On January 28, 2019, the Produce Safety Rule took effect for two groups of producers: small (less than $5 million in produce sales based on a 3-year average) and very small farms (less than $250,000 in produce sales based on a 3-year average).

Produce Safety Rule

As a part of the Food Safety Modernization Act, The Food and Drug Administration (FDA) designed the Produce Safety Rule to establish science-based minimum standards for the safe production and harvesting of fruits and vegetables that are raw agricultural commodities in an effort to reduce the risk of serious adverse health consequences. These requirements do not apply to produce that is rarely consumed raw (e.g., asparagus, black beans, and collards), produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. A raw agricultural commodity is food in its raw or natural state, such as food grains and fresh fruit, but not foods that have been processed, fabricated, or manufactured by cooking, freezing, dehydrating, or milling. The Produce Safety Rule focuses on the five routes of contamination:

  • agricultural water
  • biological soil amendments
  • domesticated and wild animals
  • equipment, tools, and buildings
  • worker training and health and hygiene.

Thus, farms must implement procedures, processes, and practices to minimize the risk of contamination for each of the five routes. The FDA has provided a summary of the final rule, which you can find here.

Sprout Farm Compliance Obligations

Sprouts have received special attention in the Produce Safety Rule because their warm, moist, and nutrient-rich properties create an ideal condition for pathogens to grow. Between 1996 and 2014, there were 43 outbreaks, 2,405 illnesses, and 171 hospitalizations, and 3 deaths associated with sprouts, including the first documented outbreak of Listeria monocytogenes associated with sprouts in the United States. Examples of the sprout requirements include: taking measures to prevent the introduction of dangerous microbes into or onto seeds or beans used for sprouting; and testing spent sprout irrigation water from each production batch of sprouts, or in-process sprouts from each production batch, for certain pathogens. Compliance for sprouts is currently in effect for large and small farms. This year small farms must also comply with all requirements under the Produce Safety Rule for all other produce that qualify as raw agricultural commodities and very small farms must begin complying with the Produce Safety Rule sprout requirements.


Next Post: On March 18, 2019, the Foreign Supplier Verification Program takes effect for four more groups of importers.

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