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Interpretation of Food Code for obtaining consumer purchase records

We would like for the U.S. Food and Drug Administration (FDA) to provide a Food Code interpretation to inform regulatory authorities that Food Code Sections 8-304.11(H) provides sufficient authority to the regulatory authority to obtain existing consumer food product purchase records from food establishments during foodborne illness investigations.

Food Code section 8-304.11(H) states that the permit holder shall:

Comply with directives of the REGULATORY AUTHORITY including time frames for corrective actions specified in inspection reports, notices, orders, warnings, and other directives issued by the REGULATORY AUTHORITY in regard to the PERMIT HOLDER'S FOOD ESTABLISHMENT or in response to community emergencies; Section 8-304.11(H) provides sufficient authority to the regulatory authority to gather information (including existing records) to identify a contaminated food ingredient that may have entered the establishment and initiate a traceback to the supplier of the product.

Every year in the United States there are millions of cases of foodborne illness (Scallan et al., 2011), and a majority of these cases are attributable to food establishments (Jones & Angulo, 2006). Investigation of these reports of illness is of paramount importance to: a) stop additional people from being exposed and becoming ill; b) understand the system failure within a food establishment that led people to become ill; and c) identify a source of contaminated food that may have entered the food establishment. In addition, quickly identifying the source of outbreaks through consumer purchase records is crucial to identify the specific product so that public health advisories can warn consumers to avoid certain implicated products instead of broad categories (such as Romaine, tomatoes or papayas). Such advisories have an enormous economic impact on the food sector and retail food establishments. Solving outbreaks quickly using consumer purchase records also reduces the number of people that may become ill and subsequent industry liability. Some regulatory authorities have been denied access to consumer food product purchase information, and clarification that the Food Code provides authority to access these records will reduce illnesses and associated economic impacts.

The Food Code appendix 2's supporting documents reference the Voluntary National Retail Food Program Standards (VNRFPS) along with the Council to Improve Foodborne Outbreak Response's Guidelines for Foodborne Outbreak Response. Both documents include the need for investigating foodborne illness outbreaks and having the ability to trace food back to its source.

Jones, T. F., & Angulo, F. J. (2006). Eating in Restaurants: A Risk Factor for Foodborne Disease? Clinical Infectious Disease, 43, 1324-1328. doi:1058-4838/2006/4310-0017

Scallan, E., Hoekstra, R. M., Angulo, F. J., Tauxe, R. V., Widdowson, M. A., Roy, S. L., . . . Griffin, P. M. (2011). Foodborne illness acquired in the United States--major pathogens. Emerg Infect Dis, 17(1), 7-15. doi:10.3201/eid1701.091101p1

The Conference recommends....

that a letter be sent to the FDA requesting an interpretation of the Food Code clarifying that

Section 8-304.11(H) coupled with 8-402.11 provide sufficient authority for a regulatory authority to conduct a foodborne illness investigation and obtain access to existing consumer food purchase data.