FDA’s Draft Methodological Approach to Identifying High-Risk Foods

By Ching-Fu Lin

Last month, the Food and Drug Administration (FDA) published a draft methodological approach for designating high-risk foods (HRFs) as required by section 204(d)(2) of the Food Safety Modernization Act (FSMA).  HRFs identified by the FDA are subject to additional record-keeping requirements, and more frequent foreign inspections and mandatory third-party certification requirements.  The FDA is seeking comments, scientific data, and information from stakeholders to revise this draft HRF approach and to create a preliminary HRF list.

Among many available risk tools (e.g. qualitative, semi-quantitative, and quantitative methods), a semi-quantitative risk ranking model has been selected by the FDA as the most appropriate methodology for the HRF list.  There are many reasons for choosing this model, including the fact that – as explained by the FDA – it is “data-driven and comprehensive, using explicit criteria related to public health risk; … adaptive to a variety of hazards; and … flexible to consider different foods or categories of food.”

Based on the draft semi-quantitative risk ranking model, the FDA is considering and evaluating a set of seven criteria that match the factors specified in section 204(d)(2)(A) of FSMA:

(i) the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention;

(ii) the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;

(iii) the point in the manufacturing process of the food where contamination is most likely to occur;

(iv) the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;

(v) the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and

(vi) the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

The FDA’s seven criteria include (1) outbreak frequency and illness occurrence, (2) severity of illness, (3) likelihood of microbial or chemical contamination, (4) potential for the food to support pathogen growth, (5) food consumption patterns, (6) the probability of contamination and steps taken during manufacturing to reduce contamination, and (7) economic impact.

This draft methodological approach is premised on the availability of a huge amount of relevant data and information, as is the preliminary HRF list.  However, a couple of questions have not been addressed by the FDA in the document.

First, the FDA has yet to clarify what exact effects the draft methodological approach would have on the regulation of imported food products.  Based on the relevant FSMA provisions, the HRF list seems to have an important impact on the FDA’s regulation model for imported food products, since the FDA has the authority to require that high-risk imported foods be accompanied by third-party certifications as a condition of entry into the United States.  In the draft methodological approach, the data sources for determining frequency of outbreaks and occurrence of illness seem to cover mostly (if not only) domestic reported cases by the FDA, the Centers for Disease Control and Prevention (CDC), and Center for Science in the Public Interest (CSPI).  This may result in a mismatch of regulation between domestic and foreign food products, as what is not categorized as HRF domestically might pose significant public health concerns in the import context.  Therefore, it seems desirable that the scope of data sources for evaluating the above seven criteria should be clearly specified.

Second, considering the international trade implications of the draft methodological approach, its relationship with the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) seems unclear.  Article 5 of the SPS Agreement articulates the requirement that SPS measures (food safety, animal health, and plant health measures) be based on “scientific risk assessment.” With regard to food safety regulation, WTO Members (including the United States) are to take into account the risk assessment techniques developed by the Codex Alimentarius Commission.  When conducting a risk assessment, WTO Members have to consider factors such as “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.”  Economic factors, such as “the potential damage in terms of loss of production or sales, … the costs of control or eradication, … and the relative cost-effectiveness of alternative approaches to limiting risks”, should also be taken into account in the process of risk assessment.  Although the draft methodological approach is designed mainly for domestic HRF regulation, the FDA should consider addressing the approach’s link with the SPS Agreement.  The agency should also consider using relevant risk assessment techniques developed by the Codex Alimentarius Commission, given the HRF list’s possible impacts on import regulation.

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