[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);
0
b. Remove paragraphs (e)(1)(iii) and (i)(1)(i); and
0
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