Food Standards of Identity Modernization; Pasteurized Orange Juice; Request for Information, 55607-55610 [2023-17453]
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Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Proposed Rules
the docket unchanged. Because your
comment will be made public, you are
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comment does not include any
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comments, that information will be
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• If you want to submit a comment
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Register.
Authority: 52 U.S.C. 30108, 30111(a)(8).
Dated: August 10, 2023.
On behalf of the Commission,
Dara S. Lindenbaum,
Chair, Federal Election Commission.
[FR Doc. 2023–17547 Filed 8–15–23; 8:45 am]
BILLING CODE 6715–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 146
[Docket No. FDA–2023–N–2632]
Food Standards of Identity
Modernization; Pasteurized Orange
Juice; Request for Information
Food and Drug Administration,
Department of Health and Human
Services.
ACTION: Petition for rulemaking; request
for information.
AGENCY:
The Food and Drug
Administration (FDA or we) is
announcing that the Florida Citrus
Processors Association (FCPA) and
Florida Citrus Mutual (FCM) have filed
a citizen petition requesting that we
amend the standard of identity (SOI) for
pasteurized orange juice (POJ) by
adjusting the minimum soluble solids
content from 10.5° to 10° Brix. We are
issuing this document to request
comments, data, and information about
the issues presented in the petition.
DATES: Submit either electronic or
written comments and scientific data
and information by October 16, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
October 16, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
SUMMARY:
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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
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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–
2023–N–2632 for ‘‘Food Standards of
Identity Modernization; Pasteurized
Orange Juice; Request for Information.’’
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
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55607
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-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to 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, Center for Food Safety
and Applied Nutrition, Office of
Nutrition and Food Labeling (HFS–800),
Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,
240–402–2371; or Philip L. Chao, Center
for Food Safety and Applied Nutrition,
Office of Regulations and Policy (HFS–
024), Food and Drug Administration,
5001 Campus Dr., College Park, MD
20740, 240–402–2378.
SUPPLEMENTARY INFORMATION:
I. FCPA and FCM Petition
The SOI for POJ requires that the
product contains not less than 10.5
percent by weight of orange juice
soluble solids (also expressed as degree
Brix), 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 (§ 146.140(a) (21 CFR
146.140(a)). The Brix level expresses the
percentage of orange juice solids present
in a product. The SOI for POJ allows for
the addition of concentrated orange
juice ingredients and certain optional
sweetening ingredients to adjust the
Brix (§ 146.140(b) and (c)), provided that
the label of POJ bears a statement that
the concentrated orange juice ingredient
or optional sweetening ingredient has
been added (§ 146.140(e)(1) and (2)).
Under this standard, the ‘‘optional
sweetening ingredients’’ (or
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‘‘sweeteners’’) are sugar, invert sugar,
dextrose, dried corn sirup, and dried
glucose sirup (§ 146.140(c)).
The FCPA and FCM jointly submitted
a citizen petition (Docket No. FDA–
2022–P–1668) on July 25, 2022, asking
us to amend the SOI for POJ to reduce
the minimum soluble solids
requirement for POJ from 10.5° to 10°
Brix, exclusive of the solids from any
added optional sweetening ingredients.
See Citizen Petition from 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
called the Dockets Management Staff),
Food and Drug Administration, dated
July 22, 2022 (‘‘Petition’’). The FCPA
and FCM 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 of 11.8°. The petitioners
asserted that, based on the fruits used in
preparing POJ at that time, FDA set a
minimum Brix value of 10.5° for the POJ
standard (Petition at page 3).
The FCPA and FCM stated that
Florida’s average Brix level has steadily
dropped over the past couple of decades
due to a bacterial disease called ‘‘citrus
greening disease,’’ also known as
Huanglongbing (id.). (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
mottle leaves, stunted grown, reduced
fruit size, premature fruit drop, corky
veins, and root decline, and the disease
eventually causes tree death. See USDA
APHIS, ‘‘Citrus Greening,’’ at https://
www.aphis.usda.gov/aphis/ourfocus/
planthealth/plant-pest-and-diseaseprograms/pests-and-diseases/citrus/
citrus-greening#:∼:text=Huanglongbing
%20(HLB)%2C%20also
%20known,when%20feeding%20on
%20new%20shoots). There is no cure
for citrus greening disease. The FCPA
and FCM also maintained that severe
weather, particularly Hurricane Irma in
2017, has resulted in reduced
production of oranges and normal fruit
sugar content (Petition at pages 3 to 4).
The FCPA and FCM stated that, due to
these factors, seasonal average Brix
values (weighted by volume) are
hovering below the minimum of 10.5°
Brix (Petition at page 4). The FCPA and
FCM stated that the POJ SOI was
carefully constructed to reflect the
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qualities of U.S. oranges, and asserted
that it should now be updated to align
with the properties of the modern U.S.
crop (Petition at page 5).
The FCPA and FCM noted that the
POJ SOI sets specific requirements for
juice content and labeling, including a
minimum fruit sugar level (Petition at
page 3). The FCPA and FCM stated that
most fruit juices, albeit many of which
have a relatively lower volume of sales,
have no U.S. standards and that this
regulatory discrepancy further
emphasizes the need to amend the
orange juice SOI to keep pace with
modern scientific understanding and
naturally occurring dynamics impacting
product production (Petition at page 7).
The FCPA and FCM asserted that
without such an update, POJ products
will be further disadvantaged in the
market (id.).
The FCPA and FCM maintained that
the SOIs for various orange juice
products are intended to serve the
interest of consumers and the POJ
standard established POJ as a highquality and minimally processed juice
that is heat-treated to eliminate
potentially harmful pathogens and is
not concentrated or reconstituted with
added water (Petition at page 3). They
asserted that consumers widely
understand POJ to be natural, not from
concentrate juice made from mature
Florida oranges (Petition at page 5),
although they did not provide
information demonstrating this
consumer understanding.
The Petition included the results of a
consumer survey to assess orange juice
and consumer ‘‘willingness to buy’’
orange juice with varying levels of
sweetness under hypothetical settings
which was conducted online among a
total of 1,027 adult men and women,
aged 18 to 69 years old, who consume
100 percent fruit juice at least once in
a typical 2-week period (Petition at
Appendix 4). From this consumer
survey, the FCPA and FCM concluded
that 96 percent of the consumers in the
study accepted the idea that a natural
product, like orange juice, could have
varying levels of sweetness (Petition at
page 6). The FCPA and FCM also noted
that 95 percent of those surveyed agreed
that orange juice with less sugar should
still be called orange juice, and 76
percent claimed they would have no
concerns with a less sweet orange juice
(id.). The petitioners did not provide
information on how these general
statements and preferences relate to the
Brix level for POJ.
The FCPA and FCM stated that the
10° minimum Brix level they request for
POJ is consistent with the minimum
Brix level of 10° for the SOI for canned
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orange juice specified in 21 CFR
146.141 (Petition at page 6). The FCPA
and FCM also asserted that the 10° Brix
level would be consistent with the
applicable Codex General Standard for
Juices and Nectars, which has no
minimum but allows for Brix for notfrom-concentrate POJ to be at the Brix
level of the fruit from which the juice
is directly expressed (id.). They also
noted that the European Fruit Juice
Directive incorporates a 10° minimum
Brix, established by the European Fruit
Juice industry in the AIJN Code of
Practice (id.). The FCPA and FCM stated
that the proposed minimum Brix
decrease would help to bring the POJ
standard into alignment with these
international food standards (Petition at
pages 6 to 7).
Finally, the FCPA and FCM
maintained that a temporary marketing
permit (TMP) under § 130.17 (21 CFR
130.17) for POJ with a lower Brix level
would not be a viable option, due to the
overwhelming presence of low-Brix
orange juice crops in recent years,
because it would be burdensome for
manufacturers to make labeling changes
and add stock keeping units for the
lower-Brix products and could cause
consumer confusion (Petition at page 5).
No information was provided on
consumer understanding.
II. Summary of the 1963 Final Order
As noted above, FDA published a
final order establishing SOIs for certain
orange juice products, including POJ, in
1963. The final order contained various
findings of fact, including a statement
that ‘‘Florida orange juices available for
processing’’ had an approximate average
Brix level of 11.8° at the time (28 FR
10900 at 10905). While the FCPA and
FCM maintained that this Brix value of
11.8° was used to set the standard for
POJ (Petition at page 3), we clarify that
FDA recognized this value in the
context of the reconstituted orange juice
standard, with FDA setting a minimum
Brix of 11.8° in its standard for
reconstituted orange juice (28 FR 10900
at 10906). By contrast, for POJ, FDA set
a minimum Brix of 10.5°, recognizing
that ‘‘the juice of many legally mature
oranges that come on the market would
not meet [a Brix of 10.5°]’’ and stating
that producers could add frozen singlestrength juice or orange juice
concentrate to achieve a higher Brix
level (28 FR 10900 at 10902). On the
basis of these and other facts and
evidence, FDA established SOIs for
orange juice and various orange juice
products.
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We invite interested persons to
submit comments, data, and information
concerning the need for, and the
appropriateness of, amending the SOI
for POJ. We especially invite comment
and supporting data, as appropriate, on
the following matters:
1. The SOI for POJ requires that the
product contains not less than 10.5
percent by weight of orange juice
soluble solids (that is, the Brix level),
exclusive of the solids of any added
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optional sweetening ingredients
(§ 146.140(a)). Would amending the SOI
for POJ from 10.5 to 10 percent by
weight of orange juice soluble solids
continue to promote honesty and fair
dealing in the interest of consumers?
Specifically, would such an amendment
result in products that are inconsistent
with consumer expectations about POJ?
The petitioners noted that POJ with a
lower Brix has less sugar—specifically,
when Brix value is lowered from 10.5°
to 10.25° or 10°, the sugar content is
reduced from 18 grams to 17 grams per
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8 oz of product (see Petition at
Appendix 4, page 19). Would POJ
products with a Brix level between 10°
and 10.5° taste less sweet or have less
orange flavor such that consumers
would not accept them? Please explain
your reasoning.
2. Below are the Nutrition Facts labels
for the POJ with different Brix levels
provided by the petitioners (id.). From
left to right are labels for product with
10.5° Brix, 10.25° Brix, and 10.0° Brix.
BILLING CODE 4164–01–P
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III. Request for Comments
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If the SOI for POJ is amended in the
manner as requested in the petition,
there may also be some nutritional
changes to POJ. Specifically, the
Nutrition Fact labels provided by the
petitioners show that several nutrients,
such as potassium, folate, and vitamin
C, would change with the Brix. Would
such products have lower levels of
certain nutrients than POJ under the
current SOI? If so, would such decreases
in nutrient levels lead consumers to not
accept such products? Would
consumers be willing to accept POJ with
differing amounts of certain nutrients?
Would it depend on the specific type of
nutrient? Please be specific and explain
your reasoning. Would it depend on the
amount the nutrient declaration was
changed? Please be specific about what
(if any amount) would be acceptable at
either a higher or lower level of what is
currently declared for POJ.
3. Orange juice that does not meet the
minimum Brix of 10.5° in the SOI may,
under § 146.140(a) and (b), be blended
with one or more of the optional
concentrated orange juice ingredients
(which would be labeled as specified in
§ 146.140(e)(1)) or with a higher-Brix
POJ to meet the 10.5° Brix minimum.
(a) Would the use of concentrated
orange juice ingredients impact
consumers’ decisions to purchase or
consume POJ products? What if
concentrated orange juice ingredients
only contribute one-fourth of the total
orange juice solids in the finished
product, as currently specified by the
SOI (§ 146.140(b))? Do consumers
expect that POJ is produced entirely
from non-concentrate orange juice?
Please explain your reasoning.
(b) Oranges from other countries and
states may be used to produce POJ with
a higher Brix. Would the use of orange
juice from other countries or other states
impact consumers’ decisions to
purchase or consume POJ products?
Please explain your reasoning.
4. Would orange juice producers
apply for a TMP under § 130.17 to
market POJ with Brix levels between 10°
and 10.5° in order to gather data on
consumers’ expectations and acceptance
of POJ with Brix levels in this range? If
orange producers would not apply for
such a TMP, please explain why. To
satisfy the labeling provision under
§ 130.17(c)(9), would labeling POJ with
Brix in this range as having lower Brix
or lower sugar be feasible? Please
explain why or why not. Is there
another way that POJ with Brix between
10° and 10.5° could be labeled if it were
market-tested under a TMP? If so, please
explain how it could be labeled.
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Authority: 21 U.S.C. 321, 341, 343, 348,
371, 379e.
Dated: August 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17453 Filed 8–15–23; 8:45 am]
BILLING CODE 4164–01–C
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 147
[EPA–HQ–OW–2023–0073; FRL 9916–03–
OW]
State of Louisiana Underground
Injection Control Program; Class VI
Program Revision Application; Notice
of Availability of New Information
Environmental Protection
Agency (EPA).
ACTION: Notice of availability; request
for comment.
AGENCY:
This document supplements
the proposed ‘‘State of Louisiana
Underground Injection Control Program;
Class VI Program Revision Application’’
rule of May 4, 2023, to approve a
revision to the State’s Safe Drinking
Water Act (SDWA) section 1422 UIC
program to include Class VI injection
well primary enforcement responsibility
(primacy). On June 30, 2023, the
Louisiana Department of Natural
Resources (LDNR) supplemented its
Class VI primacy application to include
Act No. 378 (HB 571), which revised
portions of Louisiana law relevant to
LDNR’s application. On June 14, 2023,
Act No. 378 was signed into law and
went into effect during the comment
period for EPA’s proposal. This
document presents and requests public
comment on LDNR’s supplement to its
application, which was not available in
the docket EPA–HQ–OW–2023–0073 at
the time of the Environmental
Protection Agency’s (EPA) May 4, 2023,
proposal.
DATES: Comments must be received on
or before September 15, 2023.
ADDRESSES: You may send comments,
identified by Docket ID No. EPA–HQ–
OW–2023–0073, by any of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov/ (our
preferred method). Follow the online
instructions for submitting comments.
• Mail: U.S. Environmental
Protection Agency, EPA Docket Center,
Water Docket, Mail Code 28221T, 1200
Pennsylvania Avenue NW, Washington,
DC 20460.
• Hand Delivery or Courier: EPA
Docket Center, WJC West Building,
SUMMARY:
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Room 3334, 1301 Constitution Avenue
NW, Washington, DC 20004. The Docket
Center’s hours of operations are 8:30
a.m.–4:30 p.m., Monday–Friday (except
Federal Holidays).
Instructions: All submissions received
must include the Docket ID No. for this
rulemaking. Comments received may be
posted without change to https://
www.regulations.gov/, including any
personal information provided. For
detailed instructions on sending
comments and additional information
on the rulemaking process, see the
‘‘Public Participation’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
Suzanne Kelly, Drinking Water
Infrastructure Development Division,
Office of Ground Water and Drinking
Water (4606M), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460;
telephone number: (202) 564–3887; or
Lisa Pham, U.S. EPA Region 6,
Groundwater/UIC Section (Mail code
WDDG), 1201 Elm Street, Suite 500,
Dallas, Texas 75720–2102; telephone
number: (214) 665–8326. Both can be
reached by emailing: LAClassVINOA@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. Public Participation
A. Written Comments
Submit your comments, identified by
Docket ID No. EPA–HQ–OW–2023–
0073, at https://www.regulations.gov
(our preferred method), or the other
methods identified in the ADDRESSES
section. Once submitted, comments
cannot be edited or removed from the
docket. The EPA may publish any
comment received to its public docket.
Do not submit to EPA’s docket at
https://www.regulations.gov any
information you consider to be
Confidential Business Information (CBI),
Proprietary Business Information (PBI),
or other information whose disclosure is
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submit CBI, contact Lisa Pham, contact
information available in the FOR
FURTHER INFORMATION CONTACT section.
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primary submission (i.e., on the web,
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Please visit https://www.epa.gov/
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Agencies
[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Proposed Rules]
[Pages 55607-55610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17453]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 146
[Docket No. FDA-2023-N-2632]
Food Standards of Identity Modernization; Pasteurized Orange
Juice; Request for Information
AGENCY: Food and Drug Administration, Department of Health and Human
Services.
ACTION: Petition for rulemaking; request for information.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that the Florida Citrus Processors Association (FCPA) and Florida
Citrus Mutual (FCM) have filed a citizen petition requesting that we
amend the standard of identity (SOI) for pasteurized orange juice (POJ)
by adjusting the minimum soluble solids content from 10.5[deg] to
10[deg] Brix. We are issuing this document to request comments, data,
and information about the issues presented in the petition.
DATES: Submit either electronic or written comments and scientific data
and information by October 16, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 16, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: 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-2023-N-2632 for ``Food Standards of Identity Modernization;
Pasteurized Orange Juice; Request for Information.'' 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 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, Center for Food
Safety and Applied Nutrition, Office of Nutrition and Food Labeling
(HFS-800), Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2371; or Philip L. Chao, Center for Food Safety and
Applied Nutrition, Office of Regulations and Policy (HFS-024), Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2378.
SUPPLEMENTARY INFORMATION:
I. FCPA and FCM Petition
The SOI for POJ requires that the product contains not less than
10.5 percent by weight of orange juice soluble solids (also expressed
as degree Brix), 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 (Sec. 146.140(a) (21 CFR 146.140(a)). The Brix level
expresses the percentage of orange juice solids present in a product.
The SOI for POJ allows for the addition of concentrated orange juice
ingredients and certain optional sweetening ingredients to adjust the
Brix (Sec. 146.140(b) and (c)), provided that the label of POJ bears a
statement that the concentrated orange juice ingredient or optional
sweetening ingredient has been added (Sec. 146.140(e)(1) and (2)).
Under this standard, the ``optional sweetening ingredients'' (or
[[Page 55608]]
``sweeteners'') are sugar, invert sugar, dextrose, dried corn sirup,
and dried glucose sirup (Sec. 146.140(c)).
The FCPA and FCM jointly submitted a citizen petition (Docket No.
FDA-2022-P-1668) on July 25, 2022, asking us to amend the SOI for POJ
to reduce the minimum soluble solids requirement for POJ from 10.5[deg]
to 10[deg] Brix, exclusive of the solids from any added optional
sweetening ingredients. See Citizen Petition from 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 called the Dockets
Management Staff), Food and Drug Administration, dated July 22, 2022
(``Petition''). The FCPA and FCM 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 of
11.8[deg]. The petitioners asserted that, based on the fruits used in
preparing POJ at that time, FDA set a minimum Brix value of 10.5[deg]
for the POJ standard (Petition at page 3).
The FCPA and FCM stated that Florida's average Brix level has
steadily dropped over the past couple of decades due to a bacterial
disease called ``citrus greening disease,'' also known as Huanglongbing
(id.). (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 mottle
leaves, stunted grown, reduced fruit size, premature fruit drop, corky
veins, and root decline, and the disease eventually causes tree death.
See USDA APHIS, ``Citrus Greening,'' at https://www.aphis.usda.gov/
aphis/ourfocus/planthealth/plant-pest-and-disease-programs/pests-and-
diseases/citrus/citrus-
greening#:~:text=Huanglongbing%20(HLB)%2C%20also%20known,when%20feeding%
20on%20new%20shoots). There is no cure for citrus greening disease. The
FCPA and FCM also maintained that severe weather, particularly
Hurricane Irma in 2017, has resulted in reduced production of oranges
and normal fruit sugar content (Petition at pages 3 to 4). The FCPA and
FCM stated that, due to these factors, seasonal average Brix values
(weighted by volume) are hovering below the minimum of 10.5[deg] Brix
(Petition at page 4). The FCPA and FCM stated that the POJ SOI was
carefully constructed to reflect the qualities of U.S. oranges, and
asserted that it should now be updated to align with the properties of
the modern U.S. crop (Petition at page 5).
The FCPA and FCM noted that the POJ SOI sets specific requirements
for juice content and labeling, including a minimum fruit sugar level
(Petition at page 3). The FCPA and FCM stated that most fruit juices,
albeit many of which have a relatively lower volume of sales, have no
U.S. standards and that this regulatory discrepancy further emphasizes
the need to amend the orange juice SOI to keep pace with modern
scientific understanding and naturally occurring dynamics impacting
product production (Petition at page 7). The FCPA and FCM asserted that
without such an update, POJ products will be further disadvantaged in
the market (id.).
The FCPA and FCM maintained that the SOIs for various orange juice
products are intended to serve the interest of consumers and the POJ
standard established POJ as a high-quality and minimally processed
juice that is heat-treated to eliminate potentially harmful pathogens
and is not concentrated or reconstituted with added water (Petition at
page 3). They asserted that consumers widely understand POJ to be
natural, not from concentrate juice made from mature Florida oranges
(Petition at page 5), although they did not provide information
demonstrating this consumer understanding.
The Petition included the results of a consumer survey to assess
orange juice and consumer ``willingness to buy'' orange juice with
varying levels of sweetness under hypothetical settings which was
conducted online among a total of 1,027 adult men and women, aged 18 to
69 years old, who consume 100 percent fruit juice at least once in a
typical 2-week period (Petition at Appendix 4). From this consumer
survey, the FCPA and FCM concluded that 96 percent of the consumers in
the study accepted the idea that a natural product, like orange juice,
could have varying levels of sweetness (Petition at page 6). The FCPA
and FCM also noted that 95 percent of those surveyed agreed that orange
juice with less sugar should still be called orange juice, and 76
percent claimed they would have no concerns with a less sweet orange
juice (id.). The petitioners did not provide information on how these
general statements and preferences relate to the Brix level for POJ.
The FCPA and FCM stated that the 10[deg] minimum Brix level they
request for POJ is consistent with the minimum Brix level of 10[deg]
for the SOI for canned orange juice specified in 21 CFR 146.141
(Petition at page 6). The FCPA and FCM also asserted that the 10[deg]
Brix level would be consistent with the applicable Codex General
Standard for Juices and Nectars, which has no minimum but allows for
Brix for not-from-concentrate POJ to be at the Brix level of the fruit
from which the juice is directly expressed (id.). They also noted that
the European Fruit Juice Directive incorporates a 10[deg] minimum Brix,
established by the European Fruit Juice industry in the AIJN Code of
Practice (id.). The FCPA and FCM stated that the proposed minimum Brix
decrease would help to bring the POJ standard into alignment with these
international food standards (Petition at pages 6 to 7).
Finally, the FCPA and FCM maintained that a temporary marketing
permit (TMP) under Sec. 130.17 (21 CFR 130.17) for POJ with a lower
Brix level would not be a viable option, due to the overwhelming
presence of low-Brix orange juice crops in recent years, because it
would be burdensome for manufacturers to make labeling changes and add
stock keeping units for the lower-Brix products and could cause
consumer confusion (Petition at page 5). No information was provided on
consumer understanding.
II. Summary of the 1963 Final Order
As noted above, FDA published a final order establishing SOIs for
certain orange juice products, including POJ, in 1963. The final order
contained various findings of fact, including a statement that
``Florida orange juices available for processing'' had an approximate
average Brix level of 11.8[deg] at the time (28 FR 10900 at 10905).
While the FCPA and FCM maintained that this Brix value of 11.8[deg] was
used to set the standard for POJ (Petition at page 3), we clarify that
FDA recognized this value in the context of the reconstituted orange
juice standard, with FDA setting a minimum Brix of 11.8[deg] in its
standard for reconstituted orange juice (28 FR 10900 at 10906). By
contrast, for POJ, FDA set a minimum Brix of 10.5[deg], recognizing
that ``the juice of many legally mature oranges that come on the market
would not meet [a Brix of 10.5[deg]]'' and stating that producers could
add frozen single-strength juice or orange juice concentrate to achieve
a higher Brix level (28 FR 10900 at 10902). On the basis of these and
other facts and evidence, FDA established SOIs for orange juice and
various orange juice products.
[[Page 55609]]
III. Request for Comments
We invite interested persons to submit comments, data, and
information concerning the need for, and the appropriateness of,
amending the SOI for POJ. We especially invite comment and supporting
data, as appropriate, on the following matters:
1. The SOI for POJ requires that the product contains not less than
10.5 percent by weight of orange juice soluble solids (that is, the
Brix level), exclusive of the solids of any added optional sweetening
ingredients (Sec. 146.140(a)). Would amending the SOI for POJ from
10.5 to 10 percent by weight of orange juice soluble solids continue to
promote honesty and fair dealing in the interest of consumers?
Specifically, would such an amendment result in products that are
inconsistent with consumer expectations about POJ? The petitioners
noted that POJ with a lower Brix has less sugar--specifically, when
Brix value is lowered from 10.5[deg] to 10.25[deg] or 10[deg], the
sugar content is reduced from 18 grams to 17 grams per 8 oz of product
(see Petition at Appendix 4, page 19). Would POJ products with a Brix
level between 10[deg] and 10.5[deg] taste less sweet or have less
orange flavor such that consumers would not accept them? Please explain
your reasoning.
2. Below are the Nutrition Facts labels for the POJ with different
Brix levels provided by the petitioners (id.). From left to right are
labels for product with 10.5[deg] Brix, 10.25[deg] Brix, and 10.0[deg]
Brix.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TP16AU23.000
[[Page 55610]]
If the SOI for POJ is amended in the manner as requested in the
petition, there may also be some nutritional changes to POJ.
Specifically, the Nutrition Fact labels provided by the petitioners
show that several nutrients, such as potassium, folate, and vitamin C,
would change with the Brix. Would such products have lower levels of
certain nutrients than POJ under the current SOI? If so, would such
decreases in nutrient levels lead consumers to not accept such
products? Would consumers be willing to accept POJ with differing
amounts of certain nutrients? Would it depend on the specific type of
nutrient? Please be specific and explain your reasoning. Would it
depend on the amount the nutrient declaration was changed? Please be
specific about what (if any amount) would be acceptable at either a
higher or lower level of what is currently declared for POJ.
3. Orange juice that does not meet the minimum Brix of 10.5[deg] in
the SOI may, under Sec. 146.140(a) and (b), be blended with one or
more of the optional concentrated orange juice ingredients (which would
be labeled as specified in Sec. 146.140(e)(1)) or with a higher-Brix
POJ to meet the 10.5[deg] Brix minimum.
(a) Would the use of concentrated orange juice ingredients impact
consumers' decisions to purchase or consume POJ products? What if
concentrated orange juice ingredients only contribute one-fourth of the
total orange juice solids in the finished product, as currently
specified by the SOI (Sec. 146.140(b))? Do consumers expect that POJ
is produced entirely from non-concentrate orange juice? Please explain
your reasoning.
(b) Oranges from other countries and states may be used to produce
POJ with a higher Brix. Would the use of orange juice from other
countries or other states impact consumers' decisions to purchase or
consume POJ products? Please explain your reasoning.
4. Would orange juice producers apply for a TMP under Sec. 130.17
to market POJ with Brix levels between 10[deg] and 10.5[deg] in order
to gather data on consumers' expectations and acceptance of POJ with
Brix levels in this range? If orange producers would not apply for such
a TMP, please explain why. To satisfy the labeling provision under
Sec. 130.17(c)(9), would labeling POJ with Brix in this range as
having lower Brix or lower sugar be feasible? Please explain why or why
not. Is there another way that POJ with Brix between 10[deg] and
10.5[deg] could be labeled if it were market-tested under a TMP? If so,
please explain how it could be labeled.
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Dated: August 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17453 Filed 8-15-23; 8:45 am]
BILLING CODE 4164-01-C