Prevention

1.1 Advance a proposed rule for agricultural water for covered produce other than sprouts.

On March 15, 2019 the FDA extended the compliance dates for the agricultural water requirements for non-sprout covered produce to allow time to consider an approach that would address challenges while continuing to achieve public health goals. In preparing for Produce Safety Rule implementation, stakeholders identified practical challenges with implementing certain agricultural water requirements across the diversity of farming operations and water sources, and in response to these challenges and new scientific data the FDA has announced our intention to engage in rulemaking on this matter.  The FDA has made significant progress on development of the proposed rule for agricultural water provisions of the Produce Safety Rule for covered produce other than sprouts and intends to issue a proposed rule in 2021.

Continuing

Prevention

1.2 Emphasize to growers the importance of using good agricultural practices (GAPs) for agricultural water.

Throughout 2020, the FDA continually engaged with growers about the importance of using good agricultural practices, especially as they apply to agricultural water. The FDA met with California and Arizona Leafy Green Marketing Agreements (LGMA) to specifically discuss updates to and developments of LGMA water metrics, met with stakeholders to continue to plan an agricultural water workshop in North Carolina, and participated in the International Association for Food Protection Annual Conference regarding treatment of agricultural water to assure its safe use.

Continuing

Prevention

1.3 Support Environmental Protection Agency approval of an FDA- developed protocol that chemical companies and other agricultural water stakeholders may use in obtaining new and amended registrations of antimicrobial products for use in treating irrigation water.

On June 30, 2020 the FDA announced a new standardized protocol to evaluate the effectiveness of treatments in reducing microbial contamination in agricultural water, which was developed through a collaboration with the U.S. Environmental Protection Agency (EPA). This protocol is intended to help companies develop data on the effectiveness of their products in inactivating pathogens, such as E. coli or Salmonella, in preharvest agricultural water, and was developed through a collaboration between scientists in the FDA’s Center for Food Safety and Applied Nutrition and subject matter experts at the EPA. EPA’s approval of this protocol means that companies may use the data developed using the protocol to support registration of new treatment products, or amendments to current products’ labels, for use against foodborne pathogens in preharvest agricultural water.

Complete

Prevention

2.1  Prioritize routine inspections and on-farm readiness reviews, in partnership with states, for leafy greens farms covered by the Produce Safety Rule.

The FDA requested that states prioritize inspections and On-Farm Readiness Reviews (OFRR) at farms that grow, harvest, pack, or hold leafy greens, resulting in a substantive increase of the number of leafy greens farms evaluated in 2020. The states, with support from National Association of State Departments of Agriculture (NASDA), have conducted over 1,400 OFRR to date. In addition, NASDA have collaborated in developing approaches for addressing observation scenarios most frequently encountered on farms.  Five scenarios have been completed and were presented via national seminar Feb. 12, 2021. FDA- NASDA and a number of additional scenarios are under development.

Continuing

Prevention

2.2 Provide 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.

In 2020, the FDA provided technical assistance to numerous industry stakeholders who led the way in industry adoption of audit standards and verification activities. 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. As a result of this review process, California and Arizona LGMA approved new metrics in August with changes to water and field sanitation requirements. Audits with these updated standards began the week of 11/16/2020, and more proposed changes may occur soon for adjacent land and soil amendments.

Continuing under the New Era of Smarter Food Safety

Prevention

3.1 Engage 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.

In 2020, the FDA met with and established multiple partnerships with retail and food service stakeholders to discuss their role and actions to enhance the safety of leafy greens. Throughout the year, the FDA has convened meetings of the Restaurant Food Safety Partnership, Retail Food Store Partnership, and Leafy Greens Safety Coalition of Retailers, with a unified goal of strengthening the role leafy greens buyers can play in food safety issues, especially as they relate to leafy greens. 

Continuing under the New Era of Smarter Food Safety

Prevention

4.1  Initiate 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.

In 2020, the FDA met with Western Growers Association (WGA) to discuss how the FDA can provide support to their data trust project and provided written formal support to the organization, in the form of a letter, encouraging widespread participation from industry stakeholders.  FDA offered to provide technical assistance, and feedback on data reporting mechanisms to WGA to improve the quality and usability of their data output. This project has also been discussed with various industry trade groups to encourage participation by leafy greens growers.

Continuing under the New Era of Smarter Food Safety

Prevention

5.1 Continue FDA’s focused sampling assignments for romaine lettuce, publicly communicating results in a timely manner.

In 2019, the FDA began a focused sampling assignment for romaine lettuce sourced primarily from California and Arizona, which was suspended due to COVID-19 constraints in March 2020.  However, on October 8, 2020 this assignment was resumed and the remainder of the planned 270 samples were collected between November and December of 2020. Once samples have been analyzed, results will be shared in a final report.

Continuing

Prevention

5.2  Work 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.

In 2020, the FDA completed several enhanced detection and isolation protocols for the sampling of STEC and Salmonella. These methods represent vast improvements to those previously available to FDA and were shared with several stakeholders at separate events in 2020. The first of these events was held in April 2020 when Center for Food Safety and Applied Nutrition (CFSAN) environmental microbiologists organized and hosted the first ever CFSAN/Office of Regulatory Affairs (ORA) Environmental Microbiology Methods Summit. The second, held in June 2020, was a single-day environmental microbiology roundtable between the Office of Regulatory Science and the Office of Applied Research and Safety Assessment within CFSAN that included highlighted research talks and discussions on recent advances in current leafy green and other produce safety research efforts underway. The third event took place in November 2020 at an Association of Official Analytical Chemists (AOAC) convened national environmental methods symposium where CFSAN environmental food safety microbiologists delivered a series of presentations to industry and other food safety stakeholders on recent scientific developments and advances related to the collection and analysis of complex environmental samples on the produce farm and surrounding environments. The method of Dead-End Ultrafiltration (DEUF)  of agricultural and surface waters is now being shared and transferred to Rapid Response Teams (RRT) in participating states to enable a more rapid and effective response when engaging in environmental sampling of farms and surrounding areas. Current efforts are being spearheaded by an FDA-led RRT High-Volume Water Sampling/DEUF Workgroup which includes Federal and State collaborating partners.

Continuing

Prevention

6.1 Provide education and technical assistance to government partners and industry stakeholders regarding potential impacts of adjacent and nearby land use on produce safety.

In 2020, the FDA provided education and technical assistance on the potential impacts of adjacent and nearby land use on produce safety. Speaking with regulators through the FDA’s Technical Assistance Network, the FDA has been able to reach a wide variety of partners on the issue of adjacent land use. Adjacent land use was also addressed in a workshop surrounding issues related to Biological Soil Amendments of Animal Origin, which was held in 2019.

Continuing

Prevention

7.1  Actively discuss region-specific issues in real time with a broad  array of Yuma, Arizona growing region stakeholders.

In 2020, the FDA established regularly occurring meetings between the FDA, the Arizona Department of Agriculture, and the Yuma Fresh Vegetable Association to discuss leafy greens safety issues on a monthly basis. While numerous topics have been covered in these discussions, one significant outcome was coming to an agreement on commonly used terms within the Arizona vegetable community and regulators to promote communication and facilitate understanding amongst all parties. 

Continuing

Prevention

7.2  Actively discuss region-specific issues in real time with a broad array of California growing region stakeholders.

In 2020, the FDA established regularly occurring 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 on a monthly basis. These monthly meetings enabled the FDA, CDFA and CDPH to update, coordinate and assure progress on key action items within the Leafy Greens STEC Action Plan.

Continuing

Response

8.1 Publish an outbreak investigation report including traceback and sampling activities conducted in the Salinas Valley growing region of California.

On May 21, 2020 the FDA published the investigation report “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Three Outbreaks of E. coli O157:H7 During the Fall of 2019.” In addition to outlining the epidemiological and on-farm investigation approaches, the key finding was that the “FDA considers adjacent or nearby land use for cattle grazing as the most likely contributing factor associated with these three outbreaks. While the agency could not confirm a definitive source or route(s) of contamination of the romaine fields, the Agency considers indirect transmission of fecal material from adjacent and nearby lands from water run-off, wind, animals or vehicles to the romaine fields, or to the agricultural water sources used to grow the romaine, as possible routes of contamination.” Further, “These findings reinforce our concern about the possible impacts of nearby and adjacent land use on the safety of leafy green crops and further underscore the importance of implementing appropriate risk mitigation strategies.”

Complete

Response

9.1 Conduct follow-up surveillance inspections during the romaine growing/harvest season of farms identified in previous outbreaks.

On September 25, 2020 the FDA, in consultation with the California Department of Food and Agriculture, issued a mission critical assignment to conduct a follow-up investigation of farms in the Salinas, California growing region during harvest.  The objectives of this investigation were to: determine, evaluate, sample, and document reasonably likely potential sources of contamination in areas associated with a history of E. coli O157:H7 outbreaks; determine, evaluate, and document reasonably likely potential routes of contamination during the harvesting of romaine lettuce; identify and assess all tools and equipment controlled by Salinas, California farms/ranches and/or used during harvest; and identify, describe, and assess the conditions of the harvest activities, operations, tools, and crews at farms/ranches of interest. Currently 152 samples have been collected and are being analyzed.

 Continuing

Response

10.1 Publish a proposed 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.

On September 23, 2020 the FDA published in the Federal Register a proposed rule, which, if finalized, would 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. The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of FSMA. The proposed Food Traceability List includes all types of leafy greens, including fresh-cut leafy greens. When finalized, the proposal would standardize the data elements and information firms must establish and maintain, and the information they would need to send to the next entity in the supply chain to facilitate rapid and accurate traceability needed to prevent or mitigate foodborne illness outbreaks.

Complete

Response

10.2  Prioritize work with leafy green stakeholders to design and initiate a pilot on concepts needed for traceability to further scale, such as testing interoperability of tracing systems and public-private data sharing.

In July 2020, the FDA began engagement in a Leafy Green Pilot Task Force, led by several industry organizations, which lasted through October 2020. The key objectives of this group were to: focus on various romaine-containing products for pilots; plan, initiate, and work with identified volunteers/industry experts to execute each pilot scenario; and review and synthesize the data in a final report to be shared with the FDA and leafy green stakeholders. The Leafy Green traceability pilot final report was published by the Leafy Greens Task Force in early December 2020.

Complete

Response

11.1  Work with retailers and government partners to improve the timely collection and transmission of purchase information during a traceback investigation, including providing technical assistance in efforts to develop electronic data requests and data-sharing templates to support rapid traceback and convergence analysis.

The FDA has been part of the Shopper History Outbreak Partnership (SHOP) Workgroup since 2016 and has served as a co-lead of the group, along with the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and a state representative since 2018. Working with state representatives this workgroup has begun development of a best practices document regarding the use of shopper history during foodborne illness investigations.  The workgroup is also partnering with the Council to Improve Foodborne Outbreak Response (CIFOR) Industry Workgroup to compile a list of state authorities for requesting shopper history

Continuing

Response

12.1  Work with 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.

In 2020 the FDA improved the process for sample analysis and reporting in a few ways. The FDA facilitated pushing genome assemblies rather than raw data of FDA isolates to PulseNet; established a dashboard to retrieve assemblies which are generated in real-time for FDA isolates; and devoted resources to increase staffing to assist with pushing data to PulseNet.

Continuing under the New Era of Smarter Food Safety

Response

13.1  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.

Internally gains have been made by drafting a proposed systems-based, root cause analysis approach summary, which can be refined as more analyses are conducted in the future.

Continuing under the New Era of Smarter Food Safety

Response

13.2  Collaborate with federal, state, industry, consumer, and academic stakeholders to advance, standardize, and increase awareness about the value of root cause analysis protocols for food safety.

In 2020 the FDA helped to advance the understanding and usage of root cause analysis (RCA) protocols for a variety of stakeholders. In March 2020, Pew Charitable Trusts released a “A Guide for Conducting a Food Safety Root Cause Analysis: Approaches for investigating contamination incidents and preventing recurrence,” for which the FDA provided technical assistance. The FDA also conducted multiple, ongoing discussions with produce industry trade and buyer groups about encouraging widespread industry adoption of root cause analysis and participated in the United Fresh, Produce Marketing Agreement, and California Leafy Green Marketing Agreement’s webinar “Understanding Root Cause Analysis.” Specifically, the FDA has stressed the benefits to industry of RCA; clearly defining what a produce RCA entails, initiating  RCAs when preventive measures failures are detected  outside of an outbreak situation; determined means for produce farms to conduct RCAs  as they may not have the ability themselves; and determined how to best disseminate knowledge gleaned from RCAs to inform industry best practices and standards moving forward.

Continuing under the New Era of Smarter Food Safety

Response

14.1 Collaborate with government partners to review and evaluate outbreak communication mechanisms and propose enhancements for continuous improvement.

In November 2020, 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.

Continuing under the New Era of Smarter Food Safety

Addressing Knowledge Gaps

15.1  Support ongoing Yuma Longitudinal Study.

In 2020 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. Despite this, the research team accomplished several targeted sampling events where researchers collected and examined samples from the environment that included surface and canal waters, canal sediment, and dust. The team also collected animal scat samples to assess the impact that animal intrusion and native wildlife may have on the growing environment. The  FDA developed an Environmental Studies webpage that includes general information about the studies in which the FDA collaborates on including the Yuma Longitudinal Study. Please see Environmental Studies webpage for additional information.

Continuing

Addressing Knowledge Gaps

15.2  Initiate California Longitudinal Study.

In July 2020 the FDA formally initiated the California Longitudinal Study when the first pilot sampling in the Central Coast of California was completed. Since that time, the FDA communicated with industry stakeholders on the goals of the study, identifying key questions and hypotheses, and encouraging agricultural stakeholders to enroll in the study, among other objectives.

Continuing

Addressing Knowledge Gaps

16.1 Collaborate with CDC, state and other federal partners to conduct a retrospective analysis of past leafy green outbreaks, mining available data and evaluating potential contributing factors.

In October 2020, 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. The study notes, “More outbreaks were linked to romaine lettuce (54%) than to any other type of leafy green. More outbreaks occurred in the fall (45%) and spring (28%) than in other seasons. Barriers in epidemiologic and traceback investigations complicated identification of the ultimate outbreak source.” And suggests, “Research on the seasonality of leafy green outbreaks and vulnerability to STEC contamination and bacterial survival dynamics by leafy green type are warranted. Improvements in traceability of leafy greens are also needed.”

Complete

Addressing Knowledge Gaps

16.2 Collaborate with research organizations to evaluate the role of seasonality in STEC outbreaks involving leafy greens.

In 2020 the FDA has been unable to collaborate fully with research organizations due to constraints placed on the agency by COVID-19.

Continuing

Addressing Knowledge Gaps

17.1 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.

In 2020 the FDA evaluated, updated, and prioritized its research interests related to adjacent and nearby land use to communicate knowledge gaps and research interests. These interests were then shared with other organizations, including other federal food safety agencies, food industry groups, and academia, to highlight research interests in those key knowledge gaps related to adjacent and nearby land use. Information about adjacent land use interests was also presented to educational partners and food safety professionals, and the FDA discussed educational activities related to adjacent and nearby land use, current farm practices and mitigation strategies, and challenges and barriers to controlling adjacent and nearby land use risks with those key stakeholders.

Continuing

Addressing Knowledge Gaps

17.2  Work 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.

In 2020, the FDA provided technical assistance to a California Department of Food and Agriculture 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.

Continuing

Addressing Knowledge Gaps

18.1 Continue analyzing samples of commercial compost for the presence of foodborne pathogens to inform baseline understanding. Encourage the standardization and collection of data around compost.

In 2020, the FDA, contracted with an external laboratory that has analyzed a number of samples, 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. A second round of contractor-based sampling is now underway to analyze additional compost samples. In addition, the FDA is working with collaborators at the California Department of Food and Agriculture who collected and analyzed samples during Fall 2020 sampling. Progress for both compost samplings has been slowed somewhat in 2020 and 2021 due to COVID-19.

In 2020, the FDA met with the California Department of Food and Agriculture, California Department of Public Health, and CalRecycle in a series of three webinars to present the FDA’s approach to the safe production, use and storage of Biological Soil Amendments of Animal Origin for the production of covered produce. In these webinars, the FDA discussed effective sampling and inspectional protocols.

Continuing