The Key Provisions of the Agreement

2.4 Scientific risk assessment

The requirement to base SPS measures on a scientific risk assessment (when they are not based on an international standard), articulated in Articles 5.1, 5.2, and 5.3, is a key component of the SPS Agreement’s reliance on scientific evidence for the justification of SPS measures.

Article 5.1 requires that SPS measures be based on an assessment of the risks to human, animal or plant life or health. It does not necessarily require that the importing country itself must do the risk assessment — but the importing country must be able to demonstrate that its measure is based on an “appropriate” risk assessment. Members are to take into account the risk assessment techniques developed by the three sister organizations.

Article 5.2 explains what kinds of information shall be taken into account when undertaking a risk assessment:

• available scientific evidence;
• relevant processes and production methods;
• relevant inspection, sampling and testing protocols;
• prevalence of specific diseases or pests;
• existence of pest- or disease-free areas;
• relevant ecological and environmental conditions; and
• quarantine or other treatment.

Article 5.3 identifies the economic factors which shall be taken into account when undertaking a risk assessment for animal or plant health:

• the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease;
• the costs of control or eradication in the territory of the importing Member; and
• the relative cost-effectiveness of alternative approaches to limiting risks.

The SPS Agreement contains two definitions for risk assessment, depending on whether it deals with a pest or disease risk affecting humans, plants and animals, or whether it is a food-related risk to human or animal health. In the case of food-related risk, it is sufficient to evaluate the potential for adverse effects. In the case of pest or disease risk, one must evaluate the likelihood of entry, establishment or spread according to the SPS measures which might be applied, and the associated potential biological and economic consequences.

To find out how this article has been applied in dispute settlement see relevant findings in the Hormones and Salmon cases.