• 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.
  • The FDA has partnered with the University of Arizona, the Wellton-Mohawk Irrigation and Drainage District (WMIDD), and members of the Yuma area leafy greens industry, with support from the Arizona Department of Agriculture, to better understand the ecology of human pathogens in the Yuma agricultural region.  The Yuma agricultural region encompasses Yuma County in Arizona and the Imperial Valley in California, and is a leader in the production of leafy greens in the United States. The initiative will be a multi-year study to focus on how these pathogens survive, move, and possibly contaminate produce prior to harvest.
  • The launch of the initiative comes on the heels of the largest E. coli O157:H7 outbreak in the United States since 2006.  As our readers may know, the outbreak began in the spring of 2018 and was linked to romaine lettuce grown in Yuma. The outbreak resulted in 210 reported illnesses from 36 states, 96 hospitalizations, 27 cases of hemolytic uremic syndrome (HUS), and 5 deaths. In response, FDA conducted an Environmental Assessment (EA) of the Yuma growing region in collaboration with the Centers for Disease Control and Prevention (CDC), the Arizona Department of Agriculture, WMIDD, and state partners from June through August 2018. A summary of the EA can be found here.
  • The findings of the EA made clear that further collaboration among leafy greens stakeholders and FDA is needed to better understand potential sources of microbial contamination, the prevalence and persistence of human pathogens in the ecosystem near growing areas, and the best management practices to prevent future outbreaks. Thus, in this new partnership, FDA will work with water quality, food safety, and agricultural experts from the University of Arizona Cooperative Extension, representatives from the WMIDD, and members of the Yuma area leafy greens industry. Throughout the initiative, research teams will collect and examine samples from the environment, such as surface waters, canal sediment, and dust. The team will also collect scat samples to assess the impact that animal intrusion and native wildlife may have on the growing environment. FDA intends for the results from the partnership to lead to improved practices that prevent or mitigate food safety risks, and enhance the safety of produce grown in the region.
  • On August 19, two consumer groups, Center for Food Safety (CFS) and Center for Environmental Health (CEH), filed suit against the FDA in California federal court for its failure to promulgate final regulations and complete actions by mandatory deadlines set by Congress in the Food Safety Modernization Act of 2011 (FSMA). At issue in the lawsuit is Section 422 of the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by FSMA.  Section 422 (21 U.S.C. 350k) required that by January 4, 2013, FDA establish a program to detect and address foodborne illness outbreaks with more accredited laboratories and provide a database of accredited labs.  Among other requirements, FDA was to establish a program for the testing of food by accredited laboratories; establish a publicly available registry of accreditation; and develop model standards that a laboratory must meet in order to be accredited by a recognized accreditation body. 21 U.S.C. §350k(a).
  • In the complaint, CFS and CEH allege that missing the 2013 deadline and failing to propose final regulations by six years violated FSMA and the Administrative Procedures Act (APA), and “is putting millions of lives at continued risk from contracting foodborne illness, contrary to Congress’s commands.” According to CFS staff attorney, Ryan Talbott, “[a]ccurate laboratory testing is essential to reduce the foodborne illness threat. […] FDA was required to establish a comprehensive food testing program years ago, but has yet to do so. We will hold FDA accountable and protect the public health, as we always have.”
  • The lawsuit comes after 2018 saw several foodborne illness outbreaks, most notably the multistate outbreak of E. coli linked to romaine lettuce. In 2018, the Centers for Disease Control and Prevention (CDC) investigated 24 foodborne illness outbreaks as compared to 7 outbreaks in 2017.  This year, the CDC has already investigated 12 outbreaks.
  • CFS and CEH have sued FDA over missed FSMA deadlines twice before. Our readers may recall the 2012 suit against FDA after the agency missed seven statutory Congressional deadlines for promulgating FSMA’s food safety regulations. See Str. For Food Safety v. Hamburg, 954 F.Supp.2d 965 (N.D. Cal. 2013). The 2012 Court held that “FDA’s failure to promulgate the mandated regulations by their statutory deadlines constituted a failure to act under the Administrative Procedure Act (APA) and unlawful withholding of the regulations in violation of FSMA and the APA.” The Court granted injunctive relief and established a timeline for FDA to promulgate the final regulations. In October of 2018, CFS and CEH sued the agency for failure to classify and designate certain foods as “high-risk” for foodborne illness purposes, and to create additional recordkeeping requirements for facilities handling such foods by the statutory deadlines. On June 7, 2019, via Consent Decree, FDA agreed to a schedule of deadlines to establish reporting requirements for “high-risk” foods.
  • FDA has yet to respond to the current CFS and CEH complaint. Keller and Heckman will continue to monitor the developments of this case.
  • Researchers with the U.S. Department of Agriculture’s Agricultural Marketing Service have isolated Escherichia (E.) coli O157:H7 from a variety of pest flies in leafy green fields planted up to 180 meters away from cattle feedlots.  Among most fly species captured on sticky traps at leafy green farms, 22.3-29 flies per 1,000 flies carried E. coli O157:H7.
  • In 2018, Shiga toxin-producing E. coli O157:H7 in romaine lettuce was responsible for an outbreak that sickened 62 people in 16 states, of whom 25 were hospitalized.
  • The researchers noted that more work is needed to determine the human health risk posed by these flies and whether they are capable of contaminating leafy greens and causing a foodborne illness outbreak.
  • On Tuesday, March 5, FDA Commissioner Scott Gottlieb announced he would resign at the end of the month. Gottlieb, a physician and former deputy commissioner in the George W. Bush administration, was confirmed as FDA Commissioner in May 2017. The resignation was not sought by the White House, as confirmed by a senior White House official. Rather Gottlieb, who commutes weekly to Washington from Connecticut, said he wants to spend more time with his family. In a letter to FDA staff, Gottlieb noted “[t]here’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family these past two years and missing my wife and three young children.”
  • Unlike some former commissioners, during his tenure, Gottlieb focused much of his time on issues related to food and tobacco. For example, as part of its 2018 Strategic Policy Roadmap, FDA signaled its intent to modernize certain standards of identity (SOI) to address current barriers to the development of healthier products while making sure consumers have accurate information about the foods they eat.  Relatedly, under Gottlieb’s direction, FDA requested comments on the use dairy terms in the labeling of plant-based products. See our previous posts on SOI modernization and the plant-based products labeling debate. As for food safety, examples of FDA action include plans to modernize oversight of imported food and the investigation of several product recalls, including the November 2018 romaine lettuce E. coli outbreak. And in April 2018, FDA issued its first ever mandatory recall. Additionally, Commissioner Gottlieb dedicated his efforts to reducing tobacco-related disease and death and curtailing youth access to tobacco products and e-cigarettes. Tobacco- and e-cigarette-related posts can be found here.
  • Prior to his departure, Commissioner Gottlieb vowed to continue to work to cement more of FDA’s pending efforts, to secure the 2020 budget, and to help transition the agency to new leadership. At this time, Commissioner Gottlieb’s replacement has not been announced.
  • E. coli O157:H7 and other enterohemorrhagic E. coli (EHEC) typically cause acute bloody diarrhea, which can be severe and may lead to hemolytic uretic syndrome (HUS), a type of kidney failure that can be fatal.  Exposure to E. coli O157:H7 most often occurs through consumption of undercooked ground beef or raw vegetables including, as reported here, the Romaine lettuce that was linked to a multistate outbreak last year.
  • Although E. coli are sensitive to most commonly used antibiotics, treatment of infections is limited to hydration, dialysis, or other supportive care because no antibiotics have been shown to alleviate symptoms or prevent development of HUS.  Some antibiotics, in fact, are suspected of increasing the release of enterotoxins and the risk of HUS.  A study of Aurodox, however, found that this secondary metabolite produced by a common soil bacterium may be a candidate for anti-virulence therapy for treatment of E. coli O157:H7 and other EHEC infections.  The study, “Characterisation of the mode of action of Aurodox, a Type III Secretion System inhibitor from Streptomyces goldiniensis” in Infection and Immunity (2018), found that Aurodox reduces the ability of E. coli to bind to human cells and, unlike antibiotics, does not induce the protein in E. coli that triggers toxin production.
  • The ultimate goal of preventing the contamination of food with E. coli and other pathogens in the first place is many years if not decades away from fruition.  In the meantime, a treatment that could reduce the pathogenicity of E. coli O157:H7 and other EHEC could save the save lives of individuals who become infected, including children and the elderly who are the populations most at risk for fatal complications.

 

  • A May 24 letter from nine consumer and food safety groups urges the U.S. Food and Drug Administration (FDA) “to designate produce, including leafy greens, as a high-risk food category and propose regulations that will enhance product tracing for produce in the event of an outbreak.”  The six-page letter was signed by the Center for Foodborne Illness Research & Prevention; Center for Science in the Public Interest; Consumer Federation of America; Consumers Union; Food & Water Watch; National Consumers League; The Pew Charitable Trusts; STOP Foodborne Illness; and Trust for America’s Health.
  • As discussed in this blog, FDA and the Centers for Disease Control and Prevention (CDC) are investigating a multistate outbreak of E. coli O157:H7 illnesses linked to romaine lettuce from the Yuma, Arizona growing region.  A June 1, 2018 update to FDA’s website (devoted to the ongoing investigation), indicates the Arizona Leafy Greens Marketing Agreement has confirmed that romaine lettuce is no longer being produced and distributed from the Yuma growing region and the last date of harvest was April 16, 2018 (i.e., well beyond the 21-day shelf life for Romaine).  However, as noted in the May 24, 2018 letter from consumer and food safety groups, the source of the E. coli contamination has not been precisely identified.  Regarding the lack of traceability requirements for produce, the May 24, 2018 letter states “FDA has no means to swiftly determine where a bag of lettuce was grown or packaged.”
  • Farms are entirely excluded from the traceability requirements of the Bioterrorism Act.  Further, while the Food Safety Modernization Act (FSMA) Produce Safety Rule established specific recordkeeping requirements, traceability coding is not a requirement.  FDA completed a study on enhancing traceability and issued a FSMA-mandated Report to Congress in 2016, but has yet to create a list of high-risk foods and issue a proposed rule for enhanced recordkeeping.
  • It is unlikely that FDA will establish traceability requirements for high risk foods or produce a list of high risk foods (which could potentially include leafy greens) within the 6-month timeframe that is requested by the May 24, 2018 letter.  But greater adoption throughout the supply chain of the Produce Traceability Initiative (PTI),  a voluntary industry system introduced years ago, would make it easier for agencies to track supply chains when investigating illness outbreaks.  It is estimated that only 60% of produce is shipped in cases that have PTI labels.  Other companies may use different traceability programs, using their own codes for a field, a season, a production location, or a commodity.  Consistency in traceability programs would improve the speed and accuracy of tracebacks.