Commentary: Farmers question practicality of FDA food safety rules

Issue Date: January 27, 2016
By Chelsea Molina
Chelsea Molina
The U.S. Food and Drug Administration under the Food Safety Modernization Act has defined agricultural water as, “any water that is likely to, or will contact covered produce or the harvested or harvestable portion of the crop.”

Now that the U.S. Food and Drug Administration's Food Safety Modernization Act has become the law of the land, those of us working in agriculture—especially the farmers and food companies that will be directly impacted by the rules—are left scratching our heads on what it all means and how it will be interpreted, implemented and enforced on farms and agricultural operations.

Five years ago this month, FSMA was signed into law. Since then, we have done anything but wait patiently for the FDA to release the final rules that would affect how farmers and those involved in agriculture, grow, harvest and handle food. FDA proposed seven foundational rules to implement FSMA and based on feedback from public comments, webinars and listening sessions, in fall of 2014, the agency repurposed certain aspects of four of the rules.

One of the most anticipated repurposings was for the final produce safety rule, released in November 2015. The FDA states that the revisions were designed to make the rule more practical, flexible and effective. However, even after Farm Bureau was actively engaged in the rulemaking process and offered many comments, the revisions still leave us questioning its "practicality" and clarity.

In an effort to clarify the produce safety rule, Farm Bureau jointly sponsored two informational sessions in Tulare and Seaside, hosted by FDA and the California Department of Food and Agriculture, where FDA recognized that the rule is not perfect.

At the Seaside presentation that I attended, FDA senior policy advisor Ritu Nalubola focused on the produce safety rule's key requirements including: agricultural water, biological soil amendments, worker training, health and hygiene, equipment, tools and buildings, sprouts, and domesticated and wild animals.

As we continue to seek clarification and wait for FDA to release guidelines of detailed and specific information that farmers are expected to know and follow, here are some quick examples of how the rule may affect farmers' everyday practices.

Let's start with water. FDA defined agricultural water as, "any water that is likely to, or will contact covered produce or the harvested or harvestable portion of the crop."

In the final rule, two sets of criteria are established for microbial water. First, no detectable generic E. coli are allowed for certain uses of agricultural water. Stringency of microbial criteria is dependent on use, but some examples include water for handwashing, water that contacts produce surface and postharvest wash. Second, rather than a single test, a geometric mean (GM) and statistical threshold value (STV) will be used for measurement of microbial bacteria in agricultural water. For growing activities such as irrigation, the GM of samples must be 126 colony forming units (CFU) or less of generic E.coli per 100 milliliter of water and the STV of samples is 410 CFU or less of generic E.coli in 100 mL.

The rule allows for microbial die-off in the field up to four consecutive days between the last irrigation and harvest and it allows for microbial reduction or removal postharvest through commercial practices or storage.

Requirements for water testing are categorized by untreated surface water and untreated groundwater. Untreated surface water requires 20 samples in the first two to four years to establish a baseline and then five samples every year thereafter. The testing requirements for untreated groundwater include four samples in the first year to establish a baseline and then a minimum of one sample every subsequent year.

The biological soil amendments section requires that raw manure applications must follow a 90- or 120-day pre-harvest interval depending on whether the manure comes in contact with the produce or not. Certified compost does not have a preharvest interval.

Training and employee health and hygiene are important requirements in the new rule. Any employees, including supervisors who handle produce or contact food surfaces, must be trained on certain topics, including the importance of health and hygiene.

Standards related to equipment, tools, and buildings are covered in the rule, which includes greenhouses, germination chambers and similar structures, and hand-washing facilities. Measures that must be taken to comply with the rule involve appropriate storage, maintenance, and cleaning of equipment and tools.

The rule also incorporates requirements specific to sprouts. This includes testing of spent sprout irrigation water from each production batch of sprouts for certain pathogens. Sprouts will not be allowed to enter the market until it is verified that these required pathogen test results are negative.

One of the most unpractical portions of the rule falls under the domesticated and wild animals section. The rule declares that farmers are required to take all measures reasonably necessary to identify and not harvest produce that is likely to be contaminated from animal intrusion. At a minimum, this requires all covered farms to visually examine growing areas and all covered produce they plan to harvest.

The average farm size in California is 312 acres. For those not on a farm every day, it is hard to envision what an acre looks like. With Super Bowl right around the corner, I have to lean to my favorite comparison. An acre is about the size of a football field. To visually examine animal intrusions on that amount of land before and during the peak of harvest is not practical, as FDA eluded to with the release of the repurposed rule.

There are many areas in this rule that remain unpractical and unclear and we only have about two years before the first compliance dates are set to take effect. In the meantime, I encourage all farmers, large or small, to continue to become familiar with the rule and contact the CFBF Federal Policy Department with questions or concerns.

We will be partnering with the American Farm Bureau Federation to offer in-depth FSMA trainings this year, so stay tuned.

(Chelsea Molina is a federal policy legislative analyst for the California Farm Bureau Federation. She may be contacted at

Permission for use is granted, however, credit must be made to the California Farm Bureau Federation when reprinting this item.