The FDA today published its “Investigation Summary: Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E. coli O157:H7.”

First, a hat tip to the FDA investigators for getting at the report critically fast and during the governmental shutdown.  It is prompt, science based, investigations that will identify the “root cause” of an outbreak that will then be used to stop or at least minimize future foodborne illness clusters of outbreaks. Despite the good work, however, except for the one named farm the rest of the traceback work is shrouded in mystery.  The FDA and the leafy green industry knows way more than it is telling the public, and that is wrong for too many reasons.

Some interesting, and alarming findings the outbreak and the initial investigation impressions:

• There were 62 reported illnesses in 16 states and the District of Columbia, resulting in 25 hospitalizations and two cases of hemolytic uremic syndrome (HUS). There were no deaths. However, the FDA and the CDC just gives the public numbers, not some of the brutal realities of the long-term impacts like the 70-year-old New York woman who will remain on dialysis for the rest of her life or the 3-year-old Canadian boy who suffered severe brain damage and will require a life time of ongoing care.
• All E. coli O157:H7 isolates in Fall of 2018 from ill consumers had a rare genetic fingerprint, as determined by whole genome sequencing, that was closely related to one previously seen in ill consumers in the U.S. and Canada in the Fall of 2016 and the Fall of 2017. This is significant as it indicates, not only has there been multiple, significant E. coli outbreaks, but they are likely linked to the same growing region and probably the same farm.
• The romaine lettuce that made people sick was likely harvested between late September and mid-November 2018, a conclusion based on: known production practices; the anticipated shelf-life of romaine lettuce; and the fact that reported illness- onset dates occurred from October 7 through December 4, 2018.

Through its investigation the FDA has identified the following factors and findings as those that most likely contributed to the contamination of romaine lettuce from one farm (Adams Brothers Farm) in Santa Maria in Santa Barbara County, California, that was linked to some illnesses during this outbreak.

• The outbreak strain of E. coli O157:H7 was found in the sediment of an on-farm water reservoir in Santa Maria in Santa Barbara County, California.
• The outbreak strain was not found anywhere else in sampling done during the investigation in various California leafy greens growing areas and counties.
• FDA has concluded that the water from the on-farm water reservoir where the outbreak strain was found most likely led to contamination of some romaine lettuce consumed during this outbreak.
• Traceback investigation analysis indicated that other ranches owned by the same farm as well as other farms may have introduced into commerce contaminated romaine lettuce or other produce items. These other farms did not use water from the water reservoir where the outbreak strain of E. coli O157:H7 was found and FDA was unable to identify a potential source of contamination.
• FDA has concluded that the water from the on-farm water reservoir where the outbreak strain was found was most likely not effectively treated with a sanitizer and this may have led to contaminated water directly contacting romaine lettuce after harvest or by the washing/rinsing harvest equipment food contact surfaces.
• There are several ways in which water from the on-farm water reservoir may have come into contact with the implicated romaine lettuce, including direct harvest/postharvest application to the crop and/or use of reservoir agricultural water on harvest equipment food contact surfaces.
• Foodborne illness outbreaks caused by this specific strain of E. coli O157:H7 occurred in 2016, 2017, and 2018, indicating that the outbreak strain may have either persisted in the environment or may been repeatedly introduced into the environment from an unknown source. Public health officials in the U.S. and Canada were unable to definitively confirm the food vehicle and ultimate source(s) of the 2016 and 2017 illnesses.

Despite finding that E. coli outbreaks spanning years likely came from the same are or farm and was most likely caused by the same factors enumerated above, the FDA only sets forth “recommendations” that growers of leafy greens assess their growing operations for compliance with applicable requirements of the FSMA Produce Safety Rule and GAPs, including (see my snide comments in bold):

• Assure that all agricultural water (water that directly contacts the harvestable portion of the crop and/or food contact surfaces and harvest equipment) used by growers is safe and of adequate sanitary quality for its intended use. This may (not must) include the development and use of validated and verified treatment of agricultural water, when growers choose to use agricultural water treatment as a preventive measure (any agricultural water treatment must also adhere to any other Federal, State, Local, or other regulations on implementation);
• Assess and mitigate risks related to wild animal intrusion that may contaminate agricultural water (without a requirement to do so);
• Assess and mitigate risks related to land uses near or adjacent to agricultural water sources that may contaminate agricultural water (without a requirement to do so); and
• Perform 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. The goal of a root cause analysis is to determine the likely source of the contamination, if prevention measures have failed, and whether additional measures are needed to prevent a reoccurrence (without a requirement to do so).

Other FDA recommendations have a broader target audience.

• FDA urges (at least it is not begging) other government and non-government entities, produce growers and trade associations both domestically and internationally to develop real time procedures to quickly explore the possible scope, source(s) and route(s) of contamination when human pathogens of public health significance are detected by routine pre-harvest or finished product verification testing. Local in-depth knowledge and actions are critical in helping determine likely potential routes of contamination of leafy greens in the regions in which they are grown. This information is critical to developing and implementing appropriate science and risk based preventive measures to reduce the potential for another outbreak associated with leafy greens or other fresh produce commodities. Widespread sharing of such findings among the leafy greens and produce industry would also be helpful to increase awareness of potential routes of contamination and preventive measures (without a requirement to do so).
• FDA continues to recommend (suggest, plead, beg, whine) that leafy green growers, buyer/shippers, and retailers be able to trace product back to the specific source in real time and make information about the source, such as harvest date and standardized growing regions, readily available for consumers on either packaging, point of sale signs, or by other means. In response to this outbreak FDA requested, and the leafy greens industry agreed to provide, voluntary labeling of romaine lettuce products to provide consumers with information on where their romaine lettuce is grown and the date on which it was harvested. The purpose of this new voluntary (why voluntary?) labeling was to help consumers discern, in the event of an outbreak, whether romaine lettuce products available for purchase at retail stores or restaurants were harvested after the outbreak or not grown in an implicated growing region. The voluntary labeling also provides for improved romaine lettuce traceability and, if need be, provides FDA with the ability to focus future public health communications about the safety of romaine lettuce from a particular growing region or harvest date.
• FDA strongly encourages (emphasis on “strongly”) the entire leafy greens supply chain to adopt traceability best practices and state-of-the-art technology to assure quick, accurate and easy access to key data elements from farm to fork when leafy greens are involved in a potential recall or outbreak. Fresh produce, including leafy greens, are a highly perishable commodity, and traceability information should facilitate the rapid tracking of implicated product throughout the entire supply chain to expedite its removal from commerce, prevent additional consumer exposures, and properly focus any recall actions. A key element that would assist tracing efforts during an outbreak is the ability to identify specific farms or ranches and dates of harvest for product that contribute to production lots if product has been commingled. While it is important to understand where the product was grown and not simply the location of the business entity that shipped or processed it, it is equally important to be able to determine which farm(s) and growing region(s) are responsible for supplying the contaminated product, and the time frame when product was supplied.
• This information is crucial to the development of accurate public health messages to protect the public and empower retail establishments and consumers to take appropriate actions to prevent exposure. Without the ability to identify the growing region or specific suppliers of suspected shipments, public messaging by FDA and other public health partners during outbreaks or recalls will continue to be broad out of necessity, likely including farms and growing regions that are not responsible for the contamination. If supplier data are maintained when the product is co-mingled and consumers can differentiate where and when product was harvested, it is easier to narrow the number of suspected shipments and suppliers of the contaminated product once it is processed – after so many outbreaks the co-mingling and lack of transparency may well be the point – keep things confused and perhaps no one will be singled out?

My takeaway?  FDA has the skill to help industry combat these outbreaks by getting to the likely “root cause” of an outbreak.  However, the FDA is hampered by lack of public transparency with its traceback findings.  This lack of transparency leaves the public in a fog as to how to be smart consumers of a food product that has an unfortunate history that is likely to be its future as well.  Furthermore, it is past time for pleas and voluntary requirements.  The FDA and the leafy green growers know what needs to be done to minimize illnesses and loss of life.  It’s past time for please!

I take a ferry to work guarded at times by now unpaid members of the Coast Guard.  Next week with increasing trepidation, I will go through TSA Security with more unpaid professionals on the job monitoring security to then board a plane to be routed to NYC by unpaid Air Traffic Controllers.  I am not sure I could focus on my job while wondering how bills were to be paid.

The shutdown hit close to home this morning when I opened my laptop at 5:30 A.M. to see a flood of hundreds of “Out of Office” notifications responding to emails generated from last night blog posts on Salmonella in flour and spinach.

Here are just a few:

“Thank you for your message. I am not in the office at this time. I am on furlough without access to email, due to the lapse in federal government funding. I will return your message as soon as possible once funding has been restored. For information about available government services, visit USA.gov.”

“Due to the absence of either an FY 2019 appropriation or Continuing Resolution for FDA, I am out of the office on furlough status and I am not able to read or respond to your message.”

“I am currently out of the office.” 

Odd way to run a government.