Requirements for Additional Traceability Records for Certain Foods; Proposed Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade “A” Pasteurized Milk Ordinance

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 1</CFR> <DEPDOC>[Docket No. FDA-2024-N-1939]</DEPDOC> <SUBJECT>Requirements for Additional Traceability Records for Certain Foods; Proposed Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade “A” Pasteurized Milk Ordinance</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Proposed exemption. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is proposing to grant an exemption for certain cottage cheese products from the requirements of the Requirements for Additional Traceability Records for Certain Foods rule (the Food Traceability Rule). The Agency is taking this action in accordance with the FDA Food Safety Modernization Act and FDA's implementing regulations. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Submit either electronic or written comments on the notice by September 16, 2024 to ensure that the Agency considers your comment on the proposed exemption. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments as follows: <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2024-N-1939 for “Requirements for Additional Traceability Records for Certain Foods; Proposed Exemption for Cottage Cheese Regulated by the National Conference on Interstate Milk Shipments Grade “A” Pasteurized Milk Ordinance.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Katherine Vierk, Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2122, <E T="03">Katherine.Vierk@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> On November 21, 2022, FDA published in the <E T="04">Federal Register</E> (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) <E T="03">et seq.</E> 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 the <E T="04">Federal Register</E> 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 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 23k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━