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Lawsuit Brings Resolution to Publication of High-Risk Foods List


It will be eight years after the initial deadline, but by September 8, 2020, FDA has committed to designating the list of high-risk foods and publishing a proposed rule with recordkeeping requirements for those foods, as required by the congressionally mandated Food Safety Modernization Act (FSMA) signed into law in January 4, 2011. The original deadline for the high-risk list was one year after the date of enactment. By November 7, 2022, the final rule is to be published in the Federal Register, with the list of high-risk foods published on the FDA website.


The new dates were set in a June 7, 2019, Consent Decree, as ordered by U.S. District Court Judge Yvonne Gonzalez Rogers resulting from the settlement of a lawsuit filed in October 2018 by the Center for Food Safety and the Center for Environmental Health against HHS and FDA for failing to publish the high-risk list or accompanying recordkeeping rule.

The settlement was made without the admission or denial of the allegations made in the complaint, and the Parties agreeing “that resolution of this matter without further litigation is in the best interest of the Parties and the public, and that entry of this Consent Decree is the most appropriate means of resolving this action.


So, do we have any thoughts on what FDA may consider to be high risk? To some extent this list is obvious, and in other ways, it is a minefield for the food industry. I would expect we can look at a few primary places for insight: These could include key recalls and outbreaks (e.g., leafy greens), foods for which FDA has issued advisories and/or commerce restrictions (such as raw milk), and published FSMA rules, such as the Produce Safety Rule’s calling out of sprouts for special requirements.


Other previous FDA publications and drafts could also provide clues, as cited in a recent blog by Foodborne Illness Attorney Bill Marler. I would have to agree, particularly with his reference to FDA’s Draft Approach for Designating High-Risk Foods of February 2014, which stated that the designation of high-risk foods “must be based on the historical public health significance of the food with respect to outbreaks and cases of foodborne disease, as well as a number of food- and processing-related factors.”


Additionally, the Draft Approach document listed factors FDA would consider as being:

  1. The known safety risks of a food, including the history and severity of foodborne illness outbreaks and CDC foodborne illness data.

  2. The likelihood that a 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 production processes.

  3. The point in the manufacturing process of a food where contamination is most likely to occur.

  4. The likelihood of contamination and steps taken during manufacturing to reduce its possibility.

  5. The likelihood that consuming a food will result in a foodborne illness due to contamination.

  6. The likely or known severity, including health and economic impacts, of a foodborne illness attributed to a food.

Take particular note of #3. If FDA is to follow this listing of considerations, it will not only be designating high-risk foods themselves, but could also designate process points as being high risk. In #3, it does not state the factor as being focused on a particular food but as being “the point in the manufacturing process” where contamination is most likely to occur.


As FDA figures this out we would also hope that the agency takes into consideration any comments it received from its 2014 publication of Designation of High-Risk Foods for Tracing; Request for Comments and for Scientific Data and Information, which includes the same six factors for consideration, along with a lengthy list of questions on which it was seeking comment, scientific data, and information.


Creating a list of high-risk foods may appear to some to be a great idea. I am not a big fan of this approach. As we have learned, any food can become high risk if you don’t grow, produce, transport or sell it with appropriate food safety controls. Is the list about the history of the food itself or about the programs of those controlling the risk at growing/manufacturing level Using this list to require more details for product tracking is a great idea – but we need that for all foods not just high risk.


I worry that industry will spend too much time trying to navigate from the high risk to the “low risk” list. To some extent this will be driven by the degree of demonization of high-risk foods, and I hope that consumer groups and others providing opinions do not lose sight that any food, if not grown/manufactured/transported/sold with appropriate food safety controls, can be high risk.


FDA has a large and complex job in front of it, which is most likely why it has taken so long; I also suspect that FDA has not seen this as a great public health tool and so has not given it priority. But I hope that FDA is able to leverage this for the minor gains it will give us and not create a “two tier” structure for food that will create potential complacency in the low-risk category.

About The Acheson Group (TAG)

Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com

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