Proposed Rule2025-13420
Proposal To Revoke 23 Standards of Identity for Foods
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Published
July 17, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is proposing to revoke 23 standards of identity for food. FDA is taking this action because we tentatively conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements.
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<title>Federal Register, Volume 90 Issue 135 (Thursday, July 17, 2025)</title>
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[Federal Register Volume 90, Number 135 (Thursday, July 17, 2025)]
[Proposed Rules]
[Pages 33339-33346]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13420]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 136, 139, 146, 161, and 169
[Docket No. FDA-2025-N-1307]
RIN 0910-AJ12
Proposal To Revoke 23 Standards of Identity for Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
revoke 23 standards of identity for food. FDA is taking this action
because we tentatively conclude that these standards are no longer
necessary to promote honesty and fair dealing in the interest of
consumers. This proposed action would reduce redundant regulatory
requirements.
DATES: Submit either electronic or written comments on the proposed
rule by September 15, 2025. FDA does not intend to extend the comment
period.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. 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 September 15, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments 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 comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<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 comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-N-1307 for ``Proposal to Revoke 23 Standards of Identity for
Foods.'' Received comments, 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 a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
[[Page 33340]]
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
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
<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, the
plain language summary of the proposed rule of not more than 100 words
as required by the ``Providing Accountability Through Transparency
Act,'' or the electronic and written/paper comments received, go to
<a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in
brackets in the heading of this document, into the ``Search'' box and
follow the prompts and/or go to the Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Claudine Kavanaugh, Office of
Nutrition and Food Labeling, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371;
Meridith L. Kelsch, Office of Policy, Regulations, and Information,
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 Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Background
III. Description of the Proposed Rule
IV. Proposed Effective Date
V. Preliminary Economic Analysis of Impacts
A. Introduction
B. Overview of Benefits, Costs, and Transfers
VI. Analysis of Environmental Impact
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. Consultation and Coordination with Indian Tribal Governments
I. Executive Summary
A. Purpose of the Proposed Rule
This action proposes to remove 23 standards of identity for food
that FDA tentatively concludes are no longer necessary to promote
honesty and fair dealing in the interest of consumers.
B. Summary of the Major Provisions of the Proposed Rule
This action proposes to remove the following food standard
regulations:
Part 136--Bakery Products
<bullet> 136.130 Milk bread, rolls, and buns
Part 139--Macaroni and Noodle Products
<bullet> 139.117 Enriched macaroni products with fortified protein
<bullet> 139.120 Milk macaroni products
<bullet> 139.121 Nonfat milk macaroni products
<bullet> 139.122 Enriched nonfat milk macaroni products
<bullet> 139.140 Wheat and soy macaroni products
<bullet> 139.160 Vegetable noodle products
<bullet> 139.165 Enriched vegetable noodle products
<bullet> 139.180 Wheat and soy noodle products
Part 146--Canned Fruit Juices
<bullet> 146.121 Frozen concentrate for artificially sweetened
lemonade
<bullet> 146.126 Frozen concentrate for colored lemonade
<bullet> 146.137 Frozen orange juice
<bullet> 146.148 Reduced acid frozen concentrated orange juice
<bullet> 146.150 Canned concentrated orange juice
<bullet> 146.151 Orange juice for manufacturing
<bullet> 146.152 Orange juice with preservative
<bullet> 146.153 Concentrated orange juice for further manufacturing
<bullet> 146.154 Concentrated orange juice with preservative
Part 161--Fish and Shellfish
<bullet> 161.136 Olympia oysters
<bullet> 161.176 Frozen raw lightly breaded shrimp
Part 169--Food Dressings and Flavorings
<bullet> 169.180 Vanilla-vanillin extract
<bullet> 169.181 Vanilla-vanillin flavoring
<bullet> 169.182 Vanilla-vanillin powder
In addition to the removal of these food standards, this action
proposes to amend regulations that reference these food standards.
C. Legal Authority
We are issuing this proposed rule based on our authority under
section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 341), which directs the Secretary of Health and Human Services
(Secretary) to issue regulations fixing and establishing for any food a
reasonable definition and standard of identity, quality, or fill of
container whenever in the judgment of the Secretary such action will
promote honesty and fair dealing in the interest of consumers. This
proposed rule is also issued upon the Secretary's authority under
section 701(a) of the FD&C Act (21 U.S.C. 371) for the efficient
enforcement of the FD&C Act.
D. Costs and Benefits
Based on our analysis, we anticipate benefits from some revoked
food standards in the form of producer and consumer surplus generated
by increased flexibility. We anticipate cost savings from revoking
these food standards in the form of eliminating the need for companies
to read and understand food standards during product development. We
discuss these impacts qualitatively.
II. Background
President Trump has directed the heads of executive departments and
agencies to eliminate unnecessary and burdensome regulations (Executive
Order 14192, ``Unleashing Prosperity Through Deregulation'' (90 FR
9065, February 6, 2025; signed January 31, 2025)). Independently,
Secretary Kennedy has expressed support for deregulatory initiatives
across all HHS components to focus on the core mission to Make America
Healthy Again (see ``Request for Information (RFI): Ensuring Lawful
Regulation and Unleashing Innovation to Make America Healthy Again''
(90 FR 20478, May 14, 2025)). Revoking these 23 standards of identity
is consistent with these directives. It is also consistent with section
6 of Executive Order 13563, ``Improving Regulation and Regulatory
Review'' (76 FR 3821, January 21, 2011), which requires agencies to
periodically conduct retrospective analyses of existing regulations to
identify those ``that might be outmoded, ineffective, insufficient, or
excessively burdensome, and to modify, streamline, expand, or repeal
them'' accordingly.
In line with the President's deregulatory agenda and the
Secretary's direction, we have initiated a review of food standards to
assess which standards are outdated or unnecessary and are good
candidates for revocation. This rulemaking is one of several that FDA
is planning to streamline its food standard regulations. Throughout
this document, we refer to standards of identity for food products as
``standards'' or ``food standards.''
[[Page 33341]]
III. Description of the Proposed Rule
FDA issued most food standards regulations before 1980. FDA's
initial approach to food standards during the 1940s to 1960s was
oriented to maintaining the value of food and preventing economic
adulteration. In the absence of premarket safety standards and labeling
for ingredients, many early food standards have been described as
``recipe standards,'' prescribing, under a common or usual name for the
food, the ingredients that must and could be used, sometimes with a
manufacturing process, and many provided very limited flexibility (60
FR 67492, 67494, December 29, 1995). This approach both addressed
economic adulteration or debasement and ensured that ingredients in,
and the production processes used for, standardized foods were ones
that FDA regarded as safe (id.).
Since 1938, the FD&C Act has been amended numerous times, including
amendments related to ingredient safety, ingredient labeling (including
allergen labeling), food packaging, safe food production and
manufacturing practices, and nutrition labeling information and claims.
The standards in this proposed rule predate many of these amendments.
The FD&C Act's amendments, along with developments and changes in
nutrition, food science, agriculture, and production/manufacturing,
mean these food standards may be unnecessary now. For example, the food
industry may have moved away from the standardized food to make
different, nonstandardized foods. A standard may be an inappropriate
impediment to adopting new technologies or food reformulation that
would make a food easier to produce or give consumers more choices,
including healthier choices that support the Secretary's Make America
Healthy Again priorities. Further, some food standards may be redundant
in that they provide for additional ingredients to be added to another
standardized food or otherwise apply to a food that could be
effectively covered by a broader standard. In other cases, substantial
time has passed since the standard was established or last amended, and
the standard appears to have less significance. In all these
situations, the utility of a standard may be quite diminished, and
revocation of a food standard may be appropriate as we would not expect
that the standard is necessary to promote honesty and fair dealing in
the interest of consumers.
We also note that the history of food standards teaches us that
consumer preferences and the food industry sometimes change faster than
FDA can issue or update regulations, and we should therefore use food
standards judiciously. When a food standard no longer promotes honesty
or fair dealing in the interest of consumers, FDA may consider whether
it is more appropriate to revoke the standard, rather than to amend the
standard or replace it with a new one. In those instances, other
provisions of the FD&C Act and its implementing regulations for the
food would still apply and may permit more flexibility and innovation.
FDA believes that food standards are most appropriate when, for
example, they protect against instances of economic adulteration or
debasement or standardize foods that are likely targets thereof,
standardize foods that are important staples of the U.S. diet (either
in their inherent nutrient profile or volume), set enrichment or
fortification criteria, or standardize foods that are particularly
significant in domestic programs or international trade.
Considering the history and appropriateness of food standards along
with the current FD&C Act and its implementing regulations, we have
identified some initial categories of standards that describe
situations when we may consider revoking a food standard. In this
proposed rule, we identify four categories of food standards that we
tentatively conclude are no longer necessary ``to promote honesty and
fair dealing in the interest of consumers'' (21 U.S.C. 341). As we
continue our review of all the food standard regulations, we may
identify additional categories for revocation.
Category 1: Standardized Foods With Little to No Market in the U.S.
These are foods for which FDA's initial research (described below)
shows little to no evidence of a market in the U.S. Our tentative
conclusion is that maintaining a standard for a food that has little to
no U.S. market is not necessary to promote honesty and fair dealing in
the interest of consumers.
Category 2: Standardized Food That Would Be Covered by 21 CFR 130.10 in
the Absence of Its Standard of Identity
Section 130.10 is a cross-cutting standard that covers foods that
deviate from a standard of identity due to compliance with an expressed
nutrient content claim defined by FDA regulation (21 CFR 130.10(a)).
There are several expressed nutrient content claims defined under FDA's
regulations in 21 CFR 101.54 through 101.62. These regulations define
claims such as ``fat free,'' ``low sodium,'' and ``reduced calorie''
and can be met by reducing nutrients such as fat, salt, and sugar in
foods. Manufacturers may wish to reduce nutrients in standardized foods
consistent with these claims. In some cases, an additional specific
food standard exists to permit reductions in fat, salt, or sugar. These
standards tend to predate the establishment of 21 CFR 130.10. Before 21
CFR 130.10 was issued, specific standards that allowed these kinds of
products were useful; now, however, we tentatively conclude that, in
some instances, they may be redundant. We are not currently aware of
any evidence suggesting that separate standards would, in this
situation, remain necessary to promote honesty and fair dealing in the
interest of consumers.
Category 3: Standardized Foods That Include the Name of Another
Standardized Food in Their Names
There are some standardized foods that are similar to other
standardized foods except for the addition of certain ingredients
(e.g., fruits, vegetables, or meats), which may be accompanied by other
very minor modifications to reflect changes resulting from the addition
of these ingredients. In such cases, we propose to revoke the standards
for the foods with additional ingredients so that they are
nonstandardized foods. We note that, after revocation, the
nonstandardized food may have a name that includes the common or usual
name of the standardized food, along with any additions that may be
needed to the name to reflect the new ingredient(s) (see 21 CFR 101.3).
As we have previously stated, a nonstandardized food may be labeled
with a name that includes the common or usual name of a standardized
food, provided that the name of the nonstandardized food is not
misleading. The goal of the revocations proposed under category 3 is to
avoid redundant standards that are no longer necessary to promote
honesty and fair dealing in the interest of consumers.
Category 4: Standardized Foods That Could Be Covered by a Broader
Standard
Some standardized foods are covered by the standard specified under
their common or usual name and also fit within the description of a
broader standard for that category or type of food. In this case, FDA
believes the more specific standard may not be needed and the food
could instead be covered under the broader standard. FDA may conclude
that the specific standard is redundant and unnecessary to promote
honesty and fair dealing in the interest of consumers. Once the
[[Page 33342]]
specific standard is revoked and the food is covered under the broader
standard, section 403(a)(1) of the FD&C Act (relating to false or
misleading labeling) may require the continued use of descriptive words
already in the labeling of the food, e.g., geographic origins, or
description(s) of ingredient quantity. These descriptive words may come
from the common or usual name or provisions that were in the specific
standard. The goal of the revocations proposed under category 4 is to
avoid redundant standards that are no longer necessary to promote
honesty and fair dealing in the interest of consumers.
FDA has performed an initial review of Parts 136, 139, 146, 161,
and 169, which cover standards for bakery products, macaroni and noodle
products, canned fruit juices, fish and shellfish, and food dressings
and flavorings, respectively. FDA conducted research to determine the
market status of each standardized food listed in these parts to assess
likely sales, both in person and online. We searched commercial
databases of retail food products to evaluate if the identified food
standards are currently on the market. The advanced search tool was
used to limit results with the following parameters: product name, food
product category, and region where sold (U.S.). If necessary for the
product, we also narrowed the search by food ingredients, food
characteristics, and year. We also considered recent sales data using
the information from an additional market research company. Because
these databases do not capture online sales, we performed internet and
online shopping searches using product names. The internet searches
helped with assessing the product's name and whether the statement of
identity (21 CFR 101.3(b)) generally appears sufficient. As explained
above, FDA research was primarily focused on market status. Our review
of foods' names was very broad and should not be regarded as a
compliance or enforcement review.
Based on these considerations and our market research, we
tentatively conclude that 23 food standards should be revoked because
they fall into one or more of the categories described above and are
not necessary to promote honesty and fair dealing in the interest of
consumers. The 23 food standards are listed in Table 1 along with the
primary applicable considerations for revocation described above.
Table 1--Amendments to Food Standards
[Parts 136, 139, 146, 161, 169]
----------------------------------------------------------------------------------------------------------------
CFR section Title Primary reason(s) for revocation
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136.130......................... Milk bread, rolls, and buns...... Category 1: Standardized foods with little
to no market in the U.S.
139.117......................... Enriched macaroni products with Category 1: Standardized foods with little
fortified protein. to no market in the U.S.
139.120......................... Milk macaroni products........... Category 1: Standardized foods with little
to no market in the U.S.
139.121......................... Nonfat milk macaroni products.... Category 1: Standardized foods with little
to no market in the U.S.
139.122......................... Enriched nonfat milk macaroni Category 1: Standardized foods with little
products. to no market in the U.S.
139.140......................... Wheat and soy macaroni products.. Category 1: Standardized foods with little
to no market in the U.S.
139.160......................... Vegetable noodle products........ Category 1: Standardized foods with little
to no market in the U.S.
139.165......................... Enriched vegetable noodle Category 1: Standardized foods with little
products. to no market in the U.S.
139.180......................... Wheat and soy noodle products.... Category 1: Standardized foods with little
to no market in the U.S.
146.121......................... Frozen concentrate for Category 1: Standardized food with little
artificially sweetened lemonade. to no market in the U.S.
146.126......................... Frozen concentrate for colored Category 3: Standardized food that includes
lemonade. the name of another standardized food in
its name.
146.137......................... Frozen orange juice.............. Category 1: Standardized food with little
to no market in the U.S.
146.148......................... Reduced acid frozen concentrated Category 1: Standardized food with little
orange juice. to no market in the U.S.
146.150......................... Canned concentrated orange juice. Category 1: Standardized food with little
to no market in the U.S.
146.151......................... Orange juice for manufacturing... Category 1: Standardized food with little
to no market in the U.S.
146.152......................... Orange juice with preservative... Category 1: Standardized food with little
to no market in the U.S.
146.153......................... Concentrated orange juice for Category 1: Standardized food with little
further manufacturing. to no market in the U.S.
146.154......................... Concentrated orange juice with Category 1: Standardized food with little
preservative. to no market in the U.S.
161.136......................... Olympia oysters.................. Category 4: Standardized food that could be
covered by a broader standard.
161.176......................... Frozen raw lightly breaded shrimp Category 4: Standardized food that could be
covered by a broader standard.
169.180......................... Vanilla-vanillin extract......... Category 1: Standardized food with little
to no market in the U.S.
169.181......................... Vanilla-vanillin flavoring....... Category 1: Standardized food with little
to no market in the U.S.
169.182......................... Vanilla-vanillin powder.......... Category 1: Standardized food with little
to no market in the U.S.
----------------------------------------------------------------------------------------------------------------
Additionally, because we are proposing to remove these standards
from the regulations, we are also proposing to amend the following
regulations that reference these standards to reflect their removal
from the regulations:
<bullet> 21 CFR 136.110(c)(6), to remove reference to Sec.
136.130;
<bullet> 21 CFR 146.140(a) and (b), to remove reference to Sec.
146.153;
<bullet> 21 CFR 146.141(a), to remove reference to Sec. 146.137;
<bullet> 21 CFR 146.145(a), to remove reference to Sec. Sec.
146.137, 146.151, and 146.153; and
<bullet> 21 CFR 146.146(a), to remove reference to Sec. Sec.
146.150 and 146.153.
These proposed amendments would not alter the substantive
requirements in the regulations, rather, they would remove refences to
the regulations we propose to revoke.
IV. Proposed Effective Date
FDA proposes to make these revocations effective 60 days after
publication of a final rule.
V. Preliminary Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the proposed rule under Executive
Order 12866 (``Regulatory Planning and Review'' (58 FR 51735, October
4, 1993)), Executive Order 13563,
[[Page 33343]]
Executive Order 14192, the Regulatory Flexibility Act, and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866 and 13563 direct us to assess all benefits
and costs of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits.
Rules are ``economically significant'' under Executive Order 12866 if
they ``have an annual effect on the economy of $100 million on 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 proposed rule is not a significant regulatory
action under Executive Order 12866.
Executive Order 14192 requires that any new incremental costs
associated with significant new regulations ``shall, to the extent
permitted by law, be offset by the elimination of existing costs
associated with at least ten prior regulations.'' This proposed rule,
if finalized as proposed, is expected to be deregulatory under
Executive Order 14192.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because we do not estimate this rule would have any costs to
businesses, we propose to certify that the proposed rule will not have
a significant economic impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act of 1995 (Section 202(a)) requires
us to prepare a written statement, which includes estimates of
anticipated impacts, before proposing ``any rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any 1 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 proposed rule would not result in an expenditure
in any year that meets or exceeds this amount.
B. Overview of Benefits, Costs, and Transfers
This proposed rule would revoke 23 food standards that are no
longer necessary to promote honesty and fair dealing in the interest of
consumers. We anticipate benefits from some revoked food standards in
the form of producer and consumer surplus generated by increased
flexibility. We anticipate cost savings from revoking these food
standards in the form of eliminating the need for companies to read and
understand food standards during product development. We do not
anticipate any costs to consumers as these food standards are no longer
necessary to promote honesty and fair dealing in the interest of
consumers. We discuss these impacts qualitatively and summarize the
impacts in Table 1.
Table 1--Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
[Millions of 2024 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
Primary Low High ------------------------------------
Category estimate estimate estimate Year Discount Period Notes
dollars rate (%) covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized..................................................... $0 $0 $0 2024 7 .......... ...........
Monetized ($millions/year)..................................... 0 0 0 2024 3 .......... ...........
Annualized..................................................... .......... .......... .......... .......... 7 .......... ...........
Quantified..................................................... .......... .......... .......... .......... 3 .......... ...........
------------------------------------------------------------------------------------
Qualitative.................................................... Revoking these food standards may lead to increases in producer and consumer
surplus generated by increased flexibility.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized..................................................... 0 0 0 2024 7 .......... ...........
Monetized ($millions/year)..................................... 0 0 0 2024 3 .......... ...........
Annualized..................................................... .......... .......... .......... .......... 7 .......... ...........
Quantified..................................................... .......... .......... .......... .......... 3 .......... ...........
------------------------------------------------------------------------------------
Qualitative.................................................... Revoking these food standards may lead to cost savings in product development from
removing the need for companies to read and understand the food standards.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal........................................................ .......... .......... .......... .......... 7 .......... ...........
Annualized..................................................... .......... .......... .......... .......... 3 .......... ...........
------------------------------------------------------------------------------------
Monetized ($millions/year)..................................... From:
To: ..........
------------------------------------------------------------------------------------
Other.......................................................... .......... .......... .......... .......... 7 .......... ...........
Annualized..................................................... .......... .......... .......... .......... 3 .......... ...........
------------------------------------------------------------------------------------
Monetized ($millions/year)..................................... From:
To: ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None.
Small Business: None.
Wages: None.
Growth: None.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Benefits encompass positive and negative benefits. Costs encompass costs and cost savings.
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.
[[Page 33344]]
Table 2--E.O. 14192 Summary Table
[In millions of 2024 dollars, discounted over an infinite time horizon
at a 7 percent discount rate]
------------------------------------------------------------------------
Primary Low High
estimate estimate estimate
------------------------------------------------------------------------
Present Value of Costs........... $0 ........... ...........
Present Value of Cost Savings.... 0 ........... ...........
Present Value of Net Costs....... 0 ........... ...........
Annualized Costs................. 0 ........... ...........
Annualized Cost Savings.......... 0 ........... ...........
Annualized Net Costs............. 0 ........... ...........
------------------------------------------------------------------------
Note: Values in parentheses denote net negative costs (i.e. net cost
savings).
We have developed a Preliminary Economic Analysis of Impacts that
assesses the impacts of the proposed rule. The full analysis of
economic impacts is available in the docket for this proposed rule 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>.
VI. Analysis of Environmental Impact
We have determined under 21 CFR 25.32(a) that this proposed action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VII. Paperwork Reduction Act of 1995
This proposed rule contains no new or revised collection of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520)
is not required.
VIII. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132, ``Federalism'' (64 FR
43255, August 10, 1999). We have determined that this proposed rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.
IX. Consultation and Coordination With Indian Tribal Governments
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175, ``Consultation and
Coordination with Indian Tribal'' (65 FR 67249, November 9, 2000). We
have tentatively determined that the rule does not contain policies
that would have a substantial direct effect on one or more Indian
Tribes, on the relationship between the Federal Government and Indian
Tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian Tribes. We invite comments from
tribal officials on any potential impact on Indian Tribes from this
proposed action.
List of Subjects
21 CFR Part 136
Bakery products, Food grades and standards.
21 CFR Part 139
Food grades and standards.
21 CFR Part 146
Food grades and standards, Fruit juices.
21 CFR Part 161
Food grades and standards, Frozen foods, Seafood.
21 CFR Part 169
Food grades and standards, Oils and fats, Spices and flavorings.
Therefore, under the Federal Food, Drug, and Cosmetic Act, we
propose that 21 CFR parts 136, 139, 146, 161, and 169 be amended as
follows:
PART 136--BAKERY PRODUCTS
0
1. The authority citation for part 136 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Sec. 136.110 [Amended]
0
2. Section 136.110 is amended by revising paragraph (c)(6) to read as
follows:
Sec. 136.110 Bread, rolls, and buns.
* * * * *
(c) * * *
(6) Milk and/or other dairy products: Whenever nonfat milk solids
in any form are used, carrageenan or salts of carrageenan complying
with the provisions of part 172 of this chapter may be used in a
quantity not in excess of 0.8 percent by weight of such nonfat milk
solids.
* * * * *
Sec. 136.130 [Removed]
0
3. Section 136.130 is removed.
PART 139--MACARONI AND NOODLE PRODUCTS
0
4. The authority citation for part 139 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Sec. Sec. 139.117, 139.120, 139.121, 139.122, 139.140, 139.160,
139.165, and 139.180 [Removed]
0
5. Sections 139.117, 139.120, 139.121, 139.122, 139.140, 139.160,
139.165, and 139.180 are removed.
PART 146--CANNED FRUIT JUICES
0
6. The authority citation for part 146 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Sec. Sec. 146.121, 146.126, and 146.137 [Removed]
0
7. Sections 146.121, 146.126, and 146.137 are removed.
Sec. 146.140 [Amended]
0
8. Section 146.140 is amended by revising paragraphs (a) and (b) to
read as follows:
Sec. 146.140 Pasteurized orange juice.
* * * * *
(a) Pasteurized orange juice is the food prepared from unfermented
juice obtained from mature oranges as specified in Sec. 146.135, to
which may be added not more that 10 percent by volume of the
unfermented juice obtained from mature oranges of the species Citrus
reticulata or Citrus reticulata hybrids (except that this limitation
shall not apply to the hybrid
[[Page 33345]]
species described in Sec. 146.135). Seeds (except embryonic seeds and
small fragments of seeds that cannot be separated by good manufacturing
practice) are removed, and pulp and orange oil may be adjusted in
accordance with good manufacturing practice. If the adjustment involves
the addition of pulp, then such pulp shall not be of the washed or
spent type. The solids may be adjusted by the addition of the optional
concentrated orange juice ingredient specified in paragraph (b) of this
section. One or more of the optional sweetening ingredients listed in
paragraph (c) of this section may be added in a quantity reasonably
necessary to raise the Brix or the Brix-acid ratio to any point within
the normal range usually found in unfermented juice obtained from
mature oranges as specified in Sec. 146.135. The orange juice is so
treated by heat as to reduce substantially the enzymatic activity and
the number of viable microorganisms. Either before or after such heat
treatment, all or a part of the product may be frozen. The finished
pasteurized orange juice contains not less than 10.5 percent by weight
of orange juice soluble solids, exclusive of the solids of any added
optional sweetening ingredients, and the ratio of the Brix hydrometer
reading to the grams of anhydrous citric acid per 100 milliliters of
juice is not less than 10 to 1.
(b) The optional concentrated orange juice ingredient referred to
in paragraph (a) of this section is frozen concentrated orange juice as
specified in Sec. 146.146; but the quantity of such concentrated
orange juice ingredient added shall not contribute more than one-fourth
of the total orange juice solids in the finished pasteurized orange
juice.
* * * * *
Sec. 146.141 [Amended]
0
9. Section 146.141 is amended by revising paragraph (a) to read as
follows:
Sec. 146.141 Canned orange juice.
(a) Canned orange juice is the food prepared from orange juice as
specified in Sec. 146.135, to which may be added not more than 10
percent by volume of the unfermented juice obtained from mature oranges
of the species Citrus reticulata or Citrus reticulata hybrids (except
that this limitation shall not apply to the hybrid species described in
Sec. 146.135). Seeds (except embryonic seeds and small fragments of
seeds that cannot be separated by good manufacturing practice) are
removed. Orange oil and pulp may be adjusted in accordance with good
manufacturing practice. The adjustment of pulp referred to in this
paragraph does not permit the addition of washed or spent pulp. Liquid
condensate recovered from the deoiling operation may be added back. One
or more of the optional sweetening ingredients named in paragraph (b)
of this section may be added, in a quantity reasonably necessary to
raise the Brix or the Brix-acid ratio to any point within the normal
range usually found in unfermented juice obtained from mature oranges
as specified in Sec. 146.135. The food is sealed in containers and so
processed by heat, either before or after sealing, as to prevent
spoilage. The finished canned orange juice tests not less than 10[deg]
Brix, and the ratio of the Brix hydrometer reading to the grams of
anhydrous citric acid per 100 milliliters of juice is not less than 9
to 1.
* * * * *
Sec. 146.145 [Amended]
0
10. Section 146.145 is amended by revising paragraph (a) to read as
follows:
Sec. 146.145 Orange juice from concentrate.
(a) Orange juice from concentrate is the food prepared by mixing
water with frozen concentrated orange juice as defined in Sec.
146.146. To such mixture may be added orange juice as defined in Sec.
146.135, pasteurized orange juice as defined in Sec. 146.140, orange
oil, orange pulp, and one or more of the sweetening ingredients listed
in paragraph (b) of this section. The finished orange juice from
concentrate contains not less than 11.8 percent orange juice soluble
solids, exclusive of solids of any added optional sweetening
ingredients. It may be so treated by heat as to reduce substantially
the enzymatic activity and the number of viable microorganisms.
* * * * *
Sec. 146.146 [Amended]
0
11. Section 146.146 is amended by revising paragraph (a) to read as
follows:
Sec. 146.146 Frozen concentrated orange juice.
(a) Frozen concentrated orange juice is the food prepared by
removing water from the juice of mature oranges as provided in Sec.
146.135, to which may be added unfermented juice obtained from mature
oranges of the species Citrus reticulata, other Citrus reticulata
hybrids, or of Citrus aurantium, or both. However, in the
unconcentrated blend, the volume of juice from Citrus reticulata or
Citrus reticulata hybrids shall not exceed 10 percent (except that this
limitation shall not apply to the hybrid species described in Sec.
146.135) and from Citrus aurantium shall not exceed 5 percent. The
concentrate so obtained is frozen. In its preparation, seeds (except
embryonic seeds and small fragments of seeds that cannot be separated
by good manufacturing practice) and excess pulp are removed, and a
properly prepared water extract of the excess pulp so removed may be
added. Orange oil, orange pulp, orange essence (obtained from orange
juice), orange juice and other orange juice concentrate as provided in
this section, water, and one or more of the optional sweetening
ingredients specified in paragraph (b) of this section may be added to
adjust the final composition. The juice of Citrus reticulata and Citrus
aurantium, as permitted by this paragraph, may be added in single
strength or concentrated form prior to concentration of the Citrus
sinensis juice, or in concentrated form during adjustment of the
composition of the finished food. The addition of concentrated juice
from Citrus reticulata or Citrus aurantium, or both, shall not exceed,
on a single-strength basis, the 10 percent maximum for Citrus
reticulata and the 5 percent maximum for Citrus aurantium prescribed by
this paragraph. Any of the ingredients of the finished concentrate may
have been so treated by heat as to reduce substantially the enzymatic
activity and the number of viable microorganisms. The finished food is
of such concentration that when diluted according to label directions
the diluted article will contain not less than 11.8 percent by weight
of orange juice soluble solids, exclusive of the solids of any added
optional sweetening ingredients. The dilution ratio shall be not less
than 3 plus 1. For the purposes of this section, the term ``dilution
ratio'' means the whole number of volumes of water per volume of frozen
concentrate required to produce orange juice from concentrate having
orange juice soluble solids of not less than 11.8 percent by weight
exclusive of the solids of any added optional sweetening ingredients.
* * * * *
Sec. Sec. 146.148, 146.150, 146.151, 146.152, 146.153, and
146.154 [Removed]
0
12. Sections 146.148, 146.150, 146.151, 146.152, 146.153, and 146.154
are removed.
PART 161--FISH AND SHELLFISH
0
13. The authority citation for part 161 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Sec. Sec. 161.136 and 161.176 [Removed]
0
14. Sections 161.136 and 161.176 are removed.
[[Page 33346]]
PART 169--FOOD DRESSINGS AND FLAVORINGS
0
15. The authority citation for part 169 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Sec. Sec. 169.180, 169.181, and 169.182 [Removed]
0
16. Sections 169.180, 169.181, and 169.182 are removed.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-13420 Filed 7-16-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on July 17, 2025.
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.