[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Proposed Rules]
[Pages 21148-21171]
[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.

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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: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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

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 http://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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 http://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 http://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,<PHONE_NUMBER>.

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,<PHONE_NUMBER> 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,<PHONE_NUMBER>.

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

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

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          Abbreviation/acronym                    What it means
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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
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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.

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

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.

    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.

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.

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.

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.

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,<PHONE_NUMBER>, 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.''

     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

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

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 http://www.regulations.gov. References without asterisks are not on public

display at http://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 http://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.

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,<PHONE_NUMBER>. 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.
* * * * *

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