Rule2026-20848
Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 13, 2026
Effective
December 14, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is issuing a final rule to amend our standard of identity 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 major risk factor for heart disease and stroke. The rule will 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.
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<title>Federal Register, Volume 91 Issue 196 (Tuesday, October 13, 2026)</title>
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[Federal Register Volume 91, Number 196 (Tuesday, October 13, 2026)]
[Rules and Regulations]
[Pages 65040-65070]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20848]
[[Page 65039]]
Vol. 91
Tuesday,
No. 196
October 13, 2026
Part II
Department of Health and Human Services
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Food and Drug Administration
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21 Parts 130, 131, 133, et al.
Use of Salt Substitutes To Reduce the Sodium Content in Standardized
Foods; Final Rule
Federal Register / Vol. 91, No. 196 / Tuesday, October 13, 2026 /
Rules and Regulations
[[Page 65040]]
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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: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is issuing a
final rule to amend our standard of identity 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
major risk factor for heart disease and stroke. The rule will 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: This rule is effective December 14, 2026. The incorporation by
reference of certain material listed in this rule is approved by the
Director of the Federal Register as of December 14, 2026. Submit either
electronic or written/paper objections or requests for a hearing on
amendments to standards of identity for dairy products in parts 131 and
133 (21 CFR parts 131 and 133) under this final rule by November 12,
2026. See section VI for further information on the filing of
objections on amendments to standards of identity for dairy products in
parts 131 and 133.
ADDRESSES: You may submit objections and requests for a hearing on
amendments to standards of identity for dairy products in parts 131 and
133 as follows. Please note that late, untimely filed objections will
not be considered. Electronic objections must be submitted on or before
November 12, 2026. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
November 12, 2026. Objections 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 objections the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection 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 objection, that information will be
posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection 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:
<bullet> 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.
<bullet> For written/paper objections submitted to the Dockets
Management Staff, FDA will post your objection, 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 objections, those filed in a
timely manner (see (ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objection 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 objections. The second copy, which will have
the claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 objection 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT: Andrew Yeung and Rumana Yasmeen,
Office of Nutrition and Food Labeling, Human Foods Program (HFS-800),
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-2371; or Holli Kubicki, Office of Regulations and International
Programs, Human Foods Program, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Acronyms in This Document
III. Background
A. Need for the Regulation/History of the Rulemaking
B. Summary of Comments to the Proposed Rule
C. Incorporation by Reference
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
[[Page 65041]]
A. Introduction
B. Description of General Comments and FDA Response
C. Salt Substitute Definition Comments and FDA Response
D. Fish and Shellfish Comments and FDA Response
E. Incorporation by Reference Comments and FDA Response
F. Technical Amendments
G. Out-of-Scope Comments
VI. Effective Date
VII. Economic Analysis of Impacts
A. Introduction
B. Overview of Benefits, Costs, and Transfers
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 Final Rule
The final rule amends 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 in a food. Foods
for which FDA has established SOI are referred to as ``standardized
foods.'' The amendments permit the use of safe and suitable salt
substitutes to replace some or all of the added salt used in the
manufacture of standardized foods. (Salt substitutes may already be
used in the manufacture of non-standardized foods.) The final rule does
not list specific salt substitutes; instead, the final rule generally
allows ingredients or combinations of ingredients to be used as salt
substitutes in standardized foods by manufacturers currently or in the
future.
The final rule supports efforts to reduce sodium content in
standardized foods and may help to improve consumer dietary patterns by
reducing sodium consumption. According to the Dietary Guidelines for
Americans, the general population, ages 14 and above, should consume
less than 2,300 milligrams per day of sodium (Ref. 1). Reducing sodium
consumption may help reduce the risk of hypertension, a major risk
factor for heart disease and stroke. The final rule provides
manufacturers the flexibility to use safe and suitable salt substitutes
and allows for innovation in producing healthier standardized foods.
The final rule also promotes honesty and fair dealing in the interest
of consumers and accommodates their preferences for lower-sodium
varieties of foods.
B. Summary of the Major Provisions of the Final Rule
FDA is amending 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 are amending our
regulation titled ``Food Standards: General'' (part 130 (21 CFR part
130)) to create a new subpart C titled ``Flexibility in Standardized
Foods'' and add a new section titled ``Ingredient Flexibility in
Standardized Foods'' to define salt substitute. We also amend 80 SOI to
permit salt substitutes.
Within the 80 SOI we are amending, we are also updating the
incorporation by reference (IBR) information to refer to the most
recent versions of the IBR materials available at the time of
publication and to provide updated contact information for obtaining
the IBR materials. For example, the rule updates the referenced methods
of analysis to those in the ``Official Methods of Analysis of AOAC
INTERNATIONAL,'' 22nd Ed., 2023. We also make technical amendments to
correct inconsistencies and typographical errors in some SOI
regulations.
We conclude that these 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 issuing this rule under sections 201, 401, 402, and 701 of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321,
341, 342, and 371). We discuss our legal authority in greater detail in
section IV.
D. Costs and Benefits
There are no regulatory costs of the final rule as there are no
regulatory requirements or regulatory penalties if manufacturers of a
standardized food choose not to take advantage of the flexibility to
use salt substitutes. We qualitatively discuss other costs that may
come from voluntary reformulation and re-labeling costs, as well as
potential consumer dissatisfaction with altered product properties. We
qualitatively discuss the benefits of the final rule, which come in the
form of increased flexibility for manufacturers and potential public
health benefits stemming from decreased sodium consumption.
II. Table of Abbreviations/Acronyms in This Document
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Abbreviation/acronym What it means
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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.
SOI....................................... Standard(s) of Identity.
U.S.C..................................... United States Code.
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III. Background
A. Need for the Regulation/History of the Rulemaking
In the Federal Register of April 10, 2023 (88 FR 21148), we
published a proposed rule titled ``Use of Salt Substitutes To Reduce
the Sodium Content in Standardized Foods.''
Salt substitutes are ingredients that can help reduce sodium in
processed, packaged, and prepared foods. 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, 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.
SOI have been established to ensure that the characteristics,
ingredients, and production processes of specific foods are consistent
with what consumers expect. Various parties have expressed concern that
many SOI are out of date and may impede innovation, including the
ability to produce healthier foods (Ref. 2). FDA's work to update SOI
generally falls into three categories:
<bullet> Establishing principles to more transparently communicate
what we will consider when determining whether to revise, eliminate, or
establish a food standard;
<bullet> Updating individual SOI to allow for continued innovation
in the marketplace, including updating SOI to reflect modern
technologies and processing methods; and
<bullet> Updating SOI to ensure they are supporting the production
and innovation of healthier food.
See <a href="https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/standards-identity-food">https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/standards-identity-food</a>.
[[Page 65042]]
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. While manufacturers may modify the sodium
content of certain standardized foods using salt substitutes in
accordance with the general definition and standard under Sec. 130.10,
they must decrease the sodium in the foods consistent with the amount
specified in a nutrient content claim under Sec. 101.61 (21 CFR
101.61). It may be impracticable for manufacturers to reduce sodium
content of standardized foods to these amounts.
We heard support from interested parties for the use of salt
substitutes through our related work to help reduce sodium consumption.
Through our work on the ``Voluntary Sodium Reduction Goals: Target Mean
and Upper Bound Concentrations for Sodium in Commercially Processed,
Packaged, and Prepared Foods; Guidance for Industry'' (2021 Voluntary
Sodium Reduction guidance) (Ref. 3) and ``The Use of an Alternate Name
for Potassium Chloride in Food Labeling; Guidance for Industry''
(Potassium Chloride guidance) (Ref. 4), we learned that various
parties, including industry, consumers, consumer advocacy groups,
scientific organizations, and professional health organizations,
generally support allowing the use of salt substitutes. In another
public engagement, some parties discussed modernizing SOI to allow the
use of salt substitutes using a ``horizontal approach'' (Ref. 2). 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.
As discussed in the proposed rule, we considered several options
for permitting salt substitutes in standardized foods and evaluated how
to apply this change across multiple SOI (88 FR 21148 at 21151). The
final rule uses a horizontal approach to amending the SOI in that a
single provision defining salt substitutes (see Sec. 130.30 (21 CFR
130.30(c)(1))) applies across the various SOI that permit salt as an
ingredient. Because the use of salt substitutes in these SOI is
currently limited, 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 may
also contribute to our goal to help reduce sodium across the food
supply. It may facilitate voluntary industry efforts toward sodium
reduction by providing flexibility and supporting innovation in the
production of healthier standardized foods. This in turn may provide
more choices to consumers and help some consumers to gradually reduce
the sodium in their diet and contribute to better health outcomes.
Reducing sodium may help reduce the risk of hypertension, a major risk
factor for heart disease and stroke (Refs. 5 through 7). The final rule
supports the Make America Healthy Again initiative by providing
manufacturers of standardized foods flexibility to innovate and make
more healthful, lower-sodium foods, which may help lower chronic
disease rates. See <a href="https://www.whitehouse.gov/priorities/maha/">https://www.whitehouse.gov/priorities/maha/</a>.
Ingredients added to standardized foods, like ingredients added to
non-standardized foods, must comply with other requirements of the FD&C
Act, including the pre-market review and approval requirements for food
additives under section 409 of the FD&C Act (21 U.S.C. 348). This
rulemaking does not provide either an authorization or an exemption
from regulation as a food additive under section 409 of the FD&C Act.
Ingredients that are food additives are deemed unsafe except to the
extent that FDA has approved their use (section 409(a) 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 it becoming a component
of food, if such substance is not generally recognized among qualified
experts as safe (GRAS) under the conditions of its intended use
(section 201(s) 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).
B. Summary of Comments to the Proposed Rule
We received more than 120 comments on the proposed rule from
consumers, consumer groups, trade organizations, manufacturers, public
health organizations, public advocacy groups, local government
agencies, and other organizations. We describe and respond to the
comments in section V (``Comments on the Proposed Rule and FDA
Response'') of this document. The topics addressed most frequently in
the comments include:
<bullet> General supportive comments regarding the rule and sodium
reduction efforts.
<bullet> General supportive comments regarding ingredient
flexibility to use salt substitutes to support innovation to make
healthier foods.
<bullet> Additional or alternative efforts to achieve sodium
reduction.
<bullet> Concerns with specific ingredients.
<bullet> Support for and additional suggestions or questions
regarding the definition of salt substitute.
C. Incorporation by Reference
Several SOI amended by the rule previously referred to older
versions of the AOAC Official Methods. We are updating the IBR
information to provide the most recent version of the IBR materials and
up-to-date contact information for obtaining the IBR materials.
Therefore, FDA is incorporating by reference the methods listed below
from the ``Official Methods of Analysis of AOAC INTERNATIONAL,'' 22nd
Ed., 2023, which have been approved by the Office of the Federal
Register.
<bullet> Definition of Terms and Explanatory Notes. This front
matter to Official Methods of Analysis includes Table 1, Nominal
Dimensions of Standard Test Sieves (USA Standard Series). The table
lists the test sieve designations and their nominal dimensions.
<bullet> AOAC Appendix C, Reference Tables, 909.04, Correction
Factors for Gasometric Determination of Carbon Dioxide (Reference
Table 909.04). The reference lists the correction factors of carbon
dioxide measurements for different atmospheric conditions.
<bullet> AOAC Official Method 923.02, Carbon Dioxide (Total) in
Baking Powders: Gasometric Determination. The reference describes
the reagent and the apparatus used in measuring the amount of carbon
dioxide released from a sample.
<bullet> AOAC Official Method 926.07, 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.
<bullet> AOAC Official Method 932.12, Solids (Soluble) in Fruits and
Fruit Products: Refractometer Method. The reference provides a
method reference for measuring soluble solids and the formula for
calculating the percentage of soluble solids in a sample.
<bullet> AOAC Official Method 932.14, Solids in Syrups. The
reference provides the method for measuring the percentage of
soluble solids in a sample.
<bullet> AOAC Official Method 935.36, Solids (Total) in Bread. The
reference provides the method for measuring the percentage of solids
in a sample.
<bullet> AOAC Official Method 938.06, Fat in Butter. The reference
provides the method for measuring the percentage of fat in a sample.
<bullet> 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.
[[Page 65043]]
<bullet> AOAC Official Method 945.48, 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.
<bullet> 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.
<bullet> 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.
<bullet> AOAC Official Method 990.21, Solids-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 (<a href="https://academic.oup.com/officialmethodsofanalysis-aoac">https://academic.oup.com/officialmethodsofanalysis-aoac</a>). You may
inspect a copy at Dockets Management Staff, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500,
<a href="/cdn-cgi/l/email-protection#0a43485855476b7e6f78636b665543647b7f6378636f794a6c6e6b24626279246d657c"><span class="__cf_email__" data-cfemail="b8f1faeae7f5d9ccddcad1d9d4e7f1d6c9cdd1cad1ddcbf8dedcd996d0d0cb96dfd7ce">[email protected]</span></a>, between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Legal Authority
We are issuing this final rule under sections 201, 401, 402, and
701 of 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 conclude that
permitting the use of salt substitutes to replace some or all of the
added salt used in the production of standardized foods will promote
honesty and fair dealing in the interest of consumers. Many consumers
desire more nutritious and healthy food options, such as lower-sodium
versions of foods. The final rule allows for industry development and
sale of such foods while ensuring that standardized foods meet consumer
expectations and preferences with respect to lower-sodium varieties.
We also are issuing this final 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) of
the FD&C Act ``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 effectuates 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 final rule may help
provide more options to consumers while ensuring that the foods
maintain their basic nature and essential characteristics. The
amendments to the SOI for dairy products under parts 131 and 133 are
issued under section 701(e) of the FD&C Act.
V. Comments on the Proposed Rule and FDA Response
A. Introduction
FDA proposed amending 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.
Additionally, we proposed amending 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 proposed amending 80 SOI to permit salt
substitutes (see Table 1).
Table 1--Amendments to Standards of Identity To Permit Salt Substitutes
------------------------------------------------------------------------
CFR section and title Revision
------------------------------------------------------------------------
Sec. 131.111 Acidified milk..... Revises other optional ingredients
to add salt substitute to paragraph
(e)(8).
Sec. 131.112 Cultured milk...... Revises other optional ingredients
to add salt substitute to paragraph
(d)(8).
Sec. 131.160 Sour cream......... Revises optional ingredients to add
salt substitute to paragraph
(b)(5).
Sec. 131.162 Acidified sour Revises optional ingredients to add
cream. salt substitute to paragraph
(b)(4).
Sec. 131.170 Eggnog............. Revises other optional ingredients
to add salt substitute to paragraph
(e)(2).
Sec. 133.102 Asiago fresh and Adds paragraph (c)(3) to permit salt
asiago soft cheese. substitute.
Sec. 133.106 Blue cheese........ Revises other optional ingredients
to add paragraph (b)(3)(vii) to
list salt substitute.
Sec. 133.108 Brick cheese....... Revises other optional ingredients
to add paragraph (b)(3)(v) to list
salt substitute.
Sec. 133.111 Caciocavallo Adds paragraph (c)(3) to permit salt
siciliano cheese. substitute.
Sec. 133.113 Cheddar cheese..... Revises other optional ingredients
to add paragraph (b)(3)(vi) to list
salt substitute.
Sec. 133.118 Colby cheese....... Adds paragraph (c)(4) to permit salt
substitute.
Sec. 133.123 Cold-pack and club Revises optional ingredients to add
cheese. salt substitute to paragraph
(c)(3).
Sec. 133.124 Cold-pack cheese Revises other optional ingredients
food. to add salt substitute to paragraph
(e)(3).
Sec. 133.127 Cook cheese, koch Revises other optional ingredients
kaese. to add salt substitute to paragraph
(b)(3)(v).
Sec. 133.129 Dry curd cottage Revises paragraphs (b)(1)(i), (ii),
cheese. and (iii) that describe the food to
permit salt substitute.
Sec. 133.133 Cream cheese....... Revises other optional ingredients
to add salt substitute to paragraph
(b)(3)(i).
Sec. 133.136 Washed curd and Revises other optional ingredients
soaked curd cheese. to add paragraph (b)(3)(vi) to list
salt substitute.
Sec. 133.138 Edam cheese........ Revises other optional ingredients
to add paragraph (b)(3)(v) to list
salt substitute.
Sec. 133.141 Gorgonzola cheese.. Revises other optional ingredients
to add paragraph (b)(3)(vii) to
list salt substitute.
Sec. 133.144 Granular and Revises other optional ingredients
stirred curd cheese. to add paragraph (b)(3)(vi) to list
salt substitute.
Sec. 133.147 Grated American Revises other optional ingredients
cheese food. to add salt substitute to paragraph
(c)(5).
Sec. 133.148 Hard grating Adds paragraph (c)(2) to permit salt
cheeses. substitute.
Sec. 133.149 Gruyere cheese..... Revises other optional ingredients
to add paragraph (b)(3)(iv) to list
salt substitute.
Sec. 133.150 Hard cheeses....... Adds paragraph (c)(3) to permit salt
substitute.
Sec. 133.152 Limburger cheese... Revises other optional ingredients
to add paragraph (b)(3)(iv) to list
salt substitute.
Sec. 133.153 Monterey cheese and Revises other optional ingredients
monterey jack cheese. to add salt substitute to paragraph
(b)(3)(iii).
Sec. 133.155 Mozzarella cheese Revises other optional ingredients
and scamorza cheese. to add salt substitute to paragraph
(b)(3)(iii).
[[Page 65044]]
Sec. 133.156 Low-moisture Revises other optional ingredients
mozzarella and scamorza cheese. to add salt substitute to paragraph
(b)(3)(iii).
Sec. 133.160 Muenster and Revises other optional ingredients
munster cheese. to add paragraph (b)(3)(vi) to list
salt substitute.
Sec. 133.162 Neufchatel cheese.. Revises other optional ingredients
to add salt substitute to paragraph
(b)(3)(i).
Sec. 133.164 Nuworld cheese..... Revises other optional ingredients
to add paragraph (b)(3)(iv) to list
salt substitute.
Sec. 133.165 Parmesan and Adds paragraph (c)(3) to permit salt
reggiano cheese. substitute.
Sec. 133.169 Pasteurized process Revises other optional ingredients
cheese. to add salt substitute to paragraph
(d)(3).
Sec. 133.173 Pasteurized process Revises other optional ingredients
cheese food. to add salt substitute to paragraph
(e)(4).
Sec. 133.179 Pasteurized process Revises other optional ingredients
cheese spread. to add salt substitute to paragraph
(f)(5).
Sec. 133.181 Provolone cheese... Revises other optional ingredients
to add paragraph (b)(3)(vi) to list
salt substitute.
Sec. 133.182 Soft ripened Revises paragraph (b) that describes
cheeses. the food to permit salt substitute.
Sec. 133.183 Romano cheese...... Adds paragraph (c)(3) to permit salt
substitute.
Sec. 133.184 Roquefort cheese, Revises other optional ingredients
sheep's milk blue-mold, and blue- to add paragraph (b)(3)(ii) to list
mold cheese from sheep's milk. salt substitute.
Sec. 133.185 Samsoe cheese...... Revises other optional ingredients
to add paragraph (v)(3)(v) to list
salt substitute.
Sec. 133.186 Sap sago cheese.... Revises paragraph (a)(2) to permit
salt substitute.
Sec. 133.187 Semisoft cheeses... Revises paragraph (b) that describes
the food to permit salt substitute.
Sec. 133.188 Semisoft part-skim Revises paragraph (b) that describes
cheeses. the food to permit salt substitute.
Sec. 133.189 Skim milk cheese Add paragraph (d)(2) to permit salt
for manufacturing. substitute.
Sec. 133.190 Spiced cheeses..... Revises other optional ingredients
to add salt substitute in paragraph
(b)(3)(iii).
Sec. 133.195 Swiss and Revises other optional ingredients
emmentaler cheese. to add paragraph (b)(3)(vii) to
list salt substitute.
Sec. 136.110 Bread, rolls, and Revises optional ingredients to add
buns. salt substitute to paragraph
(c)(4).
Sec. 137.180 Self-rising flour.. Revises paragraph (a) that describes
the food to add salt substitute.
Sec. 137.270 Self-rising white Revises paragraph (a) that describes
corn meal. the food to add salt substitute.
Sec. 139.110 Macaroni products.. Revises optional ingredients to add
salt substitute to paragraph
(a)(4).
Sec. 139.150 Noodle products.... Revises optional ingredients to add
salt substitute to paragraph
(a)(2).
Sec. 145.110 Canned applesauce.. Revises optional ingredients to add
salt substitute to paragraph
(a)(2)(iii).
Sec. 145.130 Canned figs........ Revises optional ingredients to add
salt substitute to paragraph
(a)(5).
Sec. 150.110 Fruit butter....... Revises optional ingredients to add
salt substitute to paragraph
(c)(4).
Sec. 155.120 Canned green beans Revises optional ingredients to add
and canned wax beans. salt substitute to paragraph
(a)(3)(i).
Sec. 155.130 Canned corn........ Revises optional ingredients to add
salt substitute to paragraph
(a)(3)(i).
Sec. 155.170 Canned peas........ Revises optional ingredients to add
salt substitute to paragraph
(a)(2)(i).
Sec. 155.190 Canned tomatoes.... Revises optional ingredients to add
salt substitute to paragraph
(a)(2)(iv).
Sec. 155.191 Tomato concentrates Revises optional ingredients to add
salt substitute to paragraph
(a)(2)(i).
Sec. 155.194 Catsup............. Revises paragraph (a)(1)(iv) that
describes the food to add salt
substitute.
Sec. 155.200 Certain other Revises optional ingredients to add
canned vegetables. salt substitute to paragraph
(c)(4)(i).
Sec. 155.201 Canned mushrooms... Revises optional ingredients to add
salt substitute to paragraph
(a)(3)(i).
Sec. 156.145 Tomato juice....... Revises paragraph (a)(1) that
describes the food to add salt
substitute.
Sec. 158.170 Frozen peas........ Revises optional ingredients to add
salt substitute in paragraph
(a)(1)(iv).
Sec. 161.145 Canned oysters..... Revises paragraph (a)(1) that
describes the food to add salt
substitute.
Sec. 161.170 Canned Pacific Revises optional ingredients to add
salmon. salt substitute to paragraph
(a)(4)(i).
Sec. 161.173 Canned wet pack Revises optional ingredients to add
shrimp in transparent or salt substitute to paragraph
nontransparent containers. (a)(4)(i).
Sec. 161.190 Canned tuna........ Revises seasoning and flavoring
ingredients to add salt substitute
to paragraph (a)(6)(1).
Sec. 163.111 Chocolate liquor... Revises optional ingredients to add
salt substitute to paragraph
(b)(6).
Sec. 163.112 Breakfast cocoa.... Revises optional ingredients to add
salt substitute to paragraph
(b)(4).
Sec. 163.123 Sweet chocolate.... Revises optional ingredients to add
salt substitute to paragraph
(b)(3).
Sec. 163.124 White chocolate.... Revises optional ingredients to add
salt substitute to paragraph
(b)(4).
Sec. 163.130 Milk chocolate..... Revises optional ingredients to add
salt substitute to paragraph
(b)(3).
Sec. 166.110 Margarine.......... Revises optional ingredients to add
salt substitute to paragraph
(b)(2).
Sec. 168.130 Cane sirup......... Revises optional ingredients to add
salt substitute to paragraph
(b)(1).
Sec. 168.140 Maple sirup........ Revises optional ingredients to add
salt substitute to paragraph
(b)(1).
Sec. 168.160 Sorghum sirup...... Revises optional ingredients to add
salt substitute to paragraph
(b)(1).
Sec. 168.180 Table sirup........ Revises optional ingredients to add
salt substitute to paragraph
(b)(7).
Sec. 169.140 Mayonnaise......... Revises other optional ingredients
to add salt substitute to paragraph
(d)(1).
Sec. 169.150 Salad dressing..... Revises other optional ingredients
to add salt substitute to paragraph
(e)(1).
------------------------------------------------------------------------
We proposed updating 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. We also proposed
technical amendments to correct inconsistencies and typographical
errors in some SOI regulations.
We tentatively concluded that the proposed amendments were
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.
We describe and respond to the comments on the proposed rule in
sections B through F of this section. We have numbered each comment to
help distinguish between different comments. We have grouped similar
comments together under the same number, and, in some cases, we have
separated different issues discussed in the same comment and designated
them as distinct comments for purposes of
[[Page 65045]]
our responses. The number assigned to each comment or comment topic is
purely for organizational purposes and does not signify the comment's
value or importance or the order in which comments were received.
B. Description of General Comments and FDA Response
Many comments we received on the proposed rule make general remarks
supporting or opposing the proposed rule without focusing on a
particular proposed provision. In the following paragraphs, we discuss
and respond to such general comments. We respond to more specific
comments in sections V.C, V.D, V.E, and V.F.
(Comment 1) Many comments support the proposed rule and other FDA
efforts to reduce sodium in the food supply as an important step to
reducing diet-related chronic disease risk. Some comments that support
the proposed rule also state that ingredient flexibility to use salt
substitutes would help support ongoing sodium reduction efforts by
industry to make healthier foods.
(Response 1) In the proposed rule, we stated that reducing sodium
in the food supply may help reduce sodium intake, which in turn may
help to reduce the risk of diet-related chronic disease, including
hypertension, heart disease, and stroke (see 88 FR 21148 at 21150). We
appreciate the comments supporting the rule and acknowledging the
potential for ingredient flexibility to reduce sodium content in the
food supply.
(Comment 2) We proposed using, and the final rule adopts, a
``horizonal approach'' to amending the SOI to allow salt substitutes in
certain standardized foods. As described in the proposed rule, a
horizontal approach to amending standards involves making changes that
apply to all or to broad categories of SOI (see 88 FR 21148 at 21151
and Ref. 2). Several comments support the horizontal approach for this
rulemaking and say that concurrently updating the SOI to allow salt
substitutes is efficient, practical, and results in uniform application
of principles. A few comments question whether the horizontal approach
to amending the SOI could be more efficiently achieved by a single
amendment to part 130 without the corresponding amendments to each SOI.
One comment asks us to clarify that the use of salt substitutes as
defined in the rule applies to the SOI that cross-reference the SOI
amended by the final rule.
(Response 2) We appreciate the support for the horizontal approach
to amending the SOI to allow salt substitutes in standardized foods. In
developing the proposed rule, we carefully reviewed the structure of
part 130 in relationship to the individual standards in parts 131
through 169 (21 CFR parts 131 through 169) and determined that the
clearest and most efficient way to permit the use of salt substitutes
in the individual standards was to create a definition in part 130
along with individual amendments to certain standards based on the
context in which salt is permitted and how the standards are written.
Additionally, not every SOI that permits salt corresponded to a food
for which use of salt substitutes should be allowed (see request for
comments regarding the SOI for oysters (Sec. 161.130) (88 FR 21148 at
21152)). For these reasons, we disagree that a single amendment to part
130 without amendments to the individual standards would be the right
approach for the types of revisions included in this rulemaking;
however, we may consider that approach in future rulemakings, as
appropriate.
The final rule amends 80 SOI to permit the use of salt substitutes
as defined in Sec. 130.30. A SOI that cross-references one of the 80
SOI amended by the final rule would also be permitted to use salt
substitutes as defined in Sec. 130.30. Therefore, the final rule
permits the use of salt substitutes in 139 SOI: 80 SOI by amendment to
the SOI in the final rule and the remaining 59 SOI by an existing
cross-reference in SOI amended by the final rule.
(Comment 3) A few comments suggest that sodium reduction be
achieved by lowering the sodium content of standardized foods without
the addition of salt substitutes. Some comments state that consumer
tastes will adapt over time to a gradual reduction of sodium content in
foods and argue that we do not need to allow the use of salt
substitutes in standardized foods. Some comments say that we should
focus our efforts on working with manufacturers to develop and promote
lower-sodium options, such as using only herbs and spices, to replace
salt or requiring manufacturers to reduce sodium in food products.
(Response 3) By providing greater flexibility to manufacturers who
wish to use salt substitutes in standardized foods, this rulemaking
also aligns with our efforts to help reduce sodium consumption. As more
than 70 percent of Americans' sodium intake comes from foods where
sodium is added during food manufacturing and commercial food
preparation, lowering population intake of sodium to more moderate
levels involves lowering the amount of sodium added to commercially
processed, packaged, and prepared foods in the U.S. marketplace (Refs.
8 and 9). For this reason, in addition to continued education
initiatives, a multi-faceted approach is needed to help lower the
burden of diet-related chronic disease, including providing consumers
with information about sodium via nutrition labeling, encouraging
sodium reduction in the food supply with our voluntary sodium reduction
goals, and offering manufacturers the flexibility to use safe and
suitable salt substitutes in standardized foods to allow for the
development of lower-sodium foods.
We agree with the comments that consumer taste preferences may
adapt and adjust over time to the gradual reduction of sodium content
in foods. We have noted that people usually do not notice small
reductions in sodium, and, over time, people's taste buds adjust to
these changes, especially if they are made gradually (see <a href="https://www.fda.gov/food/food-labeling-nutrition/sodium-reduction-food-supply">https://www.fda.gov/food/food-labeling-nutrition/sodium-reduction-food-supply</a>).
However, the amount of sodium that can be removed without substitution
may be limited, particularly in standardized foods for which salt is a
required ingredient.
Depending on the food, salt may be important for taste, microbial
safety, or other functions. 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. For this reason, relying on sodium reduction
alone, without the use of salt substitutes or limiting to specific
ingredients such as herbs and spices only to replace salt, may not
sufficiently help with an overall reduction in sodium in the food
supply.
Regarding the comments suggesting that we require manufacturers to
reduce sodium, we discuss our approach to set voluntary sodium
reduction goals in response 4.
(Comment 4) Several comments discuss our efforts to reduce sodium
in the food supply through the sodium reduction goals announced via our
October 2021 Voluntary Sodium Reduction guidance (Ref. 3).
Some comments state that, without the ability to use salt
substitutes in standardized foods, there is a significant limitation on
a manufacturer's ability to reduce sodium content as recommended by the
goals in the guidance.
Several comments suggest that we monitor progress toward meeting
the sodium reduction targets in addition to allowing the use of salt
substitutes in
[[Page 65046]]
standardized foods. The comments state that we should issue new sodium
reduction targets adjusted based on progress made on sodium reduction
as well as the flexibility to use salt substitutes in standardized
foods under this rulemaking.
(Response 4) In the proposed rule, we recognized that manufacturers
of standardized foods have few options for reducing the sodium content
of their products (88 FR 21148 at 21151). Thus, the final rule provides
manufacturers the flexibility to use salt substitutes to reduce sodium
content of standardized foods. In the proposed rule, we also discussed
our other efforts aimed at encouraging gradual, efficient reduction in
overall sodium content in processed, packaged, and prepared food
products (see 88 FR 21148 at 21150), including the Voluntary Sodium
Reduction guidance (Ref. 3). The 2021 Voluntary Sodium Reduction
guidance is intended to provide measurable, voluntary short-term (2.5-
year) goals for sodium content in commercially processed, packaged, and
prepared foods to reduce excess population sodium intake, while
recognizing and supporting the important technical and safety roles of
sodium in food. The goals are intended to complement existing efforts
by manufacturers, restaurants, and food service operations to achieve
sodium reduction.
We continue to monitor the sodium content of the food supply,
evaluate progress towards achieving the targets in the October 2021
Voluntary Sodium Reduction guidance, and engage with interested parties
on sodium reduction efforts and the targets. In the Federal Register of
August 16, 2024 (89 FR 66727), we announced the availability of the
``Voluntary Sodium Reduction Goals: Target Mean and Upper Bound
Concentrations for Sodium in Commercially Processed, Packaged, and
Prepared Foods; Draft Guidance for Industry (Edition 2).'' The draft
guidance, when finalized, will describe our views on the next voluntary
goals (Phase II (3-year)) for sodium reduction in a variety of
identified categories of foods that are commercially processed,
packaged, or prepared. Anyone may submit comments to the public docket
for the draft guidance.
(Comment 5) Some comments state that taste is an important
attribute of food and that the use of salt substitutes can help reduce
sodium intake without compromising consumers' taste preferences or
expectations when choosing healthier foods. Other comments say that the
use of potassium chloride may give a bitter or metallic taste to food
but suggest that research supports replacement of sodium with potassium
chloride below certain levels to help avoid the bitter or metallic
taste.
(Response 5) We agree with comments that the use of salt
substitutes can help meet consumer taste preferences in foods with
lower sodium and that the bitter or metallic taste of potassium
chloride may be avoided at certain lower usage levels. We recognize
that salt serves various functions in standardized foods and that salt
may be important for taste. Further, the definition of salt substitute
states, in relevant part, that a salt substitute is an ingredient (or
combination of ingredients) used to perform the functions of salt in
the food (see Sec. 130.30(c)(1) and 88 FR 21148 at 21153). Therefore,
manufacturers have the flexibility to choose the salt substitute and
amount used to accommodate consumer taste preferences when replacing
salt in the food.
(Comment 6) Many comments discuss the role of salt in food aside
from taste and the technical challenges in reformulating foods to
contain less sodium. The comments say salt may play important
microbiological safety and stability roles, including, for example,
controlling moisture and fermentation, and, as a result, reformulating
products can take time. Some comments ask that we ensure that using
other ingredients to replace salt does not impact safety due to the
role of salt in food. Many comments also state that any further
guidance or requirements for specific ingredients beyond what is
existing and in the proposed rule would inhibit reformulation.
A few comments request clarification that the final rule does not
require a minimum amount of sodium reduction to use salt substitutes in
standardized foods.
(Response 6) The general provisions of Sec. 130.30 prohibit
ingredients used as substitutes from changing the basic nature and
essential characteristics of standardized foods (see Sec. 130.30(b)).
When an ingredient that serves as a substitute is used to replace salt,
i.e., a salt substitute, this requirement ensures that characteristics
such as stability and moisture content are maintained. The definition
of salt substitute in the final rule requires that the ingredient or
combination of ingredients used as the salt substitute serve the
functions of salt in the food (see Sec. 130.30(c)(1)). Thus, 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, including
functions related to safety and quality. Food manufacturers are
responsible for ensuring the safety of their food, regardless of
whether they choose to use salt substitutes.
As for the comments asking us to clarify that the final rule does
not require a minimum amount of sodium reduction to use salt
substitutes in standardized foods, we note that the definition of salt
substitute (Sec. 130.30(c)(1)) does not require a minimum replacement
level of salt or prescribe the sodium content of standardized foods
containing salt substitutes. The final rule only requires that some of
the salt be replaced when a salt substitute is used in a standardized
food (id.).
(Comment 7) Several comments are concerned that allowing the use of
salt substitutes in standardized foods will result in the addition of
what comments characterize as ``harmful'' or ``man-made'' chemicals.
According to some comments, these chemicals are not needed or wanted in
food and may cause adverse health consequences to consumers or pose
risks to individuals suffering from various medical conditions or co-
morbidities. Some comments disagree with the proposed rule because they
believe it would introduce the use of salt substitutes in general (in
both standardized and non-standardized foods) or would introduce or
otherwise ``approve'' specific salt substitutes in the food supply.
Some comments say the rulemaking would provide manufacturers with
the opportunity to use salt substitutes without sufficient, long-term,
or transparent safety data. Other comments ask whether safe levels have
been established for salt substitutes and whether guidelines are needed
to prevent excessive use.
(Response 7) We disagree that the final rule will allow harmful
chemicals to be used as salt substitutes in standardized foods or that
salt substitutes will be used without sufficient safety data or at
unsafe levels. As discussed in section III.A of this document, salt
substitutes used as ingredients in food (whether standardized or not)
must comply with the pre-market review and approval requirements for
food additives under section 409 of the FD&C Act or be exempt from the
definition of a food additive. Ingredients that are food additives are
deemed unsafe except to the extent that FDA has approved their use
(section 409(a) of the FD&C Act). FDA's authorization of a food
additive is based on the conditions of use and includes specific use
limitations where appropriate. In addition, the use of substances under
the GRAS provision in
[[Page 65047]]
the definition of a food additive must meet the criteria for GRAS. The
definition of salt substitute in Sec. 130.30(c)(1) specifies that a
salt substitute is ``a safe and suitable ingredient.'' An unapproved
food additive is deemed unsafe under section 409(a) of the FD&C Act and
is not ``safe and suitable,'' as defined in Sec. 130.3(d)(3). The
definition of ``safe and suitable'' in Sec. 130.3(d)(2) further limits
the amount of salt substitutes used to levels no higher than necessary
to achieve their intended purpose in food. This final rule does not
permit the use of any ingredients or substances that are not already
permitted in non-standardized foods. Therefore, the final rule does not
permit unsafe ingredients or substances in the food supply.
The term ``man-made'' is not defined in the FD&C Act, and we are
unclear what substances or ingredients are referred to by this term.
However, as discussed in response 11, salt substitutes must be included
in the ingredient declaration on the label of standardized foods, which
will enable consumers to select foods in accordance with their dietary
preferences or other needs, such as medical conditions (see Sec.
130.3(e)).
Regarding the comments that suggest the rulemaking ``approved''
salt substitutes for use in the food supply, the comments may have
misinterpreted the rule. As discussed earlier in this response, the
final rule provides manufacturers the flexibility to replace salt in
certain standardized foods with ingredients available to manufacturers
of non-standardized food. The final rule does not alter the statutory
or regulatory processes pertaining to food additives.
(Comment 8) Many comments discuss the use of potassium-based
ingredients as salt substitutes, primarily potassium chloride. (In this
document, we use the term ``potassium-based ingredients'' to refer to
``potassium,'' ``potassium chloride,'' or other types of potassium-
containing ingredients.) Some comments note that allowing potassium-
based ingredients as a salt substitute could increase the potassium
content of a standardized food, thereby increasing the amount of
potassium in the U.S. food supply. Some comments believe that the final
rule would result in salt being replaced only with potassium chloride
or that potassium chloride is the only salt substitute.
Some comments discuss the positive effects of potassium on lowering
the risk of high blood pressure and other health benefits and that the
information on potassium content of a food is already provided in the
updated Nutrition Facts label for individuals who may need to limit
potassium intake.
(Response 8) While we included potassium chloride as one example of
an ingredient that might be used as a salt substitute in the preamble
of the proposed rule, we note that the final rule does not limit salt
substitutes to only potassium-based ingredients. Furthermore, we do not
know how many foods will be voluntarily reformulated because of the
final rule or which ingredients will be used to reformulate
standardized foods. As a result, we cannot determine the extent to
which the final rule may affect the amount of potassium in the food
supply. Salt substitutes, including potassium chloride, are already
permitted in non-standardized foods. Product labeling, such as the
Nutrition Facts label and ingredient list, informs consumers of the
potassium content of the food. The same information will be available
for standardized foods. Furthermore, this rule restricts the use of
salt substitutes to levels no higher than necessary to achieve their
intended purpose and we expect the use of potassium chloride to replace
salt will be self-limiting because of its inherent bitter and metallic
taste characteristics (Refs. 10 and 11).
(Comment 9) Some comments state that potassium-based ingredients
used as salt substitutes could impact those that need to monitor their
potassium intake due to health conditions, such as chronic kidney
disease and heart failure, and medication uses because of an increased
risk of hyperkalemia. (Hyperkalemia, in general terms, is a condition
where there is too much potassium in the blood.) Some comments suggest
that a large portion of the population is affected with chronic kidney
disease (CKD), including end stage kidney disease and kidney failure,
and that some individuals may not know that they are affected by the
disease or may not check the labels or be able to see or understand the
labels of these potentially reformulated standardized foods. Further,
some comments mention that many individuals need to limit both sodium
and potassium, so low-sodium foods may be appealing to them without
realizing that some of these foods may contain potassium-based
ingredients. Thus, the comments claim that potassium-based ingredients
added to standardized foods would effectively be sources of ``hidden''
potassium for individuals with CKD or who otherwise need to monitor
potassium in their diet.
Other comments express concerns that allowing potassium-based
ingredients in standardized foods would further reduce food choices of
those with kidney disease who may already struggle with limited food
options. Some comments suggest that evidence may not support the notion
that the use of potassium-based ingredients as salt substitutes leads
to hyperkalemia. Other comments say more research is needed to
understand the relationship between potassium intake and hyperkalemia.
The comments urge us to consider the risk posed by using, or the lack
of research or guidelines on the use of, potassium-based ingredients in
standardized foods to individuals requiring careful monitoring of
potassium intake.
(Response 9) We recognize the need for certain individuals to
monitor potassium intake and emphasize the importance of using
information on the food label to help with food selections. The
nutrient declaration and percent Daily Values on the Nutrition Facts
label provide quantitative information for consumers so that they may
follow advice they have received from a health care professional
concerning their conditions (81 FR 33742 at 33750). A manufacturer of a
standardized food choosing to use potassium-based ingredients must
declare the required potassium information on the Nutrition Facts label
of a food containing two or more percent of the recommended daily
intake for potassium per serving (21 CFR 101.9(c)(8)(ii) and (iii)). As
a result, the potassium information about standardized foods that may
be reformulated in response to this rule will be readily available to
consumers--just as it is currently available on the label of non-
standardized foods that have been permitted to contain potassium
chloride for decades. The ingredient statement of standardized foods
made with potassium chloride as an ingredient must declare ``potassium
chloride'' or ``potassium salt'' to inform consumers of its presence
(see section 403(i)(2) of the FD&C Act (21 U.S.C. 343(i)(2)); see also
Sec. 101.4(a)(1) (21 CFR 101.4(a)(1)) and Ref. 4).
(Comment 10) Some comments express concerns that glutamate-
containing ingredients, mainly monosodium glutamate (MSG), will be used
as a salt substitute in standardized foods, thereby making it harder to
find foods that do not contain MSG.
(Response 10) The final rule does not require any specific
ingredient to be used in standardized foods as a salt substitute.
Rather, as discussed in response 7, the final rule permits the use of
safe and suitable ingredients to replace salt in standardized foods. We
did not receive information about the number of foods that will be
reformulated based on the final rule, or
[[Page 65048]]
which ingredients will be used to reformulate standardized foods.
Therefore, we have no data or information supporting the opinion
expressed in comments that it will become harder to find foods that do
not contain MSG as a result of this rule. If MSG is used as a salt
substitute in standardized foods as a result of this rule,
manufacturers must declare MSG in the ingredient statement in
accordance with our labeling requirements (see Sec. 101.4(a)) and 21
U.S.C. 343(i)(2)) as discussed in response 11. Additionally, 21 CFR
101.22(h)(5) requires that MSG used as an ingredient in food be
declared by the common or usual name of ``monosodium glutamate.''
Therefore, consumers can use the information in the ingredient
statement of the label to decide whether to purchase a food containing
MSG as an ingredient and can avoid these foods if desired.
(Comment 11) Some comments express concerns that ingredients used
to replace salt would not appear on the label or that the final rule
would allow these ingredients to be labeled with the general term
``salt substitute'' in standardized foods. Some comments state that
certain consumers will be more likely to purchase lower-sodium foods if
the foods are labeled with the specific salt substitute used or are
otherwise labeled as lower-sodium foods.
Other comments ask that the final rule require clear, consistent,
and easy to understand labeling of the ingredients used to replace salt
for transparency and to help consumers to make informed food choices,
such as avoiding an ingredient that can cause sensitivity or allergenic
reaction. Several comments request that the final rule require a clear
labeling mechanism for consumers to easily identify the ingredients
which were not previously used in standardized foods, such as new
ingredients or allergens. In contrast, some comments indicate that
existing labeling regulations already require the declaration of the
ingredients used to replace salt.
(Response 11) The final rule does not prescribe any new labeling
requirements for ingredients used to replace salt in standardized
foods. However, existing labeling requirements apply to salt
substitutes used in standardized foods. Ingredients, including salt
substitutes, are required to be declared in the ingredient statement of
standardized foods by their common or usual names (Sec. 101.4(a)(1);
see also 21 U.S.C. 343(i)(2) and Sec. 130.3(e)). Our regulations, at
Sec. 101.4(b), require that food ingredients be declared by a specific
name and not a collective (generic) name unless a specific exception is
provided. While the final rule defines ``salt substitute'' in the new
part 130, subpart C, it does not establish ``salt substitute'' as a
collective name of ingredients used to replace salt in standardized
foods. Further, if the ingredient used as a salt substitute is or
contains a major food allergen, the label must also declare the
allergen as prescribed in section 403(w) of the FD&C Act.
Regarding the suggestion of additional labeling mechanisms for new
ingredients used in reformulated standardized foods, we do not require
any additional labeling of new ingredients used in reformulated
standardized or non-standardized foods. The comments did not provide a
reason why the labeling for standardized foods should be different from
non-standardized foods. However, manufacturers of both standardized and
non-standardized foods can choose to disclose information on the
package voluntarily. For example, manufacturers could include
reformulation information if statements made on the package are
truthful and not misleading (see section 403(a)(1) of the FD&C Act (a
food is deemed to be misbranded if its labeling is false or misleading
in any particular). Thus, we decline to establish additional labeling
mechanisms as suggested by the comments.
(Comment 12) Some comments discuss the use of additional labeling
for standardized foods reformulated with potassium ingredients as a
safeguard for individuals who need to monitor or limit their potassium
intake. Several comments recommend clear labeling of any potassium
added from salt substitutes for these individuals if the final rule
will allow the use of potassium-based ingredients as salt substitutes.
The comments suggest labeling of potassium added from salt substitutes,
and other comments recommend use of a temporary disclosure of increased
potassium content in front-of-package labeling. Comments also support
the need for potassium disclosure when potassium is added to
standardized foods labeled as ``low sodium'' since many individuals to
whom this labeling may appeal (i.e., individuals who need to monitor
sodium intake) must monitor potassium intake. Some comments suggest
that the additional food labeling would help individuals recognize the
potassium from salt substitutes in the reformulated standardized foods
and lead them to check the Nutrition Facts label and make appropriate
food choices. Some comments say that foods containing potassium-based
ingredients should bear a warning statement for individuals at risk for
hyperkalemia.
Other comments suggest that any added statement on the front of the
package regarding potassium should not dissuade consumers who do not
need to limit potassium intake. Some comments oppose additional
labeling of reformulated standardized foods and suggest that such a
requirement could negate the intent of the final rule to help support a
healthier food supply. These comments say that labeling that focuses on
risk could hinder consumers' understanding of potassium's health
benefits and noted that potassium is an under-consumed nutrient in the
general U.S. population.
(Response 12) As discussed in response 11, the final rule does not
create new labeling requirements or change existing labeling
requirements for a standardized food reformulated with salt
substitutes. If manufacturers of a standardized food replace sodium
chloride with potassium-based ingredients, they must declare these
ingredients on the label in accordance with Sec. 101.4(a) (see also
section 403(i)(2) of the FD&C Act). As discussed in response 9,
manufacturers must also declare quantitative information on potassium
in the food on the Nutrition Facts label (21 CFR 101.9(c)(8)(ii)), and
consumers can decide whether to consume the food based on this
information.
We disagree that foods containing potassium-based ingredients
should bear a warning statement for individuals at risk for
hyperkalemia. Warning statements can be required under sections
403(a)(1) and 201(n) of the FD&C Act on grounds that the labeling is
misleading if it fails to reveal facts material with respect to
consequences which may result from the use of the article to which the
labeling relates under the conditions of use as are customary or usual
(see section 201(n) of the FD&C Act). However, given that facts about
potassium content are already required on other parts of the label, we
do not believe that a warning statement about hyperkalemia should be
required. Individuals who limit their potassium intake for health
reasons are already on notice to monitor the potassium content of foods
they consume and can use the Nutrition Facts label and ingredient
statement to decide whether a food may contain too much potassium for
their diet. We also note that many foods, standardized and non-
standardized, contain potassium and such a requirement could result in
a large quantity of products in the food
[[Page 65049]]
supply bearing a warning statement, which would undermine the utility
of such a statement. Widespread use of such warning statements could
also deter people who need to consume more potassium from consuming
potassium-containing foods. Further, manufacturers can already choose
to voluntarily disclose potassium-related information on the package.
For example, we discussed in response 11 that manufacturers can include
reformulation information provided that statements made on the package
are truthful and not misleading. Manufacturers can also choose to
declare the level of potassium in accordance with 21 CFR 101.13 and
101.54. For food labeled as ``low sodium,'' the sodium content of the
food must meet the requirements of the nutrient content claim (Sec.
101.61(b)(4)).
(Comment 13) Several comments suggest monitoring or modeling
certain ingredients before or in addition to implementing the final
rule. Some comments ask that we monitor sodium and potassium in the
food supply. Other comments ask that we conduct modeling or other
studies to ensure that ingredients used as salt substitutes continue to
be safe.
Other comments suggest that, following the publication of the final
rule, we encourage the use of the Nutrition Facts label, conduct
outreach to educate stakeholders, consumers, and clinicians on the
potential presence of potassium-based ingredients in standardized
foods, and update education materials as appropriate with certain
information about standardized foods likely to be reformulated with
potassium-based ingredients.
(Response 13) We discuss our effort to monitor sodium in the food
supply in response 4. Regarding the suggestion to monitor or model the
amount of potassium in the food supply, the rule does not limit salt
substitutes to potassium-based ingredients in standardized foods. For
example, yeast extracts, MSG, amino acids, and dairy extracts are other
ingredients discussed in the scientific literature that could
potentially serve as a salt substitute (Ref. 8). We did not receive
information regarding the number of standardized foods likely to be
reformulated with potassium-based ingredients. We plan to monitor
relevant data and scientific publications for changes in U.S.
consumption patterns in potassium intake.
Currently, we have made available extensive nutrition education
resources on the Nutrition Facts label for consumers, dietitians, and
educators as well as continuing medical education videos for physicians
and health care professionals on how to counsel patients to make
healthy food choices using the Nutrition Facts label (<a href="https://www.fda.gov/food/nutrition-education-resources-materials/nutrition-facts-label">https://www.fda.gov/food/nutrition-education-resources-materials/nutrition-facts-label</a>). These resources include information on sodium in packaged
foods (<a href="https://www.fda.gov/food/nutrition-education-resources-materials/sodium-nutrition-facts-label">https://www.fda.gov/food/nutrition-education-resources-materials/sodium-nutrition-facts-label</a>) as well as the changes to the
Nutrition Facts label that require declaration of the amount of
potassium and its percent daily value (<a href="https://www.fda.gov/food/nutrition-facts-label/whats-nutrition-facts-label">https://www.fda.gov/food/nutrition-facts-label/whats-nutrition-facts-label</a>). We also have
information available to help educate consumers about how to use the
Nutrition Facts label as a tool to make informed decisions about
dietary sodium (<a href="https://www.fda.gov/food/nutrition-education-resources-materials/sodium-your-diet">https://www.fda.gov/food/nutrition-education-resources-materials/sodium-your-diet</a>). Additionally, on January 16, 2025, FDA
issued a proposed rule titled, ``Food Labeling: Front-of-Package
Nutrition Labeling'' (90 FR 5426), which, among other things, would
require most foods to bear a front-of-package Nutrition Info box on the
principal display panel that details and interprets the relative amount
of certain nutrients to limit, including sodium, in a serving of food.
If finalized this rule will provide accessible, at-a-glance information
to help consumers quickly and easily identify how foods can be part of
a healthy diet.
We decline to develop consumer and patient education materials with
information on reformulated standardized foods likely to have
potassium-based ingredients. In the proposed rule, we requested public
comment on the possible producer response, including how many
manufacturers may choose to take voluntary action in response to the
final rule, what share of standardized foods may be reformulated, and
the types of salt substitutes manufacturers may use (see 88 FR 21148 at
21158). While some comments express general support for the flexibility
to use salt substitutes to innovate to develop lower sodium
standardized foods, the comments do not provide information about
definitive plans to reformulate products based on the proposed rule.
Some comments make general remarks about the potential to use potassium
in various categories of products but do not provide information on the
specific standardized foods to be reformulated or levels of
substitution associated with reformulations. Therefore, any list that
we could develop of standardized foods likely to be reformulated with
potassium-based ingredients would be too speculative to be useful.
(Comment 14) Some comments state that the proposed rule would help
to address health disparities. A few comments say that the proposed
rule would particularly benefit older individuals who are both more at
risk for hypertension and less likely to have taste buds adjust to
gradual reductions in sodium. Other comments say that the proposed rule
would not help reduce racial health disparities because the use of salt
substitutes to reduce sodium content of food is not an intervention
specific to the diets or disease risks of African Americans but of all
Americans.
Some comments express concern that several minority populations and
lower-income and food-insecure communities are more likely to be
affected by kidney disease and that risks associated with the adoption
of potassium-based salt substitutes would contribute to structural
injustices and health disparities.
(Response 14) We discussed in the proposed rule that permitting the
use of salt substitutes in standardized foods would contribute to the
reduction of sodium across the food supply (88 FR 21148 at 21151).
Reducing the sodium content in the food supply is not intended as an
intervention for any particular group of consumers, but for all
consumers.
SOI regulations are intended to promote honesty and fair dealing in
the interest of consumers (section 401 of the FD&C Act). SOI
regulations do not address dietary restrictions related to individuals'
specific disease conditions or their use of certain medications. The
product's ingredient list and Nutrition Facts label, including nutrient
declaration and percent Daily Value, while not targeting individuals'
specific diseases or conditions, may be able to provide quantitative
information for consumers to use to follow advice they have received
from a health care professional concerning their conditions.
C. Salt Substitute Definition Comments and FDA Response
Several comments address various aspects of the definition of salt
substitute under new subpart C--Flexibility in Standardized Foods in
part 130. This definition applies to all standardized foods in parts
131 through 169 for which salt substitutes are a permitted ingredient
under this rulemaking (see Sec. 130.30(a); see Table 1 for the list of
SOI amended). New subpart C limits ingredients used as salt substitutes
to those that do not change the basic nature and essential
[[Page 65050]]
characteristics of the food (Sec. 130.30(b)). The definition in the
proposed rule under Sec. 130.30(c) provided that a ``salt substitute''
is ``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.'' We explained in the proposal that salt
substitute was defined broadly to provide flexibility and facilitate
innovation without the need for future rulemaking. By not listing
specific salt substitutes, the definition could cover ingredients or
combinations of ingredients that may be used as salt substitutes in the
future, because of advances in food science and technological changes
(see 88 FR 21148 at 21153).
(Comment 15) Many comments generally support the proposed
definition's approach to not list specific salt substitutes and agree
it would allow flexibility to innovate to develop more healthful
offerings while maintaining the basic nature and essential
characteristics of the food. A few comments disagree with the approach
and request that the definition list specific salt substitutes so that
only the listed ingredients could be used as salt substitutes. The
comments state that such change to the rule would increase the
development of new salt substitutes and that we should have a process
for approving new salt substitutes to be added to the list. A few
comments request that FDA amend the definition of salt substitute to
specifically exclude salt substitutes that are ``self-certified'' as
GRAS. The comments argue that allowing salt substitutes that are
``self-certified'' as GRAS would not promote honesty and fair dealing
in the interest of consumers because ``self-certified'' salt
substitutes would effectively allow introduction of salt substitutes
into standardized foods without notifying FDA or the public.
(Response 15) We decline to change the definition in the final rule
to list specific salt substitutes that are allowed in standardized
foods or to include a process for adding certain salt substitutes to
such a list. As we explained in the proposed rule, by defining salt
substitute broadly and by not listing specific salt substitutes, we are
providing for flexibility and facilitating innovation without the need
for additional rulemaking (see 88 FR 21148 at 21153). We agree that the
final rule may result in development of new salt substitutes and noted
the potential for innovation throughout the proposed rule; however, we
disagree that there is a need to create a separate process for
approving salt substitutes for use in standardized foods. As we
explained in the proposed rule, the requirements for food additives and
GRAS uses of substances apply to salt substitutes used in standardized
foods, just as they apply to non-standardized foods (see 88 FR 21148 at
21153). Furthermore, the general requirements for substitutes in Sec.
130.30(b) and the definition of salt substitute in Sec. 130.30(c)(1)
ensure that the substitute will not change the basic nature and
essential characteristics of the food and that only safe and suitable
ingredients are used as salt substitutes.
We interpret the comments' references to ``self-certified'' as
referring to salt substitutes for which a firm has not obtained FDA
review of a GRAS conclusion. Requirements related to GRAS conclusions
are outside the scope of this rulemaking. For more information about
GRAS and available resources, see <a href="https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras">https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras</a>.
Additionally, as discussed in response 11, the ingredients used in
a food must be labeled according to applicable requirements.
(Comment 16) Some comments suggest minor revisions to the
definition of salt substitute. The comments acknowledge that the
proposed definition would cover ``ingredients or combinations of
ingredients that may be used as salt substitutes in the future'' (88 FR
21148 at 21153) but propose revisions to the codified to incorporate
this language. Specifically, the comments would revise proposed Sec.
130.30(c) to read as follows: ``Salt substitute means a safe and
suitable ingredient (or combination of ingredients) that is used at
present or in the future to replace some or all of the added salt
(sodium chloride), to reduce sodium in the food, and that serves one or
more functions of salt in the food'' (suggested revisions are
italicized). The comments say these revisions would provide more
clarity and ensure flexibility for necessary salt substitute
functionality, including the combinations of ingredients that may be
needed.
(Response 16) We decline to revise Sec. 130.30(c)(1) to explicitly
include the text ``at present or in the future'' as requested by some
comments. We agree that the definition of salt substitute in Sec.
130.30(c)(1) includes safe and suitable ingredients that are presently
in use or that will be in future use, that replace some or all of the
added salt, and that serve the functions of salt in the food. However,
we believe that the definition of Sec. 130.30(c)(1) is written broadly
enough to include both ingredients in present use and ingredients in
future use, so that the proposed revision to the text is not needed.
This interpretation was explained in the preamble of the proposed rule,
which stated that the proposed definition ``would cover ingredients or
combinations of ingredients currently used as salt substitutes and
ingredients and combinations of ingredients that may be used as salt
substitutes in the future, as a result of advances in food science and
technological changes'' (88 FR 21148 at 21153).
Further, we decline to revise Sec. 130.30(c)(1) to state that a
salt substitute replaces ``one or more'' functions of the salt in the
food. The text of Sec. 130.30(c)(1) states that a salt substitute
``serves the functions of salt in the food.'' For an ingredient or
combination of ingredients to be a salt substitute, it must replace the
functions of salt when added salt is reduced. The text proposed by the
comments indicates that an ingredient or combination of ingredients
need only serve one of the functions of salt in a food. If the amount
of salt removed impacts multiple functions, then the ingredient(s) used
as salt substitutes should serve those functions. If the salt only
served one function in the food, then the salt substitute must serve
the same function. We note that if we were to revise the text of Sec.
130.30(c)(1) as proposed, manufacturers could arbitrarily choose which
functions of salt are replaced by the salt substitute.
(Comment 17) Some comments request additional guidance or
clarification regarding the definition of salt substitute. A few
comments request additional guidance on what constitutes ``safe and
suitable'' in Sec. 130.30(c). Other comments ask us to clarify in the
preamble to the final rule that types of ingredients, e.g., flavors,
flavor enhancers, and mineral salts, are included in the definition of
salt substitute because, according to the comments, these types of
ingredients are often crucial components of reformulations to reduce
sodium while maintaining consumer taste preferences.
(Response 17) Regarding comments requesting additional guidance on
the meaning of ``safe and suitable'' in the definition of salt
substitute, ``safe and suitable'' is defined in the definitions and
interpretations for standardized foods (see Sec. 130.3(d)). According
to this definition, an ingredient is safe and suitable if it performs
an appropriate function in the food, is used at a level no higher than
necessary to achieve its intended purpose, and is not an unapproved
food additive or color additive as used in the food. We note
[[Page 65051]]
that we have revised the parenthetical in the definition of salt
substitute so that ``safe and suitable'' also modifies the combination
of ingredients to read as follows: ``(or combination of safe and
suitable ingredients).'' This additional language further clarifies
that all ingredients used as a salt substitute, whether used alone or
in combination, must be safe and suitable.
We note that certain types of ingredients, such as flavors, flavor
enhancers, and mineral salts, may comprise salt substitutes if they
meet the criteria in Sec. 130.30(b) and (c). As we stated in the
proposed rule, we drafted the definition of salt substitute 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 (88 FR 21148 at 21153). The types of
ingredients, such as flavors, flavor enhancers, and mineral salts, that
may be used as salt substitutes will depend on the ingredient or
ingredients that can replace the functions of salt in the food, while
still meeting the other criteria in the definition of salt substitute.
It is important that manufacturers consider the particular functions of
salt that would be lost at a given level of substitution in the
standardized food and the types of ingredients to substitute for the
lost function. For example, the SOI for self-rising flour (21 CFR
137.180) and canned corn (21 CFR 155.130) include salt as an
ingredient. If the replacement of salt causes a loss of flavor in these
foods, the rule will permit a flavor ingredient or flavor ingredients
that otherwise meet the definition of salt substitute to be used.
However, since self-rising flour has a low level of moisture and does
not need preservation with ingredients to prevent microbial spoilage
and canned corn is thermally processed to achieve commercial sterility,
using an ingredient that only prevents microbial spoilage will not
align with the definition of salt substitute because salt does not
serve the function of preventing spoilage in these products.
D. Fish and Shellfish Comments and FDA Response
Salt is a required or optional ingredient in several SOI in part
161 (21 CFR part 161) Fish and shellfish. We proposed amending the
following SOI in part 161 which permit salt as a required or optional
ingredient: Canned oysters (Sec. 161.145), Canned Pacific salmon
(Sec. 161.170), Canned wet pack shrimp in transparent or
nontransparent containers (Sec. 161.173), and Canned tuna (Sec.
161.190). We did not propose to amend the SOI for Oysters (Sec.
161.130), Frozen raw breaded shrimp (Sec. 161.175), and Frozen raw
lightly breaded shrimp (Sec. 161.176).
The SOI for oysters (Sec. 161.130) does not include salt as a
required or optional ingredient. Instead, the SOI provides for the
optional use of saltwater containing less than 0.75 percent salt in the
shucking of oysters (Sec. 161.130(b)). In the proposed rule, we
described our understanding that current industry practice is to use
accessible seawater rather than to constitute a solution for the
shucking process. Therefore, because salt was not an added ingredient,
we did not propose to amend the SOI to allow salt substitutes. We
requested comment on this approach and our understanding of current
industry practice (see 88 FR 21148 at 21152).
(Comment 18) One comment asks us to amend the SOI for oysters
(Sec. 161.130) to allow for the use of salt substitutes. The comment
acknowledges that current industry practice is not to use a prepared
salt and water solution for the processing of oysters but suggests that
we permit the use of salt substitutes in the SOI for oysters to
accommodate any future use of salt substitutes in such solution.
(Response 18) The SOI for oysters prescribes the amount of salt
present in the saltwater solution (less than 0.75 percent salt) and the
length of time the oysters are in contact with the water or saltwater
solution (not more than 30 minutes) (see Sec. 161.130(b)). These
parameters were set to help ensure that no appreciable loss of solids
or absorption of water occurs during washing, which could impact flavor
and nutritive content of the oysters (see 11 FR 9331 at 9332-9333,
August 27, 1946). Allowing the use of salt substitutes to lower the
salt content of this solution without also changing the other
parameters, such as length of time the oysters are in contact with
water, could affect the amount of shrinkage or water absorption of the
oysters. Further, the SOI requires that the oysters are packed without
any added substance (see Sec. 161.130(b)). The effect of using salt
substitutes for processing oysters is unlikely to be the same as using
salt, which could result in oysters being packed with an added
substance. Therefore, we decline to amend the SOI for oysters in the
final rule.
(Comment 19) One comment requests that the SOI for frozen raw
breaded shrimp at Sec. 161.175 and, by reference, the SOI for frozen
raw lightly breaded shrimp at Sec. 161.176, also be amended to permit
the use of salt substitutes. The comment explains that these SOI allow
for safe and suitable batter and breading ingredients but prohibit the
use of artificial flavorings, artificial sweeteners, artificial colors,
and chemical preservatives. The comment would amend the SOI to
explicitly allow salt substitutes and also provide that use of a salt
substitute is not limited by the existing ingredient prohibitions in
the SOI.
(Response 19) As previously discussed, we intended to amend SOI
that include salt as a required or optional ingredient to provide
manufacturers with ingredient flexibility to reduce salt in these
foods. The SOI for frozen raw breaded shrimp at Sec. 161.175 does not
explicitly provide for the use of salt as an ingredient. The SOI
provides for the use of safe and suitable batter and breading
ingredients (Sec. 161.175(a)), but excludes artificial flavorings,
artificial sweeteners, artificial colors, and chemical preservatives
(Sec. 161.175(d)). Thus, manufacturers can use salt and salt
substitutes that are not artificial flavorings, artificial sweeteners,
artificial colors, or chemical preservatives in frozen raw breaded
shrimp. Therefore, we decline to amend the SOI for frozen raw breaded
shrimp (Sec. 161.175) to explicitly permit salt substitutes. Because
the SOI for frozen raw lightly breaded shrimp at Sec. 161.176 cross
references Sec. 161.175, we are not amending the SOI for frozen raw
lightly breaded shrimp for the same reasons.
E. Incorporation by Reference Comments and FDA Response
(Comment 20) Some comments ask that we update the incorporation by
reference information. One comment notes that the rule should
incorporate by reference the 22nd Ed. (2023) of the ``Official Methods
of Analysis of AOAC INTERNATIONAL'' and not the 21st Ed. (2019) as
proposed. One comment agrees with the change to update the number for
the method in 21 CFR 155.170 for canned peas.
Other comments request that we update the incorporation by
reference information in other sections which we did not propose to
update, e.g., the SOI for frozen raw breaded shrimp and frozen raw
lightly breaded shrimp (Sec. Sec. 161.175 and 161.176).
(Response 20) We have reviewed the specific methods referenced by
the proposed rule and note that there were no substantive changes
between the 21st Ed. of the ``Official Methods of Analysis of AOAC
INTERNATIONAL'' that we proposed to incorporate by reference and the
newer 22nd Ed. Therefore, we
[[Page 65052]]
agree to incorporate by reference the 22nd Ed. (2023) of the ``Official
Methods of Analysis of AOAC INTERNATIONAL'' in the final rule.
As for the comments requesting updates to the incorporation by
reference information in the SOI for frozen raw breaded shrimp and
frozen raw lightly breaded shrimp (Sec. Sec. 161.175 and 161.176), we
decline this request. We are reviewing materials incorporated by
reference in other regulations and will consider updating the material
incorporated by reference in these SOI within the scope of that effort.
We note that we have included technical amendments to make formatting
changes to certain SOI that have not been updated to allow the use of
salt substitutes to accommodate the use of a centralized IBR section in
21 CFR parts 131, 137, 139, 150, 155, and 161. There are no substantive
changes to these SOI, and we have not updated the material that they
incorporate by reference; these SOI have only been updated to point to
a new centralized IBR section, if applicable. This change will help
consolidate and streamline future IBR updates.
F. Technical Amendments
We proposed technical amendments to correct inconsistencies and
typographical errors in several of the SOI that specify salt as a
required or optional ingredient. We received no adverse comments
regarding these proposed changes.
Therefore, the final rule amends:
<bullet> 21 CFR 133.118(c)(2) to replace ``143'' with ``145''.
<bullet> 21 CFR 133.150(c)(2) to replace ``143'' with ``145''.
<bullet> 21 CFR 133.150(e)(1) to replace ``unusual'' with ``usual''.
<bullet> 21 CFR 133.182(c)(2) to replace ``143'' with ``145''.
<bullet> 21 CFR 133.184(b) to replace ``Operational'' with
``Optional''.
<bullet> 21 CFR 133.186(c) to replace ``Nonmenclature'' with
``Nomenclature''.
<bullet> 21 CFR 133.187(c)(2) to replace ``143'' with ``145''.
<bullet> 21 CFR 133.188(c)(2) to replace ``143'' with ``145''.
<bullet> 21 CFR 155.170(b)(1)(iii) to replace ``shrivelled'' with
``shriveled''.
<bullet> 21 CFR 158.170(b)(1)(iii) to replace ``shrivelled'' with
``shriveled''.
<bullet> 21 CFR 168.140(a) to replace ``mapel'' with ``maple''.
G. Out-of-Scope Comments
FDA also received several comments outside of the scope of this
rulemaking. These comments raise issues related to:
<bullet> The Environmental Protection Agency's (EPA's) ``Safer Choice
and Design for the Environment'' program and insect repellants.
<bullet> Work with the United States Department of Agriculture (USDA),
Food Safety and Inspection Service to harmonize broader SOI principles.
<bullet> Appropriate use of the horizontal approach for other SOI
changes (e.g., processing changes).
<bullet> Enforcement discretion to use salt substitutes in standardized
foods pending issuance of the final rule.
<bullet> Intake of certain ingredients (e.g., sugar), nutrients (e.g.,
phosphorus), or types of foods (e.g., processed foods) or use of
chemicals generally in the food supply.
<bullet> FDA's sodium reduction efforts or sodium reduction strategies
we could consider (e.g., labeling, taxation).
<bullet> The safety of specific, individual ingredients that may be
used as salt substitutes.
<bullet> Impacts of the rule on specific, individual ingredients (e.g.,
kosher salt).
<bullet> Proposed amendments to Sec. 101.4(b) (21 CFR 101.4(b) to
allow the use of ``and/or'' labeling for salt substitutes.
<bullet> Consumer education for target populations, including those
with specific conditions and/or nutrition needs.
<bullet> Work to address factors affecting health equity and
cardiovascular disease.
We do not respond to these out-of-scope comments. Regarding
comments about the safety of specific salt substitutes, we note that we
re-review substances when we receive new safety information or data and
have instituted a post-market review process to review substances more
systematically for continued safety.
VI. Effective Date
This rule is effective December 14, 2026 except as to any
provisions in the SOI for dairy products that may be stayed by the
filing of proper objections. If you will be adversely affected by one
or more provisions in the SOI for dairy products of this regulation,
you may file with the Dockets Management Staff (see ADDRESSES) either
electronic or written/paper objections. You must separately number each
objection, and within each numbered objection you must specify with
particularity the provision(s) to which you object, and the grounds for
your objection. Within each numbered objection, you must specifically
state whether you are requesting a hearing on the particular provision
that you specify in that numbered objection. If you do not request a
hearing for any particular objection, you waive the right to a hearing
on that objection. If you request a hearing, your objection must
include a detailed description and analysis of the specific factual
information you intend to present in support of the objection in the
event that a hearing is held. If you do not include such a description
and analysis for any particular objection, you waive the right to a
hearing on the objection.
Any objections received in response to the regulation may be seen
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.
VII. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 14192, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801,
Pub. L. 104-121), 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.
Rules are significant under section 3(f)(1) of Executive Order 12866 if
they may have an annual effect on the economy of $100 million or more;
or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities. The Office of Information and Regulatory Affairs (OIRA)
has determined that this final rule is a significant regulatory action
as defined by section 3(f)(1) of Executive Order 12866.
Executive Order 14192 requires that any new incremental costs
associated with certain significant regulatory actions ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least 10 prior regulations.'' The final rule allows
manufacturers of affected products to gain flexibility in using salt
substitutes. This flexibility potentially would allow them to
reformulate their products to increase their product offerings and
therefore potentially increase their profits. Producing new products
can reduce average operational costs by enabling economies of scale and
scope. Increasing the number of products
[[Page 65053]]
increases consumer surplus by providing more options tailored to
individual preferences, allowing consumers to choose products that
better align with their willingness to pay. However, due to the
voluntary nature of the rule, no changes in costs of production or
increase in consumer satisfaction can be quantified. This final rule is
considered an Executive Order 14192 deregulatory action.
Because this rule is likely to result in an annual effect on the
economy of $100 million or more or to meet other criteria specified in
the Congressional Review Act/Small Business Regulatory Enforcement
Fairness Act, OIRA has determined that this rule does fall within the
scope of 5 U.S.C. 804(2).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the final rule would not impose regulatory costs on
small entities, we certify that the final 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 estimates of
anticipated impacts, before issuing ``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 $187
million, using the most current (2024) Implicit Price Deflator for the
Gross Domestic Product. This final rule will not result in a mandated
expenditure in any year that meets or exceeds this amount.
B. Overview of Benefits, Costs, and Transfers
There are no regulatory costs of the final rule as there are no
regulatory requirements or regulatory penalties if manufacturers of a
standardized food choose not to take advantage of the flexibility to
use salt substitutes. Other costs considered may come from voluntary
reformulation and re-labeling costs, as well as potential consumer
dissatisfaction with altered product properties. The benefits of the
final rule come in the form of increased flexibility for manufacturers
and potential public health benefits stemming from decreased sodium
consumption.
We believe that some manufacturers may reformulate (and as a
result, re-label) standardized foods with salt substitutes to lower
sodium in their products if the voluntary reformulation of their
products would be profitable (producer surplus). The resulting new
products may lead to increased consumer satisfaction (consumer
surplus). Table 1 summarizes the estimated benefits and costs of the
final rule.
Table 1--Summary of Benefits, Costs, and Distributional Effects of the Final Rule
[Millions of 2024 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (year)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year....... $0 $0 $0 2024 7 10 ................................
0 0 0 2024 3 10 ................................
Annualized Quantified..................... .......... .......... .......... .......... .......... .......... ................................
---------------------------------------------------------------------------------------------------------
Qualitative............................... Potential increased consumer .......... .......... .......... ................................
surplus and producer surplus.
Potential health benefits of
reduced sodium consumption
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/year....... 0 0 0 2024 7 10 ................................
0 0 0 2024 3 10 ................................
Annualized Quantified..................... .......... .......... .......... .......... .......... .......... ................................
---------------------------------------------------------------------------------------------------------
Qualitative............................... Potential costs from voluntary .......... .......... .......... Compliance with the final rule
reformulation and re-labeling, as is voluntary. There are no
well as possible consumer regulatory costs.
dissatisfaction
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized $millions/ 0 0 0 2024 7 .......... ................................
year.
0 0 0 2024 3 .......... ................................
---------------------------------------------------------------------------------------------------------
From/To................................... From:
To: ..........
---------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/year. 0 0 0 2024 7 .......... ................................
---------------------------------------------------------------------------------------------------------
0 0 0 2024 3 .......... ................................
---------------------------------------------------------------------------------------------------------
From/To....................................... From: To: ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government:
Small Business:
Wages:
Growth:
--------------------------------------------------------------------------------------------------------------------------------------------------------
In line with Executive Order 14192, in table 2 we estimate present
and annualized values of costs, cost savings, and net costs over a
perpetual time horizon. We estimate that this rule will generate $0 in
annualized net costs at a
[[Page 65054]]
7 percent discount rate, discounted relative to year 2024, over a
perpetual time horizon.
Table 2--Executive Order 14192 Summary Table
[Millions of 2024 dollars, discounted over a perpetual time horizon relative to year 2024 at a 7 percent
discount rate]
----------------------------------------------------------------------------------------------------------------
Lower bound Upper bound
Primary (7%) (7%) (7%)
----------------------------------------------------------------------------------------------------------------
Present Value of Costs.......................................... $0 $0 $0
Present Value of Cost Savings................................... 0 0 0
Present Value of Net Costs...................................... 0 0 0
Annualized Costs................................................ 0 0 0
Annualized Cost Savings......................................... 0 0 0
Annualized Net Costs............................................ 0 0 0
----------------------------------------------------------------------------------------------------------------
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 12) and at
<a href="https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria">https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria</a>.
VIII. Analysis of Environmental Impact
We previously considered the environmental effects of this rule, as
stated in the proposed rule (88 FR 21148 at 21160). We stated that we
had 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'' such that neither an environmental assessment
nor an environmental impact statement is required. We have not received
any new information or comments that would affect our previous
determination (Ref. 13).
IX. Paperwork Reduction Act of 1995
This final 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. This final rule refers to the
previously approved collection of information for food labeling
regulations (OMB Control No. 0910-0381).
X. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the 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 rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects 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. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive order and, consequently, a
tribal summary impact statement is not required.
XII. References
The following references marked with an asterisk (*) are on display
at 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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. Although FDA verified the website addresses
in this document, please note that 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, 2025-2030,''
10th Ed., January 2026. Available at <a href="https://www.dietaryguidelines.gov">https://www.dietaryguidelines.gov</a> (accessed May 28, 2026).
*2. FDA, ``Horizontal Approaches to Food Standards of Identity
Modernization; Public Meeting; Request for Comments,'' September 27,
2019. Transcript available at <a href="https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-horizontal-approaches-food-standards-identity-modernization-09272019-09272019">https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-horizontal-approaches-food-standards-identity-modernization-09272019-09272019</a> (accessed May 28, 2026).
*3. 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, Docket
number FDA-2014-D-0055. Available at <a href="https://www.fda.gov/media/98264/download">https://www.fda.gov/media/98264/download</a> (accessed May 28, 2026).
*4. FDA, ``The Use of an Alternate Name for Potassium Chloride in
Food Labeling: Guidance for Industry,'' December 2020, Docket number
FDA-2019-D-0892. Available at <a href="https://www.fda.gov/media/125081/download">https://www.fda.gov/media/125081/download</a> (accessed May 28, 2026).
5. Coxson, P.G., N.R. Cook, M. Joffres, et al., ``Mortality Benefits
From US Population-Wide Reduction in Sodium Consumption: Projections
From 3 Modeling Approaches,'' Hypertension, 61(3):564-570, 2013.
Available at <a href="https://www.ahajournals.org/doi/10.1161/hypertensionaha.111.201293">https://www.ahajournals.org/doi/10.1161/hypertensionaha.111.201293</a> (accessed May 28, 2026).
6. National Academies of Sciences, Engineering, and Medicine,
``Dietary Reference Intakes for Sodium and Potassium,'' Washington,
DC: The National Academies Press, 2019. Available at <a href="https://doi.org/10.17226/25353">https://doi.org/10.17226/25353</a> (accessed June 24, 2026).
7. Graudal, N.A., T. Hubeck-Graudal and G. Jurgens, ``Effects of Low
Sodium Diet Versus High Sodium Diet on Blood Pressure, Renin,
Aldosterone, Catecholamines, Cholesterol, and Triglyceride,''
Cochrane Database of Systematic Reviews, 12:CD004022, 2020.
Available at <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD004022.pub5/full">https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD004022.pub5/full</a> (accessed June 24, 2026).
*8. Institute of Medicine, ``Strategies To Reduce Sodium Intake in
the United States,'' Washington, DC: The National Academies Press,
2010. Available at
[[Page 65055]]
<a href="https://www.ncbi.nlm.nih.gov/books/n/nap12818/pdf/">https://www.ncbi.nlm.nih.gov/books/n/nap12818/pdf/</a> (accessed May 28,
2026).
*9. Harnack L.J., M.E. Cogswell, J.M. Shikany, et al. ``Sources of
Sodium in US Adults From 3 Geographic Regions,'' Circulation,
135:1775-1783, 2017. Available at <a href="https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.116.024446">https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.116.024446</a> (accessed May 28, 2026).
*10. van Buren L., M. D[ouml]tsch-Klerk, G. Seewi, et al. ``Dietary
Impact of Adding Potassium Chloride to Foods as a Sodium Reduction
Technique,'' Nutrients, 8:235, 2016. Available at <a href="https://doi.org/10.3390/nu8040235">https://doi.org/10.3390/nu8040235</a> (accessed May 28, 2026).
11. Sinopoli D.A. and H.T. Lawless, ``Taste Properties of Potassium
Chloride Alone and in Mixtures with Sodium Chloride Using a Check-
All-That-Apply Method,'' Journal of Food Science, 77:S319-S322,
2012. Available at <a href="https://ift.onlinelibrary.wiley.com/doi/10.1111/j.1750-3841.2012.02862.x">https://ift.onlinelibrary.wiley.com/doi/10.1111/j.1750-3841.2012.02862.x</a> (accessed May 28, 2026).
*12. FDA, ``Use of Salt Substitutes To Reduce the Sodium Content in
Standardized Foods: Final Regulatory Impact Analysis, Regulatory
Flexibility Analysis, Unfunded Mandates Reform Act Analysis,'' 2026.
Available at <a href="https://www.fda.gov/economics-staff/regulatory-impact-analyses-ria">https://www.fda.gov/economics-staff/regulatory-impact-analyses-ria</a>.
*13. FDA, Human Foods Program. Memorandum from Mariellen Pfeil,
Supervisory Biologist, Office of Food Chemical Safety, Dietary
Supplements and Innovation, Office of Pre-Market and Additive
Safety, Environmental Review Team, to Andrew Yeung, Senior Advisor,
Nutrition Center of Excellence (NCE), Office of Nutrition and Food
Labeling (ONFL), Division of Food Labeling and Standards (DFLS), and
Rumana Yasmeen, Food Technologist, NCE, ONFL, DFLS, Product
Evaluation & Labeling Branch 2. ``Categorical Exclusion--Use of Salt
Substitutes To Reduce the Sodium Content in Standardized Foods,''
June 1, 2026.
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, 21 CFR
parts 130, 131, 133, 136, 137, 139, 145, 150, 155, 156, 158, 161, 163,
166, 168, and 169 are 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, consisting of Sec. Sec. 130.30 through 130.39, to
read as follows:
Subpart C--Flexibility in Standardized Foods
Sec.
130.30 Ingredient flexibility in standardized foods.
130.31 through 130.39 [Reserved]
Subpart C--Flexibility in Standardized Foods
Sec. 130.30 Ingredient flexibility in standardized foods.
(a) The definitions listed in paragraph (c) of this section apply
to parts 131 through 169 of this subchapter.
(b) The ingredients used as substitutes must not change the basic
nature and essential characteristics of the food.
(c)(1) Salt substitute means a safe and suitable ingredient (or
combination of safe and suitable 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]
Sec. Sec. 130.31 through 130.39 [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. 131.1 to subpart A to read as follows:
Sec. 131.1 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at the Food and
Drug Administration (FDA) and at the National Archives and Records
Administration (NARA). Contact FDA's Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852; 240-402-7500;
<a href="/cdn-cgi/l/email-protection#9fd6ddcdc0d2feebfaedf6fef3c0d6f1eeeaf6edf6faecdff9fbfeb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="e7aea5b5b8aa869382958e868bb8ae8996928e958e8294a7818386c98f8f94c9808891">[email protected]</span></a>. For information on the availability
of this material at NARA, visit <a href="http://www.archives.gov/federal-register/cfr/ibr-locations">www.archives.gov/federal-register/cfr/ibr-locations</a> or email <a href="/cdn-cgi/l/email-protection#e08692ce898e9390858394898f8ea08e819281ce878f96"><span class="__cf_email__" data-cfemail="4523376b2c2b36352026312c2a2b052b2437246b222a33">[email protected]</span></a>. The material may be
obtained from the following sources:
(a) AOAC INTERNATIONAL (AOAC), 2275 Research Blvd., Suite 300,
Rockville, MD 20850-3250; 1-800-379-2622; <a href="http://www.aoac.org">www.aoac.org</a>.
(1) Official Methods of Analysis of the Association of Official
Analytical Chemists, 13th Ed., 1980; IBR approved for Sec. Sec.
131.110(d); 131.115(d); 131.120(c); 131.125(c); 131.127(d); 131.130(d);
131.147(d); 131.149(c); 131.150(c); 131.155(c); 131.157(c); 131.180(c).
(2) Official Methods of Analysis of AOAC INTERNATIONAL, 21st Ed.,
2019, vol. 1--
(i) AOAC Official Method 989.05, Fat in Milk: Modified Mojonnier
Ether
[[Page 65056]]
Extraction Method, Section 33.2.26; IBR approved for Sec. 131.200(e).
(ii) AOAC Official Method 990.21, Solids-Not-Fat in Milk: By
Difference between Total Solids and Fat Contents, Section 33.2.45; IBR
approved for Sec. 131.200(e).
(3) Official Methods of Analysis of AOAC INTERNATIONAL, 22nd Ed.,
published 4 January 2023 (available at <a href="https://academic.oup.com/aoac-publications/book/45491">https://academic.oup.com/aoac-publications/book/45491</a>)--
(i) AOAC Official Method 945.48, Evaporated Milk (Unsweetened); IBR
approved for Sec. Sec. 131.160(c); 131.162(c).
(ii) AOAC Official Method 947.05, Acidity of Milk: Titrimetric
Method; IBR approved for Sec. Sec. 131.111(f); 131.112(e); 131.160(c);
131.162(c).
(iii) AOAC Official Method 989.05, Fat in Milk: Modified Mojonnier
Ether Extraction Method; IBR approved for Sec. Sec. 131.111(f);
131.112(e); 131.170(f).
(iv) AOAC Official Method 990.21, Solids-Not-Fat in Milk: By
Difference between Total Solids and Fat Contents; IBR approved for
Sec. Sec. 131.111(f); 131.112(e); 131.170(f).
(b) International Organization for Standardization (ISO), Chemin de
Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; +41 22 749 01
11; <a href="http://www.iso.org">www.iso.org</a>.
(1) ISO 7889:2003(E), Yogurt--Enumeration of Characteristic
Microorganisms--Colony-Count Technique at 37 [deg]C, 1st Ed., 2003-02-
01.
(2) [Reserved]
Note 1 to paragraph (b): ISO 7889:2003(E) is co-published as IDF
117:2003(E).
0
5. In Sec. 131.110, revise the introductory text of paragraph (d) to
read as follows:
Sec. 131.110 Milk.
* * * * *
(d) Methods of analysis. The methods referenced in this paragraph
(d) are from the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (incorporated by reference, see
Sec. 131.1).
* * * * *
0
6. 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. The AOAC methods referenced in this
paragraph (f) are incorporated by reference (see Sec. 131.1):
(1) Milkfat content--As determined by the method prescribed in AOAC
Official Method 989.05.
(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.
(3) Titratable acidity--As determined by the methods prescribed in
AOAC Official Method 947.05 or by an equivalent potentiometric method.
* * * * *
0
7. 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. The AOAC methods referenced in this
paragraph (e) are incorporated by reference (see Sec. 131.1):
(1) Milkfat content--As determined by the method prescribed in AOAC
Official Method 989.05.
(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.
(3) Titratable acidity--As determined by the methods prescribed in
AOAC Official Method 947.05 or by an equivalent potentiometric method.
* * * * *
0
8. In Sec. 131.115, revise the introductory text of paragraph (d) to
read as follows:
Sec. 131.115 Concentrated milk.
* * * * *
(d) Methods of analysis. The methods referenced in this paragraph
(d) are from the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (incorporated by reference, see
Sec. 131.1).
* * * * *
0
9. In Sec. 131.120, revise paragraph (c) to read as follows:
Sec. 131.120 Sweetened condensed milk.
* * * * *
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in ``Fat--Official Final Action,'' Section 16.185
from the Official Methods of Analysis of the Association of Official
Analytical Chemists, 13th Ed. (incorporated by reference, see Sec.
131.1).
* * * * *
0
10. In Sec. 131.125, revise the introductory text of paragraph (c) to
read as follows:
Sec. 131.125 Nonfat dry milk.
* * * * *
(c) Methods of analysis. The methods referenced in this paragraph
(c) are from the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (incorporated by reference, see
Sec. 131.1).
* * * * *
0
11. In Sec. 131.127, revise the introductory text of paragraph (d) to
read as follows:
Sec. 131.127 Nonfat dry milk fortified with vitamins A and D.
* * * * *
(d) Methods of analysis. The methods referenced in this paragraph
(d) are from the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (incorporated by reference, see
Sec. 131.1).
* * * * *
0
12. In Sec. 131.130, revise the introductory text of paragraph (d) to
read as follows:
Sec. 131.130 Evaporated milk.
* * * * *
(d) Methods of analysis. The methods referenced in this paragraph
(d) are from the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (incorporated by reference, see
Sec. 131.1).
* * * * *
0
13. In Sec. 131.147, revise the introductory text of paragraph (d) to
read as follows:
Sec. 131.147 Dry whole milk.
* * * * *
(d) Methods of analysis. The methods referenced in this paragraph
(d) are from the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (incorporated by reference, see
Sec. 131.1).
* * * * *
0
14. In Sec. 131.149, revise the introductory text of paragraph (c) to
read as follows:
Sec. 131.149 Dry cream.
* * * * *
(c) Methods of analysis. The methods referenced in this paragraph
(c) are from the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (incorporated by reference, see
Sec. 131.1).
* * * * *
0
15. In Sec. 131.150, revise paragraph (c) to read as follows:
Sec. 131.150 Heavy cream.
* * * * *
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in sections 16.156 and
[[Page 65057]]
16.059, under ``Fat, Roese-Gottlieb Method--Official Final Action''
from the Official Methods of Analysis of the Association of Official
Analytical Chemists, 13th Ed. (incorporated by reference, see Sec.
131.1).
* * * * *
0
16. In Sec. 131.155, revise paragraph (c) to read as follows:
Sec. 131.155 Light cream.
* * * * *
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in sections 16.156 and 16.059, under ``Fat, Roese-
Gottlieb Method--Official Final Action'' from the Official Methods of
Analysis of the Association of Official Analytical Chemists, 13th Ed.
(incorporated by reference, see Sec. 131.1).
* * * * *
0
17. In Sec. 131.157, revise paragraph (c) to read as follows:
Sec. 131.157 Light whipping cream.
* * * * *
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in sections 16.156 and 16.059, under ``Fat, Roese-
Gottlieb Method--Official Final Action'' from the Official Methods of
Analysis of the Association of Official Analytical Chemists, 13th Ed.
(incorporated by reference, see Sec. 131.1).
* * * * *
0
18. 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. The AOAC methods referenced in this
paragraph (c) are incorporated by reference (see Sec. 131.1):
(1) Milkfat content--AOAC Official Method 945.48G.
(2) Titratable acidity--AOAC Official Method 947.05.
* * * * *
0
19. 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. The AOAC methods referenced in this
paragraph (c) are incorporated by reference (see Sec. 131.1):
(1) Milkfat content--AOAC Official Method 945.48G.
(2) Titratable acidity--AOAC Official Method 947.05.
* * * * *
0
20. 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. The AOAC methods referenced in this
paragraph (f) are incorporated by reference (see Sec. 131.1).
(1) Milkfat content--As determined by the method prescribed in AOAC
Official Method 989.05.
(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.
* * * * *
0
21. In Sec. 131.180, revise paragraph (c) to read as follows:
Sec. 131.180 Half-and-half.
* * * * *
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in sections 16.156 and 16.059, under ``Fat, Roese-
Gottlieb Method--Official Final Action'' from the Official Methods of
Analysis of the Association of Official Analytical Chemists, 13th Ed.
(incorporated by reference, see Sec. 131.1).
* * * * *
Sec. 131.200 [Amended]
0
22. In Sec. 131.200:
0
a. Amend paragraphs (e)(1)(i) and (ii) and (e)(3) by adding the text
``(incorporated by reference, see Sec. 131.1)'' immediately before the
closing period of each paragraph.
0
b. Remove paragraph (i).
PART 133--CHEESES AND RELATED CHEESE PRODUCTS
0
23. The authority citation for part 133 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
0
24. 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
25. In Sec. 133.106, add paragraph (b)(3)(vii) to read as follows:
Sec. 133.106 Blue cheese.
* * * * *
(b) * * *
(3) * * *
(vii) Salt substitute.
* * * * *
0
26. In Sec. 133.108, add paragraph (b)(3)(v) to read as follows:
Sec. 133.108 Brick cheese.
* * * * *
(b) * * *
(3) * * *
(v) Salt substitute.
* * * * *
0
27. 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
28. In Sec. 133.113, add paragraph (b)(3)(vi) to read as follows:
Sec. 133.113 Cheddar cheese.
* * * * *
(b) * * *
(3) * * *
(vi) Salt substitute.
* * * * *
0
29. 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
30. 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
31. In Sec. 133.124, revise paragraph (e)(3) to read as follows:
Sec. 133.124 Cold-pack cheese food.
* * * * *
[[Page 65058]]
(e) * * *
(3) Salt or salt substitute.
* * * * *
0
32. 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
33. In Sec. 133.129, revise paragraphs (b)(1)(i) through (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, and it is then drained. The curd may be washed with water and
further drained. It may be pressed, chilled, worked, seasoned with salt
or salt substitute; or
(ii) Food grade phosphoric acid, lactic acid, citric acid, or
hydrochloric acid, with or without rennet and/or other safe and
suitable milk-clotting enzyme that produces equivalent curd formation,
is added in such amount as to reach a pH of between 4.5 and 4.7;
coagulation to a firm curd is achieved while heating to a maximum of
120 [deg]F without agitation during a continuous process. The
coagulated mass may be cut; it may be warmed; it may be stirred; it is
then drained. The curd is washed with water, stirred, and further
drained. It may be pressed, chilled, worked, seasoned with salt or salt
substitute.
(iii) Food grade acids as provided in paragraph (b)(1)(ii) of this
section, D-Glucono-delta-lactone with or without rennet, and/or other
safe and suitable milk clotting enzyme that produces equivalent curd
formation, are added in such amounts as to reach a final pH value in
the range of 4.5-4.8, and it is held until it becomes coagulated. The
coagulated mass may be cut; it may be warmed; it may be stirred; it is
then drained. The curd is then washed with water and further drained.
It may be pressed, chilled, worked, and seasoned with salt or salt
substitute.
* * * * *
0
34. In Sec. 133.133, revise paragraph (b)(3)(i) to read as follows:
Sec. 133.133 Cream cheese.
* * * * *
(b) * * *
(3) * * *
(i) Salt or salt substitute.
* * * * *
0
35. In Sec. 133.136, add paragraph (b)(3)(vi) to read as follows:
Sec. 133.136 Washed curd and soaked curd cheese.
* * * * *
(b) * * *
(3) * * *
(vi) Salt substitute.
* * * * *
0
36. In Sec. 133.138, add paragraph (b)(3)(v) to read as follows:
Sec. 133.138 Edam cheese.
* * * * *
(b) * * *
(3) * * *
(v) Salt substitute.
* * * * *
0
37. In Sec. 133.141, add paragraph (b)(3)(vii) to read as follows:
Sec. 133.141 Gorgonzola cheese.
* * * * *
(b) * * *
(3) * * *
(vii) Salt substitute.
* * * * *
0
38. In Sec. 133.144, add paragraph (b)(3)(vi) to read as follows:
Sec. 133.144 Granular and stirred curd cheese.
* * * * *
(b) * * *
(3) * * *
(vi) Salt substitute.
* * * * *
0
39. In Sec. 133.147, revise paragraph (c)(5) to read as follows:
Sec. 133.147 Grated American cheese food.
* * * * *
(c) * * *
(5) Salt or salt substitute.
* * * * *
0
40. In Sec. 133.148, revise paragraph (c) to read as follows:
Sec. 133.148 Hard grating cheeses.
* * * * *
(c)(1) For the purposes of this section, the word ``milk'' means
cow's milk or goat's milk or sheep's milk or mixtures of two or all of
these. Such milk may be adjusted by separating part of the fat
therefrom or (in the case of cow's milk) by adding one or more of the
following: Cream, skim milk, concentrated skim milk, nonfat dry milk;
(in the case of goat's milk) the corresponding products from goat's
milk; (in the case of sheep's milk) the corresponding products from
sheep's milk; water in a quantity sufficient to reconstitute any such
concentrated or dried products used.
(2) During the cheesemaking process, where the curd is salted, salt
substitute may be used.
* * * * *
0
41. In Sec. 133.149, add paragraph (b)(3)(iv) to read as follows:
Sec. 133.149 Gruyere cheese.
* * * * *
(b) * * *
(3) * * *
(iv) Salt substitute.
* * * * *
0
42. In Sec. 133.150, revise the first sentence of paragraph (c)(2),
add paragraph (c)(3), and revise paragraph (e)(1) to read as follows:
Sec. 133.150 Hard cheeses.
* * * * *
(c) * * *
(2) Milk shall be deemed to have been pasteurized if it has been
held at a temperature of not less than 145 [deg]F for a period of not
less than 30 minutes, or for a time and at a temperature equivalent
thereto in phosphatase destruction. * * *
(3) During the cheesemaking process, where the curd is salted, salt
substitute may be used.
* * * * *
(e) * * *
(1) The specific common or usual name of such hard cheese, if any
such name has become generally recognized therefor; or
* * * * *
0
43. In Sec. 133.152, add paragraph (b)(3)(iv) to read as follows:
Sec. 133.152 Limburger cheese.
* * * * *
(b) * * *
(3) * * *
(iv) Salt substitute.
* * * * *
0
44. In Sec. 133.153, revise paragraph (b)(3)(iii) to read as follows:
Sec. 133.153 Monterey cheese and monterey jack cheese.
* * * * *
(b) * * *
(3) * * *
(iii) Salt or salt substitute.
* * * * *
0
45. In Sec. 133.155, revise paragraph (b)(3)(iii) to read as follows:
Sec. 133.155 Mozzarella cheese and scamorza cheese.
* * * * *
(b) * * *
(3) * * *
(iii) Salt or salt substitute.
* * * * *
[[Page 65059]]
0
46. In Sec. 133.156, revise paragraph (b)(3)(iii) to read as follows:
Sec. 133.156 Low-moisture mozzarella and scamorza cheese.
* * * * *
(b) * * *
(3) * * *
(iii) Salt or salt substitute.
* * * * *
0
47. In Sec. 133.160, add paragraph (b)(3)(vi) to read as follows:
Sec. 133.160 Muenster and munster cheese.
* * * * *
(b) * * *
(3) * * *
(vi) Salt substitute.
* * * * *
0
48. In Sec. 133.162, revise paragraph (b)(3)(i) to read as follows:
Sec. 133.162 Neufchatel cheese.
* * * * *
(b) * * *
(3) * * *
(i) Salt or salt substitute.
* * * * *
0
49. In Sec. 133.164, add paragraph (b)(3)(iv) to read as follows:
Sec. 133.164 Nuworld cheese.
* * * * *
(b) * * *
(3) * * *
(iv) Salt substitute.
* * * * *
0
50. In Sec. 133.165, add paragraph (c)(3) to read as follows:
Sec. 133.165 Parmesan and reggiano cheese.
* * * * *
(c) * * *
(3) During the cheesemaking process, where the curd is salted, salt
substitute may be used.
* * * * *
0
51. In Sec. 133.169, revise paragraph (d)(4) to read as follows:
Sec. 133.169 Pasteurized process cheese.
* * * * *
(d) * * *
(4) Salt or salt substitute.
* * * * *
0
52. In Sec. 133.173, revise paragraph (e)(4) to read as follows:
Sec. 133.173 Pasteurized process cheese food.
* * * * *
(e) * * *
(4) Salt or salt substitute.
* * * * *
0
53. In Sec. 133.179, revise paragraph (f)(5) to read as follows:
Sec. 133.179 Pasteurized process cheese spread.
* * * * *
(f) * * *
(5) Salt or salt substitute.
* * * * *
0
54. In Sec. 133.181, add paragraph (b)(3)(vi) to read as follows:
Sec. 133.181 Provolone cheese.
* * * * *
(b) * * *
(3) * * *
(vi) Salt substitute.
* * * * *
0
55. In Sec. 133.182, revise and republish paragraph (b) and revise
paragraph (c)(2) to read as follows:
Sec. 133.182 Soft ripened cheeses.
* * * * *
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria or other harmless flavor-producing bacteria, present
in such milk or added thereto. Sufficient rennet, rennet paste, extract
of rennet paste, or other safe and suitable milk-clotting enzyme that
produces equivalent curd formation, singly or in any combination (with
or without purified calcium chloride in a quantity not more than 0.02
percent, calculated as anhydrous calcium chloride, of the weight of the
milk) is added to set the milk to a semisolid mass. Harmless artificial
coloring may be added. After coagulation, the mass is so treated as to
promote and regulate the separation of whey and curd. Such treatment
may include one or more of the following: cutting, stirring, heating,
dilution with water or brine. The whey, or part of it, is drained off,
and the curd is collected and shaped. It may be placed in forms and may
be pressed. Harmless flavor-producing microorganisms may be added. It
is cured under conditions suitable for development of biological curing
agents on the surface of the cheese, and the curing is conducted so
that the cheese cures from the surface toward the center. Salt or salt
substitute may be added during the procedure. A harmless preparation of
enzymes of animal or plant origin capable of aiding in the curing or
development of flavor of soft ripened cheeses may be added, in such
quantity that the weight of the solids of such preparation is not more
than 0.1 percent of the weight of the milk used.
(c) * * *
(2) Milk shall be deemed to have been pasteurized if it has been
held at a temperature of not less than 145 [deg]F for a period of not
less than 30 minutes, or for a time and at a temperature equivalent
thereto in phosphatase destruction.
* * * * *
0
56. In Sec. 133.183, add paragraph (c)(3) to read as follows:
Sec. 133.183 Romano cheese.
* * * * *
(c) * * *
(3) During the cheesemaking process, where the curd is salted, salt
substitute may be used.
* * * * *
0
57. In Sec. 133.184, revise paragraphs (b) introductory text and
(b)(3) to read as follows:
Sec. 133.184 Roquefort cheese, sheep's milk blue-mold, and blue-mold
cheese from sheep's milk.
* * * * *
(b) Optional Ingredients. The following safe and suitable
ingredients may be used:
* * * * *
(3) Other optional ingredients. (i) Enzymes of animal, plant, or
microbial origin, used in curing or flavor development.
(ii) Salt substitute.
* * * * *
0
58. In Sec. 133.185, add paragraph (b)(3)(v) to read as follows:
Sec. 133.185 Samsoe cheese.
* * * * *
(b) * * *
(3) * * *
(v) Salt substitute.
* * * * *
0
59. In Sec. 133.186, revise paragraphs (a)(2) and (c) to read as
follows:
Sec. 133.186 Sap sago cheese.
(a) * * *
(2) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section is allowed to become sour, and is heated to
boiling temperature, with stirring. Sufficient sour whey is added to
precipitate the casein. The curd is removed, spread out in boxes, and
pressed, and while under pressure is allowed to drain and ferment. It
is ripened for not less than 5 weeks. The ripened curd is dried and
ground; salt or salt substitute and dried clover of the species
Melilotus coerulea are added. The mixture is shaped into truncated
cones and ripened. The optional ingredient in paragraph (b)(2) of this
section may be added during this procedure.
* * * * *
(c) Nomenclature. The name of the food is ``sap sago cheese.''
* * * * *
[[Page 65060]]
0
60. In Sec. 133.187, revise and republish paragraph (b) and the first
sentence of paragraph (c)(2) to read as follows:
Sec. 133.187 Semisoft cheeses.
* * * * *
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria or other harmless flavor-producing bacteria, present
in such milk or added thereto. Sufficient rennet, rennet paste, extract
of rennet paste, or other safe and suitable milk-clotting enzyme that
produces equivalent curd formation, singly or in any combination (with
or without purified calcium chloride in a quantity not more than 0.02
percent, calculated as anhydrous calcium chloride, of the weight of the
milk) is added to set the milk to a semisolid mass. Harmless artificial
coloring may be added. After coagulation, the mass is so treated as to
promote and regulate the separation of whey and curd. Such treatment
may include one or more of the following: cutting, stirring, heating,
dilution with water or brine. The whey, or part of it, is drained off,
and the curd is collected and shaped. It may be placed in forms and may
be pressed. Harmless flavor-producing microorganisms may be added. It
may be cured in a manner to promote the growth of biological curing
agents. Salt or salt substitute may be added during the procedure. A
harmless preparation of enzymes of animal or plant origin capable of
aiding in the curing or development of flavor of semisoft cheese may be
added, in such quantity that the weight of the solids of such
preparation is not more than 0.1 percent of the weight of the milk
used.
(c) * * *
(2) Milk shall be deemed to have been pasteurized if it has been
held at a temperature of not less than 145 [deg]F for a period of not
less than 30 minutes, or for a time and at a temperature equivalent
thereto in phosphatase destruction. * * *
* * * * *
0
61. In Sec. 133.188, revise and republish paragraph (b) and the first
sentence in paragraph (c)(2) to read as follows:
Sec. 133.188 Semisoft part-skim cheeses.
* * * * *
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless lactic-acid-
producing bacteria or other harmless flavor-producing bacteria, present
in such milk or added thereto. Sufficient rennet, rennet paste, extract
of rennet paste, or other safe and suitable milk-clotting enzyme that
produces equivalent curd formation singly or in any combination (with
or without purified calcium chloride in a quantity not more than 0.02
percent, calculated as anhydrous calcium chloride, of the weight of the
milk) is added to set the milk to a semisolid mass. Harmless artificial
coloring may be added. After coagulation, the mass is so treated as to
promote and regulate the separation of whey and curd. Such treatment
may include one or more of the following: cutting, stirring, heating,
dilution with water or brine. The whey, or part of it, is drained off,
and the curd is collected and shaped. It may be placed in forms and may
be pressed. Harmless flavor-producing microorganisms may be added. It
may be cured in a manner to promote the growth of biological curing
agents. Salt or salt substitute may be added during the procedure. A
harmless preparation of enzymes of animal or plant origin capable of
aiding in the curing or development of flavor of semisoft part-skim
cheese may be added in such quantity that the weight of the solids of
such preparation is not more than 0.1 percent of the weight of the milk
used.
(c) * * *
(2) Milk shall be deemed to have been pasteurized if it has been
held at a temperature of not less than 145 [deg]F for a period of not
less than 30 minutes, or for a time and at a temperature equivalent
thereto in phosphatase destruction. * * *
* * * * *
0
62. In Sec. 133.189, revise paragraph (d) to read as follows:
Sec. 133.189 Skim milk cheese for manufacturing.
* * * * *
(d)(1) For the purposes of this section, ``skim milk'' means cow's
milk from which the milk fat has been separated.
(2) During the cheesemaking process, where the curd is salted, salt
substitute may be used.
* * * * *
0
63. In Sec. 133.190, revise paragraph (b)(3)(iii) to read as follows:
Sec. 133.190 Spiced cheeses.
* * * * *
(b) * * *
(3) * * *
(iii) Salt or salt substitute.
* * * * *
0
64. In Sec. 133.195, add paragraph (b)(3)(vii) to read as follows:
Sec. 133.195 Swiss and emmentaler cheese.
* * * * *
(b) * * *
(3) * * *
(vii) Salt substitute.
* * * * *
PART 136--BAKERY PRODUCTS
0
65. The authority citation for part 136 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
0
66. In Sec. 136.110, revise paragraphs (c)(4) and (d) to read as
follows:
Sec. 136.110 Bread, rolls, and buns.
* * * * *
(c) * * *
(4) Salt or salt substitute.
* * * * *
(d) Total solids are determined by the method prescribed in AOAC
Official Method 935.36(a), Solids (Total) in Bread, except that if the
baked unit weighs 454 grams (1 pound) or more, one entire unit is used
for the determination; if the baked unit weighs less than 454 grams,
enough units to weigh 454 grams or more are used. AOAC Official Method
935.36(a), Solids (Total) in Bread, Official Methods of Analysis, 22nd
Ed., published 4 January 2023 (available at <a href="https://academic.oup.com/aoac-publications/book/45491">https://academic.oup.com/aoac-publications/book/45491</a>), is incorporated by reference into this
section with the approval of the Director of the Federal Register under
5 U.S.C 552(a) and 1 CFR part 51. This incorporation by reference (IBR)
material is available for inspection at the Food and Drug
Administration (FDA) and at the National Archives and Records
Administration (NARA). Contact FDA's Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852; 240-402-7500;
<a href="/cdn-cgi/l/email-protection#501912020f1d3124352239313c0f193e21253922393523103634317e3838237e373f26"><span class="__cf_email__" data-cfemail="561f1404091b372233243f373a091f3827233f243f332516303237783e3e2578313920">[email protected]</span></a>. For information on the availability
of this material at NARA, visit <a href="http://www.archives.gov/federal-register/cfr/ibr-locations">www.archives.gov/federal-register/cfr/ibr-locations</a> or email <a href="/cdn-cgi/l/email-protection#fe988cd097908d8e9b9d8a979190be909f8c9fd0999188"><span class="__cf_email__" data-cfemail="d9bfabf7b0b7aaa9bcbaadb0b6b799b7b8abb8f7beb6af">[email protected]</span></a>. This material is also
available from AOAC INTERNATIONAL, 2275 Research Blvd., Suite 300,
Rockville, MD 20850-3250; 1-800-379-2622; <a href="http://www.aoac.org">www.aoac.org</a>.
* * * * *
PART 137--CEREAL FLOURS AND RELATED PRODUCTS
0
67. The authority citation for part 137 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
0
68. Add subpart A, consisting of Sec. Sec. 137.1 through 137.100, to
read as follows:
Subpart A--General Provisions
Sec.
[[Page 65061]]
137.1 Incorporation by reference.
137.2 through 137.100 [Reserved]
Subpart A--General Provisions
Sec. 137.1 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at the Food and
Drug Administration (FDA) and at the National Archives and Records
Administration (NARA). Contact FDA's Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852; 240-402-7500;
<a href="/cdn-cgi/l/email-protection#400902121f0d2134253229212c1f092e31352932292533002624216e2828336e272f36"><span class="__cf_email__" data-cfemail="256c67777a68445140574c44497a6c4b54504c574c4056654341440b4d4d560b424a53">[email protected]</span></a>. For information on the availability
of this material at NARA, visit <a href="http://www.archives.gov/federal-register/cfr/ibr-locations">www.archives.gov/federal-register/cfr/ibr-locations</a> or email <a href="/cdn-cgi/l/email-protection#3452461a5d5a47445157405d5b5a745a5546551a535b42"><span class="__cf_email__" data-cfemail="e88e9ac681869b988d8b9c818786a886899a89c68f879e">[email protected]</span></a>. The material may be
obtained from AOAC INTERNATIONAL (AOAC), 2275 Research Blvd., Suite
300, Rockville, MD 20850-3250; 1-800-379-2622; <a href="http://www.aoac.org/:">www.aoac.org/:</a>
(a) Official Methods of Analysis of the Association of Official
Analytical Chemists, 13th Ed., 1980; IBR approved for Sec. Sec.
137.105(a) and (c); 137.190; 137.195; 137.200(c); 137.211(b);
137.250(b); 137.300(b); 137.350(e).
(b) Official Methods of Analysis of AOAC INTERNATIONAL, 22nd Ed.,
published 4 January 2023 (available at <a href="https://academic.oup.com/aoac-publications/book/45491">https://academic.oup.com/aoac-publications/book/45491</a>)--
(1) AOAC Official Method 923.02, Carbon Dioxide (Total) in Baking
Powders: Gasometric Determination; IBR approved for Sec. Sec.
137.180(c); 137.270(b).
(2) AOAC Appendix C, Reference Tables, 909.04, Correction Factors
for Gasometric Determination of Carbon Dioxide (Reference Table
909.04); IBR approved for Sec. Sec. 137.180(c); 137.270(b).
Sec. Sec. 137.2 through 137.100 [Reserved]
0
69. In Sec. 137.105:
0
a. Revise and republish the introductory text of paragraph (a); and
0
b. Amend paragraphs (c)(1) through (3) by revising the first sentence
and removing the second sentence in each paragraph.
The revisions read as follows:
Sec. 137.105 Flour.
(a) Flour, white flour, wheat flour, plain flour, is the food
prepared by grinding and bolting cleaned wheat, other than durum wheat
and red durum wheat. To compensate for any natural deficiency of
enzymes, malted wheat, malted wheat flour, malted barley flour, or any
combination of two or more of these, may be used; but the quantity of
malted barley flour so used is not more than 0.75 percent. Harmless
preparations of [alpha]-amylase obtained from Aspergillus oryzae, alone
or in a safe and suitable carrier, may be used. When tested for
granulation as prescribed in paragraph (c)(4) of this section, not less
than 98 percent of the flour passes through a cloth having openings not
larger than those of woven wire cloth designated ``212 [micro]m (No.
70)'' complying with the specifications for such cloth set forth in
Table 1 ``Nominal Dimensions of Standard Test Sieves (U.S.A. Standard
Series)'', under the heading ``Definitions of Terms and Explanatory
Notes'' from the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (incorporated by reference, see
Sec. 137.1). The flour is freed from bran coat, or bran coat and germ,
to such extent that the percent of ash therein, calculated to a
moisture-free basis, is not more than the sum of 1/20 of the percent of
protein therein, calculated to a moisture-free basis, plus 0.35. Its
moisture content is not more than 15 percent. It may contain ascorbic
acid in a quantity not to exceed 200 parts per million as a dough
conditioner. Unless such addition conceals damage or inferiority or
makes the flour appear to be better or of greater value than it is, one
or any combination of two or more of the following optional bleaching
ingredients may be added in a quantity not more than sufficient for
bleaching or, in case such ingredient has an artificial aging effect,
in a quantity not more than sufficient for bleaching and such
artificial aging effect:
* * * * *
(c) * * *
(1) Ash is determined by the method prescribed in section 14.006,
``Direct Method--Official Final Action'', under the heading ``Ash
(5)'', from the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (incorporated by reference, see
Sec. 137.1). * * *
(2) Protein is 5.7 times the nitrogen as determined by the method
prescribed in section 2.057, ``Improved Kjeldahl Methods for Nitrate-
Free Samples (20--Official Final Action'', from the Official Methods of
Analysis of the Association of Official Analytical Chemists, 13th Ed.
(incorporated by reference, see Sec. 137.1). * * *
(3) Moisture is determined by the method prescribed in sections
14.002 and 14.003, ``Vacuum Oven Method (2)--Official Final Action'',
under the heading ``Total Solids Moisture, Indirect Method'', from the
Official Methods of Analysis of the Association of Official Analytical
Chemists, 13th Ed. (incorporated by reference, see Sec. 137.1).
* * * * *
0
70. In Sec. 137.180, revise paragraphs (a), (c) introductory text, and
(c)(1) to read as follows:
Sec. 137.180 Self-rising flour.
(a) Description. Self-rising flour, self-rising white flour, self-
rising wheat flour, is an intimate mixture of flour, sodium
bicarbonate, and one or more of the acid-reacting substances
monocalcium phosphate, sodium acid pyrophosphate, and sodium aluminum
phosphate. It is seasoned with salt or salt substitute. When it is
tested by the method prescribed in paragraph (c) of this section, not
less than 0.5 percent of carbon dioxide is evolved. The acid-reacting
substance is added in sufficient quantity to neutralize the sodium
bicarbonate. The combined weight of such acid-reacting substance and
sodium bicarbonate is not more than 4.5 parts to each 100 parts of
flour used. Subject to the conditions and restrictions prescribed by
Sec. 137.105(a), the bleaching ingredients specified in such section
may be added as optional ingredients. If the flour used in making the
self-rising flour is bleached, the optional bleaching ingredient used
therein (see Sec. 137.105(a)) is also an optional ingredient of the
self-rising flour.
* * * * *
(c) Method of analysis. Follow the method prescribed in AOAC
Official Method 923.02A, and 923.02B (incorporated by reference, see
Sec. 137.1): Instead of using AOAC Official Method 923.02C use the
following procedure:
(1) Weigh 17 grams of the official sample into flask A, add 15-20
glass beads (4-6 mm. diameter), and connect this flask with the
apparatus (fig. 923.02). Open stopcock C and by means of the leveling
bulb E bring the displacement solution to the 25 cc. graduation above
the zero mark. (This 25 cc. is a partial allowance for the volume of
acid to be used in the decomposition.) Allow the apparatus to stand 1-2
minutes to ensure that the temperature and pressure within the
apparatus are the same as those of the room. Close the stopcock, lower
the leveling bulb somewhat to reduce the pressure within the apparatus,
and slowly run into the decomposition flask from burette F 45 cc. of
sulfuric acid (1 + 5). To prevent the liberated carbon dioxide from
escaping through the acid burette into the air, keep the displacement
solution in the leveling
[[Page 65062]]
bulb at all times during the decomposition at a lower level than that
in the gas-measuring tube. Rotate and then vigorously agitate the
decomposition flask for 3 minutes to mix the contents intimately. Allow
to stand for 10 minutes to bring to equilibrium. Equalize the pressure
in the measuring tube by means of the leveling bulb and read the volume
of gas from the zero point on the tube. Deduct 20 cc. from this reading
(this 20 cc. together with previous allowance of 25 cc. compensates for
the 45 cc. acid used in the decomposition). Observe the temperature of
the air surrounding the apparatus and also the barometric pressure and
multiply the number of milliliters of gas evolved by the factor given
in Reference Table 909.04 (incorporated by reference, see Sec. 137.1)
for the temperature and pressure observed. Divide the corrected reading
by 100 to obtain the apparent percent by weight of carbon dioxide in
the official sample.
* * * * *
0
71. In Sec. 137.190:
0
a. Remove the last two sentences; and
0
b. Revise the 3rd sentence.
The revision reads as follows:
Sec. 137.190 Cracked wheat.
* * *Cracked wheat contains not more than 15 percent of the
moisture as determined by the method prescribed in section 7.002 under
``Preparation of Sample--Official Final Action'', and section 7.003
under ``Moisture--Official Final Action. I. Drying in Vacuo at 95-
100[deg] (2)'', from the Official Methods of Analysis of the
Association of Official Analytical Chemists, 13th Ed. (incorporated by
reference, see Sec. 137.1).
0
72. In Sec. 137.195:
0
a. Remove the last two sentences; and
0
b. Revise the 3rd sentence.
The revision reads as follows:
Sec. 137.195 Crushed wheat.
* * *Crushed wheat contains not more than 15 percent of moisture as
determined by the method prescribed in section 7.002 under
``Preparation of Sample--Official Final Action'' and section 7.003
under ``Moisture--Official Final Action. I. Drying in Vacuo at 95-
100[deg] (2)'' from the Official Methods of Analysis of the Association
of Official Analytical Chemists, 13th Ed. (incorporated by reference,
see Sec. 137.1).
0
73. In Sec. 137.200, revise paragraph (c)(1) and the first sentence of
paragraph (c)(2) and remove the second sentence of paragraph (c)(2) to
read as follows:
Sec. 137.200 Whole wheat flour.
* * * * *
(c) * * *
(1) Moisture is determined by the method prescribed in section
14.002 ``Vacuum Oven Method--Official Final Action'' and section 14.003
``Determination'' from the Official Methods of Analysis of the
Association of Official Analytical Chemists, 13th Ed. (incorporated by
reference, see Sec. 137.1).
(2) The method referred to in paragraph (a) of this section is as
follows: Use No. 8 and No. 20 sieves, having standard 8-inch full-
height frames, complying with the specifications set forth in Table 1,
``Nominal Dimensions of Standard Test Sieves (U.S.A. Standard
Series)'', under the heading ``Definitions of Terms and Explanatory
Notes'' from the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (incorporated by reference, see
Sec. 137.1). * * *
0
74. In Sec. 137.211, amend paragraph (b)(2) by revising the first
sentence and removing the second and third sentences to read as
follows:
Sec. 137.211 White corn flour.
* * * * *
(b) * * *
(2) The method referred to in paragraph (a) of this section is as
follows: Weigh 5 grams of sample into a tared truncated metal cone (top
diameter 5 centimeters, bottom diameter 2 centimeters, height 4
centimeters), fitted at bottom with 70-mesh wire cloth complying with
the specifications for No. 70 wire cloth in Table 1, ``Nominal
Dimensions of Standard Test Sieves (U.S.A. Standard Series)'', under
the heading ``Definitions of Terms and Explanatory Notes'' from the
Official Methods of Analysis of the Association of Official Analytical
Chemists, 13th Ed. (incorporated by reference, see Sec. 137.1). * * *
0
75. In Sec. 137.250:
0
a. Revise the introductory text of paragraph (b)(1); and
0
b. Amend paragraph (b)(2) by revising the first sentence and removing
the second and third sentences.
The revisions read as follows:
Sec. 137.250 White corn meal.
* * * * *
(b)(1) For the purposes of this section, moisture, fat, and crude
fiber content will be determined by the following methods referenced in
this paragraph (b)(1) from the Official Methods of Analysis of the
Association of Official Analytical Chemists, 13th Ed. (incorporated by
reference, see Sec. 137.1):
* * * * *
(2) The method referred to in paragraph (a) of this section is as
follows: Use No. 12 and No. 25 sieves, having standard 20.3 centimeter
(8-inch) diameter full-height frames, complying with the specifications
for wire cloth and sieve frames in ``Nominal Dimensions of Standard
Test Sieves (U.S.A. Standard Series)'' from the Official Methods of
Analysis of the Association of Official Analytical Chemists, 13th Ed.
(incorporated by reference, see Sec. 137.1), prescribed in Sec.
137.105(a). * * *
0
76. In Sec. 137.270, revise paragraphs (a), (b) introductory text, and
(b)(1) to read as follows:
Sec. 137.270 Self-rising white corn meal.
(a) Description. Self-rising white corn meal is an intimate mixture
of white corn meal, sodium bicarbonate, and one or both of the acid-
reacting substances monocalcium phosphate and sodium aluminum
phosphate. It is seasoned with salt or salt substitute. When it is
tested by the method prescribed in paragraph (b) of this section, not
less than 0.5 percent of carbon dioxide is evolved. The acid-reacting
substance is added in sufficient quantity to neutralize the sodium
bicarbonate. The combined weight of such acid-reacting substance and
sodium bicarbonate is not more than 4.5 parts to each 100 parts of
white corn meal used.
(b) Method of analysis. Follow the method prescribed in AOAC
Official Method 923.02A and 923.02B (incorporated by reference, see
Sec. 137.1): Instead of using AOAC Official Method 923.02C use the
following procedure:
(1) Weigh 17 grams of the official sample into flask A, add 15-20
glass beads (4-6 mm. diameter), and connect this flask with the
apparatus (fig. 923.02). Open stopcock C and by means of the leveling
bulk E bring the displacement solution to the 25 cc. graduation above
the zero mark. (This 25 cc. is a partial allowance for the volume of
acid to be used in the decomposition.) Allow the apparatus to stand 1-2
minutes to ensure that the temperature and pressure within the
apparatus are the same as those of the room. Close the stopcock, lower
the leveling bulb somewhat to reduce the pressure within the apparatus,
and slowly run into the decomposition flask from burette F 45 cc. of
sulfuric acid (1 + 5). To prevent the liberated carbon dioxide from
escaping through the acid burette into the air, keep the displacement
solution in the leveling bulb at all times during the decomposition at
a lower level than that in the gas-measuring tube. Rotate and then
vigorously agitate the decomposition flask for 3 minutes to mix the
contents intimately. Allow to
[[Page 65063]]
stand for 10 minutes to bring to equilibrium. Equalize the pressure in
the measuring tube by means of the leveling bulb and read the volume of
gas from the zero point on the tube. Deduct 20 cc. from this reading
(this 20 cc. together with previous allowance of 25 cc. compensates for
the 45 cc. acid used in the decomposition). Observe the temperature of
the air surrounding the apparatus and also the barometric pressure and
multiply the number of milliliters of gas evolved by the factor given
in the Reference Table 909.04 (incorporated by reference, see Sec.
137.1) for the temperature and pressure observed. Divide the corrected
reading by 100 to obtain the apparent percent by weight of carbon
dioxide in the official sample.
* * * * *
0
77. In Sec. 137.300, amend paragraph (b)(2) by revising the first
sentence and removing the second and third sentences to read as
follows:
Sec. 137.300 Farina.
* * * * *
(b) * * *
(2) The method referred to in paragraph (a) of this section is as
follows: Use No. 20 and No. 100 sieves, having standard 20.3 centimeter
(8-inch) full-height frames, complying with the specifications for such
cloth set forth in Table 1, ``Nominal Dimensions of Standard Test
Sieves (U.S.A. Standard Series)'' under the heading ``Definitions of
Terms and Explanatory Notes'' from the Official Methods of Analysis of
the Association of Official Analytical Chemists, 13th Ed. (incorporated
by reference, see Sec. 137.1). * * *
0
78. In Sec. 137.350, revise and republish paragraph (e) to read as
follows:
Sec. 137.350 Enriched rice.
* * * * *
(e) The method referred to in paragraph (c) of this section is as
follows: Mix the contents of one or more containers and transfer \1/2\
pound thereof to a 4-liter flask containing 2 liters of distilled water
at room temperature (but not below 20 [deg]C). Stopper the flask and
swirl it moderately for \1/2\ minute so that the rice is in motion and
in uniform suspension. Allow the rice to settle for \1/2\ minute, then
pour off 1,600 milliliters of the water, together with any floating and
suspended matter, and discard. To the contents of the flask, add 1,600
milliliters of distilled water and 20 milliliters of 10 N hydrochloric
acid. Agitate vigorously and wash down the sides of the flask with 150
milliliters of 0.1 N hydrochloric acid. To avoid excess foaming during
the extraction, heat the mixture slowly to about 100 [deg]C, agitate if
necessary, and maintain at this temperature until air is expelled.
Again wash down the sides of the flask with 150 milliliters of 0.1 N
hydrochloric acid. Heat the mixture in an autoclave at 120 [deg]C to
123 [deg]C for 30 minutes, remove and cool to room temperature. Dilute
the mixture with distilled water so that the total volume is 2,500
milliliters. Swirl the flask, and while the solids are in uniform
suspension pour off about 250 milliliters of the mixture for later
determination of iron (and calcium, if this is to be determined). With
filter paper that has been shown not to adsorb thiamine, riboflavin, or
niacin, filter enough of the remaining mixture for determination of
thiamine, riboflavin, and niacin. (In the case of a mixture difficult
to filter, centrifuging or filtering through fritted glass, or both,
using a suitable analytical filter-aid, may be substituted for, or may
precede, filtering through paper.) Dilute an aliquot of filtrate with
0.1 N hydrochloric acid, so that each milliliter contains about 0.2
microgram of thiamine, and determine thiamine by the ``Rapid
Fluorometric Method--Official Final Action,'' in section 43.034 of
``Official Methods of Analysis of the Association of Official
Analytical Chemists'' (AOAC), 13th Ed. (incorporated by reference, see
Sec. 137.1). With a suitable aliquot determine riboflavin by the
method prescribed in section 43.041(a) by the ``Fluorometric Method--
Official Final Action,'' AOAC, 13th Ed., beginning with the third
sentence of the second paragraph, ``Adjust, with vigorous agitation * *
*.'' Determine niacin in a 200-milliliter aliquot of the filtrate by
the ``Colorimetric Method--Official Final Action,'' in section 43.045,
AOAC, 13th Ed., beginning with the sixth sentence of the first
paragraph, ``Adjust to pH 4.5 with * * *.'' Evaporate to dryness a 100-
milliliter aliquot of the nonfiltered material withdrawn while
agitating, and determine iron using the method ``Iron--Official Final
Action,'' in sections 14.011, 14.012, and 14.013, AOAC, 13th Ed., and,
if required, determine calcium as directed in section 14.014 under the
heading ``Calcium--Official Final Action,'' AOAC, 13th Ed.
* * * * *
PART 139--MACARONI AND NOODLE PRODUCTS
0
79. The authority citation for part 139 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
0
80. Add subpart A, consisting of Sec. Sec. 139.1 through 139.100, to
read as follows:
Subpart A--General Provisions
Sec.
139.1 Incorporation by reference.
139.2 through 139.100 [Reserved]
Subpart A--General Provisions
Sec. 139.1 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at the Food and
Drug Administration (FDA) and at the National Archives and Records
Administration (NARA). Contact FDA's Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852; 240-402-7500;
<a href="/cdn-cgi/l/email-protection#226b60707d6f435647504b434e7d6b4c53574b504b4751624446430c4a4a510c454d54"><span class="__cf_email__" data-cfemail="fbb2b9a9a4b69a8f9e89929a97a4b2958a8e9289929e88bb9d9f9ad5939388d59c948d">[email protected]</span></a>. For information on the availability
of this material at NARA, visit <a href="http://www.archives.gov/federal-register/cfr/ibr-locations">www.archives.gov/federal-register/cfr/ibr-locations</a> or email <a href="/cdn-cgi/l/email-protection#5a3c28743334292a3f392e3335341a343b283b743d352c"><span class="__cf_email__" data-cfemail="1e786c3077706d6e7b7d6a7771705e707f6c7f30797168">[email protected]</span></a>. The material may be
obtained from AOAC INTERNATIONAL (AOAC), 2275 Research Blvd., Suite
300, Rockville, MD 20850-3250; 1-800-379-2622; <a href="http://www.aoac.org">www.aoac.org</a>:
(a) Official Methods of Analysis of the Association of Official
Analytical Chemists, 13th Ed., 1980; IBR approved for Sec. 139.117(a).
(b) AOAC Official Method 926.07, Solids (Total) and Loss on Drying
(Moisture) in Macaroni Products, Official Methods of Analysis of AOAC
INTERNATIONAL, 22nd Ed., published 4 January 2023; IBR approved for
Sec. Sec. 139.110(a); 139.150(a). (Available at <a href="https://academic.oup.com/aoac-publications/book/45491">https://academic.oup.com/aoac-publications/book/45491</a>.)
Sec. Sec. 139.2 through 139.100 [Reserved]
0
81. In Sec. 139.110, revise paragraphs (a)(4) and (5) to read as
follows:
Sec. 139.110 Macaroni products.
(a) * * *
(4) Salt or salt substitute, in a quantity that seasons the food.
(5) Gum gluten, in such quantity that the protein content of the
finished food is not more than 13 percent by weight. The finished
macaroni product contains not less than 87 percent of total solids as
determined by AOAC Official Method 926.07A (incorporated by reference,
see Sec. 139.1).
* * * * *
0
82. In Sec. 139.117:
0
a. Lift the stay published at 43 FR 11695, Mar. 21, 1978;
[[Page 65064]]
0
b. Revise the introductory text of paragraph (a)(2); and
0
c. Stay the section indefinitely.
The revision reads as follows:
Sec. 139.117 Enriched macaroni products with fortified protein.
(a) * * *
(2) Each such finished food when tested by the methods described in
the cited sections of Official Methods of Analysis of the Association
of Official Analytical Chemists, 13th Ed. (incorporated by reference,
see Sec. 139.1):
* * * * *
0
83. In Sec. 139.150, revise paragraphs (a)(2) and (4) to read as
follows:
Sec. 139.150 Noodle products.
(a) * * *
(2) Salt or salt substitute, in a quantity that seasons the food.
* * * * *
(4) Concentrated glyceryl monostearate (containing not less than 90
percent monoester) in a quantity not exceeding 3 percent by weight of
the finished food. The finished noodle product contains not less than
87 percent of total solids as determined by AOAC Official Method
926.07A (incorporated by reference, see Sec. 139.1). The total solids
of noodle products contains not less than 5.5 percent by weight of the
solids of egg, or egg yolk.
* * * * *
PART 145--CANNED FRUITS
0
84. The authority citation for part 145 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
0
85. In Sec. 145.110:
0
a. Revise the paragraph-level designation for the 4th paragraph level
from lowercase italic letters (i.e., (a) et seq.) to uppercase non-
italic letters (i.e., (A) et seq.);
0
b. Revise paragraphs (a)(1) and (a)(2)(iii); and
0
c. In paragraph (a)(4), remove the text ``(a)(2)(viii)(b)'' and add, in
its place, the text ``(a)(2)(viii)(B)''.
The revisions read as follows:
Sec. 145.110 Canned applesauce.
(a) * * *
(1) Definition. Canned applesauce is the food prepared from
comminuted or chopped apples (Malus domestica Borkhausen), which may or
may not be peeled and cored, and which may have added thereto one or
more of the optional ingredients specified in paragraph (a)(2) of this
section. The apple ingredient is heated and, in accordance with good
manufacturing practices, bruised apple particles, peel, seed, core
material, carpel tissue, and other coarse, hard, or extraneous
materials are removed. The food is sealed in containers. It is so
processed by heat, either before or after sealing, as to prevent
spoilage. The soluble solids content, measured by refractometer and
expressed as percent sucrose (degrees Brix) with correction for
temperature to the equivalent at 20 [deg]C (68 [deg]F), is not less
than 9 percent (exclusive of the solids of any added optional nutritive
carbohydrate sweeteners) as determined by AOAC Official Method 932.12
but without correction for invert sugar or other substances. AOAC
Official Method 932.12, Solids (Soluble) in Fruits and Fruit Products:
Refractometer Method, Official Methods of Analysis of AOAC
INTERNATIONAL, 22nd Ed., published 4 January 2023 (available at <a href="https://academic.oup.com/aoac-publications/book/45491">https://academic.oup.com/aoac-publications/book/45491</a>) is incorporated by
reference into this section with the approval of the Director of the
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved
incorporation by reference (IBR) material is available for inspection
at the Food and Drug Administration (FDA) and the National Archives and
Records Administration (NARA). Contact the FDA at FDA's Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852;
240-402-7500; <a href="/cdn-cgi/l/email-protection#3a73786865775b4e5f48535b566573544b4f5348535f497a5c5e5b14525249145d554c"><span class="__cf_email__" data-cfemail="9cd5decec3d1fde8f9eef5fdf0c3d5f2ede9f5eef5f9efdcfaf8fdb2f4f4efb2fbf3ea">[email protected]</span></a>. For information on
the availability of this material at NARA, visit <a href="http://www.archives.gov/federal-register/cfr/ibr-locations">www.archives.gov/federal-register/cfr/ibr-locations</a> or email <a href="/cdn-cgi/l/email-protection#3f594d1156514c4f5a5c4b5650517f515e4d5e11585049"><span class="__cf_email__" data-cfemail="bcdace92d5d2cfccd9dfc8d5d3d2fcd2ddcedd92dbd3ca">[email protected]</span></a>.
This material is available from AOAC INTERNATIONAL, 2275 Research
Blvd., Suite 300, Rockville, MD 20850-3250; 1-800-379-2622;
<a href="http://www.aoac.org">www.aoac.org</a>.
(2) * * *
(iii) Salt or salt substitute.
* * * * *
0
86. In Sec. 145.130, revise and republish paragraphs (a) and (c)(1) to
read as follows:
Sec. 145.130 Canned figs.
(a) Ingredients. Canned figs is the food prepared from one of the
optional fig ingredients specified in paragraph (b) of this section and
one of the optional packing media specified in paragraph (c) of this
section, to which lemon juice, concentrated lemon juice or organic
acid(s) is added, when necessary to reduce the pH of the finished
product to pH 4.9 or below. Such food is sealed in a container and
before or after sealing is so processed by heat as to prevent spoilage.
Such food may also contain one, or any combination of two or more of
the following safe and suitable optional ingredients:
(1) Natural and artificial flavoring.
(2) Spice.
(3) Vinegar.
(4) Unpeeled segments of citrus fruits.
(5) Salt or salt substitute.
* * * * *
(c) * * *
(1)(i) The optional packing media referred to in paragraph (a) of
this section, as defined in Sec. 145.3 are:
(A) Water.
(B) Fruit juice(s) and water.
(C) Fruit juice(s).
(ii) Such packing media may be used as such or any one or any
combination of two or more safe and suitable nutritive carbohydrate
sweetener(s) may be added. Sweeteners defined in Sec. 145.3 shall be
as defined therein, except that a nutritive carbohydrate sweetener for
which a standard of identity has been established in part 168 of this
chapter shall comply with such standard in lieu of any definition that
may appear in Sec. 145.3.
* * * * *
PART 150--FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
0
87. The authority citation for part 150 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
0
88. Add subpart A, consisting of Sec. Sec. 150.1 through 150.100, to
read as follows:
Subpart A--General Provisions
Sec.
150.1 Incorporation by reference.
150.2 through 150.100 [Reserved]
Subpart A--General Provisions
Sec. 150.1 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at the Food and
Drug Administration (FDA) and at the National Archives and Records
Administration (NARA). Contact FDA's Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852; 240-402-7500;
<a href="/cdn-cgi/l/email-protection#4c050e1e13012d38293e252d201305223d39253e25293f0c2a282d6224243f622b233a"><span class="__cf_email__" data-cfemail="d19893838e9cb0a5b4a3b8b0bd8e98bfa0a4b8a3b8b4a291b7b5b0ffb9b9a2ffb6bea7">[email protected]</span></a>. For information on the availability
of this material at NARA, visit <a href="http://www.archives.gov/federal-register/cfr/ibr-locations">www.archives.gov/federal-register/cfr/ibr-locations</a> or email <a href="/cdn-cgi/l/email-protection#d6b0a4f8bfb8a5a6b3b5a2bfb9b896b8b7a4b7f8b1b9a0"><span class="__cf_email__" data-cfemail="274155094e4954574244534e4849674946554609404851">[email protected]</span></a>. The material may be
obtained from AOAC INTERNATIONAL (AOAC),
[[Page 65065]]
2275 Research Blvd., Suite 300, Rockville, MD 20850-3250; 1-800-379-
2622; <a href="http://www.aoac.org">www.aoac.org</a>:
(a) Official Methods of Analysis of the Association of Official
Analytical Chemists, 13th Ed., 1980; IBR approved for Sec. Sec.
150.140(d); 150.160.
(b) Official Methods of Analysis of AOAC INTERNATIONAL, 22nd Ed.,
published 4 January 2023 (available at <a href="https://academic.oup.com/aoac-publications/book/45491">https://academic.oup.com/aoac-publications/book/45491</a>)--
(1) AOAC Official Method 932.12, Solids (Soluble) in Fruits and
Fruit Products: Refractometer Method; IBR approved for Sec.
150.110(d).
(2) AOAC Official Method 932.14, Solids in Syrups; IBR approved for
Sec. 150.110(d).
Sec. Sec. 150.2 through 150.100 [Reserved]
0
89. In Sec. 150.110, revise paragraphs (c)(4) and (d)(3) and (5) to
read as follows:
Sec. 150.110 Fruit butter.
* * * * *
(c) * * *
(4) Salt or salt substitute.
* * * * *
(d) * * *
(3) The soluble solids content of the finished fruit butter is not
less than 43 percent, as determined by AOAC Official Method 932.12
(incorporated by reference, see Sec. 150.1).
* * * * *
(5) The weight of fruit juice or diluted fruit juice or
concentrated fruit juice (optional ingredient, paragraph (c)(6) of this
section) from a fruit specified in paragraph (b)(1) of this section is
the weight of such juice, as determined by the method prescribed in
paragraph (d)(2) of this section, except that the percent of soluble
solids is determined by AOAC Official Method 932.14C (incorporated by
reference, see Sec. 150.1); the weight of diluted concentrated juice
from any other fruits is the original weight of the juice before it was
diluted or concentrated.
* * * * *
0
90. In Sec. 150.140, revise paragraph (d)(3) to read as follows:
Sec. 150.140 Fruit jelly.
* * * * *
(d) * * *
(3) The soluble-solids content of the finished jelly is not less
than 65 percent, as determined by the method prescribed in section
31.011, under ``Solids by Means of Refractometer--Official Final
Action'' from the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (incorporated by reference, see
Sec. 150.1).
* * * * *
0
91. In Sec. 150.160, revise paragraph (d)(5) to read as follows:
Sec. 150.160 Fruit preserves and jams.
* * * * *
(d) * * *
(5) The soluble-solids content of the finished jam or preserve is
not less than 65 percent, as determined by the method prescribed in
section 22.024, under ``Soluble Solids by Refractometer in Fresh and
Canned Fruits, Jellies, Marmalades, and Preserves--Official Final
Action'', except that no correction is made for water-insoluble solids,
from the Official Methods of Analysis of the Association of Official
Analytical Chemists, 13th Ed. (incorporated by reference, see Sec.
150.1).
* * * * *
PART 155--CANNED VEGETABLES
0
92. The authority citation for part 155 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
0
93. Add Sec. 155.1 to subpart A to read as follows:
Sec. 155.1 Incorporation by reference.
Certain material is incorporated by reference into this part with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at the Food and
Drug Administration (FDA) and at the National Archives and Records
Administration (NARA). Contact FDA's Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852; 240-402-7500;
<a href="/cdn-cgi/l/email-protection#c78e8595988aa6b3a2b5aea6ab988ea9b6b2aeb5aea2b487a1a3a6e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="29606b7b7664485d4c5b404845766047585c405b404c5a694f4d480741415a074e465f">[email protected]</span></a>. For information on the availability
of this material at NARA, visit <a href="http://www.archives.gov/federal-register/cfr/ibr-locations">www.archives.gov/federal-register/cfr/ibr-locations</a> or email <a href="/cdn-cgi/l/email-protection#ef899dc186819c9f8a8c9b868081af818e9d8ec1888099"><span class="__cf_email__" data-cfemail="2442560a4d4a57544147504d4b4a644a4556450a434b52">[email protected]</span></a>. The material may be
obtained from AOAC INTERNATIONAL (AOAC), 2275 Research Blvd., Suite
300, Rockville, MD 20850-3250; 1-800-379-2622 <a href="http://www.aoac.org">www.aoac.org</a>:
(a) Official Methods of Analysis of the Association of Official
Analytical Chemists, 13th Ed., 1980; IBR approved for Sec. 155.3(a),
(e), and (f).
(b) Official Methods of Analysis of AOAC INTERNATIONAL, 22nd Ed.,
published 4 January 2023 (available at <a href="https://academic.oup.com/aoac-publications/book/45491">https://academic.oup.com/aoac-publications/book/45491</a>)--
(1) [AOAC] Definition of Terms and Explanatory Notes; IBR approved
for Sec. Sec. 155.120(b); 155.130(b).
(2) AOAC Official Method 938.10, Solids (Alcohol-Insoluble) in
Canned Peas: Gravimetric Method; IBR Sec. 155.170(b).
0
94. In Sec. 155.3, revise paragraphs (a), (e), and (f) to read as
follows:
Sec. 155.3 Definitions.
* * * * *
(a) The procedure for determining drained weight is set forth in
sections 32.001-32.003 from the Official Methods of Analysis of the
Association of Official Analytical Chemists, 13th Ed. (incorporated by
reference, see Sec. 155.1).
* * * * *
(e) Tomato soluble solids means the sucrose value as determined by
the method prescribed in sections 32.014 to 32.016 and 52.012, under
the headings ``Soluble Solids in Tomato Products Official Final
Action'' and ``Refractive Indices (n) of Sucrose Solutions at 20[deg]''
from the Official Methods of Analysis of the Association of Official
Analytical Chemists, 13th Ed. (incorporated by reference, see Sec.
155.1). If no salt has been added, the sucrose value obtained from the
referenced tables shall be considered the percent of tomato soluble
solids. If salt has been added either intentionally or through the
application of the acidified break, determine the percent of such added
sodium chloride as specified in paragraph (f) of this section. Subtract
the percentage so found from the percentage of total soluble solids
found (sucrose value from the refractive index tables) and multiply the
difference by 1.016. The resultant value is considered the percent of
``tomato soluble solids.''
(f) Salt means sodium chloride, determined as chloride and
calculated as percent sodium chloride, by the method prescribed in
sections 32.025 to 32.030, under the heading ``Method III
(Potentiometric Method)'' from the Official Methods of Analysis of the
Association of Official Analytical Chemists, 13th Ed. (incorporated by
reference, see Sec. 155.1).
0
95. In Sec. 155.120:
0
a. Revise the paragraph-level designation for the 4th paragraph level
from lowercase italic letters (i.e., (a) et seq.) to uppercase non-
italic letters (i.e., (A) et seq.);
0
b. In paragraph (a)(2)(iii)(E), remove the text ``(a)(2)(iii)(c)'' and
add, in its place, the text ``(a)(2)(iii)(C)'';
0
c. In paragraph (a)(2)(iii)(F), remove the text ``(a)(2)(iii)(d)'' and
add, in its place, the text ``(a)(2)(iii)(D)'';
0
d. In paragraph (a)(2)(iii)(G), remove the text ``paragraph
(a)(2)(iii)(a) to (f)'' and add, in its place, the text ``paragraphs
(a)(2)(iii)(A) through (F)'';
0
e. Revise paragraph (a)(3)(i);
0
f. In paragraph (b)(1)(i), remove the text ``(a)(2)(iii) (c) and (d)''
and
[[Page 65066]]
``(a)(2)(iii)(g)'' and add, in their places, the text ``(a)(2)(iii)(C)
and (D)'' and ``(a)(2)(iii)(G)'', respectively;
0
g. Revise paragraph (b)(2)(i);
0
h. In paragraph (b)(2)(iii) introductory text, remove the text
``(a)(2)(iii) (c), (d) or (f)'' and add, in its place, the text
``(a)(2)(iii)(C), (D), or (F)''; and
0
i. In paragraph (b)(2)(vi), remove the text ``(a)(2)(iii)(b)'' and add,
in its place, the text ``(a)(2)(iii)(B)''.
The revisions read as follows:
Sec. 155.120 Canned green beans and canned wax beans.
(a) * * *
(3) * * *
(i) Salt or salt substitute.
* * * * *
(b) * * *
(2) * * *
(i) Determine the gross weight of the container. Open and
distribute the contents of the container over the meshes of a U.S. No.
8 circular sieve with openings of 2.36 mm (0.0937 in), which has been
previously weighed. The diameter of the sieve is 20.3 cm (8 in) if the
quantity of contents of the container is less than 1.36 kg (3 lb) and
30.5 cm (12 in) if such quantity is 1.36 kg (3 lb) or more. The bottom
of the sieve is woven-wire cloth that complies with the specifications
of such cloth set forth in Table 1 of AOAC Definition of Terms and
Explanatory Notes, titled Nominal Dimensions of Standard Test Sieves
(USA Standard Series) (incorporated by reference, see Sec. 155.1).
Without shifting the material on the sieve, incline the sieve 17[deg]
to 20[deg] to facilitate drainage. Two minutes after drainage begins,
weigh the sieve and the drained material. Record in grams (ounces) the
weight so found, less the weight of the sieve, as the drained weight.
Dry and weigh the empty container and subtract this weight from the
gross weight to obtain the net weight. Calculate the percent of drained
liquid in the net weight.
* * * * *
0
96. In Sec. 155.130:
0
a. Revise the paragraph-level designation for the 4th paragraph level
from lowercase italic letters (i.e., (a) et seq.) to uppercase non-
italic letters (i.e., (A) et seq.); and
0
b. Revise paragraphs (a)(3)(i), (b)(2)(i), and (b)(5).
The revisions read as follows:
Sec. 155.130 Canned corn.
(a) * * *
(3) * * *
(i) Salt or salt substitute.
* * * * *
(b) * * *
(2) * * *
(i) Determine the gross weight of the container. Open and
distribute the contents of the container over the meshes of a U.S. No.
8 circular sieve, which has previously been weighed. The diameter of
the sieve is 20.3 cm. (8 in) if the quantity of the contents of the
container is less than 1.36 kg. (3 lb), and 30.5 cm. (12 in) if such
quantity is 1.36 kg. (3 lb) or more. The bottom of the sieve is woven-
wire cloth that complies with the specifications for such sieve set
forth in Table 1 of AOAC Definition of Terms and Explanatory Notes,
titled Nominal Dimensions of Standard Test Sieves (USA Standard Series)
(incorporated by reference, see Sec. 155.1). Without shifting the
material on the sieve, so incline the sieve at approximately 17[deg] to
20[deg] angle to facilitate drainage. Two minutes from the time
drainage begins, weigh the sieve and the drained material. Record, in
grams (ounces), the weight so found, less the weight of the sieve, as
the drained weight. Dry and weigh the empty container and subtract this
weight from the gross weight to obtain the net weight. Calculate the
percent of drained liquid in the net weight.
* * * * *
(5) If the quality of canned corn falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear
t
[…truncated; see source link]Indexed from Federal Register on October 13, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.