The FDA’s Proposed Rule for Additional Traceability adds more recordkeeping across the food manufacturing supply chain for some foods—including fresh produce and some refrigerated foods

It also includes a new requirement to provide records more quickly to the FDA when asked—ASAP or within 24 hours at most, in the form of an electronic sortable spreadsheet. Processors who currently keep paper records may be hardest hit, because it’s difficult to respond that fast when the data is stored on paper.

Sounds costly.

Actually, we see the opposite. We’ve assessed the new rule in detail and talked to the FDA and some of our clients. The new rule should lead to less total cost, not more.

Less foodborne illness for consumers. Faster assessment times for the FDA. Fewer and smaller recalls for food manufacturers. And an opportunity for food manufacturers to reduce costs on the factory floor with the help of automations for quality and traceability. All this from a new FDA rule? Wow.

OK, maybe it will save money instead. But how?

There’s a cost savings for many food companies that far exceeds the cost of upgrading from manual, paper-based processes to software that can provide the spreadsheets for the FDA immediately.

It’s the cost of recalls.

Today, we at Tamlin often see data gaps in the supply chain. For example, a traceability lot code for tomatoes assigned at the grower may get lost by the time those tomatoes are being made into jars of salsa in a producer’s factory.

If it’s not clear which tomatoes need to be recalled, then to minimize the number of people who become ill, additional tomatoes and and products that use them must be destroyed to be on the safe side.

In contrast, if it’s clear exactly which tomatoes are the source of the problem, only those tomatoes and products need to be destroyed.

This impacts everyone in that tomato supply chain. For example, the salsa producer may be able to avoid the cost, disruption, and negative publicity of a recall because it’s clear that the tomatoes they received are good.

For many food processors, the cost of a single recall easily exceeds the cost of implementing software and changing internal processes to enhance traceability recordkeeping.

The new proposed FDA traceability rule extends today’s “one forward, one back” tracking for some foods to remove the data gaps, allowing faster and more accurate traceability, continuously across the full supply chain from growers to processors to shippers.

➤ Because of this, we anticipate that even more foods will be added to the proposed rule’s list over time.

We’ve posted our recent recorded webinar overview of the proposed FDA rule

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Learn about the FDA’s Proposed Rule for Additional Traceability