Leafy Greens STEC Action Plan
What's New
The FDA and its partners in the public and private sectors have made significant progress in advancing the safety of leafy greens since the release in March 2020 of the Leafy Greens STEC Action Plan (LGAP). While millions of servings are consumed safely every day, this produce has been implicated in outbreaks of foodborne illness caused by Shiga toxin-producing E. coli (STEC), the most common of which is E. coli O157:H7.
On this page, we outline the actions that are ongoing and new in 2021 to advance our work in three priority areas: prevention, response and addressing knowledge gaps. We also list, in greater detail, accomplishments made in reaching LGAP goals.
- Introduction
- Looking Ahead to 2021
- Updated Actions and Approaches for 2021
- Leafy Greens STEC Action Plan Accomplishments
Introduction
Because of reoccurring foodborne illness outbreaks associated with leafy greens consumption, the U.S. Food and Drug Administration (FDA or the agency) announced a set of actions to help enhance the safety of fresh leafy greens by publishing the 2020 Leafy Greens STEC Action Plan (LGAP or the plan). The plan to help prevent outbreaks caused by Shiga toxin-producing E. coli (STEC) was designed to support an integrated food safety system and help foster a more urgent, collaborative, and action-oriented approach between the FDA and stakeholders in the public and private sectors. Helping to ensure the safety of fresh leafy greens is a shared responsibility that requires collaboration among many stakeholders in an agricultural ecosystem, often referred to as a One Health approach.
Priority Areas Infographic
(PDF 3MB)
Since the initial publication in March 2020 and outreach around the LGAP, the FDA has made significant progress by enhancing prevention strategies, improving response activities by the FDA and other entities, and identifying and addressing the knowledge gaps that exist around STEC contamination of leafy greens.
Leafy greens are among the most widely consumed vegetables and an important part of an overall healthy diet. While millions of servings are consumed safely every day, leafy greens have been repeatedly associated with illnesses caused by pathogenic E. coli, and we believe that more must be done to break this cycle of reoccurring outbreaks.
In the United States, E. coli O157 outbreaks were first linked to contaminated leafy greens in 1995. Later, studying a decade of investigations between 2009 and 2018, the FDA and Centers for Disease Control and Prevention (CDC) identified 40 foodborne outbreaks of STEC infections in the U.S. with a confirmed or suspected link to leafy greens. While most strains of E. coli are harmless, STEC can cause bloody diarrhea, anemia, blood-clotting problems, and kidney failure – conditions that are potentially life-threatening. The most common STEC, E. coli O157:H7, is the type most often associated with outbreaks.
Most leafy greens are grown outdoors, where they may be exposed to human pathogens via contaminated soil, fertilizers, animals, air/dust, and/or water. In addition, leafy greens are mostly consumed raw, without cooking or other processing steps to eliminate microbial hazards. The Produce Safety Rule established by the FDA Food Safety Modernization Act (FSMA) sets science-based minimum standards to help ensure that water, soil amendments (e.g., fertilizer or compost), and food contact surfaces do not contribute to produce contamination. The Produce Safety Rule also addresses animal intrusion into fields and worker hygiene. The FDA is now working in collaboration with state regulatory agencies to verify compliance with the Produce Safety Rule requirements via routine inspections.
The FDA has an unwavering commitment to advancing the safety of fresh leafy greens through FSMA implementation and meeting the goals set forth in the LGAP.
Looking Ahead to 2021
Significant progress has been made on the Leafy Greens STEC Action Plan over the past year. As progress has been made, it has also led to the identification of additional steps that can be taken to further advance the safety of leafy greens. At the same time, 2020 presented unique challenges to implementing the action plan. The COVID-19 pandemic specifically made some actions difficult to accomplish, creating the need to continue some work with renewed emphasis in the year ahead.
Because outbreaks have continued to occur, including a multistate outbreak of E. coli O157:H7 infections in 2020 linked to leafy greens, the FDA understands that there is more work to be done. Looking ahead to 2021 and beyond, the FDA will continue adapting our strategic and tactical approaches as more information about contributing factors that may lead to leafy greens contamination are identified. The agency will proceed in a well-reasoned, scientific, evidence-based manner to ensure these learnings are utilized to enhance the safety of leafy greens and protect consumers.
The plan, updated and focused for 2021, is informed by work and knowledge gained over the past year. New actions have been added based on information collected and lessons learned. These new activities are a direct result of the substantial actions achieved on the 2020 action plan to date.
This updated 2021 plan is also a renewed commitment to advancing actions from the plan that the agency was unable to fully execute in 2020, either due to the pandemic or because they were actions that were never intended to be completed within a single year’s timeframe.
As outbreaks have continued to occur, despite significant efforts in recent years, greater emphasis will be needed around such complex issues as adjacent land use, agricultural water, and understanding likely routes by which human pathogens may contaminate leafy greens.
For some of the most pressing issues around the broader agricultural environmental and animal activity, industry leadership will be critical to addressing potential hazards, and industry will need support from a variety of other partners. With this in mind, the FDA will continue to build on critical partnerships with other government entities, all parts of the leafy greens industry, consumer groups, retailers, and the broader agricultural community to achieve the public health impacts envisioned, recognizing that food safety is a shared responsibility.
Updated Actions and Approaches for 2021
Building on the original LGAP released in 2020, the FDA has updated the approaches the agency will take in 2021 to advance the safety of leafy greens. The following table provides the approaches that will be taken in each of the three priority areas: Prevention, Response and Addressing Knowledge Gaps.
New approaches have been identified with bold text. In addition, key accomplishments in 2020 are listed for each priority area. For a full listing of 2020 actions, accomplishments and status updates, please see the Leafy Greens STEC Action Plan Accomplishments page.
|
Priority |
LGAP |
Approaches for 2021 |
Key Accomplishments in 2020 |
|---|---|---|---|
|
Prevention |
1.1 Publish a proposed rule for agricultural water provisions of the Produce Safety Rule for covered produce other than sprouts; open for public comments. 1.1.1 Convene public meetings and outreach after publishing the proposed rule to facilitate stakeholder understanding. 1.1.2 Develop and distribute online tools to assist growers in evaluating potential risks posed by their water sources and determining potential management options. |
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Prevention |
1. Advance Agricultural Water Safety |
1.2 Continue grower education emphasizing the importance of using good agricultural practices (GAPs) for agricultural water. 1.2.1 Develop, with national and state partners, an agricultural water systems workshop piloted in North Carolina, in 4th quarter 2021, and for national delivery virtually or in person in 2022. |
1.2 Engaged with numerous growers about the importance of using GAPs, especially as they apply to agricultural water, including via the California and Arizona Leafy Green Marketing Agreements (LGMA) and the International Association of Food Protection Annual Conference. |
|
Prevention |
1. Advance Agricultural Water Safety |
1.3.1 Engage and reach out to chemical suppliers and other agricultural water stakeholders concerning the new Environmental Protection Agency protocol to encourage the availability of agricultural water treatment options that are registered for use in preharvest water. |
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Prevention |
2.1 Continue prioritized routine inspections, in partnership with states, for leafy greens farms covered by the Produce Safety Rule. 2.1.1 Continue technical support to NASDA in their leadership, with states, in conducting voluntary On Farm Readiness Reviews (OFRR). 2.1.2 Continue collaboration with NASDA in developing responsive approaches to most frequently encountered observations on farms. |
2.1 The FDA requested prioritized inspections and On-Farm Readiness Reviews (OFRR), and states, with support from National Association of State Departments of Agriculture (NASDA), have conducted over 1,400 OFRRs to date. In addition, NASDA have collaborated in developing approaches for addressing observation scenarios most frequently encountered on farms. |
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Prevention |
2. Enhance Inspections, Audits and Certification Programs |
2.2 Continue work providing technical assistance to efforts by industry and stakeholders to enhance audit standards and verification activities related to agricultural water, adjacent or nearby land use, and soil amendments. This work continues under the New Era of Smarter Food Safety Core Element 2.4 “Inspection, Training, & Compliance Tools”. |
2.2 The FDA participated in a series of LGMA and Western Growers Association (WGA) meetings offering technical assistance to the LGMA’s metrics review process and perspective on how current metrics and updates relate to the Produce Safety Rule. |
|
Prevention |
3.1 Continue engagement with retailer and food service stakeholders on the role of strengthened buyer specifications, such as enhanced third party-audits, end-to-end traceability, and root cause analysis activities in enhancing the safety of leafy greens. This work continues under the New Era of Smarter Food Safety Core Elements 1 “Tech-enabled Traceability: and 2 “Smarter Tools and Approaches for Prevention and Outbreak Response.” |
3.1 The FDA met with and established multiple partnerships with retail and food service stakeholders (Restaurant Food Safety Partnership, Retail Food Store Partnership, and Leafy Greens Safety Coalition) to discuss means to enhance the safety of leafy greens. |
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Prevention |
4.1 Continue support for work with stakeholders to create a voluntary public-private data trust for leafy greens, a bank of large volumes of data generated by industry (e.g., traceability data, audits, microbiological testing data, etc.) that can be accessed for analytical work to further strengthen preventive approaches. |
4.1 The FDA met with Western Growers Association and offered support, through the form of a letter, for widespread participation from industry in their data trust program. |
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Prevention |
5. Microbiological Surveys for STEC Detection and Enhanced Sampling Protocols |
5.1.1 Conduct additional, focused sampling assignments for romaine lettuce grown in Arizona using local contract labs to provide analysis results more promptly and to minimize the possibility that potentially contaminated produce would be distributed. A focused sampling assignment will also be conducted for romaine lettuce grown in California. |
5.1 FDA completed a focused sampling assignment of romaine lettuce grown in Arizona. A report on the results of this assignment is forthcoming. |
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Prevention |
5. Microbiological Surveys for STEC Detection and Enhanced Sampling Protocols |
5.2 Continue working with stakeholders to share knowledge on new technologies and sampling approaches (what to sample, when to sample, where to sample, how often to sample, etc.) that increase the ability to detect STEC, with the goal of more effective industry sampling and testing. |
5.2 The FDA completed several enhanced detection and isolation protocols for the sampling of STEC and Salmonella. These methods were shared at the CFSAN/ORA Environmental Microbiology Methods Summit, the FDA Office of Regulatory Science / Office of Applied Research and Safety Assessment roundtable and at an Association of Official Analytical Chemists (AOAC)-convened national environmental methods symposium. |
|
Prevention |
6. Increase Awareness and |
6.1 Continue providing education and technical assistance to government partners and industry stakeholders regarding potential impacts of adjacent and nearby land use on produce safety. 6.1.1 Advance development of practical resources (e.g., fact sheets) to assist growers in assessing and mitigating risks. |
6.1 The FDA provided education and technical assistance to regulators and industry through FDA’s Technical Assistance Network. |
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Prevention |
6. Increase Awareness and |
6.2 Enhance coordination with government partners as well as local, regional, and national industry stakeholder collaborations to incorporate and achieve recommended strategies for minimizing risks presented by the presence of livestock on adjacent and nearby land. |
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Prevention |
6. Increase Awareness and |
6.3 Communicate approaches and tools that aid federal investigators and state inspectors with identifying risk factors associated with adjacent land use. |
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Prevention |
7. Establish and Strengthen Regular Outreach and Communication Programs for Stakeholders in Growing Regions |
7.1 Continue ongoing dialogue on region-specific issues in real time with a broad array of Yuma growing region stakeholders. |
7.1 The FDA established monthly meetings between the FDA, the Arizona Department of Agriculture, and the Yuma Fresh Vegetable Association to discuss leafy greens safety issues. |
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Prevention |
7. Establish and Strengthen Regular Outreach and Communication Programs for Stakeholders in Growing Regions |
7.2 Continue ongoing dialog on region-specific issues in real time with a broad array of California growing region stakeholders. |
7.2 The FDA established monthly meetings between the FDA, the California Department of Food and Agriculture (CDFA), and the California Department of Public Health (CDPH) to discuss leafy greens safety issues. |
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Response |
8.2 Continue promptly releasing new investigation findings, as they shed light on the potential routes and possible mitigation strategies for STEC contamination of leafy green, including but not limited to a reports on the STEC contamination of leafy greens in fall of 2020. |
8.1 In 2020 and early 2021, FDA published the investigation reports on the 2019 and 2020 STEC outbreaks linked to the consumption of leafy greens which outlined the epidemiological and traceback information, on-farm investigation approaches, and key findings. |
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Response |
8. Investigation Reports |
8.3.1 Convene additional meetings with the leafy greens industry and trade associations to deliver investigation outcomes and encourage knowledge sharing with members to reduce leafy greens contamination risks. |
8.3 The FDA convened numerous meetings with the leafy greens industry and trade associations to deliver investigation outcomes and encourage knowledge sharing with members to reduce leafy greens contamination risks. |
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Response |
9. Conduct Follow-Up Surveillance During the Fall 2020 California Growing/ Harvest Season |
9.1 California Department of Food (CDFA) and Agriculture, in coordination with California Department of Public Health (CDPH) and FDA, will conduct focused follow-up investigations in a prioritized manner of farms/ranches identified by foodborne illness outbreak traceback investigations. Special emphasis will be on soil amendment use and lands adjacent to leafy greens to gain clarity and understanding of cattle distribution or movements. |
9.1 The FDA, in consultation with the California Department of Food and Agriculture (CDFA), issued a mission critical assignment to conduct follow-up investigations of farms in the Salinas, California growing region during harvest. |
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Response |
10.1.1 Advance the development of a final rule for implementing FSMA Section 204 related to the records required for tracking and tracing designated foods, which may serve as a foundation for traceability throughout the entire food system. This work continues under the New Era of Smarter Food Safety Core Element 1.1 "Develop Foundational Components." |
10.1 The FDA published in the Federal Register a proposed rule, which, if finalized, will establish additional traceability recordkeeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. |
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Response |
10. Promote |
10.2.1 Collaborate on an Institute of Food Technologists-led effort to develop further documentation of the leafy greens pilot completed in 2020 including (1) providing additional details on how each pilot team executed their tracebacks, (2) developing considerations for future pilot project methodologies and real world traceback investigations, and (3) providing education and outreach materials. This work continues under the New Era of Smarter Food Safety Core Element 1.3 "Leveraging the Digital Transformation." |
10.2 The FDA collaborated with an industry-led Leafy Green Pilot Task Force to plan, initiate, and work with identified volunteers/industry experts to execute pilot scenarios; and review and synthesize the data in a report published by the Leafy Greens Task Force in December 2020. |
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Response |
11.1 Continue work with retailers and government partners to improve the timely collection and transmission of purchase information during an open traceback investigation, including providing technical assistance in efforts to develop electronic data requests and data-sharing templates to support rapid traceback and convergence analysis. This work continues under the New Era of Smarter Food Safety Core Element 1.3 "Leveraging the Digital Transformation." |
11.1 The FDA served as the co-lead with US Department of Agriculture’s Food Safety Inspection Service (USDA FSIS) in the Shopper History Outbreak Partnership (SHOP) Workgroup. Working with state representatives this workgroup has begun development of a best practices document regarding the use of shopper history during foodborne illness investigations. |
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Response |
12. Accelerate Whole Genome Sequencing Data Submissions by States |
12.1 Continue work with Centers for Disease Control and Prevention (CDC) and state departments of health to determine ways to expedite sample analysis and reporting into PulseNet and the existing public National Center for Biotechnology Information database. |
12.1 The FDA improved the process for sample analysis and reporting, including pushing genome assemblies rather than raw data of FDA isolates to PulseNet; established a dashboard to retrieve assemblies that are generated in real-time for FDA isolates; and devoted resources to increase staffing to assist with pushing data to PulseNet. |
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Response |
13.1 Continue to strengthen root cause analysis procedures, coordinating with federal, state, local, tribal and territorial partners to ensure rapid deployment as soon as an outbreak is traced to a specific site. This work continues under the New Era of Smarter Food Safety Core Element 2.1 "Invigorate Root Cause Analysis." |
13.1 The FDA developed a proposed systems-based, root cause analysis approach summary that can be refined as more analyses are conducted in the future.
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Response |
13. Advance Root Cause Analysis Activities |
13.2 Continue to collaborate and encourage federal, state, industry, consumer, and academic stakeholders to advance, standardize, and increase awareness about the value of root cause analysis protocols for food safety. This work continues under the New Era of Smarter Food Safety Core Element 2.1 "Invigorate Root Cause Analysis." |
13.2 The FDA conducted multiple discussions with produce industry trade and buyer groups to encourage widespread industry adoption of root cause analysis and the FDA participated in industry-led education outreach efforts on this topic. |
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Response |
14.1 Continue to collaborate with government partners to review and evaluate outbreak communication mechanisms and propose enhancements for continuous improvement. This work continues under the New Era of Smarter Food Safety Core Element 2.5 "Outbreak Response." |
14.1 FDA published a new webpage summarizing ongoing outbreak investigations. This webpage, which is updated weekly, increased transparency and the availability of risk communication information for stakeholders about currently developing foodborne outbreaks. |
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Addressing Knowledge Gaps |
15.1 Continue to support the ongoing Yuma Longitudinal Study |
15.1 The FDA entered into the second year of the multi-year longitudinal study. The second year of the study slowed due to restrictions associated with the COVID-19 pandemic. |
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Addressing Knowledge Gaps |
15. Longitudinal Studies |
15.2 Continue to support the ongoing California Longitudinal Study. Continue year 1 planning activities and engage in full sampling activities post COVID-19 pandemic to continue to shed light on how human pathogens survive, move and possibly contaminate produce prior to harvest. |
15.2 The FDA formally initiated a multi-year California Longitudinal Study. The study has been slowed due to restrictions associated with the COVID-19 pandemic. |
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Addressing Knowledge Gaps |
16.1 Continue to collaborate with Centers for Disease Control and Prevention (CDC), state and other federal partners to conduct a retrospective analysis of past leafy green outbreaks, mining available data and evaluating potential contributing factors. 16.1.1 Publish an additional review of FDA-investigated on-farm findings associated with outbreaks of Shiga toxin-producing Escherichia coli infections linked to romaine lettuce from 2009-2018. |
16.1 The FDA along with Center for Disease Control and Prevention (CDC) collaborators published the study, "Lessons Learned from a Decade of Investigations of Shiga Toxin–Producing Escherichia coli Outbreaks Linked to Leafy Greens, United States and Canada” in Emerging Infectious Diseases.
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Addressing Knowledge Gaps |
16. Data Mining and Analytics on Previous Outbreaks |
16.2 Continue to collaborate with research organizations to evaluate the role of seasonality in STEC outbreaks involving leafy greens. 16.2.1 Participate in a planned Center for Produce Safety STEC & leafy greens colloquium planned for early 2021. |
16.2 The FDA has been unable to collaborate fully with research organizations due to constraints placed on the agency by COVID-19. |
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Addressing Knowledge Gaps |
16. Data Mining and Analytics on Previous Outbreaks |
16.3 Develop machine learning, traceback investigation tools for produce that leverage quantitative risk assessment in further support of risk mitigation strategies. |
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Addressing Knowledge Gaps |
17.1 Continue to collaborate with federal and state partners, research organizations, and industry stakeholders to identify existing data and knowledge on the impact of adjacent and nearby land use on leafy greens growing areas. Prioritize collection of additional data and information that will help growers implement effective science-based mitigation strategies. 17.1.1 Communicate and engage with government partners and other stakeholders, including industry and retail trade associations, to (1) understand current practices, opportunities and barriers for implementing best management strategies; and (2) explore a list of options and practical priorities for pre-harvest best management strategies. |
17.1 The FDA evaluated, updated, and prioritized its research interests related to adjacent and nearby land use and communicated these knowledge gaps and research interests to other organizations, including other federal food safety agencies, food industry groups, and academia. |
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Addressing Knowledge Gaps |
17. Adjacent and Nearby Land Use |
17.2 Continue working with government partners and industry stakeholders to explore the feasibility of implementing pre-harvest best management strategies for cattle raised near leafy green growing areas and encourage research into pre-harvest mitigation strategies related to cattle. 17.2.1 Provide technical assistance to a locally led, locally convened multi-stakeholder workgroup representing multiple aspects of California agriculture to explore immediate actions that can be taken to reduce the risks created when leafy green production and neighboring agriculture entities, including range land cattle, operate on adjacent land. 17.2.2 Conduct literature review and encourage research on the potential role of vaccination or use of feed additives in reducing the shedding of STEC by cattle on adjacent lands. |
17.2 The FDA provided technical assistance to a locally led, locally convened effort called California Agricultural Neighbors workgroup that is being led by the CDFA and Monterey County Farm Bureau to identify what actions can be taken now to reduce the risk of STEC contamination of leafy greens in this specific growing region. |
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Addressing Knowledge Gaps |
18.1.1 Finalize and post a document summarizing all actionable data for consideration in directing future policy, guidance, and research activities around the safe and effective use of biological soil amendments of animal origin. 18.1.2 Advance second round of contractor-based sampling now underway to analyze additional compost samples.
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18.1 The FDA, utilizing an external contract laboratory, commenced collecting and analyzing numerous samples for microbial pathogens, including finished brown compost collected from the South West Arizona and Imperial Valley, California leafy green growing regions and soil samples collected by the FDA from the Yuma region. In addition, the FDA collaborated with the California Department of Food and Agriculture (CDFA) who collected and analyzed samples during Fall 2020 sampling. Progress for compost samplings slowed somewhat in 2020 due to COVID-19. |
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| Addressing Knowledge Gaps | 18. Compost Sampling Assignment with California | 18.2 California Department of Food and Agriculture (CDFA), with state partners will conduct additional surveillance sampling of biological soil amendments of animal origin. Results of this surveillance work will serve as important data points to ensure the entire system works in an effective, integrated way to help ensure soil amendments are processed and handled in a manner to reduce or eliminate microbial pathogens. |
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Previous Versions
November 2020 Status Update of the 2020 Leafy Greens Action Plan