Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations 31117 

■ c. Adding ‘‘For the period (MMDDYY) 

from 

and ‘‘Number of months included in 

this statement 

in the ‘‘Statement of Income (Loss) or 

Statement of Comprehensive Income, As 

Applicable’’ section in a new line 

immediately preceding the line reading 

‘‘REVENUE’’. 

■ d. Removing ‘‘B. Additions (including 

non-conforming capital of $ 

and adding in its place ‘‘B. Additions 

(including non-conforming capital of $ 

■ e. Removing ‘‘(k)(1)—$2,500 capital 

category as per Rule 15c3–3’’ and 

adding in its place ‘‘(k)(1)—Limited 

business (mutual funds and/or variable 

annuities only)’’ in the ‘‘Claiming an 

Exemption from Rule 15c3–3’’ section. 

■ f. Removing ‘‘3. Other accrued 

withdrawals’’ and adding in its place 

‘‘3. Other anticipated withdrawals’’ in 

the ‘‘Other Capital Withdrawals— 

Recap’’ section. 

■ g. In the ‘‘Computation of CFTC 

Minimum Capital Requirements’’ 

section, removing 

‘‘v. Enter the sum of Lines A.ii and 

A.iv..... lll 

and adding in its place: 

‘‘v. Amount of uncleared swap 

margin.....$lll 

vi. If the FCM is also registered as a 

swap dealer, enter 2% of Line 

A.v. . . . . $lll 

vii. Enter the sum of Lines A.ii, A.iv, 

and A.vi.....$lll 

Note: The text of Part IIC of Form 

X–17A–5 does not, and this amendment will 

not, appear in the Code of Federal 

Regulations. 

■ 6. Amend Part IIC of Form X–17A–5 

(referenced in § 249.617 of this chapter) 

by: 

■ a. Removing 

in Lines 13.B., 13.B.1. and 13.B.2. of the 

Balance Sheet section and adding in its 

place 

respectively. 

b. Removing 

in Lines 9 and 10 of Column B the 

Regulatory Capital section and adding 

in its place 

respectively. 

Dated: May 27, 2021. 

Vanessa A. Countryman, 

Secretary. 

[FR Doc. 2021–11572 Filed 6–10–21; 8:45 am] 

BILLING CODE 8011–01–P 

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. 

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 


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139321 to __ 139331" 

@263b $ __ 142601" 

@2621) $ 142601". 

174461 

174471 

174551" 

"~200b~', "16631 bl" and "l6636b~' 

"~200bbl", "16631 bij" and '16636bij", 

"l7206bl" and "l7205bl" 

"l7206bij" and "l7205bbl", 
31118 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations 

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 

§ 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 milkderived 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 

(§ 131.203 (21 CFR 131.203)) and nonfat 

yogurt (§ 131.206 (21 CFR 131.206)) and 

amend the standard of identity for 

yogurt (§ 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 


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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations 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 

(§ 131.203) and nonfat yogurt 

(§ 131.206) and amend the standard of 

identity for yogurt (§ 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 (§ 131.200), lowfat yogurt 

(§ 131.203), nonfat yogurt (§ 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 

(§§ 131.200(c)(1), 131.203(c)(1), and 

131.206(c)(1) (redesignated as 

§§ 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 (§§ 131.200(a), 131.203(a), 

and 131.206(a)); (3) provisions that 

excluded the addition of preservatives 

(§§ 131.200(c), 131.203(c), and 

131.206(c) (redesignated as 

§§ 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 

(§§ 131.200(a), 131.203(a), and 

131.206(a)); and (5) § 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 

§ 131.200(c)(1) (redesignated as 

§ 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 


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31120 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations 

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 

§§ 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 

§ 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 § 101.62(b)) and ‘‘light’’ or ‘‘reduced 

calorie’’ (see § 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 

§ 101.62(b)(1) for ‘‘no fat’’ and 

§ 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 § 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 

§ 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 (§ 131.203) 

and nonfat yogurt (§ 131.206) and 

amend the standard of identity for 

yogurt (§ 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 (§ 131.203) 

and nonfat yogurt (§ 131.206) so that 

yogurt (under proposed § 130.200) could 

be modified according to the ‘‘low fat’’ 

and ‘‘no fat’’ nutrient content claim 

definitions in § 101.62(b), thereby 

bringing lowfat yogurt and nonfat yogurt 

within the coverage of § 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 §§ 131.203 

and 131.206. 

We also proposed numerous changes 

to the standard of identity for yogurt in 

§ 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 


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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations 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 (§ 131.200), lowfat 

yogurt (§ 131.203), or nonfat yogurt 

(§ 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 § 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 107

colony forming units per gram (CFU/g) 

of live and active cultures at the time of 

manufacture with a reasonable 

expectation of 106 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 

§ 131.200(a) has the same meaning as 

the phrase ‘‘bulky flavors’’ used in 

§ 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 


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most of the dairy standards, we have 

revised the rule to adopt the term 

‘‘bulky flavoring ingredients.’’ 

(Comment 5) Currently, the stayed 

provisions in §§ 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 

§ 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 

§ 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 § 131.200(a) 

refers to milk fermentation by the 

characterizing cultures (L. delbrueckii, 

subspecies bulgaricus, and S. 

thermophilus), and other cultures as 

described in § 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 § 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 


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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 

§ 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 § 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 

§ 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 107

CFU/g of live and active cultures at the 

time of manufacture but did not support 

the inclusion of ‘‘reasonable expectation 

of 106 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 heattreated, the provisions on fermentation, 

minimum titratable acidity, and 

maximum pH already ensure that the 

bacterial culture is above 107 CFU/g 

after culturing. 

(Response 8) The proposed rule 

specified a minimum level of live and 

active cultures of 107 CFU/g at the time 

of manufacture with a reasonable 

expectation of 106 CFU/g through the 

manufacturer’s assigned shelf life of the 

product. We have included these 

minimum levels in the final rule under 

§ 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 °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 nonheated yogurt, the mixture of S. 

thermophilus and L. bulgaricus is 

typically well above the minimum 106

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 106 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 


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107 CFU/g of live and active cultures at 

the time of manufacture with a 

reasonable expectation of 106 CFU/g 

throughout the manufacturer’s assigned 

shelf life of the product (§ 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 § 131.200(a) and other 

cultures as described in § 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 

§ 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 107 CFU/g of live 

and active cultures at the time of 

manufacture with a reasonable 

expectation of 106 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 § 131.200(a) regarding the 

minimum number of live and active 

microorganisms yogurt may contain, to 

§ 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 nonheat-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) Heattreated 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 § 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 

107 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 § 131.200. For 

example, we expect that an ingredient 

used in a yogurt drink is yogurt made 

in accordance with § 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 

§ 101.4(a) and (b). 

D. Section 131.200(b)—Basic Dairy 

Ingredients 

The proposed rule, at § 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 § 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 

§ 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 


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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 

§ 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 (§ 131.200(c)) lists cream, milk, 

partially skimmed milk, or skim milk as 

the basic dairy ingredients. Proposed 

§ 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 § 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 (§ 131.115) 

and dry whole milk (§ 131.147) are 

appropriate ingredients to reconstitute 

to produce reconstituted milk. Nonfat 

dry milk (§ 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 § 131.200(b), if 

safe and suitable, they can be used in 

yogurt as optional dairy ingredients 

under § 131.200(c). Moreover, limiting 

the basic dairy ingredients to those in 

§ 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 § 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 § 131.200(b). 

E. Section 131.200(c)—Optional Dairy 

Ingredients 

The proposed rule at § 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 § 131.200(a), would specify 

that yogurt is a food produced by 

culturing one or more of the basic dairy 

ingredients (§ 131.200(b)) and any of the 

optional dairy ingredients (§ 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 

§ 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 


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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 (§ 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 (§ 130.3(d)(1)) and be 

used at a level no higher than necessary 

to achieve its intended purpose in that 

food (§ 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 

§ 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 (§ 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 § 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 § 131.200(c) 

in the final rule. 

Although the proposed rule would 

require the minimum of 8.25 percent 

milk solids not fat at § 131.200(a), and 

as discussed in the preamble (74 FR 

2443 at 2448), the proposed rule at 

§ 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 

§ 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 § 131.200(a). 

Additionally, we note that the phrase 

‘‘nonfat solids content’’ in proposed 

§ 131.200(c) would mean the same as 

the phrase ‘‘milk solids not fat’’ in the 

proposed § 131.200(a). Therefore, to be 

consistent in the terms used, we have, 

on our own initiative, revised 

§ 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 postpasteurization 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 


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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 milkderived 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 

(§ 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 § 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 

§ 131.200(d)(1) without change. 

(Comment 18) The proposed rule, at 

§ 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 nonnutritive 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 § 131.200(d)(2) to specify the use 

of ‘‘sweeteners’’ in yogurt rather than 

‘‘nutritive carbohydrate sweeteners.’’ If 

we were to amend § 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 


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making a nutrient content claim. This is 

not what we had intended under the 

regulatory framework of § 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 § 130.10. As such, products 

containing nonnutritive sweeteners, but 

that otherwise comply with the 

requirements in § 131.200, are not the 

standardized food ‘‘yogurt’’ and are 

different standardized foods (e.g., 

‘‘reduced calorie yogurt’’) under 

§ 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 § 101.3. We 

note that this approach is consistent 

with the approach under our current 

regulations as § 130.10 permits 

deviations to §§ 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 

§ 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, § 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 

§ 131.200(d)(2). However, under 

§ 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 § 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 

§ 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 

§ 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 

§ 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 (§ 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 § 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 

§ 131.200(d)(5) and (6), respectively. We 

also have renumbered § 131.200(d)(6) as 

§ 131.200(d)(7). 

(Comment 22) The proposed rule, at 

§ 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 


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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 § 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 § 131.200(d)(7) (see response 21). 

(Comment 23) The proposed rule 

would revoke § 131.200(b), which 

provides for optional addition of 

vitamins A and/or D in yogurt, and 

revoke § 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 § 101.54. We explained in the 

proposed rule that we believed it was 

appropriate to apply the provisions of 

§ 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 

§ 131.200(b) and, if so, what the 

justification for retaining these 

provisions would be, and the 

appropriateness of applying § 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 

§ 131.200, we have placed the 

provisions regarding optional vitamin 

addition in § 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 § 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 § 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 § 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 § 131.200(d), also provides for 

the use of specific functional categories 

of ingredients such as emulsifiers and 

stabilizers. We revised § 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 § 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 § 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 § 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 

§ 131.200(e) to refer to the 21st edition 

of the AOAC Methods. 

The proposed rule inadvertently 

deleted the milkfat method of analysis 

from § 131.200(e). Therefore, on our 

own initiative, we have revised 

§ 131.200(e) by restoring the method of 

analysis for milkfat referencing the 


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updated modified Mojonnier ether 

extraction method in section 33.2.26 of 

the AOAC Methods: Official Method 

989.05. Thus, we have revised 

§ 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 

§ 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 § 131.200(e)(1)(ii) and (iii), 

respectively, because we have restored 

the inadvertent deletion of the method 

of analysis for milkfat at 

§ 131.200(e)(1)(i). 

Proposed § 131.200(e)(2) would adopt 

the potentiometric method for pH as 

described in § 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 § 131.200(e)(2) without 

change. 

(Comment 25) Proposed 

§ 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 °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 § 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 

§ 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 

§ 131.200(d)(2) instead of using the term 

‘‘sweeteners.’’ Likewise, we have 

decided to retain ‘‘nutritive 

carbohydrate sweetener’’ in 

§ 131.200(f)(1)(i) rather than use the 

term ‘‘sweetener.’’ The requirement in 

§ 131.200(f)(1)(i) continues to apply 

only to nutritive carbohydrate 

sweeteners and is not amended under 

this final rule. Under § 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 § 131.200(a), (b), (c), and (d) 

necessitate additional changes in 

§ 131.200(f) regarding nomenclature 

provisions in the final rule. 

(Comment 27) Currently, 

§ 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 § 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 ‘‘heattreated 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 


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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 ‘‘heattreated after culturing’’ when the final 

product does not contain live and active 

cultures. Therefore, we have revised 

§ 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 107

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 107 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 

§ 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 

§ 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 § 131.200 could 

be modified to produce lower-fat 

versions of yogurt under § 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 § 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 § 131.203 

and § 131.206 will result in lowfat 

yogurt and nonfat yogurt being covered 

under the general definition and 

standard of identity in § 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 § 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 

§ 130.10. For foods covered under the 

general definition and standard, 


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§ 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 § 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 § 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 § 130.10(b) would not necessarily 

make these products consistent with 

other modified dairy foods. FDA has not 

enforced § 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 § 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 lowerfat 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 § 130.10(b) to 

exempt lower-fat yogurt products from 

vitamin A fortification. 

This final rule revises § 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 § 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/officialmethods-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)|IDF 

117:2003(E)), Yogurt—Enumeration of 

Characteristic Microorganisms—ColonyCount Technique at 37 °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. 

central@iso.org. ISO 7889|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 × 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 


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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 

107 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 106 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 (§ 131.203) 

and nonfat yogurt (§ 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 107 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 heattreated 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®, 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®, 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 

108 CFU/g at the time of manufacture is 

higher than our standard of at least 107

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 107 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 


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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 performula 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 onetime 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 (§ 131.203) 

and nonfat yogurt (§ 131.206). The 

revocation will result in lowfat yogurt 

and nonfat yogurt being covered under 

the general definition and standard of 

identity in § 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 § 131.203 and § 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 § 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 § 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 §§ 131.203 and 

131.206 will have to be reformulated to 

meet the fat content requirements for 

‘‘low fat’’ and ‘‘no fat’’ under 

§ 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 § 101.62(b) and be covered 

as a standardized food under § 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 


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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 onetime 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 


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31136 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations 

TABLE 3—ANNUAL COSTS TO SMALL FIRMS OF FINAL YOGURT RULE—Continued 

[Millions 2019$] 

Discount rate 

(%) 

Low 

($) 

High 

($) 

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/aboutfda/reports/economic-impact-analysesfda-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 


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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations 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 UltraFiltered 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 ByProducts 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-methodsfood/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 °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 FermentedThen-Pasteurized Milk: Effects of ShortTerm 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 

■ 1. The authority citation for part 130 

continues to read as follows: 

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

371. 

■ 2. In § 130.10, revise paragraph (b) to 

read as follows: 

§ 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 

§ 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 

■ 3. The authority citation for part 131 

continues to read as follows: 

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

371, 379e. 

■ 4. Revise § 131.200 to read as follows: 

§ 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 


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31138 Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations 

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 

§ 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 °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 

§ 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 107 colony forming 

units per gram (CFU/g) at the time of 

manufacture with a reasonable 

expectation of 106 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 fedreg.legal@

nara.gov 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 °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). 

§ 131.203 [Removed] 

■ 5. Remove § 131.203. 

§ 131.206 [Removed] 

■ 6. Remove § 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 


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