CHICAGO — Industry has until January 2025 to be compliant with Section 204, a proposed rule in the Food Safety Modernization Act, but companies could take four steps to prepare now, said Julie McGill, vice president of supply chain strategy and insights at FoodLogiQ. The US Food and Drug Administration should announce the final rule Nov. 7 of this year.
Section 204 will establish additional record-keeping requirements beyond those already in the FSMA. They will apply to certain foods, including dairy, seafood and ready-to-eat products, and certain ingredients.
Companies now may review the proposed rule, assign internal owners, map product life cycles and evaluate current capabilities, McGill said in her presentation March 3 at the American Society of Baking’s BakingTech in Chicago.
The FDA’s website has much information on the proposed rule, McGill said.
“They have recordings,” she said. “They have examples.”
Internal owners within a company may involve those on financial teams, those in specific food categories and those in information technology (IT).
“Big picture, this is going to touch a lot of parts of your business because we’re not only talking about data,” McGill said. “We’re talking about operation. We’re talking about ingredients or finished products. We’re talking about shipping, receiving, etc.”
Mapping product life cycles will involve the supply chain.
“Big picture, what does your supply chain look like?” she said. “You’re going to want to know your current capabilities.”
Section 204 will require companies to capture data and store it for two years. In the event of a recall, the FDA will want data within 24 hours. The proposed rule says it should be on a spreadsheet.
“They are not prescribing blockchain or cloud or whatever,” McGill said.
Section 204 applies to those who process, pack or hold foods on the food traceability list (FTL), which includes foods and ingredients that will need additional record-keeping. Critical tracking events may take place at any part in the supply chain that involves the growing, receiving, transforming, creating or shipping of food.
Food items on the FTL in the proposed rule include leafy greens as expected, but others surprised, McGill said. All nut butters, including peanut and almond butters, are on the list as are soft cheeses like mozzarella, brie, blue and feta. Other items include fresh herbs, peppers, melons, shell eggs and a number of seafood items.
McGill gave peanut butter and peanut butter sandwich cookies as examples of Section 204’s complexity.
“Since peanut butter is on the list, not only does the processor have to track what they made and who they shipped it to, the distributor has to track what they got and who they shipped it to,” she said.
Manufacturers of peanut butter sandwich cookies will need to track where they sourced the peanut butter and the production process, but baking, a kill-step, means the tracking ends there.
“But the cookies that have the finished goods, outbound, don’t need to be tracked because we’ve had a kill step,” McGill said.