The implementation of a new traceability rule is more than a year and a half away, and the FDA won’t start enforcing the requirements of the rule until 2027, but a former agency leader says companies should begin making changes now.
Frank Yiannas, the former deputy commissioner of food policy and response at the Food and Drug Administration, recently gave Food Safety News insights into Rule 204 of the Food Modernization Act. Yiannas helped draft the rule and is now consulting with companies beginning to take action to meet its requirements.
One method some companies are planning to use — Advanced Shipping Notices (ASNs) — is a shortcut to meeting Rule 204 that “is a concerning narrative regarding FSMA 204 compliance . . . one that threatens to undercut the core objective of the rule,” Yiannas said.
“We think ASNs are good in general but problematic when used for food safety,” Yiannas said, adding that the technology does not provide the level of traceability intended by the rule.
He said it would be better if food companies focused on two critical events rather than a broad approach to general traceability. Those two events are shipping and receiving records, which most consumers likely believe are already used.
Yiannas likened the shipping and receiving records in food safety to ordering goods online. For example, he said, if you order a shirt and get a different shirt, a simple Advance Shipping Notice can provide erroneous information. The problem with ASNs is that they indicate what should have been sent, but not necessarily what was received — and oftentimes there’s a discrepancy between the two.
“I’m afraid in a foodborne illness outbreak this bad traceability information could make crucial differences,” Yiannas said. “The challenge is to know that what an entity is receiving is what they ordered.”
One reason companies cite for not pursuing better shipping and receiving information is the cost of labor involved. But, there is a high-tech option that requires less labor and is lower in cost than current technology.
Yiannas described a system that allows better tracking of food that goes beyond current radio frequency identification (RFID). Such technology is available through Wiliot.
Steve Statler, CMO of Wiliot, described the technology as requiring a sensor about the size of a postage stamp that does not require employees to read the information when it is collected. It can be available instantly but is also retrievable during traceability efforts such as those needed during investigations of outbreaks. The information meets the letter and intent of Rule 204, Yiannas said.
“Until now retailers have been able to get by with a snapshot in time instead of full information about shipping and receiving,” said Statler.
In addition to providing more complete information, the technology is less expensive overall, costing $36 instead of 1.000. It can use Bluetooth in dock doors to read the small tags on food shipments.
Yiannas said the new high-tech option can also provide information about temperature tracking in addition to shipping and receiving data. He said in many instances companies have been running in the dark and with the high-tech options now available they can operate in real time with complete information.
Although the new Rule 204 doesn’t go into effect until 2026, Yiannas said companies need to begin shifting operations now so that they will be ready.
According to a spokesperson for the FDA, enforcement of the rule won’t begin until January of 2027. Depending on the nature of a violation, it is generally FDA’s practice to allow individuals and firms to take prompt and voluntary corrective action before we initiate an enforcement action.
“The FDA may issue advisory action letters, which include Untitled and Warning Letters, or take other actions to notify firms of violations to encourage voluntary compliance,” according to the FDA spokesperson.
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