Scientific Opinion, EFSA Panel on Plant Health (PLH)
The Scientific Panel on Plant Health was requested by EFSA to develop a guidance document on a harmonised framework for risk assessment of organisms harmful to plants and plant products and the identification and evaluation of risk management options. The document provides guiding principles on assessment practices and approaches when assessing risks to plant health to support the decision-making process under Council Directive 2000/29/EC. The framework aims at implementing the fundamental principles of risk assessment as laid down in Regulation (EC) No 178/2002, most importantly the independence and transparency of risk assessments carried out by EFSA. The document discusses the main issues of the pest risk assessment process: terminology, data requirements and data-related uncertainties. Furthermore, the document provides a framework for pest risk assessment and evaluation of pest risk management options. For the assessment of entry, establishment and spread of pests; both qualitative and quantitative approaches are recommended. An EFSA-adapted EPPO scheme is proposed should a qualitative approach be followed. The assessment of potential consequences of pest introduction and spread considers direct and indirect effects on all affected plant species as well as on the environment. The assessment of economic impacts falls outside the remit of EFSA. For the characterization of the overall risk, the use of risk matrices is proposed to combine qualitative scores. Upon request by the risk manager, risk management options may be identified. Potential changes in risk level resulting from different management options may also be assessed. Uncertainty and sensitivity analysis should be performed for the whole assessment process. For transparency reasons, the process of data collection should be recorded and included in the assessment. Principal requirements for the documentation of the pest risk assessment process are also discussed.