i- On June 17, 2024, FDA published a proposed exemption for certain cottage cheese products from the Requirements for Additional Traceability Records for Certain Foods rule (the Food Traceability Rule). FDA initially announced its intention to consider an exemption for cottage cheese regulated under the Grade “A” Pasteurized Milk Ordinance (PMO) in the preamble to the final Food Traceability Rule in November 2022.
- As we have previously blogged, the Food Traceability Rule is one of nine major finalized rules intended to implement the Food Safety Modernization Act and thereby reduce the prevalence of foodborne illness. The Rule is intended to allow for faster identification and removal of potentially contaminated food from the market. The Food Traceability List (FTL) designates the foods subject to the rule, and manufacturers must maintain additional records about critical tracking events in their supply chain related to foods on the list.
- 21 CFR 1.1360-1400 describe the circumstances and process by which FDA may exempt a food from the Food Traceability Rule requirements. In general, FDA will modify requirements applicable to a food or type of entity, or exempt a food or type of entity, when the Agency determines that application of the Rule’s requirements that would otherwise apply to the food or type of entity is not necessary to protect the public health. FDA may consider a modification or exemption on its own initiative or in response to a citizen petition. FDA uses a risk-ranking model inform the FTL by evaluating known or reasonably foreseeable hazards related to commodities.
- Cottage cheese is included on the FTL in the commodity “Cheese (made from pasteurized milk), fresh soft or soft unripened” based on the risk for Listeria monocytogenes and other pathogen contamination after pasteurization steps. However, because the PMO has specific processing requirements for Grade “A” cottage cheese that address these risk factors, and because Grade “A” cottage cheese undergoes enhanced regulatory oversight during manufacturing, FDA has tentatively concluded that application of the Food Traceability Rule requirements to Grade “A” cottage cheese is not necessary to protect public health.
- FDA is accepting comments on the proposed exemption until September 16, 2024. Keller and Heckman will continue to monitor and provide updates on the proposal and the Food Traceability Rule generally.
FDA Proposes Traceability Exemption for Cottage Cheese
Tuesday, June 18, 2024
