Federal Register, Volume 90 Issue 149 (Wednesday, August 6, 2025)

[Federal Register Volume 90, Number 149 (Wednesday, August 6, 2025)]
[Proposed Rules]
[Pages 37817-37824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-14949]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 146

[Docket No. FDA-2022-P-1668]
RIN 0910-AI98

Food Standards of Identity Modernization; Pasteurized Orange
Juice

AGENCY: Food and Drug Administration, Health and Human Services.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
amend the standard of identity for pasteurized orange juice (POJ) by
lowering the minimum orange juice soluble solids content from 10.5[deg]
to 10[deg] Brix. We tentatively conclude that this proposed amendment
will promote honesty and fair dealing in the interest of consumers and
provide industry greater flexibility in the manufacture of pasteurized
orange juice. This action, if finalized, will respond to a citizen
petition submitted by the Florida Citrus Processors Association Inc.
and Florida Citrus Mutual Inc.

DATES: Either electronic or written comments on the proposed rule must
be submitted by November 4, 2025.

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 November 4, 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-2022-P-1668 for ``Food Standards of Identity Modernization;
Pasteurized Orange Juice; Proposed Rule.'' 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/

[[Page 37818]]

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: Vivien Yan Peng, Office of Nutrition
and Food Labeling, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2371; or Keronica C. Richardson, Office
of Policy, Regulations, and Information, 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. Legal Authority
C. Costs and Benefits
II. Background
A. Need for the Regulation
B. History of the Rulemaking
III. Legal Authority
IV. Description of the Proposed Rule
A. Scope/Applicability
B. Amending the Standard of Identity Regulation To Reduce the
Minimum Brix Level
V. Proposed Effective/Compliance Dates
VI. Questions About POJ SOI
VII. Preliminary Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Proposed Rule

FDA is proposing to revise the standard of identity (SOI) for POJ
established at 21 CFR 146.140 (Sec. 146.140). The SOI currently
requires that finished POJ contain not less than 10.5 percent by weight
of orange juice soluble solids, exclusive of the solids of any added
optional sweetening ingredients (Sec. 146.140(a)). The percentage
soluble solids by weight of an aqueous solution (e.g., grams of sucrose
in 100 grams of solution at 68 degrees F) can be expressed as Brix or
degree of Brix ([deg] Brix). The current SOI for POJ therefore requires
a minimum orange juice soluble solids of 10.5[deg] Brix. The proposed
rule, if finalized, will amend the POJ standard by lowering the minimum
orange juice soluble solids from 10.5[deg] to 10[deg] Brix for finished
POJ. We tentatively conclude that this proposed amendment will promote
honesty and fair dealing in the interest of consumers and provide
greater flexibility in the manufacture of POJ (see section 401 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341)).

B. Legal Authority

We are issuing this proposed rule consistent with our authority in
sections 401 and 701 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 341, 371).

C. Costs and Benefits

The proposed rule, if finalized, would not require firms in the POJ
industry to change their manufacturing processes or behavior in any
way. Qualitative benefits include flexibility for manufacturers,
flexibility of product choice for consumers, and potential
sustainability for manufacturers in the face of disease or climate
impacts. We note specifically that the proposed rule does not require
any behavioral changes on the part of manufacturers, as it provides
manufacturers with greater flexibility rather than imposing any
restrictions. The proposed changes would provide for a wider range of
products to be marketed as POJ. No changes would be required for
products that already meet the existing POJ standard. Therefore, any
changes made by manufacturers of POJ would be voluntary. The proposed
rule, if finalized, would not impose any compliance costs to firms. We
estimate cost savings to manufacturers due to substitution to cheaper
inputs. The annualized costs would range from -$14.7 million to -$106.7
million, with a primary estimate of -$52.3 million, at a 7 percent
discount rate, and from -$14.8 million to -$107.0 million, with a
primary estimate of -$52.5 million, at a 3 percent discount rate.

II. Background

A. Citizen Petition and FDA's Request for Information

The Florida Citrus Processors Association Inc. and Florida Citrus
Mutual Inc. (``petitioners'') jointly submitted a citizen petition
(Docket No. FDA-2022-P-1668) on July 22, 2022, asking us to amend the
SOI for POJ to reduce the minimum orange juice soluble solids content
for POJ from 10.5[deg] to 10[deg] Brix, exclusive of the solids from
any added optional sweetening ingredients. See Citizen Petition from
the Florida Citrus Processors Association Inc. and Florida Citrus
Mutual Inc., entitled ``Request to Amend Pasteurized Orange Juice
Standard of Identity,'' sent to the Division of Dockets Management (now
the Dockets Management Staff), Food and Drug Administration, dated July
22, 2022 (``Petition'').
The petitioners stated that when FDA issued the SOI for POJ in 1963
(see ``Orange Juice and Orange Juice Products; Definitions and
Standards of Identity; Findings of Fact and Final Order,'' 28 FR 10900,
October 11, 1963), FDA recognized that Florida was the dominant
supplier of juice oranges with an average Brix level of 11.8[deg]. The
petitioners asserted that, based on the fruits used in preparing POJ at
that time, FDA set a minimum Brix level of 10.5[deg] for the POJ
standard (Petition at page 3). However, the petitioners stated that the
average Brix of Florida oranges has steadily dropped since 2010-2011
due to a bacterial disease called ``citrus greening disease,'' also
known as Huanglongbing (Petition at pages 3-4). According to
information on the U.S. Department of Agriculture (USDA), Animal and
Plant Health Inspection Service's (APHIS) website, symptoms of trees
infected with citrus greening include blotchy mottled leaves, stunted
growth, reduced fruit production, reduced fruit size, bitter fruit, and
premature fruit drop. See USDA APHIS, ``Citrus Greening and Asian
Citrus Psyllid,'' at https://www.aphis.usda.gov/plant-pests-diseases/citrus-diseases/citrus-greening-and-asian-citrus-psyllid. Currently,
there is no cure or mitigating treatment for citrus greening disease
and most trees die within a few years of being infected (id.). The U.S.
production forecast for oranges is down to the lowest level in 88 years
due to diseases like citrus greening and unfavorable

[[Page 37819]]

weather (see USDA Foreign Agricultural service Global Market Analysis,
``Citrus: World Markets and Trade,'' at https://www.fas.usda.gov/data/citrus-world-markets-and-trade-01302025. The petitioners also stated
that severe weather, particularly Hurricane Irma in 2017, has resulted
in the reduced production of oranges and lower average fruit sugar
content (Petition at pages 3-4). The soluble solids in orange juice
consist mainly of sugars. The petitioners explained that, due to these
factors, seasonal average Brix levels (weighted by volume) are hovering
below the minimum of 10.5[deg] Brix (Petition at page 4). The
petitioners stated that the SOI for POJ was carefully constructed to
reflect the qualities of U.S. oranges at the time the SOI was
established, however they asserted that the SOI should now be updated
to align with the modern U.S. crop (Petition at page 5). Hence, while
still under review, the current USDA standard for Grades of POJ is
based on the current POJ SOI (Ref. 1).
The POJ SOI allows for the addition of optional concentrated orange
juice ingredients to increase the POJ solids to meet the minimum
10.5[deg] Brix (Sec. 146.140(a)) with the label declaration of
``prepared in part from concentrated orange juice,'' ``with added
concentrated orange juice,'' or ``concentrated orange juice added''
(Sec. 146.140(e)(1)). This label declaration enables consumers to
identify POJ made from only expressed orange juice and POJ that has
been made with concentrated orange juice ingredients. The petitioners
asserted that ``not from concentrate'' orange juice is the most popular
form of orange juice, indicating that consumers have a preference for
POJ that is made from expressed juice rather than from concentrated
juice (Petition at page 5). The petitioners explained that almost the
entire Florida orange crop is used for the production of ``not from
concentrate'' POJ (Petition at pages 4-5), thereby emphasizing the
importance of Florida oranges in meeting consumer demand for ``not from
concentrate'' POJ. Florida plays a vital role in the orange juice
industry, although other states like California, Arizona, and Texas
also contribute to the overall citrus production in the United States.
Some states, such as California, primarily produce orange crops for the
fresh market. However, in Florida, almost the entire orange crop is
used to make POJ that is ``not from concentrate'' (Petition at page 4).
The petitioners further explained that while ``not from concentrate''
orange juice may have a lower Brix value, the reduction in sugar
content would be minimal and would unlikely impact consumer acceptance
with respect to characteristics like taste and flavor (Petition at
pages 5-6). The petitioners stated that most fruit juices, albeit many
of which have a relatively lower volume of sales, have no SOI and that
``this regulatory discrepancy further emphasizes the need to amend the
SOI for POJ to keep pace with modern scientific understanding and
naturally occurring dynamics impacting product production (Petition at
page 7)''. The petitioners also stated that the 10[deg] minimum Brix
level they requested for POJ is consistent with the minimum Brix level
of 10[deg] in the SOI for canned orange juice (See 21 CFR 146.141)
(Petition at page 6).
In the Federal Register of August 16, 2023, we published a request
for information (RFI) (Docket No. FDA-2023-N-2632) seeking comments on
several topics, including if amending the POJ SOI could result in
products that are inconsistent with consumer expectations and if
consumers would accept changes in the nutritional value of POJ with a
lower minimum soluble solids content (88 FR 55607, August 16, 2023). We
requested this information to determine whether the SOI for POJ should
be amended. Many comments supported lowering the Brix level. The
comments stated that the Brix level is an intrinsic variable for
oranges based on year, origin, and crops. The comments also asserted
that most consumers would not notice the difference in taste and flavor
of POJ with Brix levels between 10[deg] and 10.5[deg] and that any
nutritional differences are minimal. A few comments opposed the
petition, stating that there was no benefit to consumers if FDA lowered
the Brix level. However, these comments did not indicate or provide
evidence suggesting that consumers would be disadvantaged by lowering
the Brix level.
The petitioners provided supplemental materials to their petition
with new information on the decreasing average Brix level from the
2022-2023 orange season) and findings from a recent study demonstrating
consumers' acceptance of POJ with a lower Brix level of 10[deg]. See
Citizen Petition Supplemental Materials from the Florida Citrus
Processors Association Inc. and Florida Citrus Mutual Inc., entitled
``Citizen Petition Supplemental Materials,'' sent to the Division of
Dockets Management (now the Dockets Management Staff), Food and Drug
Administration, dated May 23, 2024 (``Supplemental Materials''). The
petitioners also noted that the average Brix level continued to fall in
2022-2023 with an average Brix level of 9.7[deg] due to tree stress
caused by weather and disease pressures (Supplemental Materials at
Appendix 2). The petitioners urged FDA to take swift action to amend
the SOI for POJ by lowering the minimum Brix level from 10.5[deg] to
10[deg] (Supplemental Materials at page 1).
We received another citizen petition, jointly submitted from
Florida Department of Citrus, Florida Citrus Processors Association,
Florida Citrus Mutual and the Juice Products Association, regarding
SOIs for orange juice and orange juice products (Docket No. FDA-2023-P-
5063) on November 15, 2023, for which most of the requests are outside
the scope of this rulemaking. However, one request is relevant to the
POJ SOI. The POJ standard in Sec. 146.140(a currently provides for a
maximum allowable percentage of Citrus reticulata (i.e., mandarin or
tangerine oranges) or Citrus reticulata hybrids juice of not more than
10 percent by volume. The request seeks to increase the maximum
allowable percentage from 10 percent to 15 percent. The petition states
that, ``Increasing the permitted percentage of juices from tangelos and
tangerines would contribute to a better balancing of juice from oranges
in diminishing supply and juice from oranges where there is a
surplus.'' The petition cited a 2021 study conducted by University of
Florida Institute of Food and Agricultural Sciences Citrus Research and
Education Center that found orange juice and Sugar Belle[supreg] blends
at 50-50% levels performed better in sensory evaluation than pure
orange juice. The study further noted that ``consumer acceptance of the
OJ label revealed that adding up to 30% tangerine juice to OJ might
still be considered OJ by most consumers, providing an initial guide
for citrus legislation to loosen the regulation on the content of
tangerine juice blended with 0J.'' While the proposed rule does not
propose increasing the maximum allowable percentage of Citrus
reticulata or Citrus reticulata hybrids juice because we do not know
the potential impacts of such a change on POJ, in section VI. of this
proposed rule, we invite comments about increasing the maximum
allowable percentage of Citrus reticulata or Citrus reticulata hybrids
in Sec. 146.140(a).

B. History of the Rulemaking

FDA published a final order establishing SOIs for orange juice and
orange juice products, including POJ, in 1963 (28 FR 10900, October 11,
1963). The final order contained various findings of fact, first being
that ``[t]he

[[Page 37820]]

food commonly and usually known as orange juice is the natural liquid
that is squeezed from mature oranges'' (28 FR 10900 at 10901). The
order found that a new product had been developed that was heat-treated
and that the name of this product is pasteurized orange juice (28 FR
10900 at 10901 through 10902). In establishing minimum composition
requirements for this product, the record supported a minimum orange
juice soluble solids of not less than 10.5[deg] Brix. Specifically,
Florida was the dominant supplier of orange juice at the time, so we
looked to the characteristics of Florida oranges (See 28 FR 10900 at
10905). The final order further stated that when fruit of low Brix is
used in the manufacture of POJ, the Brix level may be adjusted by
adding frozen single strength juice or orange juice concentrate, the
latter being limited to one-fourth of the total orange juice solids (28
FR 10900 at 10902). The standard of identity permitted frozen
concentrated orange juice (as specified in Sec. 146.146) and
concentrated orange juice for manufacturing (as specified in Sec.
146.153) when made from mature oranges as optional concentrated orange
juice ingredients (28 FR 10900 at 10906).

C. Need for the Regulation

Section 401 of the FD&C Act permits us to establish a reasonable
definition and standard of identity when such action will promote
honesty and fair dealing in the interest of consumers. The Brix level
of expressed juice, in contrast to concentrated juice, is subject to
the vagaries of nature and therefore has a naturally occurring range
beyond the manufacturer's control (see 58 FR 2897 at 2906). As such, a
reasonable definition and standard of identity for POJ should take this
circumstance into consideration. We recognize that citrus greening
disease has caused damage to Florida's orange crop and to much of the
orange crop of the United States. See USDA APHIS, ``Citrus Greening and
Asian Citrus Psyllid,'' at https://www.aphis.usda.gov/plant-pests-diseases/citrus-diseases/citrus-greening-and-asian-citrus-psyllid. We
also acknowledge that until a treatment is found to prevent or cure
citrus greening disease, it is unlikely that the orange crop will
recover and that the Brix level of juice from oranges will return to
levels previously seen. The data submitted by the petitioners
demonstrates that the Brix value of Florida oranges has been decreasing
since 2010-2011, and a minimum Brix of 10.0[deg] for POJ appears to be
a reasonable level based on information submitted by the petitioners
showing the historical seasonal Brix levels decreasing by year
(Supplemental Materials at Appendix 2).
We have also considered whether amending the SOI for POJ would
promote honesty and fair dealing in the interest of consumers. Although
the SOI for POJ permits the addition of concentrated orange juice to
raise the Brix level, some modern-day consumers may prefer POJ that is
made from only expressed juice rather than from added concentrated
juice. The petitioners assert that ``not from concentrate'' orange
juice has become the most popular orange juice form. Since the SOI for
POJ was established, consumers have come to prefer 100% juice, and
labeling requirements have been established to inform consumers whether
juice products are from concentrate (see 21 CFR 101.30(b)(3), (i), and
102.33(g)). Lowering the minimum Brix to 10.0[deg] may prevent the
addition of concentrated orange juice ingredients because they would
not be needed to meet this minimum.
We further note that, as asserted by the petitioners and in
comments submitted to the RFI we reviewed, lowering the minimum Brix
from 10.5[deg] to 10.0[deg] is unlikely to affect the taste of POJ.
Nutrition labels for POJ provided by the petitioners show that a
serving (8 oz) of orange juice with a Brix of 10.5[deg] has 18 grams of
sugar, whereas a serving of orange juice with a Brix of 10.0[deg] has
17 grams of sugar. Thus, lowering the minimum Brix of POJ, as proposed
in this rule, would result in one gram difference in sugar content per
serving. Moreover, data submitted by the petitioners indicates that a
change in Brix from 10.5[deg] to 10.0[deg] has a minimal impact on the
nutrient levels in orange juice.
Based on this information, we tentatively conclude that amending
the SOI for POJ to permit a minimum Brix of 10.0[deg] is reasonable and
will promote honesty and fair dealing in the interest of consumers.
Because the Brix value is a minimum value, orange juice processors may
produce POJ with higher Brix. The proposed rule would lower the minimum
Brix, thereby permitting more flexibility in the range of orange juice
that can be used in the manufacture of POJ.
Pending issuance of a final rule amending the SOI for POJ or a
response to the 2022 citizen petition in accordance with 21 CFR
10.30(e)(2), FDA intends to consider the exercise of enforcement
discretion when POJ is manufactured with a Brix from 10.0[deg] to
10.5[deg] and is otherwise in compliance with Sec. 146.140.

III. Legal Authority

We are issuing this proposed rule consistent with our authority in
sections 401 and 701 of the FD&C Act (21 U.S.C. 341, 371). Section 401
of the FD&C Act permits us to promulgate regulations establishing for
foods a reasonable definition and standard of identity to promote
honesty and fair dealing in the interest of consumers.

IV. Description of the Proposed Rule

A. Scope/Applicability

The proposed rule, if finalized, would amend the SOI for POJ in
Sec. 146.140. Our regulation, at Sec. 146.140(a), requires a minimum
orange juice soluble solids content of 10.5[deg] Brix for POJ. The
proposed rule would lower the minimum orange juice soluble solids
content from 10.5[deg] to 10[deg] Brix.

B. Amending the Standard of Identity Regulation To Reduce the Minimum
Brix Level

The proposed rule, if finalized, would amend Sec. 146.140(a) to
allow the manufacture of POJ with a lower soluble solids content, which
in turn impacts sugar content. The sugar content is reduced by 1 gram
per serving (8 oz) when the Brix level of POJ decreases from 10.5[deg]
to 10[deg]. This change is expected to have insignificant impact on
taste and flavor and may facilitate the manufacture of POJ without
added concentrated orange juice ingredients. The proposed rule reflects
FDA's efforts to update and modernize food standards by aligning the
standard with current crop properties and providing greater production
flexibility, while maintaining the basic nature and essential
characteristics of standardized foods. We tentatively conclude that
this action would promote honesty and fair dealing in the interest of
consumers.
This proposed rule, if finalized as proposed, is expected to be an
E.O. 14192 deregulatory action.

V. Proposed Effective and/or Compliance Date(s)

We propose that any final rule that may result from this rulemaking
become effective 30 days after its publication in the Federal Register.
The final rule would apply to POJ products produced or delivered for
introduction into interstate commence on or after the effective date.
We propose that the compliance date for any final rule that may result
from this rulemaking be 30 days after its publication in the Federal
Register.

[[Page 37821]]

VI. Questions About POJ SOI

The petitioners requested that we amend the SOI for POJ to lower
the minimum Brix level to 10[deg] (Petition at page 2). The proposed
standard was published when Florida oranges, the dominant supplier, had
an average Brix level of 11.8[deg] and FDA published the SOI with a
minimum Brix level of 10.5[deg] (28 FR 10905). Currently, we understand
that Brix level has been declining over the past few decades, making it
challenging for manufacturers to meet the current minimum Brix level of
10.5[deg] (Petition at pages 3-4).
Thus, in addition, we invite comment on whether the minimum Brix
level requirement should be further reduced or removed entirely from
the SOI for POJ due to the steadily declining Brix levels. Would
removal of a minimum Brix requirement better promote honesty and fair
dealing in the interest of consumers while supporting innovation?
Specifically, would it result in products that continue to meet
consumers expectations about POJ? Please explain your answers and
provide references and data that support your explanation, if possible.
We also invite comment on whether the SOI for POJ should be revoked
so that manufacturers have more flexibility in POJ production. This
would result in POJ being a nonstandardized food, similar to other
juices such as apple, grape, and cranberry juices. Is the SOI for POJ
no longer necessary to promote honesty and fair dealing in the interest
of consumers such that it should be revoked? Please explain your
answers and provide references and data that supports your explanation,
if possible.
As mentioned in section II.A, we received a citizen petition
requesting that we increase the maximum allowable amount of unfermented
juice that can be obtained from mature oranges of the species Citrus
reticulata or Citrus reticulata hybrids from 10 percent by volume to 15
percent by volume of the unfermented juice (see Sec. 146.140(a)). We
understand from industry that Citrus reticulata is sweeter than Citrus
sinensis and thus has a higher Brix value. Increasing the maximum
allowable amount of juice from Citrus reticulata to 15 percent by
volume could help increase the overall Brix value of POJ. We invite
comment on the acceptability of increasing the maximum allowable amount
of unfermented juice from Citrus reticulata or Citrus reticulata
hybrids from 10% to 15% by volume in Sec. 146.140(a). If such change
were made, would the essential characteristics of POJ be preserved?
Please explain and provide any data or factual information.

VII. Preliminary Economic Analysis of Impacts

We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 14192, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866 and 13563 direct us to assess all benefits,
costs, and transfers of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits. 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.'' The Office of
Information and Regulatory Affairs (OIRA) has determined that this
proposed rule is a significant regulatory action under Executive Order
12866. This proposed rule, if finalized as proposed, is expected to be
an Executive Order 14192 deregulatory action.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because we tentatively conclude that this proposed rule, if
finalized, would not generate compliance costs to industry, 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 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 proposed rule would not result in an
expenditure in any year that meets or exceeds this amount.
The proposed rule, if finalized, would not require firms in the POJ
industry to change their manufacturing practices or behavior in any
way. As a result, we tentatively conclude that there would be no
compliance costs associated with the proposed rule. The proposed rule
would allow additional flexibility for, and the opportunity for
innovation regarding, POJ, providing benefits to industry without
harming consumers. Manufacturers may experience cost savings if they
are able to avoid blending single strength orange juice with higher
Brix or orange juice concentrate, or if they are able to substitute
cheaper inputs into the manufacturing process, such as using cheaper
local lower-Brix oranges that previously would not have been used to
meet the SOI. We note specifically that the proposed rule does not
require any behavioral changes on the part of manufacturers, as it
provides manufacturers with greater flexibility rather than imposing
any restrictions. The proposed changes would provide for a wider range
of products to be marketed as POJ. No changes would be required for
products that already meet the existing POJ standard. Therefore, any
changes made by manufacturers of POJ would be voluntary.
Our primary estimate of cost savings experienced by manufacturers
is -$52.3 million, annualized at 7% over 10 years; this primary
estimate is -$52.5 million, annualized at 3% over 10 years. Therefore,
we tentatively conclude that the proposed rule to amend the SOI for
POJ, if finalized, is a deregulatory action under Executive Order
14192. Table 1 provides a summary of the benefits and costs associated
with the proposed rule. We request comment on our described benefits
and costs of the proposed rule.

[[Page 37822]]

Monetized $millions/year.................. 0 0 0 2024 3 10 ................................
Annualized................................ .......... .......... .......... .......... 7 .......... ................................
Quantified................................ .......... .......... .......... .......... 3 .......... ................................
---------------------------------------------------------------------------------------------------------
Qualitative............................... .......... .......... .......... .......... .......... 10 Benefits include additional
flexibility for firms in
production and innovation
---------------------------------------------------------------------------------------------------------
Costs:
Annualized................................ -52.3 -14.7 -106.7 2024 7 10 ................................
Monetized $millions/year.................. -52.5 -14.8 -107.0 2024 3 10 ................................
Annualized................................ .......... .......... .......... .......... 7 .......... ................................
Quantified................................ .......... .......... .......... .......... 3 .......... ................................
---------------------------------------------------------------------------------------------------------
Qualitative...............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal................................... .......... .......... .......... .......... 7 .......... ................................
Annualized................................ .......... .......... .......... .......... 3 .......... ................................
Monetized $millions/year.................. .......... .......... .......... .......... .......... .......... ................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To................................... From:
To:
---------------------------------------------------------------------------------------------------------
Other..................................... .......... .......... .......... .......... 7 .......... ................................
Annualized................................ .......... .......... .......... .......... 3 .......... ................................
Monetized $millions/year.................. .......... .......... .......... .......... .......... ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To................................... From:
To:
---------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None...
Small Business: None......................
Wages: None...............................
Growth: None..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------

In line with Executive Order 14192, in Table 2 we estimate present
and annualized values of costs, cost savings, and net costs over an
infinite time horizon, assuming 1% annual growth in cost savings
corresponding to 1% annual growth of POJ market in perpetuity.

Table 2--E.O. 14192 Summary Table
[Millions of 2024 dollars, discounted over an infinite time horizon at a
7 percent discount rate]
------------------------------------------------------------------------
Primary estimate
------------------------------------------------------------------------
Present Value of Costs.............................. $0
Present Value of Cost Savings....................... -732.0
Present Value of Net Costs.......................... -732.0
Annualized Costs.................................... 0
Annualized Cost Savings............................. -51.2
Annualized Net Costs................................ -51.2
------------------------------------------------------------------------

The proposed rule, if finalized, would not require firms in the POJ
industry to change their manufacturing practices or behavior in any
way. As a result, we tentatively conclude that there would be no
compliance costs associated with the proposed rule. The proposed rule
would allow additional flexibility for, and the opportunity for
innovation regarding, POJ, providing benefits to industry without
harming consumers. Manufacturers may experience cost savings if they
are able to avoid blending single strength orange juice with higher
Brix or orange juice concentrate, or if they are able to substitute
cheaper inputs into the manufacturing process, such as using cheaper
local lower-Brix oranges that previously would not have been used to
meet the SOI. Our primary estimate of cost savings experienced by
manufacturers is -$52.3 million, annualized at 7% over 10 years; this
primary estimate is -$52.5 million, annualized at 3% over 10 years.
Therefore, we tentatively conclude that the proposed rule to amend the
SOI for POJ, if finalized, is a deregulatory action under Executive
Order 14192. Table 1 provides a summary of the benefits and costs
associated with the proposed rule. We request comment on our described
benefits and costs of the proposed rule.

[[Page 37823]]

Table 1--Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
[Millions of 2024 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized................................ $0 $0 $0 2024 7 10 ................................
Monetized $millions/year.................. 0 0 0 2024 3 10 ................................
Annualized................................ .......... .......... .......... .......... 7 .......... ................................
Quantified................................ .......... .......... .......... .......... 3 .......... ................................
---------------------------------------------------------------------------------------------------------
Qualitative............................... .......... .......... .......... .......... .......... 10 Benefits include additional
flexibility for firms in
production and innovation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized................................ -52.3 -14.7 -106.7 2024 7 10 ................................
Monetized $millions/year.................. -52.5 -14.8 -107.0 2024 3 10 ................................
Annualized................................ .......... .......... .......... .......... 7 .......... ................................
Quantified................................ .......... .......... .......... .......... 3 .......... ................................
---------------------------------------------------------------------------------------------------------
Qualitative...............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal................................... .......... .......... .......... .......... 7 .......... ................................
Annualized................................ .......... .......... .......... .......... 3 .......... ................................
Monetized $millions/year.................. .......... .......... .......... .......... .......... .......... ................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To................................... From:
To:
---------------------------------------------------------------------------------------------------------
Other..................................... .......... .......... .......... .......... 7 .......... ................................
Annualized................................ .......... .......... .......... .......... 3 .......... ................................
Monetized $millions/year.................. .......... .......... .......... .......... .......... .......... ................................
---------------------------------------------------------------------------------------------------------
From/To................................... From:
To:
---------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None...
Small Business: None......................
Wages: None...............................
Growth: None..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------

In line with Executive Order 14192, in 2 we estimate present and
annualized values of costs, cost savings, and net costs over an
infinite time horizon.

Table 2--E.O. 14192 Summary Table
[Millions of 2024 dollars, discounted over an infinite time horizon at a 7 percent discount rate]
----------------------------------------------------------------------------------------------------------------
Primary estimate Low estimate High estimate
----------------------------------------------------------------------------------------------------------------
Present Value of Costs................................. $0 $0 $0
Present Value of Cost Savings.......................... -320.9 -90.3 -654.0
Present Value of Net Costs............................. -320.9 -90.3 -654.0
Annualized Costs....................................... 0 0 0
Annualized Cost Savings................................ -22.5 -6.3 -45.8
Annualized Net Costs................................... -22.5 -6.3 -45.8
----------------------------------------------------------------------------------------------------------------

We request comment on our described benefits and costs of the
proposed rule. We have developed a full Preliminary Economic Analysis
of Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 2) and at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

VIII. Analysis of Environmental Impact

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

IX. Paperwork Reduction Act of 1995

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 is not required.

X. Federalism

We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
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

[[Page 37824]]

implications as defined in the Executive Order and, consequently, a
federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

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

XII. References

The following references are on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov and at the
website address provided below. FDA has verified the website addresses
as of the date this document publishes in the Federal Register, but
websites are subject to change over time.

1. U.S. Department of Agriculture. ``United States Standards for
Grades of Orange Juice, January 10, 1983''. https://www.ams.usda.gov/sites/default/files/media/Canned_Orange_Juice_Standard%5B1%5D.pdf.
2. Food Standards of Identity Modernization; Pasteurized Orange
Juice; Proposed Rule, Docket No. FDA-2022-P-1668, Preliminary
Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis,
Unfunded Mandates Reform Act Analysis. https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

List of Subjects in 21 CFR Part 146

Food grades and standards, Fruit juices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, we propose
that 21 CFR part 146 be amended as follows:

PART 146--CANNED FRUIT JUICES

0
1. The authority citation for part 146 continues to read as follows:

Authority: 21 U.S.C. 341, 371.
0
2. In Sec. 146.140, revise paragraph (a) by replacing ``10.5 percent
by weight'' to read as ``10 percent by weight.''
* * * * *

Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-14949 Filed 8-5-25; 8:45 am]
BILLING CODE 4164-01-P