Guest Column | October 24, 2017

FSMA's Produce Safety Rule: A Practical Guide For Compliance

By Pamela Sweeten, Founder, P. Sweeten Consulting

FSMA is widely regarded as the most path-breaking food safety act in modern U.S. history; its primary focus is finally tilted from response to prevention. This overriding shift in approach underlines the graveness of the situation and reaffirms the importance of food safety laws. Food contamination has always been the foremost concern for food safety departments, and finally, after the implementation of FSMA, the FDA expects a reduction of about 20 percent in the overall number of foodborne illnesses stemming from produce, with more than a 60 percent reduction in illnesses from agricultural water.

Prevention Is Key
FDA recorded data highlights the importance of prevention at the supply chain. As per the CDC, more than 128,000 Americans are hospitalized from foodborne illnesses each year. Of those 128,000, almost 3,000 die from foodborne diseases. These figures are alarming and call for immediate attention and drastic measures.

This data further demonstrates that nearly one in three deaths from foodborne diseases is the direct result of produce-related outbreaks, with every other outbreak associated with fresh produce commodities. The above-mentioned statistics clearly signify the importance of stopping contamination at the supply chain level. This directly impacted President Obama’s decision to sign FSMA into law and empowering the FDA to take precautionary measures, rather than responding to food safety events.

The Produce Safety Rule
For the first time, a set of guidelines is defined for safe agricultural practices. Separate rules are put into motion for farming, harvesting, packing, and storing fruits and vegetables. These rules been designed to govern changes in the existing agricultural hierarchy. FSMA’s Produce Safety Rule acts as a pivot for the industry, as all safety measures and guidelines are either derived from it, or are extensions of the rule, such as the Preventive Controls for Human Food Rule. (A full list of FSMA’s rules can be found here).

These guidelines will be overseen by government officials. These recommendations are in accordance with the FDA-issued supplemental notice in 2014. Over the course of three years, several revisions have been made to the rules, allowing them to become more practical and flexible.

The Produce Safety Rule applies only to fruits and vegetables consumed raw and in large quantities, such as potatoes, carrots, apples, and onions. It is not applicable on rarely-consumed commodities, such as winter squash.

Water Testing
Water testing is the most crucial component of FSMA’s Produce Safety Rule. Water is the main source of nutrition for produce and why the FDA is taking a firm stance on requiring farmers to have a microbial water quality profile. To ensure the adequate sanitary quality of water consumed by the produce, farmers and producers must submit periodic water samples. The testing frequency depends on the type of water — surface or ground.

Surface - Untreated surface water for growing produce, other than sprouts, is considered the most vulnerable to external influences. Therefore, surface water should be tested more frequently (five times per year after the initial survey). The initial survey consists of a minimum of 20 samples.

Ground - Untreated groundwater for produce, other than sprouts requires an initial survey with a minimum of four samples, plus an additional, random sample per year.

The final rule consists of two sets of criteria for microbial water quality, which test for generic E. coli.

  • No detectable E. coli is allowed for agricultural water, such as water used on food-contact surfaces and water used to wash hands that come in contact with produce during and after harvesting. If E. coli is detected, the water must no longer be used immediately, and corrective actions must be taken.
  • Water that is directly applied to growing produce must meet the geometric mean (GM) and the statistical threshold (STV) of “the GM of samples is 126 or less CFU of generic E. coli per 100 mL of water and the STV of samples is 410 CFU or less of generic E. coli in 100 mL of water.”

All growers are given two to four years for sampling, and sampling begins on January 1, 2018.

Water used for sprouts does not require any testing. Moreover, the rules for water testing are flexible and are designed to facilitate growers. Even if the water sample fails to fulfill the STV or GM criteria, growers would not be directed to discontinue water supply immediately. Instead, radical steps, such as helping the grower treat water and remove the sources of contamination, would be taken with the aid of the FDA before the final reinspection and discontinuation of water would be treated as a last resort.

Biological Soil Amendment
The rule also imposes a specified limit on farmers regarding the use of raw manure and fertilizers. Application methods and time intervals for fertilizers and manure are 120-day interval for crops in contact with the soil and 90 days for crops not in contact with soil to ensure safe and healthy produce. 

Equipment, Tools, And Buildings
Farm personnel are further required to follow a strict cleanliness protocol; moreover, a set of recommendations is also proposed for the sanitation of tools and equipment being used in the field. 

Tools and equipment must be:

  • Of adequate construction, design, and workmanship. Tools and equipment must be able to be properly cleaned and maintained.
  • Stored and maintained to prevent pests from harboring in the equipment and contaminating the produce.
  • Inspected, cleaned, sanitized, and maintained. Food-contact surfaces of the equipment and tools must also follow these rules to protect against contamination.
  • Using instruments or controls that are accurate, precise, and adequately maintained

Worker Training, Health, And Hygiene
Additionally, farm personnel will be required to receive formal training from supervisors on food hygiene and food safety, as well as health and personal hygiene. At least one supervisor must successfully complete food safety training deemed adequate by the FDA. 

A separate set of rules are defined for domestic animals, which require farmers to “take all measures reasonably necessary to identify and not harvest produce that is likely contaminated.” Farmers are asked to visually examine the area they will, and if there is significant evidence of possible contamination, the farmer must take measures, such as placing flags outlining the affected area. Although the final rule does not require establishing waiting periods between grazing and harvest, the FDA encourages farmers to voluntarily consider applying such intervals as appropriate for the farm’s commodities and practices. The agency will consider providing guidance on this practice in the future, as needed. 

Although these are the current final rules, the rules will be constantly modified because of feedback from the agricultural sectors. Those affected by the rules want to create safe food, but in a way that is both practical and efficient.

Who The Produce Safety Rule Affects
Everyone in the fresh food supply chain will be affected by FSMA’s Produce Safety Rule. Farmers are the first block of the long chain and their actions directly impact the quality of the product. It goes without saying their operations will be impacted by the Produce Safety Rule. Those who are part of a farm’s supply chain — processors, manufacturers, store owner, etc. — will need to comply with FSMA’s Preventive Controls Rule. Lastly, farm processors, direct food marketers, and food hub owners also need to comply with the final rule.

The U.S. has enacted its biggest change to our food safety laws in more than 70 years with FSMA. Many believe this is long overdue and the lack of produce safety rules in the past has resulted in more than 100,000 Americans being hospitalized each year, with a percentage of them dying. The FDA will ensure the implementation of these rules in coming years. The Produce Safety Rule is one of the most decisive rules, as it presets basic rules for producers. These rules will ensure contamination-free production, which is the major highlight of FSMA; prevention is better than response. Although the testing of water samples is a long and painstaking process, with proper government backing it is believed to yield remarkable results for the American population.

About The Author
Pamela Sweeten is an authority on the Food Safety Modernization Act. She has worked in the agricultural industry for over twenty years.  Pamela works with growers, manufacturers and transporters.  She specializes in increasing efficiency and ensuring the safety and integrity of their food from farm to table through the use of tracking, data storage technology.   Pamela is available to advise on products and processes of cleaning and sanitation practices. She can be contacted at to help you to train staff, assist your operation in evaluating and establishing food safety protocols and processes, in addition to answering your food safety questions.