The FDA continues to chase a paperless paper trail with the announcement of a proposed food traceability rule. The agency will be taking comments on the proposal for two months.

The proposal is tentatively set to be published in the Federal Register on Wednesday. Comments will be accepted for 120 days after publication. 

One part of the food industry that’s been in the outbreak hot seat in recent years was quick to respond to the Food and Drug Administration’s rulemaking announcement. Officials with the California Leafy Greens Marketing Agreement (LGMA) issued a “been there, doing that” statement just hours after the FDA announcement Monday.

“This has been part of the LGMA requirements since the organization was formed in 2007,” according to a statement from the voluntary industry group. “It appears the members of the LGMA in California and Arizona are already in compliance with new requirements announced today.”

The LGMA, which covers about 80 percent of the lettuce and other leafy greens grown in the United States, was organized after a deadly 2006 E. coli outbreak traced to a field of spinach. More recently, romaine lettuce has caused several outbreaks.

While leafy greens are one of the foods included on the FDA’s high-risk list there are a number of others. The FSMA requires FDA to designate high-risk foods for which the proposed additional recordkeeping requirements “are appropriate and necessary to protect the known safety risks of a particular food, including the history and severity of the public health.” The high-risk food designation must be based on the following factors:

• foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention (CDC);
• the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce the food;
• the point in the manufacturing process of the food wher contamination is most likely to occur;
• the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
• the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and
• the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

“We will publish a final version of the Food Traceability List on our website when we issue the final rule, and we will updat the list as appropriate,” according to the FDA’s summary of its proposed rule.

“. . . (The rule is) designed to improve the traceability information available for these foods during foodborne illness outbreaks and to increase the speed and precision of trace forward investigations for recall events.”

The traceability rule is part of the regulatory framework Congress required of the FDA in the 2011 Food Safety Modernization Act (FSMA). Other mandated rules, such as the Produce Safety Rule, are already in place.

“The core components of the proposed rule are the requirements to establish and maintain records containing key data elements (KDEs) associated with different critical tracking events (CTEs) in a listed food’s supply chain, including the growing, receiving, transforming, creating, and shipping of listed foods,” according to FDA’s Monday announcement. 

“The recordkeeping requirements we propose emphasize the importance of documenting the applicable traceability lot codes and linking these codes to other KDEs at critical points in the supply chain of food to aid product tracing during an investigation of a foodborne illness outbreak or during a recall.”

FDA Deputy Commissioner Frank Yiannas said untangling the mess of shipping and sales records that currently hampers outbreak investigations is something everyone can understand.

Yiannas is the agency’s biggest cheerleader for electronic tracing and is pushing for a transition from paper-based recordkeeping to electronic records.

“Not only does this help us to remove potentially unsafe products from the market more quickly, preventing additional illness or death, but it also helps us to conduct root cause investigations to figure out what went wrong leading to the outbreak,” Yiannas said in a statement about the proposed rule. 

“Without knowing the source of contaminated food is extremely hard, if not impossible, for us to fully diagnose the problem and work with industry to develop and implement strategies to prevent similar issues in the future. Recent outbreaks of foodborne illness tied to fresh produce like leafy greens and papayas, among others, highlight the importance of this work.”

The agency summary about the rulemaking described the collection of regulations as being the key to establishing “a consistent approach for product tracing for the different types of products and firms subject to this regulation.” 

The proposed rule also specifies the data elements and information firms must establish and maintain, along with information they must send, in certain circumstances, to the next entity in the supply chain. The rule also would help establish a foundation for the use of consistent food tracing terminology, and a universal understanding of the critical information needed for a standardized and efficient system for traceability. 

What happened to the two-step?
There will be a new dance for some in food town if the proposed rule is written into the federal code. Congress already requires that food companies be able to trace their products one step forward — who they sold it to — and one step back — who they bought it from.

The FDA explained regulations in excess of that FSMA rule are the proposed rule: “. . . Congress directed FDA to adopt additional recordkeeping requirements to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death to humans or animals resulting from foods being adulterated.”

Requiring additional traceability steps isn’t just about public health, either, according to the proposed rule. There is a financial factor.

“Efficient traceability enables the government and the food industry to take action more quickly, thus preventing illnesses and reducing economic harm,” according to the FDA summary.

New footwork to learn
The recordkeeping and documentation requirements proposed by the FDA are not anything more than many businesses already have in hand — literally, according to the agency. But if Dancer A can’t read the handwriting on her dance card then Dancer B has little chance of taking her for a twirl.

“The rule also would help establish a foundation for the use of consistent food tracing terminology, a transition from paper-based recordkeeping to electronic records, and a universal understanding of the critical information needed for a standardized and efficient system for traceability,” according to the summary of the rulemaking document.

“Piecing together information from several types of documents to extract useful tracing data at each point in the supply chain is laborious and time-consuming, significantly slowing the tracing process and potentially putting more consumers at risk.”

Exemptions
As with the Produce Rule and other pieces of the FSMA, the proposed recordkeeping traceability rule includes exemptions. The exemptions run from partial to complete. Some were imposed by Congress and others FDA is proposing on its own.

The proposed rule also includes special requirements for foods on the Food Traceability List that are subjected to a kill step.

Proposed full exemptions include:

• some small retail food establishments; 
• small farms; 
• farms selling food directly to consumers;
• certain food produced and packaged on a farm; 
• food that receives certain types of processing; and 
• transporters of food.

Partial exemptions include:

• certain commingled raw agricultural commodities (not including fruits and vegetables subject to the produce safety regulations);
• fishing vessels;
• retail food establishments that receive a listed food directly from a farm; and
• farm to school and farm to institution programs.

As support for the need for the proposed traceability recordkeeping rule, the FDA included details about a number of foodborne outbreaks. Those outbreaks, as presented by the FDA were:

• In 2018, the FDA investigated a cluster of illnesses caused by Cyclospora cayetanensis at small restaurants. We were unable to obtain enough information to identify specific farms/growers (from among several suppliers) as the source of the products suspected of contamination (e.g., basil, cilantro, vegetable trays) due to the restaurants’ lack of records indicating lot numbers received and lack of linking to information throughout the supply chain. In the absence of more specific data at the retail food establishment, we had to conduct a broader record collection involving numerous suppliers to ensure that we had sufficient tracing information to accurately determine what lots likely would have been available for consumption or purchase at the establishments by the sickened persons. One benefit of the proposed requirements is that they would allow us to conduct comparative analyses on supply chains of multiple commodities to rule in or out specific ingredients in outbreaks in which ill persons have reported concerns about mixed-ingredient foods.
• Lack of traceability has led to delays in product recalls and notification to the public, allowing potentially contaminated foods to remain on the market longer. In 2017, the manufacturer of a soy nut butter product recalled the product after it was found to be the source of a multistate outbreak of Shiga toxin-producing Escherichia coli (E. coli) that sickened 32 people (81 percent of whom were younger than 18) in 12 states (Refs. 2 to 4). Weeks later, another company announced a recall of its products because they were made with soy nut butter supplied by the original company (Ref. 5). Inadequate traceability significantly impeded product actions for a potentially contaminated product associated with this outbreak investigation.

• Inadequate traceability can affect both traceback and trace forward investigations. In 2015, FDA, CDC, and multiple states investigated a multistate outbreak of Salmonella associated with imported cucumbers that ultimately sickened 907 people (Ref. 6). While the traceback was able to identify a single grower of the cucumbers resulting in product recalls, the CDC reported additional sporadic cases of Salmonella 6 months after the recall. Having more robust trace forward information could have helped ensure a more complete recall by identifying more locations that received the contaminated product and may have helped assess whether there were other contaminated products on the market subject to the same conditions that led to the contamination of cucumbers.

• During an outbreak of Salmonella Typhimurium in 2008, almost 4,000 peanut butter- containing products were recalled over a period of three and a half months. Cases of illness were first seen in patients residing in a long-term care facility and other institutional settings. Records at these locations identified a common brand of peanut butter, which led to a common manufacturer, and a recall of the brand was initiated. But illnesses continued to be reported across the United States, and further case interviews indicated that the illnesses could not be explained by consumption of the recalled brand of peanut butter. An extensive traceback and trace forward investigation led to expanded recalls over several months, during which many potentially contaminated peanut butter products remained available in the marketplace. This outbreak illustrates the challenges posed by ingredient-based outbreaks and the lack of standardized records documenting a product’s distribution chain. Manual review of a variety of records was necessary to determine the subsequent commercial recipients of the peanut butter and the inclusion of the peanut butter as an ingredient in other food products. This time-consuming review resulted in a delay in the identification of the many products ultimately recalled in this outbreak.

• Poor traceability records also can lead to an inability to appropriately narrow the scope of a recall. In 2018, a leafy greens mix was linked to an outbreak of Shiga toxin-producing E. coli. FDA identified numerous farms that could potentially have produced leafy greens linked to the outbreak. Traceback data gathered during the investigation led to the issuance of a public advisory to not consume chopped romaine lettuce from the identified growing region. However, the lack of traceability records hindered our ability to identify specific lots and growers of contaminated products. After the initial advisory was issued, we identified an additional cluster of illnesses in people who consumed whole-head romaine lettuce from the same region. As a result, we expanded the initial public advisory to include all romaine lettuce from the identified growing region. Because we were unable to identify a point of origin for the food that made people ill, we were unable to narrow the scope of the advisory but instead had to expand it.

• Poor traceability can affect not only outbreaks caused by infectious pathogens but also illnesses associated with fish poisonings. For example, in 2019, the FDA investigated a cluster of 50 illnesses that were attributed to Scombrotoxin fish poisoning. In cases of fish toxin poisonings, the illness onset can occur within minutes of consuming fish products, making it even more vital to have specific tracing data available at the point of sale. Because cases reported a variety of frozen tuna products due to inconsistent product descriptions, FDA’s traceback investigation traced all cuts of tuna supplied by two firms rather than narrowing the focus to one specific cut of tuna (Ref. 10). The traceback investigation was unable to confirm that the most recent shipments to the points of sale contained the actual product used to prepare meals reported by the cases, due to the extended 2-year shelf life of the frozen product and lack of recordkeeping for this product. Additionally, the traceback investigation could not identify/implicate lot codes at the point of sale because at least two distributors reboxed product into different packaging, and there was potential commingling of product at least one point of sale. Given the extended shelf life and lack of lot codes available at the point of sale, the traceback investigation could not determine relevant lot codes for the implicated products. Due to these traceability limitations, the Agency was only able to place one of the importers of the contaminated tuna products on an import alert, and multiple recalls were required to ensure that importers removed all contaminated products.

• During the investigation of an outbreak of E. coli O26 in 2015 at a restaurant, the available consumer data could not identify a single ingredient for tracing because customers who became ill had consumed a variety of dishes with multiple common ingredients. This problem was magnified by the lack of information linking the distribution center to the point of sale.

• In the last few years, numerous outbreaks associated with leafy greens have resulted in expansive recalls due to, among other reasons, a lack of uniform data collection across the supply chain. While our traceback activities identified farms that could have supplied affected products during the timeframe of interest for those outbreaks, a lack of data about the source of individual lots restricted our ability to identify which farms actually supplied the contaminated product.