E. Coli in Leafy Greens Called a “Reasonably Foreseeable Hazard” by FDA: What Does it Mean for Growers?

After a new wave of Shiga toxin-producing E. coli (STEC) outbreaks in romaine lettuce that started in 2018, leafy greens have been synonymous with risk even for those outside the food supply chain. Since the outbreaks, the industry has started taking additional steps to reduce the hazard and make leafy greens safer for consumers.

Traceback investigations linked the outbreaks of E. coli O157:H7 to California’s Central Valley including a 2018 outbreak associated with the Santa Maria region and a 2019 outbreak traced to the Salinas Valley. In April 2021, FDA released its investigation report, updated the Leafy Greens STEC Action Plan, and stated that this strain of E. coli O157:H7 is now considered a “reasonably foreseeable hazard” in the Central Valley.

Even though growers were aware of leafy greens as a potential risk before now, the new designation essentially raises the bar for preventing E. coli O157:H7.

What is a “Reasonably Foreseeable Hazard”?

A reasonably foreseeable hazard is any food safety risk that a reasonable person could predict based on past evidence and an understanding of the food production process. FDA will declare something to be a reasonably foreseeable hazard in order to protect consumers against risks that are well known to be associated with a certain crop, region, or climate.

Risks exist anytime a ready-to-eat food is exposed to the environment before it is packaged and the food, once packaged, can’t be treated for the potential pathogen. The primary risk categories are biological hazards like bacteria, chemical hazards like pesticides, and physical hazards like animal intrusion. Beyond that, all risks can be broken down into two types: inherent and non-inherent. Inherent risks are unavoidable in the food production process. Things like risky adjacent land use can’t be avoided, but should be minimized through process controls. Non-inherent risks can be avoided. This category includes things like using contaminated agricultural water, which a grower can prevent entirely though better standard operating procedures.

Both types of reasonably foreseeable hazards are addressable and by adding them to its list,  FDA expects food producers to put the appropriate controls in place. If an audit reveals a reasonably foreseeable hazard that wasn’t part of an operation’s food safety plan, the potential consequences and fines are higher. Incidents involving reasonably foreseeable hazards allow greater control by FDA compared to incidents related to an unforeseen risk that a producer couldn’t reasonably be expected to anticipate.

Why This is a Change

Although E coli was a known hazard before, it is meaningful that FDA has specifically called E. coli O157:H7 “reasonably foreseeable.”

FDA’s report on recent outbreaks of this strain of E. coli showed key trends providing strong links to support that leafy green contamination by this pathogen is linked to adjacent or upland cattle activity. In their report, FDA said: “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.”

This new evidence means that growers can and should implement specific controls to avoid predictable risks of cattle feeding or grazing near leafy green production. Food Safety News stated that “The message is that, without effective preventive measures, such leafy greens are in violation of federal food safety regulatory standards.” Although it might not mean FDA will go out and start issuing new fines, it does signal a heightened urgency around this hazard.

What Do Growers Need to Do Now?

Growers in California’s Central Valley growing region need to start planning for E. coli O157:H7 and implement preventive controls where possible. FDA’s Produce Safety Rule dictates that growers need to take steps to identify and not harvest potentially affected covered crops, and when harvesting covered crops, take all established precautions to avoid contamination.

These are some of the concrete steps a grower can take

1. Evaluate hazards: The FDA requirement states: “You must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control.” Food safety teams need to think through every step in their growing and harvesting process as well as the scientific evidence and past events, and note every hazard.
2. Consider and evaluate risk posed by adjacent land use: Since this strain of E. coli is linked to adjacent land use, it’s critical to communicate with nearby land users to evaluate local risks and figure out how to implement a plan for E. coli O157:H7. 
3. Emphasize prevention: The FSMA Produce Safety Rule and Good Agricultural Practices have established recommendations for putting preventive measures in place. These should be included in every SOP and should be updated as often as needed.
4. Improve traceability: Traceability is a food safety pillar that can’t enhance prevention, but can facilitate a faster response to crises when they occur. Growers should acquaint themselves with new traceability requirements as they arise (read about the FDA’s Proposed Traceability Rule) and ensure that they have the recordkeeping capabilities in place to comply with future rules. 
5. Participate in provenance labeling: Labeling the general area where produce is grown is a less advanced traceability strategy than detailed PTI labeling, but at least allows the general location to be traced quickly in case of an outbreak so a recall can target the correct product quickly and keep consumers safe.
6. Implement enhanced recordkeeping: Documentation standards are rising every year, and the most prepared growers document around self-audits, visual field inspections, pre-harvest inspections, and corrective actions when inspections fail. Using a digital recordkeeping platform like HeavyConnect can make this step easier and means that records are accessible from anywhere in case of an emergency.
7. Conduct root cause analyses: When a pathogen is identified, growers should do all they can to learn how it occurred. This gives them a personalized learning opportunity to find out what could have been done differently to avoid the same risk in the future.

Small farms are exempt from FDA’s Produce Safety Rule, but should still follow Good Agricultural Practices in order to keep their products safe from known risks, including E. coli.

Staying Prepared & Coexisting with Hazards

Most growers, packers, and shippers already had plans in place to protect against risks in leafy greens production, so this new announcement shouldn’t pose a large additional burden. Food safety professionals are accustomed to looking ahead and staying aware of existing and emerging threats. It’s important to have a food safety team and SOPs in place that can adapt quickly to new risks. By learning from industry news, outbreak investigations, and neighboring growers, they can take action to get ahead of reasonably foreseeable hazards like E. coli O157:H7.