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Traceability / FDA

Friday Round-up (7/31/20): FDA Webinar Announces Industry Pilot for Romaine Traceback

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The FDA hosted a webinar this week to provide further detail on the latest work surrounding their Leafy Greens Action Plan. The hour-long event was designed to provide an update on key initiatives associated with the plan, including a new protocol for pre harvest agricultural water, as well as additional details on early pilot programs for leafy greens.

The 2020 Leafy Greens STEC Action Plan, published in March of 2020, was created to address foodborne illness outbreaks resulting from leafy greens, which are disproportionately affected by pathogen contamination due to outdoor growing conditions, and are also often consumed as a raw ingredient. According to the FDA, “Between 2009 and 2018, FDA and Centers for Disease Control and Prevention (CDC) identified 40 foodborne outbreaks of Shiga toxin-producing E. coli (STEC) infections in the U.S. with a confirmed or suspected link to leafy greens.”

Leafy Greens in the New Era of Smarter Food Safety

Traceability, preventative food safety and improved root cause analysis are central focuses for the agency, and each play a heavy role in the New Era for Smarter Food Safety Blueprint, which was published in July 2020. The blueprint specifically calls out leafy greens as an area of interest for strengthening predictive analytics capabilities, stating the FDA will “begin by working with stakeholders to create a ‘leafy greens data trust.’” Leafy greens are considered a high-risk food by the agency, and the leafy greens industry will likely be impacted by new rules slated for publication in September of 2020, in accordance with FSMA Rule 204.

Who is Impacted by the Leafy Greens Action Plan

While nearly all STEC outbreaks originate from farms, responding to food safety incidents requires working back from the affected consumers and end-product. Therefore, the Leafy Greens Action Plan is inclusive of enhanced water safety, auditing and inspections, microbiological analysis, land use analysis, in addition to improved recall communications and buyer specifications. It will take a broad and systemic approach to advance both prevention and response to STEC-related incidents. To this end, the FDA says, “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. This plan is designed to help foster a more urgent, collaborative and action-oriented approach.”

The Romaine Traceability Pilot

A new leafy greens pilot will soon be underway. The stated goal of the charter is to “deliver the key traceability concepts needed for scaling better industry practices such as testing interoperability of tracing systems and public-private data sharing.” The stakeholders hope to both provide better visibility into coordinated outbreak response, as well as evaluate the usefulness of templates like the Produce Traceability Initiative (PTI) Traceback Template, which was developed by the Romaine Task Force.

The program is structured to include three pilot groups, each with designated industry experts serving as investigators. Given a package of lettuce—purchased from real retailers throughout the United States—the teams will request product event data throughout the supply chain, attempting to identify the source of the purchased romaine. The FDA has indicated that participation in pilot is voluntary, and all company information and data collected throughout the process will remain fully anonymized. The members conducting each mock investigation have already been selected, however the FDA has not published the industry experts involved.

The pilot is intended to be a fast and effective way to evaluate the status of whole-chain traceability today, laying the groundwork for more rapid response to foodborne illness outbreaks. The Task Force Charter states, “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 in the Leafy Greens STEC Action Plan.” The pilot is not an endorsement of the PTI Traceback template, or the use of the GS1-128 barcode. It is also not an indication that the Traceback template or the use of excel have become requirements

New Protocol For Agricultural Water

During the webinar, the FDA also announced a new protocol for the development and registration of treatments for preharvest agricultural water. The protocol is intended to “protect agricultural water from the many ways it can be contaminated in the environment or from unsanitary practices on a farm.” The protocol enables companies to develop more actionable data surrounding water quality, and enable stronger consumer protections in relation to the leafy greens industry. 

“This new protocol is a huge milestone for produce safety and for the Leafy Greens Action Plan released by the FDA earlier this year. Working together, the FDA and EPA have supported the development of this protocol that may ultimately help farmers address contamination issues in their water sources and protect consumers from foodborne illness,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas. “We must all work together to help ensure the safety of produce to consumers across the country. We will continue to work with our partners in industry, government and academia on this and other longer-term studies on the ecology of human pathogens in specific growing regions, and new efforts as part of the New Era of Smarter Food Safety Initiative.”


View FoodLogiQ's COVID-19 Food Industry Resource Center for industry-specific updates, resources and information on the coronavirus crisis. For supply chain traceability and risk mitigation guidance, see our general Resource Center.

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Posted by Anna Ploegh on Jul 31, 2020 6:31:57 PM

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