FSMA’s produce safety rule was established to improve food safety of raw produce for human consumption. The majority of foodborne illnesses are caused by agricultural commodities consumed raw. Therefore by providing oversight, the FDA now has control of the majority of the food supply from farm to fork. The rule addresses six key areas, (1) water quality, (2) biological soil amendments, (3) sprouts, (4) domesticated and wild animals, (5) worker training and health and hygiene, and (6) equipment, tools and building.

Water Quality

Several pathogens are waterborne including E.coli, Salmonella, Salmonella typhi, Shigella spp., Campylobacter, Vibrio cholera, Hepatitis A, and Norovirus. By ensuring the safety of water used on farms, produce safety can be improved. Therefore the FDA has determined that no E. coli should be present in water used on farms to wash hands or food contact surfaces, nor come in contact with produce. Water used for irrigating sprouts must also be free of E. coli. The presence of E. coli is an indication of fecal contamination and the likely presence of other pathogens. Water used for irrigating produce (except sprouts) may contain E. coli however, as long was the amounts are within tolerance limits set by the rule. The water supply must be tested initially and annually to ensure that E. coli levels are within limits. Greater frequency is required for surface water (e.g. from rivers and lakes) compared to ground water (wells) since surface water is more prone to contamination. Where limits are not met, corrective actions allowed may include establishing water treatment, or allowing enough time interval between application of irrigation and harvest, or between harvest and end of storage. Sufficient time interval will help to reduce population of pathogens on produce surface.

Biological Soil Amendments

The FDA is conducting risk assessments to determine the appropriate time interval between application of raw manure and harvest. In the mean time, it does not object to farms following the USDA’s Organic Program Standard which establishes a 120 day time interval between application of raw manure and harvest when the edible portion of the produce is in contact with the soil, and a 90 day interval when the edible portion is above the ground. Compost used must be appropriately treated to reduce pathogens. The treatment method used must be based on a scientifically validated method. Currently, treatment of compost in the agricultural industry include the use of chlorine, ozone, UV light and pasteurization.


Sprouts have been implicated in several foodborne illnesses. This is due to the nature of the food material having a high water activity and high nutrient density. The rule therefore sets standards for control of Listeria. For effective control, Listeria testing of spent irrigation water and environmental testing is required. Corrective actions must be carefully documented.

Domesticated Wild Animals

Farms must make efforts to reduce fecal contamination of produce by domesticated animals including animals used as ‘workers’ on the farm, and wild animals. This could be done by appropriate fencing. Fecal contamination may be assessed by documenting the number and/frequency of animals sited in growing areas, amount of field damage, and actual excreta observed in the field. The FDA makes it clear that the rule should not be interpreted to mean that it is encouraging or requiring the killing or trapping of wild animals and destruction of their habitats.

Worker Training and Health and Hygiene

Workers on farms covered by this rule must now be trained in food safety. This include reporting illnesses and personal hygiene practices such as handwashing.

Equipment, Tools, and Buildings

While farm facilities and equipment may not be at the standard of food processing facilities; they must still be designed and maintained in a way that will prevent or reduce the risk of contamination and adulteration of produce.

Exemptions for this Rule

  1. Produce that are not “raw agricultural commodities”. The produce must be in its raw and natural state
  2. Produce rarely consumed raw e.g. potatoes, asparagus and beans
  3. Produce for personal and farm use
  4. Farms with sales less than $25,000 per year as an average of the last three years.¬†Farms with sales less than $500,000 per year as an average of the last three years, that sells directly to the customer (an individual or restaurant) within a 275 miles radius can seek a “qualified exemption”
Courtney Simons
Courtney Simons is a food science professor. He holds a BS degree in food science and a Ph.D. in cereal science from North Dakota State University.
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