• 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.
  • On  June 28, 2018 the Centers for Disease Control (CDC) announced that the outbreak of E. Coli linked to romaine lettuce is over.  This outbreak, which sickened at least 210 people in 36 states, with at least five deaths attributed, is believed to have been caused by romaine lettuce grown and harvested in the Yuma (Arizona) growing region, though the outbreak cannot be explained by a single grower, harvester, processor, or distributor.
  • Until recently, the source of the contamination was unknown, but the environmental assessment conducted by FDA and CDC has identified the presence of E. coli with “the same genetic finger print as the outbreak strain” in irrigation canal water from the region.  FDA is continuing to investigate.
  • This is the most recent example of FDA’s use of whole genome sequencing to better understand the source of outbreaks.  The possible connection to irrigation water is bound to cause public health advocates to push for a more immediate compliance date for Agricultural Water Standards than the proposed 2022-2024 (depending on farm size) dates currently under consideration.
  • According to the Wall Street Journal (paywall), the impact of the recent E. coli outbreak in romaine lettuce continues to ripple through the market, causing a 44.5% drop in retail sales of romaine as compared to the previous year and a 27.6% drop in sales of lettuce overall.
  • Retailers, restaurants, and growers are already facing multiple lawsuits arising out of the lettuce recall, which sickened 172 people in 32 states and which resulted in 1 death and 75 hospitalizations.
  • Aside from identifying Yuma, Arizona as the growing area that was the source of the tainted lettuce, FDA has not otherwise identified the primary source of the outbreak.  The lack of traceability has led to discussions as to whether blockchain, a digital ledger system developed originally to verify cryptocurrency transactions, could help with foodborne illness outbreak traceability in the future.
  • The Centers for Disease Control and Prevention (CDC) found that romaine lettuce from the Yuma, Arizona growing region could be contaminated with E. coli O157:H7.  Thus far, 53 people infected with the outbreak strain of E. coli O157:H7 have been reported from 16 states. Thirty-one people have been hospitalized, including 5 people who have developed a type of kidney failure called hemolytic uremic syndrome. No deaths have been reported.
  • On April 20, the CDC expanded its warning to consumers to cover all types of romaine lettuce from the Yuma growing region. The warning now includes whole heads and hearts of romaine lettuce, in addition to chopped romaine and salads and salad mixes containing romaine.  Because package labels do not often identify growing regions, the CDC recommends consumers throw out any romaine lettuce, even if partially eaten, and avoid eating romaine lettuce at restaurants.
  • The contaminated growing region was identified after state and local health officials in Alaska interviewed sick inmates at a correctional facility to ask about the foods they ate and other exposures before they became ill. Traceback investigations show that the lettuce ill people ate came from whole heads of romaine lettuce from Yuma. However, at this time, no common grower, supplier, distributor, or brand has been identified. A lack of traceability coding has been blamed for the failure in identifying the source of the romaine. Traceability labeling and coding would allow finished product sent to retailers and foodservice operations to be traced back through the supply chain virtually immediately.
  • While the Food Safety Modernization Act (FSMA) Produce Safety Rule established specific recordkeeping requirements, traceability coding is not a requirement. Despite the lack of a federal requirement, it is possible food producers, specifically those who grow fresh fruits and vegetables, may begin to utilize traceability software to minimize the spread of outbreaks. Keller and Heckman will continue to monitor the multistate outbreak linked to romaine lettuce.
  • FDA’s Produce Safety Rule (PSR), finalized in 2015 under the Food Safety Modernization Act (FSMA), established “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” including requirements applicable to agricultural water using a direct application method during growing activities (commonly referred to as ‘‘pre-harvest agricultural water’’).  As we have discussed, FDA was criticized, following foodborne illness outbreaks linked to lettuce, for extending the compliance dates for the agricultural water requirements applicable to covered produce (other than sprouts) until January 26, 2022 for the largest farms, and one or two years later for small and very small farms, respectively.
  • On December 6, 2021, FDA published a proposed rule that would replace the pre-harvest microbial water quality criteria and testing requirements of the 2015 rule, which stakeholders complained were too complex, with new rules that would require farms covered by the PSR to assess their pre-harvest agricultural water system annually, and whenever a significant change occurs, to identify any conditions likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces and, based on their assessments, determine whether corrective or mitigation measures are needed to reduce the potential for contamination.  The proposed rule includes:
    • New provisions requiring consideration of agricultural water sources, distribution systems, and practices, as well as adjacent and nearby land uses, and other relevant factors in conducting pre-harvest agricultural water assessments for hazard identification and risk management decision making;
    • A testing option for certain covered farms that elect to test their pre-harvest agricultural water for generic Escherichia coli (E. coli) (or other appropriate indicator organism, index organism, or analyte) to help inform their agricultural water assessments;
    • Flexible options for mitigation measures, such as, for example, using microbial die-off or removal post-harvest (i.e., between harvest and end of storage, and during activities such as commercial washing) as a mitigation measure, provided the covered farm has adequate supporting scientific data and information;
    • Expedited implementation of mitigation measures for known or reasonably foreseeable hazards related to certain adjacent and nearby land uses, such as animal grazing and the presence of livestock and wildlife; and
    • Required management review of pre-harvest agricultural water assessments.
  • Information on proposed compliance dates will be announced in a forthcoming notice.  In the meantime, FDA intends to exercise enforcement discretion for the agricultural water requirements for covered produce (other than sprouts).  Additionally, FDA is working on plans to hold two virtual public meetings to discuss the proposal and hear feedback and is developing an online tool to assist farms in evaluating potential risks posed by their water sources and in determining potential management options.  The solicitation period for comments on the proposed amendments is scheduled to close on April 5, 2022.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • FDA published a report on June 11 that expresses concerns with farm animal operations located nearby fields growing produce. The report focuses on a 2020 Salmonella enteritidis outbreak in peaches that affected 101 people across 17 states and explains FDA’s testing and traceback processes from the outbreak.
  • The report explains that FDA connected pathogen samples from peaches and peach tree leaves to a strain of Salmonella on an adjacent chicken operation using whole-genome sequencing on chicken isolates from the same period as the outbreak. The results prompted additional testing around the company’s orchards where other strains of Salmonella were connected to genetically identical pathogens found in beef and cattle isolates from an adjacent cattle feedlot. The findings helped FDA quickly identify and prioritize investigations at certain peach packing and holding operations and other peach orchards.
  • The report states these findings underscore FDA’s concern about the potential impact adjacent land uses have on produce safety, including the potential impact of dust exposure. Past outbreaks have been linked at least in part to animal feeding operations, including a 2018 E. coli outbreak in romaine lettuce. FDA encourages collaboration between neighboring farms to identify areas of concern and tailor their land management to the specific practices and conditions on individual farms.
  • On July 13, the FDA announced its New Era of Smarter Food Safety Blueprint, which outlines the Agency’s plan to create a safer food system over the next decade. The Blueprint represents achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. The Blueprint builds on the work that FDA has already implemented through FSMA and also outlines a partnership between government, industry, and public health advocates to create a modern approach to food safety.
  • The Blueprint is centered around four core elements:
    • Tech-enabled Traceability – FDA wants to utilize new technologies and integrate data streams to identify outbreaks and trace the origin of contaminated food to its source in minutes.
    • Smarter Tools and Approaches for Prevention and Outbreak Response – The Blueprint includes plans to strengthen the FDA’s procedures and protocols for conducting root cause analyses that can identify how a food became contaminated and figure out how to help prevent contamination from happening again. The need for greater traceability and predictive analytics is seen in the Agency’s most recent efforts to improve the safety of romaine and other leafy greens.
    • New Business Models and Retail Modernization – FDA is also examining new business models for the production and delivery of food, while ensuring that those foods continue to be safe for consumers. New business models include novel ways of producing foods and ingredients, such as cell-cultured food products. FDA is also committed to exploring new approaches of food safety that go beyond traditional training and inspection for retail establishments and restaurants.
    • Food Safety Culture – The Blueprint also focuses on fostering the growth of and strengthening the food safety culture on farms and in food facilities all over the world. For instance, in order to make dramatic reductions in foodborne disease, the Agency believes they must do more to influence and change human behavior, as well as to address how employees think about food safety and educating consumers.
  • FDA originally intended to publish the Blueprint in March, but was forced to postpone and turn attention to addressing the public health emergency posed by the COVID-19 pandemic. However, as explained by the FDA, the pandemic has made it even more clear that the actions outlined in the Blueprint are essential to protect and promote food safety.
  • As our readers know, this blog has previously covered the romaine lettuce E. coli outbreaks that occurred in the spring and fall of 2018. Ultimately, FDA determined that the outbreak that occurred in the spring of 2018 may have been caused by Concentrated Animal Feeding Operations (CAFOs) in the Yuma, Arizona area, and the outbreak that occurred in the fall of 2018 may have been due to a contaminated on-farm water reservoir.
  • On November 19, U.S. Senator Kirsten Gillibrand, D-NY announced her new legislation to help improve food safety across the country. The Expanded Food Safety Inspection Act would expand FDA’s investigative authorities to trace the source of outbreaks of foodborne illness. Under existing law and regulations, FDA is limited to investigating the produce farms from where the outbreaks originated. However, FDA does not have the ability to access nearby farms that may be the source of contamination or that may have contributed to the root cause of a foodborne illness outbreak. As explained in a press release, the Expanded Food Safety Inspection Act would allow the FDA to coordinate with state and local public health organizations, the USDA, and the CDC in order “to better determine the source of outbreaks and give them the authority to investigate contamination from nearby farms.” This would help eliminate sources of contamination directly, decrease the chances of repeated outbreaks within the same region, and facilitate the quick recall of dangerous food products.
  • Senator Gillibrand is to introduce the bill in the Senate within the coming weeks. The legislation is endorsed by the Center for Science in the Public Interest and the Consumer Federation of America. We will continue to monitor developments on the Expanded Food Safety Inspection Act

The Daily Intake is taking a break for the Thanksgiving holiday and will return on December 2, 2019.  We wish you a wonderful Thanksgiving holiday! 

  • On November 20, the Centers for Disease Control and Prevention (CDC), in conjunction with the Food and Drug Administration (FDA) and several state agencies, announced that it is currently investigating an outbreak of Shiga toxin-producing E. coli (STEC) O157:H7 infections that has so far impacted at least 17 people across 8 states. The first reported illnesses date back to September 24, 2019. Investigators are looking into a branded chicken Caesar salad as a potential source, after the Maryland Department of Health (MDH) identified E. coli O157 in an unopened package. However, MDH is still conducting a whole genome sequencing (WGS) analysis to determine if it is closely related genetically to the E. coli identified in this outbreak.
  • As previously reported on this blog, in January 2019, FDA’s Food Safety and Inspection Service (FSIS) transitioned to using only WGS for Shiga toxin-producing E. coli (STEC) in an effort to update its analytical methods to the state of the art. The method of WGS determines the order of all of the DNA building blocks (nucleotides) in an organism’s entire genome in a single laboratory process, and a comparison of the DNA sequence of an isolated bacterial pathogen to the sequences from other samples in a DNA database can pinpoint the source of a foodborne disease outbreak.
  • The recent outbreak follows a similar outbreak of E. coli 0157:H7 from 2018 that was ultimately traced to romaine lettuce. The 2018 outbreak included 62 cases from 16 states and the District of Columbia, and prompted FDA to issue recommendations for leafy greens growing operations as well as a partnership between FDA and leafy greens stakeholders in Arizona to enhance food safety. Subsequent research from the U.S. Department of Agriculture’s Agricultural Marketing Service found that pest flies were a potential vector in the spread of the E. coli O157:H7 and contamination of leafy greens.