EPPO Workshop on Zonal Efficacy Assessments
In the framework of the new EC Regulation 1107/2009 (replacing 91/414/EEC), mutual recognition and zonal authorizations are core principles of dossier submission for the authorization of plant protection products. Many of the technical details for conducting zonal authorizations still needed to be addressed, agreed and harmonized among EPPO member countries. To address these issues, an EPPO Workshop was proposed.
Although the outcomes of this Workshop are directly relevant to EU Member States, it is acknowledged that the principles defined for zonal evaluation may be used by other EPPO countries wishing to adopt the zonal concept for the authorization of plant protection products.
At the kind invitation of the German Federal Ministry of Food, Agriculture and Consumer Protection an ad hoc EPPO Workshop on Zonal Efficacy Assessments took place at the Julius Kühn Institute Berlin-Dahlem on 2011-04-05/06. Thanks are due to the Julius Kühn Institute Braunschweig and Berlin-Dahlem, for excellent organization of this meeting.
A total of 88 participants (majority being officials from the national regulatory authorities) from 24 EPPO countries (AT, BE, BG, CZ, DK, FI, FR, DE, GR, HU, LV, LT, NL, NO, PL, PT, RO, RS, SK, SI, SE, CH, TR, GB), representatives of crop protection companies, ECPA (European Crop Protection Association) and the European Commission, met to consider various aspects of the zonal efficacy assessment situation in the EPPO region.
The Workshop was organized as a series of lecture sessions, smaller working group tasks and plenary discussion sessions.
- Welcome address - Peter Zwerger (JKI, Braunschweig, DE)
- Summary of the zonal requirements of the Regulation 1107/2009 to gain a shared understanding of the relevant processes - Ton Rotteveel (European Commission)
- EPPO standards and Zonal Authorizations - David Richardson (Independent Expert)
- ECPA view on zonal authorizations - Euros Jones (ECPA)
- Presentation of the position of the northern zone - Per Kudsk (Aarhus University, DK)
Introductory lectures were followed by presentations of four target scenarios, followed by discussions aiming to define common principles:
- Colorado beetle – Udo Heimbach (DE)
- Aphids on stone fruit – Martin Hommes (DE)
- Cereal disease for the central zone – Barbara Meijkamp (NL)
- Apera spica-venti in winter cereals – Ingrid den Hoed (GB)
In the afternoon of the first day, the workshop split into four Working Groups to address four different, realistic datasets (scenarios):
a. Fungicide (potato, phytophthora/alternaria) - Chair: Lise Nistrup-Jorgensen, Rapporteur: Andy Leadbeater
b. Insecticide (Cydia pomonella codling moth) - Chair: Claudia Jilesen, Rapporteur: Chris Longhurst
c. Herbicide (maize, grass and broad leaf herbicide) - Chair: Per Kudsk, Rapporteur: Beth Hall
d. Seed treatments (wireworms) - Chair: Udo Heimbach, Rapporteur: Patrice Duvert
These working groups discussed the following issues:
- Number and location of trials for a zonal submission
- Dealing with agronomic and target pest variation within a zone and between zones
- National requirements/ core dossier requirements
- Minimum effective dose
- Major and minor crops/uses (including data requirements in a zone)
- Use of extra-zonal data
- Adjacent and succeeding crops
On the second day, the workshop addressed issues relating to zonal dRR (draft Registration Reports) and BAD (Biological Assessment Dossier). The discussion was opened by the following three presentations:
- Guidance document on zonal assessment of efficacy - Laurent Thibault (ANSES, FR)
- UK comments on draft guidance documentation, and future development - Sue Mattock (CRD, GB)
- Format and content of Biological Dossier - Patrice Duvert (ECPA)
Workshop conclusions and recommendations
The final workshop conclusions and recommendations were collated after working group and plenary discussion.
Ad hoc meeting of the EPPO Panel on General Standards on Efficacy Evaluation
The workshop was immediately followed by an ad hoc meeting of the Panel on General Standards on Efficacy Evaluation. The meeting was convened to elaborate and organize the post-workshop action plan and to assign tasks accordingly: see Appendices to Workshop conclusions and recommendations above.
New draft EPPO Standard: Principles of zonal data production and evaluation
Following the input collected at the EPPO Workshop on Zonal Efficacy Assessments, EPPO has worked with its technical experts to develop a new draft Standard. This has ‘working document’ status, which means that it can be modified and new comments can also be proposed. Meanwhile, the draft will be reviewed by EPPO technical Panels and subject to country consultation. For further information see the EPPO approval procedure.
The EPPO Secretariat wishes to thank all participants and particularly the Julius Kühn Institute Berlin-Dahlem (host) and JKI-Braunschweig (local organizer). Special thanks are also due to the Workshop presenters, organizers, Chairs and Rapporteurs for their input (in alphabetical order):
Ringols Amitis (EPPO)
Patrice Duvert (ECPA)
Beth Hall (ECPA)
Udo Heimbach (JKI, DE)
Martin Hommes (JKI, DE)
Claudia Jilesen (PPS, NL)
Euros Jones (ECPA)
Per Kudsk (University of Aarhus, DK)
Andy Leadbeater (ECPA)
Chris Longhurst (ECPA)
Sue Mattock (CRD, GB)
Barbara Meijkamp (PPS, NL)
Lise Nistrup-Jorgensen (University of Aarhus, DK)
David Richardson (Independent Expert)
Anton Rotteveel (European Commission)
Robert Sunley (EPPO)
Laurent Thibault (ANSES, FR)
Vlasta Zlof (EPPO)
Peter Zwerger (JKI, DE)