The FDA released its final proposed rule under the Food Safety Modernization Act in September. The FSMA Food Traceability Proposed Rule identifies and creates increased traceability requirements for certain high-risk foods and products that contain those high-risk foods.
During an SFA regulatory conference call, Monday, Jeni Lamb Rogers, regulatory counsel to the SFA and partner at PSL Law Group, discussed the proposed requirements for makers, distributors, and retailers, as well as the limited exemptions to the rule.
“It’s important to note that this rule is different from other FSMA rules,” Rogers noted. “It has a broader application beyond manufacturers and farmers that will reach restaurants and retailers as well.”
To decide which foods this rule will apply to, the FDA built an algorithm that matched hazards with different processing practices and different foods. The agency then put the foods that are deemed the highest risk on the Food Traceability List. Among the foods on the list are all cheese other than hard cheeses, shell eggs, tree nut or peanut butters, leafy greens, fresh herbs, cucumbers, melons, peppers, sprouts, tomatoes, tropical tree fruits, other fresh cut fruits and vegetables, finfish, crustaceans, mollusks and bivalves, and ready-to-eat deli salads. In addition, any food that contains one of the above foods will also be subject to this rule, unless it goes through a “kill step” process, which eliminates the food-borne illness risk.
The proposed rule identifies five “critical tracking events” that would require records containing “key data elements,” which would vary depending on the event being performed. The critical tracking events include:
Growing. For products such as fruits and vegetables, this is the first step of the supply chain.
Receiving. This is an event in the food’s supply chain in which a food is received by someone other than the end customer. Food makers, co-packers, labelers, and retailers are all categorized under this event. The first receiver is the first person, other than a farm, who purchases and takes physical possession of a listed food.
Transformation. This involves changing a food on the Food Traceability List, its package, and/or its label by combining ingredients or processing a food.
Creation. Creating is the making of a food on the Food Traceability List through manufacturing or processing using only ingredients that are not on the list.
Shipping. This is when a food is arranged for transport from a defined location to another defined location at a different farm, a first receiver, or subsequent receiver.
Key data elements that are required to be established and maintained involve linking the product’s traceability lot code (assigned by first receiver) to other information such as where and when the product was grown or created, quantity and unit of measure, how and when it was transformed, and/or how and when it was shipped.
There are a couple exemptions to this rule. Transporters are not subject to this rule, and, as mentioned, foods that receive a certain type of processing or “kill step” may be partially exempt, though they still have to keep records around the receipt of the product and the kill step. There is also a proposal that small retail food establishments that employ 10 or fewer full-time employees would be either fully or partially exempt from these requirements. The FDA wants to hear from stakeholders regarding these options during the public comment period and public hearings.
Listen to the full recording now.
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