Yesterday, as part of FDA’s ongoing effort to expand the ability to recall foods and to identify foodborne outbreaks, the agency proposed specific rules regarding traceability of certain foods. The foods in question, which have been highlighted as the those foods more likely to convey foodborne illness, include: cheeses other hard cheese, shell eggs, nut butter, many fresh vegetables (cucumber, herbs, lettuce, sprouts, peppers, tomatoes, deli salads), fruit (melons, tropical tree fruit), fish (fin fish including smoked fish), and all crustaceans and mollusks (lobster to oysters). The rules apply to manufacturers, processors, packers, or persons who hold food with the exemption of certain smaller produce farms and egg producers. The rules require application of a traceability code derived at the start from a “growing area” or where a product may have been “transformed” or mixed from multiple growing areas. Based on the applicability through the system of distribution, albeit exempting retail food establishment, and the extensive recordkeeping required to be maintained for two years, a foodborne illness outbreak could, presumably, be rapidly traced to the source or location of contamination and then other foods that were in the same location or source or could have been contaminated can be investigated and recalled. The duration of record-keeping is to ensure that an FDA investigator can ascertain whether the company has been in compliance in realtime.
While the system thus seems thorough and reasonable, FDA was required to perform an economic impact analysis. This analysis suggested that the rules would add $8B in costs to producers and result in over 40,000 extra hours of work for farms. In general, in the past, FDA’s estimates of costs have been grossly underestimated as, of course, FDA does not contemplate down-stream effects and infrastructure changes such as business consolidation, the loss of small businesses including family farms, the creation of wholly new businesses involved in tracing and attendant costs, changes in availability of certain foods, especially in low income areas, and increased distance required for transport to major cities when is a loss of local farms near urban areas. The latter might have an impact on food flavor and quality which is not included in an economic analysis. Loss of food quality or availability of fresh foods would have an unknown health impact or, at least, a potential impact on quality of life. Further, the impact of increased cost of fresh foods may result in diminishing use of what are, arguably, the best and most basic components of a healthy diet. That latter “cost” may be understood as an impact on life expectancy and healthcare costs due to increased early cardiovascular and oncologic diseases among low income residents or a switch to processed and less healthy foods among all consumers. That said, the overall benefits have been unclear although they would seem obvious: tracing an outbreak to source and containing spread of sometimes fatal disease. Since passage of the Food Safety Modernization Act in 2013, of which these regulations are a part, however, there has not been a substantial decrease in foodborne outbreaks. This latter could be due to better understanding and reporting which uncovers previously undetected disease. However, this thesis is not entirely supported since the illnesses in question (salmonella, listeria, etc.) do not appear to have reduced in incidence in CDC reports over the last decade although, again, this may reflect the combination of reduction in actual disease but increased reporting of such outbreaks. Nonetheless, the human costs and benefits have yet to be objectively assessed.