By Bill Marler

A federal judge in California has told the Food and Drug Administration, which is the nation’s leading food regulator, to stop dragging its feet on the long-awaited rules surrounding food recalls and outbreaks of foodborne illness.

U.S. District Court Judge Yvonne Gonzalez Rogers ordered the Department of Health and Human Services (HHS) and the FDA to designate a list of “high-risk foods,” create new recordkeeping requirements for some companies that handle those foods and post that information publicly by 2020. The agencies had been sued by two consumer advocacy groups, the Washington D.C.-based Center for Food Safety and the Oakland, CA-based Center for Environmental Health,that alleged the government agencies were not complying with an important food safety timetable. 2019-06-07–doc-33-1–consent-decree_35775

In the complaint, which was filed in October 2018, the two groups said the government agencies weren’t implementing rules in the Food Safety Modernization Act (FSMA), a landmark law signed by President Barack Obama on Jan. 4, 2011. A wide-ranging package of regulations, FSMA is concerned, above all, with preventing outbreaks of foodborne illness. It gives FDA — the division of HHS that regulates 80 percent of the country’s food supply — greater authority to track potentially hazardous ingredients and mandate product recalls. 2018-10-15–doc-01–complaint_50519

Part of those regulations revolves around high-risk foods — defined as those that are most commonly recalled or are produced in a way that makes them more likely to harbor harmful bacteria.

In the Consent Decree filed June 7, 2019, the FDA agreed to a schedule for action, including:

Sept. 8, 2020 – Deadline for FDA to designate the list of “high risk” foods as required by the FSMA Section 204(d)(2)(A).

Sept. 8, 2020 – Deadline for FDA to publish a proposed rule, including record-keeping requirements for high-risk foods, also as required by FSMA Section 204(d)(2)(A).

Nov. 7, 2022 – Deadline for FDA to issue a final rule, including record-keeping requirements for high-risk foods, also as required by FSMA Section 204(d)(2)(A).

The FDA has, to date, considered “high risk” foods to be soft cheeses, seafood, custard-filled bakery products, some fruits and vegetables, and baby formula. So, going forward, how will the FDA determine what is high risk? Perhaps FDA draft documents might give clue?

Section 204(d)(2) of the FDA Food Safety Modernization Act (FSMA) requires the Food and Drug Administration (“FDA” or “we”) to designate high-risk foods (HRFs) for which additional recordkeeping requirements are appropriate and necessary to protect the public health. These additional recordkeeping requirements will make it easier to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak. Designation of HRFs must be based on the historical public health significance of the food with respect to outbreaks and cases of foodborne disease, as well as food- and processing-related factors.

Factors to Be Considered Under section 204(d)(2)(A) of FSMA, FDA’s designation of HRFs must be based on the following factors:

  1. 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 (CDC);
    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.

My vote for the high-risk list:
Raw milk and products made from it
Raw juice
Raw sprouts
Pre-cut fruit and vegetables (including leafy greens)
Raw shellfish
Uncooked flour

Any others?