- Standardized end-to-end traceability recordkeeping for produce, seafood and other items prone to cause foodborne illnesses have been proposed by the FDA. The proposed regulations were published in the Federal Register this week.
- This would establish a single method for tracing different items, which could help government officials quickly pinpoint the origin of different food items when there is an outbreak. In a statement on the proposed rule from Frank Yiannas, the FDA's deputy commissioner for food policy and response, he said that while some producers have good traceability systems for their products and ingredients, they often are not compatible with others. Others have none, he wrote.
- Enacting this framework is part of the sweeping Food Safety Modernization Act, which was signed into law by President Obama in 2011. It has taken years for all parts of FSMA to be enacted, but, as several large-scale outbreaks related to produce have shown, enhanced traceability could help contain an outbreak more quickly.
In factories and processing facilities, FSMA has been the driving force for many updates. Instead of simply reacting to outbreaks, the law put the onus on manufacturers to develop plans and procedures to stop contaminated food from reaching consumers in the first place.
But contamination doesn't only happen in factories. In recent years, the most widespread and devastating outbreaks have come from problems with produce. The CDC found foodborne illness was on the rise last year, with leafy greens being one of the areas of most concern.
When fruits and vegetables become contaminated, many times the source of the problem is contaminated water that was used to grow the crops. With produce coming from a vast amount of different farms and regions, it's sometimes difficult to pinpoint an exact source. An outbreak last year that was linked to romaine lettuce salad kits and sickened more than 150 people did not have an identified source for almost three months. In 2018, a nascent E. coli outbreak led then-FDA Commissioner Scott Gottlieb to order retailers, restaurants and consumers to destroy all romaine lettuce, regardless of its source, two days before Thanksgiving.
While the FDA has been working with leafy greens growers and processors to improve water testing and inspections, a uniform traceability system could make it easier for the agency to quickly find out where a contamination originated without stopping all sales of the product. Though some food and produce companies have embraced blockchain and contracted companies to create internal traceability systems, those are worthless if they are not easily understood by food safety regulators.
"Simply put, we lack a harmonized system of traceability from farm to fork that is universally understood and utilized," Yiannas wrote in his statement on the proposal.
Because it has taken FDA years to roll out all of the aspects of FSMA, the Center for Food Safety sued the department in 2018 to force it to enact the entirety of the law. According to a consent decree filed to settle the case last year, FDA agreed to publish this regulation in the Federal Register this month.
"It should not have taken litigation for FDA to publish this proposed rule but now that it is out, we will be analyzing the merits of the proposal closely and continue to ensure the agency follows the law in finalizing the rule,” Center for Food Safety staff attorney Ryan Talbott said in a written statement.
The proposed regulation sets out detailed records that all facilities that manufacture, process, pack or hold certain foods — either as standalone products or ingredients — must keep. These records indicate sourcing, processing steps, transportation methods, storage and destinations. Under the proposal, the records would be detailed, including exact geographic areas from which crops were harvested or fish were caught. And while these records would not have to be kept digitally, in the event of an outbreak, digital copies would need to be quickly transmitted to FDA.
The traceability standard doesn't apply to all food items or ingredients. The items on the list were identified as more likely to be contaminated and causing severe and costly illnesses. The list includes soft cheese, eggs, nut butters, cucumbers, fresh herbs, leafy greens, melons, peppers, sprouts, tomatoes, tropical fruit, fresh fruits and vegetables, finfish, crustaceans, mollusks and ready-to-eat deli salads.
The cost of this regulation would be borne by manufacturers, producers and processors. The cost estimate varies from the hundreds of millions to the billions of dollars, depending on what different companies need to do. However, while the regulation sets out which data needs to be collected — and indicates it could be much more extensive than what is done now — it does not mandate all companies to use a single provider to collect or parse this data. Previous investments in traceability systems would not be invalidated; the data and terminology just needs to be reset to fit with what every other entity is collecting.
Despite the investment, the proposed regulation points out the regulations could bring significant cost savings. It estimates an 84% faster identification of the source of foodborne illness, meaning fewer costly recalls. Fewer people getting sick from food also is a financial benefit. Recalls bring negative publicity to producers, and safer food means more satisfied consumers, which can translate into better sales.