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

摘要

The European Food Safety Authority (EFSA) requested the Panel on Plant Health (PLH Panel) to provide\udguidance for the evaluation of the effectiveness of the options for plants and plant products for reducing the risk\udof introduction and spread of harmful organisms in the European Union territory. Two operational tools are\udpresented: a checklist for evaluating a proposed risk reduction option (RRO) and a database of references\udcorresponding to published guidance documents or experimental assessments of RROs. The checklist can be\udused by the Panel or the dossier-submitting parties to verify whether all required information is provided in\udsupport of a RRO, to quickly describe information supplied to EFSA and to identify major gaps in the data. Four\udtypes of RRO assessments are distinguished in the proposed checklist according to their purposes and\udcharacteristics: experimental assessment of the effectiveness of the option to reduce pest infestation in plant\udmaterial/products under laboratory/controlled conditions; experimental assessment of the effectiveness of the\udoption to reduce pest infestation in plant material/products under operational conditions; analysis of the\udapplicability of the RRO; and assessment of the effectiveness of the option to reduce the risk of pest entry from\udan infested area to a pest-free area. The database of references is intended to assist the Panel in (i) identifying\udpotential 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.