Proposed Rule2023-17453
Food Standards of Identity Modernization; Pasteurized Orange Juice; Request for Information
Primary source
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Published
August 16, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 157 (Wednesday, August 16, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: 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
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