The U.S. Food and Drug Administration is cracking down once again on food producers, with a new and tougher requirement for product safety and traceability. 

The Food Safety Modernization Act (FSMA) came into effect in 2011. It laid out a series of specific actions to prevent contamination of food products at all points along the supply chain.

Now, FDA is proposing to implement additional recordkeeping and reporting requirements for “persons who manufacture, process, pack or hold foods the agency has designated for inclusion on the Food Traceability List.” The FTL consists of food items that FDA deems to bear the highest risk to consumers, based on criteria such as frequency of outbreak, severity of illness, likelihood of contamination and potential for pathogen growth.

A key part of FDA’s New Era of Smarter Food Safety blueprint, announced in July, 2020, the new proposed rule would implement FSMA’s section 204(d), which covers food traceability. It identifies 24 specific categories that the agency wants industry to be able to track and trace to an unprecedented level of detail, according to Dean Wiltse, chief executive officer of supply chain software vendor Mojix.

Current law requires only that entities in the food industry be able to declare from where they directly bought something, and to whom they directly sold it — “one up and one back,” as the agency describes it. The implementation of Rule 204 would impose a much broader standard, identifying specific items “that now need to be tracked and traced by everyone that touches them,” Wiltse says.

The reporting requirement is similarly strict with regard to time. Where it might have previously taken food producers and sellers up to 10 days to access that level of detail, they will now be required to respond within 24 hours.

Barring FDA’s request for a delay, Wiltse says, the agency is likely to submit the new rule to a federal judge in November of this year, at which point it will go through the process of being codified into law.  

The rule, if implemented as proposed, provides a grace period of two years within which companies unable to supply the required information would not be subject to penalties. There’s also an exception for what FDA terms “certain small originators,” such as smaller produce and egg farms, but it’s not entirely clear where FDA is currently drawing the line, Wiltse says.

Penalties for non-compliance could amount to substantial fines or even jail time, notes Mojix marketing director Hélène de Lailhacar.

Food producers and retailers need to begin preparing for the new rule now. “We see a real need not just for traceability, but for transparency and visibility into the [entire] supply chain,” says Jim Hardeman, chief purchasing officer and chief marketing officer with CMX, vendor of a software platform for managing quality, risk and compliance.

Many food sellers, including retailers, grocers and restaurants, currently lack visibility beyond their tier 1 suppliers, says Hardeman. Now they’ll need to cite the specific origin, all the way back to the farm, of all products, ingredients and formulations that go into manufacturing.

Standards already exist to help them achieve that degree of visibility, most notably the Global Location Number (GLN) system established by GS1 US. It provides a unique key in the form of a 13-digit number for identifying all parties and locations in a supply chain.

An estimated 70% of the food industry in the U.S. has adopted that standard, says Wiltse, but it’s not as widely employed in other countries, which account for 20% of the nation’s food supply. A GS1 US-compliant barcode can identify everything from the specific farm, product type and harvest date to ship date — information that becomes instantly available to every entity that handles the item along the chain. At the grocery or restaurant end, software allows sellers to scan the applicable information and determine whether a given product is being subject to recall. The technology makes the process relatively straightforward even for a restaurant chain with thousands of locations and an extensive list of ingredients to manage.

By being able to access the precise origin of a contaminated food item during a recall, producers wouldn’t necessarily have to destroy all product that came from a particular farm or region. (That has often been the case with sensitive items such as romaine lettuce.) “Now the cost is pinpointed down to the lot level,” says Wiltse.

As onerous as implementation of Rule 204 might seem to the food industry, it will bring benefits to end consumers. “More of them are wanting transparency,” Hardeman says. “They want to know where the food they’re buying is coming from. “That’s super beneficial for brand loyalty.”