Food Safety Modernization Act’s Mandatory Produce Inspection

By:  Diana E. McMonagle and Vander L. Beatty

The highly publicized romaine lettuce contamination incidents of 2018 have placed a sharp focus on the safety of the nation’s produce supply. The first outbreak of illnesses started in March of 2018.1 The Centers for Disease Control and Prevention (the “CDC”) recorded over two-hundred incidents of E. coli infection in thirty-six states, with twenty-seven people who developed kidney failure, as well as five deaths.2 Regulatory officials tracked the source of the contamination to romaine lettuce cultivated in the Yuma growing region.3 The second outbreak began in October of 2018, when more than sixty people were infected with a strain of shiga toxin-producing E. coli.4 The CDC received infection reports from 16 states and the District of Columbia, with twenty-five people hospitalized.5 Epidemiologic tests indicated the likely source of the outbreak was infected romaine lettuce harvested in the central coastal growing regions of northern and central California.6

The 2018 romaine lettuce events have not been the only contamination events linked to fresh produce. For example, in 2006, an outbreak linked to spinach contaminated with shiga toxin-producing E. coli resulted in one-hundred ninety-nine illnesses in twenty-six states. 7 More than one-hundred people were hospitalized, and three died.8 In 2011, an outbreak of Listeria monocytogenes was linked to the consumption of contaminated whole cantaloupes.9 The cantaloupes, which were grown in Colorado, caused illnesses in 28 states.10 Even though the cantaloupes were recalled, nearly 150 people became ill, of whom 143 were hospitalized, and 33 died.11

Fortunately, the legislative wheels have been in motion to improve the safety of fruits and vegetables. In 2011, Congress passed the Food Safety Modernization Act (“FSMA”).12 The law is momentous in that it was the first major reform of the food safety regime by the Food & Drug Administration (the “FDA”) in seventy years.13 FSMA shifted the FDA’s focus from reactive to preventive controls and expanded FDA powers to inspect and recall.14

Section 105 of FSMA, the Produce Safety Rule (the “PSR”), requires covered farms to implement preventive practices to decrease food safety risks related to fresh produce.15 The PSR was designed to reduce risks to public health arising from microbial contamination of produce and to enhance the FDA’s ability to trace microbial contamination outbreaks to their source.  Under the PSR, a covered farm is one that grossed more than $25,000 in produce sales annually during the previous three years.16 The PSR governs the growing, harvesting, packing, or holding of any fruit or vegetable, nut or herb, in its unprocessed state, that is usually consumed raw.17

The PSR requires covered farms to implement certain recordkeeping requirements.18 For example, covered facilities are required to create and implement a written food safety plan that includes, inter alia, a hazard examination, preventive measures and a recall program.19 The hazard examination should consider known or reasonably foreseeable biological, chemical, and physical hazards.20 If the hazard analysis identifies a hazard requiring preventive measures, the facility must have a written recall plan that describes the procedures to perform a recall of the product.21 The recall plan must include processes to inform consignees, alert the public, and appropriately dispose of recalled product.22

The FDA has issued a draft guidance providing recommendations to assist farms in developing their own food safety practices that comply with the PSR.23 The National Association of State Departments of Agriculture in combination with the FDA created a voluntary review program that allows producers to proactively determine how prepared they are to comply with the enforcement of the PSR.24 These voluntary reviews are called On-Farm Readiness Reviews and provide specific recommendations for improving farm operations and implementing best practices.25

Inspections of farms for compliance with the PSR began in July of 2019.26 It is expected that the initial inspections will be informational only, and fines for non-compliance will only be levied in egregious instances.27 The FDA released a new inspection form, FDA 4056 (Produce Farm Inspection Observations Form), which will be used by the FDA to provide feedback to farms on their compliance with the PSR.28 This will be used in place of the traditional FDA inspection form 483.

The efforts to keep the nation’s food products safe continues, and it is hoped that the PSR will provide a practical means for FSMA to accomplish its overall goal to prevent potentially devastating and deadly outbreaks before they occur.


  1. Centers for Disease Control and Prevention, E. Coli Outbreaks, 2018 Outbreaks,
  2. Id.
  3. Id.;, (“The Yuma growing region is part of the Arizona/California area known for producing $4 billion of leafy greens annually, or about 90 percent of the country’s leafy greens.”)
  4. Centers for Disease Control and Prevention, E. Coli Outbreaks, 2018 Outbreaks,
  5. Id.
  6. Id.
  7. FDA,
  8. Id.
  9. Id.
  10. Id.
  11. Id.
  12. Pub. L. No. 111-353, 124 Stat. 3885 (2011).
  13. Renee Johnson, The Federal Food Safety System: A Primer, Congressional Research Service Report, RS22600 (Jan. 11, 2011).
  14. Michael R. Taylor, FDA Deputy Commissioner for Foods, The FDA Food Safety Modernization Act: Putting Ideas into Action, Presentation to the Food & Drug Law Institute Food Safety Conference, Jan. 27, 2011; available at
  15. Prior to the enactment of FSMA, “the FDA ha[d] oversight of more than 44,000 U.S. food manufacturers, plus well over 100,000 additional registered food facilities such as warehouses and grain elevators. In addition, some 200,000 foreign facilities are registered with the agency. Various estimates of unannounced compliance inspections of domestic establishments by FDA officials range from once every five years to once every 10 years, on average, although the agency claims to visit about 6,000 so-called high risk facilities on an annual basis.” Renee Johnson, The Federal Food Safety System: A Primer, Congressional Research Service Report, RS22600, 2 (Jan. 11, 2011).
  16. 21 C.F.R. § 112.1(a)(1).
  17. Id.; 80 Federal Register 228 (November 27, 2015), p. 7452.
  18. 21 CFR § 112.141-150.
  19. See FDA,
  20. Id.
  21. Id.
  22. Id.
  23. FDA,
  24. National Association of State Departments of Agriculture,
  25. Id.
  26. Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration; Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response; Melinda Plaisier, FDA Associate Commissioner of Regulatory Affairs, See
  27. FDA,
  28. National Association of State Departments of Agriculture,