Step by step, FDA officials are tackling the link between E. coli outbreaks and leafy greens. They released their new plan today with many steps repeating their walk thus far, but new footprints are planned to leave the mark of improved food safety.

Announced in a Voices Blog entry from the Food and Drug Administration, the commissioner and deputy commissioner of the agency joined forces to point at obvious environmental problems with leafy greens production. They had a laser focus on romaine lettuce, partly because of five E. coli O157: H7 traced to it from 2017 through 2019.

“The plan is a mix of all the work going on as well as new efforts,” FDA’s Deputy Commissioner for Food Policy and Response Frank Yiannas told Food Safety News this afternoon. 

Yiannas said one area of increased focus is the review of the impact that animal agriculture has on the contamination of fresh produce growing fields. Regardless of whether major corporate feedlot operations are involved — such as the ones on Yuma, AZ, that have been associated with outbreaks — or small family operations with one irrigation pond, animal feces provide pathogen sources for water runoff and dust particles.

Hand in hand with concentrated animal feeding operations (CAFOs) is the question of irrigation water, Yiannas said. Toward that FDA officials plan to publish a new federal rule for agriculture water standards by the end of this year. The rulemaking process after publication in the Federal Register can take years, but not if an item is fast-tracked. The ag water rule is already overdue, with the new deadline 2022.

A third key element that is new to FDA’s leafy greens response, Yiannas said, is closer scrutiny of third-party audit companies that food producers use to gain food safety certification.

“We are already working with third-party auditing firms to let them know they are not doing a good job and we have already made progress,” Yiannas told Food Safety News.

The FDA’s 2020 plan does not include any specific enforcement measures against third-party auditors that are found to be failing to accurately review food safety practices at food businesses.

One roadblock that had to be overcome on FDA’s road to its new plan was the noise of information overload. Yiannas said sorting through the noise of duplicated data and missing pieces of key information was incredibly time-consuming. Information from states, academia, and other federal agencies flooded FDA sub-agencies and departments. 

But, digging through the data has given the agency a clearer picture of the problems that need to be resolved. Romaine is one of those problems cited throughout the 2,400-word plan. 

“This produce commodity has been too often implicated in outbreaks of foodborne illness. These include recurring outbreaks of E. coli O157: H7 infections tied to consumption of romaine lettuce, which is very popular in this country,” said FDA Commissioner of Food and Drugs Stephen Hahn today.

As far as recent romaine outbreaks, Yiannas said part of the 2020 plan is to release investigation information that has previously been withheld from the pubic. The reporting is listed under the response category in the plan.

“. . . we will soon be publishing an investigation report on three outbreaks of E. coli O157: H7 infections tied to romaine lettuce and leafy greens between November and December 2019. Each was tied to the Salinas Valley in California. We will also be conducting follow-up surveillance of fields in that region during this fall’s growing/harvest season,” Yiannas said.

“As public health officials, we are concerned by these recurring outbreaks and we believe all involved with the production and sale of fresh leafy greens can do better.”

Background
Since 2017 a string of E. coli O157H:7 outbreaks across the U.S. and Canada have sickened more than 500 people and been linked to leafy greens grown in the U.S. Of the confirmed patients nearly 200 were so sick they had to be admitted to hospitals. Fifty of the patients developed acute kidney failure called hemolytic uremic syndrome (HUS). There were seven reported deaths. 

“Food safety is a shared responsibility that involves food producers, distributors, manufacturers, retailers, and regulators. We’ve previously called on the leafy green industry to do more, and meeting our own responsibility involves collaboration with state partners on education, training, and inspections,” said FDA Commissioner Stephen Hahn. 

“This plan is designed to help foster a more urgent, collaborative and action-oriented approach.”

Some of the produce industry has responded partly by increasing the distance between massive feedlot operations and open leafy green growing fields. The fields are irrigated with water from open canals adjacent to the 100,000 head feedlots. Some new water considerations continue to be reviewed.

The California and Arizona Leafy Greens Marketing Agreement organizations are also involved in research that they say they have been conducting since 2017. Members of the organizations agree to abide by a set of self-imposed regulations that are audited by state inspectors.

Advance Agricultural Water Safety

In recent outbreaks associated with romaine lettuce consumption, the microbial contamination of agricultural water was identified as a potential contributing factor.

2020 Actions:

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

Emphasize to growers the importance of using good agricultural practices (GAPs) for agricultural water while we are working on the proposed rule.

Support Environmental Protection Agency approval of an FDA-developed protocol that chemical companies may use in obtaining registration of antimicrobial products for use in treating irrigation water.

Enhance Inspection, Auditing, and Certification Programs

Recent leafy greens outbreaks have revealed gaps in audit standards and certification programs that need bolstering in order to maximize their effectiveness as food safety verification tools. 

2020 Actions:

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

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.

Buyer Specifications

Retail and foodservice produce buyers can play an important role in ensuring the safety of leafy greens. Some buyers have begun to strengthen their food safety specifications for purchasing leafy greens.

2020 Action:

Engage retailer and foodservice 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.

Leafy Green Data Trust

With the food industry becoming increasingly digital and new data streams arising from advances in technology, it is more important than ever that there be mechanisms for data to be shared by government and industry to avoid duplication of efforts and to inform prevention with the most robust data sets available.

2020 Action:

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.

Microbiological Surveys for STEC Detection and Enhanced Sampling Protocols:  FDA is conducting assignments to test samples of romaine lettuce grown in the Central Coast, Central Valley, and Imperial Valley in California and in Yuma, Arizona, for pathogenic E. coli and Salmonella to support prevention efforts.

2020 Actions:

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

Work with stakeholders to share knowledge on new technologies and sampling approaches (what to sample, when to sample, wher to sample, how often to sample, etc.) that increase the ability to detect STEC, with the goal of more effective industry sampling and testing. 

Increase Awareness and Address Concerns Around Adjacent and Nearby Land Use: Adjacent and nearby land use, particularly land use involving livestock production, has the potential to be a source of pathogens, especially STEC, that can contaminate produce. More focus and work are needed to better understand how to evaluate and mitigate potential hazards.

2020 Action:

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

Publish Salinas Outbreak Investigation Report

Between November and December 2019, FDA and multiple state and federal partners were involved in the investigation of three outbreak investigations related to three separate E. coli O157:H7 strains and the consumption of romaine lettuce or leafy greens. It is important to share further information about the investigation approach and factors that potentially contributed to the contamination.

Conduct Follow-Up Surveillance During the Fall 2020 California Growing/Harvest Season

Leafy greens grown in the Salinas Valley of California have been associated with several recent outbreaks of pathogenic STEC. FDA and state partners conducted on-farm investigations in late 2019 to identify factors that may have contributed to the outbreaks. Traceback investigations have identified farms that may have supplied contaminated products. Maintaining surveillance efforts during the 2020 growing/harvest season on these farms may enhance the ability of FDA and government partners to prevent future contamination.

Promote Tech-Enabled Traceability

Public health agencies have gotten better at detecting foodborne illnesses, but our ability to trace back to the source of contaminated foods has been hampered, in part, by the lack of modernized food traceability capabilities. Achieving end-to-end traceability throughout the leafy greens supply chain could make it possible to rapidly trace a contaminated food to its source, which can help shorten outbreaks, narrow product warnings, and prevent illnesses.

Improve Utilization of Shopper Card Data

Point-of-purchase recordkeeping, such as shopper cards, can improve the speed and accuracy of traceback investigations by helping retail facilities determine what specific products were purchased and may have been consumed.  However, more work is needed to streamline the process for gathering these data.

Accelerate Whole Genome Sequencing Data Submission by States

Whole-genome sequencing (WGS) reveals the complete DNA make-up of an organism. We use this technology to determine the relatedness among foodborne pathogens and clinical cases during foodborne illness outbreaks. WGS also facilitates the identification of illnesses that may be part of an outbreak, as well as any links to food or environmental samples. Ensuring that samples are processed and reported in an expedited fashion is critical for efficient outbreak investigations.

Advanced Root Cause Analysis Activities

The repeat nature of STEC outbreaks in leafy greens illustrates the importance of root cause analyses to characterize how the contamination took place, inform what preventive measures are needed, and prevent future outbreaks. New models for conducting root cause analyses may increase the effectiveness of these tools.

Enhance Outbreak and Recall Communications

Communications during outbreaks are essential for spurring swift industry action and notifying consumers of potentially contaminated products.  In addition, outbreak communications are important for informing industry of ongoing food safety issues within the leafy greens sector.  Continuous improvements are needed to ensure that communication during outbreaks and recalls is effective in reaching all industry and consumer stakeholders.