The Centers for Disease Control and Prevention (CDC) has uncovered a new strain of E. coli that has been responsible for multiple outbreaks of foodborne illness over recent years, including those related to romaine lettuce and other leafy greens.

The REPEXH02 strain is believed to have first come to light at the end of 2015, with the agency noting that it was responsible for dozens of hospitalizations and many cases of hemolytic uremic syndrome (HUS), a serious issue that can often impede blood clotting in infected people and cause kidney failure.

A study by CDC researchers utilized whole genome sequencing to examine the DNA of a strain and track the bacteria that cause foodborne illness, which allowed them to determine whether outbreaks were caused by the same strain, and the link involved with others. The new strain consists of two clades with different geographic distributions, one of which has notable genomic features.  

E. coli O157:H7 is estimated to cause 63,000 domestically acquired foodborne illnesses and 20 deaths in the United States each year, according to the CDC. The agency found that 58% of recent E. coli-related illnesses were attributed to vegetable row crops, with the majority coming from leafy greens. In 2019, a large outbreak related to romaine lettuce from California’s Salinas Valley caused 167 cases and hospitalized 85 people from 27 states. In 2020, 40 infections occurred in 19 states, 20 people were hospitalized and four developed HUS. No further outbreaks from the strain have been associated with the strain.

The newly identified strain has a toxin type associated with more severe disease in those infected, according to the CDC. Still, additional study is needed to understand factors that contribute to the bacteria’s emergence and persistence in specific environments, the authors wrote.

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A multistate outbreak of Listeria monocytogenes infections that caused the death of two people (one in Michigan, one in Wisconsin) has been linked to packaged salads produced by Dole Fresh Vegetables, Inc., according to a CDC investigation.

The CDC says the outbreak linked to Dole products has also been responsible for 17 illnesses and 13 hospitalizations reported in Idaho, Iowa, Maryland, Michigan, Minnesota, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Utah, and Wisconsin. Those impacted range in age from 50 to 94 years of age, and 82% percent are women.

A second outbreak linked to salad products involves branded and private label products produced by Fresh Express products according to CDC.

In December 2021, Dole issued a voluntary recall on packaged salads produced at its Bessemer City, NC, and Yuma, AZ processing facilities. In January 2022, Dole issued a second voluntary recall, removing all Dole-branded and private label packaged salads processed at its Springfield, Ohio, and Soledad, Calif.-based production facilities that contained iceberg lettuce.

In addition to Dole packaged salads,  private label brands containing the contaminated lettuce include Ahold, HEB, Kroger, Lidl, Little Salad Bar, Marketside, Naturally Better, Nature’s Promise, President’s Choice and Simply Nature.

The recall is for products showing “Best if used by” dates from November 30, 2021, through January 9, 2022. The products affected include Caesar kits, mixed greens, garden salads, and more, sold in either bags or clamshells. Additionally, the  products involved include  product lot codes that begin with the letter “B,” “N,” “W” or “Y” displayed in the upper right-hand corner of the package. Consumers and retailers who still have products in their refrigerators involved in either recall are urged to discard them immediately.

A spokesperson for Dole told The Washington Post that the company was confident it had identified and corrected all issues related to the listeria outbreak. “Throughout the FDA and CDC investigations, Dole provided full access and transparency into all of our facilities, our processes, and our operations,” spokesperson William Goldfield told the paper. “Delivering safe, high-quality fruits and vegetables is our top priority, and we are deeply saddened and sorry that we did not meet our standard.”

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FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of Listeria monocytogenes infections. According to the CDC, as of December 21, 2021, 10 people infected with the outbreak strain of Listeria monocytogenes have been reported from eight states, with ten hospitalizations and one death. Illnesses started on dates ranging from July 26, 2016 to October 19, 2021.

As a part of routine sampling, the Michigan Department of Agriculture and Rural Development collected a product sample of Fresh Express Sweet Hearts salad mix with a Use-By-Date of December 8, 2021, for testing. The sample tested positive for Listeria monocytogenes and subsequent whole genome sequencing (WGS) analysis determined that the Listeria monocytogenes present in the samples matches the strain that has caused illnesses in this outbreak.

In response to the sample results and the ongoing outbreak investigation, Fresh Express voluntarily ceased production at its Streamwood, Ill., facility and initiated a recall of certain varieties of its branded and private label salad products produced at the facility and distributed across 19 states. The recall includes all use-by dates of fresh salad items with product codes Z324 through Z350. Product codes are located on the front of the packages below the use-by date. No other Fresh Express products are subject to recall. A full list of recalled products is available on FDA’s website.

This is an ongoing investigation and additional information will be provided as it becomes available.

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FDA has proposed a revision to the agricultural water section of the Produce Safety Rule, which would better ensure the safety of produce.

The changes would require farms to conduct comprehensive assessments that would help identify and mitigate hazards in water used to grow produce.

“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, in a statement. “If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives.”

Elizabeth A. Bihn, PhD, director of the Produce Safety Alliance, notes that the proposed rule will primarily impact Subpart E of the rule, as this section relates to water used prior to harvest in the production of covered produce on covered farms. “Growers should prepare by evaluating the water used during produce production prior to harvest,” she tells Food Quality & Safety. “This may include assessing upstream and adjacent land activities that can influence the quality of their surface water sources. It may also include testing their surface water sources for quantified generic E. coli prior to use and throughout the season and inspecting their wells to ensure there are no structural issues.”

As written in the FDA proposal, these changes task individual growers with assessing the risks in their farms’ water sources and distribution systems.

Dr. Bihn says there are some parts of the proposed rule that she feels ask growers to understand nuances that many researchers are still figuring out. “It is extremely important that fresh produce growers understand microbial risks, water quality, and how water can carry and distribute microbial contamination to the crops they grow,” she says. “The requirement for agricultural water assessment could help move them in the right direction, recognizing growers will need resources to help them understand relevant research and how to apply it as a guide in their decision-making assessment of risks.”

The LGMA Food Safety Programs in Arizona and California have conducted a review of the proposal and determined that the LGMA requirements appear to meet and exceed what is being proposed. “What is notable is that the FDA has moved away from requiring the multitude of indicator organism testing, required under the original proposed water rule, for a risk assessment modeled after hazards that are proximate to the water,” says Greg Komar, LGMA’s technical director. “Water testing might be used to assist with the assessment but is not required.”

The comment period is currently underway and ends on April 5, 2022. At that point, FDA will review comments, make revisions, and issue the final rule. If it goes forward, Komar expects an enforcement date to come in the last quarter of 2022 or 2023, based on farm size.

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In an effort to prioritize the safety of leafy greens, FDA has released its findings of a sampling report it conducted on romaine lettuce collected earlier this year from Yuma County, Ariz.

In February 2021, FDA started collecting samples of romaine lettuce from commercial coolers, with plans to sample through the end of the romaine harvest season in the growing region. This was in response to a 2018 multistate E. coli outbreak, which saw 210 infections and five deaths in 36 states.

The agency collected 504 romaine samples and tested the lettuce for Shiga toxin-producing E. coli (STEC), specifically enterohemorrhagic E coli. (EHEC), and Salmonella spp. Each sample consisted of 10 subsamples, and each subsample was made up of at least 300 grams of romaine lettuce (whole heads, hearts, or individual leaves).

The investigation discovered E. coli O130:H11 in one sample. The isolate was found to be moderate to high-risk, though the FDA report noted that it wasn’t linked to any known human illnesses, and no product ever reached consumers. Furthermore, FDA investigated the farm where the sample came from and identified possible sources and routes of contamination, and just one of these total 24 samples yielded another strain found on the outer leaves of romaine lettuce. The strain was further characterized as low risk to human health, and FDA’s analysis indicated the strain was not linked with any past known foodborne illness outbreaks.

FDA says it continues to make the safety of leafy greens a priority, an initiative that includes its Leafy Greens STEC Action Plan (LGAP), which features public health approaches related to response and prevention, and addressing knowledge gaps. “Romaine lettuce and other leafy greens are among the most widely consumed vegetables in the United States and are an important part of a healthy diet,” the report says. “The agency is working on several fronts to help prevent microbial contamination of leafy greens and to prevent outbreaks of foodborne illness. The FDA continues to collaborate with industry, states, academia, and other stakeholders through activities outlined in the LGAP to address this important public health issue.”

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Low-income residents are at a greater risk than residents in high-income communities of contracting foodborne illness, according to a new study by researchers at the University of Houston. The study, published last month in the Journal of Food Protection, examined the safety and quality of loose-leaf romaine lettuce accessible to low-income populations living in Houston, Texas.

Sujata Sirsat, PhD, an associate professor at the University of Houston’s Conrad N. Hilton College of Hotel and Restaurant Management in Texas and lead author of the study, tells Food Quality & Safety that this was a subject she wanted to explore because of the nutritional disparities she’s seen in low-income neighborhoods. “This is fundamentally characterized by lack of access to fresh, nutritious, and healthful foods,” she says. “As we have more federal and state programs addressing this need, our research question was: Is the produce accessible to low-income communities safe and of high quality from a microbial standpoint?”

The researchers purchased fresh greens from five different retailers in both low- and high-income socioeconomic status areas over a six-month period. The samples underwent reverse transcription polymerase chain reaction testing for pathogen contamination. The investigators found a disparity between the microbial quality and safety of the produce accessible to low-income communities and those collected from the high-income areas.

While both communities saw positive results for Staphylococcus aureus—38% of samples in high-income areas tested positive for the pathogen and 87% tested positive in those collected from low-income areas—no other pathogens were found in the produce sampled in the high-income areas. However, greens collected from the low-income areas tested positive for E. coli O157:H7 (4%), Salmonella spp. (53%), and Listeria monocytogenes (13%).

The research also showed that romaine lettuce in low-income communities had higher levels of spoilage microorganisms, fecal contaminants, and pathogens.

“It’s a big, big problem,” Dr. Sirsat says. “We shouldn’t see this type of empirical evidence.”

Though the study did not identify why the disparity exists, Dr. Sirsat theorizes it could be because of time and temperature abuse of produce; potential cross contamination at various stages in the supply chain; or challenges and differences in the supply chain contributing to contamination.

“There is no quick fix to this problem. Further studies will be needed to identify and address the issue or issues at its root,” she adds. “Investing in fresh produce is critical to the long-term health of communities. We need to be able to investigate the supply chain in depth to be able to identify what is happening, from farm to fork.”

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Baker Farms is recalling their Baker Farms, Kroger, and SEG Grocers brands of bagged kale due to possible contamination with Listeria monocytogenes. The recall impacts one-pound bagged kale with a best buy date of September 18, 2021.

On September 15, Baker Farms was notified by a customer that the product tested positive for Listeria monocytogenes. The products were distributed in plastic bags between August 30 and September 1 and packaged in clear plastic bags. They were sold to distribution centers in 11 states:  Alabama, Arkansas, Florida, Georgia, Kansas, Missouri, Mississippi, North Carolina, New York, Ohio, and Virginia.

No illnesses have been reported to date, and no other bagged greens are included in the recall. For more information on the specific products affected, visit the FDA website.

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Over the past three years, CDC has reported approximately 6,000 domestically-acquired cases of cyclosporiasis in the U.S., and the agency believes this number is lower than the actual amount of people infected. The first known contamination in U.S. produce appeared in 2018, with the most famous outbreak occurring in McDonald’s salads that same year. In 2021, there have been 208 reported illnesses, resulting in 21 hospitalizations and no deaths.

In response to this growing problem, FDA unveiled a new plan earlier this month creating a task force to improve prevention, enhance response activities, and fill knowledge gaps to help prevent Cyclospora contamination in food.

Led by multidisciplinary experts across FDA and CDC, the task force’s goal is to decrease the public health burden of foodborne illness caused by Cyclospora in produce.

“In the area of prevention, the new action plan highlights how we’re addressing this food safety issue through the development and delivery of prevention-focused education materials and outreach to stakeholders,” Frank Yiannas, FDA’s deputy commissioner for food policy and response, said in a statement. “We’re also working with industry to encourage the development of rapid test kits to specifically detect Cyclospora to better facilitate industry testing and root cause analysis activities.”

In addition, FDA plans to partner with others in the industry to find ways to improve control over Cyclospora in the environment and on farms, as well as collaborate with CDC to better understand the case distribution of cyclosporiasis across the U.S. and to advance genotyping methods in clinical, food, and environmental samples.

When it comes to improving response, FDA will expand lab capacity to sample and test for the parasite, providing a greater capacity to investigate outbreak events.

“The FDA is also developing a new investigational tool to help guide assessments of farms potentially implicated in a Cyclospora outbreak to determine potential sources and routes of contamination,” Yiannas said.

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E. coli outbreaks linked to leafy greens grown in the California Central Coastal region have plagued the area since 2017, despite efforts to stop them. The most recent outbreak, in the fall of 2020, prompted an FDA investigation; the agency published its findings in April 2021.

The investigation found that samples collected in response to leafy greens outbreaks in 2019 and 2020 contained the same strain of Shiga toxin-producing E. coli (STEC) O157:H7. In light of this finding, FDA analyzed trends across outbreaks that had occurred each fall since 2017 and found three key trends in the contamination of leafy greens by E. coli O157:H7 in recent years: a reoccurring strain, a reoccurring region, and reoccurring concerns with the potential impacts of adjacent lands.

According to Jim Gorny, PhD, senior science advisor for produce safety at FDA’s Center for Food Safety and Applied Nutrition in College Park, Md., the reoccurring pathogenic E. coli strain appears to be a reasonably foreseeable hazard, specifically in the South Monterey County area of the Salinas Valley and Santa Maria Valley growing regions.

FDA’s report recommended that agricultural communities in the affected areas work to identify where the reoccurring strain of pathogenic E. coli is persisting in the environment and the likely routes of lettuce contamination with the strains of STEC. Furthermore, FDA encouraged producers in the Central Coast of California growing region to participate in the California Longitudinal Study, an initiative launched in November 2020 to improve food safety after continued E. coli outbreaks, and in a locally led, locally convened workgroup organized by the California Department of Food and Agriculture and the Monterey County Farm Bureau to identify what actions can be taken to reduce contamination.

When pathogens are identified through microbiological surveys or pre-harvest or post-harvest testing, FDA recommends that growers implement industry-led root cause analyses to determine how the contamination likely occurred and then implement appropriate prevention and verification measures, Dr. Gorny says.

Another Step: Updating the Leafy Greens Action Plan

In addition to its investigation, FDA has updated its Leafy Greens STEC Action Plan (LGAP), originally released in 2020, for 2021. The new plan includes steps the agency will take in collaboration with leafy green stakeholders to advance lettuce safety.

The update is informed by work and knowledge gained over the past year. “New actions have been added based on information collected and lessons learned, including those from the 2020 investigative report,” Dr. Gorny says. “The updated plan includes a renewed emphasis on actions to prevent contamination stemming from activities on adjacent land, announces new actions that build on the accomplishments and learnings from the 2020 plan, and renews FDA’s commitment to complete certain actions that were difficult to accomplish in 2020 due to challenges presented by the COVID-19 pandemic.”

In commenting on the updated LGAP, Ben Miller, MPH, PhD, senior director of scientific and regulatory affairs at The Acheson Group, a global food safety consulting group based in Bigfork, Mont., says, “These approaches have been updated for 2021 to better understand how STEC can move from the surrounding environment and contaminate produce grown in California and Arizona. Based on investigations in 2019 and 2020, addressing risks from nearby cattle operations form the basis of many updates in the 2021 plan.”

The updated LGAP includes 33 specific action items.

A Closer Look at LGAP

The updated LGAP emphasizes three components:

• Enhancing prevention strategies;
• Improving response activities by FDA and other entities; and
• Identifying and addressing knowledge gaps that exist around STEC contamination of leafy greens.

Regarding prevention strategies, Dr. Miller says the new approaches are largely focused on irrigation water and adjacent land use; however, the close proximity of cattle to these growing areas and unknown routes of contamination from the environment to leafy greens makes developing and validating effective mitigation and control measures difficult.

Ensuring that outbreak response activities are conducted as quickly and thoroughly as possible is essential for preventing illnesses, Dr. Gorny says. In addition, it is critical that FDA and stakeholders share lessons learned to inform future prevention efforts.

“Much of the 2021 focus is on improving information sharing between FDA and the industry and improving the rapidity and accuracy of traceback investigations,” Dr. Miller says. “Sharing learnings from past outbreaks can help the FDA and industry better understand potential sources of contamination. Traceback investigations have demonstrated their usefulness in helping determine the cause of outbreaks and point investigators to suspect growing fields to narrow the scope of field investigations and sampling. Improving traceability can also limit the impact and scope of consumer advisories when the next outbreak occurs if the source of an outbreak can be quickly identified.”

While FDA and stakeholders have greatly expanded what is known about leafy greens safety, knowledge gaps still exist, which can be explored in new ways through the use of emerging technologies, Dr. Gorny says. Addressing these knowledge gaps is critical to advancing future prevention activities.

It’s also important to recognize that these are not siloed areas of focus, but rather numerous points of intersection and mutual reinforcement, Dr. Gorny adds.

Each of these three approaches acknowledges a current lack of data or consensus in a particular area. “By collecting more data, FDA hopes to create a more objective assessment of contributing risk factors and preventive measures for leafy greens grown in the Yuma and Salinas regions,” Dr. Miller says.

Outlook

FDA and the leafy greens industry have been working to reduce E. coli contamination in leafy greens since 2006. “A lot of progress has been made and, while the risk is less today than it was in 2006, the ongoing outbreaks show that risks still exist,” says David Acheson, MD, CEO, and president of The Acheson Group.

Obviously, the problem has not been resolved despite the California Leafy Greens Marketing Agreement, a program implemented in 2007 to ensure safe leafy greens and a much greater use of testing than in the past, Dr. Acheson says. “Part of the problem links back to gaining a better understanding of the root cause, for example, the movement of E. coli in dust and driven by the wind—which is hard to control,” he says.

Dr. Acheson says situations still exist in which growers are not fully leveraging what is known around risk: Some still grow lettuce at the bottom of a hill on which cattle are grazing. While there are many more controls in place today, along with regulatory requirements in the form of the FSMA Final Rule on Produce Safety, the risks remain and the ultimate controls are elusive. “As long as both live animals and leafy greens are raised in the same broader environment, this problem is not likely to totally go away,” he says.

Mitigating the Issue

In order to resolve the issue of E. coli contaminating leafy greens, Dr. Miller says it’s important to understand how STEC from the environment makes its way onto leafy greens. “Monitoring and treating irrigation water is common sense and an achievable control compared to controlling by windborne contamination,” he says. “Seasonal climate patterns may contribute to windborne contamination in the Salinas Valley; more research is needed in this area to understand the role that weather, climate, and cattle proximity play in field-level contamination.”

A root cause analysis will seek to eliminate the hazard at its source, as cattle are a known and well-documented reservoir for STEC, Dr. Miller says. Cattle vaccines against E. coli O157:H7 are commercially available, although their uptake has been limited. Cattle may not be the only source of environmental STEC where lettuce is grown, although FDA investigations in 2019 and 2020 identified the outbreak strain in cattle feces surrounding growing fields identified in traceback investigations.

While more research is needed to understand how STEC moves from cattle to leafy greens, testing technology can also play a role in detecting contamination events. “With COVID-19, we’ve seen that rapid testing platforms can be quickly developed and in-line harvesting sampling with rapid turnaround times could allow the industry to more quickly detect field-level contamination at harvest time,” Dr. Miller says.

“If we continue to see outbreaks associated with animal agricultural operations, policy makers may decide that additional regulations on this industry are needed to help manage these risks through prioritizing land use or other regulatory changes,” Dr. Miller adds. “Produce growers are growing a ready-to-eat food product outdoors, and there are probably limits on what they can independently do to detect and prevent sporadic contamination events that may still lead to an outbreak. Success in reducing these risks will require multiple stakeholders to come together and identify how they can minimize the risk of STEC in the environment in these growing regions.”

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The CEA Food Safety Coalition (FSC), a group comprised of leaders in the controlled environment agriculture (CEA) industry, has announced the first-ever food safety certification program specifically for CEA-grown leafy greens.

Members of the coalition can now choose to be assessed for the CEA Leafy Greens Module and, upon successful completion, will be allowed to use the CEA food-safe seal on certified product packaging. The module is measured against science-based criteria and is an add-on to existing compliance with an underlying Global Food Safety Initiative (GFSI) recognized food safety standard.

“Current food safety standards were written for the field, and many do not address the unique attributes of controlled, indoor environments,” says Marni Karlin, executive director of the coalition. “This new certification process and the accompanying on-pack seal helps to unify CEA growers while also differentiating them from traditional field agriculture.”

CEA takes a technology-based approach to produce optimal growing conditions inside controlled environments such as greenhouses and indoor vertical farms. Plants are typically grown year-round using hydroponic, aeroponic, or aquaponic methods, without the need for pesticides and unaffected by climate or weather.

“The CEA industry is rapidly expanding and predicted to support more than 10% of U.S. vegetable and herb production by 2025,” says Rebecca Anderson, technical key account manager for GLOBALG.A.P. North America. “The CEA FSC Leafy Green Module will set a new industry standard for CEA-grown produce while driving consumer awareness of the innovations happening in indoor agriculture today.”

The certification program is available to all coalition members for a nominal cost and must be completed on an annual basis. CEA growers can be assessed for multiple sites across four key areas:

• Hazard analysis: use of water, nutrients, growing media, seeds, inputs, site control and other relevant factors.
• Water: all contact with the plant and with food contact surfaces. The use of recirculating water will require a continuing hazard analysis. Will also require zone-based environmental monitoring based on company-specific risk assessment.
• Site control/infrastructure system design: all food contact surfaces and adjacent food contact surfaces, including plant containers; will also assess associated farm physical hazards, including lighting, robotics, sensors, equipment, and utensils.
• Pesticide use/testing: the use of pesticides or herbicides during the plant life cycle.

The coalition was founded in 2019 to represent the interests of CEA leafy greens growers in developing credible and appropriate food safety standards while educating consumers and regulators alike on the value of controlled environment agriculture.

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