EPPO Expert Working Group for the extrapolation database

 

Composition (last updated September 2024)

 

 

Terms of Reference (as agreed by the Executive Committee in 2020)

Introduction

Since 2007 EPPO has developed extrapolation tables to be used in conjunction with EPPO Standard PP 1/257 Efficacy and crop safety extrapolations for minor uses and these are publicly available on the EPPO Website [now in the form of a database]. The 82 published extrapolation tables provide detailed lists of acceptable extrapolations organized by crop or pest groups for regulatory authorities and applicants in the context of the registration of plant protection products (PPP) for minor uses. Most of the tables are ‘specific’ for a crop group and a number of generic tables (i.e. those covering pests or diseases which affect several crops or crop groups) have been developed. Most of them present extrapolation possibilities for the evaluation of the effectiveness of PPP and 17 are for crop safety (mostly for herbicides). The work for fungicide and insecticide tables has been carried out by an ad hoc Expert Working Group which met from 2012 to 2016, under the supervision of the EPPO Panel on Efficacy Evaluation of Fungicides and Insecticides. The work for herbicide tables was carried out by the EPPO Panel on Efficacy Evaluation of Herbicides and PGRs.

 

The EPPO Working Party on PPP acknowledged that the set of tables is now finalized and no new extrapolation tables have been proposed by the members of the EPPO Panels on efficacy evaluation so far. As the tables are sometimes difficult to interpret and use, the Working Party noted that a searchable database to retrieve the extrapolation possibilities for minor uses reported in the tables would be very useful and that possibilities for creating this database should be explored. The creation of a database will make the information more accessible and will create an opportunity to improve the use of acceptable extrapolation possibilities proposed in the current tables and ensure their consistency.

 

Discussions have been carried out between EPPO and the Minor Uses Coordination Facility (MUCF) for a possible joint project for the database development. To achieve its own objectives the MUCF intends to extend the database to extrapolation possibilities for residue data for minor uses. While developing the database it will be taken into account that the extrapolation possibilities for residues and efficacy/crop safety are different. For residues, for example, extrapolation possibilities only relate to crops, whereas for efficacy they are related to a combination of pests and crops. In addition, for efficacy and residues there are different crop grouping systems.

 

One of the challenges which need to be highlighted is that there is no harmonized definition of a minor/major crop; different organizations and countries have different definitions based on different criteria (this applies both to residues and efficacy). The MUCF has initiated some work on harmonizing the minor crop status.

 

Members of the EPPO efficacy Panels as well as the EPPO Working Party on Panel Protection Products highlighted the importance of considering possibilities for extrapolations for major uses. Several national or regional guidelines exist for major extrapolations (e.g. SANCO 2005, PP 1/95 Slugs etc., EU north zone or national guidelines). Consideration for major uses extrapolation should however not delay the development of the database on minor uses efficacy extrapolation.

 

Scope

The Expert Working Group will assist for the creation and development of a searchable database to retrieve extrapolation possibilities for efficacy. The Database will first be populated with the information already available in the published EPPO tables for efficacy and crop safety. Major uses extrapolation will also be considered and, if possible, proposed. The EWG will not be dealing with the section for residue data in the database and the Expert Working Group will not be involved in the technical development of the database. The EWG will work under the supervision of the EPPO Panel on General Standards for Efficacy Evaluation. Support from the EPPO Panel on Efficacy Evaluation of Fungicides and Insecticides and the Panel on Efficacy Evaluation of Herbicides and PGRs will be solicited to validate new extrapolation possibilities. The Working Party on PPP will be informed about and approve the possible improvement in the content of the extrapolation tables for minor uses and the possible addition of extrapolation possibilities for major uses.

 

Tasks

• The following tasks need to be carried out to develop the extrapolation database. The list comprises tasks related to the development of the database as well as tasks related to the improvement of the information available on published extrapolation tables in order to adapt to the database structure and requirements:
• Validate the prototype for a database that will be developed by the EPPO Secretariat,
• Cross check all tables (specific and generic) to ensure consistency and verify that extrapolation possibilities presented in one table are cross referenced in all other relevant tables,
• Ensure consistency between the crop groups agreed in the Harmonized Classification of EPPO Codes to describe PPP uses and those used in the extrapolation tables,
• Include all existing extrapolation possibilities in the database,
• Explore the possibilities to apply the same approach developed for minor uses for major uses as well, when possible and approved, include them in the database. The EWG will consider whether new tables need to be developed, or existing tables be updated for extrapolation for major crops before these are added to the database,
• Assist the EPPO Secretariat in finding ways to track versions of the extrapolation database, so that the version in effect at the time of a PPP application can be retrieved if necessary.

 

Membership of the Expert Working Group

Members of the EPPO ad hoc Expert Working Group for extrapolation tables which met from 2012 to 2016 will be contacted to be part of the EWG that will develop the database. A new Call for nominations will also be launched for the EPPO member countries. Representative(s) of the MUCF will be invited to join the EWG. The expertise of the group should be representative for the EPPO region and for the different types of products. The EPPO Secretariat can also invite, on an ad hoc basis, experts from NPPOs or experts from institutions outside the NPPOs (including experts from the MUCF Commodity Expert Groups) when specific expertise is needed. The efficacy EPPO Panels will be informed that the EWG is being revived and might propose experts to join the Group.

 

Timing of meetings

Two face-to-face meetings per year and additional teleconferences, as needed, might be envisaged in the early stage of database development. The first meeting is envisaged to be held before the end of 2020. Work will continue through e-mail consultation in between meetings. Each face-to-face meeting will last two days maximum. Meetings will continue to be organized until a stable version of the database is available and all information in the published EPPO extrapolation tables is entered in the database.

 

Outcome

The database will contain all information already available in the published EPPO tables for efficacy and crop safety for minor uses and will be comprise fields such as ‘pests’ or ‘pest groups’, ‘indicator crops’, ‘extrapolation to other crops’ (or ‘crop groups’), extrapolation with reduced data or with no data, etc. The output of a search should be presented in a format similar to the existing tables, if possible. However, as it has been noted that the current tables are difficult to interpret the output in the database could be reconsidered and presented in a more user-friendly format. The database will also indicate when there are no extrapolation possibilities, so that the user will know the situation for the crop and/or pest concerned. Additionally, the database may be extended to major crops extrapolations.

 

The access to the database will be open but fees for access might be considered in a similar way as is done for the EPPO Database on PP1 Standards. The likely users of the database are relevant government bodies, efficacy evaluators, and industry (applicants and minor uses advisors) in the context of the registration of PPP.

 

If tables are modified, an archived version of the modified extrapolation possibility is made available to allow users to recover its status at a particular time.

 

References

CRD (GB) Extrapolations for cereals in ‘CRD Efficacy Guideline 407: cereals and maize pests’ https://www.hse.gov.uk/pesticides/resources/G/g407.pdf

CRD (GB) Extrapolations for oilseed rape in ‘CRD Efficacy Guideline 405 Data requirements for oilseed rape and vegetable brassicas pests, diseases and weeds’ at https://www.hse.gov.uk/pesticides/resources/G/g405.pdf

CTBG (NL) Plant Protection Products Efficacy Document - Extrapolation tables: https://english.ctgb.nl/plant-protection/documents/assessment-framework-ppp/2020/04/01/content-8.-efficacy-nl-part-em2020-2

EPPO Document 19-24855 WP-PPP on Consideration of some major use extrapolations via an EPPO Expert Working Group 

EPPO Extrapolation Tables (to be used in conjunction with EPPO Standard PP 1/257 Efficacy and crop safety extrapolations for minor uses). /RESOURCES/eppo_databases/extrapolation_database

SANCO Document (SANCO/D3/S12.395857, October 2005) ‘Proposal for extending and harmonizing efficacy and crop safety extrapolations to reduce the need for efficacy trials on minor crops, October 2005. In the document there are also extrapolations for ‘major crops’.

SANCO (SANCO 7525/VI/95, Rev. 10.1, 01 December 2015) Document Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs - especially Table 1 to 4 are relevant.