EPPO Standards for efficacy evaluation of plant protection products

General introduction

Background

In 1977, the European and Mediterranean Plant Protection Organization (EPPO) began publishing Guidelines for the efficacy evaluation of plant protection products . The main purpose of the Guidelines was to harmonize the process of efficacy evaluation within the registration procedure of EPPO member countries by describing how field trials should be conducted in order to test the efficacy of plant protection products being proposed for registration. EPPO Council recommends to its Member Governments that plant protection products registered for use in their countries should previously be tested for efficacy in order that such products (as potentially harmful chemicals) should not be used unless there is a positive benefit in terms of the control of plant pests or other plant protection purposes; the Guidelines are the regional standards recommended by the Council of EPPO for this evaluation. They are thus directed at the registration authority of each country which may either use the Guidelines directly to perform their own product testing, or indicate to the applicant the methods that must be applied to achieve registration. An important secondary goal is the possibility that efficacy data generated in one country using the EPPO methods may be acceptable for the registration purposes in other countries.
The General Guidelines of FAO concerning 'Efficacy Data for the Registration of Pesticides for Plant Protection' (FAO, 1989) are considered by the EPPO Working Party on Plant Protection Products as the basic background document for the format of the EPPO Guidelines. The FAO Guidelines were produced by the FAO Panel of Experts on Pesticides Specifications, Registration Requirements and Application Standards, and include details on the purpose of the Guidelines within countries, and on the exchange of efficacy data between countries. In general, each EPPO Guideline gives the minimum requirements for a field trial on a specific crop-pest combination, though many Guidelines cover groups of pests and/or groups of crops if these share common characteristics relevant to efficacy testing. In addition to these specific crop/pest Guidelines, the series of Guidelines also includes a number of general Guidelines covering topics of common relevance to efficacy testing (i.e. phytotoxicity assessment, design and analysis of trials, conduct and reporting of trials, and assessing effects on succeeding crops). Also in the series are a number of Guidelines covering testing methods for evaluating the effects of plant protection products on honey bees and other beneficial organisms that may be employed in integrated pest management programmes (i.e. Encarsia formosa, Trichogramma cacoeciae, Phytoseiulus persimilis).
The Guidelines first appeared as numbered sets of leaflets in separate English and French versions but since 1984, they have been published bilingually in Bulletin OEPP/EPPO Bulletin. The concept of numbered sets of Guidelines was discontinued in 1988 and individually numbered Guidelines were thereafter published in Bulletin OEPP/EPPO Bulletin as and when they were completed; these latter Guidelines also appeared as off-printed leaflets to be added to the previous sets. The Guidelines were later re-classified as a single set of EPPO Regional Standards. The present numbering system retains the original sequence number and now also indicates that each is an EPPO Standard on Plant Protection Products (PP) in series no. 1, Standards on efficacy evaluation (e.g. PP 1/25).
In 1997, after more than 20 years of work on the preparation of these Standards, EPPO decided that the Standards should be gathered together and published in one complete set (of four volumes). In addition, this publication provided the opportunity to revise the older Standards in order to bring them all to the same modern format. This revision did not change any of the technical details, but harmonized aspects of format in the sections of text common to all Standards. In 2004, a 2nd edition (in five volumes) was published and included in addition several new Standards of the type "General standards for efficacy evaluation of plant protection products". Paper brochures containing standards approved during the year were published as updates to this new edition in the period 2004-2007.
The programme of development and revision of the Standards continues within the EPPO technical bodies concerned, and the new and revised Standards produced will continue to be published in Bulletin OEPP/EPPO Bulletin.
From 2008, it was decided that Standards will be available from the EPPO website in a searchable database. New and revised Standards will be posted on the website every year.

Procedure for preparation and approval of Standards

Technical bodies involved in the procedure

The Standard programme is carried out by three elements within EPPO: (1) the Working Party on Plant Protection Products – a decision-making body to which all EPPO Member Governments may send representatives and on which ECPA is permanently represented; (2) Panels on efficacy evaluation of specific groups of plant protection products composed of specialists selected by the Working Party in consultation with the governments concerned; (3) the Secretariat of EPPO. The Panels are: the Panel on Efficacy Evaluation of Fungicides and Insecticides (which also deals with miscellaneous other products such as acaricides and bactericides); the Panel on Efficacy Evaluation of Herbicides and Plant Growth Regulators; the Panel on Rodent Control (rodenticides), and the Panel on General Standards on Plant Protection Products.
The Working Party decides the programme of work and approves the finalized Standards. It directs the Panels specifically to prepare draft Standards. The Secretariat services both Working Party and Panel meetings and has the responsibility to incorporate the changes proposed during the consultative phases of the procedure. The task of preparing efficacy evaluation Standards is only one of several areas of work for the Working Party, but is the principal task of the Panels. From 2008 the Panels have also been developing extrapolations tables linked to EPPO Standard PP 1/257 Efficacy and crop safety extrapolations for minor uses.

Details of the procedure

The procedure followed for an individual Standard has been summarized in Fig. 1. Very briefly, this procedure, which applies to all EPPO regional standards, may be stated as follows: the Panels draft Standards which are submitted to all Member Governments in a consultative phase. The Secretariat of EPPO redrafts the Standards in consequence, for final approval by the Working Party, which then submits them to the Executive Committee and Council of EPPO to be accepted and recommended to all Member Governments. Note that Standards considered by the Working Party to be in need of revision or updating, enter the same sequence of consideration, beginning with expert Panel review and finalized by approval at EPPO Council. 
In summary, the Working Party decides the Standard format and establishes general policies for Standard preparation (sequence, level of detail, etc.). The Working Party having decided that a certain Standard should be prepared, actions the Secretariat to prepare a first draft in the standard format; the source may be a national standard or a draft specifically prepared by a Panel member or by the Secretariat. This first draft is examined in detail by the appropriate Panel whose members may consult with any appropriate specialists. The Panel may be able to finalize its approved version of the draft at one meeting, or this operation may extend over two or more meetings, with appropriate consultations. When the Panel has agreed its version, the Secretariat submits it to all Member Governments for comment and criticism. Up to this stage, the draft is worked on entirely in English but, on submission to the Member Governments, a French version is also prepared.
In the consultative phase, specialists in the NPPOs of the Member Governments consider the Standards and send any comments and criticisms to the Secretariat, which adjusts the text accordingly. The Secretariat is not obliged to make changes to take account of a comment, but it generally attempts to do so since the objective is to make the Standards clearly acceptable to all Member Governments. If the comments are at variance with the Working Party's general policies, the change will generally not be made, but the point will be raised as appropriate at the next Working Party meeting. Comments of a very substantial or technical nature may lead the Secretariat to decide that a Standard requires more work at Panel level.
The adjusted Standard text then goes to the Working Party for approval. If the changes made are not acceptable to the Working Party, the Standard is sent back to whatever step in the procedure the Working Party considers appropriate.
Standards approved by the Working Party are then proposed to the Executive Committee and Council of EPPO for final approval. Passage through these two bodies in succession is prescribed by the Convention and Rules of Procedure of the Organization, and the respect of these rules ensures that every possibility is given for Member Governments to register their comments or criticisms. Although, in theory, the decisions of the Executive Committee and Council are by simple majority vote, decisions on EPPO Standards are taken by consensus. In other words, objection by a single country is considered a sufficient basis for sending the Standard concerned back to the Working Party. In this case, Council might decide upon special procedures for approval of this Standard.

Fig. 1. Pathway for the development of an EPPO Standard