[Federal Register Volume 90, Number 135 (Thursday, July 17, 2025)]
[Proposed Rules]
[Pages 33334-33339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-13424]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 /
Proposed Rules
[[Page 33334]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 131, 133, 135, and 184
[Docket No. FDA-2025-N-1225]
RIN 0910-AJ11
Proposal To Revoke 18 Standards of Identity for Dairy Products
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 18 standards of identity for dairy products. FDA is taking this
action as we tentatively conclude that these standards are no longer
necessary to promote honesty and fair dealing in the interest of
consumers. This proposed action would reduce redundant regulatory
requirements.
DATES: Either electronic or written comments on the proposed rule must
be submitted by September 15, 2025. FDA does not intend to extend the
comment period.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of 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:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
[FDA-2025-N-1225] for ``Proposal to Revoke 18 Standards of Identity for
Dairy Products.'' 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents, 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
https://www.regulations.gov and insert the docket number, found in
brackets in the heading of this document, into the ``Search'' box and
follow the prompts and/or go to the Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Jessie Zhao, Office of Nutrition and
Food Labeling, Human Foods Program, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2371; or Meadow Platt,
Office of Policy, Regulations, and Information, Human Foods Program,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-2378.
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
[[Page 33335]]
V. Preliminary Analysis of Economic Impacts and Initial Regulatory
Flexibility Analysis
A. Foods With Little to No Market
B. Foods Covered by Redundant Food Standard Regulations
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 18 dairy standards 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 131--Milk and Cream
131.111 Acidified milk
131.162 Acidified sour cream
Part 133--Cheeses and Related Cheese Products
133.111 Caciocavallo siciliano cheese
133.116 Low sodium cheddar cheese
133.121 Low sodium colby cheese
133.125 Cold-pack cheese food with fruits, vegetables, or
meats
133.127 Cook cheese, koch kaese
133.134 Cream cheese with other foods
133.140 Gammelost cheese
133.154 High-moisture jack cheese
133.164 Nuworld cheese
133.168 Pasteurized blended cheese with fruits, vegetables,
or meats
133.170 Pasteurized process cheese with fruits, vegetables,
or meats
133.174 Pasteurized process cheese food with fruits,
vegetables, or meats
133.185 Samsoe cheese
133.186 Sap sago cheese
Part 135: Frozen Desserts
135.115 Goat's Milk Ice Cream
135.130 Mellorine
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. Under
section 701(e) of the FD&C Act (21 U.S.C. 371(e)), any action for the
amendment or repeal of any definition and standard of identity under
section 401 of the FD&C Act for any dairy product, such as cheeses or
frozen dairy products, must be begun by a proposal made either by the
Secretary on his own initiative or by petition of any interested
persons, showing reasonable grounds therefor, filed with the Secretary.
D. Costs and Benefits
We are publishing this proposed rule under the formal rulemaking
process. Executive Order 12866 does not require us to analyze the costs
and benefits of proposed rules that we publish under this rulemaking
process (see Executive Order 12866, ``Regulatory Planning and Review''
(58 FR 51735, October 4, 1993)). However, we have examined the economic
implications of this proposed rulemaking on small businesses. The
Regulatory Flexibility Act (5 U.S.C. 601-612) requires us to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed rule would create cost savings
or negligible costs for small entities, we propose to certify that the
proposed rule will not have a significant economic impact on a
substantial number of small entities.
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 18 standards of identity for
dairy products 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 18, 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 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. This rulemaking addresses dairy standards of
identity. Throughout this document we refer to standards of identity
for dairy products as ``standards'' or ``food standards.''
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
duplicative in that they provide for additional ingredients to be added
to another standardized food. Other times, 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.
[[Page 33336]]
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 three categories of dairy 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 kinds 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 proposed revocation 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 131, 133, and 135,
which cover standards for milk and cream, cheeses and related cheese
products, and frozen desserts, 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 a
commercial database 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 (see 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 the considerations and our market research, we have
tentatively concluded that 18 dairy product 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 18 dairy products are listed in Table 1
along with the applicable considerations for revocation described
above.
Table 1--Amendments to Food Standards for Dairy Products
[Parts 131, 133, 135]
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CFR section Title Reason(s) for revocation
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131.111................................. Acidified milk............................ Category 1.
131.162................................. Acidified sour cream...................... Category 1.
133.111................................. Caciocavallo siciliano cheese............. Category 1.
133.116................................. Low sodium cheddar cheese................. Categories 1, 2.
133.121................................. Low sodium colby cheese................... Categories 1, 2.
[[Page 33337]]
133.125................................. Cold-pack cheese food with fruits, Category 3.
vegetables, or meats.
133.127................................. Cook cheese, koch kaese................... Category 1.
133.134................................. Cream cheese with other foods............. Category 3.
133.140................................. Gammelost cheese.......................... Category 1.
133.154................................. High-moisture jack cheese................. Category 1.
133.164................................. Nuworld cheese............................ Category 1.
133.168................................. Pasteurized blended cheese with fruits, Category 3.
vegetables, or meats.
133.170................................. Pasteurized process cheese with fruits, Category 3.
vegetables, or meats.
133.174................................. Pasteurized process cheese food with Category 3.
fruits, vegetables, or meats.
133.185................................. Samsoe cheese............................. Category 1.
133.186................................. Sap sago cheese........................... Category 1.
135.115................................. Goat's milk ice cream..................... Category 1.
135.130................................. Mellorine................................. Category 1.
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Additionally, because we are proposing to remove Sec. 133.111,
Caciocavallo siciliano cheese, we are proposing to remove the reference
to Sec. 133.111 in Sec. 184.1157(c)(2), which pertains to the use of
benzoyl peroxide as an ingredient in specific foods.
IV. Proposed Effective Date
FDA proposes to make these revocations effective 60 days after
publication of a final rule.
V. Preliminary Analysis of Economic Impacts and Initial Regulatory
Flexibility Analysis
We are publishing this proposed rule under the formal rulemaking
process. Executive Order 12866 does not require us to analyze the costs
and benefits of proposed rules that we publish under this rulemaking
process.
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 the proposed rule would create cost savings or
negligible costs for small entities, we propose to certify that the
proposed rule will not have a significant economic impact on a
substantial number of small entities. This analysis, as well as other
sections in this document, serves as the Initial Regulatory Flexibility
Analysis, as required under the Regulatory Flexibility Act.
The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4; 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.
A. Foods With Little to No Market
As described above, FDA has reviewed available market data to
identify food standards that cover few marketed products. We rely on
point-of-sale data from Circana to identify food products with little
to no market at multi-outlet and convenience retailers from 2019
through 2024.\1\ Circana defines multi-outlet and convenience retailers
as brick-and-mortar food, drug, mass-market (including Walmart), club
(excluding Costco), dollar, military, and convenience stores. We
obtained annual data on dollar sales and unit sales from relevant
products at the Universal Product Code (UPC) level.
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\1\ Food and Drug Administration custom research definitions
based on Circana, LLC (fka Information Resources Inc.) data 2019 to
2024, dollar sales, unit sales, product name, and descriptive label
variables, Total Multi Outlet with Convenience.
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To identify standardized food products, we used the following
methods:
1. We identified the standards of identity for each food based on
the text of the food standard in 21 CFR part 131, 133, or 135.
2. We manually reviewed the Circana data to identify descriptive
variables that determine whether a product is subject to the food
standard.
3. We developed search terms for each food standard to
systematically identify relevant products.
4. We reviewed the search results for accuracy and quality control.
We also searched Mintel Global New Products Database (GNPD), a
commercial database of retail food products, to evaluate if the
identified food standards are currently on the market.\2\ 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.
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\2\ See Mintel Global New Products Database (GNPD), http://www.mintel.com/global-new-products-database, downloaded on May 2025.
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The Circana and Mintel data do not cover all distribution channels
for food products. Notably, the data does not include online sales and
sales from specialty retailers. To supplement our analysis of the
Circana and Mintel data, we also conducted an internet search to
identify products for sale online or sold exclusively in specialty
stores. We only concluded that a food standard had little to no market
if we found few products through both our market data analysis and our
internet search.
Through this analysis, FDA has concluded that little to no market
exists for foods under the following food standards:
1. Acidified Milk,
2. Acidified sour cream,
3. Caciocavallo siliciano cheese,
4. Low sodium cheddar cheese,
5. Low sodium colby cheese,
6. Cook cheese, koch kaese,
7. Gammelost cheese,
8. High-moisture jack cheese,
9. Nuworld cheese,
10. Samsoe cheese,
11. Sap sago cheese,
[[Page 33338]]
12. Goat's milk ice cream, and
13. Mellorine.
Because few products covered by these food standards are currently
marketed, revoking these 13 food standards would affect few small
businesses. Any small businesses that market one of the covered
products may realize benefits of additional flexibility in product
development. FDA requests comment on any benefits or costs associated
with revoking these 13 food standards.
B. Foods Covered by Redundant Food Standard Regulations
Some food products are covered by multiple food standards or could
easily be marketed as a nonstandardized food using the name of a
standardized food in the nonstandardized food's full name. Food
products covered by redundant standards include:
1. Cold-pack cheese food with fruits, vegetables, or meats,
2. Cream cheese with other foods,
3. Pasteurized blended cheese with fruits, vegetables, or meats,
4. Pasteurized process cheese with fruits, vegetables, or meats,
and
5. Pasteurized process cheese food with fruits, vegetables, or
meats.
This rule would affect cheese manufacturing firms in the North
American Industry Classification System (NAICS) code 311513. The Small
Business Administration (SBA) defines a small business in NAICS 311513
as a business with 1,250 or fewer employees.\3\ The U.S. Census
Statistics of U.S. Businesses data from 2022 lists industries by
establishment size.\4\ The largest establishment size category is 500+
employees for NAICS 311513, which is lower than the SBA cutoff. If we
assume all 35 firms in that category are not small, then the remaining
375 firms, or around 91 percent (=375/410), of firms would be
classified as small. If those 35 firms are small businesses, then 100
percent of manufacturers in NAICS 311513 are small. We do not expect
all manufacturers in NAICS 311513 are making foods covered by the five
food standards listed above. We summarize the number and estimated
revenues for small firms potentially affected by this proposed rule in
Table 2.
---------------------------------------------------------------------------
\3\ https://www.sba.gov/document/support-table-size-standards.
\4\ https://www.census.gov/data/tables/2022/econ/susb/2022-susb-annual.html.
Table 2--Number, Percent, and Estimated Revenues for Firms by Employee Size Category
[NAICS 311513 Cheese Manufacturing]
----------------------------------------------------------------------------------------------------------------
Estimated
Employees Number of Percent of revenues ($
firms firms (%) millions)
----------------------------------------------------------------------------------------------------------------
<5.............................................................. 106 25.9 $150.2
5 to 9.......................................................... 58 14.1 102.5
10 to 19........................................................ 61 14.9 321.6
20 to 99........................................................ 95 23.2 2,311.6
100 to 499...................................................... 55 13.4 9,685.3
500+............................................................ 35 8.5 54,987.3
-----------------------------------------------
Total....................................................... 410 100.0 67,558.5
----------------------------------------------------------------------------------------------------------------
These five redundant standards may create confusion for
manufacturers or slow innovation. To the extent that this creates
costs, revoking these food standards would generate cost savings for
manufacturers of such products. FDA requests comment on any benefits or
costs associated with revoking these five food standards.
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
FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 (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 131
Dairy products, Food grades and standards, Milk.
21 CFR Part 133
Dairy products, Food grades and standards, Food labeling.
21 CFR Part 135
Food grades and standards, Food labeling, Frozen foods, Ice cream.
21 CFR Part 184
Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act, we
propose
[[Page 33339]]
that 21 CFR parts 131, 133, 135, and 184 be amended as follows:
PART 131--MILK AND CREAM
0
1. The authority citation for part 131 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Sec. Sec. 131.111 and 131.162 [Removed]
0
2. Sections 131.111 and 131.162 are removed.
PART 133--CHEESES AND RELATED CHEESE PRODUCTS
0
3. The authority citation for part 133 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Sec. Sec. 133.111, 133.116, 133.121, 133.125, 133.127, 133.134,
133.140, 133.154, 133.164, 133.168, 133.170, 133.174, 133.185, and
133.186 [Removed]
0
4. Sections 133.111, 133.116, 133.121, 133.125, 133.127, 133.134,
133.140, 133.154, 133.164, 133.168, 133.170, 133.174, 133.185, and
133.186 are removed.
PART 135--FROZEN DESSERTS
0
5. The authority citation for part 135 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Sec. Sec. 135.115 and 135.130 [Removed]
0
6. Sections 135.115 and 135.130 are removed.
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
0
7. The authority citation for part 184 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348, and 371.
Sec. 184.1157 [Amended]
0
8. Section 184.1157 is amended by revising paragraph (c)(2) to read as
follows:
Sec. 184.1157 Benzoyl peroxide.
* * * * *
(c) * * *
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: flour; milk used for
production of Asiago fresh and Asiago soft cheese (Sec. 133.102),
Asiago medium cheese (Sec. 133.103), Asiago old cheese (Sec.
133.104), Blue cheese (Sec. 133.106), Gorgonzola cheese (Sec.
133.141), Parmesan and reggiano cheese (Sec. 133.165), Provolone
cheese (Sec. 133.181), Romano cheese (Sec. 133.183), and Swiss and
emmentaler cheese (Sec. 133.195) in part 133 of this chapter; and
annatto-colored whey, such that the final bleached product conforms to
the descriptions and specifications for whey, concentrated whey, or
dried whey in Sec. 184.1979(a)(1), (2), or (3), respectively.
* * * * *
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-13424 Filed 7-16-25; 8:45 am]
BILLING CODE 4164-01-P