In the final FSMA 204 Traceability Rule, FDA included provisions for updating of the Food Traceability List (FTL) to designate new foods on the list, for which enhanced traceability is required, and to remove foods from the list when appropriate. With the rule coming into compliance in January 2026, FDA has already taken action to enact that provision: initiating a proposal to exempt certain cottage cheese products from the list.
This should not really come as a surprise, as FDA stated in a comment response of the final rule that it is “considering initiating a process under § 1.1360 to determine whether to exempt cottage cheese regulated under the PMO from the subpart S requirements.” (Subpart S defines the additional traceability records required of those on the FTL.)
Cottage cheese was on the final rule’s FTL in the commodity “Cheese (made from pasteurized milk), fresh soft or soft unripened,” for which FDA’s Risk-Ranking Model for Food Tracing (RRM-FT) took into account potential post-pasteurization in-process contamination with environmental pathogens, such as L. monocytogenes.
Through the semiquantitative RRM-FT, FDA evaluates known or reasonably foreseeable hazards in a wide range of commodities, then scores commodity-hazard pairs according to data and seven criteria consistent with the requirements in FSMA. Based on data and RRM-FT results, FDA identified commodities and associated commodity-hazard pairs which scored in the moderate to strong range for inclusion on the FTL. Due to its risk score of 430, “Cheese (made from pasteurized milk), fresh soft or soft unripened” is included on the FTL.
However, much of the cottage cheese produced in the US is regulated by the National Conference on Interstate Milk Shipments (NCIMS) under the federal-state IMS program, which requires that producers implement the safe production and processing requirements of the Grade “A” Pasteurized Milk Ordinance (PMO). These manufacturers are required to not only control pathogens during pasteurization but also prevent contamination during post-pasteurization processing. Also required is record documentation and adherence to provisions that dictate inspection and sampling frequencies.
FDA considers these standards, requirements, and procedures to represent the most current science-based knowledge and be adequate for the protection of the health and safety of the consumer. Therefore, the exemption, which would apply to manufacturers of cottage cheese that are both regulated under PMO requirements and are IMS listed, is proposed because the agency determined that application of the FTL requirements is not necessary to protect public health.
While the exemption does seem to make sense, it also seems that the original criteria for the inclusion of these cheeses should apply to other commodities as well. For example, while leafy greens and fresh herbs are on the FTL, a footnote in an FDA Memorandum for Record notes that the designations “fresh-cut” and “fresh” do not include previously frozen forms of the food. However, if a fresh herb is frozen then thawed, the freezing would not be a kill step and an herb used without further processing (commercially or in the home) could be at risk.
With FDA’s proposed exemption of certain cottage cheeses from the FTL showing the agency’s willingness to remove or add specific commodities without enacting a full revision of the rule, there are likely to be further changes as FDA continues to consider comments – both those included in the rule as well as post-finalization industry and association requests – for the agency to reevaluate other current FTL-listed commodities.
TAG has been closely following, and assisting client compliance with, the Traceability Rule and FTL, and will be presenting a roundtable at the IAFP Conference in July on how the FDA defined strong evidence for Food Traceability List (FTL) Foods and its implications for the Future. Join us for a regulatory/industry discussion on this hot topic!
