Understanding Produce Regulations

By: Allison Howell

Federal regulations are complicated, technical, and often difficult for consumers to understand. But everyone eats produce. A basic understanding of what types of produce or produce commodities are included or not included in federal regulations and what those regulations mean can help consumers make informed decisions about buying, preparing, and consuming produce safely.

Background on FSMA

First introduced in the House of Representatives in 2009, the Food Safety Modernization Act of 2010 (FSMA) underwent several revisions and amendments before being signed into law by President Obama in early 2011. It was the first piece of federal legislation to address food safety since The Federal Food Drug, and Cosmetic Act of 1938 [1]. FSMA greatly expanded the United States Food and Drug Administration’s (FDA) regulatory authority. FSMA is a great accomplishment in terms of shifting the goal of federal oversight to preventing foodborne illness instead of reacting to it.

FSMA did not outline specific regulations for food safety, but instead expanded FDA’s regulatory authority so they could develop additional rules aimed at implementing the goals of FSMA.

^{Source: https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma}

Since FSMA was signed into law, the FDA has developed several final rules that provide specific guidance to industry and detail the FDA’s role in enforcing these rules. A full list of the proposed and final rules related to FSMA can be found at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry#rules.

One of the FSMA final rules is the “Standard for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” also known as the Produce Safety Rule [3]. The rule went into effect in January of 2016, and covered farms were required to comply by early 2020. Full details of the Produce Safety Rule can be found at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-produce-safety#requirements.

But what does FSMA mean for consumers?

Most types of produce that you can buy at a grocery store are covered by the Produce Safety Rule and producers are held accountable for adhering to the FDA’s Standard for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. That means, when you buy an apple from the grocery store, you can reasonably assume that federal regulations designed to reduce the presence of foodborne pathogens on or in apples have been followed. After giving it a quick wash with some water (you should always wash fresh produce before consuming), you can slice it up or bite right in and enjoy. It is important to remember that the Produce Safety Rule sets standards for growers that sell the produce, but poor handling or cross contamination by consumers can still lead to foodborne illness. Read more about the FDA’s recommendation for safely selecting and serving produce here: https://www.fda.gov/food/buy-store-serve-safe-food/selecting-and-serving-produce-safely.

There are several important regulations outlined in the Produce Safety Rule, but there are also certain criteria that can lead to commodities being exempt from compliance with the rule. One of those criteria is produce that is not considered a raw agricultural commodity; that is, the produce is identified as rarely consumed raw (RCR). Recently, FDA issued an Request for Information in the Federal Register Notice for commodities that they are considering characterizing as RCR and therefore exempt from the Produce Safety Rule [4]: