Leafy Greens STEC Action Plan
FDA and USDA Scientists Research Seasonal Effects Linked to E.coli Outbreaks in Bagged Romaine
The FDA and the U.S. Department of Agriculture’s Agricultural Research Service published a study on the relationship between the lettuce microbial ecology and the potential for E. coli O157:H7 survival. This research is significant in helping to reduce foodborne illnesses linked to the consumption of leafy greens. It also aligns with FDA’s efforts to advance its Leafy Greens STEC Action Plan.
Priority Areas Infographic
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Introduction
Leafy greens are among the most widely consumed vegetables and an important part of an overall healthy diet. However, while millions of servings are consumed safely every day, leafy greens have been repeatedly associated with illnesses caused by Shiga toxin-producing E. coli (STEC), the most common of which is E. coli O157:H7. FDA is committed to breaking this cycle of reoccurring outbreaks.
Over the last several years the FDA and partners in the public and private sectors have worked to enhance the safety of leafy greens through the development and implementation of the Leafy Greens STEC Action Plan (LGAP). This work includes prioritized inspections, focused sampling, stakeholder engagement and collaboration, data sharing, root cause investigations, and advancements in the science of detection and prevention.
Collectively, this work has expanded our body of knowledge about how and why outbreaks linked to leafy greens have occurred, which has guided and informed the evolution of the action plan over the years. Still, we know that we cannot fix the issue of leafy green contamination on our own. Industry leadership, along with collaboration among growers, processors, retailers, state partners, and the broader agricultural community, is critical to establishing needed prevention measures and preventing foodborne illness.
The following table provides the approaches for three priority areas: Prevention, Response, and Addressing Knowledge Gaps, as well as accomplishments that have been made since the action plan launched in March 2020.
Prevention: Advance Agricultural Water SafetyAgricultural water can be a major conduit of pathogens that can contaminate produce and a number of recent outbreaks involving leafy greens have had water contamination as a potential contributing factor. The following actions are intended to enhance the safety of agricultural water used in the production of leafy greens. |
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Approaches
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Key Accomplishments 2020-2022 |
1.1 Complete a rulemaking for the agricultural water provisions of the Produce Safety Rule for covered produce other than sprouts.
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1.2 Engage with stakeholders to collaboratively advance the safety of agricultural water through education, outreach, and technical assistance. |
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1.3. Reduce contamination through the development and use of agricultural water treatment options.
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Prevention: Enhance Inspections, Audits and Certification ProgramsEnhanced inspections, audits, and certifications can help ensure that growers are prepared for compliance with the Produce Safety Rule, provide insights to regulators regarding compliance trends, and help regulators address misunderstandings that may lead to future food safety issues on a farm. The following actions reflect how FDA intends to work with states and industry stakeholders to prioritize and enhance inspections, audits, and certifications across the leafy greens industry. |
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Approaches
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Key Accomplishments 2020-2022 |
2.1 FDA and state partners will prioritize inspections based on information collected during past foodborne illness outbreaks. |
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2.2 Continue providing technical assistance to efforts by industry and other stakeholders to enhance audit standards and verification activities related to agricultural water, adjacent or nearby land use, and soil amendments. |
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Prevention: Buyer SpecificationsRetailers are often the intermediaries between the grower and the consumer. As such, many set standards – buyer specifications – that produce growers need to meet for retailers to buy and sell their products. The FDA has identified steps we can take, including technical assistance to buyers, to improve the safety of leafy greens. |
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Approaches
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Key Accomplishments 2020-2022 |
3.1 Continue to engage and provide technical assistance to 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. |
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Prevention: Leafy Greens Data TrustShared data can help to inform our understanding of leafy greens outbreaks and mitigation strategies that can be used to prevent future outbreaks. Therefore, the FDA is interested in exploring options for public-private data trusts that help to facilitate the sharing of data. This work also falls under Core Element 2.2 “Strengthen Predictive Analytics Capabilities” of the New Era of Smarter Food Safety Blueprint. |
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Approaches
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Key Accomplishments 2020-2022 |
4.1 Engage and collaborate internally and externally to explore methods for public-private data trusts.
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Prevention: Microbiological Surveys for STEC Detection and Enhanced Sampling ProtocolsThe agency conducts microbiological sampling assignments to identify potential contamination events associated with leafy greens and to help prevent contaminated leafy greens from entering commerce, when possible. The following actions reflect the agency’s plans for enhanced sampling to improve the safety of leafy greens. |
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Approaches
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Key Accomplishments 2020-2022 |
5.1. Conduct additional, focused sampling assignments for romaine lettuce grown in Arizona and California, as necessary. |
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5.2 Continue working with stakeholders to share knowledge on new technologies and sampling approaches. |
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Prevention: Increase Awareness and Address Concerns Around Adjacent and Nearby LandSeveral recent leafy greens outbreak investigations have emphasized that conditions and practices on adjacent and nearby land can play a critical role in contributing to produce contamination. The strategies identified below are intended to raise awareness and minimize the risks stemming from certain activities and conditions on adjacent and nearby land. |
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Approaches
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Key Accomplishments 2020-2022 |
6.1 Provide education and technical assistance regarding potential impacts of adjacent and nearby land use on leafy green safety. |
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6.2 Engage with government partners as well as local, regional, and national industry stakeholders to identify strategies for minimizing risks presented by the presence of livestock on adjacent and nearby land. |
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Prevention: Establish and Strengthen Regular Outreach and Communication Programs for Stakeholders in Growing RegionsBuilding relationships with our partners in leafy green growing regions can help us to better understand and respond to contamination events in those areas. The following strategies focus on building our relationship with our leafy green stakeholders in California and Arizona, the two biggest production areas for leafy greens sold in the US. |
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Approaches
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Key Accomplishments 2020-2022 |
7.1 Continue ongoing dialogue on region-specific issues in real time with a broad array of Yuma growing region stakeholders. |
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7.2 Continue ongoing dialogue on region-specific issues in real time with a broad array of California growing region stakeholders. |
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Response: Investigation ReportsInvestigation reports provide insights into the potential routes of contamination that stakeholders can use to better assess their own farms and situations. The reports can also help to identify contamination trends over time. The FDA intends to continue to release investigation reports following STEC outbreaks linked to leafy greens. |
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Approaches
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Key Accomplishments 2020-2022 |
8.2 Continue releasing new investigation findings to shed light on the potential routes and possible mitigation strategies for STEC contamination of leafy greens. |
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Response: Conduct Follow-Up Surveillance During the Fall California Growing / Harvest SeasonPublic health officials sometimes learn about outbreaks long after the contamination event occurred, and in the case of leafy greens it can even be after the harvest season has ended, which makes investigations difficult. Therefore, the agency will work with state partners to conduct surveillance inspections and sampling of farms that may have been linked to previous outbreaks to identify potentially contributing factors and to help prevent future contamination events. |
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Approaches
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Key Accomplishments 2020-2022 |
9.1 Continue to coordinate with the California Department of Food and Agriculture (CDFA), in coordination with California Department of Public Health (CDPH), to conduct focused follow-up investigations and limited produce sampling of farms/ranches identified by foodborne illness outbreak traceback investigations. |
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Response: Promote Tech-Enabled TraceabilityWhen foodborne illness outbreaks occur, efficient product tracing helps government agencies and those who produce and sell food to rapidly find the source of the product and where contamination may have occurred. This can facilitate faster removal of the affected product from the marketplace, reducing incidences of foodborne illnesses. The strategies below are intended to help enhance the traceability of leafy greens and other products. These strategies are also a part of Core Element 1 “Tech-Enabled Traceability” of the New Era of Smarter Food Safety Blueprint. |
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Approaches
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Key Accomplishments 2020-2022 |
10.1.1 Advance the traceability of leafy greens through the issuance of the Food Traceability Final Rule. |
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10.2.1 Collaborate on an industry 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. |
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Response: Improve Utilization of Shopper Card DataMany customers use shopper loyalty cards during purchases, which can provide critical information about purchase history during an outbreak. The FDA is exploring strategies for how we can better utilize available shopper card information during outbreak and recall events. These strategies are also a part of Core Element 1 “Tech-Enabled Traceability” of the New Era of Smarter Food Safety Blueprint and the Foodborne Outbreak Response Improvement Plan. |
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Approaches
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Key Accomplishments 2020-2022 |
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. |
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Response: Accelerate Whole Genome Sequencing (WGS) Data Submissions by StatesAs a method and tool for public health, WGS provides the highest resolution of current molecular subtyping methods and provides definitive evidence to detect and characterize pathogens. Genomic data from foodborne pathogens, by itself and in combination with other information, is a robust resource that can help us rule out or rule in specific strains during outbreak events. The more strains added to public databases such as PulseNet and GenomeTrakr, the greater the opportunities we have to find similar or matching strains that can provide insight into the source of the outbreak. This work is also listed under New Era of Smarter Food Safety Core Element 2.5 “Outbreak Response.” |
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Approaches
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Key Accomplishments 2020-2022 |
12.1 Continue work with Centers for Disease Control and Prevention (CDC), state departments of health, and global laboratories to accelerate sequencing submissions to public databases such as PulseNet and GenomeTrakr. |
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Response: Advance Root Cause AnalysisFindings from root cause analyses can serve an important function in helping industry modify practices to avoid identified risks and can provide more robust data for predictive analytics. The following strategies are intended to enhance future root cause analysis work. This work is also part of Core Element 2.1 “Invigorate Root Cause Analysis” of the New Era of Smarter Food safety Blueprint. |
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Approaches
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Key Accomplishments 2020-2022 |
13.1 Coordinate with federal, state, local, tribal and territorial, and international partners to strengthen root cause analysis procedures and ensure rapid deployment as soon as an outbreak is traced to a specific site. |
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Response: Enhance Outbreak and Recall CommunicationsEnhanced outbreak and recall communications can provide transparency around emerging food safety issues to ensure that industry, consumers, and other stakeholders are on the lookout for issues, even before a specific product/source is identified. This work is also being conducted as part of the New Era of Smarter Food Safety Core Element 2.5 "Outbreak Response." |
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Approaches
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Key Accomplishments 2020-2022 |
14.1 Continue to collaborate with government partners to review and evaluate outbreak communication mechanisms and propose enhancements for continuous improvement. |
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Addressing Knowledge Gaps: Longitudinal StudiesUnderstanding how pathogens survive, move, and possibly contaminate produce prior to harvest – and over the course of time – can help us better understand how pathogens in the environment can impact the safety of leafy greens. Multi-year longitudinal studies will contribute new knowledge on how various environmental factors may influence bacterial persistence and distribution in a growing region, and how those factors may impact the risk of produce becoming contaminated. |
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Approaches
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Key Accomplishments 2020-2022 |
15.1 Continue to support the ongoing Yuma Longitudinal Study to shed light on how human pathogens survive, move, and possibly contaminate produce prior to harvest. |
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15.2 Continue to support the ongoing California Longitudinal Study focusing on manure waste and other run-off targets from large dairy operations and surrounding ecosystems. |
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Addressing Knowledge Gaps: Data Mining and Analytics on Previous OutbreaksAnalyzing data and information from past outbreaks can be used identify insights into factors that may be contributing to leafy greens outbreaks over time. These insights can help inform the development of strategies to help prevent further outbreaks. |
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Approaches
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Key Accomplishments 2020-2022 |
16.1 Collaborate with Centers for Disease Control and Prevention (CDC), as well as state and other federal partners, to conduct retrospective analyses of past leafy greens outbreaks |
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16.2 Continue to collaborate with research organizations to characterize the role of seasonality and regional factors in STEC outbreaks involving leafy greens. |
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Addressing Knowledge Gaps: Adjacent and Nearby Land UseSeveral recent leafy greens outbreak investigations have emphasized that conditions and practices on adjacent and nearby land can play a critical role in contributing to produce contamination. The following strategies are intended to help us close knowledge gaps on how activities and conditions on adjacent and nearby land can contribute to leafy green contamination and what mitigation strategies might be employed to address the issue. |
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Approaches
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Key Accomplishments 2020-2022 |
17.1 Continue to collaborate with federal and state partners, research organizations, and industry stakeholders to provide technical assistance and explore research on the impact of adjacent and nearby land use on leafy green growing areas. Prioritize collection of additional data and information that will help growers implement effective science-based mitigation strategies. |
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17.2 Continue working with government partners and industry stakeholders to explore the implications of cattle raised near leafy green growing areas and research into pre-harvest mitigation strategies related to cattle. |
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Addressing Knowledge Gaps: Compost Sampling Assignment with CaliforniaA major concern when it comes to produce contamination is the microbiological status of manure and compost used in the growing process. Understanding the effectiveness of intervention strategies designed to reduce or eliminate the presence of pathogens in compost can help inform FDA’s understanding of routes of contamination in the growing area. |
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Approaches
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Key Accomplishments 2020-2022 |
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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18.2 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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