Proposal To Revoke 18 Standards of Identity for Dairy Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Parts 131, 133, 135, and 184</CFR> <DEPDOC>[Docket No. FDA-2025-N-1225]</DEPDOC> <RIN>RIN 0910-AJ11</RIN> <SUBJECT>Proposal To Revoke 18 Standards of Identity for Dairy Products</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is proposing to revoke 18 standards of identity for dairy products. FDA is taking this action as we tentatively conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Either electronic or written comments on the proposed rule must be submitted by September 15, 2025. FDA does not intend to extend the comment period. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 15, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal: 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-2025-N-1225] for “Proposal to Revoke 18 Standards of Identity for Dairy Products.” Received comments, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), 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.” We will review this copy, including the claimed confidential information, in our 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, the plain language summary of the proposed rule of not more than 100 words as required by the “Providing Accountability Through Transparency Act,” 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> Jessie Zhao, Office of Nutrition and Food Labeling, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371; or Meadow Platt, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose of the Proposed Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Proposed Rule</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP1-2">D. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Background</FP> <FP SOURCE="FP-2">III. Description of the Proposed Rule</FP> <FP SOURCE="FP-2"> IV. Proposed Effective Date </FP> <FP SOURCE="FP-2">V. Preliminary Analysis of Economic Impacts and Initial Regulatory Flexibility Analysis</FP> <FP SOURCE="FP1-2">A. Foods With Little to No Market</FP> <FP SOURCE="FP1-2">B. Foods Covered by Redundant Food Standard Regulations</FP> <FP SOURCE="FP-2">VI. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">VII. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">VIII. Federalism</FP> <FP SOURCE="FP-2">IX. Consultation and Coordination With Indian Tribal Governments</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Proposed Rule</HD> This action proposes to remove 18 dairy standards that FDA tentatively concludes are no longer necessary to promote honesty and fair dealing in the interest of consumers. <HD SOURCE="HD2">B. Summary of the Major Provisions of the Proposed Rule</HD> This action proposes to remove the following food standard regulations: <EXTRACT> <HD SOURCE="HD3">Part 131—Milk and Cream</HD> <FP SOURCE="FP-1">• 131.111 Acidified milk</FP> <FP SOURCE="FP-1">• 131.162 Acidified sour cream</FP> <HD SOURCE="HD3">Part 133—Cheeses and Related Cheese Products</HD> <FP SOURCE="FP-1">• 133.111 Caciocavallo siciliano cheese</FP> <FP SOURCE="FP-1">• 133.116 Low sodium cheddar cheese</FP> <FP SOURCE="FP-1">• 133.121 Low sodium colby cheese</FP> <FP SOURCE="FP-1">• 133.125 Cold-pack cheese food with fruits, vegetables, or meats</FP> <FP SOURCE="FP-1">• 133.127 Cook cheese, koch kaese</FP> <FP SOURCE="FP-1">• 133.134 Cream cheese with other foods</FP> <FP SOURCE="FP-1">• 133.140 Gammelost cheese</FP> <FP SOURCE="FP-1">• 133.154 High-moisture jack cheese</FP> <FP SOURCE="FP-1">• 133.164 Nuworld cheese</FP> <FP SOURCE="FP-1">• 133.168 Pasteurized blended cheese with fruits, vegetables, or meats</FP> <FP SOURCE="FP-1">• 133.170 Pasteurized process cheese with fruits, vegetables, or meats</FP> <FP SOURCE="FP-1">• 133.174 Pasteurized process cheese food with fruits, vegetables, or meats</FP> <FP SOURCE="FP-1">• 133.185 Samsoe cheese</FP> <FP SOURCE="FP-1">• 133.186 Sap sago cheese</FP> <HD SOURCE="HD3">Part 135: Frozen Desserts</HD> <FP SOURCE="FP-1">• 135.115 Goat's Milk Ice Cream</FP> <FP SOURCE="FP-1">• 135.130 Mellorine</FP> </EXTRACT> <HD SOURCE="HD2">C. Legal Authority</HD> We are issuing this proposed rule based on our authority under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341), which directs the Secretary of Health and Human Services (Secretary) to issue regulations fixing and establishing for any food a reasonable definition and standard of identity, quality, or fill of container whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers. Under section 701(e) of the FD&C Act (21 U.S.C. 371(e)), any action for the amendment or repeal of any definition and standard of identity under section 401 of the FD&C Act for any dairy product, such as cheeses or frozen dairy products, must be begun by a proposal made either by the Secretary on his own initiative or by petition of any interested persons, showing reasonable grounds therefor, filed with the Secretary. <HD SOURCE="HD2">D. Costs and Benefits</HD> We are publishing this proposed rule under the formal rulemaking process. Executive Order 12866 does not require us to analyze the costs and benefits of propose ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 37k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━