
[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]


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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.

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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


