The US Food and Drug Administration’s food-traceability rule, published November 21, 2022, allows covered businesses to keep paper records. Those files still have to be accessible: the rule generally requires requested records within 24 hours, or a reasonable time agreed by FDA, and adds an electronic-spreadsheet requirement for certain public-health requests. The additional records concern foods on the Food Traceability List, not every food transaction. [S1]

The published rule takes effect January 20, 2023. In its November 2022 decision, FDA gave covered entities three years after that effective date to comply, extending the two-year period it had proposed. [S1]

Congress had deliberately left room for different record systems. Section 204 of the 2011 FDA Food Safety Modernization Act says the additional requirements must not prescribe specific technologies for maintaining records or demand duplicate records when the information already exists in ordinary company files. FDA’s final rule permits existing records to be supplemented and allows information to remain in more than one set of records. The traceability plan must identify their format and location. For a business assessing software, the practical question is whether its files contain the required information and can be retrieved—not whether it has purchased a particular platform. [S1][S2]

Keeping paper files and supplying a spreadsheet are separate obligations. When FDA needs information to prevent or mitigate an outbreak, assist a recall or address another public-health threat, the rule generally requires the specified critical-tracking-event information in an electronic sortable spreadsheet. The request can identify foods and date ranges or traceability lot codes. Information needed to understand the spreadsheet must accompany it. A company’s freedom to store records on paper therefore does not necessarily remove the work of assembling a usable electronic response. [S1]

Smaller restaurants and food retailers have a format exception. A retail food establishment or restaurant whose annual value of food sold or provided averages no more than $1 million over the previous three years may supply that information in another form. The test rolls forward and is adjusted for inflation using 2020 as the baseline. This is an exception to the spreadsheet format, not by itself a release from the rule’s other recordkeeping duties. [S1]

Outsourcing storage leaves the retrieval duty with the covered business. FDA allows another entity to establish and maintain records, but the covered business remains responsible for retrieving and providing them onsite within 24 hours of a request for official review. Unless the rule specifies otherwise, records must be retained for two years from creation or receipt. [S1]

Source documents

  1. FDA final rule: Requirements for Additional Traceability Records for Certain Foodshttps://www.govinfo.gov/content/pkg/FR-2022-11-21/html/2022-24417.htm
  2. FDA Food Safety Modernization Act, Public Law 111-353, section 204(d)(1)https://www.govinfo.gov/content/pkg/PLAW-111publ353/pdf/PLAW-111publ353.pdf