FDA Seeks Data on Rarely Consumed Raw Produce Commodities for Produce Safety Rule Exemption
The U.S. Food and Drug Administration (FDA) has issued an official 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. Any data collected will be used 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.
Upon FDA’s publishing of the Produce Safety rule, it included a list of RCR commodities that are almost always consumed in the U.S. after cooking, the kill step that can adequately reduce the presence of microorganisms of public health significance in most cases.
The existing RCR list is based on food consumption data and patterns from the National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA)—the dataset that represents the most comprehensive dataset available on dietary intake in the U.S., along with the U.S. Environmental Protection Agency’s Food Commodity Intake Database, 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).
Based on these data, FDA added produce commodities to the RCR list if they met three criteria:
- The commodity is consumed uncooked by less than 0.1 percent of the U.S. population.
- The commodity is not cooked by the consumer on less than 0.1 percent of eating occasions.
- 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 their intent to exercise enforcement discretion for certain commodities covered by the Produce Safety rule, while they considered pursuing rulemaking to address their unique circumstances. While this work continues, FDA is now considering a different set of commodities by opening this RFI for 90 days.
Anyone with data, information, and/or comments regarding U.S. consumption patterns of those commodities with no or low reported consumption is welcome to submit such information to FDA through the RFI docket.