EFSA Offers Guidance on a Harmonised Framework for Pest Risk Assessment

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.

11 Feb 2010 --- The European Food Safety Authority (EFSA) requested the Panel on Plant Health 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 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 framework described addresses risks presented by non-indigenous living organisms harmful to plants and/or plant products that are associated with the movement of plants, plant products and other objects, and that may enter, establish, spread and cause harmful effects on plants and/or plant products and biodiversity. In fulfilling this mandate, the Panel reviewed the internationally recognised standards for pest risk analysis and compared the risk related terminology and the process with those of EFSA. Recognising the International Plant Protection Convention (IPPC) standards as the primary source of guidance, the Panel notes that the process, as outlined in the relevant international standards for phytosanitary measures (ISPM Nos 2, 5 and 11), engages both risk assessors and risk managers without specific differentiation of their roles and responsibilities in this process. The Panel therefore, after careful analysis has adapted the IPPC guidelines to the requirements of independent and transparent assessment of pest risk set out in Regulation (EC) No 178/2002. The principal differences between the EFSA framework for pest risk assessment and the identification and evaluation of pest risk management options and the IPPC standards on pest risk analysis are that EFSA does not describe the process as pest risk analysis and use the acronym PRA, assess economic impacts in monetary terms, assess the consequences for markets, employment or tourism, assess social impacts, evaluate the cost effectiveness of phytosanitary measures or evaluate the acceptability of risk.

The framework also recognises the “Guidelines on pest risk analysis – Decision-support scheme for quarantine pests” developed by the European and Mediterranean Plant Protection Organization (EPPO) as a possible option for conducting pest risk assessment and the identification and evaluation of pest risk management options. In the EFSA framework, the scheme developed by EPPO has been adapted for this purpose following the principles of independence and transparency.

As a result, the Panel has the following conclusions regarding the elements of the risk assessment process.
i. Assessment of introduction and spread of organisms harmful to plants and/or plant products
For the assessment of the entry, establishment and spread of harmful organisms both qualitative and quantitative approaches may be used, however, in most cases a qualitative approach is followed, that may include quantitative elements. The Panel proposes to use the EFSA-adapted EPPO scheme. Transparency requires that the scoring system to be used is described in advance, including the number of ratings, the description of each rating, the method for combining scores and the classification of final risk level. However, to include these elements in the scheme, there is a need for further development.

ii. Assessment of potential consequences associated with the introduction and spread of harmful organisms
Potential direct and indirect consequences of entry, establishment and spread of harmful organisms on all affected plant species as well as environmental consequences should be assessed. The Panel recognises that quantification of economic losses in monetary values or other related economic quantifications do not belong to its remit. Therefore, the Panel will not assess economic impacts in monetary terms, export markets, employment and tourism. Consequently these aspects are not included in the risk assessment scheme developed by the Panel.
 
iii. Incorporation of the risk components into the overall characterization of the risk of a plant pest
When only quantitative approaches are used in pest risk assessment, the overall risk may be obtained by computation. Risk matrices are frequently used by risk assessors for combining qualitative scores. Although risk matrices should be used with caution, recognising that the combination of qualitative scores is still an active area of research, the Panel proposes the use of this technique for combining qualitative scores.
 
iv. Assessment of the effect of risk management options on the level of risk
Upon request by the risk manager, the Panel can identify risk management options and/or evaluate the potential changes in risk resulting from different management options. Risk management options should be formulated in line with the considerations listed in ISPM No 11. Costs of risk management options are considered to be in the realm of risk management, i.e. the European Commission.

With quantitative risk assessment methods, the Panel proposes that methods be developed to ensure that the effectiveness of a risk management option is expressed as the expected change of each risk element, should the management option be applied. With qualitative risk assessment methods, the Panel recommends that methods be developed to ensure that effectiveness of a risk management option is expressed as the expected new score for each risk element, should the management option be applied.

The changes in uncertainty of each risk element, associated with the risk management option, should be assessed according to the methods proposed by the Panel for the analysis of uncertainty. The combination of several risk management options should be identified wherever possible.

v.Harmonised methodologies to allow for consistent characterization of risk and evaluation of pest risks
To ensure transparency in risk assessment, uncertainties should be identified, characterized and documented in the assessment process. Documentation of the areas and degree of uncertainty enables risk managers to take the level of uncertainty into account in the decision-making process. The assessment of the capability of the organism to enter, to establish, to spread, and of its impact is based on scientific data, as well as, in some cases, on model simulations (e.g. climate matching and epidemiological models). All these sources of information have uncertainties. The relative importance of these uncertainties and their influence on the assessment outcome should be described.

The Panel considers that uncertainty and sensitivity analysis should be performed for the pest risk assessment as a whole, in addition to the consideration of uncertainty for each question in the assessment scheme. The most appropriate techniques will depend on the risk assessment method implemented by the risk assessor, the number of uncertain factors and the computational time of the model.
 
vi.Definition of data requirements allowing for transparent assessment of pest risks
A risk assessment requires a comprehensive evaluation of the data considered and the experimental and/or environmental conditions under which the data were generated. The information required for pest risk assessment is outlined in the international standard ISPM No 11. Each step of the risk assessment process requires its own data input.

The Panel suggests that the phase of data collection, searching, documenting the results of data searches and their validation be recorded and included in the assessment itself. These should follow normal protocols of evidence-based methods.
 
The EFSA pest risk assessments should respect the EFSA fundamental principles as laid down in Regulation (EC) No 178/2002. The opinion produced by the Panel should be fully and systematically documented and communicated to the risk manager. Understanding any limitations that influenced the Panel’s final conclusion is essential for the transparency of the process.

The conduct of a pest risk assessment requires a team effort in which there is a need for communication with the risk manager. Even though the roles of the risk assessor and the risk manager are distinct, a close collaboration between the two is essential to optimise results.

The EFSA procedures for pest risk assessment and the identification and evaluation of risk management options in this document should be kept under review to take into account the experiences of the EFSA Plant Health Panel and development work funded by EFSA under Article 36 and by other organizations worldwide.