• Nicole Cook

What does the FDA think is a “reasonably foreseeable hazard” in produce safety?


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Farms subject to the FSMA Produce Safety Rule are required to take all measures reasonably necessary to identify, and not harvest, produce that is likely to be contaminated with a “known or reasonably foreseeable hazard.” But, what qualifies as a “reasonably foreseeable hazard?” According to the FDA, growers in central California should now consider a particular strain of E. coli a “reasonably foreseeable hazard,” and all leafy green growers should take precautions to prevent contamination stemming from animals and activities on land that’s adjacent to their farm.


In April, the FDA released a report on its investigation of multiple outbreaks of E.coli O157:H7 illnesses in 2018, which were linked to romaine lettuce from the Santa Maria growing region of California, and 2019, which were linked to romaine lettuce from the Salinas growing region of California. In its investigation, the FDA found that the E. coli O157:H7 strain found in the leafy greens was the same strain identified in a sample of cattle feces taken alongside a road approximately 1.3 miles upslope from a produce farm with multiple fields tied to the outbreaks by the traceback investigations. In addition, the FDA found that the same strain was collected from a fecal sample in 2020 and tied to an outbreak that happened in 2020, which was tied to leafy greens grown in the Salinas growing region of California. As a result of this as well as other investigations, the FDA stated that it had identified key trends associated with the reoccurring contamination of leafy greens by E. coli O157:H7; most significantly, cattle operations located adjacent to and upland from the produce fields.

In its report, the FDA says that illness outbreaks in 2017, 2018, 2019, and 2020 are not a new phenomenon, and that “recent investigation findings and previous foodborne illness outbreak investigation findings dating back to 2013 suggest that a likely contributing factor for pathogenic E. coli contamination of leafy greens has been the proximity of cattle. Cattle have been repeatedly demonstrated to be a persistent source of pathogenic E. coli including E. coli O157:H7.” Accordingly, the FDA specifically recommended that industry, at least in the California Central Coast Growing Region, consider this particular strain of E. coli O157:H7 a “reasonably foreseeable hazard."


Under the FSMA Produce Safety Rule (21 CFR 112.112 and 112.113), farms must take all measures reasonably necessary to identify, and not harvest, a covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard; and handle harvested covered produce during covered activities in a manner that protects against contamination with known or reasonably foreseeable hazards.

So, now that the FDA has said that the strain of E. coli found in California’s Central Coast Growing Region should be considered a “reasonably foreseeable hazard,” what do the farms have to do to be compliant with the FSMA Produce Safety Rule?


The FDA recommends that all producers of leafy greens:

  • Be aware of and consider risk that may be posed by adjacent land use, especially as it relates to the presence of livestock and the interface between farmland, rangeland, and other agricultural areas.

  • Emphasize efforts around prevention

  • Assess growing operations to ensure implementation of appropriate science- and risk-based preventive measures, including applicable provisions of the FSMA Produce Safety Rule and good agricultural practices

  • Improve traceability

  • Increase digitization, interoperability and standardization of traceability records along the entire leafy green farm to store continuum, which would expedite traceback and prevent further illnesses. This is important at not only the grower level, but critical for shippers, manufacturers, and retailers as well, to improve overall traceability throughout the supply chain.

  • Improve industry-led provenance labeling

  • After the 2018 outbreak of E. coli associated with romaine lettuce, growers led a change in labeling to identify growing region on packaged romaine lettuce. While better food traceability back to farm is the ultimate goal, as an interim measure, provenance-labeling has been helpful in identifying during traceback investigations where potentially contaminated romaine was grown. Thus, industry should consider adoption of improved (with more detailed specificity beyond the current region designations) and expanded (to leafy greens products beyond just romaine lettuce) labeling to further protect consumers in the event of a product recall and minimize the amount of discarded product.

  • Conduct a root cause analysis when a foodborne pathogen is identified in the growing environment, in agricultural inputs (e.g., agricultural water or soil amendments), in raw agricultural commodities, or in fresh-cut ready-to-eat produce to identify how this contamination occurred

The FDA also updated its Leafy Greens Action Plan as a result of its investigation. The 2021 updated plan includes a renewed emphasis on actions to prevent contamination stemming from activities on adjacent land.


This is the first time that the FDA has identified something as a specific reasonably foreseeable hazard, and growers in California at least will have to take all measures reasonably necessary to identify, and not harvest, produce that is likely to be contaminated with it. Growers throughout the country, including in Maryland, who complete the FSMA Produce Safety Rule training. learn how to assess particular attributes like the topography and activities on adjacent land along with other factors when determining whether their produce is likely to be contaminated with a “known or reasonably foreseeable hazard.


Growers who are interested in attending a FSMA Produce Safety Rule training online should check out the Produce Safety Alliance (PSA) website for upcoming courses. Because the PSR is a federal law (applied and enforced in Maryland by the Maryland Department of Agriculture), Maryland growers can take a PSA-approved grower training offered in another state to satisfy the legal requirement for attending. Remote delivery opportunities are a temporary option being supported during the COVID-19 outbreak. This policy will be in effect until March 31, 2022, with the potential for extension pending updates on the pandemic, after which the PSA expects to revert to in-person training requirements.


And, you can find more information about updated food safety resources from ALEI in the April 2021 edition of the ALEI Quarterly Newsletter.


#ALEI #alei #foodsafety #FSMA #ProduceSafetyRule

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