Action plan for improving the peer review process. European Food Safety Authority (EFSA)

Transcription

1 TECHNICAL REPORT APPROVED: 29 November 2017 doi: /sp.efsa.2017.en-1349 Action plan for improving the peer review process European Food Safety Authority (EFSA) Abstract This document reflects on the implementation of actions on improving the peer review process on pesticides active substances. The action points are the outcome of a dedicated workshop of the 20 th meeting of the EFSA Pesticide Steering Network (PSN) as well as proposals based on complementary interactions between EFSA, the European Commission (EC) and Member States (MS). The scope of the action plan covers all steps during the peer review process: preparation of the summary dossier by the applicant, preparation of the Draft/ Renewal Assessment Report (DAR/RAR), peer review and the finalisation of the EFSA conclusion. The aim of the actions for improving the peer review process is to enhance the overall quality of the process, to optimize different steps, to improve the efficiency and to facilitate the cooperation between EFSA and MS. European Food Safety Authority, 2017 Key words: pesticides, peer review process, Network on Pesticide Steering meeting Requestor: EFSA Question number: EFSA-Q Correspondence: pesticides.peerreview@efsa.europa.eu EFSA Supporting publication 2017:EN-1349

2 Suggested citation: EFSA (European Food Safety Authority), Action plan for improving the peer review process. EFSA supporting publication 2017:EN pp. doi: /sp.efsa.2017.en ISSN: European Food Safety Authority, 2017 Reproduction is authorised provided the source is acknowledged. 2 EFSA Supporting publication 2017:EN-1349

3 Summary During the 20 th meeting of the Network on Pesticide Steering (PSN) a workshop was held on how measures improving the peer review process can be implemented as well as improving the involvement and cooperation of EFSA and Member State (MS) experts. The workshop on improving the peer review process was initiated in the aftermath of discussions at the expert meetings and the Standing Committee on Plants, Animals, Food and Feed (PAFF). Concerns as the overall quality of the peer review process and the claim that MS views are inadequately presented within the EFSA conclusion have been addressed in the scope of the workshop and resulting action points. The preliminary action plan to improve the peer review process was presented to the MS during the 21 st PSN meeting. Aim of the preliminary action plan is to optimize the different steps and improving the efficiency in the peer review process as well as enhancing the cooperation with MS. The preliminary action plan also reflects on proposals, which were not directly discussed during the PSN workshop, but are based on complementary interactions between EFSA, the European Commission (EC) and MS. It has to be noted that the proposals focus on short-term solutions considering the current Regulations. The implementation has followed a stepwise approach, starting with identification of those actions that can be implemented immediately, without the need for additional resources or further consideration by risk managers in the PAFF Standing Committee. Outside of the scope of this action plan are actions which require changes in the current legislation. The action plan is related to the following parts of the peer review process: preparation of the summary dossier by the applicant, preparation of the Draft/ Renewal Assessment Report (DAR/RAR), EFSA peer review and the finalisation of the EFSA conclusion. This Technical Report is summarising the final agreed action plan. 3 EFSA Supporting publication 2017:EN-1349

4 Table of contents Abstract... 1 Summary Introduction Action points Actions related to general issues, the preparation of summary dossiers and the discussions between the (co-)rms and the applicant FAQ document E-consultation groups Ad-hoc working group (WG) on the accordance check Other actions without tangible outcome Actions related to the peer review Ad-hoc working group (WG) on the accordance check Yearly plan of substances Implementation of a new way of commenting Clarification of expectation from experts Other actions without tangible outcome Actions related to the finalisation of the EFSA conclusion Divergent views Addressing uncertainties Conclusions... 7 Abbreviations EFSA Supporting publication 2017:EN-1349

5 1. Introduction During the 20 th meeting of the Network on Pesticide Steering (PSN) 1 a workshop was held on how measures for improving the peer review process can be implemented as well as improving the involvement and cooperation of EFSA and Member State (MS) experts. The workshop on improving the peer review process was initiated in the aftermath of discussions at the expert meetings and the Standing Committee on Plants, Animals, Food and Feed (PAFF). Concerns as the overall quality of the peer review process and the claim that MS views are inadequately presented within the EFSA conclusion have been addressed in the scope of the workshop and resulting action points. The preliminary action plan to improve the peer review process was presented to the MS during the 21 st PSN meeting 2 and further discussed in the PSN teleconference This action plan is a summary of actions undertaken for improving the peer review process, for more details please refer to the minutes of the 20 th and 21 st minutes of the PSN as well of above mentioned PSN teleconference. Aim of the preliminary action plan is to optimize the different steps and improving the efficiency in the peer review process as well as enhancing the cooperation with MS. The preliminary action plan also reflects on proposals, which were not directly discussed during the PSN workshop, but are based on complementary interactions between EFSA, the European Commission (EC) and MS. It has to be noted that the proposals focus on short-term solutions considering the current Regulations. The implementation has followed a stepwise approach, starting with identification of those actions that can be implemented immediately, without the need for additional resources or further consideration by risk managers in the PAFF Standing Committee. Outside of the scope of this action plan are actions which require changes in the current legislation. The action plan is related to the following parts of the peer review process: preparation of the summary dossier by the applicant, preparation of the Draft/ Renewal Assessment Report (DAR/RAR), peer review and the finalisation of the EFSA conclusion. This Technical Report is summarising the final agreed action plan. 2. Action points 2.1. Actions related to general issues, the preparation of summary dossiers and the discussions between the (co-)rms and the applicant FAQ document EFSA prepared a Frequently Asked Questions (FAQ) document, which contains an inventory of questions received by MS/ Applicant(s) (APPL)/ other stakeholders during the pre-submission/rms assessment phase. This document with EFSA s responses is shared with MS on the EFSA documents management system (DMS) and is updated regularly when new questions are received E-consultation groups A first pilot e-consultation group on microorganisms used in plant protection products (PPP) was created on the EFSA document management system (DMS) in order to facilitate the exchange of information, expertise and experience among experts (MS experts, EFSA s PPR Panel and its working groups and EFSA experts) in the area of risk assessment of microorganisms. Further requests for new fora were received and related consultation spaces were created (e.g. forum on botanicals and plant extracts) EFSA Supporting publication 2017:EN-1349

6 Ad-hoc working group (WG) on the accordance check An ad-hoc WG on the accordance check with MS, ECHA and EFSA has been launched in order to introduce an accordance check of the summary dossier. Moreover, it is aimed to agree on EU wide criteria for what is considered a good quality summary dossier in order to ensure a sufficiently high level of details of the study summaries as well as to ensure compliance with the data requirements and testing strategies. This is a complementary advisory step to the completeness/admissibility check of the dossier undertaken by the RMS with the aim to give clear indications to the applicant on the level of information needed for the subsequent peer review Other actions without tangible outcome Involvement of the co-rms in the pre-submission discussions and sharing of minutes/documents, particularly in complex cases. EFSA hosts the relevant documents on the EFSA document management system (DMS) accessible to all MS. Possibility for RMS to request support/advice from EFSA when complex situations are faced in the pre submission and/or risk assessment phase. Identification of meaningful representative uses by the APPL at the pre-submission level. For renewals, it is recommended to perform a screening of all existing uses and discuss at the pre-submission meeting if the use proposed by the APPL for the renewal is really representing the authorized uses. Furthermore, the additional uses for MRL setting that will be presented by the APPL as part of the approval dossier, should also be defined as early as possible. Provision of a stand-alone summary dossier for renewals as previously submitted studies need to be updated and evaluated in order to reflect the current scientific state of the art. Need for CLH report preparation discussed and agreed between APPL and RMS at presubmission level. Dedicated peer review expert meetings organized by EFSA on general topics when issues for discussion are identified that have not yet been covered by previous discussions/consultations. Prioritization of proposals for guidance update and developments are continued to be discussed at PSN meetings with the involvement of the European Commission Actions related to the peer review Ad-hoc working group (WG) on the accordance check The recently launched ad-hoc WG on the accordance check mentioned above in will introduce, in analogy of the accordance check of the summary dossier, also an accordance check of the DAR/RAR. Similarly, it is aimed to agree on EU wide criteria for what is considered a good quality DAR/RAR in order to ensure a sufficiently high level of details of the study summaries as well as to ensure comprehensive and transparent evaluation and presentation of the data and to facilitate the peer review Yearly plan of substances A yearly plan of substances under peer review was prepared and is constantly being updated. MS identify substances on which they are planning to comment, considering factors such as availability of resources and interest. This table, which can be accessed through EFSA DMS, serves the purpose of planning and does not imply commitment. The possibility of involvement of additional external experts in the commenting is considered by EFSA on a case by case base and criteria for selection of those experts are documented transparently. This will be considered in particular when insufficient MS commenting is expected. Bimonthly reminders are sent by EFSA to RMS to update planning dates for DAR/RAR submission dates Implementation of a new way of commenting An excel template has been developed by EFSA in order to streamline the commenting during the different steps of the peer review. The new excel template is envisaged to replace the commenting 6 EFSA Supporting publication 2017:EN-1349

7 tables on DAR/RAR, the reporting table, the evaluation tables and the written procedure on additional information report. The aim of the new way of commenting is to increase efficiency and fit-forpurpose of the commenting phase. Comments are entered directly into the relevant section/ subsection of the template. Additional columns were added, allowing entering justifications, clarifications and proposals in the table. The following principles were agreed on when commenting: (i) avoidance of recurrent comments, which can be handled in general peer review meeting; (ii) clarification of expectations of comments and the likelihood of impact on the risk assessment; (iii) indication of possible solution on how to address the issue Clarification of expectation from experts To increase the efficiency in the peer review meetings active participation of MS experts is essential. In particular experts who were involved in the commenting phase are expected to attend EFSA peer review meetings and be involved in the commenting phase on the draft EFSA conclusion. The substances on the agenda for the peer review meeting are allocated to specific experts who are invited to submit written contributions in advance in order to support the RMS in the discussions. A document summarising the expectations from experts has been prepared by EFSA and is shared when the call for nomination of experts is launched Other actions without tangible outcome Extension of the timelines to three weeks for commenting during the written procedure on additional information by EFSA Involvement of the applicant on an ad-hoc basis as hearing expert in the pesticides peer review meetings via teleconference for specific discussion points in case RMS/EFSA identify issues that would benefit from clarifications by the applicant Dedicated peer review expert meetings are organized by EFSA when sufficient general/recurrent issues for discussion on chemicals or microorganisms are identified as different expertise is needed Foresee more time to discuss general issues, but still linked to practical examples, and establish general recommendations on microorganisms assessment. Identification of the most important data requirements for the risk assessment of microbial active substances are to be considered in these discussions Actions related to the finalisation of the EFSA conclusion Divergent views Divergent views expressed by the RMS and/or MS during the MS commenting on the draft EFSA conclusion and the reasoning for this divergence in scientific views are summarised in the body text of the EFSA Conclusion. Further details on the divergent views will be elaborated in the background documents, and the report of the expert meetings will clearly describe possible divergent views expressed during the meeting. Similarly, minority views are reported in the EFSA Conclusion and background documents Addressing uncertainties EFSA is addressing uncertainties, including contradictory evidence or lacking data, in the scientific risk assessment by demonstrating different outcomes/endpoints together with their associated uncertainties in the EFSA Conclusion. Risk assessments supporting different options should be carried out by the RMS allowing to reflect a transparent outcome in the Conclusion. 3. Conclusions The discussion on the action plan for improving the peer review process have started in June 2016 during the 20 th meeting of the PSN. Since then, actions points have been identified and implemented in a step-wise approach. This Technical Report is summarising the finally agreed action plan and demonstrates the implementation of respective actions points and their outcome. 7 EFSA Supporting publication 2017:EN-1349

8 The aim of the initiative to optimize the different steps, to improve the efficiency in the peer review process and to enhance the cooperation with MS has been reached by implementing the action points described above, covering all steps in the peer review process. The continued discussion and collaboration between EFSA and MS/(co)RMS may show other areas and needs of improvement which can be addressed continuously. EFSA welcomes suggestions and recommendations for improvement in order to facilitate the collaboration and future risk assessment of active substances. 8 EFSA Supporting publication 2017:EN-1349

9 Abbreviations APPL DAR DMS EC EFSA FAQ MS PAFF PPP PSN RAR RMS WG Applicant Draft Assessment Report Document management system European Commission European Food Safety Authority Frequently asked questions Member States Standing Committee on Plants, Animals, Food and Feed Plant protection product Network on Pesticide Steering Renewal Assessment Report Rapporteur Member State Working group 9 EFSA Supporting publication 2017:EN-1349