| Module 11 Risk Analysis and IPPCR. Griffin Plant Production and Protection Division |
To provide an overview and introduction to the concept and practice of phytosanitary risk analysis as it has developed and is currently described by the International Plant Protection Convention (IPPC).
11.1 Introduction
11.2 SPS-IPPC relationships in risk analysis
11.3 Risk Assessment - Risk Analysis - Pest Risk Analysis (PRA)
11.4 PRA and the process for the establishment of phytosanitary measures
11.5 Decision-making
11.6 Resources and cooperation
11.7 Linkages
11.8 Benefits of PRA
11.9 Conclusion
Risk assessment required for phytosanitary measures
A fundamental tenet of the SPS Agreement is that measures for the protection of plant, animal, or human health or life are based on international standards or an assessment of risk taking into account scientific principles and evidence. This is found in Article 2 (Basic Rights and Obligations) and is the subject of Article 5 (Assessment of Risk and Determination of the Appropriate Level of Sanitary or Phytosanitary Protection). The concept also has close linkages to other principles and terms in the SPS Agreement as well as in the IPPC and associated standards.
Article 5:1 of the SPS Agreement states that WTO Members shall ensure that phytosanitary measures are based on an assessment of risk. The agreement defines risk assessment as:
The evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences; or the evaluation of the potential adverse effects on human or animal health arising from the presence of additives, contaminants, toxins, or disease-causing organisms in food, beverages or foodstuffs. (Annex A)
The IPPC uses slightly different terminology in the New Revised Text of the IPPC and associated standards to reflect the same concept and obligations. Two terms that are particularly important are found in Article II (Use of terms) in the New Revised Text:
Technically justified - justified on the basis of conclusions reached by using an appropriate pest risk analysis or, where applicable, another comparable examination and evaluation of available scientific information.
Pest risk analysis - the process of evaluating biological or other scientific evidence to determine whether a pest should be regulated and the strength of any phytosanitary measures to be taken against it.
Both the SPS Agreement and the IPPC emphasize a systematic process for gathering, evaluating and documenting scientific and other information as the basis for SPS measures affecting trade. This involves consideration of economic as well as biological aspects of pest risk for animal and plant health. However, it should be noted that the SPS does not indicate that economic factors are to be considered directly in risk assessments for human health.
Standards embody internationally-agreed risk assessment
The SPS Agreement states that a risk assessment is not required where measures are based on international standards. This is because the risk basis for the standard is already internationally agreed. However, deviations from standards must be justified by a risk assessment (Article 3). Provisional measures may be put in place without the benefit of a standard or a complete risk assessment and such measures may deviate from standards but they must have a reasonable scientific basis and must be reviewed using risk assessment when more complete information is available (Article 5:7). Further, jurisprudence on SPS disputes indicates that governments have an obligation to actively pursue the information needed to complete a risk assessment for provisional measures.
Standards also lay down good risk assessment practice
These requirements of the SPS Agreement create a direct relationship between risk assessment and international standards that are established by the relevant international organizations. Part of this relationship involves the presence or absence of standards. Where standards do not exist or are deemed inappropriate, risk assessment is needed to provide the justification for measures. Another part of the relationship involves the standards developed for performing risk assessment. In both cases, the standard setting organizations play a significant role in providing governments with the means to justify their SPS measures.
The IPPC is recognized by the SPS Agreement as the reference point for phytosanitary standards. Although pursuing an ambitious programme of standard setting to meet the expectations of the SPS Agreement, the IPPC has only a short history of standard setting. To date, most of the effort devoted to standards by the IPPC has been directed toward establishing a foundation of concept standards from which more specific standards may be later developed. However, at this early stage in phytosanitary standard setting, there are not yet specific standards that can form the basis for measures in lieu of risk assessment. Therefore, where phytosanitary measures are concerned, WTO Member governments must base their decisions on risk assessments. This means that the process used for phytosanitary risk assessment becomes extremely important to all countries.
IPPC PRA Guidelines
An important characteristic of the relationship between the IPPC and the SPS Agreement regards the scientific basis for measures. Recognizing the significance of this linkage, governments adhering to the IPPC have encouraged the development of standards for risk analysis as a priority. Guidelines for Pest Risk Analysis (ISPM No. 2) was adopted by the IPPC in 1995 and currently serves as the primary conceptual and procedural reference for phytosanitary risk analyses. This standard provides basic background regarding the application of the concept of risk analysis for phytosanitary purposes and it outlines a three-stage process for the conduct of risk analysis. ISPM No. 2 is now widely used by national plant protection organizations throughout the world as a reference outline for phytosanitary risk analysis.
IPPC specific standard for quarantine pests
Immediately following the establishment of ISPM No. 2, the IPPC began the development of detailed standards directed specifically to risk analysis for quarantine pests and regulated non-quarantine pests, with the highest priority being given to a standard for quarantine pests. This work has progressed with significant expert input and evolution over several years. A draft standard titled Pest Risk Analysis (PRA) for Quarantine Pests is nearly completed. The standard provides substantially more detailed guidance than ISPM No. 2 and will be extremely useful for developing countries that frequently express concern about not having the resources to develop their own detailed procedures.
Risk assessment one of two steps in risk analysis...
The term used in the IPPC to identify risk analysis for phytosanitary purposes is "Pest Risk Analysis" or PRA. The SPS Agreement does not refer to PRA or to risk analysis, but uses the term "risk assessment". The term "risk assessment" is used by the IPPC and the other standard setting organizations identified in the SPS Agreement (OIE1 and Codex) to describe a process contained within risk analysis; i.e. the characterization of risk based on an evaluation of the evidence to estimate the likelihood and consequences of an adverse event. In the case of plant protection, the "adverse event" is normally the introduction or spread of a harmful pest.
...the other being risk management
Risk assessment is a key element of risk analysis as it is described by the IPPC, OIE and Codex for the evaluation of risks associated with the protection of plant, animal and human health respectively. The other key element that is common to risk analysis for all three disciplines is "risk management". In this context, risk management refers to the analytical process used to identify risk mitigation options and evaluate these for efficacy, feasibility and impacts in order to decide or recommend the most appropriate means to mitigate risks that are found to be unacceptable as a result of risk assessment. The SPS Agreement does not refer to risk management per se, although the concept is implicit in that the theme of the Agreement is "measures" which result from risk-based decisions.
Other elements in risk analysis
Other elements commonly identified in risk analysis processes may vary. For instance, "risk communication" is sometimes distinguished as a separate element (e.g. see Module III.10) or other times may be addressed less directly as a factor to be emphasized throughout the process. Elements of transparency, such as documentation and uncertainty, are also sometimes given the status of distinct elements in risk analysis processes. The label and level of recognition given to these points in any particular process may change for various reasons. The primary reason is that each of the disciplines covered by the SPS Agreement (plant, animal, and human health) has its own unique characteristics, history and usage of terms.
Although the mix of terms and emphasis may seem to complicate the meaning and role of risk analysis in the SPS Agreement, there exists in practice very strong consistency in the understanding and use of the concepts represented by the terms. To this end, the IPPC strives to encourage this consistency across disciplines and promote harmonization in the interpretation and application of risk analysis concepts within the global phytosanitary community.
The core elements of PRA are risk assessment and risk management. These elements have a directly dependent relationship and are distinctly analytical in nature. In addition, risk assessment and risk management are associated with other procedures and activities needed for the establishment of phytosanitary measures. Some of these may be considered to be closely related enough to the analytical process to be part of PRA, while other procedures are clearly non-analytical but are nonetheless part of the process for the establishment of phytosanitary measures. This point is demonstrated with risk management.
As described above, the analytical sense of risk management involves identifying and evaluating options for the mitigation of risk. However, risk management in a broader context also involves decision-making and the implementation (or operational aspects) of the decisions and systems that reduce the risk in practice. The concept is also commonly extended to include the evaluation of measures that are in place to determine their appropriateness and the adjustments that may be made as a result. Based on this example, it is clear that the establishment of phytosanitary measures involves procedures that are analytical in nature as well as decisions or other activities that are operational. For IPPC purposes, those procedures that are closely related to the core analytical processes of risk assessment and risk management are included within PRA. These elements are briefly described in the following summary.
Hazard identification
Initiation. This involves defining the hazards by identifying the pest(s) and conditions, which are of concern and should be considered for risk analysis. Three points for initiation are:
The results of initiation are clearly identified pests and conditions (hazards) which become the focus for risk assessment.
Characteriz-ation of risk as acceptable or unacceptable
Risk assessment. This begins by first determining which pests to assess and then evaluating these pests for the likelihood and consequences of their introduction and/or spread. Risk assessment is composed of two distinct procedures:
Risk assessment results in characterization of the risk and conclusions regarding whether the risk is acceptable or requires mitigation. Unacceptable risks are those that exceed the appropriate level of protection for the country in question. Each government has the sovereign right to establish its own appropriate level of protection.
Evaluating risk management options for unacceptable risks
Risk Management. This involves identifying options available for reducing the risk and evaluating these for their suitability. Risk management procedures include:
Risk management results in a summary of options including recommendations for the selection of preferred options.
It is important to note that the PRA process is not linear. In particular, the evaluation of risk mitigation options for efficacy requires the use of risk assessment to determine the degree to which options reduce the risk. A baseline level of risk is established from risk assessment for the unmitigated condition. In risk management, this is compared to the mitigated situations in order to measure the efficacy of specific options.
Other elements of PRA do not fit sequentially in the process. These include uncertainty, documentation, and communication. Each of these elements has significant roles throughout the process.
Estimating the degree of uncertainty
Uncertainty. Uncertainty is a key aspect of risk. Likewise, a PRA is not complete unless it has identified and expressed the uncertainty associated with the assessment of risk and the options for risk mitigation. Uncertainty may be due to information gaps or variation in the available information.
The primary purpose in identifying and communicating uncertainty is to provide the decision-maker with as complete and objective a view of the risk as possible. Carefully noting and considering uncertainty in PRA also helps governments to identify priority research needs and highlights for trading partners the points where the provision of more or better information may improve a decision.
Transparency and consultation
Documentation and communication. Throughout the PRA process it is essential to ensure adequate documentation and communication. The process should be sufficiently documented so that the sources of information and rationale used in arriving at conclusions and recommendations are clear if reviewed at a later date or needed for a dispute.
Proper risk communication requires the two-way exchange of information. Information concerning the analyses, particularly results, is communicated to interested or impacted parties. Likewise, relevant information is also solicited and considered. This is often accomplished through an official comment process.
Factors when implementing risk management measures
The decision to select and apply a measure is often not considered to be part of the analytical process, particularly where decisions are taken in other offices or levels of government distinctly separate from the technical analysis procedures of PRA. Where this is a factor, it is particularly important to ensure that PRAs are complete and communicate the essential points that a non-technical person needs to understand. Decision-makers also need to take account of the relevant principles and obligations under the IPPC and the SPS Agreement, including:
Acquiring information
The level of resources devoted to PRA depends on many diverse factors and is not limited to resources provided by the national plant protection organization. The government assumes the responsibility for any decisions based on PRA but, in principle, anyone including private interests and trading partners may perform the PRA.
The most important resources needed for PRA are information, methods and experience. In the vast majority of cases, PRA is a relatively simple and straightforward process that follows a systematic approach to decision-making including basic documentation regarding the process and information. Methods and experience are gained with time and through ongoing efforts to improve PRA. However, the gathering of relevant information normally requires more time and effort than any other aspect of PRA.
One source of information for PRA is the scientific literature. The Internet has proven to be a significant aid to all countries trying to obtain information for PRA from experts and literature. Other sources are scientific journals and publications to the extent that these may be available. Scientific inputs may also be provided through direct communication with researchers and credible sources having firsthand experience or observations.
An extremely important source of information for PRA is official lists, reports and responses from the national plant protection organization in the country of origin. The exchange of information through official IPPC contact points is particularly useful for the verification of pest status and indications of the risk management measures that may be used or available. In instances where such information is requested for PRA, it is essential that officials receiving the request make a reasonable effort to obtain the needed information and respond in a timely manner. Where it is not possible to provide the requested information, the government should be open to provision for such information collection as may be provided through other means.
Bringing expertise to bear
Risk analysis is central to the linkage of key players in the establishment of phytosanitary measures. The national plant protection organization uses PRA to establish the technical basis for regulations. This is highly dependent on scientific inputs from the research community as well as official information from trading partners. Likewise, the private sector (industry, trade, etc.) may be important in providing information, proposing risk management options, and/or judging the feasibility of options suggested for implementation. Finally, it must be stressed that decision-makers are bound by the obligations of their country to ensure that their decisions are in conformity with the provisions of the SPS Agreement and the IPPC, i.e. based on an evaluation of the risks using scientific principles and evidence.
Benefits of a codified procedure
Aside from being a necessary step in the establishment of phytosanitary measures, PRA also provides substantial benefits that make it a truly essential tool for the implementation of phytosanitary systems.
PRA can be used to:
The same rules apply to all
If the decision to apply an SPS measure is not based on risk, then what is it based on?
If the risk-basis for a decision does not rely on scientific evidence and principles, then what can be its basis?
In any instance where the answers to these questions might indicate that measures are not based on risk and decisions are not based on scientific principles and evidence, the question becomes whether the government wishes to have other criteria for the implementation of SPS measures and accepts that these criteria may be used as the basis for measures against it as well.
In this context, it becomes clear that PRA is not only a central feature for fair trade, but also for safe trade.
______________________________
1 Office International des Epizooties.
