International Cooperation in Risk Analysis and Development of Regulations

David McNamara

Toward the end of the nineteenth century, countries started to establish phytosanitary regulations to protect their crops by limiting the introduction or spread of exotic plant pests. In order to decide on appropriate measures, it was necessary first to designate which pests were to be excluded and then to design measures that would ensure that they were not carried on imported commodities. In other words, they needed to analyze the risks associated with different commodities from different origins. The only way to do this was to consult an expert, or preferably several experts, on plant pests and to accept their opinions on which pests were likely to be important and what measures might be appropriate. This early form of pest risk analysis continued in most countries until approximately 10 to 15 years ago. The disadvantage of this system was that nobody, apart from the expert or group of experts, knew precisely how the decision on each case had been reached, or on what information it had been based, with the consequence that if there was a need to review a particular case there was no record for re-evaluation. If the original experts were not available, then the re-evaluation might be performed with different information and different criteria of evaluation. Furthermore, if a particular expert happened to have personal prejudices (e.g., believing that the organism which he/she specialized in was much more important than others), this would tend to strongly influence the expert opinion. Although in the vast majority of cases where phytosanitary measures were taken to protect against particular pests, the risk justified taking measures and the measures were justified by the risk, there were certainly instances in the regulations of many countries where it would be difficult to justify taking any measures at all (either because the pest for which the measures were taken did not present a realistic risk or because the measures taken were not appropriate to the risk). It is not surprising that the suspicion arose that certain measures were only put in place to hinder a particular trade that was undesirable for some economic or political reasons.

Pressure from the World Trade Organization (WTO), in particular, changed this. In 1994, the countries of the WTO signed the Sanitary and Phytosanitary Agreement (http://www.wto.org/
english/tratop_e/sps_e/sps_e.htm), which had the express purpose of preventing the use of sanitary or phytosanitary measures as disguised restrictions on international trade. This agreement (commonly known as the SPS Agreement) established that, with regard specifically to phytosanitary matters, countries have the right to take phytosanitary measures necessary for the protection of plant life or health. But any phytosanitary measure should be applied only to the extent necessary to protect plant life or health and should be based on scientific principles. In order to fulfil these requirements, countries should ensure that their phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to plant life or health, taking into account risk assessment techniques developed by the relevant international organizations. In fact, when this agreement was signed, there were no "risk assessment techniques developed by the relevant international organizations"; there were no international standards for this purpose that countries could refer to, and, furthermore, there was no relevant international organization active in the area of developing global standards. (Regional plant protection organizations, such as EPPO, the European and Mediterranean Plant Protection Organization (www.eppo.org), had already developed regional standards, but these could not be applied according to the SPS Agreement by countries elsewhere.) As a consequence of the signing of the SPS Agreement, the Secretariat of the International Plant Protection Convention (IPPC) (http://www.fao.org/ag/agp/agpp/pq/default.htm) became active and began a dynamic program of developing global standards 
(see paper by R. Griffin).

The second International Standard for Phytosanitary Measures produced by the Secretariat of the International Plant Protection Convention was that on Guidelines for Pest Risk Analysis (http://www.fao.org/ag/agp/agpp/pq/En/Publ/Ispm/ispm2e.pdf), which presented the essential elements of PRA. But within a short time after its appearance, it was recognized that these guidelines did not provide sufficient detail, particularly of the biological aspects of pest entry and establishment nor the economic considerations of potential pest effects, to allow countries to perform PRA with the confidence that they were adequately following a standard. A more detailed version was planned and an international working group was set up, comprising six PRA experts from different parts of the world. It was originally planned that there would be four separate subsidiary standards on the following different elements of PRA:

• pest categorization - the initial screening of a pest to determine if it has all the necessary characteristics to be a quarantine pest, in order to avoid the unnecessary performance of a detailed PRA

• assessment of probability of introduction

• assessment of potential economic impact

• risk management - evaluating phytosanitary measures that could be applied if the pest were declared a quarantine pest

but it was later decided that the product of the working group should be a single standard as the revised version of the original, which should be entitled "PRA for Quarantine Pests."

Before an International Standard for Phytosanitary Measures can be approved, it must be acceptable to the IPPC Interim Standards Committee and then be sent to all countries that are members of FAO (i.e., virtually all countries of the world) to ask for their expert opinions on the content. Thereafter, the revised version must receive final approval from the Interim Commission on Phytosanitary Measures. In the case of the standard on PRA for Quarantine Pests, it has taken several years to pass through this consultative process, and this in fact, at the time of writing, it has not yet been finally approved (although it may be so by the time this Workshop takes place).

There are two main reasons why this standard on PRA has taken such a long time to be approved. It is, first of all, a very complex subject with a lot of biological, economic, and administrative detail. There are, consequently, many points of detail that can be discussed and disputed. In particular, there is a major difference in the way countries in different parts of the world conduct PRA, based on their phytosanitary strategy. Some countries have a “closed” system of phytosanitary regulations in which all imports are prohibited until they have been specifically evaluated and permitted; such countries perform PRA on every commodity from every source that has been proposed for import. Other countries use a more “open” system, according to which all imports are permitted unless their regulations specify that the particular commodity from a certain source is prohibited or subject to specific requirements; these countries perform PRA on pests (irrespective of their origin and the commodity on which they might be carried) in order to establish which pests are undesirable and list them in their regulations. It has proved difficult to take account of these two different philosophies at every point in the standard.

Secondly, PRA is not just an essential tool for phytosanitary protection; it also imposes obligations on countries to justify their phytosanitary regulations according to an apparently complex procedure. There is, therefore, a desire by many countries to reduce their commitments in this respect. Indeed, many countries doubt that they have the capacity to perform PRA in all its complexity.

While waiting for the international standard on PRA to become approved, EPPO, the regional plant protection organization for Europe and the Mediterranean region, decided to prepare its own regional standards on PRA, in order to provide the technical capability to its member countries to evaluate risk from exotic pests and to take appropriate action. A number of separate regional standards on PRA have been produced by EPPO, including decision-making schemes on pest risk assessment (http://www.eppo.org/QUARANTINE/PRA/prassess_intro.html) and on pest risk management. These schemes are based closely on the content of the International Standard on Phytosanitary Measures in preparation, and they have allowed EPPO countries to develop experience in using the systems and to provide more expert opinion on the developing international standard.

It is obvious from what has been said so far that international cooperation is an essential element in preparing approved methods for PRA, but international cooperation is also needed to perform PRA. Many of the smaller or less, developed countries do not have the experts or have access to the information necessary to conduct PRA to an adequate level. It is in this area that regional plant protection organizations can permit countries to pool their resources. Furthermore, even those countries with sufficient resources often find it difficult to obtain scientific information about exotic pests, which, by definition, are absent from their territories. This is particularly true of forest pests, which tend to have specific regional characteristics, so that, for example, the forests of North America and those of Europe and Asia have similar but distinct flora and fauna, and are consequently more likely to exchange plant pests. Bringing together the experts from the different regions to discuss and to exchange information about potential quarantine pests would considerably improve our ability to identify potential problems and to act in advance.