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Volume X, Number 264

September 18, 2020

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FDA Requests Information That Could Result in Expanding the Rarely Consumed Raw (RCR) List of Produce Commodities Exempt From the Produce Safety Rule

FDA’s Food Safety Modernization Act (FSMA) Final Rule establishing “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (see our detailed summary here) includes an exhaustive list of commodities at 21 CFR 112.2(a)(3) that are “not covered produce” because this produce is rarely consumed raw (RCR).  FDA exempts RCR commodities because cooking is a kill step that usually can be expected to adequately reduce microorganisms of public health significance.  FDA classified produce as RCR based on food consumption patterns reported in the National Health and Nutritional Examination Survey/What We Eat in America (NHANES/WWEIA) dataset and the U.S. Environmental Protection Agency’s Food Commodity Intake Database, which is a recipe database that identifies proportions of commodity ingredients in NHANES/WWEIA codes, and also identifies the associated cooking status (uncooked or cooked) and food forms (e.g., fresh, frozen, canned).

On August 6, 2020, FDA announced a Request for Information (RFI) to open a docket for data and information related to produce with “low reported consumption” or “no reported consumption.”  A list of produce having low reported consumption (i.e., consumed by less than 1% of the weighted number of NHANES/WWEIA survey respondents) but otherwise possibly meeting the criteria for RCR listing is published in FDA’s August 10, 2020 Federal Register notice and includes such well known commodities as arugula, brussels sprouts, bok choy, chestnut, kale, lime, radish, and others.  Further, FDA lists arrowroot and fiddleheads as examples of produce that did not appear in the NHANES/WWEIA at all.

FDA is requesting commodity-specific data on whether particular produce with either no or low reported consumption in NHANES/ WWEIA is consumed cooked by almost all consumers across the U.S. and should, therefore, be categorized as RCR.  Such data could include results of a well-designed consumer survey, market data, and/or data indicating that a commodity cannot safely be consumed uncooked, e.g., because in its uncooked state it contains toxic properties.  FDA will also consider information on fermentation or any other kill steps besides cooking that adequately reduce microorganisms of public health significance.  The due date for providing the requested information is November 9, 2020.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 223


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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...