The FDA is revising the FSMA regulations. Is your business prepared?
Julie McGill, vice president of supply chain strategy and insights at FoodLogiQ, stated that although businesses may take four measures to get ready now, they would have until January 2025 to comply with Section 204, a proposed rule in the Food Safety Modernization Act. On November 7 of this year, the US Food and Drug Administration is expected to release the final rule.
In addition to the current record-keeping requirements found in the FSMA, Section 204 will impose new ones. They will cover specific foods and ingredients, such as dairy, seafood, and ready-to-eat items.
In her presentation on March 3 at the American Society of Baking’s BakingTech in Chicago, Ms. McGill stated that companies can now analyze the proposed rule, assign internal owners, map product life cycles, and evaluate current capabilities.
Many details about the proposed rule are available on the FDA website, according to Ms. McGill.She stated, “They have recordings.” “They can provide examples.”Within a company, internal owners can include those who work in information technology (IT), finance, or specialized food categories.
“Overall, this will affect many aspects of your company as we’re not just discussing data,” Ms. McGill stated. “We are discussing a surgery. We are discussing components or final goods. We are discussing delivery, receipt, etc.Management of supply chains will be involved in product life cycle mapping.
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“Overall, how does your supply chain appear?” said she. “You should be aware of your present abilities.”Companies will have to collect and retain data for two years as mandated by Section 204. In case of a recall, information must be submitted to the FDA within a day. According to the proposed rule, it ought to be on a spreadsheet.
According to Ms. McGill, “they are not prescribing blockchain, cloud, or whatever.”Foods and ingredients on the food traceability list (FTL), which comprises items and ingredients that require extra record-keeping, are subject to Section 204 for those who prepare, ship, or handle them. Any point in the supply chain where food is grown, received, processed, created, or sent can have critical tracking events.
According to Ms. McGill, some food products on the FTL in the proposed rule are unexpected, such as leafy greens. Soft cheeses like mozzarella, brie, blue, and feta are on the list, as are all nut butters, including peanut and almond butters. Fresh herbs, peppers, melons, shell eggs, and various marine items are among the additional things.
Ms. McGill illustrated the difficulty of Section 204 with examples of peanut butter and peanut butter sandwich cookies.”The distributor has to track what they got and who they shipped it to, in addition to the processor having to track what they made and who they shipped it to since peanut butter is on the list,” the representative stated.
Producers of peanut butter sandwich cookies will have to keep track of the production process and the location of their peanut butter supply, but baking, a kill-step, ensures the tracking stops there.”However, because we’ve had a kill step, the cookies that have the finished goods, outbound, don’t need to be tracked,” Ms. McGill stated.