SUPPLEMENTARY INFORMATION:

I. Background

On November 21, 2022, FDA published in the Federal Register (87 FR 70910) a final rule entitled “Requirements for Additional Traceability Records for Certain Foods” (the Food Traceability Rule), which established additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL). In the preamble to the final rule, we announced our intention to consider initiating a process under the new regulation (codified in subpart S of part 1 of title 21 of the Code of Federal Regulations (CFR)) to determine whether to exempt cottage cheese regulated under the Grade “A” Pasteurized Milk Ordinance (PMO) (Grade “A” cottage cheese) from the requirements of the Food Traceability Rule (87 FR 70910 at 70932).

As contemplated in the preamble to the final rule, we are initiating a process in accordance with § 1.1360 (21 CFR 1.1360) et seq. to determine whether it would be appropriate to exempt Grade “A” cottage cheese that appears on the Interstate Milk Shippers (IMS) List (“IMS listed Grade “A” cottage cheese”) from the requirements of the Food Traceability Rule. Section 1.1360(a) states, in part, that FDA will exempt a food or type of entity from the requirements of subpart S when we determine that application of the requirements that would otherwise apply to the food or type of entity is not necessary to protect the public health. Under § 1.1385 (21 CFR 1.1385), if FDA, on our own initiative, determines that granting an exemption from subpart S for a food or type of entity is appropriate, we will publish a notice in ( printed page 51282) the Federal Register setting forth the proposed exemption and the reasons for the proposal. The notice will establish a public docket so interested persons may submit written comments on the proposal.

Currently, cottage cheese is covered by the Food Traceability Rule because it is included on the FTL in the commodity “Cheese (made from pasteurized milk), fresh soft or soft unripened.” However, FDA recognizes that much of the cottage cheese produced in the United States is regulated through the National Conference on Interstate Milk Shipments (NCIMS). NCIMS is a cooperative program among the U.S. Public Health Service (USPHS), FDA, the States, and the dairy industry, with the objective of promoting the availability of a high quality milk supply (Refs. 1 and 2). FDA and NCIMS have together developed a cooperative, Federal-State program (the IMS Program) to ensure the sanitary quality of milk and milk products shipped interstate. All 50 States and the District of Columbia participate in the IMS Program.

The IMS Program is implemented and enforced by the States, with FDA providing oversight, including scientific, technical, and inspection expertise as set forth in an active 1977 Memorandum of Understanding (MOU) between FDA and NCIMS (Ref. 2). As described in the MOU, the IMS Program relies on the PMO, which incorporates relevant Federal requirements, and related technical documents for the sanitary standards, requirements, and procedures it follows to ensure the safety and wholesomeness of Grade “A” milk and milk products, including cottage cheese. FDA considers these standards, requirements, and procedures to be adequate for the protection of the health and safety of the consumer (Ref. 2). The NCIMS recommends changes and modifications to the PMO and other related technical documents at its biennial conferences (Ref. 3). This ensures that the PMO represents the most current science-based knowledge and experience concerning the safe production and processing of Grade “A” milk products and incorporates the latest Federal requirements for food safety (Ref. 3).

Interstate milk and milk product shippers who have been certified by Milk Sanitation Rating Officers as having attained certain identified sanitation compliance and enforcement ratings are listed on the IMS List. Such certification is based on compliance with the requirements of the PMO. Cottage cheese—including lowfat, nonfat, and dry curd—is identified using product code 7 in the IMS sanitation compliance and enforcement ratings (Ref. 4). The proposed exemption would only apply to manufacturers of cottage cheese that are both regulated under PMO requirements and IMS listed for cottage cheese.

As discussed above, cottage cheese is on the FTL because it is included in the commodity “Cheese (made from pasteurized milk), fresh soft or soft unripened.” FDA developed a Risk-Ranking Model for Food Tracing (RRM-FT) to inform the FTL. The RRM-FT is a semiquantitative risk-ranking model that evaluates known or reasonably foreseeable hazards in a wide range of commodities for FDA-regulated human foods, and scores commodity-hazard pairs according to data and seven criteria consistent with the requirements in the FDA Food Safety Modernization Act (FSMA), section 204(d)(2)(A) (Ref. 5). Results from the RRM-FT provide a risk ranking of commodities and commodity-hazard pairs. Based on data and results from the RRM-FT, the Agency considered commodities and associated commodity-hazard pairs with criteria scores in the moderate to strong range and identified commodities for inclusion on the FTL (Ref. 6). The risk score for the commodity “Cheese (made from pasteurized milk), fresh soft or soft unripened” is 430, which is driven by the risk score for the commodity-hazard pair associated with Listeria monocytogenes (Ref. 7). Because of this risk score, the commodity “Cheese (made from pasteurized milk), fresh soft or soft unripened” is included on the FTL (Ref. 6).

As explained in the preamble to the final rule, products such as soft cheeses made from pasteurized milk and nut butters made from roasted nuts can be on the FTL regardless of the fact that some or all of their ingredients were previously subjected to a kill step (87 FR 70910 at 70931-32, responses 60 and 64). This is because the RRM-FT considers potential hazards that may be introduced from exposure to the processing environment after a lethality treatment (id.). In the case of the commodity “Cheese (made from pasteurized milk), fresh soft or soft unripened,” which includes cottage cheese, the RRM-FT took into account the risk from contamination with environmental pathogens, such as L. monocytogenes, which could occur during the manufacturing process, after the pasteurization steps. Thus, while pasteurization of the incoming ingredients provides a significant level of risk-reduction, this commodity nonetheless appears on the FTL because of the risk from post-pasteurization in-process contamination, most notably with L. monocytogenes.

We are proposing to exempt IMS listed Grade “A” cottage cheese from the requirements of the Food Traceability Rule because of the specific processing requirements specified in the PMO that address the risk factors that resulted in the commodity “Cheese (made from pasteurized milk), fresh soft or soft unripened” being on the FTL, and because of the enhanced regulatory oversight of the manufacturing of such products. As discussed in the following paragraphs, manufacturers of IMS listed Grade “A” cottage cheese must comply with requirements intended to control pathogens during pasteurization and to prevent contamination during post-pasteurization processing. Additionally, there are requirements pertaining to information that must be documented in records, and provisions that dictate inspectional and sampling frequencies (Ref. 3).

Pasteurization. Both the milk and creaming mixture used in making cottage cheese must be pasteurized. The PMO requires that all pasteurization equipment be tested and inspected by the relevant Regulatory Agency every 3 months.

Post-pasteurization processing requirements. The cottage cheese processing steps that occur after milk pasteurization prior to packaging can be performed in vessels that are open to the environment, which presents a risk for contamination of in-process food with environmental pathogens, such as L. monocytogenes, if sanitary conditions are not maintained. The PMO contains specific requirements for the control of critical factors including, but not limited to, pH, filling temperature, and the use of microbial inhibitors and preservatives to address post-pasteurization contamination (Refs. 3 and 6). These requirements include:

• Ensuring that all critical factors are monitored and documented by the processing facility, the records of which are verified by the Regulatory Agency;
• Ensuring that capping, closing, and sealing of containers is done in a sanitary manner by approved mechanical equipment (hand capping of IMS listed Grade “A” cottage cheese is not permitted);
• Ensuring that Grade “A” cottage cheese is at a pH of 5.2 or below and is either:

○ Hot-filled at a temperature at or above 145 °F for containers of 4 ounces or larger, and at a temperature of 155 °F or above for containers of 2.9 ounces (these temperatures prevent the survival of L. monocytogenes, a pathogen that ( printed page 51283) might have been introduced into the product from the environment); or

o cold-filled at a temperature of 55 °F or less, with addition of the microbial inhibitor potassium sorbate at a minimum concentration of 0.06 percent, or another approved inhibitor that provides sustained inhibition of L. monocytogenes; and

• Communicating to the Regulatory Agency if there are any formulation or processing changes that affect critical food safety factors (Ref. 3).

Enhanced regulatory oversight. IMS listed Grade “A” cottage cheese manufacturers are subject to stringent regulatory oversight. All milk and milk products manufacturers regulated by the PMO, including IMS listed cottage cheese manufacturers, are subject to a three-tier inspection oversight program that includes inspections by the Regulatory Agency every 3 months, a rating performed by FDA-certified State Rating Officers every 2 years for IMS listing purposes, and check ratings performed by FDA Milk Specialists every 3 years (Refs. 1, 3, and 8). Additionally, during any consecutive 6 months, at least four samples of packaged cottage cheese made from pasteurized milk from each plant that manufactures IMS listed cottage cheese is collected by the Regulatory Agency for analysis (Ref. 3).

Considering the aforementioned features of regulation of IMS-listed Grade “A” cottage cheese, we tentatively conclude that application of the subpart S requirements to IMS listed Grade “A” cottage cheese is not necessary to protect the public health. As described above, the primary hazard associated with “Cheese (made from pasteurized milk), fresh soft or soft unripened,” which includes cottage cheese, is the risk of post-pasteurization, in-process contamination, specifically with L. monocytogenes. This hazard is well controlled when cottage cheese is manufactured in accordance with the PMO. The post-pasteurization processing requirements in the PMO ( e.g., requirements for processing steps, including container filling, to be performed under sanitary conditions; requirements relating to pH; requirements for hot-filling and cold-filling; and the requirement that all critical factors are monitored and documented by the manufacturing facility, the records of which are verified by the Regulatory Agency) provide effective control measures for this hazard. Furthermore, cottage cheese with a maximum pH of 5.2 and containing a minimum of 0.06 percent potassium sorbate, when stored at appropriate refrigeration temperature, will prevent L. monocytogenes growth. More generally, the PMO imposes stringent food safety requirements at every stage of the manufacturing process, covering both pasteurization and post-pasteurization processing, and also requires labeling to include the plant name or IMS number for product traceability. Frequent inspections that include reviewing production records documenting control of critical factors by both the States and FDA Milk Specialists provide a high level of oversight of these cottage cheese manufacturers. FDA's own involvement in the PMO and the Grade “A” program—along with the involvement of other public health governmental entities, such as USPHS and our State, Territorial, and municipal partners—provides a high degree of confidence regarding the safety of Grade “A” dairy products. Therefore, we propose to exempt from the Food Traceability Rule IMS listed Grade “A” cottage cheese that is produced and distributed in accordance with the PMO.

The discussion of the PMO in this document is based on the 2019 Revision.^[1] However, this proposed exemption would apply to any IMS listed Grade “A” cottage cheese, including Grade “A” cottage cheese regulated under past revisions of the PMO (in jurisdictions that might not have adopted the 2019 Revision) and any IMS listed Grade “A” cottage cheese manufacturers regulated under future revisions of the PMO, once such revisions are released and adopted. We do not expect future revisions of the PMO to deviate from the 2019 Revision in material ways that would affect our conclusion that IMS listed Grade “A” cottage cheese should be exempt from the requirements of subpart S, nor do we think that past revisions were materially different in ways that would affect this conclusion. If this exemption is finalized but we subsequently determine that it is necessary to revise or revoke the exemption in order to protect the public health—either because of changes to the PMO or for any other reason—we will follow the procedures set forth in 21 CFR 1.1395 and 1.1400.

In accordance with § 1.1385, we request comments on this proposed exemption. Interested persons may submit written comments on the proposed exemption in the docket established by this notice in accordance with the instructions in the ADDRESSES section of this notice. In accordance with § 1.1385(b), after considering any comments timely submitted, we will publish a notice in the Federal Register stating whether we are granting the proposed exemption for IMS listed Grade “A” cottage cheese and the reasons for our decision.

II. References

The following references are on display at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.

1. FDA and NCIMS, “Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipment (2019 Revision)”, 2019. Available at https://www.fda.gov/​media/​138115/​download?​attachment. Accessed June 3, 2024.

2. FDA and NCIMS, “Memorandum of Understanding Between the National Conference on Interstate Milk Shipments and the Food and Drug Administration”, 1977. Available at: https://www.fda.gov/​about-fda/​mou-225-78-1000. Accessed June 3, 2024.

3. FDA, “Grade “A” Pasteurized Milk Ordinance (2019 Revision),” 2019. Available at: https://www.fda.gov/​media/​140394/​download?​attachment. Accessed June 3, 2024.

4. FDA, “2024 Interstate Milk Shippers List,” 2024. Available at: https://www.fda.gov/​media/​177531/​download?​attachment. Accessed June 3, 2024.

5. FDA Memorandum, “Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204 (21 U.S.C. 2223),” September 2022. Available at: https://www.fda.gov/​media/​142247/​download?​attachment. Accessed June 3, 2024.

6. FDA Memorandum, “Designation of the Food Traceability List Using the Risk-Ranking Model for Food Tracing,” October 2022. Available at: https://www.fda.gov/​media/​142282/​download?​attachment. Accessed June 3, 2024.

7. FDA, “Risk-Ranking Model for Food Tracing: Web-based Tool for Criteria and Results,” 2022. Available at: https://cfsanappsexternal.fda.gov/​scripts/​FDARiskRankingModelforFoodTracingfinalrule/​. Accessed June 3, 2024.

8. FDA, “Compliance Program Guidance Manual 7318.003: National Conference on Interstate Milk Shipments (NCIMS) Milk Safety Program,” 2012. Available at: https://www.fda.gov/​media/​142503/​download?​attachment. Accessed June 3, 2024.