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What Is FSMA’s Produce Safety Rule All About?

Denis Storey
April 17, 2020

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The Food Safety Modernization Act (FSMA) Final Rule on Produce Safety covers science-based standards for the growing, harvesting, packing, and holding of produce for human consumption. Widely considered one of the more technical FSMA rules, TraceGains helps you begin to understand how to apply the rule and develop a strategy for compliance that's unique to the produce you grow.

Does The Rule Apply to You?

The first step is to determine if the rule even applies to your operation. The U.S. Food and Drug Administration (FDA) established the rule to cover produce, which can also be referred to as Raw Agricultural Commodities (RACs), equating to domestic and imported produce for human consumption in their raw or natural state. 

Are There Exclusions?

As with every rule, there are some exclusions:

  • Not Raw-Agricultural-Commodities (RACs)

  • Specified produce "rarely consumed raw" (e.g., pumpkin, navy beans, coffee beans, etc.)

  • Food Grains (e.g., barley, sorghum, oats, rice, etc.)

  • Produce used for personal or on-farm consumption

  • Farms with an average annual value of produce sales during three years under $25,000

The Definition of a Farm

The FDA clarifies the definition of a farm with a simple and easy-to-follow flowchart titled Coverage and Exemptions/Exclusions Flowchart. Determining coverage under the definition of a farm requires a review of the activities performed on the farm. The rule includes growing, harvesting, packing, and holding. However, certain activities such as pitting (e.g., plums) and chopping (e.g., bean chips) can remove you from the farm definition.

Exemptions and Flexibility 

Produce receiving commercial processing, including a kill step or other processes to minimize hazards, will receive a full exemption from the rule. Qualified exemptions occur when a company meets the following considerations:

  • Average food sales less than $500,000/year for three years.

  • Within the three years, sales to qualified end-users must exceed sales to all other users combined. 

Farms with a qualified exemption must also meet specific modified requirements. These include disclosing the farm's name and address where the produce was grown and adhering to higher documentation standards.

Standards for Produce Safety

The framework for this rule is interesting because the FDA looks at a farm the same way it does a manufacturing facility. Like with a manufacturing facility, you're going to take the same compliance mindset and determine where the microbial contamination can occur and define the necessary steps to mitigate these risks. In this light, the Final Rule for Produce Safety focuses on the microbial contamination of produce across the following six core areas:  

  1. Agricultural Water

  2. Biological Soil Amendments

  3. Sprouts

  4. Domesticated and Wild Animals

  5. Worker Training and Health and Hygiene

  6. Equipment, Tools, and Buildings

Agricultural Water

Two sets of criteria exist for microbial water quality. Both are based upon the presence of E. coli, which can lead to the presence of fecal matter. The rule prohibits the use of untreated surface water for any of the following purposes:

  • Water used for washing hands during and after harvest

  • Water used on food-contact surfaces

  • Water used to directly contact produce (including to make ice) during or after harvest

  • Water used for sprout irrigation

For agricultural water directly applied to growing produce (sans sprouts), two numerical values represent the central tendency of water quality (i.e., the average E. coli in a given water source. 

  • The Geometric Mean (GM) of samples equating to a maximum of 126 CFU of generic E. coli/100mL of water 

  • The Statistical Threshold (STV) of samples equating to a maximum of 410 CFU of generic E. coli/100 mL of water


The rule also sets testing requirements for untreated water. These are inclusive of surveying, frequency, and remediation step to follow if water does not meet the set testing requirements. The FDA has provided a list of scientifically valid methods for testing water quality.  

Biological Soil Amendments

Soil amendments are materials added to the soil to improve its chemical or physical makeup for growing plants or improving upon the soil's ability to hold water.  

  • Raw Manure – The FDA defines a 120-day time frame between the application of manure and the harvest date. 

  • Stabilized Compost – There are two scientifically valid composting methods to meet the rule's microbial standards to treat biological soil amendments. The FDA's Biological Soil Amendments of Animal Origin fact sheet provides more information.


Sprouts are incredibly vulnerable to harmful microbes due to the warm, damp, and nutrient-rich conditions needed for growth. Fortunately, these new requirements are in place to help prevent their contamination. These include:

  • Implementing measures to avoid the introduction of microbes

  • Testing irrigation water from each production or in-process batch of sprout water

  • Testing the environments for the growing, harvesting, picking, and holding of sprouts. 

  • Taking the appropriate corrective actions in the case of a positive test. 

Domesticated and Wild Animals

For farms with grazing or working animals, farmers can expect to take all reasonable measures to identify produce likely to be contaminated. These measures are often seasonal and require more stringent testing and adherence during the growing season. Establishing periods of grazing and harvesting is encouraged, but still voluntary, and extraneous efforts to separate animals from crops, destroy wild animal habitats, or clear borders around drainage areas is not supported. 

Worker Training and Health & Hygiene

Farmworkers and their supervisors handling covered produce require training on the importance of health and hygiene. These include the following topics:

  • How to prevent contamination of produce by ill or infected people.

  • Hygienic practices for handling covered produce. 

  • Measures to prevent visitors from contaminating covered produce. 

Equipment, Tools, and Buildings

Standards also exist to properly sanitize farm equipment, tools, and buildings as not to contaminate produce. 

The rule includes greenhouses, toilets, and handwashing stations. The rule ensures anything with the potential to contaminate produce is properly cleaned and maintained throughout the growth cycle. 

To protect the health of workers and customers, food and supplement manufacturers in the United States are strict about sanitation. The COVID-19 pandemic has made the issue even more critical as our country works to contain this crisis. TraceGains and its network of suppliers, manufacturers, and industry experts are coming together to help companies navigate the current threat to avoid operational disruption.

Listen to this recorded webinar with Jesse Leal, Lead Food Safety Inspector at AIB International, for expert insight on how your business can avoid downtime, failed audits, or worse while keeping consumers safe. Watch the recording here.