It was 2016 the last time an E. coli outbreak linked to romaine lettuce grown in California’s Salinas Valley didn’t usher in the fall season in the U.S. Each of these outbreaks carried a pathogenic calling card suggesting a recurring source of contamination- a specific genetic “fingerprint” of E. coli O157:H7.  Three years of investigations prompted suggested industry improvements that did not prevent the recurrence of widespread illness. But this year things will be different. At least in Canada.


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On October 2, the Canadian Food Inspection Agency (CFIA) announced it would be implementing temporary import conditions on romaine lettuce originating from the Salinas Valley counties including Santa Cruz, Santa Clara, San Benito and Monterey. These measures include all shipments arriving in Canada from October 7 to December 31, 2020. To be allowed importation, the products must meet the following seven requirements:

  1. The importer must have a valid Safe Food for Canadians license.
  2. If the product is not from the Salinas Valley, the importer must provide “Proof of Origin” that indicates the state and county where the product was harvested. This document must be on official company letterhead and bear the signature of the exporter and the date the letter was signed by the exporter.
  3. If a Proof of Origin is not available, the importer must provide a Certificate of Analysis demonstrating that the product has been tested and does not contain detectable levels of E. coli O157:H7.
  4. If neither a Proof of Origin or Certificate of Analysis is available at the time of import, the importer must submit a Conditional Release form allowing the product to be tested by Canadian authorities.
  5. Romaine grown in Arizona must be handled by a certified member of the Arizona Leafy Greens Marketing Agreement (LGMA).
  6. Romaine grown in California must be handled by a certified member of the California LGMA.
  7. Romaine and products containing romaine grown in the Salinas Valley counties must be accompanied by a Certificate of Analysis demonstrating that the product has been tested and does not contain detectable levels of E. coli O157:H7. This certificate must show:
    • The name of the client that requested the test.
    • The name of the laboratory that conducted the sample.
    • The date the sample was collected.
    • The Certificate number
    • A description of the product.
    • The methodology.
    • The sample weight and number of units.
    • The test result.
    • The test date.

The CFIA defined sample sizes and lots and requires that both the laboratory performing the test and the method of testing be accredited by the Standards Council of Canada (SCC), the Canadian Association for Laboratory Accreditation (CALA), or another accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA).

It also specified that the testing must be done post-processing, meaning the romaine cannot be sampled for testing during the growing process. The CFIA provided the following examples of acceptable test times:

  • Field-packaged romaine hearts could be sampled after cooling and just before they are loaded into a transport truck destined for Canada.
  • Bulk romaine could be sampled just before it is loaded into a transport truck destined for Canada.
  • Mixed salad sold in bags could be sampled during the packaging process at the processor in the USA.
  • Any product can be sampled after arriving in Canada and held pending the certificate of analysis.

E.coli lawyer -romaine lettuce in a white bowl on a table

U.S. Growers Push Back

The United Fresh Produce Association, the Produce Marketing Association and the California LGMA have all come out saying that the CFIA’s testing requirements are too onerous and complex. In particular, they say, it’s the post-harvest testing time that is most problematic.

The California LGMA says that industrywide testing on that scale isn’t possible in the timeframe provided, that industry staffing and storage is inadequate and that lab capacity simply doesn’t exist. It did not address the CFIA’s option to have the product tested in Canada.

Instead, the California LGMA is proposing pre-harvest testing. In addition, the member group says it has beefed up its irrigation water standards, enhanced testing on compost, increased the number of audits and started a pilot program on product traceback.

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What is a Reasonable Response Time?

If the U.S. leafy greens industry is saying the CFIA’s timeframe for better testing and documentation isn’t reasonable, what is? The restrictions were put in place not after one outbreak, but after four Canadian E. coli outbreaks in three years were linked to U.S. grown romaine. (Three of them coincided with the Salinas-grown U.S. outbreaks in 2017, 2018 and 2019. The fourth was part of the Yuma, AZ- grown romaine outbreak in 2018.)

The Salinas outbreaks sickened at least 275 people in the U.S., many were hospitalized, one person died. At least 19 of the people hospitalized developed hemolytic uremic syndrome (HUS) a form of kidney failure that is a complication of E. coli infections including one of our clients, 25-year-old Mariah Fisher Skadson of Brownsville, MN. She spent four days in the ICU in an induced coma. She was on a ventilator, had a feeding tube, and underwent dialysis for HUS. After Mariah’s infection was brought under control, she needed physical, occupational, and speech therapy to restore her health. Her illness is just one example of the hundreds.

Between 2009 and 2018, 40 U.S. E. coli outbreaks were linked to leafy greens, according to the Centers for Disease Control and Prevention (CDC). Together these outbreaks resulted in 1,212 illnesses, 420 hospitalizations, 77 cases of HUS and eight deaths.

After years of outbreaks linked to serious illness and death, where investigations were stymied by poor record-keeping, incomplete traceback capabilities, non-existent origin labels and inadequate product testing, one government agency decided it was time to move beyond suggested improvements. It just wasn’t ours.