[Federal Register Volume 88, Number 72 (Friday, April 14, 2023)]
[Rules and Regulations]
[Pages 22907-22910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07723]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 131

[Docket No. FDA-2000-P-0126 (Formerly Docket No. 2000P-0658)]


International Dairy Foods Association: Response to the Objections 
and Requests for a Public Hearing on the Final Rule To Revoke the 
Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard 
for Yogurt

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; response to objections and denial of public 
hearing requests; removal of administrative stay; final amendment.

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SUMMARY: The Food and Drug Administration (FDA or we) published

[[Page 22908]]

a final rule entitled ``Milk and Cream Products and Yogurt Products; 
Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt 
and To Amend the Standard for Yogurt,'' on June 11, 2021 (the 2021 
final rule). The International Dairy Foods Association (IDFA) objected 
to the final rule's provision that yogurt have either a titratable 
acidity of not less than 0.7 percent, expressed as lactic acid, or a pH 
of 4.6 or lower before the addition of bulky flavoring ingredients. We 
are denying IDFA's request for a public hearing with respect to this 
objection and are issuing a final order to modify the final rule's 
provision with respect to both pH and titratable acidity.

DATES: This order is effective April 14, 2023. The administrative stay 
is lifted April 14, 2023. The compliance date is May 15, 2023.

ADDRESSES: You may submit objections and requests for a hearing on new 
provisions added by this response to objections as follows. Please note 
that late, untimely filed objections 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 May 15, 2023. 
Objections 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 objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection 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 objection, that information will be 
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection 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 objections submitted to the Dockets 
Management Staff, FDA will post your objection, 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-2000-P-0126 for ``International Dairy Foods Association: Response 
to the Objections and Denial of the Requests for a Public Hearing on 
the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat 
Yogurt and To Amend the Standard for Yogurt.'' Received objections, 
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 an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections 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: Andrea Krause, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2371, or Holli Kubicki, 
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. Background

    Section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 341) directs the Secretary of Health and Human Services 
(Secretary) to issue regulations fixing and establishing for any food a 
reasonable definition and standard of identity whenever, in the 
judgment of the Secretary, such action will promote honesty and fair 
dealing in the interest of consumers. Under section 701(e)(1) of the 
FD&C Act (21 U.S.C. 371(e)(1)), any action for the amendment or repeal 
of any definition and standard of identity under section 401 of the 
FD&C Act for any dairy product (e.g., yogurt) must begin with a 
proposal made either by FDA under our own initiative or by petition of 
any interested persons.
    In the Federal Register of June 11, 2021 (86 FR 31117), we issued a 
final rule (the 2021 final rule) amending the definition and standard 
of identity for yogurt ((Sec.  131.200) (21 CFR 131.200)) and revoking 
the definitions and standards of identity for lowfat yogurt (21 CFR 
131.203) and nonfat yogurt (21 CFR 131.206). This action was in 
response, in part, to a citizen petition submitted by the National 
Yogurt Association. The final rule modernized the yogurt standard to 
allow for technological advances while promoting honesty and fair 
dealing in the interest of consumers.
    The preamble to the final rule stated that the effective date of 
the final rule would be July 12, 2021, except as to any provisions that 
may be stayed by the filing of proper objections (86 FR 31117 at 
31136). Pursuant to section 701(e) of

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the FD&C Act, the final rule notified persons who would be adversely 
affected by the final rule that they could file objections, specifying 
with particularity the provisions of the final rule deemed 
objectionable, stating the grounds therefor, and requesting a public 
hearing upon such objections. We gave interested persons until July 12, 
2021, to file objections and request a hearing on the final rule.
    The IDFA timely filed objections and requested a hearing with 
respect to several provisions in the final rule (see Objections and 
Request for Hearings submitted by Michael Dykes, DVM (IDFA objection), 
President and Chief Executive Officer, IDFA, dated July 12, 2021, to 
the Dockets Management Staff, Food and Drug Administration (Comment ID 
FDA-2000-P-0126-0109). Section 701(e)(2) of the FD&C Act provides that, 
until final action is taken by the Secretary, the filing of objections 
operates to stay the effectiveness of those provisions to which the 
objections are made.
    In the Federal Register of March 23, 2022 (87 FR 16394) we issued a 
final rule providing clarification on which provisions of the 2021 
final rule were stayed and which requirements of the previous final 
rule that we issued in 1981 (46 FR 9924) (1981 final rule) are in 
effect pending final action under section 701(e) of the FD&C Act. In 
the Federal Register of December 15, 2022 (87 FR 76559), we published a 
final rule (2022 final rule) denying IDFA's requests for a hearing with 
respect to all but one of their objections. The 2022 final rule 
provided modifications to certain provisions in the final rule and 
announced that the stay of effectiveness of provisions for which 
hearings were denied was lifted. We did not address IDFA's objection 
and request for a hearing on the provision in Sec.  131.200(a) that 
yogurt have either a titratable acidity of not less than 0.7 percent, 
expressed as lactic acid, or a pH of 4.6 or lower before the addition 
of bulky flavoring ingredients (hereinafter referred to as ``the 
acidity requirement''). We addressed this objection and request for a 
hearing in a proposed order, which we sent to IDFA under Sec.  12.24(d) 
(21 CFR 12.24(d)) and posted to the docket for public review (Document 
ID FDA-2000-P-0126-0129). FDA regulations provide that after the 
Commissioner serves a proposed order denying a hearing, a person has 30 
days after receipt of the proposed order to demonstrate that the 
submission justifies a hearing (Sec.  12.24(d)). FDA did not receive 
any response to the proposed order, and we are now issuing a final 
order denying IDFA's request for a hearing on the acidity requirement 
and amending the 2021 final rule with respect to this requirement.

II. Objection and Request for a Hearing on the Acidity Requirement

    The acidity requirement in Sec.  131.200(a) of the 2021 final rule 
is comprised of two options: yogurt must either have a minimum 
titratable acidity of 0.7 percent or a maximum pH of 4.6 before bulky 
flavoring ingredients are added. IDFA objected to both of these 
options, asserting that they are not practical and do not reflect 
consumer taste preferences or current industry practice for yogurt 
manufacturing. IDFA stated that the requirement will not promote 
honesty and fair dealing in the interest of consumers. IDFA asserted 
that the requirement should be a titratable acidity of not less than 
0.6 percent, expressed as lactic acid, measured in the white mass of 
the yogurt, or a pH of 4.6 or lower measured in the finished product 
within 24 hours after filling. IDFA requested a hearing on the 
following issues: (1) whether a requirement that titratable acidity or 
pH be reached prior to the addition of bulky flavors in the 
manufacturing process is consistent with the basic nature and essential 
characteristics of yogurt; (2) whether a requirement that prohibits 
yogurt from being filled at a pH of 4.8 or less and reaching a pH of 
4.6 or below within 24 hours after filling is consistent with the basic 
nature and essential characteristics of yogurt; and (3) whether a 
minimum titratable acidity requirement of 0.7 percent is in the 
interest of consumers and necessary to maintaining the basic nature and 
essential characteristics of yogurt.
    We are denying IDFA's request for a hearing with respect to both 
the titratable acidity minimum and pH maximum under Sec.  12.24(b)(1). 
We are modifying the 2021 final rule with respect to the pH maximum in 
accordance with IDFA's request, and we are modifying the 2021 final 
rule to eliminate the option of complying with a minimum titratable 
acidity.

A. Denial of Request for a Hearing on Maximum pH Option

    With respect to the maximum pH option, IDFA objected to requiring 
the pH to be reached prior to the addition of bulky flavoring 
ingredients and requiring the pH of 4.6 in the white mass of the yogurt 
prior to filling. IDFA explained that modifications made to the Grade 
``A'' Pasteurized Milk Ordinance (PMO) in 2007 exempted yogurt from 
certain cooling requirements based on an initial pH of 4.8 or below at 
filling and with the product reaching a pH of 4.6 or below within 24 
hours of filling. (The PMO is a model regulation intended to help 
States and municipalities initiate and maintain effective programs for 
the prevention of milk-borne disease. State and local milk control 
agencies can adopt the PMO.) IDFA stated that bulky flavoring 
ingredients such as fruits and fruit preparations are added before 
achieving the target pH (pH 4.6) and prior to filling. Before accepting 
this change in the PMO, FDA and the National Conference on Interstate 
Milk Shipments reviewed pathogen challenge study data regarding this 
manufacturing practice and concluded that exempting yogurt from the 
cooling requirements of the PMO is safe when this specific practice is 
followed. In its objection, IDFA also asserted that such products 
(manufactured with an initial pH of 4.8 or below at filling and with 
the product reaching a pH of 4.6 or below within 24 hours of filling) 
have been on the market for many years and accepted by consumers 
without deviating from the basic nature and essential characteristics 
of yogurt and maintaining honesty and fair dealing in the interest of 
consumer.
    We agree that the key safety control measure for finished yogurt is 
pH and, secondarily, temperature control (i.e., refrigeration). Also, 
the pH process described in the PMO for yogurt contains other factors 
that contribute to preventing growth of different kinds of 
microorganisms. For example, the relatively rapid pH drop during 
fermentation (and the final pH achieved) is the primary control measure 
for pathogenic sporeformers in yogurt. Microbiological safety by acids 
relies on the pH value of the food, and pH is a parameter that is 
easily measurable. The pH values that inhibit growth of microbial 
pathogens are generally well-known by food safety professionals and 
easily found in the scientific literature.
    Based on all available information, including the information 
presented in the objections from IDFA, FDA is amending the yogurt 
standard regarding the acidity requirement in Sec.  131.200(a). We are 
revising Sec.  131.200(a) as requested by IDFA, and consistent with the 
PMO, to require a pH of 4.6 or lower measured on the finished product 
within 24 hours after filling. The finished product refers to the 
yogurt white mass after the addition of bulky flavors. If a bulky 
flavor (e.g., fruit pieces) added to yogurt increases the pH, the pH 
must be 4.6 or lower after the product has had time to equilibrate. 
This requirement will ensure the safety

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of yogurt, while maintaining its basic nature and essential 
characteristics.
    This amendment is consistent with IDFA's proposed modification to 
the maximum pH option. Therefore, we are denying IDFA's request for a 
hearing with respect to the maximum pH option under Sec.  12.24(b)(1) 
because there is not a genuine and substantial issue of fact for 
resolution at a hearing.

B. Denial of Request for a Hearing on the Minimum Titratable Acidity 
Option

    IDFA objected to the minimum titratable acidity of 0.7 percent and 
requested that we modify the 2021 final rule to provide for a minimum 
titratable acidity of 0.6 percent. IDFA explained that a minimum 
titratable acidity of 0.6 percent is necessary to produce certain low 
calorie yogurt products that meet consumer expectations of a delicate 
and less tart yogurt taste that is not too acidic or sour. IDFA stated 
that if a titratable acidity requirement of 0.7 percent is imposed, 
some manufacturers may need to adjust formulations and add sugars to 
counteract the acidity and deliver a product that meets consumer 
expectations and preferences. IDFA emphasized that a minimum titratable 
acidity of 0.6 percent would provide manufacturers with needed 
flexibility.
    Because we are modifying the maximum pH option consistent with the 
pH specifications in the PMO, which States have adopted, manufacturers 
are already required to comply with the maximum pH option. Therefore, 
the minimum titratable acidity option in the 2021 final rule, whether 
set at 0.7 percent or 0.6 percent, is superfluous and would not provide 
flexibility to manufacturers. So long as manufacturers comply with the 
maximum pH option, they may manufacture yogurt with a titratable 
acidity of 0.6 percent and can accommodate consumer expectations and 
preferences without reformulating their products. We note that the 
maximum pH option we are finalizing has been in effect in States for 
several years and, by itself, appears sufficient to ensure the safety 
of yogurt products. With the elimination of the titratable acidity 
option, we are also removing Sec.  131.200(e)(1)(iii) Methods of 
analysis, Titratable acidity and the corresponding method incorporated 
by reference in Sec.  131.200(i)(1)(i).
    We are denying IDFA's request for a hearing on whether a minimum 
titratable acidity requirement of 0.7 percent is in the interest of 
consumers and necessary to maintaining the basic nature and essential 
characteristics of yogurt. Given our modification to the maximum pH 
option, a minimum titratable acidity option is unnecessary, and we do 
not believe there is a genuine and substantial issue of fact for 
resolution at a hearing (Sec.  12.24(b)(1)).

III. Conclusions

    For the reasons explained above, we are denying IDFA's request for 
a hearing with respect to both the maximum pH option and the minimum 
titratable acidity option under Sec.  12.24(b)(1). We are modifying the 
acidity requirement in Sec.  131.200(a) in the 2021 final rule to 
eliminate the minimum titratable acidity option and require that yogurt 
have a pH of 4.6 or lower measured on the finished product within 24 
hours after filling.
    This final order is being issued after following the process 
provided under Sec.  12.24(d). Objections to or requests for hearing on 
the modification and revocation may be submitted under 21 CFR 12.20 
through 12.22 in accordance with 21 CFR 12.26. The stay of 
effectiveness with respect to the acidity requirement is lifted upon 
publication of this final order in the Federal Register.

IV. Reference

    The following reference is 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; it is also 
available electronically at https://www.regulations.gov. 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 Health and Human Services, Public Health 
Service, Food and Drug Administration. Grade ``A'' Pasteurized Milk 
Ordinance. 2019. Available at: https://ncims.org/wp-content/uploads/2020/07/2019-PMO.pdf (last accessed February 6, 2023).

List of Subjects in 21 CFR Part 131

    Cream, Food grades and standards, Milk, Yogurt.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
131 is amended as follows:

PART 131--MILK AND CREAM

0
1. The authority citation for part 131 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 348, 371, 379e.


0
2. In Sec.  131.200:
0
a. Revise the fourth sentence of paragraph (a);
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b. Remove paragraphs (e)(1)(iii) and (i)(1)(i); and
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c. Redesignate paragraphs (i)(1)(ii) and (iii) as paragraphs (i)(1)(i) 
and (ii).
    The revision reads as follows:


Sec.  131.200  Yogurt.

    (a) * * * Yogurt contains not less than 3.25 percent milkfat, 
except as provided for in paragraph (g) of this section, and not less 
than 8.25 percent milk solids not fat and has a pH of 4.6 or lower 
measured on the finished product within 24 hours after filling. * * *
* * * * *

    Dated: April 6, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-07723 Filed 4-13-23; 8:45 am]
BILLING CODE 4164-01-P