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: Continue reading