Determining the Risk-Base of High-Risk Foods

Each month EAS answers one question sent in by readers of EASeNews. This month’s question on the risk-base of high-risk foods is answered by EAS Independent Advisor for FSMA, Charles Breen.

Question: How do you determine the Risk-Base of High-Risk Foods?

Breen: With the passage of the Food Safety and Modernization Act in 2011, Congress told FDA to identify high risk foods. FDA had (and continues) to understand the term “high risk” to mean foods that may present hazards, which, if not controlled, are likely to cause illnesses or injury when consumed.

FDA has given high risk food firms priority for inspectional purposes but has never clearly defined what is or is not “high risk.” Many high-risk food facilities are covered by specific rules, such as juice and seafood HACCP, or special programs, such as Domestic and Imported Cheese and Cheese Products, and agency support to States for the Pasteurized Milk Ordinance and Interstate Milk Shippers list.

So, what are High-risk foods? As defined in the Food Safety Modernization Act (FSMA) section 204(d)(2)(A), these include:

• Those in which there is a known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, while taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention (CDC);
• Food with a high likelihood of potential risk for microbiological or chemical contamination or that would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;
• The point in the manufacturing process of the food where contamination is most likely to occur;
• The likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
• Foods that result in a likelihood of foodborne illness should it be contaminated, and
• The likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

In the absence of defined formulas, each of these criteria could be applied qualitatively and to varying degrees to assign high risk or not high risk to facilities. In FDA’s view, this was useful to efficiently respond to new risk-based information. Likewise, it allows for less FDA attention to known high risk foods such as fluid milk that have long history of safe production. But it does not comply with the mandate in section 204(d)(2)(A) of FSMA.

Prior to the Court order to finally publish a list of high-risk firms, inspections could be tailored to meet goals within appropriated and often unpredictable resources. For example, if the goal is to inspect X % of the high-risk inventory in one fiscal year, and resources are cut, the number of facilities classed as high risk could be tweaked to still allow FDA to meet the goal. (Management cliché: Never set a milestone you don’t know you can reach.)

There are negatives to this approach. A few that come to mind include the fact that a facility can never be certain whether or not it is on the high-risk list. The lack of flexibility is frustrating for agency critics and oversight committees due to an inability to hold FDA accountable on a clearly defined, fixed level of accomplishment. Lastly and importantly, it does not comply with FSMA.

FDA recently was mandated to take specific and determined action in creating designation criteria for these high-risk categories and submitting documentation to the Office of the Federal Register for publication. Deadlines include:

• Designation of the list of high-risk foods required by FSMA Section 204(d)(2)(A) by September 8, 2020
• Publication of Proposed Rule for recordkeeping requirements for the designated high-risk foods as required by FSMA Section 204(d)(1) by September 8, 2020, with final rule publication no later than November 7, 2022
• Publication of the list of high-risk foods on the FDA website is required by FSMA Section 204(d)(2)(B) Upon publication of the Final rule in the Federal Register.

Agency critics hope that having a defined list will mean FDA’s attention to high risk foods will drive down the number of illnesses and deaths caused by pathogens. I am less sure there will be a cause and effect relationship between a list and declining harm to consumers.

While there is considerable overlap between factors in the old way FDA used, and the new way FSMA prescribes, the basic assumption has changed. It’s no longer “as many high-risk foods as the budget allows” and is now “every high-risk food no less than every three years.” It will make it more difficult to obfuscate budget shortfalls as easily as was the case before FSMA.