidance documents through communication, presentation and monitoring in order to increase the awareness, uptake and consistent use by EFSA s Panels and Units as relevant (EFSA, 2013, 2015, 2017). 5. Review and possible revision of guidance documents Cross-cutting guidance documents are reviewed regularly, at least once in a given mandate period of the Scientific Committee/ Panels, i.e. every three years, to identify if they need updating or are considered obsolete. In case no revision is needed the guidance remains applicable as is. Reasons that lead to the need to revise cross-cutting guidance documents can be the availability of new relevant, reliable and consistent scientific information/insights, the publication of new legal documents impacting several EFSA Scientific Panels, or requests from the European Commission or Member States. In addition, the identification of mistakes or ambiguities that directly influence the outcome of the scientific assessments, or result in different interpretations of the guidance by different Panels should trigger a revision. Criteria for prioritising the guidance documents that should be revised have been proposed by the Scientific Committee (EFSA, 2015). As the revision of a guidance document can lead to a major modification of an existing methodology, an analysis of the impact of the new or modified assessment methodology on already adopted scientific assessments should be carried out, to evaluate the need for and extent of updating past assessments and to schedule the work plan. This impact assessment should be discussed with the relevant Scientific Panels, EFSA management, risk managers and stakeholders (EFSA, 2017). 6. Conclusions and recommendations This document provides an overview of the EFSA cross-cutting guidance lifecycle. Specific considerations for some of the key steps in the guidance lifecycle are further detailed in supporting documents in order to make sure that the process is fully implemented and followed at corporate level. Inter-institutional guidance documents are needed to adequately address cross-sectorial issues that require a multi-competence approach. A process for how to develop such guidance documents should be agreed between EFSA and the relevant EU agencies, e.g. EMA, ECHA, ECDC, and EEA, considering the view of the relevant Commission services. 8 EFSA Supporting publication 2018:EN-1446

9 References EFSA Scientific Committee, Scientific Opinion: Guidance on the review, revision and development of EFSA s Cross-cutting Guidance Documents. EFSA Journal 2015; 13(4):4080, 11 pp. doi: /j.efsa EFSA Scientific Committee, Scientific opinion on priority topics for the development of risk assessment guidance by EFSA s Scientific Committee in EFSA Journal 2016;14(6): 4502, 9 pp. doi: /j.efsa EFSA Scientific Committee, Hardy A, Benford D, Halldorsson T, Jeger MJ, Knutsen KH, More S, Mortensen A, Naegeli H, Noteborn H, Ockleford C, Ricci A, Rychen G, Schlatter JR, Silano V, Solecki R, Turck D, Brock T, Chesson A, Karenlampi S, Lambre C, Sanz Y, Goumperis T, Kleiner J and Maurici D, Scientific opinion on scientific motivations and criteria to consider updating EFSA scientific assessments. EFSA Journal 2017;15(3):4737, 11 pp. doi: /j.efsa EFSA (European Food Safety Authority), 2018b. Guidelines on EFSA Consultations. EFSA supporting publication 2018: EN pp. doi: /sp.efsa.2018.en-1390 ISSN: EFSA Supporting publication 2018:EN-1446