Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods, 21148-21171 [2023-06456]

Download as PDF 21148 § 73.30 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules Georgia [Amended] from the Sunday prior to the Masters Golf Tournament through the Monday after (and subsequent weather days if required). 2. Section 73.30 is amended as follows: * * * * * ■ R–3004A Fort Gordon, GA [Amended] Boundaries. Beginning at lat. 33°25′03″N, long. 82°12′15″W; to lat. 33°23′48″N, long. 82°08′56″W; to lat. 33°22′20″N, long. 82°08′33″W; to lat. 33°21′33″N, long. 82°09′10″W; to lat. 33°20′15″N, long. 82°10′57″W., to lat. 33°17′41″N, long. 82°16′11″W; to lat. 33°18′23″N, long. 82°16′17″W; to lat. 33°18′22″N, long. 82°16′39″W; to lat. 33°17′29″N, long. 82°16′52″W; to lat. 33°16′57″N, long. 82°17′39″W; to lat. 33°16′56″N, long. 82°18′50″W; to lat. 33°17′27″N, long. 82°21′19″W; to lat. 33°17′41″N, long. 82°22′35″W; to lat. 33°19′26″N, long. 82°22′15″W; to lat. 33°22′37″N, long. 82°16′58″W; to lat. 33°23′50″N, long. 82°14′03″W; to the point of beginning. Designated Altitudes. Surface to but not including 2,500 feet MSL. Time of designation. By NOTAM 24 hours in advance. Controlling agency. FAA, Atlanta ARTCC. Using agency. U.S. Army, Commanding Officer, Fort Gordon, GA. Remarks. Aircraft activities must not be conducted on national holidays or from the Sunday prior to the Masters Golf Tournament through the Monday after (and subsequent weather days if required). ddrumheller on DSK120RN23PROD with PROPOSALS1 R–3004B Fort Gordon, GA [Amended] Boundaries. Beginning at lat. 33°25′03″N, long. 82°12′15″W; to lat. 33°23′48″N, long. 82°08′56″W; to lat. 33°22′20″N, long. 82°08′33″W; to lat. 33°21′33″N, long. 82°09′10″W; to lat. 33°20′15″N, long. 82°10′57″W; to lat. 33°17′41″N, long. 82°16′11″W; to lat. 33°18′23″N, long. 82°16′17″W; to lat. 33°18′22″N, long. 82°16′39″W; to lat. 33°17′29″N, long. 82°16′52″W; to lat. 33°16′57″N, long. 82°17′39″W; to lat. 33°16′56″N, long. 82°18′50″W; to lat. 33°17′27″N, long. 82°21′19″W; to lat. 33°17′41″N, long. 82°22′35″W; to lat. 33°19′26″N, long. 82°22′15″W; to lat. 33°22′37″N, long. 82°16′58″W; to lat. 33°23′50″N, long. 82°14′03″W; to the point of beginning. Designated Altitudes. 2,500 feet MSL to but not including 10,000 feet MSL. Time of designation. By NOTAM 24 hours in advance. Controlling agency. FAA, Atlanta ARTCC. Using agency. U.S. Army, Commanding Officer, Fort Gordon, GA. Remarks. Aircraft activities must not be conducted on national holidays or VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 R–3004C Fort Gordon, GA [Amended] Boundaries. Beginning at lat. 33°25′03″N, long. 82°12′15″W; to lat. 33°23′48″N, long. 82°08′56″W; to lat. 33°22′20″N, long. 82°08′33″W; to lat. 33°21′33″N, long. 82°09′10″W; to lat. 33°20′15″N, long. 82°10′57″W; to lat. 33°17′41″N, long. 82°16′11″W; to lat. 33°18′23″N, long. 82°16′17″W; to lat. 33°18′22″N, long. 82°16′39″W; to lat. 33°17′29″N, long. 82°16′52″W; to lat. 33°16′57″N, long. 82°17′39″W; to lat. 33°16′56″N, long. 82°18′50″W; to lat. 33°17′27″N, long. 82°21′19″W; to lat. 33°17′41″N, long. 82°22′35″W; to lat. 33°19′26″N, long. 82°22′15″W; to lat. 33°22′37″N, long. 82°16′58″W; to lat. 33°23′50″N, long. 82°14′03″W; to the point of beginning. Designated Altitudes. 10,000 feet MSL to 16,000 feet MSL. Times of designation. By NOTAM 24 hours in advance. Controlling agency. FAA, Atlanta ARTCC. Using agency. U.S. Army, Commanding Officer, Fort Gordon, GA. Remarks. Aircraft activities must not be conducted on national holidays or from the Sunday prior to the Masters Golf Tournament through the Monday after (and subsequent weather days if required). * * * * * Issued in Washington, DC, on April 4, 2023. Brian Konie, Acting Manager, Airspace Rules and Regulations Group. [FR Doc. 2023–07398 Filed 4–7–23; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 130, 131, 133, 136, 137, 139, 145, 150, 155, 156, 158, 161, 163, 166, 168, and 169 [Docket No. FDA–2022–N–2226] RIN 0910–AI72 Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. The Food and Drug Administration (FDA or we) is SUMMARY: PO 00000 Frm 00035 Fmt 4702 Sfmt 4702 proposing to amend our standard of identity (SOI) regulations that specify salt (sodium chloride) as a required or optional ingredient to permit the use of salt substitutes in standardized foods, to reduce the sodium content. Reducing sodium may help reduce the risk of hypertension, a leading cause of heart disease and stroke. The proposed rule, if finalized, would help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized foods lower in sodium while maintaining the basic nature and essential characteristics of the foods. DATES: Either electronic or written comments on the proposed rule must be submitted by August 8, 2023. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 8, 2023. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov 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 https://www.regulations.gov. • 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’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets E:\FR\FM\10APP1.SGM 10APP1 ddrumheller on DSK120RN23PROD with PROPOSALS1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules 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.’’ Instructions: All submissions received must include the Docket No. FDA– 2022–N–2226 for ‘‘Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov 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 https:// www.regulations.gov. 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: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov 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 VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Andrew Yeung, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2371 or Carrol Bascus, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS–024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2378. SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations/Acronyms III. Background A. Introduction B. Need for the Regulation C. FDA’s Current Regulatory Framework IV. Legal Authority V. Description of the Proposed Rule A. Scope/Applicability B. The Basic Nature and Essential Characteristics of a Standardized Food C. Definition of Salt Substitute D. Amending Standard of Identity Regulations To Permit Salt Substitutes E. Update Incorporation by Reference F. Technical Amendments VI. Proposed Effective/Compliance Dates VII. Preliminary Economic Analysis of Impacts A. Economic Analysis of Impacts B. Initial Small Entity Analysis VIII. Analysis of Environmental Impact IX. Paperwork Reduction Act of 1995 X. Federalism XI. Consultation and Coordination With Indian Tribal Governments XII. References I. Executive Summary A. Purpose of the Proposed Rule This proposed rule, if finalized, would amend FDA’s definitions and standards of identity (SOI; the acronym is used to refer to both the singular ‘‘standard of identity’’ and the plural ‘‘standards of identity’’) that specify salt (sodium chloride) as a required or optional ingredient. Foods for which FDA has established a SOI are referred to as ‘‘standardized’’ foods. The amendments would permit the use of safe and suitable salt substitutes to replace some or all of the salt used in the manufacture of standardized foods. The proposed rule would not list specific salt substitutes; instead, the proposed rule would cover ingredients or combinations of ingredients used as salt substitutes by food manufacturers currently or in the future. If finalized, PO 00000 Frm 00036 Fmt 4702 Sfmt 4702 21149 the proposed rule would support efforts to reduce sodium content in standardized foods and may help to improve consumer dietary patterns by reducing sodium consumption. On average Americans consume 50% more sodium than the recommended limit for those aged 14 and older (Ref. 1). Reducing sodium consumption may help reduce the risk of hypertension, a leading cause of heart disease and stroke. The proposed rule would allow food manufacturers the flexibility to use salt substitutes and allow for innovation in producing healthier standardized foods. The proposed rule would promote honesty and fair dealing in the interest of consumers by accommodating their preferences for lower sodium varieties of foods. This, in turn, would make lower-sodium options available to them. B. Summary of the Major Provisions of the Proposed Rule FDA is proposing to amend its SOI that specify salt as a required or optional ingredient to permit the use of safe and suitable salt substitutes in standardized foods, to reduce the sodium content. We propose to amend our regulation entitled ‘‘Food Standards: General’’ (21 CFR part 130) to create a new subpart C entitled ‘‘Flexibility in Standardized Foods’’ and add a new section entitled ‘‘Ingredient Flexibility in Standardized Foods’’ to define salt substitute. We also propose to amend 80 SOI to permit salt substitutes. We also propose to update the incorporation by reference (IBR) information of several SOI to refer to the most recent versions of the IBR materials and to provide up-to-date contact information for obtaining the IBR materials. For example, the proposed rule would update the referenced methods of analysis to those in the ‘‘Official Methods of Analysis of AOAC INTERNATIONAL,’’ 21st Ed. 2019. We also propose to make technical amendments to correct inconsistencies and typographical errors in some SOI regulations. We tentatively conclude that the proposed amendments are necessary to modernize SOI to provide flexibility and facilitate innovation in the production of standardized foods with less sodium, and to promote honesty and fair dealing in the interest of consumers. C. Legal Authority We are proposing this rule consistent with our authority in sections 201, 401, 402, 409, and 701 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 341, 342, 348, 371). We E:\FR\FM\10APP1.SGM 10APP1 21150 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules discuss our legal authority in greater detail in section IV. D. Costs and Benefits The proposed rule would amend SOI that specify salt as a required or optional ingredient, to permit the use of salt substitutes. The proposed rule would give manufacturers the flexibility to use salt substitutes in standardized foods, to reduce sodium content. If finalized, the proposed rule would not result in regulatory costs for firms. The proposal would not require manufacturers to replace salt with salt substitutes. Instead, manufacturers would have the option of using salt substitutes to replace salt in standardized foods. Should manufacturers choose to use this flexibility to reformulate some products by substituting some salt with salt substitutes, the primary benefits realized would result from lower sodium consumption by U.S. consumers who choose to purchase and consume the reformulated versions of such products, and increased profit (producer surplus) for manufacturers (or at least no decrease in profits). The primary cost of such voluntary market behavior would include reformulation and relabeling costs for the manufacturers. II. Table of Abbreviations/Acronyms Abbreviation/ acronym What it means CDRR ............. Chronic Disease Risk Reduction Intake Code of Federal Regulations Federal Food, Drug, and Cosmetic Act Food and Drug Administration FEDERAL REGISTER Generally Recognized as Safe Incorporation by Reference Milligram Standard(s) of Identity United States Code CFR ................ FD&C Act ....... FDA ................ FR .................. GRAS ............. IBR ................. mg .................. SOI ................. U.S.C. ............ III. Background ddrumheller on DSK120RN23PROD with PROPOSALS1 A. Introduction As a public health agency, FDA seeks to improve dietary patterns in the United States to help reduce the burden of diet-related chronic diseases and advance health equity as nutritionrelated chronic diseases are experienced disproportionately by certain racial and ethnic minority groups, those living in rural communities, and those with lower socioeconomic status. We are committed to accomplishing this, in part, by creating a healthier food supply for all. One way FDA is working VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 towards this goal is by helping to reduce sodium across the food supply. Americans consume, on average, 3,400 milligrams of sodium per day (mg/day) (Ref. 1). This is nearly 50 percent more than the sodium Chronic Disease Risk Reduction Intake (CDRR) established by the National Academies of Sciences, Engineering and Medicine, which sets the limit for sodium for individuals 14 years and older at 2,300 mg/day. This CDRR was adopted as a recommendation by the Dietary Guidelines for Americans, 2020–2025 (Refs. 1 and 2). Reducing sodium intake to below the CDRR level is expected to help reduce the risk of chronic disease. Excess sodium intake increases risk for hypertension, commonly referred to as high blood pressure, a leading cause of heart disease and stroke and the first and fifth leading cause of mortality in 2020 in the United States (Refs. 2–6). Decreasing sodium intake is, therefore, expected to reduce the rate of hypertension. It has been estimated that sufficient reductions in the population average sodium intake could potentially result in tens of thousands fewer cases of heart disease and stroke and associated mortality each year (Refs. 7– 9). Reducing sodium in processed, packaged and prepared foods will help create a healthier food supply. A healthier food supply has the potential to contribute to better health outcomes and reduce preventable death and disease related to poor nutrition; many of which are experienced at higher rates by certain racial and ethnic groups (Ref. 10). For example, more than 4 in 10 American adults have hypertension and that number increases to nearly 6 in 10 for non-Hispanic Black Americans (Ref. 11). African American women are almost 60 percent more likely to have hypertension when compared to nonHispanic white women, and African American adults are 30% more likely than non-Hispanic white Americans to die from coronary heart disease (CHD) (Refs. 12 and 13); further, American Indians/Alaskan Natives are 50% more like to be diagnosed with CHD than non-Hispanic Whites (Ref. 13). The proposed rule’s likely effect on increasing the availability of lower sodium products may contribute to government-wide efforts to reduce health disparities. Reducing sodium in processed, packaged and prepared food is a critical step in helping to improve consumer dietary patterns. More than 70 percent of sodium consumed in the United States comes from sodium added during manufacturing and commercial food preparation (Ref. 14). This makes it PO 00000 Frm 00037 Fmt 4702 Sfmt 4702 challenging for consumers to reduce their sodium consumption. Further, because salt (sodium chloride) serves various functions in processed, packaged, and prepared foods, industry must balance sodium reduction efforts while manufacturing products that maintain the properties of a certain food and still meet the preferences of consumers. FDA is engaged in several efforts aimed at encouraging gradual, efficient reduction of overall sodium content in processed, packaged and prepared food products. We recently issued two guidance documents for industry to support voluntary industry efforts to reduce sodium in the food supply and facilitate industry innovation toward creating healthier foods. The December 2020 guidance for industry entitled ‘‘The Use of an Alternate Name for Potassium Chloride in Food Labeling’’ (Potassium Chloride guidance) (Ref. 15) sets forth FDA’s enforcement discretion policy with respect to declaring potassium chloride as ‘‘potassium salt’’ in the ingredient statement in the labeling of food products. In October 2021, we issued guidance for industry entitled ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods’’ (Voluntary Sodium Reduction Goals guidance) (Ref. 16). The guidance document finalizes the short-term (2.5 year) voluntary sodium reduction targets in over 160 categories of packaged and restaurant prepared food. These short-term targets are based on a reduction of average sodium intake from current levels of 3,400 mg/day to 3,000 mg/day, and they serve as initial benchmarks for a broad and gradual reduction of sodium in the food supply (Ref. 16 and 17). Through the two guidance documents and this rulemaking, our intent is to support the gradual reduction of sodium across the food supply. Under our authority in section 401 of the FD&C Act, FDA establishes SOI to promote honesty and fair dealing in the interest of consumers. SOI are established under the common or usual name of a food. Such foods are said to be ‘‘standardized.’’ SOI define the food and typically provide the types of ingredients that it must contain (i.e., mandatory ingredients) and that it may contain (i.e., optional ingredients). They sometimes specify the amount or proportion of each ingredient. Many SOI also designate methods of production. We have over 250 SOI for a wide variety of food products. E:\FR\FM\10APP1.SGM 10APP1 ddrumheller on DSK120RN23PROD with PROPOSALS1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules B. Need for the Regulation Salt substitutes are ingredients that can help reduce sodium in processed, packaged and prepared foods. Food manufacturers wishing to reduce salt in their products to accommodate consumer preferences or for other reasons sometimes use substitute ingredients that provide similar taste and other technical functions of salt in foods. Most of our SOI that include salt as a required or optional ingredient do not permit the use of salt substitutes. Therefore, food manufacturers are currently precluded from using salt substitutes in the production of these standardized foods. However, manufacturers may use salt substitutes in the production of non-standardized foods. Various stakeholders have expressed concern that many SOI are out of date and may impede innovation, including the ability to produce healthier foods (Ref. 18). Manufacturers seeking to reduce sodium in standardized foods are limited because they are unable to produce foods using salt substitutes and still conform to the SOI. In this way, the SOI may become a barrier to innovation. Permitting the use of salt substitutes is aligned with FDA’s goal to reduce sodium across the food supply and our work to reduce sodium consumption. Research suggests that consumers usually do not notice small reductions in sodium and, over time, consumer palates adjust to lower sodium levels (Ref. 19). Through our work on the Voluntary Sodium Reduction Goals guidance and the Potassium Chloride guidance, we learned that stakeholders, including industry, consumers, consumer advocacy, scientific and professional health organizations, generally support allowing the use of salt substitutes. In another public engagement, some stakeholders discussed modernizing SOI to allow the use of salt substitutes using a ‘‘horizontal approach’’ (Ref. 18). A horizontal approach to amending standards is a change that could be made across all, or broad categories of SOI to provide flexibility and facilitate innovation in the production of more nutritious foods. We considered several options for permitting salt substitutes in standardized foods and evaluated how to apply this change across multiple SOI. The proposed rule, if finalized, would adopt a horizontal approach to amending the applicable SOI. The proposed rule would permit the use of salt substitutes in SOI that specify salt as a required or optional ingredient, to reduce sodium in the food. Because the use of salt substitutes in these SOI is VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 currently precluded, any use of salt substitutes by manufacturers under the rule would contribute to reduced sodium intake to some degree. Permitting the use of salt substitutes in standardized foods would contribute to our goal to reduce sodium across the food supply. It would facilitate voluntary industry efforts toward sodium reduction by providing flexibility and supporting innovation in the production of healthier standardized foods, which may help some consumers to gradually reduce the sodium in their diet and contribute to better health outcomes. The proposed rule may have the potential to contribute to government-wide efforts to reduce health disparities if the use of salt substitutes helps populations disproportionately affected by hypertension to consume less sodium. C. FDA’s Current Regulatory Framework The FD&C Act gives us the authority to establish definitions and standards for foods with respect to identity, quality, and fill of container (21 U.S.C. 341). SOI specify the permitted ingredients, both mandatory and optional, and sometimes describe the amount or proportion of each ingredient. Many SOI also prescribe a method of production or formulation. Foods for which FDA has established a SOI must conform to the applicable definition and standard. A food is misbranded if it purports to be or is represented as a food for which a SOI has been established but fails to conform to the definition and standard (21 U.S.C. 343(g)). SOI are codified in parts 130 to 169 (21 CFR parts 130 to 169). Part 130 outlines general provisions, including the use of food additives in food standards. Part 130 also includes the general definition and SOI (i.e., § 130.10). Parts 131 to 169 set forward SOI for foods in 21 food product categories. We have long interpreted the term ‘‘salt’’ in the food standards in parts 131 to 169 to refer to sodium chloride. Salt is specified as a required or optional ingredient in 80 SOI across these parts. Some SOI cross reference other SOI. For example, in part 136 (21 CFR part 136), salt is an optional ingredient in the SOI for bread, rolls, and buns (§ 136.110) which is referenced in several other SOI, including: enriched bread, rolls, and buns (§ 136.115), milk bread, rolls, and buns (§ 136.130), raisin bread, rolls, and buns (§ 136.160), and whole wheat bread, rolls, and buns (§ 136.180). The result of such cross referencing is that salt is a required or an optional ingredient in 140 SOI. PO 00000 Frm 00038 Fmt 4702 Sfmt 4702 21151 Manufacturers of standardized foods have few options for reducing the sodium content of their products. If salt is a required ingredient, they may generally use less salt. If salt is an optional ingredient, they may either use no salt or less salt. However, they cannot replace salt with another ingredient unless the standard permits the use of another ingredient. Most SOI do not provide for a substitute for salt. In some instances, we established separate SOI for low sodium foods, thereby allowing manufacturers to reduce the amount of salt used and to substitute other ingredients. Manufacturers may also modify the sodium content of standardized foods under the general definition and SOI in § 130.10 (Requirements for foods named by use of a nutrient content claim and a standardized item), provided that certain conditions are met. Deviation from a SOI is permitted under the general definition and SOI in § 130.10. The deviation must be due to a modification described by an expressed nutrient content claim defined by regulation. Expressed nutrient content claims for the sodium content of foods (e.g., ‘‘low sodium’’) are provided under § 101.61 (21 CFR 101.61) (Nutrient content claims for the sodium content of foods). Thus, sodium modifications to a standardized food are permitted if the modification meets the requirements for a nutrient content claim under § 101.61. The modified food becomes a new standardized food under § 130.10 and is named with the nutrient content claim and the name of the standardized food from which it deviates (e.g., ‘‘low sodium provolone cheese’’). It may be impracticable for manufacturers to reduce the sodium content in standardized foods to the extent required by a nutrient content claim. For example, to meet the requirements for a ‘‘reduced sodium’’ nutrient content claim, manufacturers must decrease the sodium in the food by at least 25 percent. Certain foods do not retain the same characteristics when the amount of sodium is reduced to this degree, and therefore, the general definition and SOI does not facilitate the production of lower sodium varieties. This proposed rule would allow manufacturers to reduce the sodium in standardized foods in amounts less than the amounts prescribed in § 101.61. This would provide manufacturers greater flexibility when reformulating standardized foods to lower the sodium content. Presently, three SOI specifically permit the use of a salt substitute. The SOI for low sodium cheddar cheese (§ 133.116) and low sodium colby E:\FR\FM\10APP1.SGM 10APP1 21152 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS1 cheese (§ 133.121) permit the use of a salt substitute. The SOI for low sodium colby cheese prohibits the use of salt and permits the use of a salt substitute that contains no sodium (§ 133.121(a)). The SOI for margarine (§ 166.110) specifically permits the use of potassium chloride in the manufacture of dietary margarine. Potassium chloride, in some instances, can be used as a partial substitute for sodium chloride in food processing and manufacturing. If finalized, the proposed rule would provide a new means for manufacturers to reduce the sodium content of standardized foods. Salt substitutes would be permitted in any food for which an SOI has been established and that specifies salt as a required or an optional ingredient. This would be achieved without requiring the minimum reductions in sodium content under § 101.61 and renaming of food products as is required for modifications under § 130.10. IV. Legal Authority We are issuing this proposed rule consistent with our authority in sections 201, 401, 402, 409, and 701of the FD&C Act. Section 401 of the FD&C Act 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, standard of quality, or standard of fill of container, whenever in the judgment of the Secretary, such action will promote honesty and fair dealing in the interest of consumers. We tentatively conclude that permitting the use of salt substitutes to replace some or all of the salt used in the production of standardized foods would promote honesty and fair dealing in the interest of consumers. Consumers desire more nutritious and healthy food options, such as lower sodium versions of foods. This proposed rule, if finalized, would allow for industry development and sale of such foods while ensuring that standardized foods meet consumer expectations and preferences with respect to lower-sodium varieties. FDA has codified food standards in parts 130 to 169. These regulations do not provide either an authorization or exemption from regulation as a food additive under section 409 of the FD&C Act. The FD&C Act defines ‘‘food additive,’’ in relevant part, as any substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component of food, if such substance is not generally recognized by experts as safe under the conditions of its intended use (section 201(s) of the VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 FD&C Act). The definition of ‘‘food additive’’ exempts any uses that are the subject of prior sanction (section 201(s)(4) of the FD&C Act)). Food additives are deemed unsafe except to the extent that FDA approves their use (section 409(a) of the FD&C Act). Food is adulterated when it contains an unapproved food additive (section 402(a)(2)(C) of the FD&C Act). We also are issuing this proposed rule under section 701(a) of the FD&C Act, which authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act. Regulations issued under section 701(a) ‘‘must effectuate a congressional objective expressed elsewhere in the Act’’ (Association of American Physicians and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) (citing Pharm. Mfrs. Ass’n. v. FDA, 484 F. Supp. 1179, 1183 (D. Del. 1980))). Amending SOI to permit the use of salt substitutes would effectuate the congressional objective ‘‘to promote honesty and fair dealing in the interest of consumers’’ expressed in section 401 of the FD&C Act. Permitting salt substitutes in standardized foods under this rule may help provide more options to consumers while ensuring that the foods maintain their basic nature and essential characteristics. The proposed amendments to the SOI for dairy products under parts 131, 133, and 135 are issued under section 701(e) of the FD&C Act. V. Description of the Proposed Rule The proposed rule, if finalized, would: • Amend part 130 to add a new subpart C entitled ‘‘Flexibility in Standardized Foods.’’ • Add a new § 130.30 to provide for ‘‘Ingredient Flexibility in Standardized Foods’’ and define ‘‘salt substitute’’ as a safe and suitable ingredient (or combination of ingredients) that is used to replace some or all of the added salt (sodium chloride), to reduce sodium in the food, and that serves the functions of salt in the food. • Amend the 80 SOI that specify salt as a required or an optional ingredient to add regulatory text to permit the use of salt substitute, as defined in proposed § 130.30. • Update the IBR information of several SOI to refer to the most recent versions of the IBR materials and to provide up-to-date contact information for obtaining the IBR materials. The proposed rule would also update the referenced methods of analysis to those in the ‘‘Official Methods of Analysis of AOAC INTERNATIONAL,’’ 21st Ed. 2019. PO 00000 Frm 00039 Fmt 4702 Sfmt 4702 • Make technical amendments to correct inconsistencies and typographical errors in some SOI regulations. A. Scope/Applicability The proposed rule, if finalized, would amend SOI in parts 131 to 169. Specifically, the proposed rule would permit the use of salt substitutes in the foods covered by 80 SOI that include salt as a required or an optional ingredient. The proposal would also permit the use of salt substitutes in foods covered by SOI that reference some of the 80 SOI. This rule does not propose to amend the SOI for oysters (§ 161.130). The SOI in § 161.130 provides for the optional use of salt water in the shucking of oysters. We understand that it is not standard industry practice to constitute a salt and water solution for this process. Rather, seawater accessible at the processing location is collected and used in the shucking process. Because salt is not an ingredient added by the manufacturer, we are not proposing to amend this SOI. We request comments on this approach and our understanding of current industry practice. B. The Basic Nature and Essential Characteristics of a Standardized Food Proposed § 130.30(b) would require that ingredients used as salt substitutes do not change the basic nature and essential characteristics of the standardized food. FDA previously discussed its understanding about the basic nature of a food in a proposed rule entitled ‘‘Food Standards; General Principles and Food Standards Modernization,’’ (70 FR 29214, May 20, 2005). The basic nature of a food is generally what the food is. It concerns the general attributes of the product. For example, the basic nature of a particular type of cheese is that it is a milk-derived food of a certain form and consistency. The essential characteristics of a food may contribute to achieving the basic nature of the food, but consumers may not be aware of the essential characteristics. The essential characteristics of a food are those that distinguish a food. Foods may be distinguished by their ingredients, compositional characteristics, physical characteristics, or levels of certain nutrients or the way they are produced—all of which are the essential characteristics of the food. For example, the essential characteristics of a particular type of cheese may include the bacterial culture used, the processing method, or the fat and moisture content that contribute to the unique characteristics of that cheese. E:\FR\FM\10APP1.SGM 10APP1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS1 Use of salt substitutes that do not change the basic nature and essential characteristics of the standardized food under this proposed rule is necessary to ensure the availability of foods that promote honesty and fair dealing in the interest of consumers, in accordance with section 401 of the FD&C Act. C. Definition of Salt Substitute Under the FD&C Act, any substance that is intentionally added to food is a food additive that is subject to premarket review and approval by FDA unless that substance is excluded from the definition of a food additive. These excluded food substances include substances that are generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use (‘‘generally recognized as safe’’ or ‘‘GRAS’’), or the substances are prior sanctioned and excepted from the definition of a food additive. FDA considers salt a common food ingredient that is GRAS for its intended use (21 CFR 182.1(a)). A salt substitute that is added to a standardized food, to replace some or all of the salt, must be an approved food additive or GRAS for its intended use. For example, potassium chloride is a GRAS substance (21 CFR 184.1622). The proposed rule would amend § 130.30(c)(1) to define salt substitute as a safe and suitable ingredient (see § 130.3(d)) or combination of ingredients that is used to replace some or all of the added salt (sodium chloride), to reduce the sodium in the food, and that serves the functions of salt in the food. We are proposing to define salt substitute broadly to provide flexibility and facilitate innovation in the future without the need for additional rulemaking. Thus, the proposed rule would not list specific salt substitutes; instead, the proposed rule would cover ingredients or combinations of ingredients currently used as salt substitutes and ingredients or combinations of ingredients that may be used as salt substitutes in the future, as a result of advances in food science and technological changes. Salt is a required or optional ingredient in a wide range of standardized foods. The proposed rule also would allow manufacturers the flexibility to explore new ways to replace salt and reduce the sodium content of standardized foods while preserving the basic nature and essential characteristics of the food. We recognize that salt serves various functions in standardized foods. For example, depending on the food, salt may be important for taste, microbial VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 safety, and other functions. The proposed definition would require that the salt substitute be used to replace some or all of the added salt, to reduce the sodium in the food, and serve the functions of salt in the food. This would ensure that the salt substitute performs a similar function to salt in the standardized food, while helping to reduce the sodium content. The extent to which salt can be replaced depends on the ability of the salt substitute to replicate the functions of salt in the food without compromising the food’s safety and nutritional quality. The proposed rule would not establish a minimum replacement level for salt. It would not prescribe the sodium content of the foods or any parameters pertaining to the production of the food. Manufacturers would determine the level of salt replacement appropriate for the particular standardized food. Our intent is to provide manufacturers flexibility and facilitate sodium reduction across the food supply while not changing the basic nature and essential characteristics or adversely affecting the nutritional quality and safety of standardized foods. To accomplish this, proposed § 130.30(c)(1) would limit the definition of salt substitute and therefore the use of salt substitutes to an ingredient or a combination of ingredients that serve the functions that salt served in the particular standardized food. The ingredient or combination of ingredients may include substances intended to mitigate the impact of removing salt and are needed to maintain the basic nature and essential characteristics of the food. Some manufacturers are currently using salt substitutes to reduce sodium in foods in the marketplace. Scientific articles and reports have used several examples of salt substitutes when discussing sodium reduction efforts (Ref. 19, 20, 21). The use of potassium chloride is one example of a safe and suitable ingredient discussed in the scientific literature that, in some instances, serves as a partial substitute for sodium chloride in food processing and manufacturing (Ref. 15). Other examples of ingredients listed in the scientific literature include herbs and spices, yeast extracts, monosodium glutamate, amino acids, and dairy extracts (Ref. 19). The food industry is pursuing sodium reduction efforts, including the use of salt substitutes (e.g., in products marketed as ‘‘low’’ or ‘‘reduced’’ sodium), in a variety of foods, including in canned fish and soups (Ref. 21). We request data and information on the types of salt substitutes currently being used in the U.S. market to support sodium PO 00000 Frm 00040 Fmt 4702 Sfmt 4702 21153 reduction and on potential salt substitutes that may be used as a result of the new flexibility provided in this proposed rule. D. Amending Standard of Identity Regulations to Permit Salt Substitutes We propose to amend our regulations to permit the use of salt substitutes in SOI that specify salt as a required or an optional ingredient. Foods for which FDA has established a SOI must conform to the applicable standard. Consequently, without these amendments, most standardized foods cannot be modified to replace salt with salt substitutes unless salt can be reduced in sufficient quantity to meet a nutrient content claim under § 101.61 (see section III.C). As stated previously, amending 80 applicable SOI to permit the use of salt substitutes is necessary to give manufacturers the most flexibility to use salt substitutes in standardized foods. The proposed rule would permit the use of salt, salt substitute or a combination of the two in applicable standardized foods. Salt substitutes used would be declared on the label in accordance with section 403(i)(2) of the FD&C Act. Where salt is permitted in our SOI, the use is not described uniformly in the provisions of the standards. This is largely due to the standards having been established with different structural formats. The lack of uniformity is also due to the use of salt differing across different standardized foods. In some foods, salt is a mandatory ingredient, and in other foods, salt is an optional ingredient. For some foods, salt is permitted at a specific point in the manufacturing process, whereas salt is permitted in other foods without regard to manufacturing time. These differences mean that different amendatory language in the individual standards is necessary to permit the use of salt substitutes. To address this, we propose four types of revisions to the current regulatory text in the applicable SOI. In particular, there are differences in how the use of salt is prescribed in certain SOI for cheeses and related cheese products in part 133 (21 CFR part 133). For example, several SOI for cheeses use terms such as ‘‘salted,’’ ‘‘salting,’’ ‘‘brine,’’ or ‘‘salt solution,’’ to prescribe the application of salt in the cheesemaking process. For additional clarity, the proposed amendments for cheeses and related cheese products are grouped and discussed separately from other SOI. There are 4 types of revisions to the applicable SOI in this proposed rule. E:\FR\FM\10APP1.SGM 10APP1 21154 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules The third and fourth types only apply to SOI in part 133. • Type 1: When the current text of the SOI lists ‘‘salt’’ as an optional ingredient, the proposed rule would amend the SOI to state, ‘‘salt or salt substitute.’’ • Type 2: When the current text of the SOI provides for the use of ‘‘salt’’ in a paragraph, the proposed rule would amend the SOI to state, ‘‘salt or salt substitute.’’ • Type 3: When the current text of the SOI uses terms such as ‘‘salted,’’ ‘‘salted with dry salt or brine,’’ or ‘‘salting,’’ to provide for use of salt in the food, but does not specify salt as an ingredient, the proposed rule would amend the optional ingredient list to add ‘‘salt substitute.’’ • Type 4: When the current text of the SOI uses terms such as ‘‘salted,’’ or ‘‘salted in brine,’’ to provide for the use of salt in the food, but does not provide a list of optional ingredients, the proposed rule would amend the SOI to add a paragraph stating that, ‘‘During the cheesemaking process, where the curd is salted, salt substitute may be used.’’ We summarize these changes in tables 1 and 2. 1. Amendments to SOI not in Part 133 We propose amendments to permit the use of salt substitutes in 39 SOI for products that are not cheeses or related cheese products prescribed in part 133. The amendments would occur through two types of revisions to the current regulatory text of the applicable SOI. a. Type 1 revision for SOI not in part 133. Several SOI provide for the addition of salt by listing it as an ingredient (e.g., as an ‘‘optional ingredient,’’ ‘‘other optional ingredient,’’ or including salt in a list of substances that could be added as a seasoning or flavoring.) We propose to amend these SOI to permit the addition of a salt substitute in addition to, or in place of, salt by replacing ‘‘salt’’ with ‘‘salt or salt substitute.’’ For example, the SOI for acidified milk (§ 131.111(e)(8)) lists ‘‘salt’’ under ‘‘other optional ingredients;’’ the proposed rule would replace ‘‘salt’’ with ‘‘salt or salt substitute.’’ As another example, the SOI for canned tuna (21 CFR 161.190) includes ‘‘salt’’ in a list of seasoning or flavoring ingredients (§ 161.190 (a)(6)(i)); the proposed rule would replace ‘‘salt’’ with ‘‘salt or salt substitute.’’ b. Type 2 revision for SOI not in part 133. Five SOI prescribe the use of salt in paragraphs that describe the food, rather than as part of an ingredient list. We propose to amend these SOI to permit the addition of a salt substitute in addition to, or in place of, salt by replacing ‘‘salt’’ with ‘‘salt or salt substitute’’ in the regulatory text. For example, the SOI for catsup (21 CFR 155.194) specifies the optional use of salt by stating, ‘‘[t]he food may contain salt’’; and the SOI for self-rising flour (21 CFR 137.180) specifies that the food ‘‘is seasoned with salt.’’ In both examples, we propose to replace ‘‘salt’’ with ‘‘salt or salt substitute.’’ Table 1 summarizes the amendments to the SOI for foods other than cheeses and related cheese products. We request comment on whether there would be safety concerns, technical infeasibilities, or other issues that would prevent the use of a salt substitute in any SOI listed in table 1. TABLE 1—AMENDMENTS TO DEFINITIONS AND STANDARDS OF IDENTITY—FOODS OTHER THAN CHEESES AND RELATED CHEESE PRODUCTS CFR section ddrumheller on DSK120RN23PROD with PROPOSALS1 § 131.111 § 131.112 § 131.160 § 131.162 § 131.170 § 136.110 § 137.180 § 137.270 § 139.110 § 139.150 § 145.110 § 145.130 § 150.110 § 155.120 Title Paragraph Type of revision (e)(8) (d)(8) (b)(5) (b)(4) (e)(2) (c)(4) (a) (a) (a)(4) (a)(2) (a)(2)(iii) (a)(5) (c)(4) (a)(3)(i) Type Type Type Type Type Type Type Type Type Type Type Type Type Type 1; 1; 1; 1; 1; 1; 2; 2; 1; 1; 1; 1; 1; 1; amends amends amends amends amends amends amends amends amends amends amends amends amends amends salt in optional ingredients to add salt substitute. salt in other optional ingredients to add salt substitute. salt in optional ingredients to add salt substitute. salt in optional ingredients to add salt substitute. salt in other optional ingredients to add salt substitute. salt in optional ingredients to add salt substitute. paragraph that describes the food to add salt substitute. paragraph that describes the food to add salt substitute. salt in optional ingredients to add salt substitute. salt in optional ingredients to add salt substitute. salt in optional ingredients to add salt substitute. salt in optional ingredients to add salt substitute. salt in optional ingredients to add salt substitute. salt in optional ingredients to add salt substitute. (a)(3)(i) (a)(2)(i) (a)(2)(iv) (a)(2)(i) (a)(1)(iv) (c)(4)(i) (a)(3)(i) (a)(1) (a)(1)(iv) (a)(1) (a)(4)(i) (a)(4)(i) Type Type Type Type Type Type Type Type Type Type Type Type 1; 1; 1; 1; 2; 1; 1; 2; 1; 2; 1; 1; amends amends amends amends amends amends amends amends amends amends amends amends salt in optional ingredients to salt in optional ingredients to salt in optional ingredients to salt in optional ingredients to paragraph that describes the salt in optional ingredients to salt in optional ingredients to paragraph that describes the salt in optional ingredients to paragraph that describes the salt in optional ingredients to salt in optional ingredients to § 161.190 Acidified milk ..................................... Cultured milk ..................................... Sour cream ....................................... Acidified sour cream ......................... Eggnog ............................................. Bread, rolls, and buns ...................... Self-rising flour .................................. Self-rising white corn meal ............... Macaroni products ............................ Noodle products ............................... Canned applesauce .......................... Canned figs ...................................... Fruit butter ........................................ Canned green beans and canned wax beans. Canned corn ..................................... Canned peas .................................... Canned tomatoes ............................. Tomato concentrates ........................ Catsup .............................................. Certain other canned vegetables ..... Canned mushrooms ......................... Tomato juice ..................................... Frozen peas ...................................... Canned oysters ................................ Canned Pacific salmon ..................... Canned wet pack shrimp in transparent or nontransparent containers. Canned tuna ..................................... (a)(6)(i) § 163.111 § 163.112 § 163.123 § 163.124 § 163.130 § 166.110 Chocolate liquor ................................ Breakfast cocoa ................................ Sweet chocolate ............................... White chocolate ................................ Milk chocolate ................................... Margarine .......................................... (b)(6) (b)(4) (b)(3) (b)(4) (b)(3) (b)(2) Type 1; amends salt in seasoning and flavoring ingredients to add salt substitute. Type 1; amends salt in optional ingredients to add salt substitute. Type 1; amends salt in optional ingredients to add salt substitute. Type 1; amends salt in optional ingredients to add salt substitute. Type 1; amends salt in optional ingredients to add salt substitute. Type 1; amends salt in optional ingredients to add salt substitute. Type 1; amends salt in optional ingredients to add salt substitute. § 155.130 § 155.170 § 155.190 § 155.191 § 155.194 § 155.200 § 155.201 § 156.145 § 158.170 § 161.145 § 161.170 § 161.173 VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 PO 00000 Frm 00041 Fmt 4702 Sfmt 4702 E:\FR\FM\10APP1.SGM 10APP1 add salt substitute. add salt substitute. add salt substitute. add salt substitute. food to add salt substitute. add salt substitute. add salt substitute. food to add salt substitute. add salt substitute. food to add salt substitute. add salt substitute. add salt substitute. Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules 21155 TABLE 1—AMENDMENTS TO DEFINITIONS AND STANDARDS OF IDENTITY—FOODS OTHER THAN CHEESES AND RELATED CHEESE PRODUCTS—Continued CFR section § 168.130 § 168.140 § 168.160 § 168.180 § 169.140 § 169.150 Title Paragraph Cane sirup ........................................ Maple sirup ....................................... Sorghum sirup .................................. Table sirup ........................................ Mayonnaise ...................................... Salad dressing .................................. 2. Amendments to SOI in Part 133 Type 1 and type 2 amendments are also proposed for certain SOI for cheeses and related cheese products. We propose type 3 and type 4 amendments for the several SOI in part 133 that specify salt as an ingredient, using terms such as ‘‘brine,’’ ‘‘salt brine,’’ ‘‘salt solution,’’ ‘‘salted,’’ and ‘‘salting.’’ ‘‘Brine,’’ ‘‘salt brine,’’ and ‘‘salt solution’’ are solutions containing sodium chloride and ‘‘salted’’ and ‘‘salting’’ in the manufacture of cheese refer to the use of sodium chloride. The proposed rule would provide manufacturers of standardized cheeses and related cheese products, the flexibility to use salt substitutes to replace some or all of the salt prescribed in these processes. We propose to permit the use of salt substitutes in 41 SOI for cheeses and related cheese products. Some SOI in part 133 list salt under ‘‘optional ingredients’’ or ‘‘other optional ingredients,’’ while others vary in how they prescribe the use of salt in the paragraph that describes the cheese or cheesemaking process. Because of these differences, we propose four types of revisions to the current regulatory text of the applicable SOI for cheeses and related cheese products. a. Type 1 revision for SOI in part 133. Several SOI for cheeses and related cheese products provide for the addition of salt by listing it as an ingredient (e.g., as an ‘‘optional ingredient’’ or ‘‘other optional ingredient.’’) We propose to amend these SOI to permit the addition (b)(1) (b)(1) (b)(1) (b)(7) (d)(1) (e)(1) Type of revision Type Type Type Type Type Type 1; 1; 1; 1; 1; 1; amends amends amends amends amends amends salt salt salt salt salt salt in in in in in in optional ingredients to add salt substitute. optional ingredients to add salt substitute. optional ingredients to add salt substitute. optional ingredients to add salt substitute. other optional ingredients to add salt substitute. other optional ingredients to add salt substitute. of salt substitute in addition to, or in place of, salt by replacing ‘‘salt’’ in the list with ‘‘salt or salt substitute.’’ For example, the SOI for cold-pack and club cheese lists ‘‘salt’’ under ‘‘optional ingredients’’ (§ 133.123(c)(3)). The proposed rule would replace ‘‘salt’’ with ‘‘salt or salt substitute.’’ b. Type 2 revision for SOI in part 133. Five SOI provide for the use of salt in paragraphs that describe the cheese, rather than as part of an ingredient list. We propose to amend these SOI to permit the addition of a salt substitute in addition to, or in place of, salt by replacing ‘‘salt’’ in the paragraphs with ‘‘salt or salt substitute.’’ For example, the proposed rule would replace ‘‘salt’’ with ‘‘salt or salt substitute’’ in three paragraphs of the SOI for dry curd cottage cheese (§ 133.129(b)(1)(i) through (iii)) and in one paragraph of the SOI for sap sago cheese (§ 133.186 (a)(2)). c. Type 3 revision for SOI in part 133. Some SOI for cheeses and related cheese products provide for the use of salt in a paragraph that describes the cheesemaking process, through terms such as ‘‘salted,’’ ‘‘salted with dry salt or brine,’’ or ‘‘salting,’’ and do not specify salt in a list of ingredients (e.g., as an ‘‘other optional ingredient’’). We propose to amend these SOI to permit the addition of a salt substitute in addition to, or in place of, salt by adding ‘‘salt substitute’’ as a new subparagraph in the current list of other optional ingredients. For example, the SOI for cheddar cheese (§ 133.113(a)(3)) states that ‘‘the curd is salted, stirred, further drained, and pressed into forms,’’ but does not list salt in the optional ingredients in § 133.113(b)(3). The proposed rule would amend § 133.113(b)(3) by adding a new subparagraph, ‘‘salt substitute’’ (proposed § 133.113(b)(3)(vi)). d. Type 4 revision for SOI in part 133. Several SOI for cheeses and related cheese products provide for the use of salt in a paragraph that describes the cheesemaking process through terms such as ‘‘salted’’ or ‘‘salted in brine,’’ but do not include a list of ingredients (e.g., ‘‘optional ingredient’’ or ‘‘other optional ingredient’’) that could be amended to add salt substitute. We propose to amend these SOI to explicitly permit the use of a salt substitute in the cheesemaking process. For example, the SOI for asiago fresh and asiago soft cheese (§ 133.102(b)) provides that ‘‘the curd is salted in brine and cured in a well-ventilated room,’’ but does not have an optional ingredient list. The proposed rule would amend this SOI by adding a new subparagraph at § 133.102(c)(3) to state, ‘‘During the cheesemaking process, where the curd is salted, salt substitute may be used.’’ Table 2 summarizes the amendments to the SOI for cheeses and related cheese products. We request comment on whether there would be safety concerns, technical infeasibilities, or other issues that would prevent the use of salt substitute in any SOI listed in table 2. ddrumheller on DSK120RN23PROD with PROPOSALS1 TABLE 2—PROPOSED AMENDMENTS TO DEFINITIONS AND STANDARDS OF IDENTITY—CHEESES AND RELATED CHEESE PRODUCTS CFR section Title Current paragraph Revised or added paragraph designation § 133.102 ....... (c) ................... (c)(3) .............. § 133.106 ....... Asiago fresh and asiago soft cheese. Blue cheese ........................... (b)(3) .............. (b)(3)(vii) ........ § 133.108 ....... Brick cheese .......................... (b)(3) .............. (b)(3)(v) .......... § 133.111 ....... Caciocavallo siciliano cheese (c) ................... (c)(3) .............. VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 PO 00000 Frm 00042 Fmt 4702 Sfmt 4702 Type of revision Type 4; amends SOI to add a new paragraph to permit salt substitute. Type 3; amends other optional ingredients to add new paragraph to list salt substitute. Type 3; amends other optional ingredients to add new paragraph to list salt substitute. Type 4; amends SOI to add a new paragraph to permit salt substitute. E:\FR\FM\10APP1.SGM 10APP1 21156 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules TABLE 2—PROPOSED AMENDMENTS TO DEFINITIONS AND STANDARDS OF IDENTITY—CHEESES AND RELATED CHEESE PRODUCTS—Continued CFR section Title Current paragraph Revised or added paragraph designation § 133.113 ....... Cheddar cheese .................... (b)(3) .............. (b)(3)(vi) ......... § 133.118 ....... Colby cheese ......................... (c) ................... (c)(4) .............. § 133.123 ....... Cold-pack and club cheese ... (c)(3) .............. N/A ................. § 133.124 ....... Cold-pack cheese food .......... (e)(3) .............. N/A ................. § 133.127 ....... Cook cheese, koch kaese ..... (b)(3)(v) .......... N/A ................. § 133.129 ....... Dry curd cottage cheese ....... (b)(1)(i)–(iii) .... N/A ................. § 133.133 ....... Cream cheese ....................... (b)(3)(i) ........... N/A ................. § 133.136 ....... (b)(3) .............. (b)(3)(vi) ......... § 133.138 ....... Washed curd and soaked curd cheese. Edam cheese ......................... (b)(3) .............. (b)(3)(v) .......... § 133.141 ....... Gorgonzola cheese ................ (b)(3) .............. (b)(3)(vii) ........ § 133.144 ....... (b)(3) .............. (b)(3)(vi) ......... § 133.147 ....... Granular and stirred curd cheese. Grated American cheese food (c)(5) .............. N/A ................. § 133.148 ....... Hard grating cheeses ............ (c) ................... (c)(1) and (2) § 133.149 ....... Gruyere cheese ..................... (b)(3) .............. (b)(3)(iv) ......... § 133.150 ....... Hard cheeses ......................... (c) ................... (c)(3) .............. § 133.152 ....... Limburger cheese .................. (b)(3) .............. (b)(3)(iv) ......... § 133.153 ....... (b)(3)(iii) ......... N/A ................. (b)(3)(iii) ......... N/A ................. (b)(3)(iii) ......... N/A ................. (b)(3) .............. (b)(3)(vi) ......... § 133.162 ....... Monterey cheese and monterey jack cheese. Mozzarella cheese and scamorza cheese. Low-moisture mozzarella and scamorza cheese. Muenster and munster cheese. Neufchatel cheese ................. (b)(3)(i) ........... N/A ................. § 133.164 ....... Nuworld cheese ..................... (b)(3) .............. (b)(3)(iv) ......... § 133.165 ....... Parmesan and reggiano cheese. Pasteurized process cheese .. (c) ................... (c)(3) .............. (d)(4) .............. N/A ................. (e)(4) Salt ....... N/A ................. (f)(5) Salt ........ N/A ................. § 133.181 ....... Pasteurized process cheese food. Pasteurized process cheese spread. Provolone cheese .................. (b)(3) .............. (b)(3)(vi) ......... § 133.182 ....... Soft ripened cheeses ............. (b) .................. N/A ................. § 133.183 ....... Romano cheese ..................... (c) ................... (c)(3) .............. § 133.184 ....... (b)(3) .............. (b)(3)(i) and (ii) § 133.185 ....... Roquefort cheese, sheep’s milk blue-mold, and bluemold cheese from sheep’s milk. Samsoe cheese ..................... (b)(3) .............. (b)(3)(v) .......... § 133.186 ....... Sap sago cheese ................... (a) .................. N/A ................. § 133.187 ....... Semisoft cheeses .................. (b) .................. N/A ................. § 133.155 ....... § 133.156 ....... § 133.160 ....... § 133.169 ....... § 133.173 ....... ddrumheller on DSK120RN23PROD with PROPOSALS1 § 133.179 ....... VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 PO 00000 Frm 00043 Fmt 4702 Sfmt 4702 Type of revision Type 3; amends other optional ingredients to add new paragraph to list salt substitute. Type 4; amends SOI to add new paragraph to permit salt substitute. Type 1; amends salt in optional ingredients to add salt substitute. Type 1; amends salt in other optional ingredients to add salt substitute. Type 1; amends salt in other optional ingredients to add salt substitute. Type 2; amends paragraph that describes the food to add salt substitute. Type 1; amends salt in other optional ingredients to add salt substitute. Type 3; amends other optional ingredients to add new paragraph to list salt substitute. Type 3; amends other optional ingredients to add new paragraph to list salt substitute. Type 3; amends other optional ingredients to add new paragraph to list salt substitute. Type 3; amends other optional ingredients to add a new paragraph to list salt substitute. Type 1; amend salt in other optional ingredients to add salt substitute. Type 4; amends SOI to add a new paragraph to permit salt substitute. Type 3; amends other optional ingredients to add a new paragraph to list salt substitute. Type 4; amends SOI to add a new paragraph to permit salt substitute. Type 3; amends other optional ingredients to add new paragraph to list salt substitute. Type 1; amends salt in other optional ingredients to add salt substitute. Type 1; amends salt in other optional ingredients to add salt substitute. Type 1; amends salt in other optional ingredients to add salt substitute. Type 3; amends other optional ingredients to add a new paragraph to list salt substitute. Type 1; amends salt in other optional ingredients to add salt substitute. Type 3; amends other optional ingredients to add a new paragraph to list salt substitute. Type 4; amends SOI to add a new paragraph to permit salt substitute. Type 1; amends salt in optional ingredients to add salt substitute. Type 1; amends salt in other optional ingredients to add salt substitute. Type 1; amends salt in other optional ingredients to add salt substitute. Type 3; amends other optional ingredients to add a new paragraph to list salt substitute. Type 2; amends paragraph that describes the food to add salt substitute. Type 4; amends SOI to add a new paragraph to permit salt substitute. Type 3; amends other optional ingredients to add new paragraph to list salt substitute. Type 3; amends other optional ingredients to add new paragraph to list salt substitute. Type 2; amends paragraph that describes the food to add salt substitute. Type 2; amends paragraph that describes the food to add salt substitute. E:\FR\FM\10APP1.SGM 10APP1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules 21157 TABLE 2—PROPOSED AMENDMENTS TO DEFINITIONS AND STANDARDS OF IDENTITY—CHEESES AND RELATED CHEESE PRODUCTS—Continued CFR section Title Current paragraph Revised or added paragraph designation § 133.188 ....... Semisoft part-skim cheeses ... (b) .................. N/A ................. § 133.189 ....... Skim milk cheese for manufacturing. Spiced cheeses ..................... (d) .................. (d)(1) and (2) (b)(3)(iii) ......... N/A ................. Swiss and emmentaler cheese. (b)(3) .............. (b)(3)(vii) ........ § 133.190 ....... § 133.195 ....... ddrumheller on DSK120RN23PROD with PROPOSALS1 E. Update Incorporation by Reference Several of the 80 SOI that specify salt as a required or optional ingredient contain outdated references. We propose to update the IBR paragraphs in these SOI to refer to the most recent versions of the IBR materials and to provide up-to-date contact information for obtaining the IBR materials. We propose to add IBR paragraphs to subparts A of parts 131, 137, 139, 150, 155, and 161. SOI in subparts B of these parts would reference applicable IBR paragraphs in subpart A. We also propose to update the IBR paragraphs in the SOI under parts 136, 145, and 166 which would not have IBR paragraphs in subparts A of these parts. The revised format is for administrative efficiency. Specifically, the proposed rule would update the IBR information for §§ 131.111, 131.112, 131.160, 131.162, 131.170, 136.110, 137.180, 137.270, 139.110, 139.150, 145.110, 150.110, 155.120, 155.130, 155.170, 161.145, 161.173,161.190, and 166.110. These SOI list methods of analysis that are from the 13th or 15th editions of ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists.’’ Additionally, § 155.170 lists an incorrect section number for the method for alcohol insoluble solids in canned peas. We propose to update the referenced methods of analysis to those in the ‘‘Official Methods of Analysis of AOAC INTERNATIONAL,’’ 21st Ed. 2019. These proposed changes will ensure that the reference materials are current, accessible, and meet Federal requirements pertaining to IBR (see 1 CFR part 51). • Definition of Terms and Explanatory Notes; Table 1. Nominal Dimensions of Standard Test Sieves (USA Standard Series). The reference lists the test sieve designations and their nominal dimensions. • AOAC Reference Table 909.04; Correction Factors for Gasometric Determination of Carbon Dioxide. The VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 Type of revision Type 2; amends paragraph that describes the food to add salt substitute. Type 4; amends SOI to add a new paragraph to permit salt substitute. Type 1; amends salt in other optional ingredients to add salt substitute. Type 3; amends other optional ingredients to add a new paragraph to list salt substitute. reference lists the correction factors of carbon dioxide measurements for different atmospheric conditions. • AOAC Official Method 923.02A; Reagent under Carbon Dioxide (Total) in Baking Powders-Gasometric Determination. The reference describes the reagent used in measuring the amount of carbon dioxide released from a sample. • AOAC Official Method 923.02B; Apparatus under Carbon Dioxide (Total) in Baking Powders-Gasometric Determination. The reference describes the apparatus used in measuring the amount of carbon dioxide released from a sample. • AOAC Official method 926.07A; Vacuum Oven Method, under Solids (Total) and Loss on Drying (Moisture) in Macaroni Products. The reference provides method references for the preparation of a sample and the total solid determination of a sample. • AOAC Official method 932.12; Solids (Soluble) in Fruits and Fruit Products. The reference provides a method reference for measuring soluble solids and the formula for calculating the percentage of soluble solids in a sample. • AOAC Official method 932.14C; By Means of Refractometer under Solids in Syrups. The reference provides the method for measuring the percentage of soluble solids in a sample. • AOAC Official method 935.36(a); Solids (Total) in Bread. The reference provides the method for measuring the percentage of solids in a sample. • AOAC Official method 938.06A; Indirect Method, under Fat in Butter. The reference provides the method for measuring the percentage of fat in a sample. • AOAC Official method 938.10; Solids (Alcohol-Insoluble) in Canned Peas Gravimetric Method. The reference provides the method for measuring the percentage of alcohol-insoluble solids in a sample. PO 00000 Frm 00044 Fmt 4702 Sfmt 4702 • AOAC Official Method 945.48G; under Evaporated Milk (Unsweetened). The reference provides the method for sample preparation and a method reference for measuring the percentage of milk fat in a sample. • AOAC Official Method 947.05; Acidity of Milk Titrimetric Method. The reference provides the method for measuring the percentage of lactic acid in a sample. • AOAC Official Method 989.05; Fat in Milk-Modified Mojonnier Ether Extraction method. The reference provides the method for measuring the percentage of milk fat in a sample. • AOAC Official Method 990.21; Solid-Not-Fat in Milk By Difference between Total Solids and Fat Contents. The reference provides method references for measuring total solids and fat contents of a sample and the formula for calculating the percentage of nonfat solid in a sample. You may purchase a copy of the material from AOAC International (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 20850–3250, 1–800– 379–2622. You may inspect a copy at Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500, between 9 a.m. and 4 p.m., Monday through Friday. F. Technical Amendments We also propose to make technical amendments to correct inconsistencies and typographical errors in several of the 80 SOI regulations that specify salt as a required or optional ingredient. The corrections are non-substantive. The proposed rule would: • Amend § 133.118(c)(2) to replace ‘‘143’’ with ‘‘145.’’ • Amend § 133.150(c)(2) to replace ‘‘143’’ with ‘‘145.’’ • Amend § 133.150(e)(1) to replace ‘‘unusual’’ with ‘‘usual.’’ • Amend § 133.182(c)(2) to replace ‘‘143’’ with ‘‘145.’’ E:\FR\FM\10APP1.SGM 10APP1 21158 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules • Amend § 133.184(b) to replace ‘‘Operational’’ with ‘‘Optional.’’ • Amend § 133.186(c) to replace ‘‘Nonmenclature’’ with ‘‘Nomenclature.’’ • Amend § 133.187(c)(2) to replace ‘‘143’’ with ‘‘145.’’ • Amend § 133.188(c)(2) to replace ‘‘143’’ with ‘‘145.’’ • Amend § 155.170(b)(1)(iii) to replace ‘‘shrivelled’’ with ‘‘shriveled.’’ • Amend § 158.170(b)(1)(iii) to replace ‘‘shrivelled’’ with ‘‘shriveled.’’ • Amend § 168.140(a) to replace ‘‘mapel’’ with ‘‘maple.’’ ddrumheller on DSK120RN23PROD with PROPOSALS1 VI. Proposed Effective/Compliance Dates We propose that any final rule resulting from this rulemaking be effective 30 days after the final rule’s date of publication in the Federal Register insofar as it amends non-dairy SOI. We believe that this effective date is appropriate because it will provide industry the flexibility to use salt substitutes to reduce the sodium content in standardized foods. Some manufacturers are already exploring ways to reduce sodium in standardized foods, and this proposed rule, if finalized, will assist in those efforts. For the same reasons, FDA proposes that any dairy SOI that may be amended based on this proposal, unless stayed by the filing of proper objections, will also be effective 30 days after the final rule’s date of publication in the Federal Register. VII. Preliminary Economic Analysis of Impacts We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Office of Information and Regulatory Affairs has determined that this proposed rule is a significant regulatory action as defined by Executive Order 12866 Section 3(f)(1).1 1 We note that this Executive Order 12866 applies only to the non-dairy SOI portions of this rulemaking; the dairy SOI covered by this rulemaking are ‘‘regulations or rules issued in accordance with the formal rulemaking provisions of 5 U.S.C. 556, 557’’ (see 21 U.S.C. 701(e)(1)) and therefore excluded by section (d)(1) of Executive Order (E.O.) 12866. VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. We do not anticipate the proposed rule would generate regulatory impacts on small entities. As with any voluntary market behavior, larger firms may have certain advantages over small firms in some areas, while smaller firms may have advantages in other areas. As a result, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing ‘‘any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.’’ The current threshold after adjustment for inflation is $165 million, using the most current (2021) Implicit Price Deflator for the Gross Domestic Product. The proposed rule would not result in a mandated expenditure in any year that meets or exceeds this amount. The proposed rule would permit, but not require, manufacturers to use salt substitutes to replace salt where salt is a required or optional ingredient in standardized foods. If finalized, the benefits of this rule would be additional flexibility in the manufacture of standardized foods and the potential for reduced salt consumption by consumers which may contribute to better health outcomes. We have no information to suggest the use of currently available salt substitutes would lead to improved product characteristics (e.g., shelf life) or would lead to reduced production costs and potentially lower prices. We request comment on such potential benefits of reformulation for manufacturers and on how many standardized foods manufacturers might choose to reformulate, either in the relatively near or longer-run future. The proposed rule, if finalized, would not impose requirements resulting in regulatory costs on firms or consumers. Manufacturers would have the option of using salt substitutes. There are no regulatory implications for not reading the rule or deciding not to use salt substitutes. Should manufacturers choose to use this flexibility to reformulate some products by substituting some salt with salt substitutes, the primary benefits realized would result from lower sodium consumption on average by U.S. PO 00000 Frm 00045 Fmt 4702 Sfmt 4702 consumers, assuming they choose to purchase and consume the reformulated versions of such products, and increased profit (producer surplus) for manufacturers, assuming they find offering reformulated versions of such products consistent with maximizing firm profits. The primary costs of such voluntary market behavior would be reformulation and relabeling costs for manufacturers. We currently lack data to estimate any net social benefits from voluntary market behavior relating to future use of salt substitutes made possible by this rule, but cite some published analyses below related to meeting voluntary sodium reduction targets that could partially be addressed via the flexibility provided by this rule. We request public comment on possible producer response (e.g., how many manufacturers may choose to take voluntary action in response to this rule, what share of standardized food products may get reformulated) and on possible consumer willingness to purchase and consume such products with various types of salt substitutes at various levels, which would allow us to provide a range of net social benefit estimates when this rule is finalized. A. Economic Analysis of Impacts 1. Background There are 80 SOI that specify salt as a mandatory or optional ingredient. Some of these standards are referenced by other SOI, resulting in salt as an ingredient in 140 SOI. The salt in the foods covered by these 140 SOI may serve a variety of functions such as taste, texture, moisture control, and microbial safety. FDA has a public health interest in reducing sodium across the food supply. Therefore, we propose to give manufacturers the flexibility to use salt substitutes in standardized foods where salt is a required or optional ingredient, to reduce the sodium content. While there may be potential data sources (e.g., IRI, Label Insight, Mintel, NHANES, Syndigo) that could provide market or consumption share (e.g., contribution of sodium and/or caloric intake) for foods covered by these 140 SOI, FDA does not currently have sufficient estimates to further extrapolate impacts at this time. We request public comment on additional potential data sources for estimates of market share and/or caloric and/or sodium consumption share of the products included in these SOI. We request comment on potential regulatory alternatives including allowing the use of only specified salt substitutes, at only specified levels of substitution, for only specified E:\FR\FM\10APP1.SGM 10APP1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules purposes, for only specified products, in conjunction with only specified ancillary formulation changes, or with specified labeling requirements. More generally, we request comments on potential regulatory approaches to reducing salt in food or the dietary intake of salt that do not involve allowing the use of salt substitutes in standardized foods. ddrumheller on DSK120RN23PROD with PROPOSALS1 2. Benefits of the Proposed Rule The benefit of this proposed rule is that manufacturers would have additional flexibility in producing standardized foods covered by 140 SOI, which may lead to social benefits in the form of increased consumer satisfaction (consumer surplus), increased profits (producer surplus), or both. In addition, a change in voluntary market behavior relating to patterns of food consumption, or to use a potassiumbased salt as a salt substitute and consumers who would benefit from increasing their potassium intake choose to consume those products, those consumers may experience positive health effects. Salt is a relatively inexpensive ingredient, and we would not expect manufacturers to begin using salt substitutes based on cost cutting considerations alone at this time. To explore the possibility of manufacturers voluntarily replacing salt with salt substitutes to improve the healthfulness of their standardized foods, one would need to identify the costs and level of potential substitution, and extent of consumer acceptance of salt substitutes at differing levels in different standardized foods in order to estimate the number of manufacturers who would decide to use salt substitutes. We currently lack data on these potential industry responses and request public comment from manufactures, suppliers, and consumers on the extent to which the additional flexibility provided by this rule would be used by manufacturers, hence also desired or tolerated by consumers, and viable in the supply chain. As discussed in the preamble of this rule, on average, Americans consume approximately 3,400 milligrams of sodium per day (mg/day), which is nearly 50 percent more than the recommended daily limit on sodium intake for individuals 14 years and older (Refs. 1 and 2). Excess sodium intake increases the risk for hypertension, or high blood pressure, a leading cause of heart disease and stroke (Refs. 2–6). Decreasing sodium consumption is expected to reduce hypertension and potentially result in fewer cases of heart VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 disease and stroke (Refs. 7–9 2). More than 70 percent of sodium consumed in the U.S. comes from sodium added during manufacturing and commercial food preparation (Ref. 14). The health benefits from reducing sodium consumption are expected to be higher for populations that currently have higher sodium consumption or that are more sensitive to any given level of sodium consumption than other populations. Hence, there may be potential health equity effects to any regulation that generates or facilitates reduced intake of sodium. In order to estimate such health benefits, we would need data and information on the complex pathway between allowing manufactures to use salt substitutes, the extent to which manufactures will develop products of interest to those at highest risk of hypertension, the likely demographic patterns of consumers purchasing those new products, and eventually, the extent of the reduction in sodium uptake among those at most risk of hypertension. In the absence of necessary data to fully estimate the impacts of this rule, we refer to published literature on the health benefits of sodium reduction targets to provide broader context of potential impacts of this rule. A 2018 study by Pearson-Stuttard, et al. looked at the health and economic effects of FDA’s 2016 draft voluntary sodium reduction guidance (Refs. 8 and 22) and estimated benefits of meeting sodium reduction targets in the form of medical cost savings and consumer health improvements, net of producer reformulation costs and some government administrative and monitoring costs. Over a 20-year period, the authors of the study find net social benefits from only consumer health effects to be roughly $12 billion (uncertainty range of $0 billion to $28 billion) under what it described as the most pessimistic scenario relating to potential sodium reduction among the three presented (Ref. 8). This roughly $12 billion net benefit arises from roughly $19 billion in estimated health cost savings (benefits) and just over $7 billion of estimated reformulation, administrative and monitoring costs.3 2 These studies may be sensitive to assumptions regarding consumer response. If some consumers experience disutility associated with the reformulated product and adjust their consumption pattern accordingly, this could partially offset some of the estimated health benefits. 3 These results may be sensitive to assumptions regarding consumer response to product reformulation. For example, benefits might be lower if some consumers experience disutility associated with the reformulated product and adjust their consumption pattern accordingly, which could partially offset the estimated health benefits PO 00000 Frm 00046 Fmt 4702 Sfmt 4702 21159 Since these benefit estimates are not comprehensive, we would need additional data on possible producer and consumer response to fully assess health benefits. Moreover, benefits might be higher or lower than what would be indicated by estimates that focus on the subset of effects tracked by Pearson-Stuttard et al. Benefits might be higher if firms were to realize additional profits or producer surplus from any product reformulation (since we assume firms would use salt substitutes only if profits would remain the same or increase). Benefits might also be higher due to possible changes in consumer surplus from consumers willing to buy reformulated products whose valuation includes factors beyond medical cost savings or health state utility. Benefits might be lower if some consumers experience disutility associated with the reformulated product and adjust their consumption pattern accordingly, which could partially offset the estimated health benefits presented above. In addition, as mentioned above, we currently lack data to determine how much, if any, of the aggregate effects that Pearson-Stuttard et al. attribute to broader voluntary sodium reduction efforts could be directly connected to the flexibility provided by this rule. The rule does not cover all foods analyzed in the Pearson-Stuttard, et al. scenarios, which included many non-standardized foods. With comprehensive data on the share of foods affected by this rule, we could estimate health benefits across only such products as a subset of the Pearson-Stuttard, et al. estimate. We request such data and also data on possible consumer and producer response to the flexibility provided by this rule. 3. Costs of the Proposed Rule The proposed rule, if finalized would not impose regulatory costs on manufacturers or consumers. There would be no regulatory requirements or regulatory penalties relative to the baseline of taking no regulatory action. Manufacturers would be required to use safe and suitable ingredients regardless of the amount or type of salt substitutes they choose to use. The flexibility provided by this rule creates parity for use of existing salt substitutes in both standardized and non-standardized foods (see section V.C. for discussion of examples of current salt substitutes in use) and such uses are already required to be disclosed and labeled. It is presented above. Ref. 9, for instance, indicates that its cost-effectiveness results are highly sensitive to such issues. E:\FR\FM\10APP1.SGM 10APP1 ddrumheller on DSK120RN23PROD with PROPOSALS1 21160 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules possible that a change in voluntary market behavior relating to food consumption may generate health costs. For example, to the extent manufacturers choose to use potassium chloride as a salt substitute and consumers choose to consume those products, consumers who may need to limit their potassium intake may see negative health effects that should be accounted for in cost estimates. We request comments on evidence that could contribute to a more thorough assessment (including possible quantification) of such costs. The agency will continue to monitor the use of salt substitutes in the U.S. food supply. The economic rationale for food standards involves reducing consumers’ search costs; in particular, their ability to infer certain product characteristics from representation as certain standardized foods. The proposed rule may affect product characteristics by allowing manufacturers to use salt substitutes that replace any one or any combination of the functions of added salt. However, the proposed rule would preclude ingredient substitutions that change the basic nature and essential characteristics of a standardized food. The basic nature of a food concerns the general attributes of the product that is offered for sale to consumers. The essential characteristics of a food may contribute to achieving the basic nature of the food, but consumers may not be aware of the essential characteristics. Use of safe and suitable salt substitutes that do not change the basic nature and essential characteristics of the standardized food ensures that products on the market retain their general attributes. For purposes of this analysis, we assume products that retain their general attributes will also retain consistency with consumer beliefs and expectations relating to those products and that the use of salt substitutes will therefore not generate consumer dissatisfaction relating to the identity of the standardized food. To the extent that this assumption may not be accurate, we request comment on the degree to which consumers may be willing to purchase and consume such products after salt substitutes are used. If finalized, manufacturers may choose to take advantage of the flexibility provided in this proposed rule. As discussed above, the primary potential costs of that voluntary market behavior would arise from producers choosing to use the flexibility afforded to them to reformulate some products such as reformulation, consumer testing, labeling, and possibly marketing costs. Pearson-Stuttard, et al., estimate that VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 reformulation costs (using the FDA model, Ref. 23) corresponding to the draft voluntary short term sodium reduction targets could range from $2.7 to $15 billion over a 20-year time period and that these costs would comprise roughly 95 percent of the costs related to reaching short term sodium reduction targets (Ref. 8). Producers may voluntarily choose to reformulate some products in response to this rule’s added flexibility and the magnitude of such costs would depend on the number of products reformulated. The more firms choose to reformulate using salt substitutes given the flexibility provided by this rule, the greater the share of sodium reduction efforts (and associated reformulation costs) that could be attributed to this rule. Regardless of what amount of reformulation producers voluntarily choose to undertake, they will only do so if their private benefits in the form of increased revenue are at least as much as their private costs. We request comment on the number of manufacturers who may choose to reformulate standardized food products and the extent to which manufacturers may choose to reformulate those products given this new flexibility. We also request comment on all other considerations relating to manufacturers’ voluntary market decision to use salt substitutes including cost of reformulation, ability to source substitute ingredients, expected impact on sales, profits, and consumer acceptance or lack of acceptance. B. Initial Small Entity Analysis The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. If finalized, we do not expect the proposed rule would generate impacts on small entities. The rule would not impose regulatory costs on small entities. There would be no regulatory requirements or regulatory penalties relative to the baseline of taking no regulatory action. We have no basis to suppose or estimate any other impacts on small entities. As a result, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. This analysis, as well as other sections in this document, serves as the Initial Regulatory Flexibility Analysis, as required under the Regulatory Flexibility Act. This analysis is also available in the docket for this proposed rule (Ref. 24) and at https://www.fda.gov/about-fda/ PO 00000 Frm 00047 Fmt 4702 Sfmt 4702 reports/economic-impact-analyses-fdaregulations. VIII. Analysis of Environmental Impact We have determined under 21 CFR 25.32(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. IX. Paperwork Reduction Act of 1995 FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. X. Federalism We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required. XI. Consultation and Coordination With Indian Tribal Governments We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. We invite comments from tribal officials on any potential impact on Indian tribes from this proposed action. XII. References The following references marked with an asterisk (*) are on display with the Dockets Management Staff (see ADDRESSES) 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 https:// www.regulations.gov. References without asterisks are not on public E:\FR\FM\10APP1.SGM 10APP1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules ddrumheller on DSK120RN23PROD with PROPOSALS1 display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. * U.S. Department of Agriculture and U.S. Department of Health and Human Services. ‘‘Dietary Guidelines for Americans, 2020–2025.’’ 9th Edition. December 2020. Available at https:// www.dietaryguidelines.gov; accessed February 23, 2022. 2. National Academies of Sciences, Engineering and Medicine. ‘‘Dietary Reference Intakes for Sodium and Potassium’’ (March 2019). Washington, DC: The National Academies Press. 3. Sacks, F. M., L. P. Svetkey, W. M. Vollmer, L. J. Appel, et al., ‘‘Effects on Blood Pressure of Reduced Dietary Sodium and the Dietary Approaches to Stop Hypertension (DASH) diet.’’ DASH— Sodium Collaborative Research Group. New England Journal of Medicine. 2001; 344(1): pp 3–10. 4. Graudal, N. A., T. Hubeck-Graudal, and G. Ju¨rgens, ‘‘Effects of Low-Sodium Diet vs. High-Sodium Diet on Blood Pressure, Renin, Aldosterone, Catecholamines, Cholesterol, and Triglyceride (Cochrane Review).’’ American Journal of Hypertension. 2012; 25(1): pp. 1–15. https://www.ncbi.nlm.nih.gov/pubmed/ 22068710, accessed December 9, 2020. 5. Eckel, R. H., J. M. Jakicic, J. D. Ard, J. M. de Jesus, et al., ‘‘2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A Report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines.’’ Journal of the American College of Cardiology. 2014; 63(25 Pt B): pp. 2960–84. https:// www.ncbi.nlm.nih.gov/pubmed/ 24239922; accessed December 9, 2020. 6. * Murphy, S. L., K. D. Kochanek, J. Q. Xu, and E. Arias, ‘‘Mortality in the United States, 2020.’’ NCHS Data Brief, no 427. Hyattsville, MD: National Center for Health Statistics. 2021; https:// www.cdc.gov/nchs/products/databriefs/ db427.htm; accessed Feb 23, 2022. 7. Coxson, P. G., N. R. Cook, M. Joffres, Y. Hong, et al., ‘‘Mortality Benefits From U.S. Population-Wide Reduction in Sodium Consumption: Projections From 3 Modeling Approaches.’’ Hypertension. 2013; 61(3): pp. 564–570. 8. Pearson-Stuttard, J., C. Kypridemos, B, Collins, D. Mozaffarian, et al., ‘‘Estimating the Health and Economic Effects of the Proposed U.S. Food and Drug Administration Voluntary Sodium Reformulation: Microsimulation CostEffectiveness Analysis.’’ PLoS Medicine. 2018; 15(4): pp. 1–18. 9. Smith-Spangler C. M., J. L. Juusola, E. A. Enns, D. K. Owens, and A. M. Garber, ‘‘Population Strategies to Decrease Sodium Intake and the Burden of VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 Cardiovascular Disease: A CostEffectiveness Analysis.’’ Annals of Internal Medicine. 2010; 152(8): pp. 481– 487. 10. Micha, R., J. L. Pen˜alvo, F. Cudhea, F. Imamura, et al., ‘‘Association Between Dietary Factors and Mortality from Heart Disease, Stroke, and Type 2 Diabetes in the United States.’’ Journal of the American Medical Association. 2017; 317(9): pp. 912–924. 11. * Ostchega, Y., C.D. Fryar, T. Nwankwo, and D.T. Nguyen, ‘‘Hypertension Prevalence Among Adults Aged 18 and Over: United States, 2017–2018.’’ NCHS Data Brief, no 364. Hyattsville, MD: National Center for Health Statistics. 2020; https://www.cdc.gov/nchs/ products/databriefs/db364.htm; accessed March 21, 2023. 12. * Centers for Disease Control and Prevention, ‘‘Deaths: Final Data for 2018’’ National Vital Statistics Report. 2021; 69 (13). Table 10: p. 52. Available at https://www.cdc.gov/nchs/data/nvsr/ nvsr69/nvsr69-13-508.pdf; accessed December 20, 2022. 13. * Centers for Disease Control and Prevention, ‘‘Summary of Health Statistics’’ National Health Interview Survey. 2018; Table A–1a. Available at https://www.cdc.gov/nchs/nhis/shs/ tables.htm; accessed December 20, 2022. 14. Harnack, L.J., M. E. Cogswell, J. M. Shikany, C. D. Gardner, et al., ‘‘Sources of Sodium in U.S. Adults from 3 Geographic Regions.’’ Circulation. 2017; 135: pp. 1775–1783. 15. * FDA, ‘‘The Use of an Alternate Name for Potassium Chloride in Food Labeling: Guidance for Industry.’’ December 2020. Available at https://www.fda.gov/media/ 125081/download (Docket number FDA– 2019–D–0892), accessed February 23, 2022. 16. * FDA, ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods: Guidance for Industry.’’ October 2021. Available at https:// www.fda.gov/media/98264/download (Docket number FDA–2014–D–0055), accessed February 23, 2022. 17. Mayne, S. T., R. A. McKinnon, and J. Woodcock, ‘‘Reducing Sodium Intake in the U.S. Healthier Lives, Healthier Future.’’ Journal of the American Medical Association. 2021; 326(17): pp. 1675–1676. 18. * FDA, ‘‘Horizontal Approaches to Food Standards of Identity Modernization; Public Meeting; Request for Comments.’’ September 27, 2019; transcript available at https://www.fda.gov/food/workshopsmeetings-webinars-food-and-dietarysupplements/public-meeting-horizontalapproaches-food-standards-identitymodernization-09272019-09272019. 19. Institute of Medicine. ‘‘Strategies to Reduce Sodium Intake in the United States’’ (2010). Washington, DC: The National Academies Press. 20. Do¨tsch, M., J. Busch, M. Batenburg, G. Liem, et al., ‘‘Strategies to Reduce Sodium Consumption: A Food Industry PO 00000 Frm 00048 Fmt 4702 Sfmt 4702 21161 Perspective.’’ Critical Reviews in Food Science and Nutrition. 2009; 49(10): pp. 841–851. 21. Taylor, C., M. Doyle, D. Webb, ‘‘The Safety of Sodium Reduction in the Food Supply: A Cross-Discipline Balancing Act—Workshop Proceedings.’’ Critical Reviews in Food Science and Nutrition. 2018; 58(10): pp. 1650–1659. 22. * FDA, ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods: Guidance for Industry. Draft Guidance.’’ June 2016. 23. Muth, M. K., S. Bradley, J. Brophy, K. Capogrossi, S. Karns, and C. Viator. Reformulation cost model. Contract No. HHSF–223–2011–10005B, Task Order 20. Final report. Research Triangle Park (NC): RTI International; 2015. 24. * FDA, ‘‘Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods’’ Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis. Available at https:// www.fda.gov/about-fda/reports/ economic-impact-analyses-fdaregulations. List of Subjects 21 CFR Part 130 Food additives, Food grades and standards. 21 CFR Part 131 Dairy products, Food grades and standards, Incorporation by reference, Milk. 21 CFR Part 133 Dairy products, Food grades and standards, Food labeling. 21 CFR Part 136 Bakery products, Food grades and standards, Incorporation by reference. 21 CFR Part 137 Foods, Food grades and standards, Incorporation by reference. 21 CFR Part 139 Food grades and standards, Incorporation by reference. 21 CFR Parts 145 and 150 Food grades and standards, Fruits, Incorporation by reference. 21 CFR Part 155 Food grades and standards, Incorporation by reference, Vegetables. 21 CFR Part 156 Food grades and standards, Vegetable juices. 21 CFR Part 158 Food grades and standards, Frozen foods, Vegetables. E:\FR\FM\10APP1.SGM 10APP1 21162 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules 21 CFR Part 161 Food grades and standards, Frozen foods, Incorporation by reference, Seafood. 21 CFR Part 163 Cacao products, Food grades and standards. 21 CFR Part 166 Food grades and standards, Food labeling, Incorporation by reference, Margarine. 21 CFR Part 168 Food grades and standards, Sugar. 21 CFR Part 169 Food grades and standards, Oils and fats, Spices and flavorings. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR parts 130, 131, 133, 136, 137, 139, 145, 150, 155, 156, 158, 161, 163, 166, 168, and 169 be amended as follows: PART 130—FOOD STANDARDS: GENERAL 1. The authority citation for part 130 continues to read as follows: ■ Authority: 21 U.S.C. 321, 336, 341, 343, 371. ■ * 2. Add subpart C to read as follows: * * * * Subpart C—Flexibility in Standardized Foods § 130.30 Ingredient flexibility in standardized foods. § 131.111 (a) The definitions listed in this section apply to parts 131 through 169 of this chapter. (b) The ingredients used as substitutes must not change the basic nature and essential characteristics of the food. (c) Definitions. (1) Salt substitute means a safe and suitable ingredient (or combination of ingredients) that is used to replace some or all of the added salt (sodium chloride), to reduce sodium in the food, and that serves the functions of salt in the food. (2) [Reserved] ddrumheller on DSK120RN23PROD with PROPOSALS1 PART 131—MILK AND CREAM 3. The authority citation for part 131 continues to read as follows: ■ Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e. ■ 4. Add § 131.10 to read as follows: § 131.10 Incorporation by reference. Certain material is incorporated by reference into this part with the VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration (FDA) and at the National Archives and Records Administration (NARA). Contact FDA’s Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from AOAC INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 20850–3250, 1–800–379– 2622: (a) Official Methods of Analysis, 21st Ed. (2019); (1) AOAC Official Method 945.48G, under Evaporated Milk (Unsweetened); IBR §§ 131.160(c); 131.162(c). (2) AOAC Official Method 947.05, Acidity of Milk Titrimetric Method; IBR §§ 131.111(f); 131.112(e); 131.160(c); 131.162(c). (3) AOAC Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction Method; IBR §§ 131.111(f); 131.112(e); 131.170(f). (4) AOAC Official Method 990.21, Solid-Not-Fat in Milk By Difference between Total Solids and Fat Contents; IBR §§ 131.111(f); 131.112(e); 131.170(f). (b) [Reserved] ■ 5. In § 131.111, revise paragraphs (e)(8) and (f) to read as follows: Acidified milk. * * * * * (e) * * * (8) Salt or salt substitute. * * * * * (f) Methods of analysis. Referenced methods are from ‘‘Official Methods of Analysis’’ (incorporated by reference, see § 131.10): (1) Milkfat content—As determined by the method prescribed in AOAC Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction Method. (2) Milk solids not fat content— Calculated by subtracting the milkfat content from the total solids content using the method prescribed in AOAC Official Method 990.21, Solid-Not-Fat in Milk By Difference between Total Solids and Fat Contents. (3) Titratable acidity—As determined by the methods prescribed in AOAC Official Method 947.05, Acidity of Milk Titrimetric Method or by an equivalent potentiometric method. * * * * * PO 00000 Frm 00049 Fmt 4702 Sfmt 4702 6. In § 131.112, revise paragraphs (d)(8) and (e) to read as follows: ■ § 131.112 Cultured milk. * * * * * (d) * * * (8) Salt or salt substitute. * * * * * (e) Methods of analysis. Referenced methods are from ‘‘Official Methods of Analysis’’ (incorporated by reference, see § 131.10): (1) Milkfat content—As determined by the method prescribed in AOAC Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction Method. (2) Milk solids not fat content— Calculated by subtracting the milkfat content from the total solids content using the method prescribed in AOAC Official Method 990.21, Solid-Not-Fat in Milk By Difference between Total Solids and Fat Contents. (3) Titratable acidity—As determined by the methods prescribed in AOAC Official Method 947.05, Acidity of Milk Titrimetric Method or by an equivalent potentiometric method. * * * * * ■ 7. In § 131.160, revise paragraphs (b)(5) and (c) to read as follows: § 131.160 Sour cream. * * * * * (b) * * * (5) Salt or salt substitute. * * * * * (c) Methods of analysis. Referenced methods are from ‘‘Official Methods of Analysis’’ (incorporated by reference, see § 131.10). (1) Milkfat content—AOAC Official Method 945.48G, under Evaporated Milk (Unsweetened). (2) Titratable acidity—AOAC Official Method 947.05, Acidity of Milk Titrimetric Method. * * * * * ■ 8. In § 131.162, revise paragraphs (b)(4) and (c) to read as follows: § 131.162 Acidified sour cream. * * * * * (b) * * * (4) Salt or salt substitute. * * * * * (c) Methods of analysis. Referenced methods are from ‘‘Official Methods of Analysis’’ (incorporated by reference, see § 131.10). (1) Milkfat content—AOAC Official Method 945.48G, under Evaporated Milk (Unsweetened). (2) Titratable acidity—AOAC Official Method 947.05, Acidity of Milk Titrimetric Method. * * * * * E:\FR\FM\10APP1.SGM 10APP1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules 9. In § 131.170, revise paragraphs (e)(2) and (f) to read as follows: ■ § 131.170 Eggnog. * * * * * (e) * * * (2) Salt or salt substitute. * * * * * (f) Methods of analysis. Referenced methods are from ‘‘Official Methods of Analysis’’ (incorporated by reference, see § 131.10). (1) Milkfat content—As determined by the method prescribed in AOAC Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction Method. (2) Milk solids not fat content— Calculated by subtracting the milkfat content from the total solids content using the method prescribed in AOAC Official Method 990.21, Solid-Not-Fat in Milk By Difference between Total Solids and Fat Contents. * * * * * PART 133—CHEESES AND RELATED CHEESE PRODUCTS 10. The authority citation for part 133 continues to read as follows: ■ Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e. 11. In § 133.102, add paragraph (c)(3) to read as follows: ■ § 133.102 cheese. Asiago fresh and asiago soft * * * * (c) * * * (3) During the cheesemaking process, where the curd is salted, salt substitute may be used. * * * * * ■ 12. In § 133.106, add paragraph(b)(3)(vii) to read as follows: Blue cheese. * * * * * (b) * * * (3) * * * (vii) Salt substitute. * * * * * ■ 13. In § 133.108, add paragraph (b)(3)(v) to read as follows: § 133.108 Brick cheese. ddrumheller on DSK120RN23PROD with PROPOSALS1 Caciocavallo siciliano cheese. * * (c) * * * VerDate Sep<11>2014 * * 16:51 Apr 07, 2023 Jkt 259001 * * * * (b) * * * (3) * * * (vi) Salt substitute. * * * * * ■ 16. In § 133.118, revise the first sentence of paragraph (c)(2) and add paragraph (c)(4) to read as follows: § 133.118 Colby cheese. * * * * * (c) * * * (2) Milk shall be deemed to have been pasteurized if it has been held at a temperature of not less than 145 °F for a period of not less than 30 minutes, or for a time and at a temperature equivalent thereto in phosphatase destruction. * * * * * * * * (4) During the cheesemaking process, where the curd is salted, salt substitute may be used. * * * * * ■ 17. In § 133.123, revise paragraph (c)(3) to read as follows: § 133.123 Cold-pack and club cheese. * * * * (c) * * * (3) Salt or salt substitute. * * * * * ■ 18. In § 133.124, revise paragraph (e)(3) to read as follows: § 133.124 Cold-pack cheese food. * * * * * (e) * * * (3) Salt or salt substitute. * * * * * ■ 19. In § 133.127, revise paragraph (b)(3)(v) to read as follows: Cook cheese, koch kaese. * * * * * (b) * * * (3) * * * (v) Salt substitute. * * * * * ■ 14. In § 133.111, add paragraph (c)(3) to read as follows: * Cheddar cheese. * § 133.127 * § 133.111 § 133.113 * * § 133.106 (3) During the cheesemaking process, where the curd is salted, salt substitute may be used. * * * * * ■ 15. In § 133.113, add paragraph (b)(3)(vi) to read as follows: * * * * (b) * * * (3) * * * (v) Salt or salt substitute. * * * * * ■ 20. In § 133.129, revise paragraphs (b)(1)(i) through (b)(1)(iii) to read as follows: § 133.129 Dry curd cottage cheese. * * * * * (b) * * * (1) * * * (i) Harmless lactic-acid-producing bacteria, with or without rennet and/or other safe and suitable milk-clotting PO 00000 Frm 00050 Fmt 4702 Sfmt 4702 21163 enzyme that produces equivalent curd formation, are added and it is held until it becomes coagulated. The coagulated mass may be cut; it may be warmed; it may be stirred; it is then drained. The curd may be washed with water and further drained; it may be pressed, chilled, worked, seasoned with salt or salt substitute; or (ii) Food grade phosphoric acid, lactic acid, citric acid, or hydrochloric acid, with or without rennet and/or other safe and suitable milk-clotting enzyme that produces equivalent curd formation, is added in such amount as to reach a pH of between 4.5 and 4.7; coagulation to a firm curd is achieved while heating to a maximum of 120 °F without agitation during a continuous process. The coagulated mass may be cut; it may be warmed; it may be stirred; it is then drained. The curd is washed with water, stirred, and further drained. It may be pressed, chilled, worked, seasoned with salt or salt substitute. (iii) Food grade acids as provided in paragraph (b)(1)(ii) of this section, DGlucono-delta-lactone with or without rennet, and/or other safe and suitable milk clotting enzyme that produces equivalent curd formation, are added in such amounts as to reach a final pH value in the range of 4.5–4.8, and it is held until it becomes coagulated. The coagulated mass may be cut; it may be warmed; it may be stirred; it is then drained. The curd is then washed with water, and further drained. It may be pressed, chilled, worked, and seasoned with salt or salt substitute. * * * * * ■ 21. In § 133.133, revise paragraph (b)(3)(i) to read as follows: § 133.133 Cream cheese. * * * * * (b) * * * (3) * * * (i) Salt or salt substitute. * * * * * ■ 22. In § 133.136, add paragraph (b)(3)(vi) to read as follows: § 133.136 cheese. Washed curd and soaked curd * * * * * (b) * * * (3) * * * (vi) Salt substitute. * * * * * ■ 23. In § 133.138, add paragraph (b)(3)(v) to read as follows: § 133.138 Edam cheese. * * * * * (b) * * * (3) * * * (v) Salt substitute. * * * * * E:\FR\FM\10APP1.SGM 10APP1 21164 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules temperature of not less than 145 °F for a period of not less than 30 minutes, or for a time and at a temperature equivalent thereto in phosphatase destruction. * * * (3) During the cheesemaking process, where the curd is salted, salt substitute may be used. * * * * * (e) * * * (1) The specific common or usual name of such hard cheese, if any such name has become generally recognized therefor; or * * * * * ■ 30. In § 133.152, add paragraph (b)(3)(iv) to read as follows: 24. In § 133.141, add paragraph (b)(3)(vii) to read as follows: ■ § 133.141 Gorgonzola cheese. * * * * * (b) * * * (3) * * * (vii) Salt substitute. * * * * * ■ 25. In § 133.144, add paragraph (b)(3)(vi) to read as follows: § 133.144 cheese. Granular and stirred curd * * * * * (b) * * * (3) * * * (vi) Salt substitute. * * * * * ■ 26. In § 133.147, revise paragraph (c)(5) to read as follows: § 133.147 § 133.152 Grated American cheese food. * * * * * (c) * * * (5) Salt or salt substitute. * * * * * ■ 27. In § 133.148, revise paragraph (c) to read as follows: § 133.148 Hard grating cheeses. * * * * (c)(1) For the purposes of this section, the word ‘‘milk’’ means cow’s milk or goat’s milk or sheep’s milk or mixtures of two or all of these. Such milk may be adjusted by separating part of the fat therefrom or (in the case of cow’s milk) by adding one or more of the following: Cream, skim milk, concentrated skim milk, nonfat dry milk; (in the case of goat’s milk) the corresponding products from goat’s milk; (in the case of sheep’s milk) the corresponding products from sheep’s milk; water in a quantity sufficient to reconstitute any such concentrated or dried products used. (2) During the cheesemaking process, where the curd is salted, salt substitute may be used. * * * * * ■ 28. In § 133.149, add paragraph (b)(3)(iv) to read as follows: Gruyere cheese. ddrumheller on DSK120RN23PROD with PROPOSALS1 * * * * * (b) * * * (3) * * * (iv) Salt substitute. * * * * * ■ 29. In § 133.150, revise the first sentence of paragraph (c)(2), add paragraph (c)(3), and revise paragraph (e)(1) to read as follows: § 133.150 Hard cheeses. * * * * * (c) * * * (2) Milk shall be deemed to have been pasteurized if it has been held at a VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 * * * * (b) * * * (3) * * * (iv) Salt substitute. * * * * * ■ 31. In § 133.153, revise paragraph (b)(3)(iii) to read as follows: § 133.153 Monterey cheese and Monterey jack cheese. * * § 133.149 Limburger cheese. * * * * * (b) * * * (3) * * * (iii) Salt or salt substitute. * * * * * ■ 32. In § 133.155, revise paragraph (b)(3)(iii) to read as follows: (3) * * * (i) Salt or salt substitute. * * * * * ■ 36. In § 133.164, add paragraph (b)(3)(iv) to read as follows: § 133.164 Nuworld cheese. * * * * * (b) * * * (3) * * * (iv) Salt substitute. * * * * * ■ 37. In § 133.165, add paragraph (c)(3) to read as follows: § 133.165 Parmesan and reggiano cheese. * * * * * (c) * * * (3) During the cheesemaking process, where the curd is salted, salt substitute may be used. * * * * * ■ 38. In § 133.169, revise paragraph (d)(4) to read as follows: § 133.169 Pasteurized process cheese. * * * * * (d) * * * (4) Salt or salt substitute. * * * * * ■ 39. In § 133.173, revise paragraph (e)(4) to read as follows: § 133.173 food. Pasteurized process cheese * * * * (e) * * * (4) Salt or salt substitute. § 133.155 Mozzarella cheese and scamorza cheese. * * * * * ■ 40. In § 133.179, revise paragraph * * * * * (f)(5) to read as follows: (b) * * * (3) * * * § 133.179 Pasteurized process cheese (iii) Salt or salt substitute. spread. * * * * * * * * * * ■ 33. In § 133.156, revise paragraph (f) * * * (b)(3)(iii) to read as follows: (5) Salt or salt substitute. § 133.156 Low-moisture mozzarella and * * * * * scamorza cheese. ■ 41. In § 133.181, add paragraph (b)(3)(vi) to read as follows: * * * * * (b) * * * § 133.181 Provolone cheese. (3) * * * * * * * * (iii) Salt or salt substitute. (b) * * * * * * * * (3) * * * ■ 34. In § 133.160, add paragraph (vi) Salt substitute. (b)(3)(vi) to read as follows: * * * * * § 133.160 Muenster and munster cheese. ■ 42. In § 133.182, revise the tenth sentence in paragraph (b) and revise * * * * * (b) * * * paragraph (c)(2) to read as follows: (3) * * * § 133.182 Soft ripened cheeses. (vi) Salt substitute. * * * * * * * * * * (b) * * * Salt or salt substitute may ■ 35. In § 133.162, revise paragraph be added during the procedure. * * * (b)(3)(i) to read as follows: * * * * * § 133.162 Neufchatel cheese. (c) * * * (2) Milk shall be deemed to have been * * * * * (b) * * * pasteurized if it has been held at a PO 00000 Frm 00051 Fmt 4702 Sfmt 4702 * E:\FR\FM\10APP1.SGM 10APP1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules temperature of not less than 145 °F for a period of not less than 30 minutes, or for a time and at a temperature equivalent thereto in phosphatase destruction. * * * * * ■ 43. In § 133.183, add paragraph (c)(3) to read as follows: (c) Nomenclature. The name of the food is ‘‘sap sago cheese.’’ * * * * * ■ 47. In § 133.187, revise the tenth sentence of paragraph (b) and the first sentence of paragraph (c)(2) to read as follows: § 133.183 * Romano cheese. * * * * * (c) * * * (3) During the cheesemaking process, where the curd is salted, salt substitute may be used. * * * * * ■ 44. In § 133.184, revise paragraphs (b) introductory text and (b)(3) to read as follows: § 133.184 Roquefort cheese, sheep’s milk blue-mold, and blue-mold cheese from sheep’s milk. * * * * * (b) Optional Ingredients. The following safe and suitable ingredients may be used: * * * * * (3) Other optional ingredients. (i) Enzymes of animal, plant, or microbial origin, used in curing or flavor development. (ii) Salt substitute. * * * * * ■ 45. In § 133.185, add paragraph (b)(3)(v) to read as follows: § 133.185 Samsoe cheese. * * * * * (b) * * * (3) * * * (v) Salt substitute. * * * * * ■ 46. In § 133.186, revise paragraphs (a)(2) and (c) to read as follows: ddrumheller on DSK120RN23PROD with PROPOSALS1 § 133.186 * * * * (b) * * * Salt or salt substitute may be added during the procedure. * * * * * * * * (c) * * * (2) Milk shall be deemed to have been pasteurized if it has been held at a temperature of not less than 145 °F for a period of not less than 30 minutes, or for a time and at a temperature equivalent thereto in phosphatase destruction. * * * * * * * * ■ 48. In § 133.188, revise the tenth sentence in paragraph (b) and the first sentence in paragraph (c)(2) to read as follows: § 133.188 Semisoft part-skim cheeses. * * * * * (b) * * * Salt or salt substitute may be added during the procedure. * * * * * * * * (c) * * * (2) Milk shall be deemed to have been pasteurized if it has been held at a temperature of not less than 145 °F for a period of not less than 30 minutes, or for a time and at a temperature equivalent thereto in phosphatase destruction. * * * * * * * * ■ 49. In § 133.189, revise paragraph (d) to read as follows: * (a) * * * (2) One or more of the dairy ingredients specified in paragraph (b)(1) of this section is allowed to become sour, and is heated to boiling temperature, with stirring. Sufficient sour whey is added to precipitate the casein. The curd is removed, spread out in boxes, and pressed, and while under pressure is allowed to drain and ferment. It is ripened for not less than 5 weeks. The ripened curd is dried and ground; salt or salt substitute and dried clover of the species Melilotus coerulea are added. The mixture is shaped into truncated cones and ripened. The optional ingredient in paragraph (b)(2) of this section may be added during this procedure. * * * * * 16:51 Apr 07, 2023 Semisoft cheeses. § 133.189 Skim milk cheese for manufacturing. Sap sago cheese. VerDate Sep<11>2014 § 133.187 Jkt 259001 * * * * (d)(1) For the purposes of this section, ‘‘skim milk’’ means cow’s milk from which the milk fat has been separated. (2) During the cheesemaking process, where the curd is salted, salt substitute may be used. * * * * * ■ 50. In § 133.190, revise paragraph (b)(3)(iii) to read as follows: § 133.190 Spiced cheeses. * * * * * (b) * * * (3) * * * (iii) Salt or salt substitute. * * * * * ■ 51. In § 133.195, add paragraph (b)(3)(vii) to read as follows: § 133.195 * PO 00000 * Swiss and emmentaler cheese. * Frm 00052 * Fmt 4702 * Sfmt 4702 21165 (b) * * * (3) * * * (vii) Salt substitute. * * * * * PART 136—BAKERY PRODUCTS 52. The authority citation for part 136 continues to read as follows: ■ Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e. 53. In § 136.110, revise paragraphs (c)(4) and (d) to read as follows: ■ § 136.110 Bread, rolls, and buns. * * * * * (c) * * * (4) Salt or salt substitute. * * * * * (d) Total solids are determined by the method prescribed in AOAC Official Method 935.36(a), Solids (Total) in Bread, except that if the baked unit weighs 454 grams (1 pound) or more, one entire unit is used for the determination; if the baked unit weighs less than 454 grams, enough units to weigh 454 grams or more are used. AOAC Official Method 935.36(a), Solids (Total) in Bread, ‘‘Official Methods of Analysis,’’ 21st Ed. (2019), is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C 552(a) and 1 CFR part 51. This incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration (FDA) and at the National Archives and Records Administration (NARA). Contact FDA’s Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ ibr-locations or email fr.inspection@ nara.gov. This material is also available from AOAC INTERNATIONAL, 2275 Research Blvd., Suite 300, Rockville, MD 20850–3250, 1–800–379–2622. * * * * * PART 137—CEREAL FLOURS AND RELATED PRODUCTS 54. The authority citation for part 137 continues to read as follows: ■ Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e. 55. Add subpart A, consisting of §§ 137.1 through 137.100, to read as follows: ■ Subpart A—General Provisions. Sec. 137.10 Incorporation by reference. 137.20 through 137.100 [Reserved] E:\FR\FM\10APP1.SGM 10APP1 21166 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules Subpart A—General Provisions. § 137.10 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration (FDA) and at the National Archives and Records Administration (NARA). Contact FDA’s Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from AOAC INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 20850–3250, 1–800–379– 2622: (a) Official Methods of Analysis, 21st Ed. (2019); (1) AOAC Official Method 923.02A, Reagent; IBR §§ 137.180(c); 137.270(b). (2) AOAC Official Method 923.02B, Apparatus, under Carbon Dioxide (Total) in Baking Powders Gasometric Determination; IBR §§ 137.180(c); 137.270(b). (3) Reference Table 909.04, Correction Factors for Gasometric Determination of Carbon Dioxide; IBR §§ 137.180(c); 137.270(b). (b) [Reserved] §§ 137.20 through 137.100 [Reserved] 56. In § 137.180, revise paragraphs (a), (c) introductory text, and (c)(1) to read as follows: ■ ddrumheller on DSK120RN23PROD with PROPOSALS1 § 137.180 Self-rising flour. (a) Description. Self-rising flour, selfrising white flour, self-rising wheat flour, is an intimate mixture of flour, sodium bicarbonate, and one or more of the acid-reacting substances monocalcium phosphate, sodium acid pyrophosphate, and sodium aluminum phosphate. It is seasoned with salt or salt substitute. When it is tested by the method prescribed in paragraph (c) of this section, not less than 0.5 percent of carbon dioxide is evolved. The acidreacting substance is added in sufficient quantity to neutralize the sodium bicarbonate. The combined weight of such acid-reacting substance and sodium bicarbonate is not more than 4.5 parts to each 100 parts of flour used. Subject to the conditions and restrictions prescribed by § 137.105(a), the bleaching ingredients specified in such section may be added as optional ingredients. If the flour used in making VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 the self-rising flour is bleached, the optional bleaching ingredient used therein (see § 137.105(a)) is also an optional ingredient of the self-rising flour. * * * * * (c) Method of analysis. Follow the method prescribed in AOAC Official Method 923.02A, Reagent, and 923.02B, Apparatus, under Carbon Dioxide (Total) in Baking Powders Gasometric Determination (incorporated by reference, see § 137.10): Instead of using AOAC Official Method 923.02C, Determination, use the following procedure: (1) Weigh 17 grams of the official sample into flask A, add 15–20 glass beads (4–6 mm. diameter), and connect this flask with the apparatus (fig. 923.02). Open stopcock C and by means of the leveling bulb E bring the displacement solution to the 25 cc. graduation above the zero mark. (This 25 cc. is a partial allowance for the volume of acid to be used in the decomposition.) Allow the apparatus to stand 1–2 minutes to ensure that the temperature and pressure within the apparatus are the same as those of the room. Close the stopcock, lower the leveling bulb somewhat to reduce the pressure within the apparatus, and slowly run into the decomposition flask from burette F 45 cc. of sulfuric acid (1 + 5). To prevent the liberated carbon dioxide from escaping through the acid burette into the air, keep the displacement solution in the leveling bulb at all times during the decomposition at a lower level than that in the gas-measuring tube. Rotate and then vigorously agitate the decomposition flask for 3 minutes to mix the contents intimately. Allow to stand for 10 minutes to bring to equilibrium. Equalize the pressure in the measuring tube by means of the leveling bulb and read the volume of gas from the zero point on the tube. Deduct 20 cc. from this reading (this 20 cc. together with previous allowance of 25 cc. compensates for the 45 cc. acid used in the decomposition). Observe the temperature of the air surrounding the apparatus and also the barometric pressure and multiply the number of milliliters of gas evolved by the factor given in Reference Table 909.04, ‘‘Correction Factors for Gasometric Determination of Carbon Dioxide’’, incorporated by reference, see § 137.10) for the temperature and pressure observed. Divide the corrected reading by 100 to obtain the apparent percent by weight of carbon dioxide in the official sample. * * * * * PO 00000 Frm 00053 Fmt 4702 Sfmt 4702 57. In § 137.270, revise paragraphs (a), (b) introductory text, and (b)(1) to read as follows: ■ § 137.270 Self-rising white corn meal. (a) Description. Self-rising white corn meal is an intimate mixture of white corn meal, sodium bicarbonate, and one or both of the acid-reacting substances monocalcium phosphate and sodium aluminum phosphate. It is seasoned with salt or salt substitute. When it is tested by the method prescribed in paragraph (b) of this section, not less than 0.5 percent of carbon dioxide is evolved. The acid-reacting substance is added in sufficient quantity to neutralize the sodium bicarbonate. The combined weight of such acid-reacting substance and sodium bicarbonate is not more than 4.5 parts to each 100 parts of white corn meal used. (b) Method of analysis. Follow the method prescribed in AOAC Official Method 923.02A, Reagent, and 923.02B, Apparatus, under Carbon Dioxide (Total) in Baking Powders Gasometric Determination (incorporated by reference, see § 137.10): Instead of using AOAC Official Method 923.02C, Determination, use the following procedure: (1) Weigh 17 grams of the official sample into flask A, add 15–20 glass beads (4–6 mm. diameter), and connect this flask with the apparatus (fig. 923.02). Open stopcock C and by means of the leveling bulk E bring the displacement solution to the 25 cc. graduation above the zero mark. (This 25 cc. is a partial allowance for the volume of acid to be used in the decomposition.) Allow the apparatus to stand 1–2 minutes to ensure that the temperature and pressure within the apparatus are the same as those of the room. Close the stopcock, lower the leveling bulb somewhat to reduce the pressure within the apparatus, and slowly run into the decomposition flask from burette F 45 cc. of sulfuric acid (1 + 5). To prevent the liberated carbon dioxide from escaping through the acid burette into the air, keep the displacement solution in the leveling bulb at all times during the decomposition at a lower level than that in the gas-measuring tube. Rotate and then vigorously agitate the decomposition flask for 3 minutes to mix the contents intimately. Allow to stand for 10 minutes to bring to equilibrium. Equalize the pressure in the measuring tube by means of the leveling bulb and read the volume of gas from the zero point on the tube. Deduct 20 cc. from this reading (this 20 cc. together with previous allowance of 25 cc. compensates for the 45 cc. acid used E:\FR\FM\10APP1.SGM 10APP1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules in the decomposition). Observe the temperature of the air surrounding the apparatus and also the barometric pressure and multiply the number of milliliters of gas evolved by the factor given in the Reference Table 909.04, ‘‘Correction Factors for Gasometric Determination of Carbon Dioxide’’ (incorporated by reference, see § 137.10) for the temperature and pressure observed. Divide the corrected reading by 100 to obtain the apparent percent by weight of carbon dioxide in the official sample. * * * * * § 139.110 PART 139—MACARONI AND NOODLE PRODUCTS § 139.150 58. The authority citation for part 139 continues to read as follows: ■ Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e. 59. Add subpart A, consisting of §§ 1397.10 through 139.100, to read as follows: ■ Subpart A—General Provisions. Sec. 139.10 Incorporation by reference. 139.20 through 139.100 [Reserved] Subpart A—General Provisions. ddrumheller on DSK120RN23PROD with PROPOSALS1 § 139.10 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration (FDA) and at the National Archives and Records Administration (NARA). Contact FDA’s Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from AOAC INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 20850–3250, 1–800–379– 2622. (a) Official Methods of Analysis, 21st Ed. (2019); (1) AOAC Official Method 926.07A, Vacuum Oven Method, under Solids (Total) and Loss on Drying (Moisture) in Macaroni Products; IBR §§ 139.110(a); 139.150(a). (2) [Reserved] (b) [Reserved] §§ 139.20 through 139.100 [Reserved] 60. In § 139.110, revise paragraphs (a)(4) and (5) to read as follows: ■ VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 Macaroni products. (a) * * * (4) Salt or salt substitute, in a quantity that seasons the food. (5) Gum gluten, in such quantity that the protein content of the finished food is not more than 13 percent by weight. The finished macaroni product contains not less than 87 percent of total solids as determined by AOAC Official Method 926.07A(incorporated by reference, see § 139.10). * * * * * ■ 61. In § 139.150, revise paragraphs (a)(2) and (4) to read as follows: Noodle products. (a) * * * (2) Salt or salt substitute, in a quantity that seasons the food. * * * * * (4) Concentrated glyceryl monostearate (containing not less than 90 percent monoester) in a quantity not exceeding 3 percent by weight of the finished food. The finished noodle product contains not less than 87 percent of total solids as determined by AOAC Official Method 926.07A(incorporated by reference, see § 139.10). The total solids of noodle products contains not less than 5.5 percent by weight of the solids of egg, or egg yolk. * * * * * 62. The authority citation for part 145 continues to read as follows: ■ Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e. 63. In § 145.110, revise paragraphs (a)(1) and (a)(2)(iii) to read as follows: ■ § 145.110 Frm 00054 Fmt 4702 Sfmt 4702 Canned figs. (a) * * * (5) Salt or salt substitute. * * * * * PART 150—FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS 65. The authority citation for part 150 continues to read as follows: ■ Canned applesauce. (a) * * * (1) Definition. Canned applesauce is the food prepared from comminuted or chopped apples (Malus domestica Borkhausen), which may or may not be peeled and cored, and which may have added thereto one or more of the optional ingredients specified in paragraph (a)(2) of this section. The apple ingredient is heated and, in accordance with good manufacturing practices, bruised apple particles, peel, seed, core material, carpel tissue, and other coarse, hard, or extraneous materials are removed. The food is sealed in containers. It is so processed by heat, either before or after sealing, as to prevent spoilage. The soluble solids content, measured by refractometer and expressed as percent sucrose (degrees Brix) with correction for temperature to the equivalent at 20 °C (68 °F), is not PO 00000 less than 9 percent (exclusive of the solids of any added optional nutritive carbohydrate sweeteners) as determined by AOAC Official Method 932.12 but without correction for invert sugar or other substances. AOAC Official Method 932.12, ‘‘Solids (Soluble) in Fruits and Fruit Products,’’ in ‘‘Official Methods of Analysis of AOAC INTERNATIONAL,’’ 21st Ed. (2019), is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51,. All approved incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration (FDA) and the National Archives and Records Administration (NARA). Contact the FDA at FDA’s Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240– 402–7500. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/ cfr/ibr-locations or email fr.inspection@ nara.gov. This material is available from AOAC INTERNATIONAL, 2275 Research Blvd., Suite 300, Rockville, MD 20850–3250, 1–800–379–2622. (2) * * * (iii) Salt or salt substitute. * * * * * ■ 64. In § 145.130, revise paragraph (a)(5) to read as follows: § 145.130 PART 145—CANNED FRUITS 21167 Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e. 66. Add subpart A, consisting of §§ 150.10 through 150.100, to read as follows: ■ Subpart A—General Provisions. Sec. 150.10 Incorporation by reference. 150.20 through 150.100 [Reserved] Subpart A—General Provisions. § 150.10 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration E:\FR\FM\10APP1.SGM 10APP1 21168 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules (FDA) and at the National Archives and Records Administration (NARA). Contact FDA’s Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from AOAC INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 20850–3250, 1–800–379– 2622. (a) Official Methods of Analysis, 21st Ed. (2019); (1) AOAC Official Method 932.12, Solids (Soluble) in Fruits and Fruit Products; IBR § 150.110(d). (2) AOAC Official Method 932.14C, By Means of Refractometer, under Solids in Syrups; IBR § 150.110(d). (b) [Reserved] §§ 150.20 through 150.100 [Reserved] 67. In § 150.110, revise paragraphs (c)(4), (d)(3), and (d)(5) to read as follows: ■ § 150.110 Fruit butter. ddrumheller on DSK120RN23PROD with PROPOSALS1 * * * * * (c) * * * (4) Salt or salt substitute. * * * * * (d) * * * (3) The soluble solids content of the finished fruit butter is not less than 43 percent, as determined by AOAC Official Method 932.12 (incorporated by reference, see § 150.10). * * * * * (5) The weight of fruit juice or diluted fruit juice or concentrated fruit juice (optional ingredient, paragraph (c)(6) of this section) from a fruit specified in paragraph (b)(1) of this section is the weight of such juice, as determined by the method prescribed in paragraph (d)(2) of this section, except that the percent of soluble solids is determined by AOAC Official Method 932.14C, under Solids in Syrups (incorporated by reference, see § 150.10); the weight of diluted concentrated juice from any other fruits is the original weight of the juice before it was diluted or concentrated. * * * * * PART 155—CANNED VEGETABLES 68. The authority citation for part 155 continues to read as follows: ■ Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379(e). 69. Add § 155.10 to subpart A to read as follows: ■ VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 § 155.10 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration (FDA) and at the National Archives and Records Administration (NARA). Contact FDA’s Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from AOAC INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 20850–3250, 1–800–379– 2622. (a) Official Methods of Analysis, 21st Ed. (2019); (1) Table 1, ‘‘Nominal Dimensions of Standard Test Sieves (USA Standard Series),’’ under the heading ‘‘Definition of Terms and Explanatory Notes’’; IBR §§ 155.120(b); 155.130(b). (2) AOAC Official Method 938.10, Solids (Alcohol-Insoluble) in Canned Peas Gravimetric Method; IBR § 155.170(b). (b) [Reserved] ■ 70. In § 155.120, revise paragraphs (a)(3)(i) and (b)(2)(i) to read as follows: § 155.120 Canned green beans and canned wax beans. (a) * * * (3) * * * (i) Salt or salt substitute. * * * * * (b) * * * (2) * * * (i) Determine the gross weight of the container. Open and distribute the contents of the container over the meshes of a U.S. No. 8 circular sieve with openings of 2.36 mm (0.0937 in), which has been previously weighed. The diameter of the sieve is 20.3 cm (8 in) if the quantity of contents of the container is less than 1.36 kg (3 lbs) and 30.5 cm (12 in) if such quantity is 1.36 kg (3 lbs) or more. The bottom of the sieve is woven-wire cloth that complies with the specifications of such cloth set forth in ‘‘Official Methods of Analysis’’, Table 1, ‘‘Nominal Dimensions of Standard Test Sieves (USA Standard Series),’’ under the heading ‘‘Definition of Terms and Explanatory Notes,’’ (incorporated by reference, see § 155.10). Without shifting the material on the sieve, incline the sieve 17° to 20° to facilitate drainage. Two minutes after drainage begins, weigh the sieve and the PO 00000 Frm 00055 Fmt 4702 Sfmt 4702 drained material. Record in grams (ounces) the weight so found, less the weight of the sieve, as the drained weight. Dry and weigh the empty container and subtract this weight from the gross weight to obtain the net weight. Calculate the percent of drained liquid in the net weight. * * * * * ■ 71. In § 155.130, revise paragraphs (a)(3)(i) and (b)(2)(i) to read as follows: § 155.130 Canned corn. (a) * * * (3) * * * (i) Salt or salt substitute. * * * * * (b) * * * (2) * * * (i) Determine the gross weight of the container. Open and distribute the contents of the container over the meshes of a U.S. No. 8 circular sieve, which has previously been weighed. The diameter of the sieve is 20.3 cm. (8 in) if the quantity of the contents of the container is less than 1.36 kg. (3 lbs), and 30.5 cm. (12 in) if such quantity is 1.36 kg. (3 lbs) or more. The bottom of the sieve is woven-wire cloth that complies with the specifications for such sieve set forth in ‘‘Official Methods of Analysis’’, Table 1, ‘‘Nominal Dimensions of Standard Test Sieves (USA Standard Series),’’ under the heading ‘‘Definition of Terms and Explanatory Notes’’ (incorporated by reference, see § 155.10). Without shifting the material on the sieve, so incline the sieve at approximately 17° to 20° angle to facilitate drainage. Two minutes from the time drainage begins, weigh the sieve and the drained material. Record, in grams (ounces), the weight so found, less the weight of the sieve, as the drained weight. Dry and weigh the empty container and subtract this weight from the gross weight to obtain the net weight. Calculate the percent of drained liquid in the net weight. * * * * * ■ 72. In § 155.170, revise paragraph (a)(2)(i), and paragraphs (b)(1)(iii) and (vi) to read as follows: § 155.170 Canned peas. (a) * * * (2) * * * (i) Salt or salt substitute. * * * * * (b) * * * (1) * * * * * * * * (iii) Seriously blemished peas. Not more than 1 percent of the drained weight is seriously blemished peas, i.e., peas that are hard, shriveled, spotted, E:\FR\FM\10APP1.SGM 10APP1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules discolored, or otherwise blemished to an extent that the appearance or eating quality is seriously affected. * * * * * (vi) Alcohol-insoluble solids. The alcohol-insoluble solids of smooth-skin or substantially smooth-skin peas, such as Alaska-type peas or hybrids having similar characteristics, may not be more than 23.5 percent and, of sweet green wrinkled varieties or hybrids having similar characteristics, not more than 21 percent based on the procedure set forth in tAOAC Official Method 938.10(incorporated by reference, see § 155.10). * * * * * ■ 73. In § 155.190, revise paragraph (a)(2)(iv) to read as follows: § 155.190 Canned tomatoes. (a) * * * (2) * * * (iv) Salt or salt substitute. * * * * * ■ 74. In § 155.191, revise paragraph (a)(2)(i) to read as follows: § 155.191 (a) * * * (2) * * * (i) Salt or salt substitute (sodium chloride formed during acid neutralization shall be considered added salt). * * * * * ■ 75. In § 155.194, revise paragraph (a)(1)(iv) to read as follows: ddrumheller on DSK120RN23PROD with PROPOSALS1 § 155.194 Catsup. (a) * * * (1) * * * (iv) The liquid obtained from the residue from partial extraction of juice from such tomatoes. Such liquid is strained so as to exclude skins, seeds, and other coarse or hard substances in accordance with current good manufacturing practice. Prior to straining, food-grade hydrochloric acid may be added to the tomato material in an amount to obtain a pH no lower than 2.0. Such acid is then neutralized with food-grade sodium hydroxide so that the treated tomato material is restored to a pH of 4.2 ± 0.2. The final composition of the food may be adjusted by concentration and/or by the addition of water. The food may contain salt or salt substitute (sodium chloride formed during acid neutralization shall be considered added salt) and is seasoned with ingredients as specified in paragraph (a)(2) of this section. The food is preserved by heat sterilization (canning), refrigeration, or freezing. When sealed in a container to be held at ambient temperatures, it is so VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 processed by heat, before or after sealing, as to prevent spoilage. * * * * * ■ 76. In § 155.200, revise paragraph (c)(4)(i) to read as follows: Authority: 21 U.S.C. 321, 341, 343, 348, 371. § 155.200 Certain other canned vegetables. § 158.170 81. In § 158.170, revise paragraphs (a)(1)(iv) and (b)(1)(iii) to read as follows: ■ Frozen peas. (a) * * * (3) * * * (i) Salt or salt substitute. * * * * * (a) * * * (1) * * * (iv) Salt or salt substitute. * * * * * (b) * * * (1) * * * (iii) Not more than 2 percent by weight seriously blemished peas, i.e., peas that are hard, shriveled, spotted, discolored or otherwise blemished to an extent that the appearance or eating quality is seriously affected. * * * * * PART 156—VEGETABLE JUICES PART 161—FISH AND SHELLFISH ■ 78. The authority citation for part 156 continues to read as follows: ■ Authority: 21 U.S.C. 321, 341, 343, 348, 371. Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e. 79. In § 156.145, revise paragraph (a)(1) to read as follows: ■ § 156.145 Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration (FDA) and at the National Archives and Records Administration (NARA). Contact FDA’s Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. For information on the availability of this material at NARA, visitn www.archives.gov/federal-register/cfr/ ibr-locations or email fr.inspection@ nara.gov. The material may be obtained from AOAC INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 20850–3250, 1–800–379– 2622. (a) Official Methods of Analysis, 21st Ed. (2019); (1) Table 1, ‘‘Nominal Dimensions of Standard Test Sieves (USA Standard Series),’’ under the heading ‘‘Definition of Terms and Explanatory Notes’’; IBR §§ 161.145(c); 161.173(c); 161.190(a)(7). (2) [Reserved] (b) [Reserved] ■ 84. In § 161.145, revise paragraphs (a)(1) and (c)(3) to read as follows: * * * * * (c) * * * (4) * * * (i) Salt or salt substitute. * * * * * ■ 77. In § 155.201, revise paragraph (a)(3)(i) to read as follows: § 155.201 Canned mushrooms. ■ Tomato concentrates. 21169 Tomato juice. (a) * * * (1) Definition. Tomato juice is the food intended for direct consumption, obtained from the unfermented liquid extracted from mature tomatoes of the red or reddish varieties of Lycopersicum esculentum P. Mill, with or without scalding followed by draining. In the extraction of such liquid, heat may be applied by any method which does not add water thereto. Such juice is strained free from peel, seeds, and other coarse or hard substances, but contains finely divided insoluble solids from the flesh of the tomato in accordance with current good manufacturing practice. Such juice may be homogenized, may be seasoned with salt or salt substitute, and may be acidified with any safe and suitable organic acid. The juice may have been concentrated and later reconstituted with water and/or tomato juice to a tomato soluble solids content of not less than 5.0 percent by weight as determined by the method prescribed in § 156.3(b). The food is preserved by heat sterilization (canning), refrigeration, or freezing. When sealed in a container to be held at ambient temperatures, it is so processed by heat, before or after sealing, as to prevent spoilage. * * * * * PART 158—FROZEN VEGETABLES 80. The authority citation for part 158 continues to read as follows: ■ PO 00000 Frm 00056 Fmt 4702 Sfmt 4702 82. The authority citation for part 161 continues to read as follows: 83. Add § 161.10 to read as follows: § 161.10 § 161.145 Incorporation by reference. Canned oysters. (a) * * * (1) Canned oysters is the food prepared from one or any mixture of two or all of the forms of oysters E:\FR\FM\10APP1.SGM 10APP1 21170 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules specified in paragraph (a)(2) of this section, and a packing medium of water, or the watery liquid draining from oysters before or during processing, or a mixture of such liquid and water. The food may be seasoned with salt or salt substitute. It is sealed in containers and so processed by heat as to prevent spoilage. * * * * * (c) * * * (3) Drained weight is determined by the following method: Keep the unopened canned oyster container at a temperature of not less than 68 °F or more than 95 °F for at least 12 hours immediately preceding the determination. After opening, tilt the container so as to distribute its contents evenly over the meshes of a circular sieve that has been previously weighed. The diameter of the sieve is 8 inches if the quantity of the contents of the container is less than 3 pounds and 12 inches if such quantity is 3 pounds or more. The bottom of the sieve is wovenwire cloth that complies with the specifications for such cloth set forth under ‘‘2.36 mm (No. 8)’’ in ‘‘Official Methods of Analysis,’’ Table 1, ‘‘Nominal Dimensions of Standard Test Sieves (USA Standard Series),’’ under the heading ‘‘Definition of Terms and Explanatory Notes,’’ (incorporated by reference, see § 161.10). Without shifting the material on the sieve, so incline the sieve as to facilitate drainage. Two minutes from the time drainage begins, weigh the sieve and the drained oysters. The weight so found, less the weight of the sieve, shall be considered to be the drained weight of the oysters. * * * * * ■ 85. In § 161.170, revise paragraph (a)(4)(i) to read as follows: § 161.170 Canned Pacific salmon. (a) * * * (4) * * * (i) Salt or salt substitute. * * * * * ■ 86. In § 161.173, revise paragraphs (a)(4)(i) and (c)(1) to read as follows: ddrumheller on DSK120RN23PROD with PROPOSALS1 § 161.173 Canned wet pack shrimp in transparent or nontransparent containers. (a) * * * (4) * * * (i) Salt or salt substitute. * * * * * (c) * * * (1) The standard of fill of transparent or nontransparent containers for canned wet pack shrimp is a fill such that the cut-out weight of shrimp taken from each container is not less than 60 percent of the weight of the water VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 required to fill the container. The weight of the water required to fill the container is determined by the general method provided in § 130.12(a) of this chapter. Cut-out weight is determined by the following method: Keep the unopened canned shrimp container at a temperature of not less than 68 °F nor more than 75 °F for at least 12 hours immediately preceding the determination. After opening, distribute the shrimp evenly over the meshes of a circular sieve that has been previously weighed. The diameter of the sieve is 20.3 centimeters (8 inches) if the quantity of the contents of the container is less than 1.36 kilograms (3 pounds), and 30.5 centimeters (12 inches) if such quantity is 1.36 kilograms (3 pounds) or more. The bottom of the sieve is wovenwire cloth that complies with the specifications for such cloth set forth as a 2.36 mm (No. 8) sieve in ‘‘Official Methods of Analysis’’ (incorporated by reference, see § 161.10), Table 1, ‘‘Nominal Dimensions of Standard Test Sieves (USA Standard Series), under the heading ‘‘Definition of Terms and Explanatory Notes’’ (incorporated by reference, see § 161.10) Without shifting the material on the sieve, incline the sieve at an angle of approximately 17° to 20° to facilitate drainage. Allow the shrimp to drain for 2 minutes, measured from the moment the product is poured onto the sieve. Weigh the sieve and the drained shrimp. The weight so found, less the weight of the sieve, shall be considered to be the cut-out weight of the shrimp. * * * * * ■ 87. In § 161.190, revise paragraphs (a)(6)(i) and (a)(7) introductory text to read as follows: § 161.190 Canned tuna. (a) * * * (6) * * * (i) Salt or salt substitute. * * * * * (7) For determination of the color designations specified in paragraph (a)(4) of this section, the following method shall be used: Recombine the separations of pressed cake resulting from the method prescribed in paragraph (c)(2) of this section. Pass the combined portions through a sieve fitted with woven-wire cloth of 1⁄4-inch mesh complying with the specifications for such cloth set forth in ‘‘Official Methods of Analysis’’, Table 1, ‘‘Nominal Dimensions of Standard Test Sieves (USA Standard Series),’’ under the heading ‘‘Definitions of Terms and Explanatory Notes’’ (incorporated by reference, see § 161.10) Mix the sieved material and place a sufficient quantity PO 00000 Frm 00057 Fmt 4702 Sfmt 4702 into a 307 × 113 size container (bearing a top seam and having a false bottom approximately 1⁄2-inch deep and painted flat black inside and outside) so that after tamping and smoothing the surface of the sample the material will be 1⁄8inch to 1⁄4-inch below the top of the container. Within 10 minutes after sieving through the 1⁄4-inch mesh woven-wire cloth, determine the Munsell value of sample surface. * * * * * PART 163—CACAO PRODUCTS 88. The authority citation for part 163 continues to read as follows: ■ Authority: 21 U.S.C. 321, 331, 341, 343, 348, 371, 379e. 89. In § 163.111, revise paragraph (b)(6) to read as follows: ■ § 163.111 Chocolate liquor. * * * * * (b) * * * (6) Salt or salt substitute. * * * * * ■ 90. In § 163.112, revise paragraph (b)(4) to read as follows: § 163.112 Breakfast cocoa. * * * * * (b) * * * (4) Salt or salt substitute. * * * * * ■ 91. In § 163.123, revise paragraph (b)(3) to read as follows: § 163.123 Sweet chocolate. * * * * * (b) * * * (3) Spices, natural and artificial flavorings, ground whole nut meats, ground coffee, dried malted cereal extract, salt or salt substitute, and other seasonings that do not either singly or in combination impart a flavor that imitates the flavor of chocolate, milk, or butter; * * * * * ■ 92. In § 163.124, revise paragraph (b)(4) to read as follows: § 163.124 White chocolate. * * * * * (b) * * * (4) Spices, natural and artificial flavorings, ground whole nut meats, ground coffee, dried malted cereal extract, salt or salt substitute, and other seasonings that do not either singly or in combination impart a flavor that imitates the flavor of chocolate, milk, or butter; * * * * * ■ 93. In § 163.130, revise paragraph (b)(3) to read as follows: E:\FR\FM\10APP1.SGM 10APP1 Federal Register / Vol. 88, No. 68 / Monday, April 10, 2023 / Proposed Rules § 163.130 Milk chocolate. * * * * * (b) * * * (3) Spices, natural and artificial flavorings, ground whole nut meats, ground coffee, dried malted cereal extract, salt or salt substitute, and other seasonings that do not either singly or in combination impart a flavor that imitates the flavor of chocolate, milk, or butter; PART 166—MARGARINE 94. The authority citation for part 166 continues to read as follows: ■ Authority: 21 U.S.C. 321, 341, 343, 347, 348, 371, 379e. 95. In § 166.110, revise paragraphs (a) and (b)(2) to read as follows: ■ § 166.110 Margarine. ddrumheller on DSK120RN23PROD with PROPOSALS1 (a) Description. Margarine (or oleomargarine) is the food in plastic form or liquid emulsion, containing not less than 80 percent fat determined by the method prescribed in AOAC Official Method 938.06A. AOAC Official Method 938.06A, ‘‘Indirect Method, under Fat in Butter,’’ found in ‘‘Official Methods of Analysis of AOAC INTERNATIONAL,’’ 21st Ed. (2019), is incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration (FDA) and the National Archives and Records Administration (NARA). Contact the FDA at FDA’s Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240– 402–7500. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/ cfr/ibr-locations or email fr.inspection@ nara.gov. This material is available from VerDate Sep<11>2014 16:51 Apr 07, 2023 Jkt 259001 21171 AOAC INTERNATIONAL, 2275 Research Blvd., Suite 300, Rockville, MD 20850–3250, 1–800–379–2622. Margarine contains only safe and suitable ingredients, as defined in § 130.3(d) of this chapter. It is produced from one or more of the optional ingredients in paragraph (a)(1) of this section, and one or more of the optional ingredients in paragraph (a)(2) of this section, to which may be added one or more of the optional ingredients in paragraph (b) of this section. Margarine contains vitamin A as provided for in paragraph (a)(3) of this section. * * * * * (b) * * * (2) Salt (sodium chloride) or salt substitute; potassium chloride for dietary margarine or oleomargarine. * * * * * (1) Salt or salt substitute. * * * * ■ 99. In § 168.160, revise paragraph (b)(1) to read as follows: PART 168—SWEETENERS AND TABLE SIRUPS ■ 96. The authority citation for part 168 continues to read as follows: Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e. Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e. ■ 97. In § 168.130, revise paragraph (b)(1) to read as follows: § 169.140 ■ ■ § 168.130 Cane sirup. * * * * * (b) * * * (1) Salt or salt substitute. * * * * * ■ 98. In § 168.140, revise the first sentence of paragraph (a) and paragraph (b)(1) to read as follows: § 168.140 Maple sirup. (a) Maple sirup is the liquid food derived by concentration and heat treatment of the sap of the maple tree (Acer) or by solution in water of maple sugar (maple concrete) made from such sap. * * * (b) * * * PO 00000 Frm 00058 Fmt 4702 Sfmt 9990 * § 168.160 Sorghum sirup. * * * * * (b) * * * (1) Salt or salt substitute. * * * * * ■ 100. In § 168.180, revise paragraph (b)(7) to read as follows: § 168.180 Table sirup. * * * * * (b) * * * (7) Salt or salt substitute. * * * * * PART 169—FOOD DRESSINGS AND FLAVORINGS 101. The authority citation for part 169 continues to read as follows: 102. In § 169.140, revise paragraph (d)(1) to read as follows: Mayonnaise. * * * * * (d) * * * (1) Salt or salt substitute. * * * * * ■ 103. In § 169.150, revise paragraph (e)(1) to read as follows: § 169.150 Salad dressing. * * * * * (e) * * * (1) Salt or salt substitute. * * * * * Dated: March 23, 2023. Robert M. Califf, Commissioner of Food and Drugs. [FR Doc. 2023–06456 Filed 4–7–23; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\10APP1.SGM 10APP1

Agencies

[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Proposed Rules]
[Pages 21148-21171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06456]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 130, 131, 133, 136, 137, 139, 145, 150, 155, 156, 158, 
161, 163, 166, 168, and 169

[Docket No. FDA-2022-N-2226]
RIN 0910-AI72


Use of Salt Substitutes To Reduce the Sodium Content in 
Standardized Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
amend our standard of identity (SOI) regulations that specify salt 
(sodium chloride) as a required or optional ingredient to permit the 
use of salt substitutes in standardized foods, to reduce the sodium 
content. Reducing sodium may help reduce the risk of hypertension, a 
leading cause of heart disease and stroke. The proposed rule, if 
finalized, would help support a healthier food supply by providing 
flexibility to facilitate industry innovation in the production of 
standardized foods lower in sodium while maintaining the basic nature 
and essential characteristics of the foods.

DATES: Either electronic or written comments on the proposed rule must 
be submitted by August 8, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 8, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets

[[Page 21149]]

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.''
    Instructions: All submissions received must include the Docket No. 
FDA-2022-N-2226 for ``Use of Salt Substitutes to Reduce the Sodium 
Content in Standardized Foods.'' Received comments will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov 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 https://www.regulations.gov. 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: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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.

FOR FURTHER INFORMATION CONTACT: Andrew Yeung, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2371 or Carrol Bascus, 
Center for Food Safety and Applied Nutrition, Office of Regulations and 
Policy (HFS-024), Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Acronyms
III. Background
    A. Introduction
    B. Need for the Regulation
    C. FDA's Current Regulatory Framework
IV. Legal Authority
V. Description of the Proposed Rule
    A. Scope/Applicability
    B. The Basic Nature and Essential Characteristics of a 
Standardized Food
    C. Definition of Salt Substitute
    D. Amending Standard of Identity Regulations To Permit Salt 
Substitutes
    E. Update Incorporation by Reference
    F. Technical Amendments
VI. Proposed Effective/Compliance Dates
VII. Preliminary Economic Analysis of Impacts
    A. Economic Analysis of Impacts
    B. Initial Small Entity Analysis
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Proposed Rule

    This proposed rule, if finalized, would amend FDA's definitions and 
standards of identity (SOI; the acronym is used to refer to both the 
singular ``standard of identity'' and the plural ``standards of 
identity'') that specify salt (sodium chloride) as a required or 
optional ingredient. Foods for which FDA has established a SOI are 
referred to as ``standardized'' foods. The amendments would permit the 
use of safe and suitable salt substitutes to replace some or all of the 
salt used in the manufacture of standardized foods. The proposed rule 
would not list specific salt substitutes; instead, the proposed rule 
would cover ingredients or combinations of ingredients used as salt 
substitutes by food manufacturers currently or in the future. If 
finalized, the proposed rule would support efforts to reduce sodium 
content in standardized foods and may help to improve consumer dietary 
patterns by reducing sodium consumption. On average Americans consume 
50% more sodium than the recommended limit for those aged 14 and older 
(Ref. 1). Reducing sodium consumption may help reduce the risk of 
hypertension, a leading cause of heart disease and stroke. The proposed 
rule would allow food manufacturers the flexibility to use salt 
substitutes and allow for innovation in producing healthier 
standardized foods. The proposed rule would promote honesty and fair 
dealing in the interest of consumers by accommodating their preferences 
for lower sodium varieties of foods. This, in turn, would make lower-
sodium options available to them.

B. Summary of the Major Provisions of the Proposed Rule

    FDA is proposing to amend its SOI that specify salt as a required 
or optional ingredient to permit the use of safe and suitable salt 
substitutes in standardized foods, to reduce the sodium content. We 
propose to amend our regulation entitled ``Food Standards: General'' 
(21 CFR part 130) to create a new subpart C entitled ``Flexibility in 
Standardized Foods'' and add a new section entitled ``Ingredient 
Flexibility in Standardized Foods'' to define salt substitute. We also 
propose to amend 80 SOI to permit salt substitutes.
    We also propose to update the incorporation by reference (IBR) 
information of several SOI to refer to the most recent versions of the 
IBR materials and to provide up-to-date contact information for 
obtaining the IBR materials. For example, the proposed rule would 
update the referenced methods of analysis to those in the ``Official 
Methods of Analysis of AOAC INTERNATIONAL,'' 21st Ed. 2019. We also 
propose to make technical amendments to correct inconsistencies and 
typographical errors in some SOI regulations.
    We tentatively conclude that the proposed amendments are necessary 
to modernize SOI to provide flexibility and facilitate innovation in 
the production of standardized foods with less sodium, and to promote 
honesty and fair dealing in the interest of consumers.

C. Legal Authority

    We are proposing this rule consistent with our authority in 
sections 201, 401, 402, 409, and 701 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 321, 341, 342, 348, 371). We

[[Page 21150]]

discuss our legal authority in greater detail in section IV.

D. Costs and Benefits

    The proposed rule would amend SOI that specify salt as a required 
or optional ingredient, to permit the use of salt substitutes. The 
proposed rule would give manufacturers the flexibility to use salt 
substitutes in standardized foods, to reduce sodium content. If 
finalized, the proposed rule would not result in regulatory costs for 
firms. The proposal would not require manufacturers to replace salt 
with salt substitutes. Instead, manufacturers would have the option of 
using salt substitutes to replace salt in standardized foods. Should 
manufacturers choose to use this flexibility to reformulate some 
products by substituting some salt with salt substitutes, the primary 
benefits realized would result from lower sodium consumption by U.S. 
consumers who choose to purchase and consume the reformulated versions 
of such products, and increased profit (producer surplus) for 
manufacturers (or at least no decrease in profits). The primary cost of 
such voluntary market behavior would include reformulation and 
relabeling costs for the manufacturers.

II. Table of Abbreviations/Acronyms

------------------------------------------------------------------------
          Abbreviation/acronym                    What it means
------------------------------------------------------------------------
CDRR...................................  Chronic Disease Risk Reduction
                                          Intake
CFR....................................  Code of Federal Regulations
FD&C Act...............................  Federal Food, Drug, and
                                          Cosmetic Act
FDA....................................  Food and Drug Administration
FR.....................................  Federal Register
GRAS...................................  Generally Recognized as Safe
IBR....................................  Incorporation by Reference
mg.....................................  Milligram
SOI....................................  Standard(s) of Identity
U.S.C..................................  United States Code
------------------------------------------------------------------------

III. Background

A. Introduction

    As a public health agency, FDA seeks to improve dietary patterns in 
the United States to help reduce the burden of diet-related chronic 
diseases and advance health equity as nutrition-related chronic 
diseases are experienced disproportionately by certain racial and 
ethnic minority groups, those living in rural communities, and those 
with lower socioeconomic status. We are committed to accomplishing 
this, in part, by creating a healthier food supply for all. One way FDA 
is working towards this goal is by helping to reduce sodium across the 
food supply.
    Americans consume, on average, 3,400 milligrams of sodium per day 
(mg/day) (Ref. 1). This is nearly 50 percent more than the sodium 
Chronic Disease Risk Reduction Intake (CDRR) established by the 
National Academies of Sciences, Engineering and Medicine, which sets 
the limit for sodium for individuals 14 years and older at 2,300 mg/
day. This CDRR was adopted as a recommendation by the Dietary 
Guidelines for Americans, 2020-2025 (Refs. 1 and 2). Reducing sodium 
intake to below the CDRR level is expected to help reduce the risk of 
chronic disease. Excess sodium intake increases risk for hypertension, 
commonly referred to as high blood pressure, a leading cause of heart 
disease and stroke and the first and fifth leading cause of mortality 
in 2020 in the United States (Refs. 2-6). Decreasing sodium intake is, 
therefore, expected to reduce the rate of hypertension. It has been 
estimated that sufficient reductions in the population average sodium 
intake could potentially result in tens of thousands fewer cases of 
heart disease and stroke and associated mortality each year (Refs. 7-
9).
    Reducing sodium in processed, packaged and prepared foods will help 
create a healthier food supply. A healthier food supply has the 
potential to contribute to better health outcomes and reduce 
preventable death and disease related to poor nutrition; many of which 
are experienced at higher rates by certain racial and ethnic groups 
(Ref. 10). For example, more than 4 in 10 American adults have 
hypertension and that number increases to nearly 6 in 10 for non-
Hispanic Black Americans (Ref. 11). African American women are almost 
60 percent more likely to have hypertension when compared to non-
Hispanic white women, and African American adults are 30% more likely 
than non-Hispanic white Americans to die from coronary heart disease 
(CHD) (Refs. 12 and 13); further, American Indians/Alaskan Natives are 
50% more like to be diagnosed with CHD than non-Hispanic Whites (Ref. 
13). The proposed rule's likely effect on increasing the availability 
of lower sodium products may contribute to government-wide efforts to 
reduce health disparities.
    Reducing sodium in processed, packaged and prepared food is a 
critical step in helping to improve consumer dietary patterns. More 
than 70 percent of sodium consumed in the United States comes from 
sodium added during manufacturing and commercial food preparation (Ref. 
14). This makes it challenging for consumers to reduce their sodium 
consumption. Further, because salt (sodium chloride) serves various 
functions in processed, packaged, and prepared foods, industry must 
balance sodium reduction efforts while manufacturing products that 
maintain the properties of a certain food and still meet the 
preferences of consumers.
    FDA is engaged in several efforts aimed at encouraging gradual, 
efficient reduction of overall sodium content in processed, packaged 
and prepared food products. We recently issued two guidance documents 
for industry to support voluntary industry efforts to reduce sodium in 
the food supply and facilitate industry innovation toward creating 
healthier foods. The December 2020 guidance for industry entitled ``The 
Use of an Alternate Name for Potassium Chloride in Food Labeling'' 
(Potassium Chloride guidance) (Ref. 15) sets forth FDA's enforcement 
discretion policy with respect to declaring potassium chloride as 
``potassium salt'' in the ingredient statement in the labeling of food 
products. In October 2021, we issued guidance for industry entitled 
``Voluntary Sodium Reduction Goals: Target Mean and Upper Bound 
Concentrations for Sodium in Commercially Processed, Packaged, and 
Prepared Foods'' (Voluntary Sodium Reduction Goals guidance) (Ref. 16). 
The guidance document finalizes the short-term (2.5 year) voluntary 
sodium reduction targets in over 160 categories of packaged and 
restaurant prepared food. These short-term targets are based on a 
reduction of average sodium intake from current levels of 3,400 mg/day 
to 3,000 mg/day, and they serve as initial benchmarks for a broad and 
gradual reduction of sodium in the food supply (Ref. 16 and 17). 
Through the two guidance documents and this rulemaking, our intent is 
to support the gradual reduction of sodium across the food supply.
    Under our authority in section 401 of the FD&C Act, FDA establishes 
SOI to promote honesty and fair dealing in the interest of consumers. 
SOI are established under the common or usual name of a food. Such 
foods are said to be ``standardized.'' SOI define the food and 
typically provide the types of ingredients that it must contain (i.e., 
mandatory ingredients) and that it may contain (i.e., optional 
ingredients). They sometimes specify the amount or proportion of each 
ingredient. Many SOI also designate methods of production. We have over 
250 SOI for a wide variety of food products.

[[Page 21151]]

B. Need for the Regulation

    Salt substitutes are ingredients that can help reduce sodium in 
processed, packaged and prepared foods. Food manufacturers wishing to 
reduce salt in their products to accommodate consumer preferences or 
for other reasons sometimes use substitute ingredients that provide 
similar taste and other technical functions of salt in foods. Most of 
our SOI that include salt as a required or optional ingredient do not 
permit the use of salt substitutes. Therefore, food manufacturers are 
currently precluded from using salt substitutes in the production of 
these standardized foods. However, manufacturers may use salt 
substitutes in the production of non-standardized foods. Various 
stakeholders have expressed concern that many SOI are out of date and 
may impede innovation, including the ability to produce healthier foods 
(Ref. 18). Manufacturers seeking to reduce sodium in standardized foods 
are limited because they are unable to produce foods using salt 
substitutes and still conform to the SOI. In this way, the SOI may 
become a barrier to innovation.
    Permitting the use of salt substitutes is aligned with FDA's goal 
to reduce sodium across the food supply and our work to reduce sodium 
consumption. Research suggests that consumers usually do not notice 
small reductions in sodium and, over time, consumer palates adjust to 
lower sodium levels (Ref. 19). Through our work on the Voluntary Sodium 
Reduction Goals guidance and the Potassium Chloride guidance, we 
learned that stakeholders, including industry, consumers, consumer 
advocacy, scientific and professional health organizations, generally 
support allowing the use of salt substitutes. In another public 
engagement, some stakeholders discussed modernizing SOI to allow the 
use of salt substitutes using a ``horizontal approach'' (Ref. 18). A 
horizontal approach to amending standards is a change that could be 
made across all, or broad categories of SOI to provide flexibility and 
facilitate innovation in the production of more nutritious foods. We 
considered several options for permitting salt substitutes in 
standardized foods and evaluated how to apply this change across 
multiple SOI. The proposed rule, if finalized, would adopt a horizontal 
approach to amending the applicable SOI. The proposed rule would permit 
the use of salt substitutes in SOI that specify salt as a required or 
optional ingredient, to reduce sodium in the food. Because the use of 
salt substitutes in these SOI is currently precluded, any use of salt 
substitutes by manufacturers under the rule would contribute to reduced 
sodium intake to some degree.
    Permitting the use of salt substitutes in standardized foods would 
contribute to our goal to reduce sodium across the food supply. It 
would facilitate voluntary industry efforts toward sodium reduction by 
providing flexibility and supporting innovation in the production of 
healthier standardized foods, which may help some consumers to 
gradually reduce the sodium in their diet and contribute to better 
health outcomes. The proposed rule may have the potential to contribute 
to government-wide efforts to reduce health disparities if the use of 
salt substitutes helps populations disproportionately affected by 
hypertension to consume less sodium.

C. FDA's Current Regulatory Framework

    The FD&C Act gives us the authority to establish definitions and 
standards for foods with respect to identity, quality, and fill of 
container (21 U.S.C. 341). SOI specify the permitted ingredients, both 
mandatory and optional, and sometimes describe the amount or proportion 
of each ingredient. Many SOI also prescribe a method of production or 
formulation. Foods for which FDA has established a SOI must conform to 
the applicable definition and standard. A food is misbranded if it 
purports to be or is represented as a food for which a SOI has been 
established but fails to conform to the definition and standard (21 
U.S.C. 343(g)).
    SOI are codified in parts 130 to 169 (21 CFR parts 130 to 169). 
Part 130 outlines general provisions, including the use of food 
additives in food standards. Part 130 also includes the general 
definition and SOI (i.e., Sec.  130.10). Parts 131 to 169 set forward 
SOI for foods in 21 food product categories.
    We have long interpreted the term ``salt'' in the food standards in 
parts 131 to 169 to refer to sodium chloride. Salt is specified as a 
required or optional ingredient in 80 SOI across these parts. Some SOI 
cross reference other SOI. For example, in part 136 (21 CFR part 136), 
salt is an optional ingredient in the SOI for bread, rolls, and buns 
(Sec.  136.110) which is referenced in several other SOI, including: 
enriched bread, rolls, and buns (Sec.  136.115), milk bread, rolls, and 
buns (Sec.  136.130), raisin bread, rolls, and buns (Sec.  136.160), 
and whole wheat bread, rolls, and buns (Sec.  136.180). The result of 
such cross referencing is that salt is a required or an optional 
ingredient in 140 SOI.
    Manufacturers of standardized foods have few options for reducing 
the sodium content of their products. If salt is a required ingredient, 
they may generally use less salt. If salt is an optional ingredient, 
they may either use no salt or less salt. However, they cannot replace 
salt with another ingredient unless the standard permits the use of 
another ingredient. Most SOI do not provide for a substitute for salt. 
In some instances, we established separate SOI for low sodium foods, 
thereby allowing manufacturers to reduce the amount of salt used and to 
substitute other ingredients. Manufacturers may also modify the sodium 
content of standardized foods under the general definition and SOI in 
Sec.  130.10 (Requirements for foods named by use of a nutrient content 
claim and a standardized item), provided that certain conditions are 
met.
    Deviation from a SOI is permitted under the general definition and 
SOI in Sec.  130.10. The deviation must be due to a modification 
described by an expressed nutrient content claim defined by regulation. 
Expressed nutrient content claims for the sodium content of foods 
(e.g., ``low sodium'') are provided under Sec.  101.61 (21 CFR 101.61) 
(Nutrient content claims for the sodium content of foods). Thus, sodium 
modifications to a standardized food are permitted if the modification 
meets the requirements for a nutrient content claim under Sec.  101.61. 
The modified food becomes a new standardized food under Sec.  130.10 
and is named with the nutrient content claim and the name of the 
standardized food from which it deviates (e.g., ``low sodium provolone 
cheese''). It may be impracticable for manufacturers to reduce the 
sodium content in standardized foods to the extent required by a 
nutrient content claim. For example, to meet the requirements for a 
``reduced sodium'' nutrient content claim, manufacturers must decrease 
the sodium in the food by at least 25 percent. Certain foods do not 
retain the same characteristics when the amount of sodium is reduced to 
this degree, and therefore, the general definition and SOI does not 
facilitate the production of lower sodium varieties. This proposed rule 
would allow manufacturers to reduce the sodium in standardized foods in 
amounts less than the amounts prescribed in Sec.  101.61. This would 
provide manufacturers greater flexibility when reformulating 
standardized foods to lower the sodium content.
    Presently, three SOI specifically permit the use of a salt 
substitute. The SOI for low sodium cheddar cheese (Sec.  133.116) and 
low sodium colby

[[Page 21152]]

cheese (Sec.  133.121) permit the use of a salt substitute. The SOI for 
low sodium colby cheese prohibits the use of salt and permits the use 
of a salt substitute that contains no sodium (Sec.  133.121(a)). The 
SOI for margarine (Sec.  166.110) specifically permits the use of 
potassium chloride in the manufacture of dietary margarine. Potassium 
chloride, in some instances, can be used as a partial substitute for 
sodium chloride in food processing and manufacturing.
    If finalized, the proposed rule would provide a new means for 
manufacturers to reduce the sodium content of standardized foods. Salt 
substitutes would be permitted in any food for which an SOI has been 
established and that specifies salt as a required or an optional 
ingredient. This would be achieved without requiring the minimum 
reductions in sodium content under Sec.  101.61 and renaming of food 
products as is required for modifications under Sec.  130.10.

IV. Legal Authority

    We are issuing this proposed rule consistent with our authority in 
sections 201, 401, 402, 409, and 701of the FD&C Act. Section 401 of the 
FD&C Act 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, standard of quality, or standard 
of fill of container, whenever in the judgment of the Secretary, such 
action will promote honesty and fair dealing in the interest of 
consumers. We tentatively conclude that permitting the use of salt 
substitutes to replace some or all of the salt used in the production 
of standardized foods would promote honesty and fair dealing in the 
interest of consumers. Consumers desire more nutritious and healthy 
food options, such as lower sodium versions of foods. This proposed 
rule, if finalized, would allow for industry development and sale of 
such foods while ensuring that standardized foods meet consumer 
expectations and preferences with respect to lower-sodium varieties.
    FDA has codified food standards in parts 130 to 169. These 
regulations do not provide either an authorization or exemption from 
regulation as a food additive under section 409 of the FD&C Act. The 
FD&C Act defines ``food additive,'' in relevant part, as any substance, 
the intended use of which results or may reasonably be expected to 
result, directly or indirectly, in its becoming a component of food, if 
such substance is not generally recognized by experts as safe under the 
conditions of its intended use (section 201(s) of the FD&C Act). The 
definition of ``food additive'' exempts any uses that are the subject 
of prior sanction (section 201(s)(4) of the FD&C Act)). Food additives 
are deemed unsafe except to the extent that FDA approves their use 
(section 409(a) of the FD&C Act). Food is adulterated when it contains 
an unapproved food additive (section 402(a)(2)(C) of the FD&C Act).
    We also are issuing this proposed rule under section 701(a) of the 
FD&C Act, which authorizes FDA to issue regulations for the efficient 
enforcement of the FD&C Act. Regulations issued under section 701(a) 
``must effectuate a congressional objective expressed elsewhere in the 
Act'' (Association of American Physicians and Surgeons, Inc. v. FDA, 
226 F. Supp. 2d 204 (D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v. FDA, 
484 F. Supp. 1179, 1183 (D. Del. 1980))). Amending SOI to permit the 
use of salt substitutes would effectuate the congressional objective 
``to promote honesty and fair dealing in the interest of consumers'' 
expressed in section 401 of the FD&C Act. Permitting salt substitutes 
in standardized foods under this rule may help provide more options to 
consumers while ensuring that the foods maintain their basic nature and 
essential characteristics. The proposed amendments to the SOI for dairy 
products under parts 131, 133, and 135 are issued under section 701(e) 
of the FD&C Act.

V. Description of the Proposed Rule

    The proposed rule, if finalized, would:
     Amend part 130 to add a new subpart C entitled 
``Flexibility in Standardized Foods.''
     Add a new Sec.  130.30 to provide for ``Ingredient 
Flexibility in Standardized Foods'' and define ``salt substitute'' as a 
safe and suitable ingredient (or combination of ingredients) that is 
used to replace some or all of the added salt (sodium chloride), to 
reduce sodium in the food, and that serves the functions of salt in the 
food.
     Amend the 80 SOI that specify salt as a required or an 
optional ingredient to add regulatory text to permit the use of salt 
substitute, as defined in proposed Sec.  130.30.
     Update the IBR information of several SOI to refer to the 
most recent versions of the IBR materials and to provide up-to-date 
contact information for obtaining the IBR materials. The proposed rule 
would also update the referenced methods of analysis to those in the 
``Official Methods of Analysis of AOAC INTERNATIONAL,'' 21st Ed. 2019.
     Make technical amendments to correct inconsistencies and 
typographical errors in some SOI regulations.

A. Scope/Applicability

    The proposed rule, if finalized, would amend SOI in parts 131 to 
169. Specifically, the proposed rule would permit the use of salt 
substitutes in the foods covered by 80 SOI that include salt as a 
required or an optional ingredient. The proposal would also permit the 
use of salt substitutes in foods covered by SOI that reference some of 
the 80 SOI.
    This rule does not propose to amend the SOI for oysters (Sec.  
161.130). The SOI in Sec.  161.130 provides for the optional use of 
salt water in the shucking of oysters. We understand that it is not 
standard industry practice to constitute a salt and water solution for 
this process. Rather, seawater accessible at the processing location is 
collected and used in the shucking process. Because salt is not an 
ingredient added by the manufacturer, we are not proposing to amend 
this SOI. We request comments on this approach and our understanding of 
current industry practice.

B. The Basic Nature and Essential Characteristics of a Standardized 
Food

    Proposed Sec.  130.30(b) would require that ingredients used as 
salt substitutes do not change the basic nature and essential 
characteristics of the standardized food. FDA previously discussed its 
understanding about the basic nature of a food in a proposed rule 
entitled ``Food Standards; General Principles and Food Standards 
Modernization,'' (70 FR 29214, May 20, 2005). The basic nature of a 
food is generally what the food is. It concerns the general attributes 
of the product. For example, the basic nature of a particular type of 
cheese is that it is a milk-derived food of a certain form and 
consistency. The essential characteristics of a food may contribute to 
achieving the basic nature of the food, but consumers may not be aware 
of the essential characteristics. The essential characteristics of a 
food are those that distinguish a food. Foods may be distinguished by 
their ingredients, compositional characteristics, physical 
characteristics, or levels of certain nutrients or the way they are 
produced--all of which are the essential characteristics of the food. 
For example, the essential characteristics of a particular type of 
cheese may include the bacterial culture used, the processing method, 
or the fat and moisture content that contribute to the unique 
characteristics of that cheese.

[[Page 21153]]

    Use of salt substitutes that do not change the basic nature and 
essential characteristics of the standardized food under this proposed 
rule is necessary to ensure the availability of foods that promote 
honesty and fair dealing in the interest of consumers, in accordance 
with section 401 of the FD&C Act.

C. Definition of Salt Substitute

    Under the FD&C Act, any substance that is intentionally added to 
food is a food additive that is subject to premarket review and 
approval by FDA unless that substance is excluded from the definition 
of a food additive. These excluded food substances include substances 
that are generally recognized, among qualified experts, as having been 
adequately shown to be safe under the conditions of its intended use 
(``generally recognized as safe'' or ``GRAS''), or the substances are 
prior sanctioned and excepted from the definition of a food additive. 
FDA considers salt a common food ingredient that is GRAS for its 
intended use (21 CFR 182.1(a)). A salt substitute that is added to a 
standardized food, to replace some or all of the salt, must be an 
approved food additive or GRAS for its intended use. For example, 
potassium chloride is a GRAS substance (21 CFR 184.1622).
    The proposed rule would amend Sec.  130.30(c)(1) to define salt 
substitute as a safe and suitable ingredient (see Sec.  130.3(d)) or 
combination of ingredients that is used to replace some or all of the 
added salt (sodium chloride), to reduce the sodium in the food, and 
that serves the functions of salt in the food. We are proposing to 
define salt substitute broadly to provide flexibility and facilitate 
innovation in the future without the need for additional rulemaking. 
Thus, the proposed rule would not list specific salt substitutes; 
instead, the proposed rule would cover ingredients or combinations of 
ingredients currently used as salt substitutes and ingredients or 
combinations of ingredients that may be used as salt substitutes in the 
future, as a result of advances in food science and technological 
changes.
    Salt is a required or optional ingredient in a wide range of 
standardized foods. The proposed rule also would allow manufacturers 
the flexibility to explore new ways to replace salt and reduce the 
sodium content of standardized foods while preserving the basic nature 
and essential characteristics of the food.
    We recognize that salt serves various functions in standardized 
foods. For example, depending on the food, salt may be important for 
taste, microbial safety, and other functions. The proposed definition 
would require that the salt substitute be used to replace some or all 
of the added salt, to reduce the sodium in the food, and serve the 
functions of salt in the food. This would ensure that the salt 
substitute performs a similar function to salt in the standardized 
food, while helping to reduce the sodium content. The extent to which 
salt can be replaced depends on the ability of the salt substitute to 
replicate the functions of salt in the food without compromising the 
food's safety and nutritional quality. The proposed rule would not 
establish a minimum replacement level for salt. It would not prescribe 
the sodium content of the foods or any parameters pertaining to the 
production of the food. Manufacturers would determine the level of salt 
replacement appropriate for the particular standardized food.
    Our intent is to provide manufacturers flexibility and facilitate 
sodium reduction across the food supply while not changing the basic 
nature and essential characteristics or adversely affecting the 
nutritional quality and safety of standardized foods. To accomplish 
this, proposed Sec.  130.30(c)(1) would limit the definition of salt 
substitute and therefore the use of salt substitutes to an ingredient 
or a combination of ingredients that serve the functions that salt 
served in the particular standardized food. The ingredient or 
combination of ingredients may include substances intended to mitigate 
the impact of removing salt and are needed to maintain the basic nature 
and essential characteristics of the food.
    Some manufacturers are currently using salt substitutes to reduce 
sodium in foods in the marketplace. Scientific articles and reports 
have used several examples of salt substitutes when discussing sodium 
reduction efforts (Ref. 19, 20, 21). The use of potassium chloride is 
one example of a safe and suitable ingredient discussed in the 
scientific literature that, in some instances, serves as a partial 
substitute for sodium chloride in food processing and manufacturing 
(Ref. 15). Other examples of ingredients listed in the scientific 
literature include herbs and spices, yeast extracts, monosodium 
glutamate, amino acids, and dairy extracts (Ref. 19). The food industry 
is pursuing sodium reduction efforts, including the use of salt 
substitutes (e.g., in products marketed as ``low'' or ``reduced'' 
sodium), in a variety of foods, including in canned fish and soups 
(Ref. 21). We request data and information on the types of salt 
substitutes currently being used in the U.S. market to support sodium 
reduction and on potential salt substitutes that may be used as a 
result of the new flexibility provided in this proposed rule.

D. Amending Standard of Identity Regulations to Permit Salt Substitutes

    We propose to amend our regulations to permit the use of salt 
substitutes in SOI that specify salt as a required or an optional 
ingredient. Foods for which FDA has established a SOI must conform to 
the applicable standard. Consequently, without these amendments, most 
standardized foods cannot be modified to replace salt with salt 
substitutes unless salt can be reduced in sufficient quantity to meet a 
nutrient content claim under Sec.  101.61 (see section III.C). As 
stated previously, amending 80 applicable SOI to permit the use of salt 
substitutes is necessary to give manufacturers the most flexibility to 
use salt substitutes in standardized foods. The proposed rule would 
permit the use of salt, salt substitute or a combination of the two in 
applicable standardized foods. Salt substitutes used would be declared 
on the label in accordance with section 403(i)(2) of the FD&C Act.
    Where salt is permitted in our SOI, the use is not described 
uniformly in the provisions of the standards. This is largely due to 
the standards having been established with different structural 
formats. The lack of uniformity is also due to the use of salt 
differing across different standardized foods. In some foods, salt is a 
mandatory ingredient, and in other foods, salt is an optional 
ingredient. For some foods, salt is permitted at a specific point in 
the manufacturing process, whereas salt is permitted in other foods 
without regard to manufacturing time. These differences mean that 
different amendatory language in the individual standards is necessary 
to permit the use of salt substitutes. To address this, we propose four 
types of revisions to the current regulatory text in the applicable 
SOI.
    In particular, there are differences in how the use of salt is 
prescribed in certain SOI for cheeses and related cheese products in 
part 133 (21 CFR part 133). For example, several SOI for cheeses use 
terms such as ``salted,'' ``salting,'' ``brine,'' or ``salt solution,'' 
to prescribe the application of salt in the cheesemaking process. For 
additional clarity, the proposed amendments for cheeses and related 
cheese products are grouped and discussed separately from other SOI.
    There are 4 types of revisions to the applicable SOI in this 
proposed rule.

[[Page 21154]]

The third and fourth types only apply to SOI in part 133.
     Type 1: When the current text of the SOI lists ``salt'' as 
an optional ingredient, the proposed rule would amend the SOI to state, 
``salt or salt substitute.''
     Type 2: When the current text of the SOI provides for the 
use of ``salt'' in a paragraph, the proposed rule would amend the SOI 
to state, ``salt or salt substitute.''
     Type 3: When the current text of the SOI uses terms such 
as ``salted,'' ``salted with dry salt or brine,'' or ``salting,'' to 
provide for use of salt in the food, but does not specify salt as an 
ingredient, the proposed rule would amend the optional ingredient list 
to add ``salt substitute.''
     Type 4: When the current text of the SOI uses terms such 
as ``salted,'' or ``salted in brine,'' to provide for the use of salt 
in the food, but does not provide a list of optional ingredients, the 
proposed rule would amend the SOI to add a paragraph stating that, 
``During the cheesemaking process, where the curd is salted, salt 
substitute may be used.''
    We summarize these changes in tables 1 and 2.
1. Amendments to SOI not in Part 133
    We propose amendments to permit the use of salt substitutes in 39 
SOI for products that are not cheeses or related cheese products 
prescribed in part 133. The amendments would occur through two types of 
revisions to the current regulatory text of the applicable SOI.
    a. Type 1 revision for SOI not in part 133. Several SOI provide for 
the addition of salt by listing it as an ingredient (e.g., as an 
``optional ingredient,'' ``other optional ingredient,'' or including 
salt in a list of substances that could be added as a seasoning or 
flavoring.) We propose to amend these SOI to permit the addition of a 
salt substitute in addition to, or in place of, salt by replacing 
``salt'' with ``salt or salt substitute.'' For example, the SOI for 
acidified milk (Sec.  131.111(e)(8)) lists ``salt'' under ``other 
optional ingredients;'' the proposed rule would replace ``salt'' with 
``salt or salt substitute.'' As another example, the SOI for canned 
tuna (21 CFR 161.190) includes ``salt'' in a list of seasoning or 
flavoring ingredients (Sec.  161.190 (a)(6)(i)); the proposed rule 
would replace ``salt'' with ``salt or salt substitute.''
    b. Type 2 revision for SOI not in part 133. Five SOI prescribe the 
use of salt in paragraphs that describe the food, rather than as part 
of an ingredient list. We propose to amend these SOI to permit the 
addition of a salt substitute in addition to, or in place of, salt by 
replacing ``salt'' with ``salt or salt substitute'' in the regulatory 
text. For example, the SOI for catsup (21 CFR 155.194) specifies the 
optional use of salt by stating, ``[t]he food may contain salt''; and 
the SOI for self-rising flour (21 CFR 137.180) specifies that the food 
``is seasoned with salt.'' In both examples, we propose to replace 
``salt'' with ``salt or salt substitute.''
    Table 1 summarizes the amendments to the SOI for foods other than 
cheeses and related cheese products. We request comment on whether 
there would be safety concerns, technical infeasibilities, or other 
issues that would prevent the use of a salt substitute in any SOI 
listed in table 1.

    Table 1--Amendments to Definitions and Standards of Identity--Foods Other Than Cheeses and Related Cheese
                                                    Products
----------------------------------------------------------------------------------------------------------------
        CFR section                   Title                     Paragraph                 Type of revision
----------------------------------------------------------------------------------------------------------------
Sec.   131.111              Acidified milk...........  (e)(8)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   131.112              Cultured milk............  (d)(8)                      Type 1; amends salt in other
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   131.160              Sour cream...............  (b)(5)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   131.162              Acidified sour cream.....  (b)(4)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   131.170              Eggnog...................  (e)(2)                      Type 1; amends salt in other
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   136.110              Bread, rolls, and buns...  (c)(4)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   137.180              Self-rising flour........  (a)                         Type 2; amends paragraph that
                                                                                    describes the food to add
                                                                                    salt substitute.
Sec.   137.270              Self-rising white corn     (a)                         Type 2; amends paragraph that
                             meal.                                                  describes the food to add
                                                                                    salt substitute.
Sec.   139.110              Macaroni products........  (a)(4)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   139.150              Noodle products..........  (a)(2)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   145.110              Canned applesauce........  (a)(2)(iii)                 Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   145.130              Canned figs..............  (a)(5)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   150.110              Fruit butter.............  (c)(4)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   155.120              Canned green beans and     (a)(3)(i)                   Type 1; amends salt in
                             canned wax beans.                                      optional ingredients to add
                                                                                    salt substitute.
Sec.   155.130              Canned corn..............  (a)(3)(i)                   Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   155.170              Canned peas..............  (a)(2)(i)                   Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   155.190              Canned tomatoes..........  (a)(2)(iv)                  Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   155.191              Tomato concentrates......  (a)(2)(i)                   Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   155.194              Catsup...................  (a)(1)(iv)                  Type 2; amends paragraph that
                                                                                    describes the food to add
                                                                                    salt substitute.
Sec.   155.200              Certain other canned       (c)(4)(i)                   Type 1; amends salt in
                             vegetables.                                            optional ingredients to add
                                                                                    salt substitute.
Sec.   155.201              Canned mushrooms.........  (a)(3)(i)                   Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   156.145              Tomato juice.............  (a)(1)                      Type 2; amends paragraph that
                                                                                    describes the food to add
                                                                                    salt substitute.
Sec.   158.170              Frozen peas..............  (a)(1)(iv)                  Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   161.145              Canned oysters...........  (a)(1)                      Type 2; amends paragraph that
                                                                                    describes the food to add
                                                                                    salt substitute.
Sec.   161.170              Canned Pacific salmon....  (a)(4)(i)                   Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   161.173              Canned wet pack shrimp in  (a)(4)(i)                   Type 1; amends salt in
                             transparent or                                         optional ingredients to add
                             nontransparent                                         salt substitute.
                             containers.
Sec.   161.190              Canned tuna..............  (a)(6)(i)                   Type 1; amends salt in
                                                                                    seasoning and flavoring
                                                                                    ingredients to add salt
                                                                                    substitute.
Sec.   163.111              Chocolate liquor.........  (b)(6)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   163.112              Breakfast cocoa..........  (b)(4)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   163.123              Sweet chocolate..........  (b)(3)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   163.124              White chocolate..........  (b)(4)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   163.130              Milk chocolate...........  (b)(3)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   166.110              Margarine................  (b)(2)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.

[[Page 21155]]

 
Sec.   168.130              Cane sirup...............  (b)(1)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   168.140              Maple sirup..............  (b)(1)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   168.160              Sorghum sirup............  (b)(1)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   168.180              Table sirup..............  (b)(7)                      Type 1; amends salt in
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   169.140              Mayonnaise...............  (d)(1)                      Type 1; amends salt in other
                                                                                    optional ingredients to add
                                                                                    salt substitute.
Sec.   169.150              Salad dressing...........  (e)(1)                      Type 1; amends salt in other
                                                                                    optional ingredients to add
                                                                                    salt substitute.
----------------------------------------------------------------------------------------------------------------

2. Amendments to SOI in Part 133
    Type 1 and type 2 amendments are also proposed for certain SOI for 
cheeses and related cheese products. We propose type 3 and type 4 
amendments for the several SOI in part 133 that specify salt as an 
ingredient, using terms such as ``brine,'' ``salt brine,'' ``salt 
solution,'' ``salted,'' and ``salting.'' ``Brine,'' ``salt brine,'' and 
``salt solution'' are solutions containing sodium chloride and 
``salted'' and ``salting'' in the manufacture of cheese refer to the 
use of sodium chloride. The proposed rule would provide manufacturers 
of standardized cheeses and related cheese products, the flexibility to 
use salt substitutes to replace some or all of the salt prescribed in 
these processes.
    We propose to permit the use of salt substitutes in 41 SOI for 
cheeses and related cheese products. Some SOI in part 133 list salt 
under ``optional ingredients'' or ``other optional ingredients,'' while 
others vary in how they prescribe the use of salt in the paragraph that 
describes the cheese or cheesemaking process. Because of these 
differences, we propose four types of revisions to the current 
regulatory text of the applicable SOI for cheeses and related cheese 
products.
    a. Type 1 revision for SOI in part 133. Several SOI for cheeses and 
related cheese products provide for the addition of salt by listing it 
as an ingredient (e.g., as an ``optional ingredient'' or ``other 
optional ingredient.'') We propose to amend these SOI to permit the 
addition of salt substitute in addition to, or in place of, salt by 
replacing ``salt'' in the list with ``salt or salt substitute.'' For 
example, the SOI for cold-pack and club cheese lists ``salt'' under 
``optional ingredients'' (Sec.  133.123(c)(3)). The proposed rule would 
replace ``salt'' with ``salt or salt substitute.''
    b. Type 2 revision for SOI in part 133. Five SOI provide for the 
use of salt in paragraphs that describe the cheese, rather than as part 
of an ingredient list. We propose to amend these SOI to permit the 
addition of a salt substitute in addition to, or in place of, salt by 
replacing ``salt'' in the paragraphs with ``salt or salt substitute.'' 
For example, the proposed rule would replace ``salt'' with ``salt or 
salt substitute'' in three paragraphs of the SOI for dry curd cottage 
cheese (Sec.  133.129(b)(1)(i) through (iii)) and in one paragraph of 
the SOI for sap sago cheese (Sec.  133.186 (a)(2)).
    c. Type 3 revision for SOI in part 133. Some SOI for cheeses and 
related cheese products provide for the use of salt in a paragraph that 
describes the cheesemaking process, through terms such as ``salted,'' 
``salted with dry salt or brine,'' or ``salting,'' and do not specify 
salt in a list of ingredients (e.g., as an ``other optional 
ingredient''). We propose to amend these SOI to permit the addition of 
a salt substitute in addition to, or in place of, salt by adding ``salt 
substitute'' as a new subparagraph in the current list of other 
optional ingredients. For example, the SOI for cheddar cheese (Sec.  
133.113(a)(3)) states that ``the curd is salted, stirred, further 
drained, and pressed into forms,'' but does not list salt in the 
optional ingredients in Sec.  133.113(b)(3). The proposed rule would 
amend Sec.  133.113(b)(3) by adding a new subparagraph, ``salt 
substitute'' (proposed Sec.  133.113(b)(3)(vi)).
    d. Type 4 revision for SOI in part 133. Several SOI for cheeses and 
related cheese products provide for the use of salt in a paragraph that 
describes the cheesemaking process through terms such as ``salted'' or 
``salted in brine,'' but do not include a list of ingredients (e.g., 
``optional ingredient'' or ``other optional ingredient'') that could be 
amended to add salt substitute. We propose to amend these SOI to 
explicitly permit the use of a salt substitute in the cheesemaking 
process. For example, the SOI for asiago fresh and asiago soft cheese 
(Sec.  133.102(b)) provides that ``the curd is salted in brine and 
cured in a well-ventilated room,'' but does not have an optional 
ingredient list. The proposed rule would amend this SOI by adding a new 
subparagraph at Sec.  133.102(c)(3) to state, ``During the cheesemaking 
process, where the curd is salted, salt substitute may be used.''
    Table 2 summarizes the amendments to the SOI for cheeses and 
related cheese products. We request comment on whether there would be 
safety concerns, technical infeasibilities, or other issues that would 
prevent the use of salt substitute in any SOI listed in table 2.

   Table 2--Proposed Amendments to Definitions and Standards of Identity--Cheeses and Related Cheese Products
----------------------------------------------------------------------------------------------------------------
                                                                        Revised or added
          CFR section                  Title        Current paragraph      paragraph         Type of revision
                                                                          designation
----------------------------------------------------------------------------------------------------------------
Sec.   133.102.................  Asiago fresh and   (c)..............  (c)(3)...........  Type 4; amends SOI to
                                  asiago soft                                              add a new paragraph
                                  cheese.                                                  to permit salt
                                                                                           substitute.
Sec.   133.106.................  Blue cheese......  (b)(3)...........  (b)(3)(vii)......  Type 3; amends other
                                                                                           optional ingredients
                                                                                           to add new paragraph
                                                                                           to list salt
                                                                                           substitute.
Sec.   133.108.................  Brick cheese.....  (b)(3)...........  (b)(3)(v)........  Type 3; amends other
                                                                                           optional ingredients
                                                                                           to add new paragraph
                                                                                           to list salt
                                                                                           substitute.
Sec.   133.111.................  Caciocavallo       (c)..............  (c)(3)...........  Type 4; amends SOI to
                                  siciliano cheese.                                        add a new paragraph
                                                                                           to permit salt
                                                                                           substitute.

[[Page 21156]]

 
Sec.   133.113.................  Cheddar cheese...  (b)(3)...........  (b)(3)(vi).......  Type 3; amends other
                                                                                           optional ingredients
                                                                                           to add new paragraph
                                                                                           to list salt
                                                                                           substitute.
Sec.   133.118.................  Colby cheese.....  (c)..............  (c)(4)...........  Type 4; amends SOI to
                                                                                           add new paragraph to
                                                                                           permit salt
                                                                                           substitute.
Sec.   133.123.................  Cold-pack and      (c)(3)...........  N/A..............  Type 1; amends salt in
                                  club cheese.                                             optional ingredients
                                                                                           to add salt
                                                                                           substitute.
Sec.   133.124.................  Cold-pack cheese   (e)(3)...........  N/A..............  Type 1; amends salt in
                                  food.                                                    other optional
                                                                                           ingredients to add
                                                                                           salt substitute.
Sec.   133.127.................  Cook cheese, koch  (b)(3)(v)........  N/A..............  Type 1; amends salt in
                                  kaese.                                                   other optional
                                                                                           ingredients to add
                                                                                           salt substitute.
Sec.   133.129.................  Dry curd cottage   (b)(1)(i)-(iii)..  N/A..............  Type 2; amends
                                  cheese.                                                  paragraph that
                                                                                           describes the food to
                                                                                           add salt substitute.
Sec.   133.133.................  Cream cheese.....  (b)(3)(i)........  N/A..............  Type 1; amends salt in
                                                                                           other optional
                                                                                           ingredients to add
                                                                                           salt substitute.
Sec.   133.136.................  Washed curd and    (b)(3)...........  (b)(3)(vi).......  Type 3; amends other
                                  soaked curd                                              optional ingredients
                                  cheese.                                                  to add new paragraph
                                                                                           to list salt
                                                                                           substitute.
Sec.   133.138.................  Edam cheese......  (b)(3)...........  (b)(3)(v)........  Type 3; amends other
                                                                                           optional ingredients
                                                                                           to add new paragraph
                                                                                           to list salt
                                                                                           substitute.
Sec.   133.141.................  Gorgonzola cheese  (b)(3)...........  (b)(3)(vii)......  Type 3; amends other
                                                                                           optional ingredients
                                                                                           to add new paragraph
                                                                                           to list salt
                                                                                           substitute.
Sec.   133.144.................  Granular and       (b)(3)...........  (b)(3)(vi).......  Type 3; amends other
                                  stirred curd                                             optional ingredients
                                  cheese.                                                  to add a new
                                                                                           paragraph to list
                                                                                           salt substitute.
Sec.   133.147.................  Grated American    (c)(5)...........  N/A..............  Type 1; amend salt in
                                  cheese food.                                             other optional
                                                                                           ingredients to add
                                                                                           salt substitute.
Sec.   133.148.................  Hard grating       (c)..............  (c)(1) and (2)...  Type 4; amends SOI to
                                  cheeses.                                                 add a new paragraph
                                                                                           to permit salt
                                                                                           substitute.
Sec.   133.149.................  Gruyere cheese...  (b)(3)...........  (b)(3)(iv).......  Type 3; amends other
                                                                                           optional ingredients
                                                                                           to add a new
                                                                                           paragraph to list
                                                                                           salt substitute.
Sec.   133.150.................  Hard cheeses.....  (c)..............  (c)(3)...........  Type 4; amends SOI to
                                                                                           add a new paragraph
                                                                                           to permit salt
                                                                                           substitute.
Sec.   133.152.................  Limburger cheese.  (b)(3)...........  (b)(3)(iv).......  Type 3; amends other
                                                                                           optional ingredients
                                                                                           to add new paragraph
                                                                                           to list salt
                                                                                           substitute.
Sec.   133.153.................  Monterey cheese    (b)(3)(iii)......  N/A..............  Type 1; amends salt in
                                  and monterey                                             other optional
                                  jack cheese.                                             ingredients to add
                                                                                           salt substitute.
Sec.   133.155.................  Mozzarella cheese  (b)(3)(iii)......  N/A..............  Type 1; amends salt in
                                  and scamorza                                             other optional
                                  cheese.                                                  ingredients to add
                                                                                           salt substitute.
Sec.   133.156.................  Low-moisture       (b)(3)(iii)......  N/A..............  Type 1; amends salt in
                                  mozzarella and                                           other optional
                                  scamorza cheese.                                         ingredients to add
                                                                                           salt substitute.
Sec.   133.160.................  Muenster and       (b)(3)...........  (b)(3)(vi).......  Type 3; amends other
                                  munster cheese.                                          optional ingredients
                                                                                           to add a new
                                                                                           paragraph to list
                                                                                           salt substitute.
Sec.   133.162.................  Neufchatel cheese  (b)(3)(i)........  N/A..............  Type 1; amends salt in
                                                                                           other optional
                                                                                           ingredients to add
                                                                                           salt substitute.
Sec.   133.164.................  Nuworld cheese...  (b)(3)...........  (b)(3)(iv).......  Type 3; amends other
                                                                                           optional ingredients
                                                                                           to add a new
                                                                                           paragraph to list
                                                                                           salt substitute.
Sec.   133.165.................  Parmesan and       (c)..............  (c)(3)...........  Type 4; amends SOI to
                                  reggiano cheese.                                         add a new paragraph
                                                                                           to permit salt
                                                                                           substitute.
Sec.   133.169.................  Pasteurized        (d)(4)...........  N/A..............  Type 1; amends salt in
                                  process cheese.                                          optional ingredients
                                                                                           to add salt
                                                                                           substitute.
Sec.   133.173.................  Pasteurized        (e)(4) Salt......  N/A..............  Type 1; amends salt in
                                  process cheese                                           other optional
                                  food.                                                    ingredients to add
                                                                                           salt substitute.
Sec.   133.179.................  Pasteurized        (f)(5) Salt......  N/A..............  Type 1; amends salt in
                                  process cheese                                           other optional
                                  spread.                                                  ingredients to add
                                                                                           salt substitute.
Sec.   133.181.................  Provolone cheese.  (b)(3)...........  (b)(3)(vi).......  Type 3; amends other
                                                                                           optional ingredients
                                                                                           to add a new
                                                                                           paragraph to list
                                                                                           salt substitute.
Sec.   133.182.................  Soft ripened       (b)..............  N/A..............  Type 2; amends
                                  cheeses.                                                 paragraph that
                                                                                           describes the food to
                                                                                           add salt substitute.
Sec.   133.183.................  Romano cheese....  (c)..............  (c)(3)...........  Type 4; amends SOI to
                                                                                           add a new paragraph
                                                                                           to permit salt
                                                                                           substitute.
Sec.   133.184.................  Roquefort cheese,  (b)(3)...........  (b)(3)(i) and      Type 3; amends other
                                  sheep's milk                          (ii).              optional ingredients
                                  blue-mold, and                                           to add new paragraph
                                  blue-mold cheese                                         to list salt
                                  from sheep's                                             substitute.
                                  milk.
Sec.   133.185.................  Samsoe cheese....  (b)(3)...........  (b)(3)(v)........  Type 3; amends other
                                                                                           optional ingredients
                                                                                           to add new paragraph
                                                                                           to list salt
                                                                                           substitute.
Sec.   133.186.................  Sap sago cheese..  (a)..............  N/A..............  Type 2; amends
                                                                                           paragraph that
                                                                                           describes the food to
                                                                                           add salt substitute.
Sec.   133.187.................  Semisoft cheeses.  (b)..............  N/A..............  Type 2; amends
                                                                                           paragraph that
                                                                                           describes the food to
                                                                                           add salt substitute.

[[Page 21157]]

 
Sec.   133.188.................  Semisoft part-     (b)..............  N/A..............  Type 2; amends
                                  skim cheeses.                                            paragraph that
                                                                                           describes the food to
                                                                                           add salt substitute.
Sec.   133.189.................  Skim milk cheese   (d)..............  (d)(1) and (2)...  Type 4; amends SOI to
                                  for                                                      add a new paragraph
                                  manufacturing.                                           to permit salt
                                                                                           substitute.
Sec.   133.190.................  Spiced cheeses...  (b)(3)(iii)......  N/A..............  Type 1; amends salt in
                                                                                           other optional
                                                                                           ingredients to add
                                                                                           salt substitute.
Sec.   133.195.................  Swiss and          (b)(3)...........  (b)(3)(vii)......  Type 3; amends other
                                  emmentaler                                               optional ingredients
                                  cheese.                                                  to add a new
                                                                                           paragraph to list
                                                                                           salt substitute.
----------------------------------------------------------------------------------------------------------------

E. Update Incorporation by Reference

    Several of the 80 SOI that specify salt as a required or optional 
ingredient contain outdated references. We propose to update the IBR 
paragraphs in these SOI to refer to the most recent versions of the IBR 
materials and to provide up-to-date contact information for obtaining 
the IBR materials. We propose to add IBR paragraphs to subparts A of 
parts 131, 137, 139, 150, 155, and 161. SOI in subparts B of these 
parts would reference applicable IBR paragraphs in subpart A. We also 
propose to update the IBR paragraphs in the SOI under parts 136, 145, 
and 166 which would not have IBR paragraphs in subparts A of these 
parts. The revised format is for administrative efficiency. 
Specifically, the proposed rule would update the IBR information for 
Sec. Sec.  131.111, 131.112, 131.160, 131.162, 131.170, 136.110, 
137.180, 137.270, 139.110, 139.150, 145.110, 150.110, 155.120, 155.130, 
155.170, 161.145, 161.173,161.190, and 166.110. These SOI list methods 
of analysis that are from the 13th or 15th editions of ``Official 
Methods of Analysis of the Association of Official Analytical 
Chemists.'' Additionally, Sec.  155.170 lists an incorrect section 
number for the method for alcohol insoluble solids in canned peas. We 
propose to update the referenced methods of analysis to those in the 
``Official Methods of Analysis of AOAC INTERNATIONAL,'' 21st Ed. 2019. 
These proposed changes will ensure that the reference materials are 
current, accessible, and meet Federal requirements pertaining to IBR 
(see 1 CFR part 51).
     Definition of Terms and Explanatory Notes; Table 1. 
Nominal Dimensions of Standard Test Sieves (USA Standard Series). The 
reference lists the test sieve designations and their nominal 
dimensions.
     AOAC Reference Table 909.04; Correction Factors for 
Gasometric Determination of Carbon Dioxide. The reference lists the 
correction factors of carbon dioxide measurements for different 
atmospheric conditions.
     AOAC Official Method 923.02A; Reagent under Carbon Dioxide 
(Total) in Baking Powders-Gasometric Determination. The reference 
describes the reagent used in measuring the amount of carbon dioxide 
released from a sample.
     AOAC Official Method 923.02B; Apparatus under Carbon 
Dioxide (Total) in Baking Powders-Gasometric Determination. The 
reference describes the apparatus used in measuring the amount of 
carbon dioxide released from a sample.
     AOAC Official method 926.07A; Vacuum Oven Method, under 
Solids (Total) and Loss on Drying (Moisture) in Macaroni Products. The 
reference provides method references for the preparation of a sample 
and the total solid determination of a sample.
     AOAC Official method 932.12; Solids (Soluble) in Fruits 
and Fruit Products. The reference provides a method reference for 
measuring soluble solids and the formula for calculating the percentage 
of soluble solids in a sample.
     AOAC Official method 932.14C; By Means of Refractometer 
under Solids in Syrups. The reference provides the method for measuring 
the percentage of soluble solids in a sample.
     AOAC Official method 935.36(a); Solids (Total) in Bread. 
The reference provides the method for measuring the percentage of 
solids in a sample.
     AOAC Official method 938.06A; Indirect Method, under Fat 
in Butter. The reference provides the method for measuring the 
percentage of fat in a sample.
     AOAC Official method 938.10; Solids (Alcohol-Insoluble) in 
Canned Peas Gravimetric Method. The reference provides the method for 
measuring the percentage of alcohol-insoluble solids in a sample.
     AOAC Official Method 945.48G; under Evaporated Milk 
(Unsweetened). The reference provides the method for sample preparation 
and a method reference for measuring the percentage of milk fat in a 
sample.
     AOAC Official Method 947.05; Acidity of Milk Titrimetric 
Method. The reference provides the method for measuring the percentage 
of lactic acid in a sample.
     AOAC Official Method 989.05; Fat in Milk-Modified 
Mojonnier Ether Extraction method. The reference provides the method 
for measuring the percentage of milk fat in a sample.
     AOAC Official Method 990.21; Solid-Not-Fat in Milk By 
Difference between Total Solids and Fat Contents. The reference 
provides method references for measuring total solids and fat contents 
of a sample and the formula for calculating the percentage of nonfat 
solid in a sample.
    You may purchase a copy of the material from AOAC International 
(AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 20850-3250, 1-
800-379-2622. You may inspect a copy at Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday 
through Friday.

F. Technical Amendments

    We also propose to make technical amendments to correct 
inconsistencies and typographical errors in several of the 80 SOI 
regulations that specify salt as a required or optional ingredient. The 
corrections are non-substantive. The proposed rule would:
     Amend Sec.  133.118(c)(2) to replace ``143'' with ``145.''
     Amend Sec.  133.150(c)(2) to replace ``143'' with ``145.''
     Amend Sec.  133.150(e)(1) to replace ``unusual'' with 
``usual.''
     Amend Sec.  133.182(c)(2) to replace ``143'' with ``145.''

[[Page 21158]]

     Amend Sec.  133.184(b) to replace ``Operational'' with 
``Optional.''
     Amend Sec.  133.186(c) to replace ``Nonmenclature'' with 
``Nomenclature.''
     Amend Sec.  133.187(c)(2) to replace ``143'' with ``145.''
     Amend Sec.  133.188(c)(2) to replace ``143'' with ``145.''
     Amend Sec.  155.170(b)(1)(iii) to replace ``shrivelled'' 
with ``shriveled.''
     Amend Sec.  158.170(b)(1)(iii) to replace ``shrivelled'' 
with ``shriveled.''
     Amend Sec.  168.140(a) to replace ``mapel'' with 
``maple.''

VI. Proposed Effective/Compliance Dates

    We propose that any final rule resulting from this rulemaking be 
effective 30 days after the final rule's date of publication in the 
Federal Register insofar as it amends non-dairy SOI. We believe that 
this effective date is appropriate because it will provide industry the 
flexibility to use salt substitutes to reduce the sodium content in 
standardized foods. Some manufacturers are already exploring ways to 
reduce sodium in standardized foods, and this proposed rule, if 
finalized, will assist in those efforts. For the same reasons, FDA 
proposes that any dairy SOI that may be amended based on this proposal, 
unless stayed by the filing of proper objections, will also be 
effective 30 days after the final rule's date of publication in the 
Federal Register.

VII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). 
The Office of Information and Regulatory Affairs has determined that 
this proposed rule is a significant regulatory action as defined by 
Executive Order 12866 Section 3(f)(1).\1\
---------------------------------------------------------------------------

    \1\ We note that this Executive Order 12866 applies only to the 
non-dairy SOI portions of this rulemaking; the dairy SOI covered by 
this rulemaking are ``regulations or rules issued in accordance with 
the formal rulemaking provisions of 5 U.S.C. 556, 557'' (see 21 
U.S.C. 701(e)(1)) and therefore excluded by section (d)(1) of 
Executive Order (E.O.) 12866.
---------------------------------------------------------------------------

    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. We do not anticipate the proposed rule would generate 
regulatory impacts on small entities. As with any voluntary market 
behavior, larger firms may have certain advantages over small firms in 
some areas, while smaller firms may have advantages in other areas. As 
a result, we propose to certify that the proposed rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $165 million, using the most current (2021) Implicit 
Price Deflator for the Gross Domestic Product. The proposed rule would 
not result in a mandated expenditure in any year that meets or exceeds 
this amount.
    The proposed rule would permit, but not require, manufacturers to 
use salt substitutes to replace salt where salt is a required or 
optional ingredient in standardized foods. If finalized, the benefits 
of this rule would be additional flexibility in the manufacture of 
standardized foods and the potential for reduced salt consumption by 
consumers which may contribute to better health outcomes. We have no 
information to suggest the use of currently available salt substitutes 
would lead to improved product characteristics (e.g., shelf life) or 
would lead to reduced production costs and potentially lower prices. We 
request comment on such potential benefits of reformulation for 
manufacturers and on how many standardized foods manufacturers might 
choose to reformulate, either in the relatively near or longer-run 
future.
    The proposed rule, if finalized, would not impose requirements 
resulting in regulatory costs on firms or consumers. Manufacturers 
would have the option of using salt substitutes. There are no 
regulatory implications for not reading the rule or deciding not to use 
salt substitutes. Should manufacturers choose to use this flexibility 
to reformulate some products by substituting some salt with salt 
substitutes, the primary benefits realized would result from lower 
sodium consumption on average by U.S. consumers, assuming they choose 
to purchase and consume the reformulated versions of such products, and 
increased profit (producer surplus) for manufacturers, assuming they 
find offering reformulated versions of such products consistent with 
maximizing firm profits. The primary costs of such voluntary market 
behavior would be reformulation and relabeling costs for manufacturers. 
We currently lack data to estimate any net social benefits from 
voluntary market behavior relating to future use of salt substitutes 
made possible by this rule, but cite some published analyses below 
related to meeting voluntary sodium reduction targets that could 
partially be addressed via the flexibility provided by this rule. We 
request public comment on possible producer response (e.g., how many 
manufacturers may choose to take voluntary action in response to this 
rule, what share of standardized food products may get reformulated) 
and on possible consumer willingness to purchase and consume such 
products with various types of salt substitutes at various levels, 
which would allow us to provide a range of net social benefit estimates 
when this rule is finalized.

A. Economic Analysis of Impacts

1. Background
    There are 80 SOI that specify salt as a mandatory or optional 
ingredient. Some of these standards are referenced by other SOI, 
resulting in salt as an ingredient in 140 SOI. The salt in the foods 
covered by these 140 SOI may serve a variety of functions such as 
taste, texture, moisture control, and microbial safety. FDA has a 
public health interest in reducing sodium across the food supply. 
Therefore, we propose to give manufacturers the flexibility to use salt 
substitutes in standardized foods where salt is a required or optional 
ingredient, to reduce the sodium content. While there may be potential 
data sources (e.g., IRI, Label Insight, Mintel, NHANES, Syndigo) that 
could provide market or consumption share (e.g., contribution of sodium 
and/or caloric intake) for foods covered by these 140 SOI, FDA does not 
currently have sufficient estimates to further extrapolate impacts at 
this time. We request public comment on additional potential data 
sources for estimates of market share and/or caloric and/or sodium 
consumption share of the products included in these SOI.
    We request comment on potential regulatory alternatives including 
allowing the use of only specified salt substitutes, at only specified 
levels of substitution, for only specified

[[Page 21159]]

purposes, for only specified products, in conjunction with only 
specified ancillary formulation changes, or with specified labeling 
requirements. More generally, we request comments on potential 
regulatory approaches to reducing salt in food or the dietary intake of 
salt that do not involve allowing the use of salt substitutes in 
standardized foods.
2. Benefits of the Proposed Rule
    The benefit of this proposed rule is that manufacturers would have 
additional flexibility in producing standardized foods covered by 140 
SOI, which may lead to social benefits in the form of increased 
consumer satisfaction (consumer surplus), increased profits (producer 
surplus), or both. In addition, a change in voluntary market behavior 
relating to patterns of food consumption, or to use a potassium-based 
salt as a salt substitute and consumers who would benefit from 
increasing their potassium intake choose to consume those products, 
those consumers may experience positive health effects.
    Salt is a relatively inexpensive ingredient, and we would not 
expect manufacturers to begin using salt substitutes based on cost 
cutting considerations alone at this time. To explore the possibility 
of manufacturers voluntarily replacing salt with salt substitutes to 
improve the healthfulness of their standardized foods, one would need 
to identify the costs and level of potential substitution, and extent 
of consumer acceptance of salt substitutes at differing levels in 
different standardized foods in order to estimate the number of 
manufacturers who would decide to use salt substitutes. We currently 
lack data on these potential industry responses and request public 
comment from manufactures, suppliers, and consumers on the extent to 
which the additional flexibility provided by this rule would be used by 
manufacturers, hence also desired or tolerated by consumers, and viable 
in the supply chain.
    As discussed in the preamble of this rule, on average, Americans 
consume approximately 3,400 milligrams of sodium per day (mg/day), 
which is nearly 50 percent more than the recommended daily limit on 
sodium intake for individuals 14 years and older (Refs. 1 and 2). 
Excess sodium intake increases the risk for hypertension, or high blood 
pressure, a leading cause of heart disease and stroke (Refs. 2-6). 
Decreasing sodium consumption is expected to reduce hypertension and 
potentially result in fewer cases of heart disease and stroke (Refs. 7-
9 \2\). More than 70 percent of sodium consumed in the U.S. comes from 
sodium added during manufacturing and commercial food preparation (Ref. 
14). The health benefits from reducing sodium consumption are expected 
to be higher for populations that currently have higher sodium 
consumption or that are more sensitive to any given level of sodium 
consumption than other populations. Hence, there may be potential 
health equity effects to any regulation that generates or facilitates 
reduced intake of sodium. In order to estimate such health benefits, we 
would need data and information on the complex pathway between allowing 
manufactures to use salt substitutes, the extent to which manufactures 
will develop products of interest to those at highest risk of 
hypertension, the likely demographic patterns of consumers purchasing 
those new products, and eventually, the extent of the reduction in 
sodium uptake among those at most risk of hypertension.
---------------------------------------------------------------------------

    \2\ These studies may be sensitive to assumptions regarding 
consumer response. If some consumers experience disutility 
associated with the reformulated product and adjust their 
consumption pattern accordingly, this could partially offset some of 
the estimated health benefits.
---------------------------------------------------------------------------

    In the absence of necessary data to fully estimate the impacts of 
this rule, we refer to published literature on the health benefits of 
sodium reduction targets to provide broader context of potential 
impacts of this rule. A 2018 study by Pearson-Stuttard, et al. looked 
at the health and economic effects of FDA's 2016 draft voluntary sodium 
reduction guidance (Refs. 8 and 22) and estimated benefits of meeting 
sodium reduction targets in the form of medical cost savings and 
consumer health improvements, net of producer reformulation costs and 
some government administrative and monitoring costs. Over a 20-year 
period, the authors of the study find net social benefits from only 
consumer health effects to be roughly $12 billion (uncertainty range of 
$0 billion to $28 billion) under what it described as the most 
pessimistic scenario relating to potential sodium reduction among the 
three presented (Ref. 8). This roughly $12 billion net benefit arises 
from roughly $19 billion in estimated health cost savings (benefits) 
and just over $7 billion of estimated reformulation, administrative and 
monitoring costs.\3\
---------------------------------------------------------------------------

    \3\ These results may be sensitive to assumptions regarding 
consumer response to product reformulation. For example, benefits 
might be lower if some consumers experience disutility associated 
with the reformulated product and adjust their consumption pattern 
accordingly, which could partially offset the estimated health 
benefits presented above. Ref. 9, for instance, indicates that its 
cost-effectiveness results are highly sensitive to such issues.
---------------------------------------------------------------------------

    Since these benefit estimates are not comprehensive, we would need 
additional data on possible producer and consumer response to fully 
assess health benefits. Moreover, benefits might be higher or lower 
than what would be indicated by estimates that focus on the subset of 
effects tracked by Pearson-Stuttard et al. Benefits might be higher if 
firms were to realize additional profits or producer surplus from any 
product reformulation (since we assume firms would use salt substitutes 
only if profits would remain the same or increase). Benefits might also 
be higher due to possible changes in consumer surplus from consumers 
willing to buy reformulated products whose valuation includes factors 
beyond medical cost savings or health state utility. Benefits might be 
lower if some consumers experience disutility associated with the 
reformulated product and adjust their consumption pattern accordingly, 
which could partially offset the estimated health benefits presented 
above.
    In addition, as mentioned above, we currently lack data to 
determine how much, if any, of the aggregate effects that Pearson-
Stuttard et al. attribute to broader voluntary sodium reduction efforts 
could be directly connected to the flexibility provided by this rule. 
The rule does not cover all foods analyzed in the Pearson-Stuttard, et 
al. scenarios, which included many non-standardized foods. With 
comprehensive data on the share of foods affected by this rule, we 
could estimate health benefits across only such products as a subset of 
the Pearson-Stuttard, et al. estimate. We request such data and also 
data on possible consumer and producer response to the flexibility 
provided by this rule.
3. Costs of the Proposed Rule
    The proposed rule, if finalized would not impose regulatory costs 
on manufacturers or consumers. There would be no regulatory 
requirements or regulatory penalties relative to the baseline of taking 
no regulatory action. Manufacturers would be required to use safe and 
suitable ingredients regardless of the amount or type of salt 
substitutes they choose to use. The flexibility provided by this rule 
creates parity for use of existing salt substitutes in both 
standardized and non-standardized foods (see section V.C. for 
discussion of examples of current salt substitutes in use) and such 
uses are already required to be disclosed and labeled. It is

[[Page 21160]]

possible that a change in voluntary market behavior relating to food 
consumption may generate health costs. For example, to the extent 
manufacturers choose to use potassium chloride as a salt substitute and 
consumers choose to consume those products, consumers who may need to 
limit their potassium intake may see negative health effects that 
should be accounted for in cost estimates. We request comments on 
evidence that could contribute to a more thorough assessment (including 
possible quantification) of such costs. The agency will continue to 
monitor the use of salt substitutes in the U.S. food supply.
    The economic rationale for food standards involves reducing 
consumers' search costs; in particular, their ability to infer certain 
product characteristics from representation as certain standardized 
foods. The proposed rule may affect product characteristics by allowing 
manufacturers to use salt substitutes that replace any one or any 
combination of the functions of added salt. However, the proposed rule 
would preclude ingredient substitutions that change the basic nature 
and essential characteristics of a standardized food. The basic nature 
of a food concerns the general attributes of the product that is 
offered for sale to consumers. The essential characteristics of a food 
may contribute to achieving the basic nature of the food, but consumers 
may not be aware of the essential characteristics. Use of safe and 
suitable salt substitutes that do not change the basic nature and 
essential characteristics of the standardized food ensures that 
products on the market retain their general attributes. For purposes of 
this analysis, we assume products that retain their general attributes 
will also retain consistency with consumer beliefs and expectations 
relating to those products and that the use of salt substitutes will 
therefore not generate consumer dissatisfaction relating to the 
identity of the standardized food. To the extent that this assumption 
may not be accurate, we request comment on the degree to which 
consumers may be willing to purchase and consume such products after 
salt substitutes are used.
    If finalized, manufacturers may choose to take advantage of the 
flexibility provided in this proposed rule. As discussed above, the 
primary potential costs of that voluntary market behavior would arise 
from producers choosing to use the flexibility afforded to them to 
reformulate some products such as reformulation, consumer testing, 
labeling, and possibly marketing costs. Pearson-Stuttard, et al., 
estimate that reformulation costs (using the FDA model, Ref. 23) 
corresponding to the draft voluntary short term sodium reduction 
targets could range from $2.7 to $15 billion over a 20-year time period 
and that these costs would comprise roughly 95 percent of the costs 
related to reaching short term sodium reduction targets (Ref. 8). 
Producers may voluntarily choose to reformulate some products in 
response to this rule's added flexibility and the magnitude of such 
costs would depend on the number of products reformulated. The more 
firms choose to reformulate using salt substitutes given the 
flexibility provided by this rule, the greater the share of sodium 
reduction efforts (and associated reformulation costs) that could be 
attributed to this rule. Regardless of what amount of reformulation 
producers voluntarily choose to undertake, they will only do so if 
their private benefits in the form of increased revenue are at least as 
much as their private costs. We request comment on the number of 
manufacturers who may choose to reformulate standardized food products 
and the extent to which manufacturers may choose to reformulate those 
products given this new flexibility. We also request comment on all 
other considerations relating to manufacturers' voluntary market 
decision to use salt substitutes including cost of reformulation, 
ability to source substitute ingredients, expected impact on sales, 
profits, and consumer acceptance or lack of acceptance.

B. Initial Small Entity Analysis

    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. If finalized, we do not expect the proposed rule 
would generate impacts on small entities. The rule would not impose 
regulatory costs on small entities. There would be no regulatory 
requirements or regulatory penalties relative to the baseline of taking 
no regulatory action. We have no basis to suppose or estimate any other 
impacts on small entities. As a result, we propose to certify that the 
proposed rule will not have a significant economic impact on a 
substantial number of small entities. This analysis, as well as other 
sections in this document, serves as the Initial Regulatory Flexibility 
Analysis, as required under the Regulatory Flexibility Act.
    This analysis is also available in the docket for this proposed 
rule (Ref. 24) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.32(a) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the Executive Order and, 
consequently, a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian tribes, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes. We invite comments from tribal officials 
on any potential impact on Indian tribes from this proposed action.

XII. References

    The following references marked with an asterisk (*) are on display 
with the Dockets Management Staff (see ADDRESSES) 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 https://www.regulations.gov. References without asterisks are not on public

[[Page 21161]]

display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

1. * U.S. Department of Agriculture and U.S. Department of Health 
and Human Services. ``Dietary Guidelines for Americans, 2020-2025.'' 
9th Edition. December 2020. Available at https://www.dietaryguidelines.gov; accessed February 23, 2022.
2. National Academies of Sciences, Engineering and Medicine. 
``Dietary Reference Intakes for Sodium and Potassium'' (March 2019). 
Washington, DC: The National Academies Press.
3. Sacks, F. M., L. P. Svetkey, W. M. Vollmer, L. J. Appel, et al., 
``Effects on Blood Pressure of Reduced Dietary Sodium and the 
Dietary Approaches to Stop Hypertension (DASH) diet.'' DASH--Sodium 
Collaborative Research Group. New England Journal of Medicine. 2001; 
344(1): pp 3-10.
4. Graudal, N. A., T. Hubeck-Graudal, and G. J[uuml]rgens, ``Effects 
of Low-Sodium Diet vs. High-Sodium Diet on Blood Pressure, Renin, 
Aldosterone, Catecholamines, Cholesterol, and Triglyceride (Cochrane 
Review).'' American Journal of Hypertension. 2012; 25(1): pp. 1-15. 
https://www.ncbi.nlm.nih.gov/pubmed/22068710, accessed December 9, 
2020.
5. Eckel, R. H., J. M. Jakicic, J. D. Ard, J. M. de Jesus, et al., 
``2013 AHA/ACC Guideline on Lifestyle Management to Reduce 
Cardiovascular Risk: A Report of the American College of Cardiology/
American Heart Association Task Force on Practice Guidelines.'' 
Journal of the American College of Cardiology. 2014; 63(25 Pt B): 
pp. 2960-84. https://www.ncbi.nlm.nih.gov/pubmed/24239922; accessed 
December 9, 2020.
6. * Murphy, S. L., K. D. Kochanek, J. Q. Xu, and E. Arias, 
``Mortality in the United States, 2020.'' NCHS Data Brief, no 427. 
Hyattsville, MD: National Center for Health Statistics. 2021; 
https://www.cdc.gov/nchs/products/databriefs/db427.htm; accessed Feb 
23, 2022.
7. Coxson, P. G., N. R. Cook, M. Joffres, Y. Hong, et al., 
``Mortality Benefits From U.S. Population-Wide Reduction in Sodium 
Consumption: Projections From 3 Modeling Approaches.'' Hypertension. 
2013; 61(3): pp. 564-570.
8. Pearson-Stuttard, J., C. Kypridemos, B, Collins, D. Mozaffarian, 
et al., ``Estimating the Health and Economic Effects of the Proposed 
U.S. Food and Drug Administration Voluntary Sodium Reformulation: 
Microsimulation Cost-Effectiveness Analysis.'' PLoS Medicine. 2018; 
15(4): pp. 1-18.
9. Smith-Spangler C. M., J. L. Juusola, E. A. Enns, D. K. Owens, and 
A. M. Garber, ``Population Strategies to Decrease Sodium Intake and 
the Burden of Cardiovascular Disease: A Cost-Effectiveness 
Analysis.'' Annals of Internal Medicine. 2010; 152(8): pp. 481-487.
10. Micha, R., J. L. Pe[ntilde]alvo, F. Cudhea, F. Imamura, et al., 
``Association Between Dietary Factors and Mortality from Heart 
Disease, Stroke, and Type 2 Diabetes in the United States.'' Journal 
of the American Medical Association. 2017; 317(9): pp. 912-924.
11. * Ostchega, Y., C.D. Fryar, T. Nwankwo, and D.T. Nguyen, 
``Hypertension Prevalence Among Adults Aged 18 and Over: United 
States, 2017-2018.'' NCHS Data Brief, no 364. Hyattsville, MD: 
National Center for Health Statistics. 2020; https://www.cdc.gov/nchs/products/databriefs/db364.htm; accessed March 21, 2023.
12. * Centers for Disease Control and Prevention, ``Deaths: Final 
Data for 2018'' National Vital Statistics Report. 2021; 69 (13). 
Table 10: p. 52. Available at https://www.cdc.gov/nchs/data/nvsr/nvsr69/nvsr69-13-508.pdf; accessed December 20, 2022.
13. * Centers for Disease Control and Prevention, ``Summary of 
Health Statistics'' National Health Interview Survey. 2018; Table A-
1a. Available at https://www.cdc.gov/nchs/nhis/shs/tables.htm; 
accessed December 20, 2022.
14. Harnack, L.J., M. E. Cogswell, J. M. Shikany, C. D. Gardner, et 
al., ``Sources of Sodium in U.S. Adults from 3 Geographic Regions.'' 
Circulation. 2017; 135: pp. 1775-1783.
15. * FDA, ``The Use of an Alternate Name for Potassium Chloride in 
Food Labeling: Guidance for Industry.'' December 2020. Available at 
https://www.fda.gov/media/125081/download (Docket number FDA-2019-D-
0892), accessed February 23, 2022.
16. * FDA, ``Voluntary Sodium Reduction Goals: Target Mean and Upper 
Bound Concentrations for Sodium in Commercially Processed, Packaged, 
and Prepared Foods: Guidance for Industry.'' October 2021. Available 
at https://www.fda.gov/media/98264/download (Docket number FDA-2014-
D-0055), accessed February 23, 2022.
17. Mayne, S. T., R. A. McKinnon, and J. Woodcock, ``Reducing Sodium 
Intake in the U.S. Healthier Lives, Healthier Future.'' Journal of 
the American Medical Association. 2021; 326(17): pp. 1675-1676.
18. * FDA, ``Horizontal Approaches to Food Standards of Identity 
Modernization; Public Meeting; Request for Comments.'' September 27, 
2019; transcript available at https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-horizontal-approaches-food-standards-identity-modernization-09272019-09272019.
19. Institute of Medicine. ``Strategies to Reduce Sodium Intake in 
the United States'' (2010). Washington, DC: The National Academies 
Press.
20. D[ouml]tsch, M., J. Busch, M. Batenburg, G. Liem, et al., 
``Strategies to Reduce Sodium Consumption: A Food Industry 
Perspective.'' Critical Reviews in Food Science and Nutrition. 2009; 
49(10): pp. 841-851.
21. Taylor, C., M. Doyle, D. Webb, ``The Safety of Sodium Reduction 
in the Food Supply: A Cross-Discipline Balancing Act--Workshop 
Proceedings.'' Critical Reviews in Food Science and Nutrition. 2018; 
58(10): pp. 1650-1659.
22. * FDA, ``Voluntary Sodium Reduction Goals: Target Mean and Upper 
Bound Concentrations for Sodium in Commercially Processed, Packaged, 
and Prepared Foods: Guidance for Industry. Draft Guidance.'' June 
2016.
23. Muth, M. K., S. Bradley, J. Brophy, K. Capogrossi, S. Karns, and 
C. Viator. Reformulation cost model. Contract No. HHSF-223-2011-
10005B, Task Order 20. Final report. Research Triangle Park (NC): 
RTI International; 2015.
24. * FDA, ``Use of Salt Substitutes to Reduce the Sodium Content in 
Standardized Foods'' Preliminary Regulatory Impact Analysis, Initial 
Regulatory Flexibility Analysis, Unfunded Mandates Reform Act 
Analysis. Available at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

List of Subjects

21 CFR Part 130

    Food additives, Food grades and standards.

21 CFR Part 131

    Dairy products, Food grades and standards, Incorporation by 
reference, Milk.

21 CFR Part 133

    Dairy products, Food grades and standards, Food labeling.

21 CFR Part 136

    Bakery products, Food grades and standards, Incorporation by 
reference.

21 CFR Part 137

    Foods, Food grades and standards, Incorporation by reference.

21 CFR Part 139

    Food grades and standards, Incorporation by reference.

21 CFR Parts 145 and 150

    Food grades and standards, Fruits, Incorporation by reference.

21 CFR Part 155

    Food grades and standards, Incorporation by reference, Vegetables.

21 CFR Part 156

    Food grades and standards, Vegetable juices.

21 CFR Part 158

    Food grades and standards, Frozen foods, Vegetables.

[[Page 21162]]

21 CFR Part 161

    Food grades and standards, Frozen foods, Incorporation by 
reference, Seafood.

21 CFR Part 163

    Cacao products, Food grades and standards.

21 CFR Part 166

    Food grades and standards, Food labeling, Incorporation by 
reference, Margarine.

21 CFR Part 168

    Food grades and standards, Sugar.

21 CFR Part 169

    Food grades and standards, Oils and fats, Spices and flavorings.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, we propose 
that 21 CFR parts 130, 131, 133, 136, 137, 139, 145, 150, 155, 156, 
158, 161, 163, 166, 168, and 169 be amended as follows:

PART 130--FOOD STANDARDS: GENERAL

0
1. The authority citation for part 130 continues to read as follows:

    Authority: 21 U.S.C. 321, 336, 341, 343, 371.

0
2. Add subpart C to read as follows:
* * * * *

Subpart C--Flexibility in Standardized Foods


Sec.  130.30  Ingredient flexibility in standardized foods.

    (a) The definitions listed in this section apply to parts 131 
through 169 of this chapter.
    (b) The ingredients used as substitutes must not change the basic 
nature and essential characteristics of the food.
    (c) Definitions.
    (1) Salt substitute means a safe and suitable ingredient (or 
combination of ingredients) that is used to replace some or all of the 
added salt (sodium chloride), to reduce sodium in the food, and that 
serves the functions of salt in the food.
    (2) [Reserved]

PART 131--MILK AND CREAM

0
3. The authority citation for part 131 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
4. Add Sec.  131.10 to read as follows:


Sec.  131.10  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Food and 
Drug Administration (FDA) and at the National Archives and Records 
Administration (NARA). Contact FDA's Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. For 
information on the availability of this material at NARA, visit 
www.archives.gov/federal-register/cfr/ibr-locations or email 
[email protected]. The material may be obtained from AOAC 
INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 
20850-3250, 1-800-379-2622:
    (a) Official Methods of Analysis, 21st Ed. (2019);
    (1) AOAC Official Method 945.48G, under Evaporated Milk 
(Unsweetened); IBR Sec. Sec.  131.160(c); 131.162(c).
    (2) AOAC Official Method 947.05, Acidity of Milk Titrimetric 
Method; IBR Sec. Sec.  131.111(f); 131.112(e); 131.160(c); 131.162(c).
    (3) AOAC Official Method 989.05, Fat in Milk Modified Mojonnier 
Ether Extraction Method; IBR Sec. Sec.  131.111(f); 131.112(e); 
131.170(f).
    (4) AOAC Official Method 990.21, Solid-Not-Fat in Milk By 
Difference between Total Solids and Fat Contents; IBR Sec. Sec.  
131.111(f); 131.112(e); 131.170(f).
    (b) [Reserved]
0
5. In Sec.  131.111, revise paragraphs (e)(8) and (f) to read as 
follows:


Sec.  131.111  Acidified milk.

* * * * *
    (e) * * *
    (8) Salt or salt substitute.
* * * * *
    (f) Methods of analysis. Referenced methods are from ``Official 
Methods of Analysis'' (incorporated by reference, see Sec.  131.10):
    (1) Milkfat content--As determined by the method prescribed in AOAC 
Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction 
Method.
    (2) Milk solids not fat content--Calculated by subtracting the 
milkfat content from the total solids content using the method 
prescribed in AOAC Official Method 990.21, Solid-Not-Fat in Milk By 
Difference between Total Solids and Fat Contents.
    (3) Titratable acidity--As determined by the methods prescribed in 
AOAC Official Method 947.05, Acidity of Milk Titrimetric Method or by 
an equivalent potentiometric method.
* * * * *
0
6. In Sec.  131.112, revise paragraphs (d)(8) and (e) to read as 
follows:


Sec.  131.112  Cultured milk.

* * * * *
    (d) * * *
    (8) Salt or salt substitute.
* * * * *
    (e) Methods of analysis. Referenced methods are from ``Official 
Methods of Analysis'' (incorporated by reference, see Sec.  131.10):
    (1) Milkfat content--As determined by the method prescribed in AOAC 
Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction 
Method.
    (2) Milk solids not fat content--Calculated by subtracting the 
milkfat content from the total solids content using the method 
prescribed in AOAC Official Method 990.21, Solid-Not-Fat in Milk By 
Difference between Total Solids and Fat Contents.
    (3) Titratable acidity--As determined by the methods prescribed in 
AOAC Official Method 947.05, Acidity of Milk Titrimetric Method or by 
an equivalent potentiometric method.
* * * * *
0
7. In Sec.  131.160, revise paragraphs (b)(5) and (c) to read as 
follows:


Sec.  131.160  Sour cream.

* * * * *
    (b) * * *
    (5) Salt or salt substitute.
* * * * *
    (c) Methods of analysis. Referenced methods are from ``Official 
Methods of Analysis'' (incorporated by reference, see Sec.  131.10).
    (1) Milkfat content--AOAC Official Method 945.48G, under Evaporated 
Milk (Unsweetened).
    (2) Titratable acidity--AOAC Official Method 947.05, Acidity of 
Milk Titrimetric Method.
* * * * *
0
8. In Sec.  131.162, revise paragraphs (b)(4) and (c) to read as 
follows:


Sec.  131.162  Acidified sour cream.

* * * * *
    (b) * * *
    (4) Salt or salt substitute.
* * * * *
    (c) Methods of analysis. Referenced methods are from ``Official 
Methods of Analysis'' (incorporated by reference, see Sec.  131.10).
    (1) Milkfat content--AOAC Official Method 945.48G, under Evaporated 
Milk (Unsweetened).
    (2) Titratable acidity--AOAC Official Method 947.05, Acidity of 
Milk Titrimetric Method.
* * * * *

[[Page 21163]]

0
9. In Sec.  131.170, revise paragraphs (e)(2) and (f) to read as 
follows:


Sec.  131.170  Eggnog.

* * * * *
    (e) * * *
    (2) Salt or salt substitute.
* * * * *
    (f) Methods of analysis. Referenced methods are from ``Official 
Methods of Analysis'' (incorporated by reference, see Sec.  131.10).
    (1) Milkfat content--As determined by the method prescribed in AOAC 
Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction 
Method.
    (2) Milk solids not fat content--Calculated by subtracting the 
milkfat content from the total solids content using the method 
prescribed in AOAC Official Method 990.21, Solid-Not-Fat in Milk By 
Difference between Total Solids and Fat Contents.
* * * * *

PART 133--CHEESES AND RELATED CHEESE PRODUCTS

0
10. The authority citation for part 133 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
11. In Sec.  133.102, add paragraph (c)(3) to read as follows:


Sec.  133.102  Asiago fresh and asiago soft cheese.

* * * * *
    (c) * * *
    (3) During the cheesemaking process, where the curd is salted, salt 
substitute may be used.
* * * * *
0
12. In Sec.  133.106, add paragraph(b)(3)(vii) to read as follows:


Sec.  133.106  Blue cheese.

* * * * *
    (b) * * *
    (3) * * *
    (vii) Salt substitute.
* * * * *
0
13. In Sec.  133.108, add paragraph (b)(3)(v) to read as follows:


Sec.  133.108  Brick cheese.

* * * * *
    (b) * * *
    (3) * * *
    (v) Salt substitute.
* * * * *
0
14. In Sec.  133.111, add paragraph (c)(3) to read as follows:


Sec.  133.111  Caciocavallo siciliano cheese.

* * * * *
    (c) * * *
    (3) During the cheesemaking process, where the curd is salted, salt 
substitute may be used.
* * * * *
0
15. In Sec.  133.113, add paragraph (b)(3)(vi) to read as follows:


Sec.  133.113  Cheddar cheese.

* * * * *
    (b) * * *
    (3) * * *
    (vi) Salt substitute.
* * * * *
0
16. In Sec.  133.118, revise the first sentence of paragraph (c)(2) and 
add paragraph (c)(4) to read as follows:


Sec.  133.118  Colby cheese.

* * * * *
    (c) * * *
    (2) Milk shall be deemed to have been pasteurized if it has been 
held at a temperature of not less than 145 [deg]F for a period of not 
less than 30 minutes, or for a time and at a temperature equivalent 
thereto in phosphatase destruction. * * *
* * * * *
    (4) During the cheesemaking process, where the curd is salted, salt 
substitute may be used.
* * * * *
0
17. In Sec.  133.123, revise paragraph (c)(3) to read as follows:


Sec.  133.123  Cold-pack and club cheese.

* * * * *
    (c) * * *
    (3) Salt or salt substitute.
* * * * *
0
18. In Sec.  133.124, revise paragraph (e)(3) to read as follows:


Sec.  133.124  Cold-pack cheese food.

* * * * *
    (e) * * *
    (3) Salt or salt substitute.
* * * * *
0
19. In Sec.  133.127, revise paragraph (b)(3)(v) to read as follows:


Sec.  133.127  Cook cheese, koch kaese.

* * * * *
    (b) * * *
    (3) * * *
    (v) Salt or salt substitute.
* * * * *
0
20. In Sec.  133.129, revise paragraphs (b)(1)(i) through (b)(1)(iii) 
to read as follows:


Sec.  133.129  Dry curd cottage cheese.

* * * * *
    (b) * * *
    (1) * * *
    (i) Harmless lactic-acid-producing bacteria, with or without rennet 
and/or other safe and suitable milk-clotting enzyme that produces 
equivalent curd formation, are added and it is held until it becomes 
coagulated. The coagulated mass may be cut; it may be warmed; it may be 
stirred; it is then drained. The curd may be washed with water and 
further drained; it may be pressed, chilled, worked, seasoned with salt 
or salt substitute; or
    (ii) Food grade phosphoric acid, lactic acid, citric acid, or 
hydrochloric acid, with or without rennet and/or other safe and 
suitable milk-clotting enzyme that produces equivalent curd formation, 
is added in such amount as to reach a pH of between 4.5 and 4.7; 
coagulation to a firm curd is achieved while heating to a maximum of 
120 [deg]F without agitation during a continuous process. The 
coagulated mass may be cut; it may be warmed; it may be stirred; it is 
then drained. The curd is washed with water, stirred, and further 
drained. It may be pressed, chilled, worked, seasoned with salt or salt 
substitute.
    (iii) Food grade acids as provided in paragraph (b)(1)(ii) of this 
section, D-Glucono-delta-lactone with or without rennet, and/or other 
safe and suitable milk clotting enzyme that produces equivalent curd 
formation, are added in such amounts as to reach a final pH value in 
the range of 4.5-4.8, and it is held until it becomes coagulated. The 
coagulated mass may be cut; it may be warmed; it may be stirred; it is 
then drained. The curd is then washed with water, and further drained. 
It may be pressed, chilled, worked, and seasoned with salt or salt 
substitute.
* * * * *
0
21. In Sec.  133.133, revise paragraph (b)(3)(i) to read as follows:


Sec.  133.133  Cream cheese.

* * * * *
    (b) * * *
    (3) * * *
    (i) Salt or salt substitute.
* * * * *
0
22. In Sec.  133.136, add paragraph (b)(3)(vi) to read as follows:


Sec.  133.136  Washed curd and soaked curd cheese.

* * * * *
    (b) * * *
    (3) * * *
    (vi) Salt substitute.
* * * * *
0
23. In Sec.  133.138, add paragraph (b)(3)(v) to read as follows:


Sec.  133.138  Edam cheese.

* * * * *
    (b) * * *
    (3) * * *
    (v) Salt substitute.
* * * * *

[[Page 21164]]

0
24. In Sec.  133.141, add paragraph (b)(3)(vii) to read as follows:


Sec.  133.141  Gorgonzola cheese.

* * * * *
    (b) * * *
    (3) * * *
    (vii) Salt substitute.
* * * * *
0
25. In Sec.  133.144, add paragraph (b)(3)(vi) to read as follows:


Sec.  133.144  Granular and stirred curd cheese.

* * * * *
    (b) * * *
    (3) * * *
    (vi) Salt substitute.
* * * * *
0
26. In Sec.  133.147, revise paragraph (c)(5) to read as follows:


Sec.  133.147  Grated American cheese food.

* * * * *
    (c) * * *
    (5) Salt or salt substitute.
* * * * *
0
27. In Sec.  133.148, revise paragraph (c) to read as follows:


Sec.  133.148  Hard grating cheeses.

* * * * *
    (c)(1) For the purposes of this section, the word ``milk'' means 
cow's milk or goat's milk or sheep's milk or mixtures of two or all of 
these. Such milk may be adjusted by separating part of the fat 
therefrom or (in the case of cow's milk) by adding one or more of the 
following: Cream, skim milk, concentrated skim milk, nonfat dry milk; 
(in the case of goat's milk) the corresponding products from goat's 
milk; (in the case of sheep's milk) the corresponding products from 
sheep's milk; water in a quantity sufficient to reconstitute any such 
concentrated or dried products used.
    (2) During the cheesemaking process, where the curd is salted, salt 
substitute may be used.
* * * * *
0
28. In Sec.  133.149, add paragraph (b)(3)(iv) to read as follows:


Sec.  133.149  Gruyere cheese.

* * * * *
    (b) * * *
    (3) * * *
    (iv) Salt substitute.
* * * * *
0
29. In Sec.  133.150, revise the first sentence of paragraph (c)(2), 
add paragraph (c)(3), and revise paragraph (e)(1) to read as follows:


Sec.  133.150  Hard cheeses.

* * * * *
    (c) * * *
    (2) Milk shall be deemed to have been pasteurized if it has been 
held at a temperature of not less than 145 [deg]F for a period of not 
less than 30 minutes, or for a time and at a temperature equivalent 
thereto in phosphatase destruction. * * *
    (3) During the cheesemaking process, where the curd is salted, salt 
substitute may be used.
* * * * *
    (e) * * *
    (1) The specific common or usual name of such hard cheese, if any 
such name has become generally recognized therefor; or
* * * * *
0
30. In Sec.  133.152, add paragraph (b)(3)(iv) to read as follows:


Sec.  133.152  Limburger cheese.

* * * * *
    (b) * * *
    (3) * * *
    (iv) Salt substitute.
* * * * *
0
31. In Sec.  133.153, revise paragraph (b)(3)(iii) to read as follows:


Sec.  133.153  Monterey cheese and Monterey jack cheese.

* * * * *
    (b) * * *
    (3) * * *
    (iii) Salt or salt substitute.
* * * * *
0
32. In Sec.  133.155, revise paragraph (b)(3)(iii) to read as follows:


Sec.  133.155  Mozzarella cheese and scamorza cheese.

* * * * *
    (b) * * *
    (3) * * *
    (iii) Salt or salt substitute.
* * * * *
0
33. In Sec.  133.156, revise paragraph (b)(3)(iii) to read as follows:


Sec.  133.156  Low-moisture mozzarella and scamorza cheese.

* * * * *
    (b) * * *
    (3) * * *
    (iii) Salt or salt substitute.
* * * * *
0
34. In Sec.  133.160, add paragraph (b)(3)(vi) to read as follows:


Sec.  133.160  Muenster and munster cheese.

* * * * *
    (b) * * *
    (3) * * *
    (vi) Salt substitute.
* * * * *
0
35. In Sec.  133.162, revise paragraph (b)(3)(i) to read as follows:


Sec.  133.162  Neufchatel cheese.

* * * * *
    (b) * * *
    (3) * * *
    (i) Salt or salt substitute.
* * * * *
0
36. In Sec.  133.164, add paragraph (b)(3)(iv) to read as follows:


Sec.  133.164  Nuworld cheese.

* * * * *
    (b) * * *
    (3) * * *
    (iv) Salt substitute.
* * * * *
0
37. In Sec.  133.165, add paragraph (c)(3) to read as follows:


Sec.  133.165  Parmesan and reggiano cheese.

* * * * *
    (c) * * *
    (3) During the cheesemaking process, where the curd is salted, salt 
substitute may be used.
* * * * *
0
38. In Sec.  133.169, revise paragraph (d)(4) to read as follows:


Sec.  133.169  Pasteurized process cheese.

* * * * *
    (d) * * *
    (4) Salt or salt substitute.
* * * * *
0
39. In Sec.  133.173, revise paragraph (e)(4) to read as follows:


Sec.  133.173  Pasteurized process cheese food.

* * * * *
    (e) * * *
    (4) Salt or salt substitute.
* * * * *
0
40. In Sec.  133.179, revise paragraph (f)(5) to read as follows:


Sec.  133.179  Pasteurized process cheese spread.

* * * * *
    (f) * * *
    (5) Salt or salt substitute.
* * * * *
0
41. In Sec.  133.181, add paragraph (b)(3)(vi) to read as follows:


Sec.  133.181  Provolone cheese.

* * * * *
    (b) * * *
    (3) * * *
    (vi) Salt substitute.
* * * * *
0
42. In Sec.  133.182, revise the tenth sentence in paragraph (b) and 
revise paragraph (c)(2) to read as follows:


Sec.  133.182  Soft ripened cheeses.

* * * * *
    (b) * * * Salt or salt substitute may be added during the 
procedure. * * *
* * * * *
    (c) * * *
    (2) Milk shall be deemed to have been pasteurized if it has been 
held at a

[[Page 21165]]

temperature of not less than 145 [deg]F for a period of not less than 
30 minutes, or for a time and at a temperature equivalent thereto in 
phosphatase destruction.
* * * * *
0
43. In Sec.  133.183, add paragraph (c)(3) to read as follows:


Sec.  133.183  Romano cheese.

* * * * *
    (c) * * *
    (3) During the cheesemaking process, where the curd is salted, salt 
substitute may be used.
* * * * *
0
44. In Sec.  133.184, revise paragraphs (b) introductory text and 
(b)(3) to read as follows:


Sec.  133.184  Roquefort cheese, sheep's milk blue-mold, and blue-mold 
cheese from sheep's milk.

* * * * *
    (b) Optional Ingredients. The following safe and suitable 
ingredients may be used:
* * * * *
    (3) Other optional ingredients.
    (i) Enzymes of animal, plant, or microbial origin, used in curing 
or flavor development.
    (ii) Salt substitute.
* * * * *
0
45. In Sec.  133.185, add paragraph (b)(3)(v) to read as follows:


Sec.  133.185  Samsoe cheese.

* * * * *
    (b) * * *
    (3) * * *
    (v) Salt substitute.
* * * * *
0
46. In Sec.  133.186, revise paragraphs (a)(2) and (c) to read as 
follows:


Sec.  133.186  Sap sago cheese.

    (a) * * *
    (2) One or more of the dairy ingredients specified in paragraph 
(b)(1) of this section is allowed to become sour, and is heated to 
boiling temperature, with stirring. Sufficient sour whey is added to 
precipitate the casein. The curd is removed, spread out in boxes, and 
pressed, and while under pressure is allowed to drain and ferment. It 
is ripened for not less than 5 weeks. The ripened curd is dried and 
ground; salt or salt substitute and dried clover of the species 
Melilotus coerulea are added. The mixture is shaped into truncated 
cones and ripened. The optional ingredient in paragraph (b)(2) of this 
section may be added during this procedure.
* * * * *
    (c) Nomenclature. The name of the food is ``sap sago cheese.''
* * * * *
0
47. In Sec.  133.187, revise the tenth sentence of paragraph (b) and 
the first sentence of paragraph (c)(2) to read as follows:


Sec.  133.187  Semisoft cheeses.

* * * * *
    (b) * * * Salt or salt substitute may be added during the 
procedure. * * *
* * * * *
    (c) * * *
    (2) Milk shall be deemed to have been pasteurized if it has been 
held at a temperature of not less than 145 [deg]F for a period of not 
less than 30 minutes, or for a time and at a temperature equivalent 
thereto in phosphatase destruction. * * *
* * * * *
0
48. In Sec.  133.188, revise the tenth sentence in paragraph (b) and 
the first sentence in paragraph (c)(2) to read as follows:


Sec.  133.188  Semisoft part-skim cheeses.

* * * * *
    (b) * * * Salt or salt substitute may be added during the 
procedure. * * *
* * * * *
    (c) * * *
    (2) Milk shall be deemed to have been pasteurized if it has been 
held at a temperature of not less than 145 [deg]F for a period of not 
less than 30 minutes, or for a time and at a temperature equivalent 
thereto in phosphatase destruction. * * *
* * * * *
0
49. In Sec.  133.189, revise paragraph (d) to read as follows:


Sec.  133.189  Skim milk cheese for manufacturing.

* * * * *
    (d)(1) For the purposes of this section, ``skim milk'' means cow's 
milk from which the milk fat has been separated.
    (2) During the cheesemaking process, where the curd is salted, salt 
substitute may be used.
* * * * *
0
50. In Sec.  133.190, revise paragraph (b)(3)(iii) to read as follows:


Sec.  133.190  Spiced cheeses.

* * * * *
    (b) * * *
    (3) * * *
    (iii) Salt or salt substitute.
* * * * *
0
51. In Sec.  133.195, add paragraph (b)(3)(vii) to read as follows:


Sec.  133.195  Swiss and emmentaler cheese.

* * * * *
    (b) * * *
    (3) * * *
    (vii) Salt substitute.
* * * * *

PART 136--BAKERY PRODUCTS

0
52. The authority citation for part 136 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
53. In Sec.  136.110, revise paragraphs (c)(4) and (d) to read as 
follows:


Sec.  136.110  Bread, rolls, and buns.

* * * * *
    (c) * * *
    (4) Salt or salt substitute.
* * * * *
    (d) Total solids are determined by the method prescribed in AOAC 
Official Method 935.36(a), Solids (Total) in Bread, except that if the 
baked unit weighs 454 grams (1 pound) or more, one entire unit is used 
for the determination; if the baked unit weighs less than 454 grams, 
enough units to weigh 454 grams or more are used. AOAC Official Method 
935.36(a), Solids (Total) in Bread, ``Official Methods of Analysis,'' 
21st Ed. (2019), is incorporated by reference into this section with 
the approval of the Director of the Federal Register under 5 U.S.C 
552(a) and 1 CFR part 51. This incorporation by reference (IBR) 
material is available for inspection at the Food and Drug 
Administration (FDA) and at the National Archives and Records 
Administration (NARA). Contact FDA's Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. For 
information on the availability of this material at NARA, visit 
www.archives.gov/federal-register/cfr/ibr-locations or email 
[email protected]. This material is also available from AOAC 
INTERNATIONAL, 2275 Research Blvd., Suite 300, Rockville, MD 20850-
3250, 1-800-379-2622.
* * * * *

PART 137--CEREAL FLOURS AND RELATED PRODUCTS

0
54. The authority citation for part 137 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
55. Add subpart A, consisting of Sec. Sec.  137.1 through 137.100, to 
read as follows:
Subpart A--General Provisions.
Sec.
137.10 Incorporation by reference.
137.20 through 137.100 [Reserved]

[[Page 21166]]

Subpart A--General Provisions.


Sec.  137.10  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Food and 
Drug Administration (FDA) and at the National Archives and Records 
Administration (NARA). Contact FDA's Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. For 
information on the availability of this material at NARA, visit 
www.archives.gov/federal-register/cfr/ibr-locations or email 
[email protected]. The material may be obtained from AOAC 
INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 
20850-3250, 1-800-379-2622:
    (a) Official Methods of Analysis, 21st Ed. (2019);
    (1) AOAC Official Method 923.02A, Reagent; IBR Sec. Sec.  
137.180(c); 137.270(b).
    (2) AOAC Official Method 923.02B, Apparatus, under Carbon Dioxide 
(Total) in Baking Powders Gasometric Determination; IBR Sec. Sec.  
137.180(c); 137.270(b).
    (3) Reference Table 909.04, Correction Factors for Gasometric 
Determination of Carbon Dioxide; IBR Sec. Sec.  137.180(c); 137.270(b).
    (b) [Reserved]


Sec. Sec.  137.20 through 137.100  [Reserved]

0
56. In Sec.  137.180, revise paragraphs (a), (c) introductory text, and 
(c)(1) to read as follows:


Sec.  137.180  Self-rising flour.

    (a) Description. Self-rising flour, self-rising white flour, self-
rising wheat flour, is an intimate mixture of flour, sodium 
bicarbonate, and one or more of the acid-reacting substances 
monocalcium phosphate, sodium acid pyrophosphate, and sodium aluminum 
phosphate. It is seasoned with salt or salt substitute. When it is 
tested by the method prescribed in paragraph (c) of this section, not 
less than 0.5 percent of carbon dioxide is evolved. The acid-reacting 
substance is added in sufficient quantity to neutralize the sodium 
bicarbonate. The combined weight of such acid-reacting substance and 
sodium bicarbonate is not more than 4.5 parts to each 100 parts of 
flour used. Subject to the conditions and restrictions prescribed by 
Sec.  137.105(a), the bleaching ingredients specified in such section 
may be added as optional ingredients. If the flour used in making the 
self-rising flour is bleached, the optional bleaching ingredient used 
therein (see Sec.  137.105(a)) is also an optional ingredient of the 
self-rising flour.
* * * * *
    (c) Method of analysis. Follow the method prescribed in AOAC 
Official Method 923.02A, Reagent, and 923.02B, Apparatus, under Carbon 
Dioxide (Total) in Baking Powders Gasometric Determination 
(incorporated by reference, see Sec.  137.10): Instead of using AOAC 
Official Method 923.02C, Determination, use the following procedure:
    (1) Weigh 17 grams of the official sample into flask A, add 15-20 
glass beads (4-6 mm. diameter), and connect this flask with the 
apparatus (fig. 923.02). Open stopcock C and by means of the leveling 
bulb E bring the displacement solution to the 25 cc. graduation above 
the zero mark. (This 25 cc. is a partial allowance for the volume of 
acid to be used in the decomposition.) Allow the apparatus to stand 1-2 
minutes to ensure that the temperature and pressure within the 
apparatus are the same as those of the room. Close the stopcock, lower 
the leveling bulb somewhat to reduce the pressure within the apparatus, 
and slowly run into the decomposition flask from burette F 45 cc. of 
sulfuric acid (1 + 5). To prevent the liberated carbon dioxide from 
escaping through the acid burette into the air, keep the displacement 
solution in the leveling bulb at all times during the decomposition at 
a lower level than that in the gas-measuring tube. Rotate and then 
vigorously agitate the decomposition flask for 3 minutes to mix the 
contents intimately. Allow to stand for 10 minutes to bring to 
equilibrium. Equalize the pressure in the measuring tube by means of 
the leveling bulb and read the volume of gas from the zero point on the 
tube. Deduct 20 cc. from this reading (this 20 cc. together with 
previous allowance of 25 cc. compensates for the 45 cc. acid used in 
the decomposition). Observe the temperature of the air surrounding the 
apparatus and also the barometric pressure and multiply the number of 
milliliters of gas evolved by the factor given in Reference Table 
909.04, ``Correction Factors for Gasometric Determination of Carbon 
Dioxide'', incorporated by reference, see Sec.  137.10) for the 
temperature and pressure observed. Divide the corrected reading by 100 
to obtain the apparent percent by weight of carbon dioxide in the 
official sample.
* * * * *
0
57. In Sec.  137.270, revise paragraphs (a), (b) introductory text, and 
(b)(1) to read as follows:


Sec.  137.270  Self-rising white corn meal.

    (a) Description. Self-rising white corn meal is an intimate mixture 
of white corn meal, sodium bicarbonate, and one or both of the acid-
reacting substances monocalcium phosphate and sodium aluminum 
phosphate. It is seasoned with salt or salt substitute. When it is 
tested by the method prescribed in paragraph (b) of this section, not 
less than 0.5 percent of carbon dioxide is evolved. The acid-reacting 
substance is added in sufficient quantity to neutralize the sodium 
bicarbonate. The combined weight of such acid-reacting substance and 
sodium bicarbonate is not more than 4.5 parts to each 100 parts of 
white corn meal used.
    (b) Method of analysis. Follow the method prescribed in AOAC 
Official Method 923.02A, Reagent, and 923.02B, Apparatus, under Carbon 
Dioxide (Total) in Baking Powders Gasometric Determination 
(incorporated by reference, see Sec.  137.10): Instead of using AOAC 
Official Method 923.02C, Determination, use the following procedure:
    (1) Weigh 17 grams of the official sample into flask A, add 15-20 
glass beads (4-6 mm. diameter), and connect this flask with the 
apparatus (fig. 923.02). Open stopcock C and by means of the leveling 
bulk E bring the displacement solution to the 25 cc. graduation above 
the zero mark. (This 25 cc. is a partial allowance for the volume of 
acid to be used in the decomposition.) Allow the apparatus to stand 1-2 
minutes to ensure that the temperature and pressure within the 
apparatus are the same as those of the room. Close the stopcock, lower 
the leveling bulb somewhat to reduce the pressure within the apparatus, 
and slowly run into the decomposition flask from burette F 45 cc. of 
sulfuric acid (1 + 5). To prevent the liberated carbon dioxide from 
escaping through the acid burette into the air, keep the displacement 
solution in the leveling bulb at all times during the decomposition at 
a lower level than that in the gas-measuring tube. Rotate and then 
vigorously agitate the decomposition flask for 3 minutes to mix the 
contents intimately. Allow to stand for 10 minutes to bring to 
equilibrium. Equalize the pressure in the measuring tube by means of 
the leveling bulb and read the volume of gas from the zero point on the 
tube. Deduct 20 cc. from this reading (this 20 cc. together with 
previous allowance of 25 cc. compensates for the 45 cc. acid used

[[Page 21167]]

in the decomposition). Observe the temperature of the air surrounding 
the apparatus and also the barometric pressure and multiply the number 
of milliliters of gas evolved by the factor given in the Reference 
Table 909.04, ``Correction Factors for Gasometric Determination of 
Carbon Dioxide'' (incorporated by reference, see Sec.  137.10) for the 
temperature and pressure observed. Divide the corrected reading by 100 
to obtain the apparent percent by weight of carbon dioxide in the 
official sample.
* * * * *

PART 139--MACARONI AND NOODLE PRODUCTS

0
58. The authority citation for part 139 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
59. Add subpart A, consisting of Sec. Sec.  1397.10 through 139.100, to 
read as follows:
Subpart A--General Provisions.
Sec.
139.10 Incorporation by reference.
139.20 through 139.100 [Reserved]

Subpart A--General Provisions.


Sec.  139.10  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Food and 
Drug Administration (FDA) and at the National Archives and Records 
Administration (NARA). Contact FDA's Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. For 
information on the availability of this material at NARA, visit 
www.archives.gov/federal-register/cfr/ibr-locations or email 
[email protected]. The material may be obtained from AOAC 
INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 
20850-3250, 1-800-379-2622.
    (a) Official Methods of Analysis, 21st Ed. (2019);
    (1) AOAC Official Method 926.07A, Vacuum Oven Method, under Solids 
(Total) and Loss on Drying (Moisture) in Macaroni Products; IBR 
Sec. Sec.  139.110(a); 139.150(a).
    (2) [Reserved]
    (b) [Reserved]


Sec. Sec.  139.20 through 139.100  [Reserved]

0
60. In Sec.  139.110, revise paragraphs (a)(4) and (5) to read as 
follows:


Sec.  139.110  Macaroni products.

    (a) * * *
    (4) Salt or salt substitute, in a quantity that seasons the food.
    (5) Gum gluten, in such quantity that the protein content of the 
finished food is not more than 13 percent by weight. The finished 
macaroni product contains not less than 87 percent of total solids as 
determined by AOAC Official Method 926.07A(incorporated by reference, 
see Sec.  139.10).
* * * * *
0
61. In Sec.  139.150, revise paragraphs (a)(2) and (4) to read as 
follows:


Sec.  139.150  Noodle products.

    (a) * * *
    (2) Salt or salt substitute, in a quantity that seasons the food.
* * * * *
    (4) Concentrated glyceryl monostearate (containing not less than 90 
percent monoester) in a quantity not exceeding 3 percent by weight of 
the finished food. The finished noodle product contains not less than 
87 percent of total solids as determined by AOAC Official Method 
926.07A(incorporated by reference, see Sec.  139.10). The total solids 
of noodle products contains not less than 5.5 percent by weight of the 
solids of egg, or egg yolk.
* * * * *

PART 145--CANNED FRUITS

0
62. The authority citation for part 145 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
63. In Sec.  145.110, revise paragraphs (a)(1) and (a)(2)(iii) to read 
as follows:


Sec.  145.110  Canned applesauce.

    (a) * * *
    (1) Definition. Canned applesauce is the food prepared from 
comminuted or chopped apples (Malus domestica Borkhausen), which may or 
may not be peeled and cored, and which may have added thereto one or 
more of the optional ingredients specified in paragraph (a)(2) of this 
section. The apple ingredient is heated and, in accordance with good 
manufacturing practices, bruised apple particles, peel, seed, core 
material, carpel tissue, and other coarse, hard, or extraneous 
materials are removed. The food is sealed in containers. It is so 
processed by heat, either before or after sealing, as to prevent 
spoilage. The soluble solids content, measured by refractometer and 
expressed as percent sucrose (degrees Brix) with correction for 
temperature to the equivalent at 20 [deg]C (68 [deg]F), is not less 
than 9 percent (exclusive of the solids of any added optional nutritive 
carbohydrate sweeteners) as determined by AOAC Official Method 932.12 
but without correction for invert sugar or other substances. AOAC 
Official Method 932.12, ``Solids (Soluble) in Fruits and Fruit 
Products,'' in ``Official Methods of Analysis of AOAC INTERNATIONAL,'' 
21st Ed. (2019), is incorporated by reference into this section with 
the approval of the Director of the Federal Register under 5 U.S.C. 
552(a) and 1 CFR part 51,. All approved incorporation by reference 
(IBR) material is available for inspection at the Food and Drug 
Administration (FDA) and the National Archives and Records 
Administration (NARA). Contact the FDA at FDA's Dockets Management 
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. 
For information on the availability of this material at NARA, visit 
www.archives.gov/federal-register/cfr/ibr-locations or email 
[email protected]. This material is available from AOAC 
INTERNATIONAL, 2275 Research Blvd., Suite 300, Rockville, MD 20850-
3250, 1-800-379-2622.
    (2) * * *
    (iii) Salt or salt substitute.
* * * * *
0
64. In Sec.  145.130, revise paragraph (a)(5) to read as follows:


Sec.  145.130  Canned figs.

    (a) * * *
    (5) Salt or salt substitute.
* * * * *

PART 150--FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS

0
65. The authority citation for part 150 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
66. Add subpart A, consisting of Sec. Sec.  150.10 through 150.100, to 
read as follows:
Subpart A--General Provisions.
Sec.
150.10 Incorporation by reference.
150.20 through 150.100 [Reserved]

Subpart A--General Provisions.


Sec.  150.10  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Food and 
Drug Administration

[[Page 21168]]

(FDA) and at the National Archives and Records Administration (NARA). 
Contact FDA's Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, 240-402-7500. For information on the availability 
of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The material may be 
obtained from AOAC INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 
300, Rockville, MD 20850-3250, 1-800-379-2622.
    (a) Official Methods of Analysis, 21st Ed. (2019);
    (1) AOAC Official Method 932.12, Solids (Soluble) in Fruits and 
Fruit Products; IBR Sec.  150.110(d).
    (2) AOAC Official Method 932.14C, By Means of Refractometer, under 
Solids in Syrups; IBR Sec.  150.110(d).
    (b) [Reserved]


Sec. Sec.  150.20 through 150.100  [Reserved]

0
67. In Sec.  150.110, revise paragraphs (c)(4), (d)(3), and (d)(5) to 
read as follows:


Sec.  150.110  Fruit butter.

* * * * *
    (c) * * *
    (4) Salt or salt substitute.
* * * * *
    (d) * * *
    (3) The soluble solids content of the finished fruit butter is not 
less than 43 percent, as determined by AOAC Official Method 932.12 
(incorporated by reference, see Sec.  150.10).
* * * * *
    (5) The weight of fruit juice or diluted fruit juice or 
concentrated fruit juice (optional ingredient, paragraph (c)(6) of this 
section) from a fruit specified in paragraph (b)(1) of this section is 
the weight of such juice, as determined by the method prescribed in 
paragraph (d)(2) of this section, except that the percent of soluble 
solids is determined by AOAC Official Method 932.14C, under Solids in 
Syrups (incorporated by reference, see Sec.  150.10); the weight of 
diluted concentrated juice from any other fruits is the original weight 
of the juice before it was diluted or concentrated.
* * * * *

PART 155--CANNED VEGETABLES

0
68. The authority citation for part 155 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 348, 371, 379(e).

0
69. Add Sec.  155.10 to subpart A to read as follows:


Sec.  155.10  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Food and 
Drug Administration (FDA) and at the National Archives and Records 
Administration (NARA). Contact FDA's Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. For 
information on the availability of this material at NARA, visit 
www.archives.gov/federal-register/cfr/ibr-locations or email 
[email protected]. The material may be obtained from AOAC 
INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 
20850-3250, 1-800-379-2622.
    (a) Official Methods of Analysis, 21st Ed. (2019);
    (1) Table 1, ``Nominal Dimensions of Standard Test Sieves (USA 
Standard Series),'' under the heading ``Definition of Terms and 
Explanatory Notes''; IBR Sec. Sec.  155.120(b); 155.130(b).
    (2) AOAC Official Method 938.10, Solids (Alcohol-Insoluble) in 
Canned Peas Gravimetric Method; IBR Sec.  155.170(b).
    (b) [Reserved]
0
70. In Sec.  155.120, revise paragraphs (a)(3)(i) and (b)(2)(i) to read 
as follows:


Sec.  155.120  Canned green beans and canned wax beans.

    (a) * * *
    (3) * * *
    (i) Salt or salt substitute.
* * * * *
    (b) * * *
    (2) * * *
    (i) Determine the gross weight of the container. Open and 
distribute the contents of the container over the meshes of a U.S. No. 
8 circular sieve with openings of 2.36 mm (0.0937 in), which has been 
previously weighed. The diameter of the sieve is 20.3 cm (8 in) if the 
quantity of contents of the container is less than 1.36 kg (3 lbs) and 
30.5 cm (12 in) if such quantity is 1.36 kg (3 lbs) or more. The bottom 
of the sieve is woven-wire cloth that complies with the specifications 
of such cloth set forth in ``Official Methods of Analysis'', Table 1, 
``Nominal Dimensions of Standard Test Sieves (USA Standard Series),'' 
under the heading ``Definition of Terms and Explanatory Notes,'' 
(incorporated by reference, see Sec.  155.10). Without shifting the 
material on the sieve, incline the sieve 17[deg] to 20[deg] to 
facilitate drainage. Two minutes after drainage begins, weigh the sieve 
and the drained material. Record in grams (ounces) the weight so found, 
less the weight of the sieve, as the drained weight. Dry and weigh the 
empty container and subtract this weight from the gross weight to 
obtain the net weight. Calculate the percent of drained liquid in the 
net weight.
* * * * *
0
71. In Sec.  155.130, revise paragraphs (a)(3)(i) and (b)(2)(i) to read 
as follows:


Sec.  155.130  Canned corn.

    (a) * * *
    (3) * * *
    (i) Salt or salt substitute.
* * * * *
    (b) * * *
    (2) * * *
    (i) Determine the gross weight of the container. Open and 
distribute the contents of the container over the meshes of a U.S. No. 
8 circular sieve, which has previously been weighed. The diameter of 
the sieve is 20.3 cm. (8 in) if the quantity of the contents of the 
container is less than 1.36 kg. (3 lbs), and 30.5 cm. (12 in) if such 
quantity is 1.36 kg. (3 lbs) or more. The bottom of the sieve is woven-
wire cloth that complies with the specifications for such sieve set 
forth in ``Official Methods of Analysis'', Table 1, ``Nominal 
Dimensions of Standard Test Sieves (USA Standard Series),'' under the 
heading ``Definition of Terms and Explanatory Notes'' (incorporated by 
reference, see Sec.  155.10). Without shifting the material on the 
sieve, so incline the sieve at approximately 17[deg] to 20[deg] angle 
to facilitate drainage. Two minutes from the time drainage begins, 
weigh the sieve and the drained material. Record, in grams (ounces), 
the weight so found, less the weight of the sieve, as the drained 
weight. Dry and weigh the empty container and subtract this weight from 
the gross weight to obtain the net weight. Calculate the percent of 
drained liquid in the net weight.
* * * * *
0
72. In Sec.  155.170, revise paragraph (a)(2)(i), and paragraphs 
(b)(1)(iii) and (vi) to read as follows:


Sec.  155.170  Canned peas.

    (a) * * *
    (2) * * *
    (i) Salt or salt substitute.
* * * * *
    (b) * * *
    (1) * * *
* * * * *
    (iii) Seriously blemished peas. Not more than 1 percent of the 
drained weight is seriously blemished peas, i.e., peas that are hard, 
shriveled, spotted,

[[Page 21169]]

discolored, or otherwise blemished to an extent that the appearance or 
eating quality is seriously affected.
* * * * *
    (vi) Alcohol-insoluble solids. The alcohol-insoluble solids of 
smooth-skin or substantially smooth-skin peas, such as Alaska-type peas 
or hybrids having similar characteristics, may not be more than 23.5 
percent and, of sweet green wrinkled varieties or hybrids having 
similar characteristics, not more than 21 percent based on the 
procedure set forth in tAOAC Official Method 938.10(incorporated by 
reference, see Sec.  155.10).
* * * * *
0
73. In Sec.  155.190, revise paragraph (a)(2)(iv) to read as follows:


Sec.  155.190  Canned tomatoes.

    (a) * * *
    (2) * * *
    (iv) Salt or salt substitute.
* * * * *
0
74. In Sec.  155.191, revise paragraph (a)(2)(i) to read as follows:


Sec.  155.191  Tomato concentrates.

    (a) * * *
    (2) * * *
    (i) Salt or salt substitute (sodium chloride formed during acid 
neutralization shall be considered added salt).
* * * * *
0
75. In Sec.  155.194, revise paragraph (a)(1)(iv) to read as follows:


Sec.  155.194  Catsup.

    (a) * * *
    (1) * * *
    (iv) The liquid obtained from the residue from partial extraction 
of juice from such tomatoes. Such liquid is strained so as to exclude 
skins, seeds, and other coarse or hard substances in accordance with 
current good manufacturing practice. Prior to straining, food-grade 
hydrochloric acid may be added to the tomato material in an amount to 
obtain a pH no lower than 2.0. Such acid is then neutralized with food-
grade sodium hydroxide so that the treated tomato material is restored 
to a pH of 4.2  0.2. The final composition of the food may 
be adjusted by concentration and/or by the addition of water. The food 
may contain salt or salt substitute (sodium chloride formed during acid 
neutralization shall be considered added salt) and is seasoned with 
ingredients as specified in paragraph (a)(2) of this section. The food 
is preserved by heat sterilization (canning), refrigeration, or 
freezing. When sealed in a container to be held at ambient 
temperatures, it is so processed by heat, before or after sealing, as 
to prevent spoilage.
* * * * *
0
76. In Sec.  155.200, revise paragraph (c)(4)(i) to read as follows:


Sec.  155.200  Certain other canned vegetables.

* * * * *
    (c) * * *
    (4) * * *
    (i) Salt or salt substitute.
* * * * *
0
77. In Sec.  155.201, revise paragraph (a)(3)(i) to read as follows:


Sec.  155.201  Canned mushrooms.

    (a) * * *
    (3) * * *
    (i) Salt or salt substitute.
* * * * *

PART 156--VEGETABLE JUICES

0
78. The authority citation for part 156 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 343, 348, 371.

0
79. In Sec.  156.145, revise paragraph (a)(1) to read as follows:


Sec.  156.145  Tomato juice.

    (a) * * *
    (1) Definition. Tomato juice is the food intended for direct 
consumption, obtained from the unfermented liquid extracted from mature 
tomatoes of the red or reddish varieties of Lycopersicum esculentum P. 
Mill, with or without scalding followed by draining. In the extraction 
of such liquid, heat may be applied by any method which does not add 
water thereto. Such juice is strained free from peel, seeds, and other 
coarse or hard substances, but contains finely divided insoluble solids 
from the flesh of the tomato in accordance with current good 
manufacturing practice. Such juice may be homogenized, may be seasoned 
with salt or salt substitute, and may be acidified with any safe and 
suitable organic acid. The juice may have been concentrated and later 
reconstituted with water and/or tomato juice to a tomato soluble solids 
content of not less than 5.0 percent by weight as determined by the 
method prescribed in Sec.  156.3(b). The food is preserved by heat 
sterilization (canning), refrigeration, or freezing. When sealed in a 
container to be held at ambient temperatures, it is so processed by 
heat, before or after sealing, as to prevent spoilage.
* * * * *

PART 158--FROZEN VEGETABLES

0
80. The authority citation for part 158 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 343, 348, 371.

0
81. In Sec.  158.170, revise paragraphs (a)(1)(iv) and (b)(1)(iii) to 
read as follows:


Sec.  158.170  Frozen peas.

    (a) * * *
    (1) * * *
    (iv) Salt or salt substitute.
* * * * *
    (b) * * *
    (1) * * *
    (iii) Not more than 2 percent by weight seriously blemished peas, 
i.e., peas that are hard, shriveled, spotted, discolored or otherwise 
blemished to an extent that the appearance or eating quality is 
seriously affected.
* * * * *

PART 161--FISH AND SHELLFISH

0
82. The authority citation for part 161 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
83. Add Sec.  161.10 to read as follows:


Sec.  161.10  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Food and 
Drug Administration (FDA) and at the National Archives and Records 
Administration (NARA). Contact FDA's Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. For 
information on the availability of this material at NARA, visitn 
www.archives.gov/federal-register/cfr/ibr-locations or email 
[email protected]. The material may be obtained from AOAC 
INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 
20850-3250, 1-800-379-2622.
    (a) Official Methods of Analysis, 21st Ed. (2019);
    (1) Table 1, ``Nominal Dimensions of Standard Test Sieves (USA 
Standard Series),'' under the heading ``Definition of Terms and 
Explanatory Notes''; IBR Sec. Sec.  161.145(c); 161.173(c); 
161.190(a)(7).
    (2) [Reserved]
    (b) [Reserved]
0
84. In Sec.  161.145, revise paragraphs (a)(1) and (c)(3) to read as 
follows:


Sec.  161.145  Canned oysters.

    (a) * * *
    (1) Canned oysters is the food prepared from one or any mixture of 
two or all of the forms of oysters

[[Page 21170]]

specified in paragraph (a)(2) of this section, and a packing medium of 
water, or the watery liquid draining from oysters before or during 
processing, or a mixture of such liquid and water. The food may be 
seasoned with salt or salt substitute. It is sealed in containers and 
so processed by heat as to prevent spoilage.
* * * * *
    (c) * * *
    (3) Drained weight is determined by the following method: Keep the 
unopened canned oyster container at a temperature of not less than 68 
[deg]F or more than 95 [deg]F for at least 12 hours immediately 
preceding the determination. After opening, tilt the container so as to 
distribute its contents evenly over the meshes of a circular sieve that 
has been previously weighed. The diameter of the sieve is 8 inches if 
the quantity of the contents of the container is less than 3 pounds and 
12 inches if such quantity is 3 pounds or more. The bottom of the sieve 
is woven-wire cloth that complies with the specifications for such 
cloth set forth under ``2.36 mm (No. 8)'' in ``Official Methods of 
Analysis,'' Table 1, ``Nominal Dimensions of Standard Test Sieves (USA 
Standard Series),'' under the heading ``Definition of Terms and 
Explanatory Notes,'' (incorporated by reference, see Sec.  161.10). 
Without shifting the material on the sieve, so incline the sieve as to 
facilitate drainage. Two minutes from the time drainage begins, weigh 
the sieve and the drained oysters. The weight so found, less the weight 
of the sieve, shall be considered to be the drained weight of the 
oysters.
* * * * *
0
85. In Sec.  161.170, revise paragraph (a)(4)(i) to read as follows:


Sec.  161.170  Canned Pacific salmon.

    (a) * * *
    (4) * * *
    (i) Salt or salt substitute.
* * * * *
0
86. In Sec.  161.173, revise paragraphs (a)(4)(i) and (c)(1) to read as 
follows:


Sec.  161.173  Canned wet pack shrimp in transparent or nontransparent 
containers.

    (a) * * *
    (4) * * *
    (i) Salt or salt substitute.
* * * * *
    (c) * * *
    (1) The standard of fill of transparent or nontransparent 
containers for canned wet pack shrimp is a fill such that the cut-out 
weight of shrimp taken from each container is not less than 60 percent 
of the weight of the water required to fill the container. The weight 
of the water required to fill the container is determined by the 
general method provided in Sec.  130.12(a) of this chapter. Cut-out 
weight is determined by the following method: Keep the unopened canned 
shrimp container at a temperature of not less than 68 [deg]F nor more 
than 75 [deg]F for at least 12 hours immediately preceding the 
determination. After opening, distribute the shrimp evenly over the 
meshes of a circular sieve that has been previously weighed. The 
diameter of the sieve is 20.3 centimeters (8 inches) if the quantity of 
the contents of the container is less than 1.36 kilograms (3 pounds), 
and 30.5 centimeters (12 inches) if such quantity is 1.36 kilograms (3 
pounds) or more. The bottom of the sieve is woven-wire cloth that 
complies with the specifications for such cloth set forth as a 2.36 mm 
(No. 8) sieve in ``Official Methods of Analysis'' (incorporated by 
reference, see Sec.  161.10), Table 1, ``Nominal Dimensions of Standard 
Test Sieves (USA Standard Series), under the heading ``Definition of 
Terms and Explanatory Notes'' (incorporated by reference, see Sec.  
161.10) Without shifting the material on the sieve, incline the sieve 
at an angle of approximately 17[deg] to 20[deg] to facilitate drainage. 
Allow the shrimp to drain for 2 minutes, measured from the moment the 
product is poured onto the sieve. Weigh the sieve and the drained 
shrimp. The weight so found, less the weight of the sieve, shall be 
considered to be the cut-out weight of the shrimp.
* * * * *
0
87. In Sec.  161.190, revise paragraphs (a)(6)(i) and (a)(7) 
introductory text to read as follows:


Sec.  161.190  Canned tuna.

    (a) * * *
    (6) * * *
    (i) Salt or salt substitute.
* * * * *
    (7) For determination of the color designations specified in 
paragraph (a)(4) of this section, the following method shall be used: 
Recombine the separations of pressed cake resulting from the method 
prescribed in paragraph (c)(2) of this section. Pass the combined 
portions through a sieve fitted with woven-wire cloth of \1/4\-inch 
mesh complying with the specifications for such cloth set forth in 
``Official Methods of Analysis'', Table 1, ``Nominal Dimensions of 
Standard Test Sieves (USA Standard Series),'' under the heading 
``Definitions of Terms and Explanatory Notes'' (incorporated by 
reference, see Sec.  161.10) Mix the sieved material and place a 
sufficient quantity into a 307 x 113 size container (bearing a top seam 
and having a false bottom approximately \1/2\-inch deep and painted 
flat black inside and outside) so that after tamping and smoothing the 
surface of the sample the material will be \1/8\-inch to \1/4\-inch 
below the top of the container. Within 10 minutes after sieving through 
the \1/4\-inch mesh woven-wire cloth, determine the Munsell value of 
sample surface.
* * * * *

PART 163--CACAO PRODUCTS

0
88. The authority citation for part 163 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 341, 343, 348, 371, 379e.

0
89. In Sec.  163.111, revise paragraph (b)(6) to read as follows:


Sec.  163.111  Chocolate liquor.

* * * * *
    (b) * * *
    (6) Salt or salt substitute.
* * * * *
0
90. In Sec.  163.112, revise paragraph (b)(4) to read as follows:


Sec.  163.112  Breakfast cocoa.

* * * * *
    (b) * * *
    (4) Salt or salt substitute.
* * * * *
0
91. In Sec.  163.123, revise paragraph (b)(3) to read as follows:


Sec.  163.123  Sweet chocolate.

* * * * *
    (b) * * *
    (3) Spices, natural and artificial flavorings, ground whole nut 
meats, ground coffee, dried malted cereal extract, salt or salt 
substitute, and other seasonings that do not either singly or in 
combination impart a flavor that imitates the flavor of chocolate, 
milk, or butter;
* * * * *
0
92. In Sec.  163.124, revise paragraph (b)(4) to read as follows:


Sec.  163.124  White chocolate.

* * * * *
    (b) * * *
    (4) Spices, natural and artificial flavorings, ground whole nut 
meats, ground coffee, dried malted cereal extract, salt or salt 
substitute, and other seasonings that do not either singly or in 
combination impart a flavor that imitates the flavor of chocolate, 
milk, or butter;
* * * * *
0
93. In Sec.  163.130, revise paragraph (b)(3) to read as follows:

[[Page 21171]]

Sec.  163.130  Milk chocolate.

* * * * *
    (b) * * *
    (3) Spices, natural and artificial flavorings, ground whole nut 
meats, ground coffee, dried malted cereal extract, salt or salt 
substitute, and other seasonings that do not either singly or in 
combination impart a flavor that imitates the flavor of chocolate, 
milk, or butter;

PART 166--MARGARINE

0
94. The authority citation for part 166 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 343, 347, 348, 371, 379e.

0
95. In Sec.  166.110, revise paragraphs (a) and (b)(2) to read as 
follows:


Sec.  166.110  Margarine.

    (a) Description. Margarine (or oleomargarine) is the food in 
plastic form or liquid emulsion, containing not less than 80 percent 
fat determined by the method prescribed in AOAC Official Method 
938.06A. AOAC Official Method 938.06A, ``Indirect Method, under Fat in 
Butter,'' found in ``Official Methods of Analysis of AOAC 
INTERNATIONAL,'' 21st Ed. (2019), is incorporated by reference into 
this section with the approval of the Director of the Federal Register 
under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the Food and 
Drug Administration (FDA) and the National Archives and Records 
Administration (NARA). Contact the FDA at FDA's Dockets Management 
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. 
For information on the availability of this material at NARA, visit 
www.archives.gov/federal-register/cfr/ibr-locations or email 
[email protected]. This material is available from AOAC 
INTERNATIONAL, 2275 Research Blvd., Suite 300, Rockville, MD 20850-
3250, 1-800-379-2622. Margarine contains only safe and suitable 
ingredients, as defined in Sec.  130.3(d) of this chapter. It is 
produced from one or more of the optional ingredients in paragraph 
(a)(1) of this section, and one or more of the optional ingredients in 
paragraph (a)(2) of this section, to which may be added one or more of 
the optional ingredients in paragraph (b) of this section. Margarine 
contains vitamin A as provided for in paragraph (a)(3) of this section.
* * * * *
    (b) * * *
    (2) Salt (sodium chloride) or salt substitute; potassium chloride 
for dietary margarine or oleomargarine.
* * * * *

PART 168--SWEETENERS AND TABLE SIRUPS

0
96. The authority citation for part 168 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
97. In Sec.  168.130, revise paragraph (b)(1) to read as follows:


Sec.  168.130  Cane sirup.

* * * * *
    (b) * * *
    (1) Salt or salt substitute.
* * * * *
0
98. In Sec.  168.140, revise the first sentence of paragraph (a) and 
paragraph (b)(1) to read as follows:


Sec.  168.140  Maple sirup.

    (a) Maple sirup is the liquid food derived by concentration and 
heat treatment of the sap of the maple tree (Acer) or by solution in 
water of maple sugar (maple concrete) made from such sap. * * *
    (b) * * *
    (1) Salt or salt substitute.
* * * * *
0
99. In Sec.  168.160, revise paragraph (b)(1) to read as follows:


Sec.  168.160  Sorghum sirup.

* * * * *
    (b) * * *
    (1) Salt or salt substitute.
* * * * *
0
100. In Sec.  168.180, revise paragraph (b)(7) to read as follows:


Sec.  168.180  Table sirup.

* * * * *
    (b) * * *
    (7) Salt or salt substitute.
* * * * *

PART 169--FOOD DRESSINGS AND FLAVORINGS

0
101. The authority citation for part 169 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
102. In Sec.  169.140, revise paragraph (d)(1) to read as follows:


Sec.  169.140  Mayonnaise.

* * * * *
    (d) * * *
    (1) Salt or salt substitute.
* * * * *
0
103. In Sec.  169.150, revise paragraph (e)(1) to read as follows:


Sec.  169.150  Salad dressing.

* * * * *
    (e) * * *
    (1) Salt or salt substitute.
* * * * *

    Dated: March 23, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-06456 Filed 4-7-23; 8:45 am]
BILLING CODE 4164-01-P

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