1.1  Complete a rulemaking for the agricultural water provisions of the Produce Safety Rule for covered produce other than sprouts.

• Published a proposed rule for agricultural water provisions of the Produce Safety Rule for covered produce other than sprouts; open for public comments.

• Convened two virtual public meetings to discuss the agricultural water proposed rule on 2/14/2022 and 2/25/2022.

• Developed and launched an online tool to assist growers in evaluating potential risks posed by their water sources and determining potential management options. This work also falls under the New Era of Smarter Food Safety Core Element 2.4 on Inspection, Training, and Compliance Tools.

• The FDA also released paper-based versions of the agricultural water assessment builder tool in both English and Spanish.

• Published and requested comment on a supplemental notice of proposed rulemaking regarding compliance dates for pre-harvest agricultural water requirements on 7/18/22.

1.2 Engage with stakeholders to collaboratively advance the safety of agricultural water through education, outreach, and technical assistance.

• In both 2020 and 2021, the FDA engaged with numerous growers about the importance of using Good Agricultural Practices, 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 Meeting. 

• In 2021, the FDA, with national and state partners, developed and piloted an agricultural water systems workshop in North Carolina. The pilot was held on March 10-11, 2021, and the agency is exploring options to conduct a second pilot in 2022.

• In 2021 and 2022, FDA subject matter experts participated in several stakeholder meetings and webinars to discuss requirements for harvest and post-harvest agricultural water and the potential changes to the pre-harvest standards.

1.3. Reduce contamination through the development and use of agricultural water treatment options. 

• Co-developed a protocol with the Environmental Protection Agency (EPA) for developing data in support of new and amended registrations for preharvest agricultural water treatments.

• In May 2022, announced two updates to the protocol to make it more feasible for stakeholders to develop and register their treatments.

• The FDA and the EPA are actively engaged with chemical manufacturers in support of treatment development.

• Engaged with LGMA and EPA to improve the protocol to be reflective of real-world practices.

2.1 FDA and state partners will prioritize inspections based on information collected during past foodborne illness outbreaks.

• A list of leafy greens farms identified by FDA via foodborne illness outbreak traceback investigations was provided to FDA State partners in California to inform produce farm inspection prioritization during the growing season.

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.

• In 2020, the FDA participated in a series of Leafy Greens Marketing Agreement (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.

• In 2021, the FDA participated in CA LGMA technical committee meetings, offering technical assistance on metrics review and the development of an adjacent lands risk assessment tool. FDA provided perspective on how potential updates/changes and the new risk assessment tool aligned with the Produce Safety Rule and FDA current thinking. The tool is in development.

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.

• 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. FDA also provided technical assistance to a retail trade association on recommendations for leafy green buyers including buyer specifications and barriers to the implementation of best management practices.

• FDA provided technical assistance to the Food Marketing Institute (FMI) when they updated the FMI Recommended Food Safety Practices for Leafy Greens.

4.1 Engage and collaborate internally and externally to explore methods for public-private data trusts.

• In 2020, the FDA met with Western Growers Association and offered support, through the form of a letter, for widespread participation from industry in the Western Growers Association data sharing/analytics program. 

• In 2021, FDA subject matter experts joined a newly formed Western Growers Food Safety Stakeholder Committee to explore use of the Western Growers Food Safety Data-Sharing Platform. 

• Western Growers partnered with Crème Global to develop a food safety data sharing tool. The tool can capture food safety data generated during pre-season, pre-harvest, and post-harvest activities. It currently focuses on pre-harvest data and other metadata.

• Western Growers completed the project phase with five pilot participants. The first version of the tool was released late in 2021. Currently, Western Growers is focused on recruitment of additional industry members and expanding marketing and communication efforts.

• While discrete data sharing currently is between industry participants, Western Growers has asked FDA and other stakeholders for input on what type of aggregated data would be useful to share with regulatory agencies.

• A session entitled “Driving a Cultural Change in Produce Safety through the Use of a Novel Confidential Data Sharing Platform” focused on this work at the International Association for Food Protection Annual Meeting on 8/2/2022.

5.1. Conduct additional, focused sampling assignments for romaine lettuce grown in Arizona and California, as necessary.

• In FY20-21 the FDA completed a focused sampling assignment of romaine lettuce grown in Arizona. 

• In 2021, FDA posted the result of romaine lettuce product sampling conducted in 2019 and 2021.

• In addition, the FDA conducted a product sampling assignment consisting of over 500 samples of lettuce (iceberg, leaf, and romaine) grown in Salinas Valley, from mid-May to the end of the harvest season in November 2021. A summary report was published in September 2022.

5.2 Continue working with stakeholders to share knowledge on new technologies and sampling approaches.

• 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. The methods are now fully utilized by FDA field staff during sampling.

• The FDA has posted an SOP for the use of Dead-End Ultrafiltration (DEUF) for the Detection of Bacterial Pathogens from Agricultural Water and a training video on FDA.gov.

• The FDA participated in the delivery of an AOAC Training for environmental sampling.

6.1 Provide education and technical assistance regarding potential impacts of adjacent and nearby land use on leafy green safety.

• Provided technical assistance to LGMA workgroups on hazards associated with adjacent and nearby land use activities.

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.   

• Leafy Green Safety Coalition of Retailers established to strengthen prevention practices and traceback and to improve scientific basis for assuring the safety of leafy greens.

• California Agricultural Neighbors (CAN) established and convened by California Department of Food and Agriculture (CDFA) provides an opportunity to foster awareness, collaboration, discussion, and implementation of food safety best practices among neighboring agriculture operations. The CAN released their action plan in June 2022 outlining recommended actions for good neighbor-to-neighbor communications on seasonal activities, action steps toward food safety integrity, and defining knowledge gaps that require further research and collaboration

• AFDO Healthy People 2030 STEC Leafy Green Work Group established with the object to reduce the number of infections due to STEC outbreaks.

7.1 Continue ongoing dialogue on region-specific issues in real time with a broad array of Yuma growing region stakeholders.

• The FDA established biannual meetings between the FDA, the Arizona Department of Agriculture, and the Yuma Fresh Vegetable Association to discuss leafy greens safety issues.

7.2 Continue ongoing dialogue on region-specific issues in real time with a broad array of California growing region stakeholders.

• The FDA established and continues 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.  These monthly meetings coordinate collaborative efforts to enhance the safety of leafy greens, including ongoing work on the CA Longitudinal research study, California  Agricultural  Neighbors workgroup, AFDO Healthy People 2030 Committee produce workgroup, prioritizing leafy greens farm inspections, and sampling assignments.

8.2 Continue releasing new investigation findings to shed light on the potential routes and possible mitigation strategies for STEC contamination of leafy greens.

• In 2020 and early 2021, the 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. Following each release, the FDA engaged with the industry and trade associations to discuss the findings and encourage collaboration to work toward preventing future outbreaks.

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.  

• In 2020, the FDA, in consultation with CDFA, issued a mission critical assignment to conduct follow-up investigations of farms in the Salinas, California growing region during harvest.  

• In 2021, CDFA conducted follow-up produce safety inspections of leafy greens farms and associated ranches that were identified by traceback investigation in 2020 leafy greens foodborne illness outbreaks. Results of these CDFA inspections were of the 38 priority farms inspected, none were categorized as having Official Action Indicated and 20 farms were categorized as having Voluntary Action Indicated with no significant deficiencies identified.

• In 2022, CDFA is again conducting follow-up produce safety inspections of leafy greens farms and associated ranches that were identified by traceback investigation in 2021 leafy greens foodborne illness outbreaks.

10.1.1 Advance the traceability of leafy greens through the issuance of the Food Traceability Final Rule.

• In September 2020, the FDA published in the Federal Register a proposed rule to 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, including leafy greens. The agency anticipates issuing the final rule in November 2022.

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.

• The FDA collaborated with an industry-led Leafy Green Traceability Pilot to plan, initiate, and work with identified volunteers/industry experts to execute pilot scenarios that replicated a traceback investigation; and review and synthesize the data in a report published by the Leafy Greens Task Force in December 2020.

• Lessons learned from the Leafy Green Traceability Pilot report completed by industry groups informed efforts described in the New Era of Smarter Food Safety Core Element 1.3.

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.

• 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.

• The FDA provided technical assistance to the Conference for Food Protection (CFP) Foodborne Illness Investigation Committee. This group—comprising federal, state, and local regulators, as well as industry, academic, and consumer stakeholders—is determining how consumer purchase data could be utilized during foodborne illness investigations at the state and local levels.

• The FDA has drafted and piloted the use of a Digital Data Request Template for retailers to quickly provide traceability information that links back to consumer purchase data of cases within an outbreak investigation. These templates build upon the goals outlined within the FDA Foodborne Outbreak Response Improvement Plan, which focuses on smarter ways to digitize and routinize the traceback process.

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.

• 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.

• The number of states submitting data has increased to 32, including 17 private laboratories and 8 federal partners.

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. 

• In 2020, 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.

• In 2021, In collaboration with the AFDO Healthy People 2030 Committee Produce Workgroup, FDA is working to address three main areas of Root Cause Analysis (RCA)/Root Cause Investigation (RCI): (1) Conducting RCA/RCI, (2) data sharing, and (3) implementation of RCA/RCI.  The workgroup has identified the tools currently available and most often used for RCA/RCI.

• Western Growers published two produce industry guidance documents: 1) When To Do Root Cause Analysis: A Decision-Making Guide for the Produce Industry and 2) Conducting Root Cause Analysis: A “How-To” Guide for the Produce Industry. 

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

• In 2020 the FDA launched the core investigation table 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.

• In 2021 the FDA conducted an independent review of FDA’s foodborne illness outbreak response process and recommendations were prepared and published.

• Based on the 2021 independent review, FDA’s Foodborne Illness Outbreak Response Improvement Plan was developed and published in 2022.  FDA continues to work on improvements identified in the plan.

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.

• In 2019 the FDA formally initiated a multi-year Yuma Longitudinal Study to better understand the ecology of human pathogens in the environment in the Yuma agricultural region. This initiative is a multi-year study which will focus on how these pathogens survive, move, and possibly contaminate produce prior to harvest. The FDA is now in its third year of the study. The second year of the study slowed due to restrictions associated with the COVID-19 pandemic, but the study is now back on track and extensive environmental sampling has resumed.  Numerous samples of water, sediment, and air continue to be collected and analyzed for STEC and Salmonella.

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.

• In 2020 the FDA initiated a multi-year California Longitudinal Study. The California longitudinal multi-year study will examine how pathogens survive, move through the environment, and possibly contaminate produce, through work with water quality, food safety, and agricultural experts from CDFA, the Western Center for Food Safety at UC Davis, representatives from various agriculture industries, and members of the leafy greens industry. The study is now entering its second year. The first year of the study slowed considerably due to restrictions associated with the COVID-19 pandemic.  However, the study is moving back on track and regular sampling is now underway at several environmental and agricultural sites in the Salinas growing area. 

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

• The FDA along with Centers 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 the journal, Emerging Infectious Diseases.

16.2 Continue to collaborate with research organizations to characterize the role of seasonality and regional factors in STEC outbreaks involving leafy greens.  

• The Center for Produce Safety evaluated the role of seasonality in STEC outbreaks involving leafy greens.  Five CPS Briefs were developed in 2021: 1) Hypothesis Risk Matrix, 2) Leafy Greens Production, 3) Regional Cattle Management Profile, 4) Genomics & SNPs, and 5) Bioaerosol Risk (all issue briefs can be found under the resources tab on the Center for Produce Safety’s Website.)

• FDA collaborated with USDA’s Agricultural Research Service to publish, Seasonality, shelf life and storage atmosphere are main drivers of the microbiome and E. coli O157:H7 colonization of post harvest lettuce cultivated in a major production area in California.

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.

• The FDA communicated with federal agencies and food industry groups to evaluate opportunities and barriers related to implementing science-based practices and mitigations.  Outcomes from these discussions included technical assistance activities and further outreach engagements with several industry representatives.

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.

• In 2020, the FDA provided technical assistance to a locally led, locally convened effort called California Agricultural Neighbors (CAN) 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.

• In June 2021, the California Agricultural Neighbors Interim Report on best practices to help enhance localized food safety efforts issued.  The work conducted by CAN Dialogue Group fostered a deeper understanding among Salinas Valley agricultural neighbors of the practices that commonly take place throughout the year.  The work of the group identified collective themes for discussion, recommendations for consideration, and opportunities where we can expand on current knowledge and understanding of the issues.

• FDA completed a literature review and identified the portfolio of products for pathogen reduction in cattle.

• CDFA has sponsored a Phase 1 study (being conducted by UC Davis) on the use of a cattle vaccine (E. coli 0157 SRP vaccine) to evaluate the safety in cow-calf production operations and the transference of antibodies from cows to their calves. This was the first step in a multi-phase research project.   

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.

• The FDA, utilizing an external contract laboratory, commenced collecting and analyzing numerous samples for microbial pathogens, including finished brown compost collected from the Southwest 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 restrictions.

• In 2021, the FDA, utilizing an external contract laboratory, collected and analyzed 644 manure and soil samples for Salmonella, STEC and Listeria monocytogenes.  The FDA is developing a summary report with results from the survey anticipated to be published in 2022.

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.    

• CDFA collected and tested compost and processed (heat-treated) manure samples from 39 facilities starting in fall 2019 through 2021. One compost sample contained STEC and Listeria monocytogenes. Elevated fecal coliform populations were found in finished compost in 11 facilities sampled. All but one composts with elevated fecal coliform levels used either green-waste, green-waste & food-waste, or green-waste and grape pomace as feed stocks (green-waste is non-manure biodegradable waste). The findings reinforce current policy around the use of compost as promulgated under the Produce Safety Rule.