Guidance on methodology for evaluation of the effectiveness of options for reducing the risk of introduction and spread of organisms harmful to plant health in the EU territory

The European Food Safety Authority (EFSA) requested the Panel on Plant Health (PLH Panel) to provide guidance for the evaluation of the effectiveness of the options for plants and plant products for reducing the risk of introduction and spread of harmful organisms in the European Union territory. Two operational tools are presented: a checklist for evaluating a proposed risk reduction option (RRO) and a database of references corresponding to published guidance documents or experimental assessments of RROs. The checklist can be used by the Panel or the dossier-submitting parties to verify whether all required information is provided in support of a RRO, to quickly describe information supplied to EFSA and to identify major gaps in the data. Four types of RRO assessments are distinguished in the proposed checklist according to their purposes and characteristics: experimental assessment of the effectiveness of the option to reduce pest infestation in plant material/products under laboratory/controlled conditions; experimental assessment of the effectiveness of the option to reduce pest infestation in plant material/products under operational conditions; analysis of the applicability of the RRO; and assessment of the effectiveness of the option to reduce the risk of pest entry from an infested area to a pest-free area. The database of references is intended to assist the Panel in (i) identifying potential RROs for a given pest and plant material, and (ii) quickly retrieving relevant experimental data and guidance documents for assessing a proposed RRO. In addition, the current document provides recommendations for assessing RROs, specifically: on experimental design; on the use of statistical methods including approaches for studying uncertainty; on the use of quantitative pathway analysis and spread models describing their advantages and limitations; and on recommendations for general surveillance and specific surveys.