Risk Analysis Overview

Risk Assessment

According to the SPS Agreement, risk assessment is the evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member (of the WTO) 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 for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins, or disease-causing organisms in food, feedstuffs and beverages.

Risk assessment evaluates the unmitigated (unmanaged) pest or disease risk to determine if the risk is sufficient to warrant mitigation(management). The purpose is to determine what biological or economic consequences might occur, and what the likelihood is of their occurrence. In many cases, broad agreement concerning this risk negates the need for formal risk assessments.

Formal risk assessments are conducted when the unmitigated risk is not clearly acceptable or is unacceptable. These assessments are also important when assumptions concerning the level of unmitigated risk are challenged or when new information concerning the unmitigated risk has been provided. The assessment of risk at this level typically involves the evaluation of origin, commodity, and destination risk factors.

Origin Risk Factor
APHIS analysts evaluate the export area to determine whether agents of sanitary or phytosanitary concern are present. Analysts consider the following in their evaluations:

• Prevalence of a pest or disease agent in the exporting area;
• Geographic and environmental characteristics;
• Sanitary and phytosanitary status of the adjoining or neighboring areas;
• Trading partners and practices;
• Regulatory infrastructure of the exporting country;
• Surveillance system(s);
• Previous risk assessments (including those of foreign countries) of the commodity and related commodities from the same origin.

Commodity Risk Factor
APHIS analysts consider information about the commodity to estimate the likelihood of introducing a particular pest or disease agent. Commodity factors include:

• Type or class of commodity;
• Nature of raw material used to produce commodity;
• Intended use of the product;
• Pest or disease agent survival in transit;
• Interception data.

Destination Risk Factor
APHIS analysts evaluate likelihood and consequences of a particular pest or disease agent surviving, multiplying, establishing and spreading in the territory of the importing country.

Destination factors include:

• Distribution of the commodity;
• Availability of susceptible hosts and/or competent vectors;
• Geographical and environmental characteristics.

Risk assessment is also known as hazard identification. Hazard identification is the process of identifying the biological agents that could potentially be introduced in the commodity considered for importation. A hazard represents elements or events that are potentially harmful. In risk assessment, hazard is specified by describing what might go wrong and how this might happen. A particular item or event may not pose a hazard in itself, but its introduction into a scenario where it can cause harm presents a hazard.