FDA requests information on expansion of “rarely consumed raw” list

The US Food and Drug Administration (FDA) has 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 plans to 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.

When the FDA published the Produce Safety rule, it included a list of produce commodities (the RCR list) that were to be determined almost always consumed in the United States after being cooked. Cooking is noted to be 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 US Environmental Protection Agency’s Food Commodity Intake Database (FCID).

Using these data, the 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 US population
• The commodity is not cooked by the consumer on less than 0.1 percent of eating occasions
• At least one percent of the weighted number of survey respondents reported consuming the commodity in any form.

Several commodities satisfied the first two criteria, but data did not demonstrate consumption of the commodity in any form by at least one 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 the FDA refers 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.

Previously, the FDA stated its intent to exercise enforcement discretion for certain commodities covered by the Produce Safety rule, while it considered pursuing rulemaking to address their unique circumstances. While this work continues, FDA has announced that it is now considering a different set of commodities by opening this RFI for 90 days.

FDA has invited those with data, information, and/or comments regarding US consumption patterns of those commodities with no or low reported consumption to submit such information to the agency through the RFI docket.