Federal Register, Volume 86 Issue 111 (Friday, June 11, 2021)

[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Rules and Regulations]
[Pages 31117-31138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12220]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 130 and 131

[Docket No. FDA-2000-P-0126 (formerly Docket No. 2000P-0685)]
RIN 0910-AI40

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is issuing a
final rule to revoke the standards of identity for lowfat yogurt and
nonfat yogurt and amend the standard of identity for yogurt in numerous
respects. This action is in response, in part, to a citizen petition
submitted by the National Yogurt Association (NYA). The final rule
modernizes the yogurt standard to allow for technological advances
while preserving the basic nature and essential characteristics of
yogurt and promoting honesty and fair dealing in the interest of
consumers.

DATES: This rule is effective July 12, 2021. The Director of the
Federal Register approves the incorporation by reference of certain
publications listed in the rule as of July 12, 2021.
The compliance date of this final rule is January 1, 2024. See
section X for further information on the filing of objections.
Submit either electronic or written objections and requests for a
hearing on the final rule by July 12, 2021.

ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. Electronic objections must be submitted on or before July
12, 2021. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of July 12,
2021. Objections received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is 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 ``Milk and Cream

[[Page 31118]]

Products and Yogurt Products; 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 Joan Rothenberg,
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:

Table of Contents

I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Legal Authority
B. History of the Current Standards of Identity for Yogurt,
Lowfat Yogurt, and Nonfat Yogurt
C. Description of the Proposed Rule
IV. Comments on the Proposed Rule, FDA Responses, and Description of
the Final Rule
A. Introduction
B. General Comments
C. Section 131.200(a)--Description
D. Section 131.200(b)--Basic Dairy Ingredients
E. Section 131.200(c)--Optional Dairy Ingredients
F. Section 131.200(d)--Other Optional Ingredients
G. Section 131.200(e)--Methods of Analysis
H. Section 131.200(f)--Nomenclature
I. Revoking the Standards of Identity for Lowfat Yogurt and
Nonfat Yogurt
J. Compliance Date
K. Amendments in 21 CFR 130.10
L. Incorporation by Reference
V. Economic Analysis of Impacts
VI. Federalism
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Consultation and Coordination With Indian Tribal Governments
X. Objections
XI. References

I. Executive Summary

A. Purpose of the Final Rule

We are issuing a final rule to revoke the standards of identity for
lowfat yogurt and nonfat yogurt and amend the standard of identity for
yogurt in numerous respects. This action is in response, in part, to a
citizen petition submitted by the NYA. This action modernizes the
yogurt standard to allow for technological advances while preserving
the basic nature and essential characteristics of yogurt and promotes
honesty and fair dealing in the interest of consumers.

B. Summary of the Major Provisions of the Final Rule

The final rule revokes the standards for lowfat yogurt and nonfat
yogurt. Consequently, lowfat yogurt and nonfat yogurt are covered under
the general definition and standard of identity in Sec. 130.10 (21 CFR
130.10), which sets out requirements for foods that deviate from other
standardized foods due to compliance with a nutrient content claim. The
final rule provides a modern yogurt standard to allow for technological
advances, preserves but simplifies the basic nature and essential
characteristics of yogurt, and promotes honesty and fair dealing in the
interest of consumers.
The final rule amends the standard of identity for yogurt by making
certain technical changes, permitting reconstituted forms of basic
dairy ingredients (cream, milk, partially skimmed milk, and skim milk
used alone or in combination) and the use of any optional safe and
suitable milk-derived ingredient under certain conditions. The final
rule also establishes functional classes of safe and suitable
ingredients including cultures, flavoring, color additives,
stabilizers, emulsifiers, and preservatives, and replaces the list of
nutritive sweeteners with the term ``nutritive carbohydrate
sweeteners.'' The final rule permits the optional labeling statement
``contains live and active cultures'' or similar statement if the
yogurt contains specified amounts of live and active cultures. For
yogurt treated to inactivate viable microorganisms, the final rule
requires a statement of ``does not contain live and active cultures''
on the label.

C. Legal Authority

This final rule is issued pursuant to our authority under sections
401, 403(a)(1), 201(n), and 701(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 341, 343(a)(1), 321(n), and 371(e)).
Under section 701(e) of the FD&C Act, 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 be begun by a
proposal made either by FDA under our own initiative or by petition of
any interested persons, showing reasonable grounds therefore, filed
with the Secretary. The NYA submitted such a citizen petition on
February 18, 2000, requesting that we, among other things, revoke the
standards of identity for lowfat yogurt (Sec. 131.203 (21 CFR
131.203)) and nonfat yogurt (Sec. 131.206 (21 CFR 131.206)) and amend
the standard of identity for yogurt (Sec. 131.200 (21 CFR 131.200)).

D. Costs and Benefits

Because we are publishing this rule in accordance with the formal
rulemaking provisions of 5 U.S.C. 556 and 557, this rule is exempt from
the economic

[[Page 31119]]

analysis requirements of Executive Order 12866. However, we have
examined the economic implications of this rulemaking on small
businesses. On a per firm, per year basis, estimated costs are between
approximately $0.3 million and $2.7 million per small yogurt
manufacturer per year in 2019 dollars discounted at 3 percent and
between approximately $0.4 million and $2.7 million per small yogurt
manufacturer per year discounted at 7 percent. The rule will likely
benefit some manufacturers by modernizing the yogurt standard to allow
for technological advances in food processing and to incorporate
flexibility in yogurt manufacturing while preserving the basic nature
and essential characteristics of yogurt. Because this rule may generate
compliance costs for some small firms, we believe that this rule would
have a significant economic impact on a substantial number of small
entities.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

------------------------------------------------------------------------
Abbreviation What it means
------------------------------------------------------------------------
ANPRM............................. Advance Notice of Proposed
Rulemaking.
AOAC International................ Association of Official Analytical
Collaboration International
(formerly Association of Official
Agricultural Chemists).
CFR............................... Code of Federal Regulations.
CFU............................... Colony Forming Units.
Codex............................. Codex Alimentarius Commission.
DV................................ Daily Value.
E.O............................... Executive Order.
FD&C Act.......................... Federal Food, Drug, and Cosmetic
Act.
FR................................ Federal Register.
GMP............................... Good Manufacturing Practice.
ISO............................... International Organization for
Standardization.
NLEA.............................. Nutrition Labeling and Education
Act.
NYA............................... National Yogurt Association.
RACC.............................. Reference Amount Customarily
Consumed.
UPC............................... Universal Product Code.
------------------------------------------------------------------------

III. Background

A. Legal Authority

Section 401 of the FD&C Act directs the 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. Section 403(a)(1) of the FD&C Act deems food to
be misbranded if its labeling is false or misleading in any particular.
Labeling may be misleading due to affirmative representations made or
suggested by statement, word, design, device, or any combination
thereof; labeling may also be misleading due to failure to reveal facts
material in light of such representations (see section 201(n) of the
FD&C Act).
Under section 701(e)(1) of the FD&C Act, 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. The NYA submitted a citizen
petition on February 18, 2000 (Docket No. FDA-2000-P-0126, formerly
Docket No. 2000P-0685), under our procedural regulations in 21 CFR
10.30, requesting, among other things, that we revoke the standards of
identity for lowfat yogurt (Sec. 131.203) and nonfat yogurt (Sec.
131.206) and amend the standard of identity for yogurt (Sec. 131.200).
In the Federal Register of July 3, 2003 (68 FR 39873), FDA issued an
advance notice of proposed rulemaking (ANPRM), publishing the proposals
in NYA's petition consistent with section 701(e)(1) of the FD&C Act.
The ANPRM requested comment on whether the actions proposed in the
petition would promote honesty and fair dealing in the interest of
consumers. FDA subsequently issued a proposed rule in the Federal
Register of January 15, 2009 (74 FR 2443) in part to respond to the
citizen petition. FDA is now acting pursuant to section 701(e) of the
FD&C Act to finalize the rule.

B. History of the Current Standards of Identity for Yogurt, Lowfat
Yogurt,and Nonfat Yogurt

In the Federal Register of January 30, 1981 (46 FR 9924), we
published a final rule establishing standards of identity for yogurt
(Sec. 131.200), lowfat yogurt (Sec. 131.203), nonfat yogurt (Sec.
131.206), certain milk products (21 CFR 131.111, 131.112, 131.136,
131.138, 131.144, and 131.146)), and eggnog (21 CFR 131.170)).
Interested persons were given until March 2, 1981, to file objections
and request a hearing on the final rule. Twenty-one responses were
filed objecting to specific provisions of the final rule and, in most
cases, requesting a hearing. In response to those objections, we stayed
the effective date for provisions regarding certain milk products and
eggnog. In addition, we stayed the following provisions in the
standards of identity for yogurt, lowfat yogurt, and nonfat yogurt: (1)
Provisions that restricted the type of milk-derived ingredients that
may be used to increase the milk solids not fat content (Sec. Sec.
131.200(c)(1), 131.203(c)(1), and 131.206(c)(1) (redesignated as
Sec. Sec. 131.200(d)(1), 131.203(d)(1), and 131.206(d)(1),
respectively)); (2) provisions that excluded the use of reconstituted
dairy ingredients as basic ingredients (Sec. Sec. 131.200(a),
131.203(a), and 131.206(a)); (3) provisions that excluded the addition
of preservatives (Sec. Sec. 131.200(c), 131.203(c), and 131.206(c)
(redesignated as Sec. Sec. 131.200(d), 131.203(d), and 131.206(d),
respectively)); (4) provisions that set a minimum titratable acidity of
0.9 percent, expressed as lactic acid (Sec. Sec. 131.200(a),
131.203(a), and 131.206(a)); and (5) Sec. 131.200(a) specifying that
the 3.25 percent minimum milkfat level applies after the addition of
one or more of the optional sources of milk solids not fat listed in
Sec. 131.200(c)(1) (redesignated as Sec. 131.200(d)(1)) (47 FR 41519
at 41523, September 21, 1982).
Due to competing priorities and limited resources, we did not hold
a public hearing to resolve these issues, and the effective date for
these provisions has been stayed since September 21, 1982. Therefore,
these provisions have never been in effect, and yogurt, lowfat yogurt,
and nonfat yogurt sold in interstate commerce have

[[Page 31120]]

not been required to conform to them. Consequently, yogurt, lowfat
yogurt, and nonfat yogurt have varied with respect to the type of milk-
derived ingredients used to increase the milk solids not fat content,
the use of reconstituted dairy ingredients as basic ingredients,
addition of preservatives, level of acidity, and application of the
minimum milkfat level. These products have, however, been required to
conform to the non-stayed provisions in Sec. Sec. 131.200, 131.203,
and 131.206.
In 1990, the Nutrition Labeling and Education Act (NLEA) (Pub. L.
101-535) amended the FD&C Act and established the circumstances in
which claims that describe the nutrient content of food could be made.
In response to the NLEA, we published a final rule on January 6, 1993,
entitled ``Food Labeling: Nutrient Content Claims, General Principles,
Petitions, Definitions of Terms; Definitions of Nutrient Content Claims
for the Fat, Fatty Acid, and Cholesterol Content of Food'' that
established definitions for specific nutrient content claims in part
101 (21 CFR part 101) together with principles for their use (58 FR
2302) (the 1993 final rule). At the same time, we published a final
rule entitled ``Food Standards: Requirements for Foods Named by Use of
a Nutrient Content Claim and a Standardized Term'' (58 FR 2431) that
established the general definition and standard of identity in Sec.
130.10 for foods that substitute for a standardized food but deviate
from the standard of identity due to compliance with an expressed
nutrient content claim defined by FDA regulation, including the
expressed nutrient content claims ``no fat'' and ``low fat'' (see Sec.
101.62(b)) and ``light'' or ``reduced calorie'' (see Sec. 101.60(b)).
We noted in the 1993 final rule (58 FR 2302 at 2314) that the
common or usual names of certain foods with existing standards of
identity include nutrient content claims. Lowfat yogurt and nonfat
yogurt are among these foods. We further noted that these foods are
exempt under section 403(r)(5)(C) of the FD&C Act from compliance with
nutrient content claim definitions established by regulation, provided
that the foods were subject to a standard of identity on November 8,
1990. As such, nonfat yogurt and lowfat yogurt are subject to the fat
content requirements specified in their respective standards of
identity rather than the requirements in Sec. 101.62(b)(1) for ``no
fat'' and Sec. 101.62(b)(2) for ``low fat.'' In 1995, we proposed to
revoke the standards of identity for lowfat yogurt and nonfat yogurt,
along with the standards of identity for other dairy foods, so that the
foods would be covered under Sec. 130.10 and subject to the nutrient
content claim definitions in part 101 (60 FR 56541). This action was
intended to provide for consistency in the nomenclature and labeling of
food products.
We deferred action on our proposal to revoke the standards of
identity for lowfat yogurt and nonfat yogurt (61 FR 58991, November 20,
1996), citing economic considerations and technical difficulties for
the yogurt industry if required to fortify lowfat yogurt and nonfat
yogurt in accordance with the nutritional equivalence requirement in
Sec. 130.10(b) (61 FR 58991 at 58999). We later withdrew the proposed
rule on November 26, 2004 (69 FR 68831).

C. Description of the Proposed Rule

In the Federal Register of January 15, 2009 (74 FR 2443), we
published a proposed rule to revoke the standards of identity for
lowfat yogurt (Sec. 131.203) and nonfat yogurt (Sec. 131.206) and
amend the standard of identity for yogurt (Sec. 131.200). The proposal
was, in part, in response to a citizen petition submitted by the NYA on
February 18, 2000, and our ANPRM (68 FR 39873; July 3, 2003) in which
we asked for comments and information concerning the NYA petition
(Docket No. FDA-2000-P-0126, formerly Docket No. 2000P-0685).
We proposed to revoke the standards of identity for lowfat yogurt
(Sec. 131.203) and nonfat yogurt (Sec. 131.206) so that yogurt (under
proposed Sec. 130.200) could be modified according to the ``low fat''
and ``no fat'' nutrient content claim definitions in Sec. 101.62(b),
thereby bringing lowfat yogurt and nonfat yogurt within the coverage of
Sec. 130.10. Consequently, lowfat yogurt and nonfat yogurt would be
standardized foods under the general definition and standard of
identity, rather than standardized foods under Sec. Sec. 131.203 and
131.206.
We also proposed numerous changes to the standard of identity for
yogurt in Sec. 131.200. In brief, we proposed to modify the
description of the standardized food yogurt; define basic dairy,
optional dairy, and other optional ingredients used in the manufacture
of yogurt; revoke the provisions for optional addition of vitamins A
and D and the associated labeling requirements; update or provide the
methods of analysis for milk solids not fat, titratable acidity, pH,
and live and active cultures; and modify nomenclature, including
required and recommended descriptors based on the manufacture of the
product.
We further discussed our disagreement with some of the requests in
the NYA citizen petition, including the requests to require that yogurt
contain a specified amount of live and active cultures; permit the
addition of optional milk-derived ingredients after culturing; permit
the use of whey protein concentrate as a basic dairy ingredient;
require a minimum amount of dairy ingredients; and permit a broad
category of safe and suitable ingredients for nutritional or functional
purposes (see 74 FR 2443 at 2449 through 2453).

IV. Comments on the Proposed Rule, FDA Responses, and Description of
the Final Rule

A. Introduction

We requested comments on the proposed rule by March 31, 2009. We
later extended the comment period to April 29, 2009 (Ref. 1). We
received over 6,200 comments (including more than 6,000 form letters)
from consumers, industry, trade associations, a scientific
organization, and academia.
Some comments supported one or more of the proposed requirements.
Other comments opposed certain proposed requirements, suggested changes
to the proposed requirements, or asked us to clarify the proposed
requirements. Comments from several trade associations representing
food manufacturers and ingredient suppliers supported the need to
modernize the yogurt standard to allow for recent technological
advances in food processing and to incorporate flexibility in yogurt
manufacturing while preserving the basic nature and essential
characteristics of yogurt. However, other comments urged us not to
revoke or change the standards of identity for yogurt, expressing
concerns that the proposal would reduce the requirements for yogurt,
including those provisions regarding nutrition, quality, safety, and
labeling.
In this section, we discuss the issues raised in the comments on
the proposed rule and our responses, and we describe the final rule.
For ease of reading, we preface each comment discussion with a numbered
``Comment,'' and each response with a corresponding numbered
``Response.'' We have numbered each comment to help distinguish among
different topics. The number assigned to each comment is for
organizational purposes and does not signify the comment's importance
or the order in which it was received.
We did not respond to comments outside the scope of this
rulemaking, such as comments related to the safety of domestic versus
imported ingredients, or country of origin labeling. The final rule is
limited to

[[Page 31121]]

defining the standard of identity for yogurt and revoking the standards
for lowfat yogurt and nonfat yogurt.

B. General Comments

(Comment 1) Several comments requested that we not change the
standard of identity for yogurt. The comments asserted that the
proposed rule lowers the requirements for yogurt, yields substantially
to the NYA petition, and provides yogurt manufacturers too much
flexibility in the manufacture of yogurt.
(Response 1) We disagree with the comments. The final rule does not
lower the requirements for yogurt, but rather modernizes the yogurt
standard to allow for technological advances while preserving the basic
nature and essential characteristics of yogurt and promotes honesty and
fair dealing in the interest of consumers. Technological advances in
food science and technology allow for a wider range of milk-derived
ingredients developed with advances in membrane processing technology
in the dairy industry. The final rule permits the use of emulsifiers
and preservatives to prevent separation, improve stability and texture,
and extend the shelf-life of yogurt. The final rule also allows for
modern methods for measuring acidity (pH in addition to titratable
acidity) and analysis for milkfat, total solids content, milk solids
not fat, titratable acidity, and a method to measure the characteristic
live and active cultures or microorganisms in yogurt.
As described in our responses to comments 14, 21, 22, and 30, the
final rule modifies some requirements to best preserve the integrity
and economic value that consumers expect of yogurt. In addition, the
final rule provides regulatory clarity, aligns the standard with
products on the market, reflects industry practices, and promotes
honesty and fair dealing in the interest of consumers:
Although we considered the NYA petition mentioned in section
III.C., we also considered multiple factors, such as new processing
technology and ingredients before proposing to amend the yogurt
standards.
We also disagree that the rule provides yogurt manufacturers too
much flexibility in the manufacture of yogurt. Providing flexibility in
manufacturing may increase efficiency while maintaining the basic
nature and essential characteristics of yogurt in terms of the taste,
flavor, and texture expected by consumers. For example, the variety of
yogurt products increased greatly over the years, with thicker Greek-
style yogurt becoming as popular as regular yogurt. Permitting optional
functional dairy ingredients achieves a desired protein content for
Greek-style yogurt prior to culturing/fermentation, and allows for
manufacturing without the production of the undesirable acid whey that
is potentially a disposal problem. This flexibility also allows the use
of technological advances without compromising safety or quality.
(Comment 2) Several comments said that the proposed rule would
lower the quality and safety standards for yogurt by specifically
allowing non-Grade ``A'' dairy ingredients to be used in the
manufacture of yogurt.
(Response 2) The comments may have misinterpreted the current
standards and proposed rule. The current standards for yogurt (Sec.
131.200), lowfat yogurt (Sec. 131.203), or nonfat yogurt (Sec.
131.206) do not specify the use of either Grade ``A'' or non-Grade
``A'' dairy ingredients in the manufacture of these products. Nor did
we propose or discuss the specific use of non-Grade ``A'' dairy
ingredients in the manufacture of yogurt in the proposed rule. Thus,
there is no change between the current standards and the standard of
identity for yogurt in this final rule with respect to the use of non-
Grade ``A'' ingredients. The use of safe and suitable milk-derived
ingredients as described in the final rule does not lower the value,
grade, or safety or attribute requirements for yogurt and its
ingredients.

C. Section 131.200(a)--Description

The proposed rule, at Sec. 131.200(a), would require yogurt to
contain a minimum of 3.25 percent milkfat, a minimum of 8.25 percent
milk solids not fat, and a minimum of 0.7 percent titratable acidity
expressed as lactic acid or maximum pH of 4.6, before the addition of
bulky flavoring ingredients. The proposed rule also would require
yogurt that is labeled with the optional phrase ``contains live and
active cultures'' or another appropriate descriptor to contain a
minimum of 10\7\ colony forming units per gram (CFU/g) of live and
active cultures at the time of manufacture with a reasonable
expectation of 10\6\ CFU/g throughout the manufacturer's assigned shelf
life of the food.
(Comment 3) Some comments supported the proposal requiring yogurt
to have a minimum milkfat of 3.25 percent and minimum milk solids not
fat of 8.25 percent before the addition of bulky flavoring ingredients.
However, one comment would replace the minimum 3.25 percent milkfat
requirement with a requirement of 3 g of fat (including milkfat and
other fat present in the bulky flavoring ingredients) in the finished
product per reference amount customarily consumed (RACC). The comment
said that requiring 3.25 percent milkfat before the addition of bulky
flavoring ingredients can cause inconsistency because the amount of
total fat in the finished product can vary depending on the amount and/
or type of added flavoring ingredients. The comment suggested that some
flavoring ingredients, such as chocolate, nuts, and coconut, can
contribute to total fat in the finished product. The comment stated
that a fat requirement based on the finished product would also provide
manufacturers the flexibility of adding cream after culturing.
(Response 3) As discussed in the proposed rule (74 FR 2443 at
2448), we do not believe it is appropriate to change the minimum
milkfat content to 3 g fat per 255 g, or 1.3 percent, because the
yogurt standard with the minimum 3.25 percent milkfat requirement
appears to be used in the manufacture of full-fat yogurts available in
the marketplace and is consistent with the basic nature and essential
characteristics of yogurt. According to the U.S. Department of
Agriculture (USDA) FoodData Central (2019), the total fat content of
``yogurt, plain, whole milk'' is 3.25 g/100 g serving (3.25 percent)
(Ref. 2). This is consistent with the minimum milkfat requirement of
the current standard of identity for yogurt.
We emphasize that the minimum fat requirement of 3.25 percent is
specifically for milkfat. Allowing fat from nondairy ingredients to
count towards the minimum fat level deviates from the basic nature and
essential characteristics of yogurt as other types of nondairy fats or
oils could contribute to variances in the taste, texture, color, or
aroma of yogurt (Refs. 3 and 4).
In addition, as discussed in response 15, we are not allowing the
addition of optional dairy ingredients, such as pasteurized cream,
after culturing. Therefore, it is appropriate to specify a minimum
milkfat level of 3.25 percent before the addition of bulky flavoring
ingredients.
(Comment 4) Some comments asked us to clarify whether the phrase
``bulky flavoring ingredients'' in proposed Sec. 131.200(a) has the
same meaning as the phrase ``bulky flavors'' used in Sec. 131.200(a).
One comment asked us to use the term ``bulky flavors'' in the final
rule.
(Response 4) We consider the two terms, ``bulky flavors'' and
``bulky flavoring ingredients,'' to have similar meaning. Examples of
bulky flavoring ingredients are fruit and fruit preparations. To be
consistent with

[[Page 31122]]

most of the dairy standards, we have revised the rule to adopt the term
``bulky flavoring ingredients.''
(Comment 5) Currently, the stayed provisions in Sec. Sec.
131.200(a), 131.203(a), and 131.206(a) specify that yogurt have a
titratable acidity of not less than 0.9 percent, expressed as lactic
acid. We stayed this provision of the standard on September 21, 1982
(47 FR 41519 at 41522). Titratable acidity and pH can both be used to
measure the acidity of a food product. In the proposed rule (74 FR 2443
at 2449), we proposed 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.
Several comments agreed that the stayed requirement of 0.9 percent
titratable acidity, expressed as lactic acid, should be changed. One
comment supported the minimum titratable acidity of 0.7 percent or
maximum pH of 4.6. Other comments would modify the minimum titratable
acidity to 0.6 percent measured in the cultured and fermented yogurt
before the addition of bulky flavor ingredients.
One comment said that a minimum titratable acidity of 0.7 percent
in the proposed rule is still too high for yogurt products with
chocolate or delicate fruit flavors. Another comment claimed that a
lower acidity requirement helps industry develop ``light'' yogurt
products. Other comments pointed out that a minimum 0.6 percent
titratable acidity is consistent with the Codex Standard for Fermented
Milks (CXS 243-2003) (Ref. 5). Codex Alimentarius (Codex) is an
international body established by the Food and Agriculture Organization
of the United Nations and the World Health Organization.
Some comments asked us to revise the rule so that the maximum pH of
4.6 applies to finished product within 24 hours after filling. The
comments said that, for yogurt that continues to ferment in the final
container, such as ``cup set'' and ``warm fill'' yogurt, the product pH
continues to drop during the cooling step. The comments also argued
that, based on our own safety evaluation, we allow all yogurt products
to be filled with an initial pH of 4.80 if the product pH reaches 4.6
or below within 24 hours of filling.
(Response 5) We disagree with the comments that would modify the
minimum titratable acidity to 0.6 percent or that a minimum titratable
acidity of 0.7 percent is still too high for certain yogurt products.
Providing for the measurement of acidity in yogurt as a determination
of its pH as well as its titratable acidity will introduce flexibility
in the yogurt standard and gives manufacturers the flexibility to
choose a method that best suits their product. As we noted in the
proposed rule, the NYA citizen petition recommended a maximum pH of
4.6, and we believe that allowing a minimum titratable acidity of 0.7
percent or an equivalent maximum pH of 4.6 is appropriate as it
reflects current industry practice and better meets some consumers'
taste preferences (74 FR 2443 at 2448).
The final rule's requirement of a minimum titratable acidity of 0.7
percent is similar, but not identical, to requirement or position by
Codex. We acknowledge that the Codex Standard established a minimum
composition for yogurt of 0.6 percent titratable acidity expressed as
percent lactic acid. However, yogurt products produced in compliance
with our requirement of 0.7 percent titratable acidity would comply
with the Codex Standard with respect to titratable acidity. Based on
our observation of chocolate yogurt products and yogurt flavored with a
variety of fruit flavors currently on the market that have a 0.7
percent titratable acidity, we do not believe that the differences
between our final rule and the position taken by Codex will adversely
affect the ability of manufacturers to produce yogurt with chocolate or
delicate fruit flavors or ``light'' yogurt products, while maintaining
the basic nature and essential characteristics of yogurt.
As for the comments that would revise the rule so that the maximum
pH applies to finished products within 24 hours after filling, we view
the fill pH as an in-process product characteristic for yogurt
products. Requiring a maximum pH of 4.6 in the cultured and fermented
yogurt before the addition of bulky flavor ingredients ensures the
inhibition of growth and toxin formation of Clostridium botulinum (the
pathogenic organism responsible for foodborne botulism). The
manufacturer controls the condition after filling to ensure that the
characterizing bacterial culture continues to ferment the product to
produce a yogurt product with a maximum pH of 4.6 before the addition
of bulky flavoring ingredients.
If the yogurt contains bulky flavoring ingredients, the finished
product pH reflects the equilibrium pH of the cultured and fermented
yogurt including the bulky flavoring ingredients. Some bulky flavoring
ingredients (e.g., fruit preparations) can lower the pH of the cultured
and fermented yogurt. Applying the pH requirement to finished product
after the addition of these ingredients could indirectly allow the use
of acidulants to achieve the desired pH. The yogurt standard does not
permit the use of food grade acidulants to meet the acidity or pH
requirements (see response 6). To uphold the basic nature and essential
characteristics of yogurt while maintaining product safety and
attributes, the yogurt standard must ensure that the cultured and
fermented yogurt reaches the desired titratable acidity of 0.7 percent
or maximum pH of 4.6 solely by the fermentation action of bacterial
culture and not through the additions of acidulants or bulky flavoring
ingredients like fruit preparations. Thus, we do not agree that the
maximum pH of 4.6 should apply only to the finished product.
The final rule, therefore, requires, at Sec. 131.200(a), that
yogurt have a titratable acidity of not less than 0.7 percent,
expressed as lactic acid, or a pH of 4.6 or lower. We emphasize that
both the titratable acidity and the pH requirements apply to yogurt
before the addition of bulky flavoring ingredients.
(Comment 6) Several comments stated that the term ``culturing'' as
used in Sec. 131.200(a) should only refer to milk fermentation by the
characterizing cultures (Lactobacillus delbrueckii, subspecies
bulgaricus, and Streptococcus thermophilus) and other additional
cultures allowed as optional ingredients. The comments asked us to
clarify that ``culturing'' does not refer to the addition of lactic
acid or other acidulants in modifying the standard to allow the use of
a broad category of safe and suitable ingredients that serve a
nutritional or functional purpose.
(Response 6) We agree that ``culturing'' as used in Sec.
131.200(a) refers to milk fermentation by the characterizing cultures
(L. delbrueckii, subspecies bulgaricus, and S. thermophilus), and other
cultures as described in Sec. 131.200(d)(1). ``Culturing'' does not
refer to the addition of lactic acid or other acidulants. Lactic acid
or other acidulants are not permitted as other optional ingredients
under Sec. 131.200(d).
(Comment 7) A few comments said we should not require yogurt to
contain a specified amount of live and active cultures and should
permit heat treatment of yogurt after culturing to extend shelf life.
However, many comments stated that a unique and defining characteristic
of yogurt is the presence of live and active cultures and these live
and active cultures provide health benefits. These comments indicated
that an important health benefit of live and active cultures in yogurt
is their ability to break down lactose to allow lactose intolerant
individuals to consume yogurt without uncomfortable side effects. One

[[Page 31123]]

comment stated that over 80 percent of the yogurt products sold in the
United States in the time around 2009 declared the presence of live and
active cultures either on the labels or on company websites. Another
comment provided consumer survey results to contend that consumers
expect yogurt products to contain live and active cultures. Other
comments indicated that the requirement of live and active cultures is
consistent with the Codex standard.
Other comments disagreed whether yogurt can be heat-treated after
culturing. Some comments strongly opposed heat treatment after
culturing and indicated that labeling the resultant product as
``yogurt'' is misleading and deceptive because consumers expect yogurt
to contain live and active cultures. Other comments did not object to
heat treatment after culturing if the package states that the product
does not contain live and active cultures.
Some comments opposed any changes to the heat treatment provisions
in the existing yogurt standard. The comments argued that, with
extended shelf life, heat-treated yogurt gives consumers an additional
option for a healthy dairy product. The comments also claimed that
neither the presence nor the number of living bacteria in yogurt has
any demonstrated health benefit. Some comments also suggested that some
yogurt manufacturers may want to market their yogurt products with the
claim ``contains live and active cultures.'' Many comments expressed
interest in knowing whether a yogurt product contains live and active
cultures.
(Response 7) We analyzed survey data submitted by the NYA and found
that, while a majority of respondents expected to find live and active
cultures as an ingredient in yogurt, the absence of a discussion in the
survey on the response rates raises questions regarding potential bias
in the results (Ref. 6). Consequently, we are unable to conclude, based
on this survey, that yogurt should necessarily contain live and active
cultures or that heat treatment after culturing should be prohibited.
Based on the comments discussing live and active cultures, we
believe that many consumers are interested in knowing whether the
yogurt products they purchase contains live and active cultures and
that this information may impact their purchasing decisions. We
therefore conclude that the labeling of yogurt should disclose the
absence of live and active cultures rather than the use of heat
treatment after culturing. The disclosure statement in Sec.
131.200(f)(1)(ii) has been changed in the final rule to require an
accompanying statement of ``does not contain live and active cultures''
on the product label. Thus, the rule permits the treatment of yogurt
after culturing to inactivate viable microorganisms and extend shelf
life of the product, provided that the label bears this accompanying
statement. We discuss the labeling requirements for such treated yogurt
in more detail in responses 27, 28, and 29.
We note that, in the future, new technologies other than heat
treatment (e.g., high pressure processing) may be used to inactivate
viable microorganisms in yogurt and extend yogurt shelf life.
Therefore, the final rule, at Sec. 131.200(a), states that, to extend
the shelf life of the food, yogurt may be treated after culturing to
inactivate viable microorganisms rather than limiting yogurt
specifically to heat treatment after culturing to extend the shelf life
of the food. Such treated foods require an accompanying statement of
``does not contain live and active cultures'' on the product label.
In a summary and analysis of the consumer survey results submitted
by one comment, we did not find that the consumer research results
provided evidence that consumers expect all yogurt products to contain
live and active cultures (Ref. 6).
Given consumer interest in knowing the presence of live and active
cultures in yogurt, manufacturers may wish to affirmatively convey to
consumers that live and active cultures are present. Therefore, the
final rule, at Sec. 131.200(f)(2), permits the optional labeling
statement ``contains live and active cultures'' or another appropriate
descriptor if the yogurt product contains a minimum level of live and
active cultures as explained further in response 8.
As for the comments regarding the Codex standard, the final rule is
consistent with the Codex standard, which also does not require live
and active cultures in heat treated yogurt. For yogurt that is not heat
treated, the requirement to permit the optional labeling statement
``contains live and active cultures'' is consistent with the Codex
standard.
(Comment 8) Many comments supported setting a minimum level of live
and active cultures. Some comments provided general support without
mentioning any specific levels of live and active cultures. Other
comments addressed the issue of what level of live and active cultures
must be present when the label bears a statement to this effect. Among
these comments, some agreed with our proposed levels of live and active
cultures. Some supported the minimum level of 10\7\ CFU/g of live and
active cultures at the time of manufacture but did not support the
inclusion of ``reasonable expectation of 10\6\ CFU/g throughout the
manufacturer's assigned shelf life of the product.'' One comment stated
that manufacturers do not always have control over the storage
conditions at retail levels. One comment requested that we not set a
minimum level of live and active cultures in the final rule because,
for yogurt that is not heat-treated, the provisions on fermentation,
minimum titratable acidity, and maximum pH already ensure that the
bacterial culture is above 10\7\ CFU/g after culturing.
(Response 8) The proposed rule specified a minimum level of live
and active cultures of 10\7\ CFU/g at the time of manufacture with a
reasonable expectation of 10\6\ CFU/g through the manufacturer's
assigned shelf life of the product. We have included these minimum
levels in the final rule under Sec. 131.200(f)(2) for the optional
labeling statement ``contains live and active cultures.'' We decline to
revise the rule to specify the minimum level of live and active
cultures only at the time of manufacture. The time of manufacture is
not the point when consumers purchase or consume their yogurt products.
Even though manufacturers do not always have full control over the
storage conditions at retail level, yogurt products should be properly
refrigerated throughout the distribution channel. Studies generally
indicate that the characterizing yogurt cultures survive well during
cold storage and at lowered pH levels (Refs.7 through 9). One study
shows that, when commercial yogurt products were stored at 4 [deg]C,
levels of characterizing yogurt cultures remained relatively stable
over the study period of 4 weeks, with 1.0 or less log reduction (Ref.
8). Studies also show that, in non-heated yogurt, the mixture of S.
thermophilus and L. bulgaricus is typically well above the minimum
10\6\ CFU/g at the end of refrigerated storage, even though some
reduction occurred during storage depending on the specific culture
used, the storage temperature, and other factors (Refs. 7 through 9).
Given these data indicating the minimum of 10\6\ CFU/g of live and
active cultures will likely exist throughout the shelf life of the
food, and to promote honesty and fair dealing in the interest of
consumers, the final rule permits the optional labeling statement
``contains live and active cultures'' or another appropriate descriptor
if the yogurt product contains a minimum of

[[Page 31124]]

10\7\ CFU/g of live and active cultures at the time of manufacture with
a reasonable expectation of 10\6\ CFU/g throughout the manufacturer's
assigned shelf life of the product (Sec. 131.200(f)(2)).
We also do not agree that the provisions of fermentation, minimum
titratable acidity, and maximum pH can replace the requirement of the
levels of live and active cultures in the finished product. Although
the culturing of yogurt is achieved by milk fermentation by the
characterizing culture as described in Sec. 131.200(a) and other
cultures as described in Sec. 131.200(d)(1) (see response 6), the
optional labeling statement ``contains live and active cultures'' or
another appropriate descriptor refers specifically to the presence of
live and active cultures in the finished product. The minimum level of
live and active cultures at the time of manufacturing and a reasonably
expected level throughout the assigned shelf life provide a uniform
production standard. Therefore, the final rule, at Sec.
131.200(f)(1)(ii), requires that, if the yogurt product is labeled with
the phrase ``contains live and active cultures'' or another appropriate
descriptor, the yogurt product must contain a minimum of 10\7\ CFU/g of
live and active cultures at the time of manufacture with a reasonable
expectation of 10\6\ CFU/g throughout the manufacturer's assigned shelf
life of the product.
On our own initiative, for added clarity, we relocated the
provisions in proposed Sec. 131.200(a) regarding the minimum number of
live and active microorganisms yogurt may contain, to Sec. 131.200(f),
``Nomenclature,'' describing the number of live and active
microorganisms necessary for the product to be labeled with the phrase
``contains live and active cultures.''
(Comment 9) One comment opposed heat treatment after culturing and
said that, if we permit such practice in the final rule, we should
require all non-heat-treated yogurt to contain the proposed minimum
levels of live and active cultures regardless of whether any ``live and
active cultures'' label claims are made for the product. The comment
reasoned that, under the proposed rule, there were at least three
classes of yogurt products: (1) Heat-treated yogurt after culturing;
(2) yogurt with live and active cultures and labeled with the voluntary
live and active cultures claim; and (3) yogurt with live and active
cultures but without any live and active cultures claim. The comment
said that these different classes of yogurt can create consumer
confusion and that, if we allow heat treatment of yogurt, we should
require all non-heat-treated yogurt to contain the minimum levels of
live and active cultures to reduce consumer confusion.
(Response 9) We disagree that these categories of products will
cause consumer confusion. As discussed in responses 7 and 8, it is not
evident that consumers always expect yogurt to contain live and active
cultures. As such, labeling appears to be a better approach to
informing consumers about the absence or presence of live and active
cultures. The labeling provisions in Sec. 131.200(f)(1)(ii) and (2) of
the final rule will allow consumers to identify products that do not
contain live and active cultures (which is a consequence of treatment
after culturing) and products that contain a meaningful amount of live
and active cultures. The disclosure statements specified in the
provisions are required to accompany the name on the principal display
panel of the product label and therefore readily inform consumers about
the absence or presence of live and active cultures.
(Comment 10) One comment asked us to clarify that nonstandardized
products that use yogurt as an ingredient are not required to meet the
minimum level of 10\7\ CFU/g live and active cultures. The comment gave
examples of nonstandardized products, such as frozen yogurt, yogurt-
coated cereal, and dried yogurt powder. The comment also asked us to
clarify whether foods that do not meet the standard of identity for
yogurt can continue to use the descriptive term ``yogurt'' as part of
the food's name on the label.
(Response 10) Any food that purports to be or is represented as
yogurt, must conform to the definition standard of identity for yogurt
and its label must bear the name ``yogurt'' (see 21 U.S.C. 343(g)).
Foods that do not purport to be or are not represented as yogurt, are
not subject to these requirements. In our experience, products such as
frozen yogurt, yogurt-coated cereal, and dried yogurt powder are not
represented as and do not purport to be yogurt. Instead, they are
nonstandardized foods, and their labels must bear their common or usual
names in accordance with section 403(i)(1) of the FD&C Act. Common or
usual names are generally established by common usage, though in some
cases, common or usual names for nonstandardized foods have been
established by regulation (see 21 CFR part 102, subpart B). Because no
such regulation for these nonstandardized foods exists, they should be
labeled with their common usage names (e.g., ``frozen yogurt), provided
that the names do not mislead consumers (see 21 U.S.C. 343(a)(1)).
When ``yogurt'' is used as part of the name of products such as
frozen yogurt, yogurt-coated cereal, and dried yogurt powder, we
generally expect that yogurt, or a substance derived from yogurt (i.e.,
yogurt powder) is used as an ingredient in their manufacture. The
ingredient must be or be derived from yogurt that complies with Sec.
131.200. For example, we expect that an ingredient used in a yogurt
drink is yogurt made in accordance with Sec. 131.200, which is then
combined with other ingredients to produce a drink product. The
ingredient must be declared by its common or usual name in the
ingredient statement on the product label in accordance with section
403(i)(2) of the FD&C Act, and Sec. 101.4(a) and (b).

D. Section 131.200(b)--Basic Dairy Ingredients

The proposed rule, at Sec. 131.200(b), would state that cream,
milk, partially skimmed milk, skim milk, and the reconstituted versions
of these ingredients may be used alone or in combination as the basic
dairy ingredients in yogurt manufacture. The portion of Sec.
131.200(b) that excluded the use of reconstituted versions of the basic
ingredients in yogurt was stayed in 1982, so we could not take
compliance action against the use of these ingredients until the stay
was formally resolved. Although requested by the NYA petition, we did
not propose to permit the use of whey protein concentrate as a basic
dairy ingredient in yogurt manufacture (see 74 FR 2443 at 2453).
(Comment 11) Some comments opposed the use of reconstituted forms
of basic dairy ingredients but did not provide data to support their
assertions of any potential safety or technical concerns. Other
comments supported the use of reconstituted forms of basic dairy
ingredients and stated that these ingredients are already permitted in
the manufacture of other standardized dairy foods, have been routinely
used by the yogurt industry due to the stay of Sec. 131.200(c), and do
not adversely impact the safety or characteristics of yogurt. One
comment would allow the use of all types of safe and suitable milk-
derived ingredients to meet the minimum required 8.25 percent milk
solids not fat.
(Response 11) The comments opposed to reconstituted forms of dairy
ingredients did not provide any data nor do we have any information to
indicate any technical or safety concern or that use of these
ingredients affects the basic nature and essential characteristics of

[[Page 31125]]

yogurt or does not comport with consumer expectations about the food.
Although the comments provided no data to support that yogurt
containing reconstituted forms of dairy ingredients are less acceptable
or differ in taste, flavor, or texture to yogurts produced with other
basic dairy ingredients, the use of reconstituted forms of dairy
ingredients and other optional dairy ingredients in yogurt throughout
the marketplace indicates that the basic nature and essential
characteristics of yogurt are maintained in producing acceptable and
desired yogurt products. Therefore, the final rule includes the
reconstituted versions of cream, milk, partially skimmed milk, and skim
milk among the basic dairy ingredients in Sec. 131.200(b).
(Comment 12) One comment asked us to expand the list of basic dairy
ingredients to include ultrafiltered (UF) milk, its resulting dried
products (which were stated to include milk protein concentrate and
isolate), and skim milk powder (SMP). The comment described SMP as an
ingredient nearly identical to skim milk except for the removal of
water and the standardization of protein. The comment stated that
allowing UF milk as a basic dairy ingredient for yogurt is consistent
with our proposed rule that allows the use of UF milk in standardized
cheese and cheese products (70 FR 60751, October 19, 2005). The comment
said that the addition of these ingredients does not adversely affect
yogurt characteristics or safety.
(Response 12) The current yogurt standard (Sec. 131.200(c)) lists
cream, milk, partially skimmed milk, or skim milk as the basic dairy
ingredients. Proposed Sec. 131.200(b) would expand the list by
allowing the reconstituted versions of these ingredients. Reconstituted
versions are concentrated or dry forms of milk to which water may be
added, in a sufficient quantity to reconstitute the dry or concentrated
material to fluid form.
The use of fluid UF milk and its dried products as basic
ingredients in yogurt is not consistent with the basic nature of
yogurt. Fluid UF milk and its dried products are distinctly different
from milk and dried milk, respectively. The process of ultrafiltration
selectively removes not only water, but also lactose, minerals, and
water-soluble vitamins, resulting in a compositionally different
ingredient. The use of UF milk also affects the essential
characteristics of yogurt, which is a fermented product from milk. The
lactose in milk, which is significantly reduced in UF milk, is the
substrate for the fermentation process by the bacterial culture in the
production of yogurt. In addition, the rationale underlying our 2005
proposal for use of fluid UF milk in standardized cheeses and related
cheese products (70 FR 60751) is not applicable to the use of fluid UF
milk as a basic ingredient in yogurt because cheese and yogurt have
fundamentally different production procedures and are different in
their basic nature and essential characteristics. Moreover, the data
and evidence the Agency relied on to support its tentative conclusions
in the 2005 proposal were specific to standardized cheeses and related
cheese products. For these reasons, we decline to revise Sec.
131.200(b) to add fluid UF milk and its dried products for use as basic
dairy ingredients in yogurt.
We wish to make clear that the concentrated or dried ingredient
used for reconstitution must be such that the reconstituted form does
not differ significantly from the respective cream, milk, partially
skimmed milk, or skim milk (i.e., has reestablished the same specified
water:solids ratio). For example, concentrated milk (Sec. 131.115) and
dry whole milk (Sec. 131.147) are appropriate ingredients to
reconstitute to produce reconstituted milk. Nonfat dry milk (Sec.
131.125) is an appropriate ingredient to be used with water to produce
reconstituted skim milk. Although fluid UF milk, its resulting dried
derivatives, and SMP are not basic dairy ingredients under Sec.
131.200(b), if safe and suitable, they can be used in yogurt as
optional dairy ingredients under Sec. 131.200(c). Moreover, limiting
the basic dairy ingredients to those in Sec. 131.200(b) is consistent
with producing yogurt with the taste, flavor, and texture that
consumers expect.
(Comment 13) Two comments agreed on limiting the use of whey and
whey ingredients only as optional dairy ingredients in Sec.
131.200(c). In addition, one comment strongly opposed the use of whey
protein concentrates as a basic dairy ingredient, citing negative
impacts on yogurt quality. One comment supported the use of whey
protein concentrate and whey protein isolate as basic dairy ingredients
in yogurt making, citing their nutritional, functional, and taste
properties. However, the comment did not provide data or evidence to
support these assertions.
(Response 13) As discussed in the proposed rule (74 FR 2443 at
2453), the use of whey protein concentrates, whey protein isolate, or
other similar products as the basic dairy ingredients for yogurt may
result in products that are not consistent with the taste, flavor, or
texture expected by consumers. There are no new data or information
from our own research or provided in the comments to cause us to change
this position. Therefore, as noted in response 12, the final rule
permits only the use of cream, milk, partially skimmed milk, skim milk,
or the reconstituted versions of these ingredients as the basic dairy
ingredients in the manufacture of yogurt under Sec. 131.200(b).

E. Section 131.200(c)--Optional Dairy Ingredients

The proposed rule at Sec. 131.200(c) would allow the optional use
of other safe and suitable milk-derived ingredients to increase the
nonfat solids content of the food, provided that the ratio of protein
to total nonfat solids of the food and the protein efficiency ratio of
all protein present are not decreased as a result of the use of such
ingredients.
Proposed Sec. 131.200(a), would specify that yogurt is a food
produced by culturing one or more of the basic dairy ingredients (Sec.
131.200(b)) and any of the optional dairy ingredients (Sec.
131.200(c)) with the characterizing bacterial culture. We discussed
that any optional safe and suitable milk-derived ingredients can be
used to increase the milk solids not fat of the food above the minimum
required 8.25 percent (74 FR 2443 at 2450 through 2451).
(Comment 14) The proposed rule, at Sec. 131.200(c), would allow
the use of other safe and suitable milk-derived ingredients to increase
the nonfat solids content of the food, provided that the ratio of
protein to total nonfat solids of the food, and the protein efficiency
ratio of all protein present is not decreased as a result of adding
such ingredients.
Several comments agreed with the proposed limit on the use of
optional dairy ingredients. However, other comments opposed the use of
ingredients other than fluid milk in the manufacture of yogurt. Some
comments said that, without a defined list of optional safe and
suitable milk-derived ingredients, processors would make determinations
based on financial advantages rather than consumer preferences.
Many comments strongly opposed the use of milk-derived ingredients
such as milk protein concentrate (MPC) and whey products. The comments
expressed concerns about the safety and nutritional quality of such
ingredients, the adverse effect on yogurt quality, and the negative
economic impact on the U.S. dairy farmers. Some comments opposed the
use of MPC, which the comments considered to be an inferior,
unregulated, and mostly imported dairy ingredient. Further, the
comments opposing the use of MPC questioned

[[Page 31126]]

whether we performed sufficient evaluations to understand the safety
and nutritional quality of MPC. The comment argued that, because MPC is
not allowed in other standardized dairy foods, it should not be allowed
in yogurt. Some comments indicated that MPC has not been classified as
``generally recognized as safe'' (GRAS) (21 CFR 170.3 and 170.30;
sections 201(s) and 409 of the FD&C Act) and that, according to a 2001
report from the U.S. Government Accountability Office, MPC is not
nutritionally equivalent to fluid milk (Ref. 10).
(Response 14) Like any other food ingredient, optional milk-derived
ingredients (Sec. 131.200(c)) used in yogurt must be safe and
suitable. Section 130.3(d) (21 CFR 130.3) defines safe and suitable
ingredients used in the manufacture of standardized foods. The safe and
suitable ingredient must perform an appropriate function in the food
when used (Sec. 130.3(d)(1)) and be used at a level no higher than
necessary to achieve its intended purpose in that food (Sec.
130.3(d)(2)).
We disagree with the comments that only permitting the use of fluid
milk or establishing a defined list of optional dairy milk-derived
ingredients is necessary to manufacture the taste, aroma, appearance,
and nutritional characteristics of yogurt. We do not find a technical
reason to exclude one or more types of milk-derived ingredients as
optional dairy ingredients if the use of these ingredients complies
with all our applicable regulations, including Sec. 130.3(d)(1) and
(2).
We disagree with comments regarding safety or the GRAS status of
MPC. Under FDA's GRAS notification program, a person may notify FDA of
a conclusion that a substance is GRAS under the conditions of its
intended use in human food (21 CFR part 170, subpart E). FDA has
evaluated GRAS notices for certain functional uses of MPC in food,
including yogurt, and did not question the notifier's conclusion that
these uses are GRAS (Ref. 11). FDA is not aware of any information at
this time that calls into question the safety of the use of MPC in
yogurt. We note that it is a manufacturer's responsibility to ensure
that food ingredients are safe and are otherwise in compliance with all
applicable requirements. Furthermore, any optional dairy ingredients,
such as MPC, must be ``safe and suitable'' according to our regulations
whether they are sourced domestically or imported. This means, in
relevant part, that any use must be authorized under section 409 of the
FD&C Act or be exempt from regulation as a food additive (Sec.
130.3(d)).
We likewise disagree with the comment's position that MPC is a
substandard ingredient. MPC and other non-milk dairy ingredients can be
used as optional ingredients, provided the protein efficiency ratio of
all protein present must not be decreased as a result of adding
optional ingredients. Milk protein concentrates are made by
concentrating fluid skim milk using ultrafiltration and spray drying.
Because both casein and whey proteins are concentrated in this process,
the ratio of casein to whey protein remains nearly the same as the
ratio of these components in fluid milk (Ref. 12). Although the
comments provided no data to support that yogurt containing MPC in
addition to the required dairy ingredients are less acceptable or
differ in taste, flavor, or texture to yogurts produced with other
optional dairy ingredients, the longtime use of MPC and other optional
dairy ingredients in yogurt throughout the marketplace indicates that
the basic nature and essential characteristics of yogurt are maintained
in producing acceptable and desired yogurt products.
Regarding the use of imported ingredients, we have programs in
place, for example inspecting foods that are imported to the United
States from other countries, to make sure they comply with government
standards and meet the same safety requirements as foods produced
within the United States. In general, a foreign or domestic facility
that manufactures, processes, packs, or holds food for consumption in
the United States and has to register with FDA under section 415 of the
FD&C Act (21 U.S.C. 350d) is subject to the requirements related to
preventive controls of the Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Human Food rule (21
CFR part 117). Compliance with these regulations helps ensure that
imported dairy ingredients, including imported MPC, are as safe as
domestically produced dairy ingredients.
The comment stating that the use of MPC or whey products as an
optional dairy ingredient in yogurt would have a negative economic
impact on U.S. dairy farmers did not provide specific information as to
how the use of these ingredients would have a negative economic impact.
In addition, we note that Congress did not include economic
consequences for industry (such as suppliers or manufacturers) as the
statutory basis for establishing standards of identity. Section 401 of
the FD&C Act permits FDA to establish food standards, and consequently
to amend or revoke them, only when doing so ``promotes honesty and fair
dealing in the interest of consumers.''
Regarding the comment concerning MPC's effect on nutritional
quality, the use of MPC does not diminish the nutritional quality of
yogurt. Under the proposed rule, at Sec. 131.200(c), the ratio of
protein to total nonfat solids of the food and the protein efficiency
ratio of all protein present in yogurt must not be decreased as a
result of adding the optional dairy ingredients. This provision ensures
that the milk protein amount and protein quality are not reduced after
the addition of optional dairy ingredients and should address the other
concerns regarding the use of MPC on nutritional quality. This
provision is now codified at Sec. 131.200(c) in the final rule.
Although the proposed rule would require the minimum of 8.25
percent milk solids not fat at Sec. 131.200(a), and as discussed in
the preamble (74 FR 2443 at 2448), the proposed rule at Sec.
131.200(c) did not specify this minimum when describing other safe and
suitable milk-derived ingredients that may be used to increase the
nonfat solids content of the food. Thus, on our own initiative, for
added clarity, in Sec. 131.200(c) we specify the minimum of 8.25
percent milk solids not fat above which other safe and suitable milk
derived ingredients may be used to increase the milk solids not fat
content of the food as required in Sec. 131.200(a).
Additionally, we note that the phrase ``nonfat solids content'' in
proposed Sec. 131.200(c) would mean the same as the phrase ``milk
solids not fat'' in the proposed Sec. 131.200(a). Therefore, to be
consistent in the terms used, we have, on our own initiative, revised
Sec. 131.200(c) to use the phrase ``milk solids not fat.''
(Comment 15) One comment said that the addition of optional dairy
ingredients after culturing should not be permitted for safety
concerns, such as microbial contamination. Other comments asked us to
permit the addition of optional dairy ingredients after culturing if
the optional dairy ingredients are pasteurized and handled in a manner
to prevent post-pasteurization contamination. The comments gave cottage
cheese as an example of a standardized food in which optional dairy
ingredients may be added after culturing; for example, pasteurized
cottage cheese dressing is added to the cultured curd.
One yogurt producer stated that adding pasteurized milk-derived
ingredients after culturing would conserve water and energy and would
provide production flexibility. The comment stated that characterizing
the

[[Page 31127]]

yogurt, e.g., by adjustment of the fat content, at the end of the
process rather than the beginning, would reduce water usage for
cleaning blend storage silos and flushing lines between blends. The
comment also stated that energy costs would be reduced because the
pasteurizer could operate more efficiently with fewer stoppages for
changeovers between blends.
(Response 15) We decline to revise the rule to permit optional
dairy ingredients after culturing, regardless of whether the optional
dairy ingredients are pasteurized and handled in a manner to prevent
post-pasteurization contamination. The goal of the standard of identity
is to preserve the basic nature and the essential characteristics of
yogurt consistent with consumer expectations. Yogurt has long been
considered a cultured dairy product where the dairy ingredients are
combined and cultured together. As we explained in response 5, the
yogurt standard must ensure that the cultured and fermented yogurt
reaches the desired titratable acidity 0.7 or maximum pH of 4.6 solely
by the fermentation action of bacterial culture. This ensures not only
the taste and texture characteristics of yogurt are developed, but also
maintains the product's safety and characteristics. Unlike cottage
cheese, adding optional dairy ingredients after culturing is not
consistent with the development of yogurt's characteristic flavor and
acidity. Because more than 90 different compounds are responsible for
the flavor and aroma of fermented yogurt (Ref. 3), it is essential that
the dairy ingredients be cultured together.
Likewise, regardless of the potential to conserve water and energy
in manufacturing, the addition of pasteurized milk-derived ingredients
after culturing at the end of the process, rather than the beginning,
may negatively affect the essential characteristic flavor and aroma of
yogurt. Therefore, we decline to revise the rule to permit the addition
of milk-derived ingredients after culturing.
(Comment 16) One comment agreed with our proposal to not require a
minimum amount of dairy ingredients. Another comment stated that we
should set a percentage higher than 51 percent because, according to
the comment, yogurt should be mostly made of dairy ingredients.
(Response 16) As explained in the proposed rule, the yogurt
standard requires a minimum milkfat of 3.25 percent and a minimum of
milk solids not fat of 8.25 percent before the addition of bulky
flavoring ingredients (74 FR 2443 at 2447). As noted previously, the
3.25 percent minimum milkfat requirement is consistent with the USDA
FoodData Central database for the total fat content of ``yogurt, plain,
whole milk'' (3.25 grams/100 gram serving or 3.25 percent) (Ref. 2).
With respect to the minimum milk solids not fat, a minimum of 8.25
percent is consistent with the standards found in fluid milk. Both of
these minimum requirements contribute to yogurt's characteristic
texture. We noted in the proposed rule that the yogurt standard
currently requires that the basic ingredients of yogurt be either milk
or certain milk-derived ingredients and that yogurt must contain a
specified minimum amount of milk solids not fat (74 FR 2443 at 2453).
We did not propose to require a minimum amount of dairy ingredients in
yogurt because the existing yogurt standard (Sec. 131.200(a), (b), and
(c)) adequately ensures that appropriate amounts of dairy ingredients
are used in the manufacture of yogurt (id.). Therefore, we decline to
require a minimum percentage amount of dairy ingredients in yogurt.

F. Section 131.200(d)--Other Optional Ingredients

The proposed rule, at Sec. 131.200(d), would allow other optional
safe and suitable ingredients in the manufacture of yogurt,
specifically cultures in addition to the characterizing bacterial
cultures, sweeteners, flavoring ingredients, color additives,
stabilizers, emulsifiers, and preservatives. In addition, the proposed
rule would revoke the provisions on optional addition of vitamins A and
D (74 FR 2443 at 2454).
(Comment 17) Most comments generally supported the use of safe and
suitable ingredients, specifically cultures, in addition to the
characterizing bacterial cultures. The comments stated that explicitly
providing for the use of other optional safe and suitable bacterial
cultures provides regulatory clarity for the use of microorganisms such
as probiotic strains in yogurt products. One comment also stated that
the proposal provides industry flexibility while maintaining the
product's basic nature and essential characteristics.
(Response 17) We are finalizing Sec. 131.200(d)(1) without change.
(Comment 18) The proposed rule, at Sec. 131.200(d)(2), would allow
the use of ``sweeteners'' (rather than ``nutritive carbohydrate
sweeteners'') as an optional ingredient, to permit the use of any safe
and suitable sweetening ingredient rather than certain nutritive
carbohydrate sweeteners. We explained that the proposed changes would
allow consumers to still be informed of the presence of the sweetening
ingredient through its declaration by its common or usual name in the
ingredient statement of the yogurt (74 FR 2443 at 2452). However, in
response to the NYA petition's request for the ``sweetener being
declared in the ingredient statement of the food so that non-nutritive
sweeteners may be used in yogurt without a specific declaration of its
presence in the name of the food,'' we tentatively concluded that there
is no basis to make this change (74 FR 2443 at 2451 through 2452).
Several comments supported the change to ``sweeteners,'' stating
that there should be no requirement for the declaration of nonnutritive
sweeteners in the name of the food because consumers would be
adequately informed of the presence of a sweetening ingredient through
the declaration by its common or usual name in the ingredient statement
of the yogurt. The comments also stated that amending the rule to refer
to sweeteners rather than a specific list of nutritive carbohydrate
sweeteners would provide manufacturing flexibility, encourage more low-
calorie yogurt options for consumers, and be consistent with the
sweetener provision in the standard of identity for ice cream and
frozen custard (21 CFR 135.110), which refers to ``safe and suitable
sweeteners.''
However, other comments opposed a change to ``sweeteners'' as an
optional ingredient. Some comments opposed the use of nonnutritive
sweeteners in the yogurt standard of identity because of perceived
safety concerns, with some opposing the use of specific artificial
sweeteners in yogurt. For example, some comments said that people with
sensitivities to a specific artificial sweetener would be unaware the
product contained the specific artificial sweetener and could be
adversely affected. Other comments stated that, if nonnutritive
sweeteners are used, they must be labeled in such a way that consumers
are adequately and accurately informed. Several comments would require
listing nonnutritive sweeteners in the ingredient statement.
(Response 18) We have decided not to revise Sec. 131.200(d)(2) to
specify the use of ``sweeteners'' in yogurt rather than ``nutritive
carbohydrate sweeteners.'' If we were to amend Sec. 131.200(d)(2) to
refer to ``sweeteners,'' then both nutritive carbohydrate sweeteners
and nonnutritive sweeteners would be optional ingredients under the
yogurt standard. Consequently, manufacturers could use nonnutritive
sweeteners in yogurt to reduce calories without

[[Page 31128]]

making a nutrient content claim. This is not what we had intended under
the regulatory framework of Sec. 130.10 after NLEA was enacted.
We have decided that nonnutritive sweeteners should only be
permitted when making a nutrient content claim and therefore when the
product is subject to the general definition and standard in Sec.
130.10. As such, products containing nonnutritive sweeteners, but that
otherwise comply with the requirements in Sec. 131.200, are not the
standardized food ``yogurt'' and are different standardized foods
(e.g., ``reduced calorie yogurt'') under Sec. 130.10. The name of each
of these foods must be prominently displayed in the statement of
identity on the product label in accordance with Sec. 101.3. We note
that this approach is consistent with the approach under our current
regulations as Sec. 130.10 permits deviations to Sec. Sec. 131.200,
131.203, and 131.206 in order to comply with a nutrient content claim
defined by regulation (e.g., ``reduced calorie'').
We further note that, under this approach, products deviating from
Sec. 131.200 due to the use of nonnutritive sweeteners are not
required to declare the presence of the nonnutritive sweeteners in the
name or statement of identity of the food. Instead, Sec. 130.10
requires them to bear the nutrient content claim achieved by use of
nonnutritive sweeteners in the name or statement of identity. We
believe this approach will address comments concerning the presence and
disclosure of artificial sweeteners while also providing manufacturers
flexibility to make modified yogurt products with nonnutritive
sweeteners. Unlike the proposed rule, the final rule does not permit
the use of nonnutritive sweeteners in yogurt under Sec. 131.200(d)(2).
However, under Sec. 130.10, products marketed with a nutrient content
claim in the name of the food (e.g., ``reduced calorie yogurt'') will
signal to consumers that the food differs from ``yogurt,'' ``lowfat
yogurt,'' and ``nonfat yogurt'' and contains nonnutritive sweeteners.
Consumers will continue to be informed about the presence of specific
nonnutritive sweeteners by their declaration under their common or
usual names in the ingredient statement on the label, as required by
Sec. 101.4(a).
We have also considered comments concerning safety. We consider the
safety of nonnutritive sweeteners as part of the food additive review
process or GRAS notification process. There is no evidence to indicate
that nonnutritive sweeteners, either as approved food additives or as
GRAS substances in yogurt, are unsafe when used in modified yogurt
products. We understand that some consumers may have sensitivities to
artificial sweeteners. As explained above, the name or statement of
identity of the product will put consumers on notice about the presence
of artificial sweeteners and the particular sweetener can be confirmed
by referencing the ingredient statement.
(Comment 19) Some comments asked us to require prominent
declaration or display (e.g., in large type on the principal display
panel) of nonnutritive sweeteners on yogurt containers in addition to
listing the nonnutritive sweeteners in the ingredient statements.
(Response 19) We do not agree that the name of the nonnutritive
sweetener should be prominently displayed on the yogurt containers
because, under Sec. 130.10, a yogurt product with nonnutritive
sweeteners will bear a nutrient content claim, such as ``reduced
calorie,'' in its statement of identity. Section 101.3(d) requires that
the statement of identity be presented in bold type on the principal
display panel, in a size reasonably related to the most prominent
printed matter on such panel, and in lines generally parallel to the
base on which the package rests as it is designed to be displayed. The
nutrient content claim will signal to consumers the presence of
nonnutritive sweeteners and prompt consumers to check the ingredient
statements for the types of nonnutritive sweeteners used. Disclosure of
nonnutritive sweeteners in the ingredient statement, rather than the
name or statement of identity, is consistent with the labeling of other
foods made with nonnutritive sweeteners. Nonnutritive sweeteners are
declared by their common or usual names in the ingredient statement on
the food labels in accordance with Sec. 101.4(a).
In some instances, specific requirements are necessary for the safe
use of a nonnutritive sweetener. The conditions for including this
information on the label and how and where this information is to be
presented on the label are established in the relevant food additive
regulations. For example, labels of food that contain aspartame must
bear the statement ``PHENYLKETONURICS: CONTAINS PHENYLALANINE,'' either
on the principal display panel or on the information panel, in
accordance with Sec. 172.804 (21 CFR 172.804).
Other than what is provided in these regulations, we do not see a
basis to require disclosure of nonnutritive sweeteners other than in
the ingredient statement. Therefore, we decline to require the name of
the nonnutritive sweetener be prominently displayed on the yogurt
container. However, manufacturers may declare, voluntarily, on the
principal display panel that the product is artificially sweetened or
is made with nonnutritive sweeteners as long as the declaration is
truthful and not misleading.
(Comment 20) One comment opposed the use of high fructose corn
syrup (HFCS) in yogurt.
(Response 20) HFCS is a nutritive carbohydrate. HFCS is affirmed as
GRAS and can be used in food with no limitation other than current good
manufacturing practice (Sec. 184.1866 (21 CFR 184.1866)). The comment
did not provide any data or other information to support prohibiting
the use of HFCS in yogurt, so we decline to revise the rule to exclude
HFCS as a sweetener.
(Comment 21) The proposed rule would revise Sec. 131.200(d)(5) to
permit the use of safe and suitable emulsifiers in addition to
stabilizers as optional ingredients in the manufacture of yogurts.
A few comments opposed the use of emulsifiers and questioned the
need for these ingredients in yogurt. Other comments supported the use
of emulsifiers in yogurt, indicating that this would allow industry
more flexibility in formulating products.
(Response 21) There are no data suggesting that emulsifiers pose
any safety or characteristic concerns in yogurt, provided they are used
within good manufacturing practice as described in 21 CFR 172.5(a) and
within limitations specified by our relevant food additive regulations
or are GRAS. Therefore, we decline to remove emulsifiers as an optional
ingredient in yogurt. However, to clarify that stabilizers and
emulsifiers are two different functional classes, we have, on our own
initiative, decided to list stabilizers and emulsifiers separately as
Sec. 131.200(d)(5) and (6), respectively. We also have renumbered
Sec. 131.200(d)(6) as Sec. 131.200(d)(7).
(Comment 22) The proposed rule, at Sec. 131.200(d)(6), would
permit preservatives as an optional ingredient in yogurt. Some comments
supported permitting the use of safe and suitable preservatives as
optional ingredients in the manufacture of yogurt and stated that the
use of preservatives should not be limited only to heat-treated yogurt.
Other comments opposed the use of any preservatives.
(Response 22) The proposed rule would not limit the use of
preservatives to heat-treated yogurt and would, instead, allow the use
of preservatives for all types of yogurt. The comments

[[Page 31129]]

that opposed the use of preservatives did not provide any data or
information to support their opposition, and we do not have any data
that indicate that appropriate use of preservatives has an adverse
effect on the characteristics of yogurt, particularly in the case of
yogurt that is heat-treated after culturing to have an extended shelf-
life. Therefore, we decline to revise Sec. 131.200(d)(6) regarding the
use of preservatives as an optional ingredient in yogurt, but we have
renumbered the section in the final rule as Sec. 131.200(d)(7) (see
response 21).
(Comment 23) The proposed rule would revoke Sec. 131.200(b), which
provides for optional addition of vitamins A and/or D in yogurt, and
revoke Sec. 131.200(f)(1)(iii),which pertains to labeling of yogurt
that contains added vitamins A and D. The proposed rule explained, in
part, that the provision for the optional fortification of yogurt with
vitamins A and D was established in 1981 before the implementation of
the NLEA and the adoption of the certain nutrient content and relative
claims regulations, including Sec. 101.54. We explained in the
proposed rule that we believed it was appropriate to apply the
provisions of Sec. 101.54(e) to vitamins A and D fortification of
yogurt (74 FR 2443 at 2454).
We invited comment on whether we should retain the current optional
vitamin addition provisions of Sec. 131.200(b) and, if so, what the
justification for retaining these provisions would be, and the
appropriateness of applying Sec. 101.54(e) to yogurt fortified with
vitamins A and/or D. One comment agreed with removing the provisions
pertaining to optional addition of vitamins A and D.
However, other comments asked us to retain the current optional
vitamin fortification provisions and the associated labeling provision.
The comments said that, even though such provisions are not consistent
with the NLEA and the nutrient content claim regulations, optional
vitamins A and D fortification is a longstanding practice for the
yogurt industry and is consistent with the standards of identity for
other milk products in 21 CFR part 131.
Another comment said we should revise the amounts of vitamins A and
D fortification based on percentages of recommended Daily Values (DV)
rather than specific levels per quart. The comment recommended we
modernize the optional vitamin A addition of not less than 10 percent
DV per RACC and optional vitamin D addition of not less than 25 percent
DV per RACC in the final rule.
(Response 23) Given the yogurt industry's current fortification
practice and apparent consumer acceptance of optional fortification
with corresponding ingredient declaration, the final rule does not
remove the provisions concerning the optional addition of vitamins A
and D. For these reasons, the provisions for optional addition of
vitamins A and D remain part of the yogurt standard; however, because
the final rule also reorganizes and renumbers the provisions in Sec.
131.200, we have placed the provisions regarding optional vitamin
addition in Sec. 131.200(d)(8).
We believe that modernization of the yogurt standard of identity
should include bringing the outdated vitamins A and D fortification
provisions in conformity with the way in which vitamins are now
referenced based on percentages of recommended DV rather than specific
levels per quart. Therefore, the final rule, at Sec. 131.200(d)(8),
provides for the optional addition of vitamin A if added at not less
than 10 percent Daily Value per RACC, and/or the optional addition of
vitamin D if added at not less than 25 percent Daily Value per RACC.
In addition, we decline to revoke the labeling requirements
associated with optional vitamins A and/or D addition. To inform
consumers about the optional addition of vitamins A and/or vitamin D,
these requirements remain part of the yogurt standard in Sec.
131.200(f)(1)(iii).
(Comment 24) The proposed rule discussed that the standards of
identity for yogurt, lowfat yogurt, and nonfat yogurt do not permit the
optional use of any safe and suitable ingredient for a nutritional or
functional purpose. We explained that while the NYA petition asked us
to revise our regulations to allow for such ingredients and while
comments to the ANPRM both favored and opposed the NYA recommendation,
we decided that there was not a need for a broad provision to permit
any safe and suitable ingredient for a nutritional or functional
purpose (74 FR 2443 at 2453).
The comments to the proposed rule were mixed on whether we should
add a broad provision permitting the use of any safe and suitable
ingredient that serves a nutritional or functional purpose. Some stated
that such an approach would help maintain the integrity of yogurt.
Other comments said that any safe and suitable ingredient should be
allowed to provide flexibility and to promote innovation. One comment
was concerned that yogurt bearing nutrient content claims would no
longer fall under the standard of identity without a provision that
would allow the use of any safe and suitable ingredient for a
nutritional or functional purpose. Another comment emphasized that
lactic acid and other acidulants as functional ingredients should not
be allowed.
(Response 24) As we explained in the proposed rule, our existing
regulatory framework governing standardized foods already provides for
the addition of substances for a nutritional purpose (74 FR 2443 at
2453). As for the use of ingredients for a functional purpose, the
final rule, at Sec. 131.200(c), provides for the use of optional dairy
ingredients to increase the nonfat solids content of food under certain
conditions. The final rule, at Sec. 131.200(d), also provides for the
use of specific functional categories of ingredients such as
emulsifiers and stabilizers. We revised Sec. 131.200 to retain the
optional addition of vitamins A and/or D. Section 131.200(d)(8) now
provides for optional addition of these vitamins as in our current
standard of identity for yogurt but has been revised to specify the
amounts of added vitamins A and D based on percentages of DV per RACC
rather than International Units per quart.
Although Sec. 131.200(c) and (d) permit the use of certain
optional ingredients for nutritional or functional purposes in yogurt,
lactic acid and other acidulants are not permitted as other optional
ingredients under Sec. 131.200(d). Yogurt is produced by culturing the
basic dairy ingredients and any optional dairy ingredients with a
characterizing lactic acid-producing bacterial culture, and not through
the addition of lactic acid or other acidulants (see response 6).

G. Section 131.200(e)--Methods of Analysis

The current standard of identity for yogurt lists the methods of
analysis for milkfat content, total solids content, and titratable
acidity that are from the ``Official Methods of Analysis of AOAC
International,'' 13th Ed. (1980). The proposed rule, at Sec.
131.200(e), would update the referenced methods of analysis to
``Official Methods of Analysis of AOAC International (AOAC Methods),''
18th edition, 2005. The AOAC Methods have been updated twice since the
publication of the proposed rule. The latest version is the 21st
edition, 2019. Therefore, on our own initiative, we have revised Sec.
131.200(e) to refer to the 21st edition of the AOAC Methods.
The proposed rule inadvertently deleted the milkfat method of
analysis from Sec. 131.200(e). Therefore, on our own initiative, we
have revised Sec. 131.200(e) by restoring the method of analysis for
milkfat referencing the

[[Page 31130]]

updated modified Mojonnier ether extraction method in section 33.2.26
of the AOAC Methods: Official Method 989.05. Thus, we have revised
Sec. 131.200(e)(1) by adding paragraph (i) to identify the AOAC
Official Method 989.05 for milkfat content and renumbering the
remaining paragraphs accordingly.
The proposed rule, at Sec. 131.200(e)(1)(i) and (ii), would
establish the methods of analysis for milk solids not fat and for
titratable acidity, respectively.
We did not receive comments on these provisions. However, as
explained previously, we have renumbered these provisions as Sec.
131.200(e)(1)(ii) and (iii), respectively, because we have restored the
inadvertent deletion of the method of analysis for milkfat at Sec.
131.200(e)(1)(i).
Proposed Sec. 131.200(e)(2) would adopt the potentiometric method
for pH as described in Sec. 114.90(a) (21 CFR 114.90(a)).
We did not receive comments on the method for pH that indicated a
need to change methodology, and we have finalized Sec. 131.200(e)(2)
without change.
(Comment 25) Proposed Sec. 131.200(e)(3) would discuss the
measurement of live and active cultures and refer to the use of the
aerobic plate count method described in Chapter 3 of FDA's
Bacteriological Analytical Manual, January 2001 edition (the BAM
method) (Ref. 13). Several comments objected to the use of the BAM
method. The comments indicated that the BAM method is not appropriate
for the accurate enumeration of live and active cultures in yogurt. The
comments recommended that, for accuracy and repeatability, live and
active cultures should be determined by the method described in the
International Organization for Standardization (ISO) 7889/International
Dairy Federation (IDF) 117:2003 (ISO 7889/IDF 117:2003), ``Yogurt-
Enumeration of characteristic microorganisms--colony count-technique at
37 [deg]C'' (Ref. 14).
(Response 25) We evaluated the BAM method and the ISO 7889/IDF
117:2003 method. We agree that the BAM method is a general reference
for determining plate counts and is not designed specifically for the
measurement of characterizing cultures in yogurt products. We also
agree that the ISO 7889/IDF 117:2003 method, which is specifically
designed to measure the characteristic microorganisms in yogurt, is the
appropriate method. The ISO 7889/IDF 117:2003 method is also referenced
as the appropriate method to enumerate characterizing microorganisms in
yogurt in the Standard Methods for the Examination of Dairy Products
(Ref. 15). Therefore, we have revised Sec. 131.200(e)(3) and replaced
the proposed BAM method with the ISO 7889/IDF 117:2003 method
incorporated by reference in the final rule.
(Comment 26) One comment said that, for other safe and suitable
organisms, individual yogurt manufacturers should bear the
responsibility of using validated methods to enumerate such bacteria to
substantiate label claims.
(Response 26) We agree that manufacturers using other safe and
suitable bacterial cultures have or should have the knowledge to
determine the most appropriate method to enumerate these organisms.
Therefore, the final rule does not specify methods to measure other
safe and suitable bacterial cultures to substantiate label claims.

H. Section 131.200(f)--Nomenclature

The proposed rule would revise Sec. 131.200(f) by: (1) Stating
that the word ``sweetened'' must accompany the name of the food
wherever it appears on the principal display panel or panels if a
``sweetener'' (rather than a nutritive carbohydrate sweetener) is added
without the addition of characterizing flavor; and (2) providing for
the optional labeling of ``contains live and active cultures.''
As discussed in responses 18, 19, and 20, we have decided to retain
the term ``nutritive carbohydrate sweeteners'' in Sec. 131.200(d)(2)
instead of using the term ``sweeteners.'' Likewise, we have decided to
retain ``nutritive carbohydrate sweetener'' in Sec. 131.200(f)(1)(i)
rather than use the term ``sweetener.'' The requirement in Sec.
131.200(f)(1)(i) continues to apply only to nutritive carbohydrate
sweeteners and is not amended under this final rule. Under Sec.
130.10, nonnutritive sweeteners can be used in the manufacture of
yogurt products that deviate from the standard of identity for yogurt
in order to meet an expressed nutrient content claim defined by
regulation (e.g., ``reduced calorie''). The nutrient content claim is
part of the name or the statement of identity of the food (e.g.,
``reduced calorie yogurt'') and signals to consumers that the food
differs from yogurt and contains nonnutritive sweeteners.
As discussed in responses 27, 28, and 29 regarding the labeling of
yogurt containing live and active cultures, the final rule revises the
proposed nomenclature provisions relating to heat-treated yogurt.
Changes in the final rule at Sec. 131.200(a), (b), (c), and (d)
necessitate additional changes in Sec. 131.200(f) regarding
nomenclature provisions in the final rule.
(Comment 27) Currently, Sec. 131.200(f)(1)(ii) requires that, if
the yogurt product is heat-treated after culturing, the parenthetical
phrase ``(heat-treated after culturing)'' must follow the name of the
food wherever it appears on the principal display panel or panels of
the label in letters not less than one-half of the height of the
letters used in such name. The proposed rule would revise Sec.
131.200(f)(1)(ii) by requiring the parenthetical phrase ``(heat-treated
after culturing)'' to appear after the name of the food if the dairy
ingredients have been heat-treated after culturing.
One comment opposed modifying the labeling requirements for heat-
treated yogurt. The comment also opposed the requirement of any phrase
on the label of heat-treated yogurt that would classify it as one that
does not contain live and active cultures, arguing that there is no
difference in the effect on the human body between the consumption of
yogurt with live and active cultures and those without. Other comments
expressed concerns that consumers may not understand the statement
``heat-treated after culturing,'' although one comment did agree with
the proposed rule. Another comment cited a consumer survey that
evaluated consumer understanding of the phrase ``heat-treated after
culturing.'' The comment claimed that the cited survey indicated that
the meaning of this phrase is not clear to most consumers and does not
inform consumers that the treatment destroys some or all the bacterial
cultures.
Many comments opposed heat treatment after culturing but said that,
if heat treatment after culturing is allowed, the product should be
clearly labeled (see comment 7). One comment would require a statement
on the package to indicate that the product ``does not contain live and
active cultures.''
(Response 27) As discussed in response 7, many consumers are
interested in knowing whether the yogurt product they purchase contains
live and active cultures. The term used in the proposed rule ``heat-
treated after culturing'' is a description of a manufacturing process
and does not directly inform consumers how the manufacturing process
affects the properties of finished yogurt product. Apart from the
nutritional aspect, the beneficial effect of yogurt or yogurt cultures
is reportedly either lost (Ref. 16) or reduced (Refs. 17 to 20) when
the

[[Page 31131]]

yogurt is heat-treated after culturing. In the proposed rule, we
recommended that manufacturers may consider using additional truthful
and non-misleading statements, such as ``does not contain live and
active cultures,'' in the labeling of their heat-treated yogurt
products to help consumers distinguish heat-treated yogurt from
traditional yogurt (74 FR 2443 at 2450). We evaluated the consumer
survey results and conclude that the survey findings support the belief
that many consumers do not understand the meaning of the term ``heat-
treated after culturing'' (Ref. 6). We find that the term ``heat-
treated after culturing'' does not adequately inform consumers whether
the yogurt still contains live and active cultures in the final
product. To prevent the labeling of yogurt from being misleading under
section 403(a)(1) and 201(n) of the FD&C Act, the phrase ``does not
contain live and active cultures'' should appear on the label of yogurt
instead of ``heat-treated after culturing'' when the final product does
not contain live and active cultures. Therefore, we have revised Sec.
131.200(f)(1)(ii) to require the phrase ``does not contain live and
active cultures'' if the dairy ingredients have been treated after
culturing to inactivate viable microorganisms.
(Comment 28) One comment stated that new and emerging thermal
treatment technologies that are less severe than pasteurization
conditions have been used to enhance the sensory profile of a product
or for acidity purposes. The comment asked us to clarify that, if these
heated yogurt products still contain a minimum of 10\7\ CFU/g live and
active cultures at the time of manufacture, they do not have to bear
the statement indicating that they have been heat-treated or do not
contain live and active cultures.
(Response 28) We understand that the impact of a heat treatment
will vary depending on heating temperature and holding time. We agree
that it would not be appropriate to require heated yogurt products with
10\7\ CFU/g live and active cultures to bear the ``does not contain
live and active cultures'' statement. As discussed in response 7, we
realize that, in the future, new technologies other than heat treatment
may be developed to inactivate viable microorganisms and thus extend a
product's shelf life. The ``does not contain live and active cultures''
statement should not be limited to only heat-treated yogurt. It would
be appropriate for products that have not been heat-treated but have
been treated with other alternative technologies to inactivate viable
microorganisms, to bear the ``does not contain live and active
cultures'' statement to adequately inform consumers. Therefore, we have
revised Sec. 131.200(f)(1)(ii) to require that the phrase ``does not
contain live and active cultures'' accompany the name of the food if
the yogurt has been treated after culturing to inactivate viable
microorganisms.
(Comment 29) A few comments requested that we require the statement
``does not contain live and active cultures'' to appear prominently on
the label or in the same size, font, and color as the name of the food
and in close proximity to the name of the food without intervening
material.
(Response 29) Under Sec. 131.200(f)(1)(ii), the phrase ``does not
contain live and active cultures'' is required to accompany the name of
the food wherever it appears on the principal display panel or panels
of the label in letters not less than one-half of the height of the
letters used in the name. We do not agree with the comments that the
phrase ``does not contain live and active cultures'' must appear in the
same size, font, and color as the name of the food. The comments did
not demonstrate why use of the same size, font, and color as the name
of the food would improve consumer attention to or understanding of the
phrase.

I. Revoking the Standards of Identity for Lowfat Yogurt and Nonfat
Yogurt

(Comment 30) Some comments supported revoking the standards of
identity for lowfat yogurt and nonfat yogurt such that the standardized
food yogurt under proposed Sec. 131.200 could be modified to produce
lower-fat versions of yogurt under Sec. 130.10. (For purposes of this
preamble, ``lower-fat'' versions of yogurt refers to products with less
than 3.25 percent minimum fat level specified in Sec. 131.200(a).)
Other comments were concerned that there will be no standard of
identity for these lower-fat versions of yogurt.
(Response 30) Revocation of Sec. 131.203 and Sec. 131.206 will
result in lowfat yogurt and nonfat yogurt being covered under the
general definition and standard of identity in Sec. 130.10. This
action will provide for consistency in the nomenclature and labeling of
``lowfat'' and ``no fat'' food products and help ensure ``lowfat''
yogurt meets consumer expectations. These foods, along with other
lower-fat versions of yogurt, will be standardized foods with a
standard of identity under this regulation. Because Sec. 130.10 only
permits specific deviations from the standardized food for which a
lower-fat version substitutes, many requirements in the yogurt standard
of identity will apply to lower-fat versions and will help maintain the
basic nature and essential characteristics of these products.

J. Compliance Date

(Comment 31) The proposed rule did not discuss when a final rule
would become effective or when the compliance date for a final rule
would occur.
One comment requested a 2-year implementation date for necessary
label changes after the final rule. The comment indicated that revoking
the standards of identity for lowfat yogurt and nonfat yogurt would
require these products to be fortified to achieve nutrient equivalency.
The comment also stated that the 2-year implementation date is
consistent with the Uniform Compliance Date for label changes and will
provide enough time for processors to deplete existing packaging
inventory, reformulate products, install fortification equipment, and
make the necessary label changes. Another comment asked us to align the
compliance timeline of the final yogurt rule with that of a then-
unpublished final rule to revise our Nutrition and Supplement Facts
Label requirements (79 FR 11880, March 3, 2014). The comment said that
companies could revise yogurt labels much more efficiently by making a
single set of changes in response to both sets of requirements and
minimize the economic impact of label changes.
(Response 31) The final rule is effective on July 12, 2021. The
compliance date of this final rule is January 1, 2024, consistent with
Uniform Compliance Date for final food labeling regulations that are
issued in calendar years 2021 and 2022 (see 86 FR 462, January 6,
2021).
We decline to align the compliance date with that for the final
Nutrition and Supplement Facts Label regulations. We note that the
compliance date for the final Nutrition and Supplement Facts Label
regulations is January 1, 2020, for manufacturers with $10 million or
more in annual food sales and January 1, 2021, for manufacturers with
less than $10 million in annual food sales (83 FR 19619, May 4, 2018).
Thus, these compliance dates for the Nutrition and Supplement Facts
Label regulation have already passed.

K. Amendments in 21 CFR 130.10

Revoking the standards of identity for lowfat yogurt and nonfat
yogurt brings these foods under the coverage of the general definition
and standard in Sec. 130.10. For foods covered under the general
definition and standard,

[[Page 31132]]

Sec. 130.10(b) requires nutrients to be added to restore nutrient
levels so that the product is not nutritionally inferior to the
standardized food as defined in 21 CFR parts 131 to 169. As discussed
in the proposed rule, lowfat yogurt and nonfat yogurt have a lower
vitamin A content than yogurt and therefore would be required under
Sec. 130.10(b) to be fortified with vitamin A to the same level as
yogurt.
(Comment 32) One comment supported nutritional equivalence of
lowfat yogurt and nonfat yogurt with yogurt under Sec. 130.10(b),
noting that the requirement would make these foods consistent with
other foods modified under the general definition and standard. Another
comment opposed mandatory fortification of lowfat yogurt and nonfat
yogurt with vitamin A based on the costs of compliance for industry.
(Response 32) Requiring vitamin A fortification of lower-fat yogurt
products under Sec. 130.10(b) would not necessarily make these
products consistent with other modified dairy foods. FDA has not
enforced Sec. 130.10(b) with respect to vitamin A fortification of
lower-fat milk products covered under the general definition and
standard (see South Mt. Creamery, LLC v. United States FDA, 438 F.
Supp. 3d 236 (2020)). Moreover, as noted in the proposal, the
contribution of yogurt to daily vitamin A intake is not expected to be
altered significantly if the nutritional equivalency requirement in
Sec. 130.10(b) were to apply to lowfat yogurt and nonfat yogurt.
Although yogurt consumption has increased in recent years, the
contribution of vitamin A that would result from fortification of
lower-fat yogurt products remains insignificant (Ref. 21). Thus, in
light of our enforcement policy regarding vitamin A fortification of
lower-fat milk products and the lack of public health impact from
vitamin A fortification of yogurt, we are amending Sec. 130.10(b) to
exempt lower-fat yogurt products from vitamin A fortification.
This final rule revises Sec. 130.10(b) to provide for the
exemption. Manufacturers may choose to fortify lowfat yogurt and nonfat
yogurt with vitamin A to the level in yogurt; however, they are not
required to do so. If they choose to fortify with vitamin A under Sec.
130.10(b), then vitamin A must be declared in the ingredient statement.

L. Incorporation by Reference

The final rule incorporates two references. As we explained in part
IV.G, FDA is incorporating by reference three methods from the
``Official Methods of Analysis of AOAC International,'' 21st edition
(2019). You may purchase a copy of the material from AOAC
INTERNATIONAL, 2275 Research Blvd., Suite 300, Rockville, MD 20850-
3250, USA, 301-924-7077 ext. 170. https://www.aoac.org/official-methods-of-analysis-21st-edition-2019/. The AOAC Methods have undergone
rigorous scientific review and validation to determine the performance
characteristics for the intended analytical application and fitness for
purpose. Each of the following three methods includes specific
instructions for performing the chemical analysis of a substance in a
particular matrix.
AOAC Official Method 947.05, Acidity of Milk Titrimetric
Method, 21st edition, 2019, Vol. 1.
AOAC Official Method 989.05, Fat in Milk Modified
Mojonnier Ether Extraction Method, 21st edition, 2019, Vol. 1.
AOAC Official Method 990.21, Solids-Not-Fat in Milk by
Difference between Total Solids and Fat Contents, 21st edition, 2019,
Vol. 1.
Also, FDA is incorporating by reference the International
Organization for Standardization 7889:2003(E)/International Dairy
Federation 117:2003(E) (ISO 7889:2003(E)[bond]IDF 117:2003(E)),
Yogurt--Enumeration of Characteristic Microorganisms--Colony-Count
Technique at 37 [deg]C, First edition, 2003-02-01. You may purchase a
copy of the material from the International Organization for
Standardization, ISO Central Secretariat, Chemin de Blandonnet 8, CP
401, 1214 Vernier, Geneva, Switzerland. +41 22 749 01 11.
[email protected]. ISO 7889[bond]IDF 117:2003 specifies a method for the
enumeration of characteristic microorganisms in yogurt by means of the
colony-count technique at 37 degrees Celsius. The method is applicable
to yogurts in which both characteristic microorganisms (L. delbrueckii
subspecies bulgaricus and S. thermophilus) are present and viable.

V. Economic Analysis of Impacts

This rule is issued in accordance with the formal rulemaking
provisions of 5 U.S.C. 556 and 557, and is, therefore, exempt from the
economic analysis requirements of Executive Order (E.O.) 12866 and E.O.
13563. We have examined the economic implications of this rulemaking on
small businesses.

Regulatory Flexibility Analysis

The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies
to analyze regulatory options that would minimize any significant
impact of a rule on small entities. Because this rule may generate
compliance costs for some small firms, we believe that this rule would
have a significant economic impact on a substantial number of small
entities and is therefore subject to a final regulatory flexibility
analysis (5 U.S.C. 604). The following analysis, in conjunction with
the remainder of the preamble, constitutes our final regulatory
flexibility analysis.
One requirement of the Regulatory Flexibility Act is a succinct
statement of any objectives of the rule. As stated previously in the
preamble, with this rule, we intend to amend the yogurt standard of
identity and revoke the lowfat yogurt and nonfat yogurt standards of
identity to promote honesty and fair dealing in the interest of
consumers. The amendments are intended to modernize the current yogurt
standard and allow for lowfat yogurt and nonfat yogurt to be covered
under the general definition and standard to permit flexibility and
provide for technological advances in yogurt production, while
preserving the basic nature and essential characteristics of yogurt,
lowfat yogurt, and nonfat yogurt consistent with consumer expectations
and protecting consumer interests.
This rule would affect yogurt manufacturing firms in the Standard
Industrial Classification (SIC) code 20260208 (``Yogurt
Manufacturing''). The equivalent North American Industry Classification
System (NAICS) code is 311511 (``Fluid Milk Manufacturing''). The Small
Business Administration (SBA) defines a small business in NAICS code
311511 as a business with 500 or fewer employees. This rule will not
affect firms that manufacture products such as frozen yogurt, dried
yogurt-style mixes, or products that contain yogurt as an ingredient.
We searched the Dun and Bradstreet database for U.S. firms in SIC
code 20260208 (``Yogurt Manufacturing'') and identified 450 firms. To
exclude firms not engaged in the manufacture of yogurt, we performed an
internet search of the name of each firm and identified frozen yogurt
manufacturers. After excluding frozen yogurt manufacturers, we estimate
that there are approximately 31 U.S. yogurt manufacturers, of which
approximately 9, or 29 percent (= 31 x 0.29), are small businesses per
SBA definition.
We expect that three provisions of the final rule may require some
small firms to change their current activity. The other provisions of
the final rule provide additional flexibility to firms beyond that
available under current requirements. For this analysis, we estimate
costs for those provisions that may require some small firms to change

[[Page 31133]]

their current practices. We do not estimate costs for changing
manufacturing practices in ways that would be newly permitted by the
final rule as costs of the final rule.
The three provisions that we estimate will require some small firms
to change their current practices are:
1. The requirement 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 (``Acidity Requirement'').
2. The requirement that yogurt bearing optional labeling statements
such as ``contains live and active cultures'' must contain a minimum of
10\7\ CFU/g of live and active cultures at the time of manufacture with
a reasonable expectation that the yogurt will contain live and active
cultures at a level of 10\6\ CFU/g through the manufacturer's assigned
shelf life of the product, as well as the requirement that yogurt that
is treated after culturing bear on its label the statement ``does not
contain live and active cultures'' (``Claims Requirements'').
3. The revocation of the standards of identity for lowfat yogurt
(Sec. 131.203) and nonfat yogurt (Sec. 131.206) (``Standards of
Identity Revocation'').
The following analysis estimates the costs of each provision to
small manufacturers.
1. The Acidity Requirement
The final rule requires 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. We stated that we believed that all or nearly all
yogurt currently on the market had a titratable acidity above the then-
proposed minimum cutoff of 0.7 percent, usually in the range of 1.0 to
1.3 percent, and a pH level below the proposed maximum level of 4.6,
usually ranging from 4.1 to 4.3. At the time, we estimated that the
proposed acidity requirements would generate minimal or no compliance
costs. We received no comments on this.
In the final rule, we require 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. We still believe that all or nearly all yogurt
currently on the market has a titratable acidity above the minimum
cutoff of 0.7 percent titratable acidity, usually ranging from 1.0 to
1.3 percent, and a pH level below the proposed maximum level of 4.6,
usually ranging from 4.1 to 4.3. We estimate that the Acidity
Requirement would generate minimal or no compliance costs.
2. The Claims Requirements
Yogurt manufacturers who want to include the optional statement
``contains live and active cultures'' or similar claims on labels will
be required to show that their yogurt contains at least 10\7\ CFU/g of
live and active cultures at the time of manufacture of the yogurt using
analytical testing methods. Otherwise, such a claim cannot be made. In
addition, yogurt products that are treated to inactivate viable
microorganisms after culturing but do not currently bear the claim
``does not contain live and active cultures'' will be required to add
this claim to labels. This was modified for clarity as the proposed
rule would require yogurt products that are heat-treated after
culturing to bear the claim ``heat-treated after culturing'' on their
label and it would advise, but not require, that such yogurt products
also bear the claim ``does not contain live and active cultures'' on
their label.
Based on an analysis of yogurt UPCs using the online grocery
shopping platform Peapod[supreg], approximately 85 percent of yogurt
UPCs currently make a ``contains live and active cultures'' or similar
claim. Approximately 15 percent of yogurt UPCs make no such claims. We
estimate that approximately 1,972 UPCs manufactured by small yogurt
manufacturers, or equivalently 8 small yogurt manufacturers, will be
affected by the Claims Requirement related to the ``contains live and
active cultures'' or similar claim (``Claims Requirement A'') and
approximately 348 UPCs manufactured by small yogurt manufacturers, or
equivalently 1 small yogurt manufacturer, will be affected by the
Claims Requirement related to the ``does not contain live and active
cultures'' claim (``Claims Requirement B'').
Based on further analysis of yogurt UPCs using Peapod[supreg], 56
percent of yogurt UPCs that make a ``contains live and active
cultures'' or similar claim also make a claim that they meet the NYA
standard for live and active cultures. The NYA's standard of at least
10\8\ CFU/g at the time of manufacture is higher than our standard of
at least 10\7\ CFU/g. We estimate that approximately 1,105 of the 1,972
UPCs that are affected by Claims Requirement A and are manufactured by
small yogurt manufacturers will only need to incur analytical testing
costs related to this Claims Requirement.
We do not know how many of the remaining 868 small manufacturer
yogurt UPCs that are affected by Claims Requirement A meet this Claims
Requirement. Therefore, we conservatively estimate that none do, so
that some of these UPCs will need to incur analytical testing costs and
reformulation costs to prove that they meet the 10\7\ live and active
cultures standard. Others will need to incur relabeling costs
associated with removing the ``contains live and active cultures'' or
similar claims from labels. As we are not aware of data on these
proportions, we estimate an even split between these possibilities,
with approximately 434 UPCs incurring analytical testing and
reformulation costs and approximately 434 UPCs incurring relabeling
costs. Finally, we do not know how many of the 348 small manufacturer
yogurt UPCs that do not make any kind of a ``contains live and active
cultures'' or similar claim undergo heat treatment after culturing and
would be subject to Claims Requirement B. Therefore, we conservatively
estimate that all undergo heat treatment after culturing and estimate
the relabeling costs associated with adding the phrase ``does not
contain live and active cultures'' to their labels.
We estimate analytical testing costs using information on formula
and UPC counts from 2014 Nielsen Scantrack data, as well as information
gathered on published prices from various testing laboratories. This
information was gathered by RTI International as part of its
development of the FDA Labeling Cost Model. We estimate that the total
number of yogurt formulas is approximately 6,070 and the total number
of yogurt UPCs is approximately 8,002, yielding a formula-to-UPC ratio
of 0.759 (6,070/8,002 = 0.759). The total number of UPCs that will
require analytical testing is approximately 1,539 and the total number
of formulas subject to analytical testing is approximately 1,167.
Analytical tests designed to detect pathogens in food cost between
$25.72 and $60.81 in 2019 dollars per formula. These costs represent an
estimate of the costs of measuring the amount of CFU/g in yogurt. We
estimate that two samples per formula are tested and that labor costs
to prepare samples are approximately $29.58 and shipping costs related
to shipping the samples to the testing laboratory are approximately
$70.81 in 2019 dollars. Therefore, we estimate analytical testing costs
to be between approximately $177,206 and $259,105 per year.
The number of small yogurt UPCs that will reformulate related to
Claims Requirement A is approximately 434 and the total number of
formulas subject to reformulation is approximately 329. We estimated
reformulation costs by

[[Page 31134]]

multiplying the number of formulas by estimates of per-formula costs.
We obtain per-formula cost estimates from the FDA Reformulation Cost
Model (Ref. 22), which allows the incorporation of a variety of
potential reformulation costs associated with idea generation, product
research and process development, coordinating activities, product
testing, packaging development, market testing, and production/
manufacturing. We estimate that the addition of live and active
cultures to yogurt batches represents a critical minor ingredient with
functional effects, yielding per-formula reformulation costs ranging
from approximately $28,530 to $289,845 in 2019 USD. We estimate that
some manufacturers will be able to coordinate a required reformulation
with a scheduled reformulation, resulting in lower reformulation costs
than if they were unable to coordinate. However, the extent to which
manufacturers can undertake such coordination depends on the compliance
period. For a 24-month compliance period, we estimate that 20 percent
of reformulations can be coordinated with a scheduled reformulation.
Combining this information, we estimate one-time reformulation costs
related to the Claims Requirement to be between approximately $7.5
million and $76.3 million in 2019 dollars. Annualized over 10 years and
discounted at 3 percent, reformulation costs range from approximately
$855.1 thousand to $8.7 million per year in 2019 dollars. Annualized
over 10 years at 7 percent, reformulation costs range from
approximately $1.0 million to $10.2 million per year.
We previously estimated that 434 small yogurt UPCs will undergo
relabeling related to removing their ``contains live and active
cultures'' or similar claims and 348 small yogurt UPCs will relabel
related to the addition of the phrase ``does not contain live and
active cultures'' to their label, for a total of 782 small yogurt UPCs
affected by relabeling under the Claims Requirement. We estimate the
one-time cost of changing all yogurt labels using the FDA Labeling Cost
Model. The removal and addition of claims is a major label change.
Using the Labeling Cost Model and using a 24-month compliance period,
the estimated one-time labeling cost lies between approximately $4.9
million and $12.4 million in 2019 dollars. Annualized over 10 years at
3 percent, relabeling costs range from approximately $558.3 thousand to
$1.5 million per year. Annualized over 10 years at 7 percent,
relabeling costs range from approximately $633.7 thousand to $1.7
million per year.
In total, for a 24-month compliance period, we estimate that the
Claims Requirement would cost small yogurt manufacturers between
approximately $1.6 million and $10.4 million per year in 2019 dollars,
or between $0.2 million and $1.2 million per small yogurt manufacturer
per year, discounted at 3 percent. We estimate that costs are between
approximately $1.8 million and $12.1 million per year in 2019 dollars,
discounted at 7 percent. Costs per small yogurt manufacturer are
between approximately $0.2 million and $1.3 million per year. These
estimates are summarized in table 1.

Table 1--Annual Costs to Small Firms of the Claims Requirement
[Millions 2017$]
----------------------------------------------------------------------------------------------------------------
Discount rate
(%) Low ($) High ($)
----------------------------------------------------------------------------------------------------------------
Annual Analytical Testing Costs................................. .............. $0.2 $0.3
Annual Reformulation Costs...................................... 3 0.9 8.7
7 1.0 10.2
Annual Labeling Costs........................................... 3 0.6 1.5
7 0.6 1.7
Annual Costs.................................................... 3 1.6 10.4
7 1.8 12.1
Annual Costs Per Small Firm..................................... 3 0.2 1.2
7 0.2 1.3
----------------------------------------------------------------------------------------------------------------
Notes: 24-month compliance period. One-time reformulation and labeling costs are annualized over 10 years.

3. The Standards of Identity Revocation for Lowfat Yogurt and Nonfat
Yogurt
We are revoking the standards of identity for lowfat yogurt (Sec.
131.203) and nonfat yogurt (Sec. 131.206). The revocation will result
in lowfat yogurt and nonfat yogurt being covered under the general
definition and standard of identity in Sec. 130.10. Section 130.10
sets out requirements for foods that substitute for a standardized food
but that deviate from the standard due to compliance with an expressed
nutrient content claim defined by FDA regulation.
Under Sec. 131.203 and Sec. 131.206, lowfat yogurt must contain
not less than 0.5 percent milkfat nor more than 2 percent milkfat, and
nonfat yogurt must contain less than 0.5 percent milkfat. If the fat
content of yogurt is modified to meet the expressed nutrient content
claims, ``low fat'' and ``no fat'' in Sec. 101.62(b), lowfat yogurt
must contain less than or equal to 3 grams of fat per RACC, and nonfat
yogurt must contain less than 0.5 grams per RACC. The RACC for yogurt
is 170 grams. In other words, when yogurt is modified to comply with
the expressed nutrient content claims ``low fat'' and ``no fat,'' the
resultant products are standardized foods under Sec. 130.10, and as
such, ``lowfat yogurt'' must contain less than or equal to 1.76 percent
(= 3g/170g) milkfat and ``nonfat yogurt'' must contain less than 0.29
percent (= 0.5g/170g) milkfat. As acknowledged by comments we received,
once this final rule is in effect, some lowfat yogurt and nonfat yogurt
products that currently meet the milkfat content requirements in
Sec. Sec. 131.203 and 131.206 will have to be reformulated to meet the
fat content requirements for ``low fat'' and ``no fat'' under Sec.
101.62(b). For example, a lowfat yogurt product with 2 percent milkfat
will need to be reformulated to contain no more than 1.33 percent
milkfat to comply with Sec. 101.62(b) and be covered as a standardized
food under Sec. 130.10.
To estimate the percentage of lowfat yogurt and nonfat yogurt
products affected by the Standards of Identity Revocation, we use data
from the USDA's National Nutrient Database for Standard Reference (Ref.
2). We estimate that approximately 21 percent of lowfat yogurts and 19
percent of nonfat yogurts are affected by the Standards of Identity
Revocation and will need to reformulate to reduce the fat content of
their yogurts to meet the 1.76 percent and 0.29

[[Page 31135]]

percent thresholds. We estimate that there are approximately nine small
yogurt manufacturers. Using data from the International Dairy Foods
Association, we estimate that 52 percent of yogurt sales are of lowfat
yogurt and 43 percent are of nonfat yogurt. We estimate that the number
of small lowfat yogurt manufacturers affected by the Standards of
Identity Revocation is approximately one and the number of small nonfat
yogurt manufacturers affected by the Standards of Identity Revocation
is approximately one. We estimate that there are 8,002 yogurt UPCs and
that small yogurt manufacturers comprise roughly 29 percent of all
yogurt manufacturers. We estimate that the number of small lowfat
yogurt and nonfat yogurt manufacturer UPCs affected by the Standards of
Identity Revocation are approximately 350 and approximately 200,
respectively, for a total of 550 UPCs.
We estimate reformulation costs using the FDA Reformulation Cost
Model (Ref. 22). Using the yogurt formula-to-UPC ratio of 0.759, we
estimate that the total number of small yogurt manufacturer formulas
subject to reformulation is approximately 417. We estimate
reformulation costs by multiplying the estimated number of formulas by
estimates of per-formula costs obtained from the FDA Reformulation Cost
Model. We estimate that yogurt manufacturers that need to reduce the
fat content of their yogurt will substitute lower fat milk for higher
fat milk in the production process and that this is a critical minor
ingredient with functional effects, yielding per-formula reformulation
costs ranging from approximately $28,530 to $289,845 in 2019 dollars.
For a 24-month compliance period, we estimate one-time reformulation
costs related to the Standards of Identity Revocation to be between
approximately $11.9 million and $120.9 million in 2019 dollars.
Annualized over 10 years at 3 percent, reformulation costs range from
approximately $1.4 million to $13.8 million per year. Annualized over
10 years at 7 percent, reformulation costs range from approximately
$1.6 million to $16.1 million per year.
Because small yogurt manufacturers must change the fat content of
their lowfat yogurt and nonfat yogurt, they also must change the amount
of fat declared on the Nutrition Facts Label. Using the FDA Labeling
Cost Model, we estimate the one-time cost of this minor label change to
be between approximately $1.4 million and $4.1 million in 2019 dollars
for small yogurt manufacturers. Annualized over 10 years, labeling
costs for small yogurt manufacturers are estimated to be between
approximately $161.3 thousand and $471.4 thousand per year, discounted
at 3 percent. Labeling costs for small yogurt manufacturers are
estimated to be between approximately $188.6 thousand and $551.1
thousand per year, discounted at 7 percent.
In total, for a 24-month compliance period, we estimate that
revoking the standards of identity for lowfat yogurt and nonfat yogurt
would cost small yogurt manufacturers between approximately $1.4
million and $13.8 million per year in 2019 dollars, or between
approximately $1.6 million and $16.1 million per small yogurt
manufacturer per year, discounted at 3 percent. Discounted at 7
percent, we estimate that costs are between approximately $1.8 million
and $16.6 million per year. Per small yogurt manufacturer range between
approximately $1.5 million and $16.9 million per year. These estimates
are summarized in table 2.

Table 2--Annual Costs to Small Firms of Standards of Identity Revocation
[Millions 2019$]
----------------------------------------------------------------------------------------------------------------
Discount rate
(%) Low ($) High ($)
----------------------------------------------------------------------------------------------------------------
Annual Reformulation Costs...................................... 3 $1.4 $13.8
7 1.6 16.1
Annual Labeling Costs........................................... 3 0.2 0.5
7 0.2 0.6
Annual Costs.................................................... 3 1.5 14.2
7 1.8 16.6
Annual Costs Per Small Firm..................................... 3 1.5 14.5
7 1.8 16.9
----------------------------------------------------------------------------------------------------------------
Notes: 24-month compliance period. One-time reformulation and labeling costs are annualized over 10 years.

4. Summary of Costs
The total cost of the final rule to small yogurt manufacturers for
a 24-month compliance period is approximately $3.7 million to $25.1
million per year in 2019 dollars, discounted at 3 percent. Discounted
at 7 percent, estimated annual total costs are between approximately
$4.2 million and $29.2 million. On a per firm per year basis, estimated
costs are between approximately $0.4 million and $2.8 million per small
yogurt manufacturer per year in 2019 dollars, discounted at 3 percent.
Discounted at 7 percent, estimated annual total costs are between
approximately $0.5 million and $3.2 million per small yogurt
manufacturer. These estimates are summarized in table 3.

Table 3--Annual Costs to Small Firms of Final Yogurt Rule
[Millions 2019$]
----------------------------------------------------------------------------------------------------------------
Discount rate
(%) Low ($) High ($)
----------------------------------------------------------------------------------------------------------------
Annual Cost of Claims Requirements.............................. 3 $1.6 $10.4
7 1.8 12.1
Annual Cost of Standards of Identity Revocation................. 3 1.5 14.2
7 1.8 16.6
Annual Cost of Final Yogurt Rule................................ 3 3.1 24.6
7 3.6 28.8

[[Page 31136]]

Annual Cost of Final Yogurt Rule Per Small Firm................. 3 0.3 2.7
7 0.4 3.2
----------------------------------------------------------------------------------------------------------------
Notes: 24-month compliance period.

5. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4)
(section 202(a)) requires us to prepare a written statement, which
includes an assessment of anticipated costs and benefits, before
proposing ``any rule that includes any Federal mandate that may result
in the expenditure by State, local, and tribal governments, in the
aggregate, or by the private sector, of $100,000,000 or more (adjusted
annually for inflation) in any one year.'' The current threshold after
adjustment for inflation is $158 million, using the most current (2020)
Implicit Price Deflator for the Gross Domestic Product. We do not
expect this rule to result in any 1-year expenditure that will meet or
exceed this amount.
We estimate that the annual costs of the final rule to small yogurt
manufacturers will be between approximately $3.1 million to $24.6
million, discounted at 3 percent in 2019 dollars. At a 7 percent
discount rate, we estimate that the annual costs of the final rule will
be between $3.6 and $28.8 million. Based on our analysis, we do not
expect the final rule to reach the current UMRA threshold of $158
million. We also do not expect the estimated costs of the rule to be
disproportionately incurred by any State, local, or tribal government.
The full analysis of economic impacts is available in the docket
for this final rule and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VI. Federalism

We have analyzed the final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive Order
requires agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.''
Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express
preemption provision. Section 403A(a) of the FD&C Act provides that:
``* * * no State or political subdivision of a State may directly or
indirectly establish under any authority or continue in effect as to
any food in interstate commerce--(1) any requirement for a food which
is the subject of a standard of identity established under section 401
that is not identical to such standard of identity or that is not
identical to the requirement of section 403(g). * * *''
The final rule makes changes to the standards of identity for
yogurt, lowfat yogurt, and nonfat yogurt. The final rule has preemptive
effect under section 403A(a)(1) of the FD&C Act in that it precludes
States from issuing any requirements for yogurt that are not identical
to the requirements of the final rule. Section 403A(a)(1) of the FD&C
Act displaces both State legislative requirements and State common law
duties (Riegel v. Medtronic, 128 S. Ct. 999 (2008)). In addition, as
with any Federal requirement, if a State law requirement makes
compliance with both Federal law and State law impossible, or would
frustrate Federal objectives, the State requirement would be preempted.
See Geier v. American Honda Co., 529 U.S. 861 (2000); English v.
General Electric Co., 496 U.S. 72, 79 (1990); Florida Lime & Avocado
Growers, Inc., 373 U.S. 132, 142-43 (1963); Hines v. Davidowitz, 312
U.S. 52, 67 (1941).

VII. Analysis of Environmental Impact

We have determined under 21 CFR 25.32(a) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

The final rule contains no collection of information. Therefore,
clearance by Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

IX. Consultation and Coordination With Indian Tribal Governments

We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.

X. Objections

This rule is effective as shown in the DATES section, except as to
any provisions that may be stayed by the filing of proper objections.
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Dockets Management Staff (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object, and
the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
Any objections received in response to the regulation may be seen
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov. We will

[[Page 31137]]

publish notice of the objections that we have received or lack thereof
in the Federal Register.

XI. References

The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction, or they are available as published articles and books.
Please contact either person identified in the FOR FURTHER INFORMATION
CONTACT section to schedule a date to inspect references without
asterisks. Some may be available at the website address, if listed. 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. FDA Office for Policy & Planning to the Division of Dockets
Management Memorandum, ``Extension of Comment Period on Docket No.
FDA-2000-P-0126 (Formerly Docket No. 2000P-0685) (Milk and Cream
Products and Yogurt Products; Proposal to Revoke the Standards for
Lowfat Yogurt and Nonfat Yogurt and to Amend the Standard for
Yogurt),'' March 31, 2009. Document ID: FDA-2000-P-0126-0070.
2. *United States Department of Agriculture, Agricultural Research
Service, FoodData Central, 2020, available at: https://fdc.nal.usda.gov/.
3. Routray, W. and H.N. Mishra, ``Scientific and Technical Aspects
of Yogurt Aroma and Taste: A Review,'' Comprehensive Reviews in Food
Science and Food Safety, 10(4): 208-220, 2011.
4. Cheng, H., ``Volatile Flavor Compounds in Yogurt: A Review,''
Critical Reviews in Food Science and Nutrition, 50:938-950, 2010.
5. *Codex Alimentarius Commission, ``Codex Standard for Fermented
Milks (CODEX STAN 243-2003),'' In Milk and Milk Products, Second
edition, (2011), available at: http://www.fao.org/3/i2085e/i2085e00.pdf.
6. *FDA Memorandum, ``Live and Active Culture Survey Submitted by
the National Yogurt Association Consumer Studies Comment on Survey
Report,'' 2009b.
7. Dave, R.I. and N.P. Shah, ``Viability of Yoghurt and Probiotic
Bacteria in Yoghurts Made From Commercial Starter Cultures,''
International Dairy Journal, 7:31-41, 1997.
8. Ibrahim, S.A. and J.P. Carr, ``Viability of Bifidobacteria in
Commercial Yogurt Products in North Carolina During Refrigerated
Storage,'' International Journal of Dairy Technology, 59:272-277,
2006.
9. Rosburg, V., T. Boylston, and P. White, ``Viability of
Bifidobacteria Strains in Yogurt With Added Oat Beta-Glucan and Corn
Starch During Cold Storage,'' Journal of Food Science, 75:C439-C444,
2010.
10. *United States Government Accountability Office (GAO), ``GAO-01-
326, Dairy Products: Imports, Domestic Production, and Regulation of
Ultra-Filtered Milk,'' 2001.
11. *FDA, GRAS Notice No. GRN 000504 to American Dairy Products
Institute and U.S. Dairy Export Council, November 21, 2014.
12. Boer, Ruud de. (2014). Chapter 6: Vital Membrane Processes. From
Milk By-Products to Milk Ingredients--Upgrading the Cycle. John
Wiley & Sons.
13. *FDA, ``Bacteriological Analytical Manual (BAM), Chapter 3.
Aerobic Plate Count,'' 2001; available at: https://www.fda.gov/food/laboratory-methods-food/bam-chapter-3-aerobic-plate-count.
14. International Organization for Standardization (ISO) and
International Dairy Federation (IDF), ``International Standard. ISO
7889/IDF 117:2003. Yogurt--Enumeration of Characteristic
Microorganisms--Colony-Count Technique at 37 [deg]C,'' 2003.
15. Duncan, S.E., B.R. Yaun, and S.S. Sumner, ``Microbiological
Methods for Dairy Products, Method 9.080. Yogurt and Other Fermented
Milk Products,'' In: Standard Methods for the Examination of Dairy
Products, edited by H.M. Wehr and J.F. Frank, 17th Ed., Washington,
DC, Chapter 9, pp. 261-263, American Public Health Association,
2004.
16. Lerebours, E., C. N'Djitoyap Ndam, A. Lavoine, et al., ``Yogurt
and Fermented-Then-Pasteurized Milk: Effects of Short-Term and Long-
Term Ingestion on Lactose Absorption and Mucosal Lactase Activity in
Lactase-Deficient Subjects,'' American Journal of Clinical
Nutrition, 49:823-827, 1989.
17. Marteau, P., B. Flourie, P. Pochart, C. et al., ``Effect of the
Microbial Lactase (EC 3.2.1.23) Activity in Yoghurt on the
Intestinal Absorption of Lactose: An in Vivo Study in Lactase-
Deficient Humans,'' British Journal of Nutrition, 64:71-79, 1990.
18. Ouwehand, A.C. and S.J. Salminen, ``The Health Effects of
Cultured Milk Products With Viable and Non-Viable Bacteria,''
International Dairy Journal, 8:749-758, 1998.
19. Shermak, M.A., J.M. Saavedra, T.L. Jackson, et al., ``Effect of
Yogurt on Symptoms and Kinetics of Hydrogen Production in Lactose-
Malabsorbing Children,'' American Journal of Clinical Nutrition,
62:1003-1006, 1995.
20. Varela-Moreiras, G., J. M. Antoine, B. Ruiz-Roso, et al.,
``Effects of Yogurt and Fermented-Then-Pasteurized Milk on Lactose
Absorption in an Institutionalized Elderly Group,'' Journal of the
American College of Nutrition, 11:168-171, 1992.
21. *FDA Memorandum, Juan, WenYen, ``Documentation for the Analysis
of Lowfat and Nonfat Yogurts Consumption and Contribution of Vitamin
A Over Time in the U.S. Population,'' 2021.
22. White, W.J., Gledhill, E., Karns, S., et al. (2002). Cost of
Reformulating Foods and Cosmetics (FDA Labeling Cost Model).
Research Triangle Park: RTI.

List of Subjects

21 CFR Part 130

Food additives, Food grades and standards.

21 CFR Part 131

Cream, Food grades and standards, Incorporation by reference, Milk,
Yogurt.

Therefore, 21 CFR parts 130 and 131 are amended as follows:

PART 130--FOOD STANDARDS: GENERAL

0
1. The authority citation for part 130 continues to read as follows:

Authority: 21 U.S.C. 321, 336, 341, 343, 371.

0
2. In Sec. 130.10, revise paragraph (b) to read as follows:

Sec. 130.10 Requirements for foods named by use of a nutrient content
claim and a standardized term.

* * * * *
(b) Nutrient addition. (1) Nutrients shall be added to the food to
restore nutrient levels so that the product is not nutritionally
inferior, as defined in Sec. 101.3(e)(4) of this chapter, to the
standardized food as defined in parts 131 through 169 of this chapter.
The addition of nutrients shall be reflected in the ingredient
statement.
(2) Yogurt containing less than 3.25 percent milkfat is exempt from
compliance with paragraph (b)(1) of this section with respect to
vitamin A fortification provided the product complies with all other
requirements.
* * * * *

PART 131--MILK AND CREAM

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

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

0
4. Revise Sec. 131.200 to read as follows:

Sec. 131.200 Yogurt.

(a) Description. Yogurt is the food produced by culturing one or
more of the basic dairy ingredients specified in paragraph (b) of this
section and any of the optional dairy ingredients specified in
paragraph (c) of this section with a characterizing bacterial culture
that contains the lactic acid-producing bacteria, Lactobacillus
delbrueckii

[[Page 31138]]

subsp. bulgaricus and Streptococcus thermophilus. The ingredients
specified in paragraphs (b) and (c) of this section may be homogenized
and must be pasteurized or ultra-pasteurized before the addition of the
characterizing bacterial culture. One or more of the other optional
ingredients specified in paragraph (d) of this section may also be
added. Yogurt, before the addition of bulky flavoring ingredients,
contains not less than 3.25 percent milkfat and not less than 8.25
percent milk solids not fat and has either a titratable acidity of not
less than 0.7 percent, expressed as lactic acid, or a pH of 4.6 or
lower. To extend the shelf life of the food, yogurt may be treated
after culturing to inactivate viable microorganisms.
(b) Basic dairy ingredients. Cream, milk, partially skimmed milk,
skim milk, or the reconstituted versions of these ingredients may be
used alone or in combination.
(c) Optional dairy ingredients. Other safe and suitable milk-
derived ingredients may be used to increase the milk solids not fat
content of the food above the minimum of 8.25 percent required in
paragraph (a) of this section, provided that the ratio of protein to
total nonfat solids of the food, and the protein efficiency ratio of
all protein present must not be decreased as a result of adding such
ingredients.
(d) Other optional ingredients. The following safe and suitable
ingredients may be used:
(1) Cultures, in addition to the characterizing bacterial culture
specified in paragraph (a) of this section.
(2) Nutritive carbohydrate sweeteners.
(3) Flavoring ingredients.
(4) Color additives.
(5) Stabilizers.
(6) Emulsifiers.
(7) Preservatives.
(8) Vitamin addition (optional).
(i) If added, vitamin A must be present in such quantity that the
food contains not less than 10 percent Daily Value per Reference Amount
Commonly Consumed (RACC) thereof, within limits of current good
manufacturing practice.
(ii) If added, vitamin D must be present in such quantity that the
food contains not less than 25 percent Daily Value per Reference Amount
Commonly Consumed (RACC) thereof, within limits of current good
manufacturing practices.
(e) Methods of analysis--(1) Milk--(i) Milkfat content. As
determined by the method prescribed in section 33.2.26, AOAC Official
Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction Method.
(ii) Milk solids not fat. Calculated by subtracting the milkfat
content from the total solids content using the method prescribed in
section 33.2.45, AOAC Official Method 990.21, Solids-Not-Fat in Milk by
Difference between Total Solids and Fat Contents.
(iii) Titratable acidity. As determined by the method prescribed in
section 33.2.06, AOAC Official Method 947.05, Acidity of Milk
Titrimetric Method.
(2) pH. As determined by the potentiometric method described in
Sec. 114.90(a) of this chapter.
(3) Live and active cultures. As determined by the method described
in ISO 7889:2003(E)/IDF 117:2003(E), Yogurt--Enumeration of
Characteristic Microorganisms--Colony-Count Technique at 37 [deg]C.
(f) Nomenclature. The name of the food is ``yogurt.'' The name of
the food must be accompanied by a declaration indicating the presence
of any characterizing flavoring as specified in Sec. 101.22 of this
chapter.
(1) The following term(s) must accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half of the height of the letters
used in such name:
(i) The word ``sweetened'' if a nutritive carbohydrate sweetener is
added without the addition of characterizing flavor.
(ii) The phrase ``does not contain live and active cultures'' if
the dairy ingredients have been treated after culturing to inactivate
viable microorganisms.
(iii) The phrase ``vitamin A'' or ``vitamin A added'', or ``vitamin
D'' or ``vitamin D added'', or ``vitamins A and D added'', as
appropriate. The word ``vitamin'' may be abbreviated ``vit''.
(2) The name of the food may be accompanied by the phrase
``contains live and active cultures'' or another appropriate descriptor
if the food contains a minimum level of live and active cultures of
10\7\ colony forming units per gram (CFU/g) at the time of manufacture
with a reasonable expectation of 10\6\ CFU/g through the manufacturer's
assigned shelf life of the product.
(3) The term ``homogenized'' may appear on the label if the dairy
ingredients used are homogenized.
(g) Label declaration. Each of the ingredients used in the food
must be declared on the label as required by the applicable sections of
parts 101 and 130 of this chapter.
(h) Incorporation by reference. The standards required in this
section are incorporated by reference into this section with the
approval of the Director of the Federal Register under 5 U.S.C. 552(a)
and 1 CFR part 51. To enforce any edition other than that specified in
this section, FDA must publish a document in the Federal Register, and
the material must be available to the public. All approved material is
available for inspection at the Food and Drug Administration's Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500, and is available from the sources indicated in this
paragraph (h). It is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, email [email protected] or
go to www.archives.gov/federal-register/cfr/ibr-locations.html.
(1) AOAC INTERNATIONAL, 2275 Research Blvd., Suite 300, Rockville,
MD 20850-3250:
(i) AOAC Official Method 947.05, Acidity of Milk Titrimetric
Method, Section 33.2.06, Official Methods of Analysis, 21st edition,
2019, Vol. 1.
(ii) AOAC Official Method 989.05, Fat in Milk Modified Mojonnier
Ether Extraction Method, Section 33.2.26, Official Methods of Analysis,
21st edition, 2019, Vol. 1.
(iii) AOAC Official Method 990.21, Solids-Not-Fat in Milk by
Difference between Total Solids and Fat Contents, Section 33.2.45,
Official Methods of Analysis, 21st edition, 2019, Vol. 1.
(2) ISO, ISO Central Secretariat, Chemin de Blandonnet 8, CP 401,
1214 Vernier, Geneva, Switzerland.
(i) ISO 7889:2003(E), Yogurt--Enumeration of Characteristic
Microorganisms--Colony-Count Technique at 37 [deg]C, First edition,
2003-02-01.
(ii) [RESERVED]

Note 1 to paragraph (h)(2)(i): ISO 7889:2003(E) is co-published
as IDF 117:2003(E).

Sec. 131.203 [Removed]

0
5. Remove Sec. 131.203.

Sec. 131.206 [Removed]

0
6. Remove Sec. 131.206.

Dated: June 2, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
Dated: June 7, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-12220 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P