• The Canadian Food Inspection Agency (CFIA) announced  that it is temporarily imposing import restrictions on romaine lettuce grown in the U.S.  CFIA specifies a number of ways to demonstrate that the romaine is suitable for importation, such as documenting that the romaine does not originate from the Salinas Valley of California or providing a certificate from an accredited laboratory confirming that the lettuce does not contain detectable levels of E.coli.
  • The requirements follow several outbreaks of foodborne E.coli illnesses in Canada and the United States that have been traced to romaine lettuce.  Investigations conducted by American and Canadian authorities identified the California counties of Santa Cruz, Santa Clara, San Benito and Monterey—where the Salinas Valley is located—as recurring sources of the outbreaks.
  • CFIA’s temporary import conditions are in effect from October 7, 2020 through December 31, 2020 and apply to all shipments of romaine lettuce from the U.S.
  • On December 12, 2019, the Food and Drug Administration (FDA), in conjunction with the Centers for Disease Control and Prevention (CDC) and state and local partners, reported an update of its investigation tracking three separate outbreaks linked to romaine lettuce caused by three different strains of E. coli O157:H7.  FDA reported that, through its traceback investigation (pursuant to which investigators from FDA, CDC, the California Department of Food and Agriculture (CDFA), and California Department of Public Health (CDPH) reviewed hundreds of supply chain records, visited several fields, and took a variety of samples from water, soil, soil amendments/compost, scat, and swabs), the agency was able to identify a common grower linked to the outbreaks in Salinas, California, based on available supply chain information.  FDA noted, however, that romaine from this particular grower does not appear to account for all of the illnesses in these outbreaks.
  • On January 15, 2020, FDA provided an update on the status of the investigation, as well as recent findings by the agency based on its further investigation of fields linked to the common grower it had previously identified.
  • In the January 15 statement, FDA officially lifted its November 22, 2019 consumer advisory (to avoid romaine lettuce grown in Salinas), as the growing season for this region has concluded, and FDA found there was no longer a need for consumers to avoid it.  Additionally, FDA and CDC had been tracking two multi-state romaine lettuce outbreaks (one that sickened 167 people in 27 states, and another, linked to salad kits, that sickened 10 people in five states), as well as a third outbreak in Washington State (that sickened 11 people).  In its January 15 statement, FDA also declared each of these outbreaks to be officially over.
  • As reported on this blog, on February 13, 2019, FDA released findings from the Agency’s investigation of the November 2018 outbreak of E. coli O157:H7 infections involving romaine lettuce. Those findings concluded that water from on-farm water reservoir, which was likely not effectively sanitized, most likely led to contamination of some of the romaine lettuce. In a statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Frank Yiannas, the leaders noted that moving forward, “[o]ur first goal is working with federal, state and industry partners on implementing best practices to try and prevent these outbreaks in the first place.”
  • The recent romaine lettuce outbreaks in 2018 occurred after FDA sought to extend the compliance dates for the agricultural water requirements of the Produce Safety Rule by an additional two to four years (for produce other than sprouts) in a September 2017 Proposed Rule. (82 FR 42963). The new agricultural water compliance date the FDA is proposing for the largest farms is January 26, 2022. Small farms and very small farms would have until January 26, 2023 and January 26, 2024, respectively.
  • Chair of the Congressional Food Safety Caucus, Congresswoman Rosa DeLauro condemned FDA’s delay of the Produce Safety Rule in light of the report on the romaine lettuce recall. “The FDA’s investigations into last year’s romaine lettuce recalls have confirmed what we already knew to be true: dirty irrigation water contaminates produce and makes people sick…Eight years after the Food Safety Modernization Act was signed into law, it is long past time these important rules went into effect—not delayed into the next decade.” FDA has yet to finalize its proposed extension of the Produce Safety Rule’s agricultural water requirements.
  • As previously reported on this blog, in November 2018 FDA, in conjunction with the CDC, state officials, and Canadian food and public health officials, investigated an outbreak of E. coli O157:H7 infections in multiple US states and Canadian provinces. The investigation determined the cause of the outbreak was the consumption of contaminated romaine lettuce. Indeed, thirty (83%) of 36 ill consumers interviewed reported eating romaine lettuce the week before illness onset. All E. coli O157:H7 isolates from ill consumers had a rare genetic fingerprint, as determined by whole genome sequencing (WGS), that was closely related to one previously seen in ill consumers in the fall of 2016 and the fall of 2017. The November 2018 outbreak was declared over in the US on January 9, 2019.
  • On February 13, 2019, FDA released the findings from the Agency’s investigation of the November 2018 outbreak. With the help of WGS, investigators were able to narrow down the growing location of the romaine lettuce to specific California counties. The traceback investigation further identified multiple farms that may have been the cause of the outbreak.
  • In their report, FDA identified factors that most likely contributed to the contamination of romaine lettuce, specifically from one farm in Santa Maria in Santa Barbara County, California. Those factors include the following:
    • The outbreak strain of E. coli O157:H7 was found in the sediment of an on-farm water reservoir in Santa Maria.
    • The outbreak strain was not found anywhere else in sampling done during the investigation in various California leafy greens growing areas and counties.
    • The water from the on-farm water reservoir most likely led to contamination of some of the romaine lettuce. The water was likely not effectively sanitized. The water may have come in contact with the romaine through multiple avenues, including direct harvest/postharvest application and/or use of water on harvest equipment.
    • FDA is not sure how the water became contaminated.
    • Other ranches owned by the same farm, as well as other farms, may have sold contaminated lettuce.
    • Due to the fact that the same specific strain of E. coli O157:H7 occurred in 2016 and 2017, it may be likely that the strain remained in the environment or repeatedly introduced from an unknown source.
  • Based on these findings, FDA provided recommendations for the prevention of future outbreaks. Such recommendations include adhering to the recommendations of the Environmental Assessment associated with the spring 2018 STEC outbreak, FSMAs Produce Safety Rule, and FSMAs Preventive Controls for Human Foods Rule. And specifically for growers of leafy greens, FDA recommends assessing the growing operations, assuring all agricultural water is safe and of adequate sanitary quality, and performing a root cause analysis when a foodborne pathogen is identified.
  • The findings provide hope that growers and public health officials will be able to prevent or mitigate potential future outbreaks.

The full FDA report can be accessed here.

  • As previously reported on this blog, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce. This latest outbreak, which began in the Fall 2018, is not related to the E.coli outbreak that occurred in the Spring 2018. We’ve previously covered the Spring 2018 outbreak, which was officially declared over on June 28 and may have been caused by concentrated animal feeding operations in the Yuma, Arizona area.
  • FDA determined in November 2018 that the Fall 2018 E.coli outbreak was linked to romaine lettuce grown in California during the fall of 2018. Consequently, under an agreement between FDA and a number of grower shippers, grower shippers agreed to label their romaine products with the region where they were grown and the approximate harvest date.
  • In its final update on the Fall 2018 outbreak of E. coli O157:H7 infections linked to romaine lettuce, the CDC declared that the outbreak appeared to be over. In total, from October 7, 2018 to December 4, 2018, there were 62 cases from 16 states and the District of Columbia. CDC previously identified the outbreak strain of E. coli O157:H7 in sediment collected within an agricultural water reservoir on an Adam Bros, Inc. farm in Santa Barbara County. The update notes that FDA is continuing to investigate how the E. coli bacteria could have entered the agricultural water reservoir, ways romaine lettuce from the farm could have been contaminated, and whether there are other sources of the outbreak.
  • As discussed in this blog two and three weeks ago, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce.  On November 20, CDC advised consumers, retailers, and restaurants not to eat, sell, or serve any romaine lettuce until the source of the outbreak was better understood.
  • On November 26, FDA announced that it had narrowed down the traceback to romaine lettuce grown in the central coast growing regions of northern and central California.  FDA also said that lettuce known to be grown outside of this region is safe to eat, sell, or serve.  On the same date, the United Fresh Produce Association issued a press release confirming that a number of grower shippers had negotiated an agreement with FDA.  Under the agreement, supported by multiple produce associations, including United Fresh Produce Association, grower shippers agreed to label their romaine products with the region where they were grown and the approximate harvest date.
  • On December 13, FDA provided an update on the outbreak.  The onset of the last of the 59 confirmed illnesses, with 23 hospitalized, was November 16.  FDA and CDC announced that they have narrowed down the source of the outbreak to “Monterey, San Benito, and Santa Barbara counties in California. Romaine lettuce from outside those counties need not be avoided. Consumers may notice that romaine lettuce is beginning to be available in stores with new labeling. Additionally, romaine from Ventura, San Luis Obispo, and Santa Cruz counties harvested after November 23, 2018 should be labeled with harvest area and harvest date, allowing it to be distinguished from romaine lettuce that should be avoided.”  FDA and CDC also confirmed that Hydroponically- and greenhouse-grown romaine are likely safe.
  • Of particular note, FDA and CDC confirmed via whole genome sequencing a sample from Adam Bros. Farming Inc. with the same strain of E. Coli as the outbreak.  Adam Bros. has not shipped romaine since November 20 and experts are working with the farm to identify the source of the contamination and safety measures to take before the next growing season.
    • Adam Bros. is likely not the only source of the contamination.  Per the FDA press release, “[t]he finding on this farm, however, does not explain all illnesses. The FDA’s traceback activities of romaine lettuce will continue as FDA works to determine what commonalities this farm may have with other farms and areas that are being assessed as part of the investigation.”
  • As we reported on this blog last week, FDA and the Centers for Disease Control and Prevention (CDC), along with state and local agencies, were investigating a multistate outbreak of E. coli O157:H7 illnesses that was likely linked to romaine lettuce. On November 20, the CDC advised consumers not to eat any romaine lettuce, and retailers and restaurants not to serve or sell any until more was known about the source of the outbreak. We also noted that the Public Health Agency of Canada (PHAC) and Canadian Food Inspection Agency also were coordinating with U.S. agencies as they investigated a similar outbreak in Canada.
  • On November 26, FDA announced that the E. coli O157:H7 illnesses were likely linked to romaine lettuce grown in California this fall. Preliminary traceback information indicates that ill people were exposed to romaine lettuce harvested in the central coast growing regions of northern and central California, the Agency reported. Consequently, FDA said that consumers and retailers no longer need to avoid using romaine lettuce that is certain to have been harvested from areas outside of the central coast growing regions of northern and central California.
  • FDA further announced that—based on discussions with producers and distributors—romaine lettuce entering the market will now be labeled with a harvest location and date or labeled as being grown hydroponically or in a greenhouse. “If it does not have this information, you should not eat or use it,” FDA cautioned. The United Fresh Produce Association issued a press release on November 26 confirming that a labeling agreement was negotiated between FDA and a number of romaine grow-shipper-processors, who pledged to label their romaine products with the region where they were grown and the approximate harvest date. Other produce associations, including the United Fresh Produce Association, also agreed to support the initiative, according to the release.
  • The FDA and the Centers for Disease Control and Prevention (CDC), along with state and local agencies, are investigating a multistate outbreak of E. coli O157:H7 illnesses that are likely linked to romaine lettuce. On November 20, the CDC advised consumers not to eat any romaine lettuce, and retailers and restaurants not to serve or sell any until more is known about the outbreak.
  • According to the CDC, there are currently 32 cases of E. coli across 11 states, which have been linked to the consumption of romaine. Thus far, no deaths have been reported, but 13 people have been hospitalized and one person has developed hemolytic uremic syndrome, a type of kidney failure.
  • Additionally, the Public Health Agency of Canada (PHAC) and Canadian Food Inspection Agency are also coordinating with US agencies to investigate a similar outbreak in Canada. PHAC has identified 18 people sick with the same strain across Ontario and Quebec.
  • The current outbreak E. coli strain is the same as the one identified in a 2017 outbreak, which was linked to leafy greens. However, the strain is not related to the E. coli outbreak from early 2018. Our readers may remember, we’ve previously discussed that outbreak, which was declared officially over on June 28 and may have been caused by concentrated animal feeding operations in the Yuma, Arizona area.
  • The FDA is conducting a traceback investigation to determine the source of the romaine outbreak. FDA and state authorities are also conducting laboratory analysis of romaine lettuce samples potentially linked to the current outbreak. Until a source is determined, authorities recommend people do not eat romaine lettuce.

 

The Daily Intake will return Monday, November 26. We extend our best wishes to those of you celebrating the Thanksgiving holiday.

  • As previously reported in the Daily Intake Blog and many other sources, there was a widespread outbreak of E. coli O157:H7 in the Spring of 2018.  The outbreak, which was linked to romaine lettuce grown in the Yuma, Arizona growing region, was responsible for over 200 confirmed infections and five deaths.  During FDA’s Leafy Greens Food Safety Task Force meetings on July 31 and August 1, The agency posited a theory that the contamination was due to use of water from a canal adjacent to a Concentrated Animal Feeding Operation (CAFO) and they promised an environmental assessment report once the investigation was complete.
  • On November 1, FDA Commissioner Dr. Scott Gottlieb announced the release of the environmental assessment report.  Of note:
    • FDA found E. coli O157:H7 in several samples of canal water but not in any other environmental samples tested;
    • FDA believes that the most likely source of contamination was from the canal water, but FDA could not rule out other causes; and
    • FDA believes the CAFO is the most likely source of the contamination, but did not find an obvious route of contamination.
  • FDA provided a number of recommendations regarding the growing and processing of leafy greens, including full implementation by growers and processors of the Food Safety Modernization Act (FSMA) provisions (see our blog posts relating to FSMA here).  This includes
    • Continued development of the Food Produce Rule and the agricultural water standards;
    • Implementing traceability systems; and
    • Conducting thorough root cause investigations and implementing corrective actions.
  • Dr. Gottlieb also announced that the FDA is taking steps to provide consumers with more timely information and to respond to food safety issues sooner.  This includes a newly announced plan for FDA to collect and analyze samples of romaine lettuce for contamination with human pathogens.
  • On July 31 and August 1, 2018, the U.S. Food and Drug Administration (FDA) participated in a meeting of the Leafy Greens Food Safety Task Force that was formed in response to the outbreak of E. coli O157:H7 associated with romaine lettuce from Yuma, Arizona that occurred earlier this year. During the meeting, FDA shared preliminary hypotheses about possible outbreak causes and the actions necessary to prevent a future occurrence. FDA has previously mentioned that samples of canal water in Yuma tested positive for the outbreak strain of E. coli, and that the contaminated water coming into contact with the produce was a viable explanation for the cause of the outbreak. FDA also discussed that the location of the canal is situated close to a Concentrated Animal Feeding Operation (CAFO) and can hold in excess of 100,000 head of cattle at any one time, and that FDA traceback information showed a clustering of romaine lettuce farms nearby.
  • According to foodsafetynews.com, the Task Force suggested tripling the industry-imposed 400-foot buffer zone to separate leafy greens growing fields from animal feedlots. Members of the California and Arizona Leafy Greens Marketing Agreement are accepting comments on the setback suggestion before making a final decision on required buffer zone size. This suggestion demonstrates the produce industry’s interest to have preventive measures in place before the next growing season.
  • On August 6, the FDA publicly released a statement about the CAFO hypothesis, and added that their experts are continuing to work on examining potential links between the CAFO, adjacent water, and geologic and others facts that may explain the contamination and its relationship to the outbreak. FDA will detail its findings in an environmental assessment report, though the exact release date of the report was not given.
  • As our readers may remember, we’ve previously discussed the outbreak, which was declared officially over on June 28. As a result of the outbreak, five people died and more than 200 others across 36 states were confirmed with infections.