The FDA is extending the comment period for stakeholders to submit the requested information for an additional 60 days, through January 8, 2021.
August 6, 2020
Today, the U.S. Food and Drug Administration issued a Request for Information (RFI) to open a docket for data and information related to produce that has been known to have no or low reported consumption. The Agency will use the data and information to consider whether any of these produce commodities should be added to the “rarely consumed raw” (RCR) list and thereby exempt from the Produce Safety rule. The items currently on the exhaustive RCR list are not subject to the requirements in the Produce Safety rule.
When the FDA published the Produce Safety rule, we included a list of produce commodities (the RCR list) that we determined are almost always consumed in the United States after being cooked. Cooking is a ‘kill step’ that can be expected to adequately reduce the presence of microorganisms of public health significance in most cases.
To develop the RCR list, FDA used data on food consumption patterns found in the National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA) dataset and The U.S. Environmental Protection Agency’s Food Commodity Intake Database (FCID). The NHANES/WWEIA dataset represents the most comprehensive dataset available on dietary intake in the U.S. The EPA FCID is a recipe database that identifies a proportion of commodity ingredients in the foods in the NHANES/WWEIA dataset and their cooking status (cooked or uncooked).
Using these data, the FDA added produce commodities to the RCR list if they met three criteria: First, the commodity is consumed uncooked by less than 0.1 percent of the US population. Second, the commodity is not cooked by the consumer on less than 0.1 percent of eating occasions. Third, at least 1 percent of the weighted number of survey respondents reported consuming the commodity in any form to provide a reasonable representation of how that commodity is consumed by U.S. consumers.
Several commodities satisfied the first two criteria, but data did not demonstrate consumption of the commodity in any form by at least 1 percent of survey respondents. These are referred to in the RFI as “produce commodities with low reported consumption.” Some other commodities did not appear in the NHANES/WWEIA dataset at all, which we refer to in the RFI as “produce commodities with no reported consumption.” Because these sets of commodities did not meet the third criterion, they are currently covered by the Produce Safety rule. The RFI includes an exhaustive list of commodities with low reported consumption based on the methodology used to develop the RCR list, and examples of those commodities with no reported consumption.
Previously, the FDA stated our intent to exercise enforcement discretion for certain commodities covered by the Produce Safety rule, while we considered pursuing rulemaking to address their unique circumstances. While this work continues, we are now considering a different set of commodities by opening this RFI for 90 days. We invite those with data, information, and/or comments regarding U.S. consumption patterns of those commodities with no or low reported consumption to submit such information to the agency through the RFI docket.